We first contacted Laurie Yorke of Clark, NJ last year after we saw her on-line support group for those that have suffered from the side effects of Paxil and other anti-depressants. Three years ago, Laurie almost lost her then 15 year old son, Ryan due to a reaction to a off label use of Paxil. When Ryan started taking Paxil there were no warnings about suicide, aggression or personality changes. After a year on this drug she watched him change into someone she didn’t recognize. He had gone from a social, A student to a lethargic, confrontational, failing student. It was during that time that Ryan attempted to take his own life. Desperate to find out what was happening to her son, Laurie started doing her own research on the Internet…
Archive for Drugs
Consumers Union Documents
- Consumers Union's comments of FDA Reclassification of Metal on Metal Hip Implants Source: Consumers Union (Thursday April 18, 2013)
- Real People, Real Stories: Diane's knee replacement story Source: Consumers Union (Friday March 29, 2013)
Diane of Longmont, CO shared her knee replacement story with Consumers Union. Diane had a terrible experience with her initial knee replacement and is worried about what the future holds.
- Consumer Reports: FDA cracks down on all-metal hip replacements Source: Consumer Reports (Friday January 18, 2013)
Manufacturers who want to keep selling all-metal hips will have to prove that they’re safe and effective, according to proposed new rules from the Food and Drug Administration.
- Consumer Reports: Where high drug costs hide Source: Consumer Reports (Saturday December 1, 2012)
Before filling your prescriptions, beware of these 5 traps
- Consumer Reports: Off-label drug prescribing: What does it mean for you? Source: Consumer Reports (Saturday December 1, 2012)
Doctors often prescribe medication to treat problems the drugs aren’t officially approved for, which can be good—and bad—for patients
- Consumer Reports: Alzheimer's drugs cost a lot, but help just a little Source: Consumer Reports (Saturday December 1, 2012)
More than 5 million people in the U.S. have Alzheimer’s disease, an insidious disorder that gradually destroys the brain, robbing people who have the condition of the ability to remember, complete everyday tasks, and function on their own. Several drugs are approved to treat it, including donepezil (Aricept and generic) and memantine (Namenda). But they don’t work well for most people, according to a new report from Consumer Reports Best Buy Drugs. In fact, it concluded that none of the drugs could be recommended as a Best Buy.
- Consumers Union Comments on the Proposed Rule, "Unique Device Identification System" Source: Consumers Union (Wednesday November 7, 2012)
CU strongly supports the implementation of the unique identifier for medical devices. The adoption of a Unique Device Identification (UDI) System has the potential to improve the safety of devices used by consumers as well as to promote many significant public health objectives. A well-implemented UDI system will help consumers to more easily find information about their implant/device’s safety record and to more precisely report problems that they are experiencing.
- Consumer Reports: What 'extra strength' on a drug label really means Source: Consumer Reports (Thursday November 1, 2012)
Plus other over-the-counter drug labels you might wonder about
- Consumer Reports: Meningitis cases from tainted steroids continue to rise Source: Consumer Reports (Wednesday November 21, 2012)
The outbreak of fungal meningitis due to a contaminated steroid has affected 490 people and caused 34 deaths, according to updated figures released earlier this week from the Centers for Disease Control and Prevention. (Update: As of Nov., 27, the CDC reports the number of people affected has increased to 510 and caused 36 deaths.)
- Consumer Reports: Is it OK to use a compounding pharmacy? (And what is one anyway?) Source: Consumer Reports (Friday November 16, 2012)
Until other much-needed changes occur, you should only use a medication from a compounding pharmacy if no other FDA-approved product is available, say our medical advisers.
- Consumer Reports: Did the storm ruin your drugs? Source: Consumer Reports (Wednesday October 31, 2012)
The ravages of Hurricane Sandy may have ruined your medications. Follow this advice from the Food and Drug Administration to make sure the drugs you take are safe.
- Consumer Reports: What to do after a hurricane if you use a home medical device Source: Consumer Reports (Tuesday October 30, 2012)
If you rely on electricity for home medical equipment like an oxygen tank, ventilator, medical bed, wheel chair, or blood glucose monitor, losing power can be much more than an inconvenience.
- Video: Consumer Reports Health Ratings Center Source: YouTube (Thursday October 18, 2012)
Here’s a look at some of the important work the Health Ratings Center has done since its creation in 2008.
- Consumer Reports Health: A look at the Health Ratings Center Source: Consumer Reports Health (Thursday October 18, 2012)
New video highlights some of Consumer Reports Health Ratings Center’s important accomplishments: assessing hospitals for safety, surgeons for their heart bypass records, and drugs for their effectiveness.
- Consumer Reports: Should you avoid all steroid injections for your back pain? Source: Consumer Reports (Monday October 15, 2012)
The news about fungal meningitis from steroid injections has many back pain sufferers wondering if they should now avoid the shots entirely. Our medical experts say no: The deaths and health problems currently being reported are associated with three batches of the drug made by a single pharmacy.
- Consumer Reports: FDA says one type of generic Wellbutrin XL antidepressant is ineffective Source: Consumer Reports (Friday October 5, 2012)
The Food and Drug Administration reported this week that the 300 mg dose of generic bupropion, sold under the name Budeprion XL and made by Impax Laboratories and Teva Pharmaceuticals is being removed from the market because it doesn’t work as it should.
- Consumer Reports: Death toll from contaminated steroid shots rises Source: Consumer Reports (Thursday October 11, 2012)
The CDC reported Tuesday that eleven deaths and 119 cases of fungal meningitis have now been identified as related to contaminated epidural steroid shots. The number is likely to rise.
- Consumer Reports "Ask the Pharmacist" series Source: Consumer Reports (Friday September 14, 2012)
Consumer Reports’ “Ask the Pharmacist” series
- Consumer Reports: Adults need vaccines, too Source: Consumer Reports (Wednesday August 1, 2012)
The shots are just as important for grownups as they are for kids
- Consumer Reports: How to deal with heartburn Source: Consumer Reports (Wednesday August 1, 2012)
When to treat it on your own and when to get help
- Consumer Reports: FDA warns heartburn drugs might cause severe diarrhea Source: Consumer Reports (Wednesday February 8, 2012)
FDA: Medications called proton pump inhibitors (PPIs) might increase the risk of a type of chronic diarrhea that can lead to severe intestinal problems and, in rare cases, death.
- Consumer Reports: 10 surprising dangers of vitamins and supplements Source: Consumer Reports (Friday August 3, 2012)
Don’t assume they’re safe because they’re ‘all natural’. They may be neither. Here are 10 hazards that we’ve distilled from interviews with experts, published research, and our own analysis of reports of serious adverse events submitted to the Food and Drug Administration, which we obtained through a Freedom of Information Act request. Read and be warned.
- Consumer Reports: Some dietary supplements can pose Olympic-sized problems Source: Consumer Reports (Friday August 3, 2012)
It’s hard for you to know for sure what is in some products marketed as dietary supplements. Read Consumer Reports’ new report, “10 Surprising Dangers of Vitamins and Supplements,” for more details.
- Consumer Reports: More supplements found to be adulterated with drugs Source: Consumer Reports (Thursday August 2, 2012)
Many dietary supplements, especially those that claim to enhance male sexual performance, are spiked with prescription drugs. That’s one of the conclusions of our new report on 10 surprising dangers of vitamins and supplements.
- Consumer Reports: Alzheimer's drugs do little to slow disease, our analysis shows Source: Consumer Reports (Tuesday July 31, 2012)
No currently available Alzheimer’s drug provides much, if any, improvement, and all can cause side effects.
- Consumer Reports: FDA approves weight loss drug Qsymia, but we say skip it Source: Consumer Reports (Wednesday July 18, 2012)
The Food and Drug Administration Tuesday approved Qsymia, a combination of the stimulant phentermine and the anti-seizure drug topiramate extended-release, to help obese and overweight people lose weight. But our medical advisers say the pill should be avoided because it can cause several serious side effects.
- Consumer Reports: Here's how the GlaxoSmithKline $3 billion settlement matters to you Source: Consumer Reports (Tuesday July 3, 2012)
In light of drug manufacturer GlaxoSmithKlein being hit with the largest health-care-fraud settlement in U.S. history, Consumer Reports offers important lessons for anyone who takes prescription drugs.
- Consumer Reports Health News: Sandoz recalls birth control pill Introvale due to incorrect order of tablets Source: Consumer Reports (Thursday June 7, 2012)
Sandoz has recalled 10 lots of its generic oral contraceptive Introvale after package flaws were reported that could leave women at risk for unintended pregnancy.
- Consumer Reports Health News: J&J to stop selling troublesome surgical mesh products Source: Consumer Reports (Thursday June 7, 2012)
A major manufacturer of the transvaginal mesh implants that we warned about in our recent report on unsafe medical devices is voluntarily halting marketing of four of the products.
- Consumer Reports Health News: Watch out for counterfeit ADHD drugs Source: Consumer Reports (Thursday May 31, 2012)
If you bought the drug Adderall online hoping to treat attention deficit hyperactivity disorder you better check to make sure you didn’t receive a counterfeit version. The Food and Drug Administration warned Tuesday that some of the pills sold on the Internet contain the wrong medication.
- Consumer Reports Health News: Loophole in medical device governing statute puts patients at risk Source: Consumer Reports (Monday May 21, 2012)
As the Senate prepares to vote on a bill this week to reauthorize the statute governing medical device oversight, Consumers Union, the advocacy arm of Consumer Reports called attention to a loophole that puts patients at risk.
- Consumer Reports Safety Tips for Generic Drugs Source: Consumer Reports (Friday May 25, 2012)
People taking generic drugs may be confused why one prescription refill may be a different color and shape than your previous one. Consumer Reports gives tips for patients taking generic drugs.
- Consumer Reports May 30, 2012 Op-Ed: Medical Device Loophole Leaves Patients At Risk
Op-ed by James A. Guest President & CEO, Consumer Reports, appeared in both the print and online versions of Roll Call today.
- Medical Device Loophole Leaves Patients At Risk Source: Consumers Union (Monday May 21, 2012)
Consumers Union Responds to Medical Device Industry on Recalled Predicates.
- Consumers Union Medical Device Ad in Politico
Consumers Union, the policy and advocacy arm of Consumer Reports, is calling attention to a dangerous medical device loophole that puts patients at risk in an ad in Politico today. The ad is running as the Senate prepares to vote on a bill this week to reauthorize the statute governing medical device oversight.
- Consumer Reports: New generic drugs can save you money Source: Consumer Reports (Tuesday May 1, 2012)
But it can take more than a year to see substantial savings when you switch to a generic
- Consumers Union Letter to House Energy & Commerce Health Subcommittee on MDUFA
Consumers Union urges House Energy & Commerce Health subcommittee to keep consumer safety issues in mind as they are set to mark-up the Medical Device User Fee reauthorization bill.
- Consumers Union Letter to Senators Harkin and Enzi on the Food and Drug Administration Safety and Innovation Act Source: Consumers Union (Tuesday April 24, 2012)
Consumers Union comments on the Managers Amendment in the Senate bill regarding medical device legislation.
- Consumer Reports: Senate OKs weak Safety And Innovation Act for medical devices Source: Consumer Reports (Wednesday April 25, 2012)
The Senate HELP Committee today voted to approve the Food and Drug Administration Safety And Innovation Act, and although the bill included some improvements, it lacked key medical device safety provisions.
- Consumer Reports President Jim Guest NYT Letter to the Editor: Safety of Medical Implants Source: New York Times (Friday April 13, 2012)
The President of Consumer Reports calls for common sense reforms to medical device safety oversight in a letter to the editor of New York Times.
- Consumer Reports Press Room: Many Medical Implants Such As Surgical Mesh and Metal-On-Metal Hips Never Tested For Safety, Leaving Patients At Risk Source: Consumer Reports (Wednesday March 28, 2012)
Consumer Reports press release announcing a new investigation finding that many medical implants have never been tested for safety and manufacturers are often required to do nothing more than file paperwork and pay a user fee before bringing their products to market.
- Consumer Reports Consumer News: Is your implanted medical device safe? Source: Consumer Reports (Wednesday March 28, 2012)
Consumer Reports has released a new report on Dangerous Medical Devices. You might assume so, but many implanted devices, including artificial joints and surgical mesh, were never clinically tested on humans before being put on the market, according to a new Consumer Reports investigation.
- Consumer Reports National Research Center: Medical Implant Poll (2012) Source: Consumer Reports National Research Center (Tuesday March 20, 2012)
A new Consumer Reports poll shows overwhelming public support for strong medical device safety oversight. The poll was released just as House and Senate Committees have issued draft legislation to reauthorize the statute governing medical devices and at a time when the FDA’s process for reviewing new implants has come under intense criticism.
- Consumer Reports: FDA adds risk of diabetes, memory problems to Lipitor and similar drugs Source: Consumer Reports (Thursday March 1, 2012)
Cholesterol-lowering medications called statins, including atorvastatin (Lipitor and generic), lovastatin (Mevacor and generic) and simvastatin (Zocor and generic), can increase the risk of type 2 diabetes and might cause rare cases of memory loss, according to the Food and Drug Administration.
- Consumer Reports: Don't get hooked on prescription-drug coupons Source: Consumer Reports (Thursday March 1, 2012)
They aren’t always the bargain they seem to be
- Consumers Union Testimony on Medical Device Safety Before U.S. House Committee on Energy and Commerce/Health Subcommittee
Consumers Union Testimony on Medical Device Safety before U.S. House Committee on Energy and Commerce/Health Subcommittee
- Drug Safety: Managing Multiple Drugs
The more drugs you take, the more likely you are to have a problem. Read Consumer Reports’ guide to consumers on managing multiple drugs safely.
- Drug Safety: Reading Labels and Patient Information
Consumer Reports guide to consumers on reading drug labels.
- Drug Safety: Taking Drugs as Directed
Consumer Reports advice to consumers on taking drugs safely.
- Drug Safety: Side Effects
Consumer Reports advice to consumers about drug side effects.
- Guide to "Off-Label" Drug Use
Consumers Reports guide to off-label drugs–drugs prescribed by your doctor for an unapproved use.
- Off-label drug prescribing: What does it mean for you?
According to recent research, about one in five prescriptions are written “off label,” that is, for conditions other than the ones for which they received FDA approval.
- Are prescription drugs safe? Not necessarily
More than half of all prescription drugs cause adverse effects–some serious or fatal–that aren’t detected until after the FDA approves them, sometimes many years later. Such delayed detection contributes to the high number of drug-related injuries in the U.S.
- 5 medications that are notoriously overprescribed to women
Women are prescribed lots of pills, as the statistics show. Even more disturbing, our investigative analysis finds that some of those drugs are prescribed to women when they might not need to be at all.
- FDA warns of contaminated swabs in first-aid kits
If you own a first-aid kit made by Atwater Carey, be careful. The U.S. Food and Drug Administration is warning that the disinfecting iodine swabs included in certain kits might actually cause life-threatening infections.
- Yaz, Yasmin may pose higher risk of blood clots
The new, heavily advertised birth control pills Yasmin and Yaz might be more likely to cause potentially deadly blood clots than older oral contraceptives, according to two new studies in the British Medical Journal.
- Celexa might trigger insomnia in some patients
Many people with depression also suffer from sleep problems. But in some patients the antidepressant Celexa (citalopram and generic) doesn’t help relieve insomnia and might actually cause it, according to an April study in the Journal of Clinical Psychopharmacology.
- Recall: 57,000 bottles of Topamax have a musty odor
The U.S. Food and Drug Administration has issued a recall alert for Topamax, an anti-seizure drug made by Ortho-McNeil-Janssen Pharmaceuticals, because of numerous consumer complaints of a musty odor from the drug’s bottles.
- FDA has new tool to track supplement warnings
“The U.S. Food and Drug Administration this week unveiled a new, consumer-friendly search engine that provides easy access to information about product recalls and warnings.”
- Video: Advice on staying safe in the hospital--from the experts
- Gastric bands--the long-term costs
Gastric bands are sometimes seen as a “quick fix” for people who need to lose a lot of weight. There’s no doubt they can work well, but the long-term consequences might make you think twice.
- Beware of unapproved radiation supplements
The U.S. Food and Drug Administration this week warned consumers to be wary of supplements and other products sold online and in retail stores that claim to treat or prevent the effects of radiation but are not FDA-approved for that purpose.
- FDA limits acetaminophen dose to improve safety of painkillers
Acetaminophen (Tylenol and generic) can help ease aches and pains, but too much can trigger liver failure and even death.
- Darvon, Darvocet pulled from market due to potentially fatal heart problems
The Food and Drug Administration said today that the painkiller propoxyphene is being withdrawn from the market because it has been linked to a potentially deadly heart-rhythm abnormality, even when taken at recommended doses.
- Consumer Reports AdWatch
Consumers are besieged daily by ads for prescription drugs, all beseeching you to “ask your doctor” for a given brand-name drug for an ailment that you might, or might not, actually have. Those ads don’t always tell the whole story. They might, for example, play down or omit information about nondrug options, or imply that a drug works wonders for everyone when in reality it works only marginally better than a placebo. That’s why we started the Consumer Reports AdWatch series. Check out our video commentaries on TV drug ads.
- Consumers Union letter to FDA re: bad ad initiative
Consumers Union letter to FDA re: bad ad initiative
- Consumers Union Letter to FDA Commissioner on Avandia drug safety
In light of the credible estimates of possible continuing harm to patients caused by Avandia (diabetes medication) and the fact that there are readily available alternative treatments, Consumers Union recommends that the FDA make a decision by May on whether the drug’s sales and use should continue in the U.S.
- CU Comments to California Board of Pharmacy in Support of Labels Large Enough to Read (pdf)
March 9, 2010 (Consumers Union)
- Televised hearing on MN Gift Ban bill
Minnesota legislative hearing on HF1641 (Liebling)-Gifts from drug or medical device manufacturers or distributors to physicians and formulary committee members banned. House Health Care and Human Services Policy and Oversight Committee.
- CU Letter to California Board of Pharmacy in Support of Patient-Centered Labels on Prescription Drugs
Consumers Union wrote a letter to the California Board of Pharmacy in support of proposed Section 1707.5 of Division 17 of Title 16 of the California Code of Regulations that would make labels on prescription medication containers safer and better-suited for patients’ needs by requiring pharmacies to use standardized font
- Consumers Union "To Err Is Human, To Delay Is Deadly" Webcast
On November 17, 2009, Consumers Union hosted a forum in Washington DC based on the 10-year anniversary of the Institute of Medicine (IOM) 1999 study on medical harm challenging our health system’s progress on preventing medical harm 10 years later. We released a report earlier in the year on this
- Consumers Union Report: To Err is Human-To Delay is Deadly
Ten years ago the Institute of Medicine (IOM) declared that as many as 98,000 people die each year needlessly because of preventable medical harm, including health care-acquired infections. Ten years later, we don’t know if we’ve made any real progress, and efforts to reduce the harm caused by our medical care system are few and fragmented. With little transparency and no public reporting (except where hard fought state laws now require public reporting of hospital infections), scarce data does not paint a picture of real progress.
- To Err is Human - To Delay is Deadly
Ten years later, a million lives lost, billions of dollars wasted
- Consumers Union petitions the FDA on drug safety
All too often, drug advertisements fail to present the benefits and risks of using prescription drugs in an accurate and balanced way.
- Avandia and the Commerical Impact of FDA's Credibilty Gap
GlaxoSmithKline’s diabetes drug Avandia survived a perilous FDA advisory committee review. The real question is whether the industry can survive the damage to FDA’s credibility.
- Read the text of HR 2900, the House drug safety bill
Read the text of key provisions of HR 2900, the House version of the drug safety bill now on its way to the floor for a vote. Your representative will get a chance to vote on this bill in July. Help us make sure he or she votes YES! The full bill can be viewed at www.thomas.gov by searching for the bill number HR 2900.
- HR 2900 continued
Section 603 through Section 901 of HR 2900.
- HR 2900 continued to end
Section 901 to the end, key sections of HR 2900. To view the full bill, visit www.thomas.gov and search for bill number HR 2900.
- Strong drug safety legislation goes to US House floor for a vote
Lawmakers in the US House will soon vote on a strong drug safety bill that allows the FDA to enforce labeling changes, complete safety studies, and more quickly take action to protect the public if a drug proves unsafe. The bill would also give the FDA the authority to impose meaningful fines on drug companies that fail to comply with safety measures.
- Testimony of Jim Guest President, Consumers Union, before the House
On PDUFA, Risk Evaluation & Mitigation Strategies, Clinical Trials, and Advisory Committee Conflicts.
- Summary of Testimony of Jim Guest
On PDUFA, Risk Evaluation & Mitigation Strategies, Clinical Trials, and Advisory Committee Conflicts
- How did your Senator vote on drug safety?
The Senate heard drug safety legislation and amendments over several days, with record votes on reimportation, conflict of interest, stronger post-market review and much more.
- Putting patient safety first & fixing our drug safety system
Recent controversies surrounding the safety of highly advertised, blockbuster drugs have eroded Americans’ trust in our drug safety system.
- Battle for drug safety moves to House floor
A March 2007 Consumer Reports national poll found that more than 60 percent of Americans agree that the Food and Drug Administration and Congress have failed to adequately protect them from harmful prescription drugs.
- Text of S. 1082 Senate Drug Safety Bill
Food and Drug Administration Revitalization Act (Engrossed as Agreed to or Passed by Senate)
- Text of H.R. 1561
Full text of filed bill.
- Further Actions Needed to Improve FDA's Postmarket Decision-making Process
GAO found that FDA lacked clear and effective processes for making decisions about, and providing management oversight of, postmarket drug safety issues.
- Getting Seniors, Taxpayers the Best Deal on Prescription Drugs through Medicare Part D
Seniors now face a baffling array of insurance plans with different prices and drugs covered, and premiums are expected to increase at triple the rate of inflation this year alone.
- FDA witholds important safety information from its own advisory panel, Senator says
Sen. Chuck Grassley said the Food and Drug Administration intentionally withheld key information from its own advisory panel on the drug Ketek in January 2003 about the integrity of a pivotal clinical trial used to support the safety of the drug and dismissed concerns expressed by staff-level officials before the advisory panel meeting.
- Improvements needed in FDA's oversight of direct-to-consumer advertising, new study finds
The government’s investigative arm finds that drug company spending on DTC advertising—such as that on television and in magazines—of prescription drugs increased twice as fast from 1997 through 2005 as spending on promotion to physicians or on research and development. The agency also says that DTC advertising has contributed to increases in drug spending by prompting consumers to request the advertised drugs from their physicians.
- Information you should have before your next doctor visit
Consumer Reports Best Buy Drugs identifies the most effective, safest and affordable medicines based on the scientific evidence, not drug company hype. Take these materials to your doctor to discuss which medicines might be right for you, and whether you can save money.
- When Clinical Trials Are Compromised: A Perspective from a Patient Advocate
Twelve years ago, a friend from my breast cancer support group went to court because her insurance company had refused coverage for a bone marrow transplant.
- Grassley, Baucus seek more details of drug company grant money
The senators are concerned that sales and marketing personnel – rather than medical professionals – continue to award drug company money to medical specialty groups and patient advocacy groups to promote product use, especially off-label use.
- Mandatory public clinical drug trial registry needed to help ensure prescription drug safety, IOM panel told
Consumers Union statement for today’s public hearing
- Maine first state in nation to require public clinical trials
Groundbreaking law will help improve drug safety for all Americans
- Food and Drug Administration Safety Act S.930
Facts about FDA S.930.
- Fact sheet on federal bill S. 470
Fact sheet on federal bill S. 470
- Statement of CU regarding report on the FDA’s failure to ensure the safety of rapidly approved drugs Source: Consumers Union (Tuesday May 31, 2005)
Statement of Consumers Union on Congressman Ed Markey’s Report on the FDA’s Failure to Ensure the Safety of Rapidly Approved Drugs
- Recommended reforms to Institute of Medicine panel
Recommended reforms to Institute of Medicine panel
- Pharmaceutical Market Access and Drug Safety Act of 2005, S.334 and H.R.700
Spending on prescription drugs in America has increased faster than any other category of health care expenditure.
- Lower-cost heart drugs could help expand treatment to millions of Americans
CR Best Buy Drugs identifies effective medicines that could save consumers $2,000 year for treating high-blood pressure, heart ailments
- Sen. Chuck Grassley’s take on the FDA’s drug safety program
Asks tough questions during Consumer Federation of America conference
- Consumer Reports Best Buy Drugs
Latest information on saving money on drugs to treat heartburn, arthritis, cholesterol and depression
- A Rudderless, Leaderless FDA
Read the letter and op-ed from Consumers Union concerning the Food and Drug Administration’s ability to ensure drug safety.
- CU Model Clinical Trials Bill
Consumers Union has drafted two alternative model bills for use by state legislatures that wish to address the problem of inadequately disclosed clinical trials.
- CU Model Pharmacy Benefit Managers Bill
Consumers Union has drafted a model bill for use by state legislatures that wish to ensure Pharmacy Benefit Managers (PBMs) put the interests of their clients first.
- CU Model Pharmaceutical Company Marketing Disclosure Bill
CU has drafted a model bill for use by state legislatures that wish to require disclosure of pharmaceutical company marketing to physicians.
- State-Based Mandates Requiring Registry and Reporting
Currently, drug companies conduct clinical trials but are not required to release the final results to physicians and the public if the data results do not reflect favorably on their product.
- Requiring Drug Companies to Disclose Marketing Expenditures to Physicians
Drug marketing emphasizes the latest and most expensive drugs even though these drugs may not be the best in their category according to the medical evidence.
- Fact Sheet: Disclosing Relationships Between Pharmacy Benefit Managers and Drug Companies
In recent years, PBMs have been accused of failing to act in the best interests of their clients.
- Stay safe in the hospital
The January issue of Consumer Reports on Health newsletter tells patients and their relatives how to get the best care and prevent hospital infections and medication errors.
- Free education campaign helps consumers save on medicines
- About Institutional Review Boards
All drug trials involving human subjects require IRB approval and oversight. Federal, state and institutional regulations and policy define and govern how an IRB functions. Find out more about IRBs and why implementing laws at the state level might lead to safer prescription drugs.
- FDA official's testimony about drug safety
“Vioxx is a terrible tragedy and a profound regulatory failure. I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless.”
- Q&A on the Fair Access to Clinical Trials Act
This Q&A examines one gaping hole in the current drug safety process – that the FDA and the drug makers do not have to make clinical drug trials public. It also includes an overview of the “Fair Access to Clinical Trials Act,” legislation that would require a public registry, now pending in the House and Senate.
- FDA’s proposed changes to drug safety program
Agency responds to concerns with Vioxx and anti-depressants
- Avoiding Hospital Blunders (Knowing the Risks and Speaking Up Can Help You Stay Safe)
Consumer Reports on Health gives tips on avoiding hospital blunders.
- Minnesota: Information you should have before your next doctor visit
Consumer Reports Best Buy Drugs identifies the most effective, safest and affordable medicines based on the scientific evidence, not drug company hype. Take these materials to your doctor to discuss which medicines might be right for you, and whether you can save money.
Consumers Union News Releases
- Senate Passes FDA Safety And Innovation Act
Bill Makes Some Improvements to Medical Device Oversight But Important Patient Safety Protections Still Missing
- Dangerous Medical Device Loophole Puts Patients At Risk
Consumers Union Ad Focuses on Need to Close Loophole as Senate Prepares to Vote on FDA User Fee Act
- Senate HELP Committee to Vote on Food and Drug Administration Safety And Innovation Act On Wednesday, April 25
Bill Includes Important Improvements Over Current Law But Lacks Critical Medical Device Patient Safety Provisions
- Consumers Union: Medical Device Bills Missing Critical Protections For Patients
Medical Device User Fee Bills Face Key Votes in Congress Next Week
- Consumer Reports Poll: Americans Overwhelmingly Support Strong Medical Device Safety Oversight
Industry Pressure Stymies Patient Protections In Draft House and Senate Medical Device Bills
- Patient Safety Coalition Protests FDA’s Approval Of Device Used For Treating Aneurysms
FDA Should Do More Rigorous Testing To Prove Medical Device Is Safe & Effective
- CU testifies for stronger medical device oversight at House Hearing Today
Congress Shouldn’t Sacrifice Patient Safety In The Drive to Speed Up Medical Device Approvals, CU Says
- Consumers Union steps up campaign to improve medical device safety
Consumers Union’s Safe Patient Project teams up with eight patient safety activists from around the country to Washington, D.C. to meet with lawmakers in Congress and press for improvements in the Medical Device User Fee Act (MDUFA).
- Consumer Reports Poll Finds High Levels of Concern About Medical Harm & Support For Public Ratings on Hospital Safety
A new poll released today by the Consumer Reports National Research Center found high levels of public concern about hospital-acquired infections and other forms of medical harm.
- Report Finds Medical Errors More Common
Consumers Union Calls For Public Reporting of Medical Errors
- Health Care Reform Law Poised to Make Health Care Safer
New Law Includes Important Patient Safety Provisions That Will Save Lives and Health Care Dollars
- CU Report: U.S. Health Care System Fails To Protect Patients From Deadly Medical Errors
Consumers Union Assesses Lack of Progress Ten Years After Institute of Medicine Found Up To 98,000 Die From Preventable Errors
- Drug safety bill moves to Conference Committee; send strong bill to the President!
Both houses of Congress have just passed historic drug safety reform legislation (S. 1082, HR 2900) that would allow the FDA to enforce labeling changes, complete safety studies, and more quickly take action to protect the public if a drug proves unsafe. The bill would also give the FDA the authority to impose meaningful fines on drug companies that fail to comply with safety measures.
- Human face on weak prescription safety laws
Today, Patricia Slingo appears in a full page USA Today advertisement as part of our national push to finally pass strong drug safety reform.
- Clinical trial registry analysis shows company secrecy continues
Some drug companies that have started to place information about their clinical trials in the nation’s public registry still do not place enough meaningful information there, according to a new study by the New England Journal of Medicine.
- Drug companies manipulate research findings
Jennifer Washburn (author of University.Inc: The Corporate Corruption of American Higher Education) publishes original documents in the online magazine Slate supporting contentions that Proctor and Gamble ghost wrote research findings for its researchers and refused to allow researchers full access to the underlying data.
- Amendment passes that will create greater transparency in drug safety advisory panels
Thanks to your help, the Senate just passed an amendment that will create greater transparency when the Food and Drug Administration puts scientists with drug industry ties on its advisory panels. While this measure doesn’t go as far as the bill the House passed last June, which would ban the practice, it is a step in the right direction.
- Drug safety board needs real independence, authority
Proposed oversight board symbolic step; drug safety ensured through clinical trials and Independent Drug Safety Office laws
- In Light of Celebrex News, Consumer Reports Best Buy Drugs Urges Patients to Talk to Their Doctors about Alternatives
Web site chooses generic ibuprofen and generic salsalate as Best Buy Drugs
- Patient safety activists react to USA Today story on seniors and Rx drugs
This week’s USA Today story about the problem of overprescribing serious narcotics and pain killers to seniors touched a nerve with Consumers Union’s Safe Patient Project activists. According to the story, “hundreds of thousands of the nation’s seniors are misusing prescription drugs, including narcotic painkillers, anxiety medications and other pharmaceuticals, for everything from joint pain Continue Reading
- We’re live blogging at Selling Sickness!
Consumers Union’s Safe Patient Project is here in DC at the Selling Sickness conference, and we’ll be live blogging speaker panels while we’re here. Just come back to this page to see our live updates.
- Heartbreaking news: Child discovers 2nd recall connected to her defibrillator
9-year-old child, Avery de Groh, faces a scary situation: having a recalled defibrillator which the family found out by accident. This is the second time that Avery’s family has been affected by a recalled defibrillator. Last year, Avery’s mother, Molly, shared her daughter’s story about how she was shocked by a defective defibrillator at age three and thought monsters were attacking her. Her device was later recalled by the manufacturer.
- Advocates share medical device dangers in presentation at University of Texas
Medical device safety advocates, Lana Keeton and Joleen Chambers, share their personal stories of medical device harm and the need to be informed, in a presentation at the University of Texas in Austin.
- Selling Sickness conference is putting “People Before Profits”
We are thrilled to co-sponsor and attend the upcoming Selling Sickness conference in Washington DC, co-organized by long-time drug safety advocate Kim Witczak.
- Holiday in the hospital? Stay safe!
If you have to enter a hospital over the holidays, we have some advice on how to stay safe in there.
- Safe Patient Summit inspires patient safety advocates
This week, Consumers Union’s Safe Patient Project brought 31 energized advocates from across the U.S. to the 7th annual Safe Patient summit November 12-14, with a day of presentations at Consumer Reports headquarters in Yonkers, NY.
- Update: 2012 Medical devices safety law pros and cons
Many of us like to think we could live forever. And with today’s technology, a medical device – hip replacement, heart valve, artificial knee – seems to put ‘forever’ a lot closer within reach.
- Dedicated patient safety advocate shares his story in Health Affairs article
This week I read a new article written by a dedicated patient safety advocate, Kerry O’Connell, published in Health Affairs, a prestigious healthcare journal.
- Drug company giant GlaxoSmithKline pleads guilty in “Largest Health Care Fraud Settlement in U.S. History”
Earlier this month, the U.S. Department of Justice (DOJ) announced that pharmaceutical giant GlaxoSmithKline (GSK) agreed to pay $3 billion and plead guilty for “misbranding” its antidepressants Paxil and Wellbutrin, and failing to report safety data about its diabetes drug Avandia to the FDA.
- Consumers Union Comments to FDA Advisory Panel on Metal-on-Metal Hip Implants
Lisa McGiffert, Director of Consumers Union’s Safe Patient Project comments to the FDA advisory panel on metal-on-metal hips, June 28, 2012.
- Consumer advocates attend FDA panel on safety of metal-on-metal hip implants
The FDA will examine the risks and benefits of metal-on-metal hip implants in a 2-day panel in Maryland tomorrow and Thursday (June 27-28). The agency is convening the meeting of scientific and medical experts in light of evidence that metal-on-metal hip implants fail at a higher rate than implants made of ceramic or plastic. As part Continue Reading
- Real People, Real Medical Device Stories
This week, we sent congressional staffers a person’s medical device story each morning asking them to keep real people in mind as they reconcile the differences between the House and Senate versions of the medical device bill.
- Congress passes FDA user fees law, speeds up drug/device approvals; slows down safety
It was a case of good and bad — last week the Senate passed legislation to oversee medical device safety, and while Senators agreed to increase fees to help fund some safety oversight, they missed the opportunity to include important medical device safety provisions that thousands of activists helped support. This week, the House passed their Continue Reading
- #SPPChat: What Consumers Need to Know About Medical Device User Fee Bills
The intent of our Twitter chat on May 17 was to debunk industry claims about the FDA’s device approval process and explain what consumers really need to know about the medical device user fee bills.
- Join Our Twitter Chat on May 17: “What Consumers Need To Know About Medical Device User Fee Bills”
Consumers Union’s Safe Patient Project will host its second Twitter chat on Thursday, May 17 at 1pm EST to debunk industry claims about the FDA’s device approval process and explain what consumers really need to know about the medical device user fee bills. In the wake of several high profile, device-related public health disasters–such as Continue Reading
- Consumers Gaining Momentum in the Senate on Safety In Medical Device Legislation Debate, Congress Feeling the Pressure
Last week Senators on a key committee voted on a bill that will determine the safety of a medical device you or a member of your family may need someday. Learn how consumers are taking action and what the Senate bill does and doesn’t do to improve patient safety.
- Twitter chat on Medical Device Safety
Consumers Union’s Safe Patient Project team hosted a Twitter chat on medical device safety issues on March 30 from 1-2pm ET.
- Consumers Union’s Safe Patient Project to host Twitter chat on medical devices
To help educate the public about medical device safety issues concerning Americans, Consumers Union’s Safe Patient Project will host a Twitter chat on medical devices on Friday, March 30 at 12pm CST using the hashtag #sppchat. The campaign invites any interested individuals to join the chat. The medical device industry has been pushing Congress to Continue Reading
- Consumer Reports Poll: Americans Want Strong Medical Device Safety Oversight
This week, Consumers Union issued a news release on a new Consumer Reports poll showing overwhelming public support for strong medical device safety oversight. The poll results come at a time when Congress is considering legislation that could weaken current safety standards that would make it easier for potentially unsafe devices to enter the market.
- Consumers demand safer medical devices
To make sure elected officials hear from Americans who’ve been harmed by outdated safety laws, Consumers Union’s Safe Patient Project brought 10 activists from seven states to Washington D.C. to share their medical device experiences and demand improvements. And it had a huge impact!
- Video: Advice on staying safe in the hospital–from the experts
Hear advice from consumer advocates on patient safety.
- Recall Announcement Affects Consumers Union Employee
Medical recalls can indicate potential risk of serious injury or death to patients, but they often go unnoticed.
- Let’s talk about labels
A bill in California (SB 1390) would create a minimum of 12-point font for the most crucial information on medication labels and would require translation of medication label information into commonly used non-English languages.
- California Pharmacy Board Should Support Safer Medication Labels
Guest blog post written by Syed Sayeed, Policy Analyst at Consumers Union’s West Coast Office. CU is calling on California residents to submit comments to the Pharmacy Board by March 10th, in support of requiring all pharmacies to print important label information in at least a 12-point font size.
- Medical Mistakes show on Oprah
Did you catch the Oprah Winfrey Show on Tuesday about medical mistakes? She featured actor Dennis Quaid who recalled the series of hospital errors that nearly killed his newborn twins after they were given one thousand times the amount of the blood-thinning drug Heparin—twice.
- Old Blood for Halloween
Patients given blood transfusions of blood stored 29 days or longer are twice as likely to get a hospital-acquired infection as those receiving newer blood, according to researchers at Cooper University Hospital in New Jersey.
- You Score Higher Marks than Doctors
According to new FDA data, consumers like you make up the majority of drug adverse event reports submitted, replacing physicians.
- What you should ask your doctor
Consumer Reports Health continues its AdWatch series, with this analysis of those ubiquitous Cialis ads.
- Common sense shouldn’t take two years – unless it’s the FDA
Should it really take two years to study a common-sense proposal to make drug ads better for consumers? Not unless it’s the Food and Drug Administration, which has taken foot-dragging to new heights
- What Vytorin/Zetia Ads Don’t Tell You
Last Sunday a panel of cardiologists told more than 5,000 people that high cholesterol patients shouldn’t take Vytorin and Zetia except as a last resort. Made by Merck and Schering-Plough, these widely prescribed cholesterol-lowering drugs are taken by about four million Americans.
- FDA Gets Moving on TV Drug Ad Study – Thanks to You
Can one person take on the monolithic FDA and get it to actually do something about drug safety? You bet – especially when that person is backed by 56,000 voices.
- Welcome to Pharmageddon, Where Pills Make Us Sicker
Across the Atlantic, the folks over at Social Audit cooked up a neat idea: they invited people to submit a 350-word argument on “Pharmageddon” and heard from both patients and professionals.
- Some Hospitals Provide Rxs for Error, Dissatisfaction
You may remember Dennis Quaid from The Parent Trap but nowadays he’s speaking out against medical errors…
- Antidepressant meta-study sheds light, or dark, depending
A really long time ago, Aristotle said, “Happiness is the meaning and the purpose of life, the whole aim and end of human existence.”
- Contaminants in pig intestines? Who knew!
Update on the heparin recall. Heparin is a blood thinner derived from pig intestines.
- Have an opinion on off-label drug use information? Take this survey!
Survey about whether drug companies should hand out off-label drug studies to doctors.
- Heparin recall ordered
Late yesterday, Baxter International ordered a full-scale recall on the blood thinner Heparin.
- 100 vs 1
I don’t know how many times I’ve seen the commercial where a beaver is talking to Abe Lincoln at a bus stop about some guy in a suit not being able to sleep. Or Dr. Jarvik (or his double?) rowing in a beautiful lake while telling us how Lipitor is the greatest thing since the last few blockbuster statins.
- 3 minutes of your time could save your life
I needed an antidote. Too many drug ads—smiling people glowing with the pleasure of their successful medical treatments. But of course, they are actors.
- “The Medicated Child” sparks controversy
As a camp counselor for children with disabilities a couple years ago, I never stopped to consider that one of my bipolar campers may have been on eight different kinds of medication.
- Drugmakers in hot water with NY Attorney General
A newly released study indicates that Vytorin, an expensive new cholesterol drug, is no more effective than an older drug Zocor. Although the drug makers got these results in April 2006, they failed to release them to doctors and the public–meanwhile earning $5 billion in revenue from sales of this drug last year. Sadly, we’re not shocked.
- Buried data on antidepressants
The New England Journal of Medicine issued a report that said a third of FDA-registered studies on popular antidepressants went unpublished.
- Drug company ads in your Inbox
If you ignore the plethora of drug ads on TV, you might want to check your email.
- Free drug samples hardly help the poor
If you are poor, uninsured, non-English speaking, or an ethnic or racial minority, you are less likely to receive free drug samples, according to a first of its kind study by Harvard researchers at the Cambridge Health Alliance.
- Recap of Medicare Part D in 2007
Open enrollment for your prescription drug plan under Medicare Part D ends today. Over 1,800 private insurance plans to choose from, but they all cost too much, and the costs keep climbing.
- Discount drug cards underscore need for a national solution
Some cities and counties are trying to fight high prescription drug costs, but we really need Congress to act.
- Statin drug may be approved for over the counter
Merck will be presenting to an FDA advisory committee tomorrow in an effort to get their Statin drug Mevacor approved for over-the-counter.
- Sidestepping Your Doc
Should consumers have access to certain medications at the pharmacy without a prescription?
- A huge victory — and a huge thanks
Your emails, phone calls and visits to legislators helped win new drug safety protections for all Americans
- Victory! Congress passes FDA reform!
Both Houses of Congress have now passed legislation that would require the public disclosure of the results of drug studies and would give the FDA more authority to ensure the safety of prescription drugs. Next step is for Bush to sign this bill.
- New bill introduced in Senate: Drug co’s must report how much they pay docs
Last week Senator Grassley of Iowa introduced The Physician Payments Sunshine Act in the Senate that would require drug companies to…
- The latest “New and Improved” magical drug
What happens when the patent runs out on a big, money-making drug? Invent its “improved” successor.
- No side effects, says who?
Is your doctor listening to you or the drug companies when it comes to pinpointing the cause of your symptoms?
- Back to school? got your meds?
The L.A. Times today did a great story yesterday on the rising use of Attention Deficit Hyperactivity Disorder (ADHD) drugs and how an increase in marketing in the last few years may have contributed to this.
- FDA warns parents on cough medicine for kids
After hundreds of serious injuries and a handful deaths, the FDA warns parents not to give cough medicine to children under 2 years old.
- Brilliant biochemical chutzpah
Heartburn meds Nexium and Prilosec have been in the news lately because of the possibility they may increase risk of heart attack. While the jury’s still out on this, it’s fascinating look at the amount of money that’s been poured into the marketing of these drugs.
- Drug safety bill delayed
News from Congressional Quarterly today..
- Looks like final agreement on FDA bill pushed off
Unless a miracle happens tonight or tomorrow, it looks like Congress is going to delay finalizing FDA reform legislation until they get back from summer recess in September.
- Conflict of Interest
Doctors with Drug Ties Chosen for Avandia Panel
- Historic drug safety bill passes
In a vote of 403-16, the House yesterday overwhelmingly passed historic drug safety overhaul bill.
- How do we fix this?
I finally saw “Sicko” with a friend the other night. About half way through the movie, after we hear the heart breaking tales of a few Americans’ health care disaster stories, Michael Moore asks the question, “Who are we?”..a question that stays in your mind long after the closing credits. But a more appropriate question might be: How do we fix this?
- What’s up, Doc?
Is your doctor being bought by drug companies? Wish there was a way to find out?
- Pfizer white coats, why not?
At a U.S. Senate Aging hearing today concerns were raised on doctors’ financial ties to drug companies ($19 billion in ties). One witness even said, “we have reached the point where it would be more convenient for speakers to simply wear NASCAR-style jackets emblazoned with their sponsor’s logos.”
- Great drug safety article in the New Yorker today – check it out!
In today’s New Yorker magazine is an article that describes the status of our current prescription drug approval and montitoring process so well it could be called What’s-Wrong-With-Our-Drug-Safety-System-For-Dummies… and I don’t mean that as an insult! Can we try to get this in the hands of every House member before
- Next stop: House floor for drug safety
Last night, in a vote of 39-0, the full House Energy and Commerce committee approved legislation that would provide funding for the FDA, with drug safety reforms included. Many reforms are stronger than Senate’s version passed last month. Floor vote expected after July 4th recess.
- House drug safety bill goes through first round of committee amendments
Tough restrictions on direct-to-consumer advertising stripped from the bill; other measures to weaken bill defeated.
- House subcommittee to vote on drug safety proposals today..
And a full committee vote on Rep. Pallone’s proposal Thursday. We should know by tonight how it went.
- CU Activists descend on Washington and hit the ground running for drug safety
Consumers Union hosted its first-ever Activist Summit this week in which 50 activists from all over the country came to learn, meet each other and speak out for change in Washington.
- House drug safety proposal released
A drug safety proposal was just released by Congressman Pallone (D-NJ) that will be heard in Energy and Commerce Tuesday…and right now, it’s pretty good..
- Avandia added to the growing list of drugs that just might kill you
You can’t pick up a paper or turn on the news this week without hearing about Avandia, the latest blockbuster drug in the spotlight for potentially deadly side effects. This treatment, prescribed to about 6 million diabetics since 1999, is likely to increase cardiovascular disease and heart attacks in its users.
- Battle for safer drugs now in the House
It’s time for action. With strong legislation sitting in committee, the House has a chance now to take a hard line against the drug industry.
- Senate drug safety bill passes
The vote came down to 93-1, as Senate bill S.1082 was passed this week. Drug industry lobbyists breathed a sign of relief as reimportation was not tacked on to the bill.
- Pet food safety, drug importation… everything but the kitchen sink?
The Senate debate on the FDA funding/drug safety bill continued this week. Since last Tuesday when the Senate began discussing the bill, a slew of amendments have been tacked on.
- FDA reform bill still being debated in the Senate
Debate is now scheduled to begin again at 4pm today on S.1082. The reimportation debate has become the big controversy now in debating this bill.
- Senate takes up critical drug safety bill this week
The vote on FDA reform bill S.1082 may not happen until Thursday…depends on how much time it takes members to get through all the amendments and weave through a flood of drug company lobbyists.
- What happened when you called?
We’re hoping to learn more about your Senator’s position on this bill, and improve your experience when you help us make drugs safer.
- Drug companies pushing for another payday!
I may have discovered an unknown side effect of those prescription drug TV ads—lowering my IQ. As I digested new diseases, wondering if I have them, and new cures, wondering if I should ask for them, the drug companies apparently walked away with all the money.
- Families urge Congress to reform drug safety system
Last week, over a dozen families traveled to DC to urge Congress to pass strong drug safety reforms this year.
- The race to get vaccinated
At least 20 states have recently introduced bills that would require that all young girls receive the vaccine for the HPV virus that causes cervical cancer. The vaccine, Gardasil was only approved by the FDA last June.
- Mandatory vaccine sparks controversy
Last week, TX Gov Rick Perry bypassed the state legislature and ordered that all girls entering 6th grade be vaccinated for the HPV virus, linked to cause cervical cancer.
- Drug companies hiring lobbyists with Democratic ties
Over 60% of campaign contributions from the drug industry went to Republicans last year.
- No more free lunches
There is a movement to stop industry financing of medical education by a group out of Georgetown University. Last year, the drug industry spent around $1 billion on Continuing Medical Education courses or CME’s for physicians.
- Is the party over for drug ads?
In 2006, drug companies spent over $4 billion on drug ads. However, this year, Congress may look to limit direct-to-consumer ads.
- Medicare negotiation passes House!
The US House of Representatives yesterday voted 255-170 in favor of requiring the HHS secretary to negotiate drug prices with drug manufacturers for Medicare Part D plans…
- Warning urged on Ketek
Last week, an FDA advisory committee voted to limit the prescribing of the controversial antibiotic, Ketek.
- Lilly’s actions show why we need public disclosure of data
Now we hear that Eli Lilly failed to disclose clinical trial data that showed patients on Zyprexa were over 3 times more likely to suffer from high blood sugar than those taking placebo.
- another drug company charged with hiding side effect info
The NY Times has just gotten its hands on internal, confidential documents from Eli Lilly which showed the drug company played down the side effects of its top-selling, anti-psychotic drug, Zyprexa.
- Drug trial stopped on probable future blockbuster
This weekend, drug maker Pfizer learned that it would have to stop its clinical study of heart disease drug, Torcetrapib as the drug was shown to cause an increase in death and heart injury.
- Election Results Scare Big PhRMA
The New York Times and Washington Post reported on the pharmaceutical industry’s fears of a Democratic-controlled Congress. Those fears were best captured in a secret internal memo from drug maker GlaxoSmithKline.
- How thankful is Pharma?
A November 19th article titled, “Big Pharma on a mission to woo Democrats” from London’s Financial Times reported that the industry may now have to work overtime to get in the Dems’ good graces.
- Senate Told to Strengthen Drug Safety Bill
The U.S. Senate’s Health, Education, Labor & Pensions Committee held a hearing yesterday on an important bill to reform the FDA. For the most part, everybody asked the panel to make the bill stronger, according to a story in the Washington Post. Everybody that is, except the drug industry.
- U.S. official lobbies Britain on behalf of drug industry
Put this one in the jaw-dropping-to-the-floor category: The Guardian reports that U.S. deputy health secretary Alex Azar urged his British counterparts to open the British national health system to more drugs and pushed for direct-to-consumer (DTC) drug ads in Britain.
- California law scares drug companies–because it might work to lower prices!
According to the Boston Globe, drug companies are scared that a new California will actually work the way it’s supposed to–by lowering the cost of prescription drugs for uninsured people.
- Prescription drug discount initiative passes in Oregon!
Good news! Measure 44, which will allow the uninsured in OR to receive discounts on their medications passed on Tuesday.
- Big Pharma makes out big time from Part D
Drug companies have made huge profits off the Medicare prescription drug program, or Part D. You can expect Pfizer and others to have huge holiday parties this year…they’ll be breaking out the champagne while some seniors can expect a “donut hole” in their stockings.
- Med schools coaching students on how to handle drug reps effectively
Some med schools now are starting up projects for their students to help them challenge drug company sales reps when they attempt to wine and dine docs.
- Study says Medicare Part D premiums to jump 87%
The Washington Post reported today on a new study suggesting premiums for Medicare prescription drug plans will rise by a whopping 87% next year. The report by Families USA, a national health consumer group, also says fewer states will have plans offering full coverage for most drugs needed by seniors.
- Drug companies give big money this election
Reuters reports drug companies have spent at least $9 million to keep Republicans in control of Congress. Yesterday’s article quotes stock analysts talking about the risk to drug companies if Democrats take control of one or both houses of Congress:
- Halloween trick? FDA approves anti-wrinkle shots made with plexiglas
No, no Halloween scares here folks…the FDA did just approve ArteFill, an injectable product made from cow hides and tiny plexiglas beads, used to permanently fill wrinkles.
- Survey finds close ties between drug companies and patient groups
The New Scientist’s recent survey describes how some patient groups get substantial funding from drug companies.
- Most Americans support reimportation
A Harris poll from last month shows that 4 out of 5 adults support reimportation of prescription drugs from other countries, if drug prices are much lower.
- Restless Drug Companies Promote Little-Known Diseases
Who knew treating “restless leg syndrome” would generate the latest blockbuster drug? The Wall Street Journal Online yesterday reported on how GlaxoSmithKline turned a disease no one had ever heard of into a new $500 million market for one of its old drugs.
- Drugmakers feel heat on DTC ads
At a conference yesterday in New Jersey of pharmaceutical marketing specialists, drugmakers and their ad agencies were warned that drug ads to consumers need to be more truthful and transparent.
- Former FDA chief pleads guilty to conflict of interest charges
Former FDA chief, Lester Crawford, who resigned after 2 months on the job, has plead guilty of charges of conflict of interest and lying about stock he and his wife owned in companies the FDA regulates.
- Time to stop playing games with generic drug approvals
“When is a citizen not exactly a citizen? When it’s a pharmaceutical company looking to increase its profits,” writes Consumers Union President Jim Guest in a column in the current issue of Consumers Reports. Jim’s column explains how brand-name drug companies interfere with the marketplace by unfairly blocking generic drugs from competing with the brand names.
- CU report: 80% of the time the lowest retail price beats Medicare Part D “donut hole” prices
We called 261 pharmacies in Florida to get their prices for 6 top drugs, then compared them to the new Medicare prescription drug benefit’s private insurance plans. It turns out that out of the 44 Florida plans, the private plan “donut hole” prices were usually higher than the lowest retail price.
- Another New Call for Major FDA Reform
An article just published in the Archives of Internal Medicine echoes the growing consensus of physicians and other experts calling for major FDA reform.
- Drug Companies to New Zealand: “Don’t Ban Our Ads, Or Else!”
Only two countries on earth allow drug companies to advertise prescription drugs directly to consumers: New Zealand and the U.S. Yes, that’s right, residents of the other 191 countries in the world miss out on those omnipresent TV ads we see every night.
- Editorial slams Bayer on hiding drug side effect information
In yesterday’s editorial, the NY Times writes that Bayer’s excuse for hiding serious side effect information on a widely-used drug doesn’t hold much weight.
- NY Times reports: F.D.A. Says Bayer Failed to Reveal Drug Risk Study
The New York Times is reporting that Bayer failed to tell the FDA about results from a clinical trial that revealed their drug Trasyol may have serious risks.
- Drug Industry Fears IOM Report May Hurt Profits
A report by the country’s leading scientists is leading to fears by drug industry analysts that it may prompt legislation that could in turn impact the bottom line for drug companies.
- Welcome to the Daily Dose!
Here you can get news on the safety of our medications, the high cost of drugs, Medicare Part D and the latest on the pharmaceutical lobby.
- Walmart to lower prices on generics
Walmart has announced today that it will begin offering nearly 300 generic drugs for only $4 per prescription in Florida. Other companies and pharmacies may step up and also lower the prices of their medications. But what can Congress and states do to help people afford the drugs they need?
- Millions of Californians will soon enjoy lower drug prices
On August 31st the California legislature passed a bill that would require drug companies to lower their prices, or risk being shut out of the state’s Medicaid program, or Medi-Cal. Governor Schwarzenegger is expected to sign the measure. Many thanks goes to our CA activists who helped us achieve this victory!
- Ohio residents get support from US Senator on drug safety legislation in Congress
Ohio drug safety activists Cathy and Dan Harter met with Senator DeWine (R-OH) in late June, asking that Congress do more to ensure that medications on the market are safe. We just learned that after that meeting, the Senator decided to sign onto drug safety legislation in Congress.
- Doc Confesses He Nearly Took Unnecessary Antibiotics Source: Live Science (Monday August 4, 2014)
The medical profession needs to own up to the problem of antibiotic resistance, writes Dr. Kevin Kavanagh, a doctor that was prescribed unnecessary antibiotics.
- A Loophole For Industry To Promote Off-Label? Source: Kim Witczak, Selling Sickness (Tuesday May 13, 2014)
Kim Witczak writes about a “new potential loophole being created by the FDA with its new guidance around distribution of reprints from articles that appear in medical/scientific journals.”
- USDOJ: Astellas Pharma US Inc. to Pay $7.3 Million to Resolve False Claims Act Allegations Relating to Marketing of Drug Mycamine Source: Department of Justice (Wednesday April 16, 2014)
DOJ: “Pharmaceutical company Astellas Pharma US Inc. will pay $7.3 million to resolve allegations that it violated the False Claims Act in connection with its marketing and promotion of the drug Mycamine for pediatric use, the Justice Department announced today. Astellas Pharma US Inc., located in Northbrook, Ill., manufactures and sells pharmaceutical drugs, including Mycamine.”
- Double Dip: Doctors Paid to Advise, Promote Drug Companies That Fund Their Research Source: ProPublica (Tuesday March 25, 2014)
Research has been seen as less objectionable than other forms of interactions with drug companies, but 10 percent of researchers have multiple ties among the nine companies ProPublica analyzed. That raises questions about doctors’ impartiality.
- Is All That Rambling Too Confusing?? Fda Thinks So. Source: Selling Sickness (Friday March 21, 2014)
Kim Witczak, co-founder of the US Selling Sickness conference says: “Direct-to-consumer advertising of prescription drugs shouldn’t be allowed, but since it is, I believe that the warnings should be strengthened, not reduced.”
- Inappropriate antibiotic use in emergency rooms not decreasing in adults Source: Antimicrobial Agents and Chemotherapy. (Thursday January 9, 2014)
“An analysis of emergency room (ER)visits over a 10-year period finds that while inappropriate antibiotic use is decreasing in pediatric settings, it continues to remain a problem in adults, according to an article published ahead of print in Antimicrobial Agents and Chemotherapy.” Inappropriate antibiotic use can lead to the development of antibiotic resistance.
- Hoping for Financial Compensation, Safer Drugs from Big Pharma in 2014 Source: Drug Watch Radio (Thursday January 2, 2014)
Drug Watch Radio includes CU’s Safe Patient Project campaign in its New Year’s wish list. You can listen to our interview on Drug Watch Radio here: http://www.drugwatch.com/radio/consumer-reports-interview-lisa-mcgiffert/
- In A Major Shift, Medicare Wants Power to Ban Harmful Prescribers Source: ProPublica (Monday January 6, 2014)
ProPublica reports that Medicare has issued a proposed rule that would give the agency the “authority to kick out physicians and other providers who engage in abusive prescribing. It could also take such action if providers’ licenses have been suspended or revoked by state regulators or if they were restricted from prescribing painkillers and other controlled substances.”
- Seattle Times video: How to make millions off a drug for a rare disease Source: Seattle Times (Friday January 3, 2014)
Seattle Times investigation of how drug companies are making millions by marketing off label uses.
- How a drug for few patients was turned into $81 million in sales Source: Seattle Times (Saturday November 9, 2013)
“Orphan drugs, approved for rare diseases, can become big sellers. One Seattle biotech’s drug provides a case study in how the chase for profits can turn into accusations of unlawful marketing.”
- Seattle Times Investigation: Pharma's Windfalls Source: Seattle Times (Friday January 3, 2014)
Seattle Times series on marketing of orphan drugs for off label use
- Spike in Harm to Liver Is Tied to Dietary Aids Source: New York Times (Saturday December 21, 2013)
New York Times reports: “Dietary supplements account for nearly 20 percent of drug-related liver injuries that turn up in hospitals, up from 7 percent a decade ago, according to an analysis by a national network of liver specialists.”
- ‘Let the Crime Spree Begin’: How Fraud Flourishes in Medicare’s Drug Plan Source: ProPublica (Thursday December 19, 2013)
ProPublica identified scores of doctors whose prescribing in Medicare’s drug program bore the hallmarks of fraud
- When Bacteria Can No Longer Be Stopped Source: New York Times (Sunday December 29, 2013)
Read the experts discuss solutions to antibiotic resistance from creating new antibiotics to reducing the over-prescribing of antibiotics.
- Brand-name Drug Choices Drive State’s High Medicare Costs Source: Connecticut Health I-Team (Monday October 21, 2013)
Dartmouth Atlas Project: Brand-name Drug Choices Drive State’s High Medicare Costs
- New data show antipsychotic drug use is down in nursing homes nationwide Source: CMS (Tuesday August 27, 2013)
Nursing homes are using antipsychotics less and instead pursuing more patient-centered treatment for dementia and other behavioral health care, according to new data released on Nursing Home Compare in July by the Centers for Medicare & Medicaid Services (CMS).
- George Bush’s Stent Surgery Revives Debate on Heart Care Source: Bloomberg (Tuesday August 6, 2013)
Former President George W. Bush’s decision to allow doctors to use a stent to clear a blocked heart artery, performed absent symptoms, is reviving a national debate on the best way to treat early cardiac concerns.
- Oregon DOJ cases target doctors' failure to inform patients about device payments Source: The Oregonian (Tuesday August 6, 2013)
The DOJ ruling requires Oregon Doctors to tell their patients if they receive payments form device companies.
- Big pharma mobilising patients in battle over drugs trials data Source: The Guardian (Sunday July 21, 2013)
The Guardian reports: “The pharmaceutical industry has “mobilised” an army of patient groups to lobby against plans to force companies to publish secret documents on drugs trials.”
- Weighing the cost of technology advances in medical devices Source: KevinMD.com (Wednesday July 24, 2013)
“it is not uncommon for a newly-named pacemaker or defibrillator to add several thousand dollars to the health care system over last year’s device yet they may add only minor advances over the prior year’s model.”
- Breaking the Seal on Drug Research Source: New York Times (Saturday June 29, 2013)
New York Times reports on the work of medical researcher (Peter Doshi) to push big pharma to open up clinical trial data to the public. Currently, limited and oftentimes misleading clinical trial information is published in medical journals that often have financial ties to the companies whose drugs they’re writing about.
- Move forward on medical device tracking Source: Star Tribune (Friday June 21, 2013)
Star Tribune editorial board: “Obama administration needs to push for rollout of tracking system [for medical devices].” Once fully implemented, unique device identifiers (UDIs) will help the FDA keep better track of problem devices and establish a better system for managing recalled devices.
- Final Rule for Unique Medical Device Identifier Could Come Soon Source: Health Data Management (Monday June 17, 2013)
Health Data Management reports: “The Food and Drug Administration has sent a final rule to establish a unique medical device identifier to the Office of Management and Budget for review before publication.”
- WANTED: Consumers to Report Problems Source: FDA (Monday June 3, 2013)
FDA has created a new form for consumers to report adverse events with drugs or devices. This less technical form is part of larger FDA effort to encourage consumers to submit quality reports.
- Will Obamacare kick sales reps out of the OR? Source: DOTmed.com (Thursday May 30, 2013)
Did you know that medical device sales reps can be in the operating room assisting the physician with a surgical procedure? It sounds shocking, but companies trying to save money may change that.
- FDA, facing cybersecurity threats, tightens medical-device standards Source: Washington Post (Thursday June 13, 2013)
Washington Post reports: “The Food and Drug Administration is tightening standards for a wide range of medical devices — from fetal monitors used in hospitals to pacemakers implanted in people — because of escalating concerns that the gadgets are vulnerable to cybersecurity breaches that could harm patients.”
- Steel Standing: Metal Meets Muscle; A Patient’s Perspective Source: Journal of Participatory Medicine (Wednesday June 5, 2013)
CU story sharer (Christa Davis) published in Journal of Participatory Medicine. “Summary: The author describes the detective work she did to find the reason for her mother’s unexplained deterioration and lack of muscular strength in hands and legs following joint replacement surgeries. A careful neurological workup ruled out ALS but did not result in a clear diagnosis. Her review of the medical literature suggested that metal toxicity might be causing inflammation that was destroying the muscle. She describes the numerous difficulties and eventual success she had interacting with a number of physicians as her mother’s advocate.”
- Aching joints create many problems Source: Lincoln Times-News (Saturday June 8, 2013)
Guest columnist Kathryn Yarbro writes about her knee replacement surgery and having to use a cane.
- Study shows medical devices complicate complex conditions in kids Source: Fierce Medical Devices (Friday June 7, 2013)
“As modern medical advances help more children with complex conditions live longer, a new study shows a significant number suffer from complications caused by medical devices that are also necessary for their survival.”
- Big Pharma’s Big Fines Source: Propublica (Monday March 11, 2013)
Summary of large settlements big pharma has paid for fraudulent marketing.
- Dan Walter on KevinMD: The safety data behind this ablation catheter Source: KevinMD (Tuesday May 28, 2013)
An excerpt from Collateral Damage: A Patient, a New Procedure, and the Learning Curve by Dan Walter. Dan is a member of Consumers Union’s Safe Patient Project Advocates Network.
- Pressure Grows to Create Drugs for ‘Superbugs’ Source: NYT (Sunday June 2, 2013)
The FDA is granting money to Glaxcosmithkline – up to $200 million in 5 years- to help develop medication that can work against antibiotic resistant superbugs. Glaxcosmithkline has paid the largest health care fraud settlement in US history-$3 billion.
- Op-ed coauthored by Kim Witczak: A call to challenge the “Selling of Sickness” Source: BMJ (Tuesday May 14, 2013)
Kim Witczak, co-founder of Woody Matters and member of Consumers Union’s Safe Patient Project, co-authors a “call to action” for the BMJ: “to bring an end to direct-to-consumer advertising of diagnostics and drugs, ensure appropriate testing of new drugs and devices, put forward reform of the patent system, and promote responsible health journalism. “
- Lowering Costs and Improving Care in Medicare: Promising Approaches Source: AARP (Tuesday May 7, 2013)
The Public Policy Institute brought together leading experts to discuss promising approaches to improving care and lowering Medicare costs. Panel included Lisa McGiffert, Director, Safe Patient Project, Consumers Union
- Medicare Drug Program Fails to Monitor Prescribers, Putting Seniors and Disabled at Risk Source: ProPublica (Saturday May 11, 2013)
ProPublica’s “The Prescribers” series: “Prescription data obtained by ProPublica shows widespread use of antipsychotics, narcotics and other drugs dangerous for older adults, but Medicare officials say it’s not their job to look for unsafe prescribing or weed out doctors with troubled backgrounds.”
- J&J Will Stop Sales of Metal-on-Metal Hip Replacements Source: Bloomberg (Friday May 17, 2013)
Bloomberg reports: “Johnson & Johnson (JNJ), the world’s biggest maker of health-care products, said it will stop selling metal-on-metal and ceramic-on-metal hip replacements as demand wanes for the devices and U.S. regulators seek new rules.”
- J.&J. Unit Phasing Out All-Metal Hip Devices Source: New York Times (Thursday May 16, 2013)
NY Times: “The orthopedic unit of Johnson & Johnson said Thursday that it was phasing out production of all-metal replacement hips, a move reflecting an industrywide trend to abandon the once widely used implants because of high early failure rates.”
- J&J will abandon metal hip replacement sales Source: Fierce Medical Devices (Thursday May 16, 2013)
J&J announced it will discontinue selling its metal-on-metal and ceramic-on-metal hips by the end of 2014. Consumers Union has voiced major patient safety concerns with metal-on-metal hip implants after hearing from many patients with metal-on-metal hips who faced problems and/or became disabled.
- Strengthening our National System for Medical Device Postmarket Surveillance Source: FDA (Monday April 1, 2013)
Update and next steps.
- Strengthening Our National System for Medical Device Postmarket Surveillance Source: FDA (Saturday September 1, 2012)
The report includes plans for establishing a unique device identifier and promotion of registries for tracking devices.
- Medical Bed Mattresses: FDA Safety Communication - Damaged or Worn Covers Pose Risk of Contamination and Infection Source: FDA (Friday April 19, 2013)
From January 2011 to January 2013, the FDA received 458 reports associated with medical bed mattress covers failing to prevent blood and body fluids from leaking into the mattress (fluid ingress). Fluid ingress may occur if mattress covers become worn or damaged from small holes or rips in the fabric or from incorrect cleaning, disinfecting and laundering procedures. The zipper on the cover may also allow fluid to penetrate the mattress. Some reports indicate that if blood and body fluids from one patient penetrate a mattress, they can later leak out from the mattress when another patient is placed on the bed. Patients are at risk for infection if they come into contact with blood and body fluids from other patients.
- J&J Jury Urged to Award $5 Million for Failed Metal Hip Source: Bloomberg (Monday April 15, 2013)
J&J Jury Urged to Award $5 Million for Failed Metal Hip
- St. Jude Hit by Suits Source: Wall Street Journal (Thursday April 4, 2013)
A raft of lawsuits filed Thursday against St. Jude Medical Inc. over an implanted heart device could challenge the broad liability protection that medical-device makers have enjoyed since a key Supreme Court ruling in 2008. “What the judges are recognizing now is that there’s no recourse for consumers, and that’s changing,” said Reza Torkzadeh, a Los Angeles attorney representing the plaintiffs in the new cases.
- New York Times Editorial: One Industry’s Hold on the Senate Source: New York Times (Monday April 1, 2013)
Medical device makers are lobbying Congress to repeal the medical device tax, which is a source of revenue in the health care law that would expand health coverage to 30 million uninsured people. “The industry claims the tax will hurt demand for its products, but, in fact, sales of these devices, which are not purchased directly by consumers, are unlikely to be affected by price, especially by a small tax increase. As more people receive health coverage that pays for devices, the industry will more than make up the cost of the tax.”
- Joint pain, function not always better after surgery Source: MedCity News (Wednesday March 27, 2013)
Only about half of people who have a knee or hip replaced see meaningful improvements in pain and disability in the months after surgery, a new study from Canada suggests.
- Doctor-pharma ties defended on eve of pay reporting mandate Source: American Medical News (Monday March 25, 2013)
Starting in August, pharmaceutical companies and device manufacturers must begin tracking physician payments and gifts worth as little as $10. Public disclosure of these so-called transfers of value in a searchable federal government database starts Sept. 30, 2014.
- Salesmen in the Surgical Suite Source: New York Times (Monday March 25, 2013)
New York Times story on a man who suffered a cascade of complications after receiving robotic surgery for a prostatectomy. He eventually died and his wife is suing the device maker. NYT reports on emails sent from device maker sales reps to hospitals urging them to switch their surgeries to robotic ones.
- Intuitive Surgical Loses Bid to Throw Out Robot Lawsuit Source: Bloomberg (Tuesday March 26, 2013)
The device maker must face claims that it did not providing proper training on their robotic devices.
- Illinois Hospital’s Experience with DePuy ASR Metal-on-Metal Hip Implant Underscores its Problems Source: Bad Medical Devices Blog (Friday March 22, 2013)
The high failure rate of the DePuy ASR metal-on-metal hip implant seen among the patients at one Illinois hospital underscores the dangers posed by this and other similar hip implants.
- How Much is that Hip Replacement in the Hospital? Source: Forbes (Tuesday February 12, 2013)
A study in the New England Journal of Medicine finds the cost of a hip replacement is difficult to determine.
- Medical Devices and Malware: The Latest Hospital-Acquired ‘Infection’ Source: Healthcare Informatics (Thursday March 21, 2013)
In recent months, the potential impact of malware on medical devices—and, ultimately, patient safety—has garnered considerable attention.
- FDA warns of another compounding pharmacy recall Source: Boston Herald (Wednesday March 20, 2013)
The Food and Drug Administration is warning doctors that a compounding pharmacy is recalling dozens of lots of the Roche drug Avastin after receiving reports of eye infections among patients.
- FDA warns Stryker on quality issues, marketing practices Source: MedCity News (Tuesday March 12, 2013)
Orthopedic implant maker Stryker Corp said it received a warning letter from the U.S. Food and Drug Administration related to quality concerns at its Portage, Michigan facility.
- Metal-on-Metal Hips Still a Problem Doc Says Source: Medpage Today (Wednesday March 20, 2013)
“More than 2 years after the metal-on-metal Articular Surface Replacement XL system was taken off the market, rates of repeat surgery continue to rise, experience at one facility indicates.”
- Bacteria Clog Medical Devices Very Quickly, Study Shows Source: Infection Control Today (Friday March 1, 2013)
A new study examines how bacteria clog medical devices, and the result isn’t pretty. The microbes join to create slimy ribbons that tangle and trap other passing bacteria, creating a full blockage in a startlingly short period of time.
- Morning Joe video: Medical device malfunction in women Source: MSNBC (Monday March 18, 2013)
PBS medical correspondent discusses medical device malfunction in women on MSNBC’s Morning Joe show.
- Robosurgery Suits Detail Injuries as Death Reports Rise Source: Bloomberg (Tuesday March 5, 2013)
Bloomberg reporter: Intestines fall out of woman’s vagina after robot surgery. A review of adverse incident reports sent to the Food and Drug Administration since 2009 shows an increase. As the popularity of robot surgery has grown, injury reports involving the procedures jumped to at least 115 in 2012 from 24 in 2009, while deaths rose to 30 from 11.
- Intuitive Robot Probe Threatens Trend-Setting Surgeries Source: Bloomberg (Friday March 1, 2013)
The safety of robots made by Intuitive Surgical Inc. (ISRG) is being probed by U.S. regulators, raising questions about the prospects of one of the hottest technologies in health care.
- Improved Access to Device Information: What a UDI System Can Do for Patients and Consumers Source: Brookings Institution (Tuesday February 26, 2013)
Lisa McGiffert, director of Consumers Union’s Safe Patient Project participated in a Brookings Institution webinar for consumers on the Unique Device Identifier system for medical devices. UDIs when fully implemented would improve tracking of medical devices and allow patients and doctors to be better notified about device recalls.
- Johnson & Johnson Confirms Inquiry Into Hip Devices Source: New York Times (Friday February 22, 2013)
NYT: “Federal prosecutors are investigating Johnson & Johnson’s practices in marketing a line of hip replacements recalled in 2010 because many had to be replaced within a few years — part of a string of more than 30 product recalls by the company in the last three and a half years.”
- Herbalife cozies up with UCLA Source: Los Angeles Times (Friday February 22, 2013)
Los Angeles Times: “UCLA’s Medical School has an unusually close relationship with Herbalife, which constantly promotes its connection to doctors there. Where do sensible ideas end and the shilling for Herbalife begin?”
- Johnson & Johnson discloses government probe of hip implants, surgical mesh Source: NJ.com (Friday February 22, 2013)
Johnson & Johnson disclosed government probes into two of its troubled products today.
- Journalists, Patient Advocates and Whistle blowers… Oh my! Source: The Peggy Lillis Memorial Foundation (Saturday February 23, 2013)
Christian Lillis shares highlights and stories of people he met at the Selling Sickness conference in DC.
- J&J Failed to Warn of Vaginal Mesh Risks, Jury Says Source: Bloomberg (Monday February 25, 2013)
Bloomberg: “Johnson & Johnson (JNJ)’s Ethicon unit failed to properly warn of the risks of a vaginal mesh implant and made fraudulent misrepresentations to a South Dakota nurse who sued, a New Jersey jury ruled in the first verdict in more than 2,100 lawsuits filed over the device.”
- Study: Hip implants more likely to fail in women Source: Associated Press (Monday February 18, 2013)
Associated Press reports: “Hip replacements are slightly more likely to fail in women than in men, according to one of the largest studies of its kind in U.S. patients. The risk of the implants failing is low, but women were 29% more likely than men to need a repeat surgery within the first three years.”
- Why Doctors Remain Silent Source: New York Times (Friday February 15, 2013)
“It might not be surprising to find that [Johnson & Johnson] executives acted to protect a company’s bottom line. Still, the Johnson & Johnson episode is also illuminating a broader medical issue: while experts say that doctors have an ethical obligation to warn their peers about bad drugs or medical devices, they often do not do so.”
- Johnson & Johnson recalls more metal hip implants Source: Chicago Tribune/Reuters (Thursday February 14, 2013)
Depuy, a unit of J&J that has already recalled their ASR metal on metal hip implants has issued another product recall. This recall is for Adept modular heads, a component of the metal-on-metal hip replacement device.
- New Questions About The Safety Of Hip Replacements Source: The Diane Rehm Show (Tuesday February 14, 2012)
The Food and Drug Administration recently issued new warnings on the safety of some hip replacements. As part of our occasional series, “Mind and Body,” Diane and her guests discuss what patients need to know about safety and cost of hip replacements. Full transcript here: http://thedianerehmshow.org/shows/2013-02-14/new-questions-about-safety-hip-replacements/transcript
- NYT Editorial: What a Company Knew About Its Metal Hips Source: New York Times (Sunday February 10, 2013)
NYT: Manufacturer of all-metal hips that failed and harmed many patients has a lot of explaining to do, now that there is evidence that the manufacturer knew of a serious problem with one of its models yet failed to alert patients or doctors and continued to market it aggressively.
- Price for a New Hip? Many Hospitals Are Stumped Source: New York Times (Monday February 11, 2013)
Health care prices are often hidden from consumers.
- Tim’s Horror Story regarding a ceramic on metal hip implant Source: Earl's View (Sunday February 10, 2013)
Tim’s Horror Story regarding a ceramic on metal hip implant
- Thousands of women sue over surgical mesh Source: Associated Press (Friday February 8, 2013)
Thousands of women harmed by surgical mesh implanted for pelvic organ prolapse sue manufacturers of pelvic mesh products for failing to disclose potential risks and fraudulently promoting the mesh as a safe medical device.
- Legal drugs, deadly outcomes (Dying for Relief, a Times Investigation) Source: Los Angeles Times (Sunday November 11, 2012)
Prescription overdoses kill more people than heroin and cocaine. An L.A. Times review of coroners’ records finds that drugs prescribed by a small number of doctors caused or contributed to a disproportionate number of deaths.
- Consumer group calls for laws to boost monitoring of doctors Source: Los Angeles Times (Thursday February 7, 2013)
Consumer Watchdog says reforms are needed to reduce the rising number of prescription drug overdoses and to rein in incompetent and corrupt physicians.
- Consumer Watchdog Seeks Stronger Oversight of Rx Overprescribing Source: California Healthline (Thursday February 7, 2013)
In a letter to Gov. Jerry Brown (D) on Wednesday, Consumer Watchdog called for legislation to improve monitoring of physicians who overprescribe medications, the Los Angeles Times reports. The letter was prompted by a Times investigation that found the state’s oversight of such physicians to be lacking (Girion, Los Angeles Times, 2/7).
- Hollywood cardiologist’s ties with St. Jude sales rep raises red flags Source: Miami Herald (Saturday February 2, 2013)
Hollywood doctor regularly implants St. Jude pacemakers in his patients, generating more than half a million sales for the company last year. This doctor also happens to be a business partner with a St. Jude sales rep in two corporations that run yogurt shops. This raises some conflict of interest questions in the ongoing debate over a pending disclosure policy in Congress that would more clearly reveal financial ties between doctors and the healthcare industry.
- NYT Op-ed: Health Care’s Trick Coin Source: New York Times (Friday February 1, 2013)
Ben Goldacre writes an op-ed published in New York Times commenting on the “casual lack of transparency” in medicine as evidenced by the Johnson & Johnson metal hip lawsuits, where internal documents showed that executives had known of flaws in their device for some time, but had failed to make them public.
- During Trial, New Details Emerge About Hip Maker Source: New York Times (Wednesday January 30, 2013)
“Details about the involvement of an executive with the DePuy all-metal hip implant emerged Wednesday in Los Angeles Superior Court during the trial of a patient lawsuit against the DePuy Orthopaedics division of Johnson & Johnson. More than 10,000 lawsuits have been filed against DePuy in connection with the device — the Articular Surface Replacement, or A.S.R. — and the Los Angeles case is the first to go to trial. The information about the depth of the executive’s involvement with the implant may raise questions about DePuy’s ability to put the ASR episode behind it.”
- A Call to Prevent Unsafe, High-Risk Medical Devices From Reaching Patients Source: UCSF News (Monday January 28, 2013)
Commentary Sheds Light on FDA Approval Process for Implantable Body Parts
- J&J Failed Own Safety Test in Hip Design, Witness Says Source: Bloomberg (Tuesday January 29, 2013)
Witness testified in a suit against Johnson & Johnson that the company changed their test instead of the design of the device because a redesign would be too costly.
- A Call to Prevent Unsafe High-Risk Medical Devices from Reaching the Marketplace Source: Science Daily (Tuesday January 22, 2013)
“Some “high risk” surgical devices that have been approved by the U.S. Food and Drug Administration (FDA) are not required to go through clinical trials, where a product is tested to determine its safety and effectiveness.”
- Maker Aware of 40% Failure in Hip Implant Source: New York Times (Tuesday January 22, 2013)
NYT: “An internal analysis conducted by Johnson & Johnson in 2011 not long after it recalled a troubled hip implant estimated that the all-metal device would fail within five years in nearly 40 percent of patients who received it, newly disclosed court records show.”
- Fiscal Footnote: Big Senate Gift to Drug Maker Source: New York Times (Saturday January 19, 2013)
New York Times exposes a paragraph in the “fiscal cliff” bill that “strongly favored” a drug manufactured by a company who plead guilty in a major federal fraud case.
- The Benefits of Public Advisory Committees at the FDA Source: RegBlog (Monday January 21, 2013)
New study finds: “drugs receiving public advisory committee attention in which the members had no conflicts of interests were far less likely either to require new boxed warnings or to have caused drug-specific safety alerts than those with conflicted members on the public advisory committee.”
- FDA Metal-on-Metal Hip Implants: Safety Communication
Updated safety information for metal on metal hips.
- FDA Clamps Down on Metal-on-Metal Hips Source: Medpage Today (Thursday January 17, 2013)
Metal on Metal hips are the subject of an FDA proposal to require pre-market safety testing which is currently not required.
- Doctors Weigh Risks of Metal Hips as FDA Tightens Reviews Source: Bloomberg (Thursday January 17, 2013)
Makers of all-metal, total-hip replacement products will now have to file approval applications for the strictest level of agency device review, the FDA said today in a statement on its website.
- F.D.A. Seeks to Tighten Regulation of All-Metal Hip Implants Source: New York Times (Wednesday January 16, 2013)
FDA is proposing new regulations that makers of metal-on-metal hip implants would have to prove the devices were safe and effective before they could continue selling existing ones or obtain approval for new all-metal designs.
- Dr Tower writes to Senator re concerns about the regulatory malfeasance at the FDA – Metal-on-Metal hip replacement debacle Source: Earl's View (Sunday January 6, 2013)
Letter by Alaskan orthopedic surgeon Dr. Tower to his Senator re concerns about the regulatory malfeasance at the FDA – Metal-on-Metal hip replacement debacle. Dr. Tower was injured by the same metal-on-metal hip he implanted in patients. Dr. Tower’s story was featured in Consumer Reports’ medical device May 2012 article, “Dangerous Medical Devices.”
- Patient safety: Kiani "blown away" by pledges to open up healthcare data Source: Mass Device (Monday January 14, 2013)
Medical device company CEO plans today to unveil a list of medical device companies who signed a pledge to make data gathered by their devices accessible to the public.
- Ninth Circuit Backs Plaintiffs in Medical Device Litigation Source: The Recorder (Thursday January 10, 2013)
A ruling on a state lawsuit concerning medical devices found that federal law will not pre-empt or prevent the case from moving forward.
- Anthony Chicotel: Medical board allows over-drugging of elderly patients Source: Mercury News (Tuesday January 8, 2013)
The California Medical board takes no action when elderly patients are over-medicated.
- New law to allow a hospital pharmacy to operate a centralized hospital packaging pharmacy
New addresses avoiding adverse events by barcoding drug doses that are prepared for individual unit packaging by the central pharmacy of sister hospitals. Hospitals must be certified by the board of pharmacy:
- Rochester woman in bellwether case on hip implants Source: Rochester Business Journal (Monday January 7, 2013)
A Rochester area woman’s court complaint has been selected to be heard as one of two bellwether cases that will help decide the outcome of several thousand suits targeting DePuy Orthopaedics Inc. and Johnson & Johnson for selling allegedly defective hip implants.
- Should You Have Unfettered Access to Your Implanted Medical Device Data? Source: IEEE (Friday December 7, 2012)
- J&J's first vaginal mesh trial revs up this week Source: Fierce Medical Devices (Monday January 7, 2013)
Fierce Medical Devices reports: “For Johnson & Johnson ($JNJ), jury selection is scheduled to begin Jan. 7 for one of 1,800 lawsuits in New Jersey state court accusing the company of selling unsafe vaginal mesh implants without warning patients of the dangers.”
- What's the deal with those bad hip replacements? Source: Doctor Skeptic (Tuesday January 1, 2013)
“Most people are aware that a year or two ago there were some new hip replacements that were recalled. The story behind it has all the ingredients to suit this blog: overestimation of benefit, underestimation of harm, regulation failure, and conflict of interest up the wazoo.”
- Zimmer Spine has received reports of the PEEK Ardis Interbody Spacer breaking into fragments Source: FDA (Monday January 28, 2013)
Report any problems you might have with a Zimmer spine to your physician and the FDA at www.fda.gov/MedWatch/report.htm.
- Reporting complications from medical devices to the FDA Source: FDA (Friday December 21, 2012)
- ‘Redo’ joint replacement surgeries on rise in Western Pa. Source: Pittsburgh Tribune-Review (Sunday November 25, 2012)
- YES, YOU CAN HACK A PACEMAKER (AND OTHER MEDICAL DEVICES TOO) Source: Singularity HUB (Sunday December 9, 2012)
“For years, researchers have been exposing enormous vulnerabilities in internet-connected implanted medical devices.”
- FDA pledges to work with medical device industry consortium to speed up product approvals Source: Associated Press (Monday December 3, 2012)
AP: The Food and Drug Administration said Monday it will collaborate with medical device manufacturers on a public-private partnership designed to speed up the development of new medical technology.
- Heart Gadgets Test Privacy-Law Limits Source: Wall Street Journal (Wednesday November 28, 2012)
A recent swell of digital-medical data collected on devices outside of a doctor’s office is raising some thorny questions: Who owns the rights to a patient’s digital footprint and who should control that information? WSJ’s Linda Blake reports.
- Consumer Agency Finds Most Adult Bedrail Deaths Are Among Those 60 and Older Source: New York Times (Thursday November 29, 2012)
New Consumer Product Safety Commission report cited 155 deaths involving bedrails from January 2003 to this past September. About 126 of those who died were 60 or older.
- A Female Surgical Nightmare Source: In These Times (Wednesday June 13, 2012)
How a problematic medical device has escaped FDA regulation. A look at surgical mesh used on women for a prolapsed uterus.
- Podcast: Dead On the Operating Table: A Q&A with journalist Mina Kimes Source: ProPublica (Tuesday November 27, 2012)
ProPublica interviews journalist Mina Kimes of Fortune Magazine. Her report, “Bad to the Bone: A Medical Horror Story,” lays out in detail how a medical device company navigated around Food and Drug Administration rules meant to inform and protect patients.
- Video: Ben Goldacre: What doctors don't know about the drugs they prescribe Source: YouTube (Thursday September 27, 2012)
When a new drug gets tested, the results of the trials should be published for the rest of the medical world — except much of the time, negative or inconclusive findings go unreported, leaving doctors and researchers in the dark. In this impassioned talk, Ben Goldacre explains why these unreported instances of negative data are especially misleading and dangerous.
- A Name Blacked Out, a Reputation at Risk Source: New York Times (Monday November 26, 2012)
NYT’s Barry Meier reports on a medical device company whose executives blacked out the name of a heart device component when they released a critical federal report involving the product. This is the latest development in the controversy involving the component, an electrical wire that connects an implanted defibrillator to a patient’s heart.
- FDA took 684 days to warn meningitis-linked firm: files Source: Reuters (Wednesday November 21, 2012)
(Reuters) – The U.S. Food and Drug Administration took 684 days to issue a warning letter after uncovering infractions that could potentially harm patients at the pharmacy at the center of the deadly U.S. meningitis outbreak, newly released documents show.
- Advair boomed amid health risks Source: Journal Sentinel (Saturday November 17, 2012)
Asthma guidelines written by doctors with financial ties to maker
- As drug industry’s influence over research grows, so does the potential for bias Source: Washington Post (Saturday November 24, 2012)
“Over a year-long period ending in August, NEJM published 73 articles on original studies of new drugs, encompassing drugs approved by the FDA since 2000 and experimental drugs, according to a review by The Washington Post. Of those articles, 60 were funded by a pharmaceutical company, 50 were co-written by drug company employees and 37 had a lead author, typically an academic, who had previously accepted outside compensation from the sponsoring drug company in the form of consultant pay, grants or speaker fees.”
- Oversight Failures Documented in Meningitis Outbreak Source: New York Times (Wednesday November 21, 2012)
“Newly released documents add vivid detail to the emerging portrait of the Food and Drug Administration’s ineffective and halting efforts to regulate a Massachusetts company implicated in a national meningitis outbreak that has sickened nearly 500 people and killed 34.”
- After Dozens of Deaths, Inquiry Into Bed Rails Source: New York Times (Sunday November 25, 2012)
Since those first warnings in 1995, about 550 bed rail-related deaths have occurred, a review by The New York Times of F.D.A. data, lawsuits, state nursing home inspection reports and interviews, found. Last year alone, the F.D.A. data shows, 27 people died.
- Companies go surgery shopping Source: Los Angeles Times (Saturday November 17, 2012)
Employers are sending workers on all-expenses-paid trips to top-performing hospitals that agree to low, fixed rates for surgeries, such as hip and knee surgeries.
- Unnecessary surgery show Source: White Coat, Black Art (Saturday November 3, 2012)
30 minute program about unnecessary surgery, including hip and knee replacements.
- As Sales Fall, Allergan Seeks a Buyer for Lap-Band Source: New York Times (Tuesday October 30, 2012)
Allergan said Tuesday that it was looking to divest itself of its Lap-Band, the once-popular weight-loss device that has experienced several years of falling sales, loss of market share and controversies about its safety and effectiveness.
- Going Virtual To Improve Patient Safety Source: iHealthBeat (Monday October 29, 2012)
Created using computer-aided design to comprise FDA’s “Virtual Family Tool,” the models are being used to assess the safety and efficacy of medical implants and devices, and radiologic imaging.
- Meningitis outbreak tests physician trust in compounding pharmacies Source: American Medical News (Monday October 29, 2012)
“Unlike drugmakers such as Pfizer that must follow FDA-specified manufacturing practices, the safety and quality of compounding pharmacies is regulated by state pharmacy boards.”
- Report faults states’ oversight of specialty pharmacies Source: Washington Post (Sunday October 28, 2012)
State boards have failed to adequately regulate the safety of practices at specialty pharmacies like the one at the center of the deadly fungal meningitis outbreak, according to a congressional report to be released Monday.
- Ethicon Endo-Surgery Circular Stapler Sets: Class I Recall - User Difficulty With Firing Stapler Devices Source: FDA (Friday October 26, 2012)
FDA notified healthcare professionals of a Class I Recall of these products because of difficulty users have firing the stapler devices, resulting in incomplete firing stroke and incomplete staple formation.
- Medtronic's pull influenced Infuse articles, report finds Source: Star Tribune (Thursday October 25, 2012)
U.S. Senate panel alleges that Medtronic was heavily involved in shaping the content of medical journal articles about one of its bone graft devices, downplaying its risks.
- Senate report finds Medtronic manipulated studies on its products Source: The Hill (Thursday October 25, 2012)
Leaders with the Senate Finance Committee are charging medical device maker Medtronic with manipulating studies on its spine-fusion product and failing to disclose significant financial ties to the studies’ authors.
- Has industry co-opted patient engagement? Source: Ethical Nag (Tuesday October 16, 2012)
Carolyn Thomas discusses how drug companies co-opt patient engagement websites.
- FDA Statement on Fungal Meningitis Outbreak: Additional Patient Notification Advised Source: FDA (Thursday October 18, 2012)
[Update 10/18/2012] CDC and FDA have confirmed the presence of a fungus known as Exserohilum rostratum in unopened medication vials of preservative-free methylprednisolone acetate (80mg/ml) from one of the three implicated lots from NECC (Lot #08102012@51, BUD 2/6/2013). The laboratory confirmation further links steroid injections from these lots from NECC to the multistate outbreak of fungal meningitis and joint infections. Testing on the other two implicated lots of methylprednisolone acetate and other NECC injectables continues.
- A Drug Recall That Should Frighten Us All About The FDA Source: Forbes (Wednesday October 10, 2012)
“The FDA announced last week that the 300mg generic version of Wellbutrin XL manufactured by Impax Laboratories and marketed by Teva Pharmaceuticals was being recalled because it did not work. And this wasn’t just a problem with one batch – this is a problem that has been going on with this particular drug for four or five years, and the FDA did everything it could to ignore it.”
- Meningitis Outbreak: 2 More Drugs Probed Source: MedPage Today (Monday October 15, 2012)
Two other drugs made by the New England Compounding Center (NECC) appear to be involved in the fatal meningitis outbreak that has now claimed the lives of 15 people in as many states, the FDA announced Monday.
- 2 die in meningitis outbreak; Saint Thomas neurosurgery clinic shuts down Source: The Tennessean (Monday October 1, 2012)
The Tennessee Department of Health is joining forces with the Center for Disease Control to investigate an unusual outbreak of meningitis that has hit 11 Tennesseans so far, killing two of them.
- What a Failed Vegas Sex Pill and The Meningitis Outbreak Have In Common Source: ProPublica (Wednesday October 10, 2012)
The New England Compounding Center has come under scrutiny for producing a contaminated steroid shot linked to the recent meningitis outbreak.
- Analysis: When implanted medical devices go wrong, who pays? Source: Reuters (Monday October 8, 2012)
As the number of costly, high-profile recalls rises, along with pressure to cut their own spending, insurers are starting to pin more of the responsibility on manufacturers.
- “Mesh: Definitely risky for POP, but for SUI? Eh? It might be ok still, right?” Source: Mesh Medical Device News (Wednesday October 10, 2012)
Deb wonders when the FDA will issue something on Stress Urinary Incontinence (SUI) mesh.
- BeSafeRx: FDA Helping Consumers Avoid Risks of Online Prescription Drug Purchases Source: FDA (Tuesday October 9, 2012)
FDA campaign to educate consumers about the risks of buying prescription medications over the Internet.
- Multistate Meningitis Outbreak Investigation Source: CDC (Tuesday October 9, 2012)
A steroid injection from one compounding plant in MA are tainted with Fungle Meningitis.
- Multi-State Meningitis Outbreak - CDC map of the country Source: CDC (Tuesday October 9, 2012)
Persons with Meningitis Linked to Epidural Steroid Injections usually used for lower back pain. View the CDC map to see if the contaminated shots were sent to your area.
- New England Compounding Center Issues Voluntary Nationwide Recall of All Products Source: FDA (Wednesday October 3, 2012)
New England Compounding Pharmacy, Inc., a drug compounding company, has sold tainted steroid shot that infected people with Fungal Meningitis around the country.
- Hundreds of NZ hip replacements are faulty Source: New Zealand Herald (Thursday October 4, 2012)
A victim of a faulty hip replacement is not confident an inquiry will be launched into metal-on-metal implants, despite another 400 patients this week finding out their replacements could be faulty.
- Video: Harms of Overtreatment Source: YouTube (Wednesday October 3, 2012)
Investigative journalist Jeanne Lenzer with British Medical Journal investigates overtreatment at the heart of healthcare. Overly aggressive treatment is estimated to cause 30 000 deaths among Medicare recipients alone each year. Overall, unnecessary interventions are estimated to account for 10-30% of spending on healthcare in the US.
- Antibiotic Alert: The Drug The Doctor Ordered Could Cause Deadly Side Effects Source: Forbes (Sunday September 30, 2012)
The Frightening History of Fluoroquinolones
- GAO: Medical Devices Vulnerable to Hacking, Oversight Needed Source: iHealthBeat (Friday September 28, 2012)
GAO report warns of dangers of medical devices that rely on software to operate such as pacemakers and insulin pumps could be vulnerable to hacking.
- Smith & Nephew issues failure warning on all-metal hips Source: Fierce Medical Devices (Wednesday September 26, 2012)
Smith & Nephew has issued a warning on its Birmingham metal-on-metal hip implants, telling regulators that new data reveals higher rates of failure for the devices.
- The drugs don't work: a modern medical scandal Source: The Guardian (Friday September 21, 2012)
“The doctors prescribing the drugs don’t know they don’t do what they’re meant to. Nor do their patients. The manufacturers know full well, but they’re not telling.”
- Bad to the bone: A medical horror story Source: Forbes (Tuesday September 18, 2012)
Patients getting spine surgery became unwitting participants in clinical trials testing the off label use of a cement that is injected in the spine. After reported deaths from the off label use, the company, Synthes now owned by J&J, continued to urge orthopedic surgeons to use it on patients.
- Half of drugs prescribed in France useless or dangerous, say two specialists Source: The Guardian (Friday September 14, 2012)
The doctors claim that the state wastes money on unnecessary medicine that they blame for up to 20,000 deaths annually
- Popular Antibiotics May Carry Serious Side Effects Source: New York Times (Monday September 10, 2012)
Jane Brody reports for New York Times on the debilitating side effects associated with fluoroquinolones, a class of antibiotics that includes Cipro (ciprofloxacin), Levaquin (levofloxacin) and Avelox (moxifloxacin). In addition to occasional unwanted effects on the musculoskeletal, visual and renal systems, the drugs in rare cases can seriously injure the central nervous system (causing “brain fog,” depression, hallucinations and psychotic reactions), the heart, liver, skin (painful, disfiguring rashes and phototoxicity), the gastrointestinal system (nausea and diarrhea), hearing and blood sugar metabolism.
- FDA safety alert regarding Proton Pump Inhibitors (PPIs) Source: FDA (Wednesday February 8, 2012)
FDA notified the public that the use of stomach acid drugs known as proton pump inhibitors (PPIs) may be associated with an increased risk of Clostridium difficile–associated diarrhea (CDAD).
- Unpredictable Danger Looms Close to the Heart Source: New York Times (Friday September 7, 2012)
Years after her 4-year-old daughter’s heart device had a faulty wire that needed to be removed, mother of Avery de Groh worries about what to do with her daughter’s replacement wire that was recalled in December. As many as 20 percent of 128,000 patients worldwide with the Riata device may be affected. Some patients have elected to remove the Riata lead but there are risks involved with either decision.
- Shared Decision Making for Hip and Knee Replacement Candidates Source: The Doctor Weighs In (Thursday September 6, 2012)
Hip and knee replacement candidates could benefit from shared decision making to guide their health care decisions.
- Ouch! Hospital to review woman's $83,046 scorpion sting bill Source: USA Today (Thursday September 6, 2012)
$39,652 per dose for two shots of scorpion anti-venom! There is a cure but can you afford it?
- Solicitor Says DePuy Case May Affect 600 In Cork Source: Earl's View (Saturday September 1, 2012)
Up to 3,500 Irish people were fitted with the faulty ‘metal on metal’ hip replacement implants, recalled by DePuy worldwide on August 24th, 2010 in the face of data gathered by UK academics and medics that showed higher than expected failure rates of the devices.
- Feds notify hospitals of liability for wrongly implanted heart devices Source: Modern Healthcare (Thursday August 30, 2012)
“In what experts say is a novel legal tactic to resolve hundreds of ongoing investigations simultaneously, the Justice Department is e-mailing hospitals across the country today with instructions to examine questionable implantable defibrillator surgeries on Medicare patients and estimate potential penalties under the False Claims Act.”
- "Steel Standing" : Metal allergy causes woman's muscles to wither Source: ABC 3340 (Monday July 30, 2012)
Alabama woman develops muscular problems after receiving metal implants.
- India shakes up rules on clinical trials Source: Nature (Tuesday August 21, 2012)
India’s clinical-trials system has come under intense scrutiny after a series of scandals involving alleged malpractice and patient deaths, which has sparked widespread public protests.
- Markey, Merkley Call on FDA to Reform Medical Devices Databases Source: U.S. Congressman Ed Markey (Wednesday August 15, 2012)
Today, Representative Edward J. Markey (D-Mass.) and Senator Jeff Merkley (D-Ore.) sent a letter to the Food and Drug Administration (FDA) calling on the agency to overhaul and streamline the federal databases that provide information to the public about the safety of medical devices that rarely undergo clinical trials in humans before being sold on the market. In the absence of legislation that would close the current loophole in federal law that allows defective devices to enter the market and jeopardize patient safety, the lawmakers are urging reforms be made immediately to the FDA’s main medical device databases.
- Congressmen Ask FDA to Update Database to Improve Medical Device Safety Source: New York Legal Examiner (Monday August 27, 2012)
In an effort to make the data concerning medical devices more available to the public, Representative Edward Markey (D-Massachusetts) and Senator Jeff Merkley (D-Oregon) have sent a letter to the FDA. In the letter, they ask about the FDA’s willingness to make changes to the 510(k) premarket notification database. The lawmakers requested answers to their questions by September 19, 2012.
- Fat-Melting Device a Weighty Matter for FDA Source: Fair Warning (Wednesday July 11, 2012)
For several years, doctors and medical spas around the country have touted a fat-melting device called the LipoTron 3000, or Lipo-Ex, as a revolutionary way for people to slim down. But the device has never been cleared or approved by the FDA, which would make it illegal under federal law to sell or promote it for weight loss.
- Over 123 Million Medical Device Units Recalled in Second Quarter of 2012, Reaching an Eight-Quarter High, According to the ExpertRECALL Index Source: Wall Street Journal Market Watch (Tuesday August 21, 2012)
More than 123 million units in the medical device category – which includes products like knee replacements, syringes, gels used in ultrasound procedures, dental implants, and products used in heart surgery – were recalled during the second quarter of 2012, according to the quarterly ExpertRECALL(TM) Index released today.
- ‘Toxic’ hip replacement fears – Health – Belfast Newsletter Source: Earl's View (Wednesday August 22, 2012)
Earl’s View blog reports that UK media outlets are reporting a new warning for metal on metal hip implants, claiming that the risk from the devices is greater than previously thought, with greater failure rates.
- Covidien recalls, discontinues device tied to deaths Source: Fierce Medical Devices (Wednesday August 22, 2012)
Covidien recalls its surgical tools after its products were linked to serious injuries and deaths.
- J&J's Synthes recalls bone putty over fire risk Source: Fierce Medical Devices (Tuesday August 21, 2012)
Johnson & Johnson’s ($JNJ) Synthes unit launched a recall of its Hemostatic Bone Putty, warning that the implant could catch fire if exposed to cauterization systems during surgery, and the FDA has slapped its most serious label on the affair.
- FDA warns Medtronic on manufacturing guideline violations Source: Reuters (Tuesday August 21, 2012)
The U.S. health regulator warned Medtronic Inc that certain devices manufactured by the company violated manufacturing and quality regulations that could lead to patient injuries.
- FDA warns Medtronic over implantable drug infusion pump snafu Source: Fierce Medical Devices (Tuesday August 21, 2012)
The FDA slapped Medtronic ($MDT) with a warning letter over a faulty implantable drug infusion pump that appears susceptible to corrosion, a fatal flaw that could injure patients.
- Trouble for St. Jude as study flags Durata failures Read more: Trouble for St. Jude as study flags Durata failures Source: Fierce Medical Devices (Tuesday August 21, 2012)
St. Jude Medical ($STJ) has been working to distance its Durata line of leads from the recalled Riata devices, but a new study reports that some of newer techs suffer from the same problem.
- Raising the Ritalin Generation Source: New York Times (Saturday August 18, 2012)
Bronwen Hruska writes for the New York Times about the mixed feelings she had about her 8-year-old son taking Ritalin.
- St. Jude Heart Defibrillator Recipients Need X-Rays To Check For Abnormalities: FDA Source: Reuters (Thursday August 16, 2012)
Patients implanted with certain heart defibrillators made by St. Jude Medical Inc should have X-rays or other imaging tests to check for abnormalities, the U.S. Food and Drug Administration said on Thursday.
- St. Jude’s Defibrillator Leads: Information for Patients Source: Wall Street Journal Health Blog (Monday August 16, 2010)
The FDA advised doctors to begin routinely screening the nearly 80,000 U.S. patients who have Riata defibrillator leads in their chests with X-rays to search for signs that a device’s insulation is wearing away.
- Doctors Grapple With FDA Advice For Troubled Heart Wire Source: Wall Street Journal Health Blog (Friday August 17, 2012)
When U.S. regulators advised doctors to routinely X-ray patients with a flawed St. Jude Medical Inc. heart device Thursday, top heart doctors asked, “why?” The agency doesn’t recommend that doctors treat patients any differently if they detect flaws, potentially subjecting thousands of people to unneeded medical tests.
- FDA recommends X-ray or other imaging on implanted heart defibrillators with St. Jude Medical Riata leads to help guide treatment Source: FDA (Thursday August 16, 2012)
The U.S. Food and Drug Administration recommended today that patients who have implantable heart defibrillators with Riata and Riata ST leads, manufactured by St. Jude Medical, should have X-rays or other imaging alternatives to check for abnormalities in the insulation surrounding the lead, which is a wire attached to the device that is inserted into the heart.
- Wright subpoenaed over metal hip implants Source: Fierce Medical Devices (Wednesday August 8, 2012)
Wright Medical hit with subpoena over metal-on-metal hip replacement.
- Use Of 13 Disease Registries In 5 Countries Demonstrates The Potential To Use Outcome Data To Improve Health Care’s Value Source: Health Affairs (Thursday December 1, 2011)
Abstract only. Authors of a study published in Health Affairs Dec 2011 calculate that if the United States had a registry for hip replacement surgery comparable to one in Sweden that enabled reductions in the rates at which these surgeries are performed a second time to replace or repair hip prostheses, the United States would avoid $2 billion of an expected $24 billion in total costs for these surgeries in 2015.
- Two Arms, Two Choices: If Only I’d Known Then What I Know Now Source: Health Affairs (Wednesday August 1, 2012)
Disabled by faulty arm surgery and harmed by a hospital-acquired infection, a patient wishes he’d been better informed. Article by Colorado patient safety advocate Kerry O’Connell for Health Affairs.
- Pennsylvania woman to address FDA panel on husband's hip-replacement recall Source: The Philly Inquirer (Wednesday June 27, 2012)
Pennsylvania woman travels to DC to share her husband’s story about problems with his recalled metal on metal hip.
- The FDA Is Spying on Its Own Scientists Source: Mother Jones (Wednesday August 1, 2012)
Tom Philpott: “It looks like the FDA knowingly chose to expose untold thousands of people to unnecessary cancer risk to apparently to appease General Electric and other medical-device makers.”
- Some US pharmacies "selling entire inventories to gray market" Source: PharmaTimes Online (Tuesday July 31, 2012)
Some US pharmacies are selling their entire inventories to “gray” marketeers, who make enormous profits by buying hard-to-find drugs and re-selling them at huge mark-ups, a joint Congressional investigation has found.
- Couple wins landmark trial against medical company Source: KGET (Monday July 23, 2012)
California woman harmed by vaginal mesh wins case against medical device company
- Congress Gives FDA 2 Years to Issue Social Media Guidance. All Bark, No Bite. Source: Pharma Marketing Blog (Friday July 20, 2012)
Congress Gives FDA 2 Years to Issue Social Media Guidance. All Bark, No Bite.
- Anemia drugs made billions, but at what cost? Source: The Washington Post (Thursday July 19, 2012)
A growing number of research has shown that top selling FDA-approved anemia drugs overstated the benefits, and potentially lethal side effects, such as cancer and strokes, were overlooked.
- FDA investigating how device-approval files leaked Source: Fierce Medical Devices (Monday July 16, 2012)
The FDA is already facing a lawsuit from 5 current and former investigators after the agency monitored their email communications. Now the regulator has another problem: About 75,000 pages of related confidential documents ended up posted online for all to see.
- CORRECTED-St. Jude's Riata large-diameter leads have most problems-study Source: Reuters (Monday July 16, 2012)
St. Jude Medical Inc said on Monday initial findings from a study on its Riata defibrillator leads, which were recalled in late 2011, showed that lead erosion that occurred from the inside out happened most frequently in larger diameter leads.
- St. Jude: Riata erosion more common in large leads Source: Fierce Medical Devices (Monday July 16, 2012)
St. Jude Medical ($STJ) is investigating the dangers of its now-recalled Riata leads, and the company says larger-diameter models are more likely to suffer from erosion.
- Vast F.D.A. Effort Tracked E-Mails of Its Scientists Source: New York Times (Saturday July 14, 2012)
“F.D.A. officials defended the surveillance operation, saying that the computer monitoring was limited to the five scientists suspected of leaking confidential information about the safety and design of medical devices.”
- Reports From F.D.A. Surveillance Operation Source: New York Times (Saturday July 14, 2012)
These documents were reports from a surveillance operation by the Food and Drug Administration against a group of its own scientists. For privacy reasons, the Times redacted the names of several scientists and others named in the memo who have not been publicly identified.
- As lawsuits climb, J&J may have new hip trauma Source: Fox News (Thursday July 12, 2012)
Johnson & Johnson has another metal hip problem. After recalling the ASR hip, it appears the “Pinnacle hip replacement” which was manufactured by J&J after the ASR hip is showing similar problems.
- Replay of FDA teleconference on sterilizer product recall available Source: AHA News (Friday July 6, 2012)
The Food and Drug Administration yesterday held an informational teleconference on the voluntary recall of a product used by hospitals and surgical centers to monitor the effectiveness of certain sterilization systems.
- U.S. plans IDs to track medical device safety Source: Reuters (Tuesday July 3, 2012)
“While these codes are already present for most consumer goods, in the ubiquitous barcodes scanned at the grocery store, they have been absent from life-sustaining medical devices.”
- Medical devices will begin getting special codes to help improve patient safety Source: New Jersey Star Ledger (Tuesday July 3, 2012)
FDA is developing a system to identify each medical device with a special code to help notify patients of recalls and other problems under a new rule proposed by the FDA.
- Students, doctors protest looser medical gift ban in state budget Source: Boston Globe (Friday July 6, 2012)
Governor Deval Patrick is scheduled Sunday to sign a new $32.5 billion state budget that would likely loosen a ban on gifts from drug and medical device companies to doctors. The proposed measure scales back restrictions imposed in 2008, and would now allow companies to pay for “modest” meals and refreshments for doctors as part of informational sessions about their products.
- Dr. Drew, sex advice, big $ and antidepressants Source: HealthNewsReview.org (Thursday July 5, 2012)
Gary Schwitzer reports for HealthNewsReview.org on doctors paid by GlaxoSmithKline to illegally promote its antidepressant drug Wellbutrin for many other problems, including sexual dysfunction.
- Obama Signs FDA User Fee Bill Into Law Source: Regulatory Focus (Monday July 9, 2012)
US President Barack Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law on 9 July 2012—12 days after the Senate approved the bill and 17 days after the House of Representatives passed the bill.
- Stryker recalls certain hip implant products Source: Reuters (Friday July 6, 2012)
Orthopedic implant maker Stryker Corp said it has begun to recall certain modular-neck stems used to correct hip biomechanics, due to potential risks associated with fretting and corrosion.
- Stryker recalls metal hip implants over corrosion risk Source: Fierce Medical Devices (Monday July 9, 2012)
Stryker is recalling two metal-on-metal hip implants, halting worldwide production of the devices amid concerns of fretting and corrosion.
- MoMs Hips a Grinding Dilemma for Hospitals, Doctors, FDA Source: HealthLeaders Media (Thursday July 5, 2012)
Cheryl Clark for HealthLeaders Media reports: Metal-on-metal hips — an FDA panel renews concern. Should implants be suspended until safety experts figure this out?
- FDA alerts hospitals, surgical centers to sterilizer product recall Source: AHA News (Thursday July 5, 2012)
The Food and Drug Administration Tuesday announced the voluntary recall of a product used by hospitals and surgical centers to monitor the effectiveness of certain sterilization systems.
- FDA Recalls Baby Breathing Device Source: MedPage Today (Thursday July 5, 2012)
The FDA has elevated the recall of an infant breathing circuit to Class I due to the potential formation of a crack that can reduce tidal volume in therapy and may cause death.
- Delays and Difficulties in Assessing Metal-on-Metal Hip Implants Source: NEJM (Thursday July 5, 2012)
The FDA ordered manufacturers to conduct post market studies on these devices a year ago but few have even started studies much less supply FDA with useful data on their performance.
- FDA seeks unique device ID code Source: Minneapolis Star Tribune (Tuesday July 3, 2012)
The proposed identifiers would make high-risk medical devices easier to track and recall, the agency says, improving patient safety. Article quotes Consumers Union.
- FDA lays out new system to track medical devices Source: McClatchy Newspapers (Thursday July 5, 2012)
On Tuesday, the U.S. Food and Drug Administration proposed a new system to better track high-risk medical devices after they have gone public, giving patients, doctors, regulators and consumer advocates access to information about specific products. Consumers Union quoted in the article.
- Medical devices will begin getting special codes to help improve patient safety Source: NJ Star-Ledger (Tuesday July 3, 2012)
Medical devices will start being manufactured with a special code to help identify them in the event of recalls and other problems under a new rule passed by federal regulators. Consumers Union quoted in the article.
- Medical Devices To Get Unique Identification Numbers In FDA Plan Source: Bloomberg (Tuesday July 3, 2012)
Medical devices including catheters, defibrillators, heart stents and artificial joints will carry unique identification numbers under a plan proposed by the U.S. Food and Drug Administration to improve patient safety.
- FDA says device-ID plan a 'game-changer' Source: Fierce Medical Devices (Thursday July 5, 2012)
The FDA has released its plan to track medical devices by requiring each to feature a unique identification system, which the agency hopes will improve accuracy of reporting and keep patients safe, The Wall Street Journal reports.
- FDA proposes unique device identification system for medical devices Source: FDA (Tuesday July 3, 2012)
The U.S. Food and Drug Administration proposed that most medical devices distributed in the United States carry a unique device identifier, or UDI.
- GSK pleads guilty and agrees to pay $3 billion to settle charges of improper marketing Source: Bloomberg News (Monday July 2, 2012)
British drugmaker GlaxoSmithKline agreed to plead guilty and pay $3 billion to resolve allegations that it illegally promoted prescription medicines and failed to report safety data, the U.S. said.
- Maine to get $4.4 million in GSK settlement Source: WMTW (Monday July 2, 2012)
Maine Attorney General William Schneider says Maine will get $4.4 million as part of a settlement with pharmaceutical company GlaxoSmithKline. Money part of $3 billion settlement with federal government, states.
- Florida to get $56 million from $3 billion Glaxo settlement Source: South Florida Business Journal (Monday July 2, 2012)
Florida will receive more than $56 million as part of a $3 billion settlement with GlaxoSmithKline that involved the federal government, Florida and other states, Attorney General Pam Bondi said on Monday.
- GlaxoSmithKline in $3 billion fraud settlement Source: CNN (Monday July 2, 2012)
GlaxoSmithKline was slapped with a $3 billion fine Monday by the U.S. Justice Department after failing to report safety data on some of the company’s most popular drugs.
- Glaxo Agrees to Pay $3 Billion in Fraud Settlement Source: New York Times (Monday July 2, 2012)
In the largest settlement involving a pharmaceutical company, the British drugmaker GlaxoSmithKline agreed to plead guilty to criminal charges and pay $3 billion in fines for promoting its best-selling antidepressants for unapproved uses and failing to report safety data about a top diabetes drug, federal prosecutors announced Monday. The agreement also includes civil penalties for improper marketing of a half-dozen other drugs.
- GlaxoSmithKline settles healthcare fraud case for $3 billion Source: Reuters (Monday July 2, 2012)
GlaxoSmithKline Plc has agreed to plead guilty to misdemeanor criminal charges and pay $3 billion to settle what government officials said on Monday is the largest case of healthcare fraud in U.S. history.
- GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data Source: US Department of Justice (Monday July 2, 2012)
Largest Health Care Fraud Settlement in U.S. History
- Metal Hip Replacements Could Cause Chronic Pain, Should Be Avoided Source: The Christian Post (Saturday June 30, 2012)
Reporting on FDA’s 2-day panel on the safety of metal-on-metal hip implants.
- Study: iPad use could muddle shunt settings Source: Fierce Medical Devices (Friday June 29, 2012)
The small magnets in iPads can scramble the settings on implantable shunts, a new study reports, and researchers are cautioning parents to keep a distance between the mobile devices and kids with the hydrocephalus-treating techs.
- FDA panel recommends against metal-on-metal hip implants Source: Fierce Medical Devices (Friday June 29, 2012)
Reporting on FDA’s 2-day panel examining the safety of metal-on-metal hip implants.
- FDA user fee bill passes Senate, 92-4 Source: Politico (Wednesday June 27, 2012)
Next stop-the President.
- Hip, Hip, Delay Source: Gooznews (Wednesday June 27, 2012)
Metal hip hearing comes after passage of the FDA user fee bill which fails to address inadequate safety testing crucial to safe hip implants.
- F.D.A. Hearing to Focus on Replacement Hips Source: New York Times (Tuesday June 26, 2012)
“Why were these devices implanted in 500,000 people without adequate testing?”
- FDA panel sees little use for metal-on-metal hips Source: Associated Press (Friday June 29, 2012)
Report on the FDA panel examining the safety of metal-on-metal hips.
- F.D.A. Hearing to Focus on Replacement Hips Source: New York Times (Tuesday June 26, 2012)
The Food and Drug Administration will start a two-day hearing on Wednesday meant to help doctors find ways to better monitor the risks posed by all-metal replacement hips.
- J&J Sold Vaginal Mesh Implant After Sales Halt Ordered Source: Bloomberg (Tuesday June 26, 2012)
On June 5, J&J said it will stop selling four vaginal mesh implants including the Prolift in response to lawsuits. The company will not withdraw the Prolift before its “planned discontinuation” of the mesh products over the next three to nine months.
- Hip Implant Concerns Reached 16,800 In A Decade, FDA Says Source: Bloomberg (Thursday June 21, 2012)
Almost 16,800 adverse events associated with metal-on-metal hip implants were reported in the U.S. from 2000-2011, FDA said.
- House rushes through approval of new PDUFA legislation Source: Fierce Biotech (Thursday June 21, 2012)
Next stop-the Senate and then the President’s desk.
- House Passes Compromise FDA Reauthorization Measure Source: Bloomberg (Wednesday June 20, 2012)
The House passed the drug and medical device user fee bill that came out of conference that ironed out the differences between the House and Senate bills passed earlier.
- Kidney-donor deaths linked to surgical clips raise issues of alerts, warnings Source: CNN (Thursday June 21, 2012)
Tiny surgical clips were linked to the death of a woman who donated a kidney. Hospitals are alerted against using clips in laparascopic kidney donor surgery. But at least five deaths raise issues about whether stronger warnings are needed.
- Podcast: Talking Mesh with Amanda Marcotte of RH RealityCast Source: In These Times (Monday June 18, 2012)
Lindsay Beyerstein spoke with Amanda Marcotte of RH RealityCast about “A Female Surgical Nightmare,” her new feature about how one flawed women’s health product reveals the shortcomings of the FDA’s medical device regulation system.
- A Female Surgical Nightmare Source: In These Times (Wednesday June 13, 2012)
How a problematic medical device has escaped FDA regulation. Lindsay Beyerstein reports on problems experienced by women who use mesh products for transvaginal repair of pelvic organ prolapse.
- House cheers, approves FDA reform bill Source: The Hill (Wednesday June 20, 2012)
House approves FDA User Fee compromise bill.
- Medical-device spokesman's claim on heart disease termed 'overstated,' 'outlandish' Source: MinnPost (Monday June 18, 2012)
Dale Wahlstrom of LifeScience Alley (medical device industry trade group) recently claimed that medical devices had cut the death rate from heart disease by 50% and for strokes by 30%. Those estimates have been criticized for being wildly overblown since therapeutic drugs and lifestyle changes are the main reason deaths from heart disease and strokes have dropped in recent years:
- Kera News NPR report on knee replacement surgery Source: Kera News (Monday June 18, 2012)
Kera News interviews a North Texas doctor discussing custom fit knee implants. Unfortunately, this doctor makes no mention of patient safety risks of these new knee implants.
- Knee implants: more evidence needed? Source: Biggleswade Chronicle (Monday June 18, 2012)
BBC reports on a new report in The Lancet that said more evidence is needed on long-term safety of knee implants. New implants are often introduced with little or no evidence of their effectiveness.
- Bundled Payments and Joint Replacement Source: HealthLeaders Media (Wednesday June 13, 2012)
To reduce expenses for medical devices, healthcare systems are getting involved with bundled payments, and joint replacement is seen as an important niche for such programs.
- Dialysis Company’s Failure to Warn of Product Risk Draws Inquiry Source: New York Times (Thursday June 14, 2012)
The Food and Drug Administration is investigating whether the nation’s largest operator of dialysis centers violated federal regulations by failing to inform customers of a potentially lethal risk connected to one of its products, an F.D.A. official said.
- Consumers Union Urges Congress to Adopt Stronger Medical Device Patient Safety Source: Clarksville Online (Wednesday June 13, 2012)
Consumers Union, the policy and advocacy arm of Consumer Reports, urged House and Senate leaders today to adopt a number of provisions from the Senate’s FDA User Fee Act that would better protect patients from potentially dangerous medical devices than the version passed by the House.
- More Women Need To Be Involved In Medical Device Trials Source: CT Health I Team (Friday June 8, 2012)
Only recently has the FDA proposed guidelines to improve the representation of women in clinical device trials, but these guidelines are nonbinding and experts are skeptical that the medical device industry will comply.
- U.S. Has Drug Recall Problem, Study Says Source: ABC News (Monday June 4, 2012)
In a new study published in the Archives of Internal Medicine, researchers found that the FDA issued official public notices for only about half of the recalls deemed the most serious, called Class I recalls.
- Congress leaves dangerous medical device loophole intact Source: The Orange County Register (Tuesday June 5, 2012)
Despite heavy lobbying by consumer groups, Congress last week declined to close a loophole that allows medical devices based on flawed predecessors to make it to market. Article quotes Lisa McGiffert, head of the Safe Patient Project for Consumers Union.
- Report: J&J To Stop Selling Controversial Vaginal Mesh Implants Source: Common Health (Tuesday June 5, 2012)
Common Health of Boston’s NPR news station reports on J&J’s decision to halt sales of several vaginal mesh implants that many women say have led to painful and debilitating long-term complications.
- Surgery Under Scrutiny: What Went Wrong With Vaginal Mesh Source: Common Health (Friday November 4, 2011)
Common Health of Boston’s NPR news station interviews women who have been seriously injured by vaginal mesh implants and details how these devices are cleared for sale through the FDA’s fast-track process.
- J&J To Halt Sales Of Vaginal Mesh Implants Source: Pharmalot (Tuesday June 5, 2012)
Pharmalot reports on Johnson & Johnson’s unexpected move to halt marketing of four vaginal mesh implants that have harmed women.
- Congress leaves dangerous medical device loophole intact Source: Orange County Register (Tuesday June 5, 2012)
Both House and Senate failed to include an amendment that would stop the practice of using faulty devices as predicates used in order to get a new device on the market.
- J&J To Halt Sales Of Vaginal Mesh Implants Source: Pharmalot (Tuesday June 5, 2012)
The decision involves four Gynecare products – TVT Secur; Prosima Pelvic Floor Repair System, Prolift Pelvic Floor Repair System and the Proflit MTM Pelvic Floor Repair System.
- Report: J&J To Stop Selling Controversial Vaginal Mesh Implants Source: WBUR Boston (Tuesday June 5, 2012)
J & J has stopped production of 4 vaginal mesh products: TVT Secur; Prosima Pelvic Floor Repair System, Prolift Pelvic Floor Repair System and the Proflit MTM Pelvic Floor Repair System. All four have been the subject of lawsuits involving serious patient harm.
- House affirms FDA user fee in sweeping bipartisan vote Source: MassDevice (Wednesday May 30, 2012)
House passes medical device bill, which fails to includes important provisions needed to protect patients from unsafe medical devices, according to Consumers Union, the policy and advocacy arm of Consumer Reports.
- Consumer groups unhappy with bill easing medical device FDA review process Source: Minnesota Public Radio (Tuesday May 29, 2012)
Minnesota Public Radio reports on the medical device legislation pending in Congress.
- U.S. Senate passes bipartisan FDA funding bill Source: Reuters (Thursday May 24, 2012)
Update from Reuters on the medical device user fee bill. “Congress is missing the opportunity to fix a broken system that lets too many unsafe medical devices on the market,” said Lisa McGiffert, director of the Safe Patient Project at Consumers Union.
- FDA user fee bill passed by Senate Source: Politico (Thursday May 24, 2012)
Senate passes FDA user fee bill but misses important patient safety protections. Lisa Swirsky, senior policy analyst at Consumers Union, quoted.
- White House statement on Senate medical device bill Source: White House (Thursday May 17, 2012)
The White House issues a statement endorsing the S. 3187, the Food and Drug Administration Safety and Innovation Act.
- FDA rule clears medical devices without human testing Source: The Orange County Register (Saturday May 19, 2012)
The Orange County Register reports on dangerous flaws in the fast-track 510k medical device regulatory process. Lisa McGiffert, Director of Consumers Union’s Safe Patient Project quoted.
- Bipartisanship in Congress, in Support of Pharma and Device Industries Source: Hooked: Ethics, Medicine, and Pharma (Tuesday May 15, 2012)
Howard Brody, MD, PhD writes about the bipartisan support in Congress for approving FDA user fee bills that fail to address the concerns of consumer advocates.
- Consumer Reports on the Device Mess Source: Hooked: Ethics, Medicine, and Pharma (Wednesday April 4, 2012)
Coverage on the Consumer Reports investigation of dangerous medical devices by Howard Brody, MD, PhD.
- Video: Questionable medical bill passes through House committee Source: KGO-TV San Francisco ABC7 (Wednesday May 16, 2012)
Medical device bills in Congress fail to address a dangerous loophole that allows FDA fast-track approval of medical devices as long as they resemble devices that have already been approved, even if the original devices have been recalled for safety defects.
- Medical Device Recalls Soar During First Quarter, ExpertRECALL Index Shows Source: Wall Street Journal (Monday May 14, 2012)
Medical device recalls increased more than 160 percent in the first quarter of 2012, affecting more than five times as many units than the previous quarter, according to the quarterly ExpertRECALL(TM) Index.
- Medical Implant Recalls Raises Questions About 510k Review Process Source: U.S. PIRG (Thursday May 10, 2012)
The huge increase in recalls and repeat surgeries calls into question if the 510 (k) review process is really protecting consumer’s health.
- Agonizing Choices for Heart Patients Source: Wall Street Journal (Friday May 11, 2012)
Patient with recalled defibrillator lead decides he wants to have his leads removed to avoid the device failing. The removal surgery can be damaging as well, but a growing number of patients are making the difficult decision to remove the leads. 79,000 U.S. patients are implanted with the troubled Riata defibrillator lead.
- American Pain Foundation Shuts Down as Senators Launch Investigation of Prescription Narcotics Source: ProPublica (Tuesday May 8, 2012)
American Pain Foundation shuts down as senators probe painkiller industry.
- FDA user fee bill appears safe from GOP poison pills Source: Politico (Sunday May 6, 2012)
“There’s a bipartisan push to get the FDA bill — negotiated with the medical device and pharmaceutical industries — enacted ahead of the Supreme Court ruling on the health reform law expected in June, which could quickly pull a relatively bipartisan health-related bill into a swamp of political grandstanding.”
- MDUFMA: FDA user fee agreements survive partisan fray in the House Source: MassDevice (Monday May 7, 2012)
Lawmakers are motivated to maintain bipartisan momentum on FDA user fee bills. A U.S. House version of a bill reauthorizing FDA user fees for medical devices and pharmaceuticals, posted just before the weekend, will head to the House Energy & Commerce Subcommittee tomorrow for an open markup session.
- How Does the FDA Monitor Your Medical Implants? It Doesn’t, Really Source: ProPublica (Thursday May 3, 2012)
How many Americans get medical implants each year? The FDA doesn’t know either.
- More women describe transvaginal mesh problems Source: CTV News (Tuesday May 1, 2012)
Since CTV News first reported on a class action lawsuit filed on behalf of women who say they have had life-altering complications from something called transvaginal surgical mesh sling, more women have come forward with similar complaints.
- Four Medical Implants That Escaped FDA Scrutiny Source: ProPublica (Monday April 30, 2012)
ProPublica takes a closer look at four types of implantable medical devices that have drawn the most criticism: hip implants, surgical mesh, heart valve rings and defibrillator leads.
- Practical steps to help the device industry Source: Star Tribune (Sunday April 29, 2012)
StarTribune’s Howard Root writes that the industry needs a better prepared labor force. It can’t all be blamed on regulations.
- New York Times Editorial: Cozy Deal Source: New York Times (Saturday April 28, 2012)
“The best approach would be for the government to fully finance the F.D.A. That is unlikely to happen. So before it ratifies any new deal on “user fees,” Congress must ensure that patient safety is the first priority.”
- Senate panel adds safety measures to FDA user fee act Source: MassDevice (Wednesday April 25, 2012)
The U.S. Senate’s Health, Education, Labor & Pensions Committee passes the “Food & Drug Administration Safety and Innovation Act,” but fails to include provisions consumer advocates insist are necessary to protect patients from unsafe medical devices.
- FDA Plans ID-Tag System to Detect Faulty Devices Source: Wall Street Journal (Wednesday April 25, 2012)
FDA’s unique identifier system will tap medical and billing records from hospitals and insurance companies that could potentially allow the agency to know more precisely the rate at which a device is failing, and which patients have devices prone to malfunctions. Five years ago, Congress authorized the creation of Unique Device Identifiers but we still don’t have them.
- Michigan Lawmaker Wants FDA Promoting Jobs, Industry Source: Mesh Medical Device Newsdesk (Friday April 20, 2012)
Jane Akre reports on the medical device user fee debate in Congress. One Michigan lawmaker has proposed a legislative amendment that would change the FDA’s mission to include job creation.
- FDA rips Europe's system for medical device reviews Source: Star Tribune (Sunday April 22, 2012)
Under pressure by the medical device industry to speed up device approvals in the upcoming reauthorization of medical device user fees, an FDA report sheds light on the safety issues associated with the device approval process in the European Union.
- FDA Warns of Contaminated Ultrasound Gel Source: MedPage Today (Wednesday April 18, 2012)
he FDA has warned consumers against using three lots of an ultrasound transmission gel because of a risk of bacterial infection.
- The Human Cost of FDA Decisions: For a Midwestern Family, A Breakdown in Drug Safety Hits Home Source: Union of Concerned Scientists (Tuesday April 10, 2012)
The Union of Concerned Scientists blogs about Gwen’s story about her mother, Maxine, who suffered strokes and memory loss after being prescribed Vioxx. Vioxx is a drug that had won FDA approval in 1999 after the drug’s maker manipulated clinical trials to hide data suggesting that the drug increased the risk of strokes and heart attacks.
- House Energy & Commerce Health Subcommittee April 18, 2012 Hearing on FDA User Fees Source: U.S. House Energy & Commerce Committee (Tuesday April 17, 2012)
House Energy & Commerce Subcommittee on Health will hold a hearing on April 18, 2012 at 10:15am to discuss FDA User Fees, including the Medical Device User Fee Act (MDUFA). The hearing will also be webcast on the committee website.
- Jim Guest Letter to the Editor: Safety of Medical Implants Source: New York Times (Friday April 13, 2012)
The President of Consumer Reports calls for common sense reforms to medical device safety oversight in a letter to the editor of New York Times.
- Australia, New Zealand, recall J&J hip implant components Source: Fierce Medical Devices (Monday April 16, 2012)
Johnson & Johnson is facing more bad news over its metal-on-metal artificial hip implant products, this time in New Zealand and Australia.
- Ex-Medicare chief Berwick lauds medical device industry Source: MassDevice (Friday April 6, 2012)
“Erstwhile Centers for Medicare & Medicaid Services chief Dr. Donald Berwick tells MassDevice.com that, despite a clutch of headline-grabbing recalls, medical device makers are doing good work for patients.”
- Bad Wire in Heart Device Led to 22 Deaths, Study Says Source: New York Times (Tuesday March 27, 2012)
A defect in wires that connect hearts to defibrillators caused at least 22 deaths, possibly as a result of a short circuit that is difficult to detect during routine monitoring, according to a study in the journal Heart Rhythm.
- St. Jude to Stop Selling Certain Device Wires Source: New York Times (Wednesday April 4, 2012)
Following news coverage of flawed St. Jude heart devices, St. Jude Medical will stop selling two types of wires used in devices that treat heart failure because conductive wires in some cases were sticking out of their insulation.
- Troubling Flaws in a Heart Device Shake Implant Makers Source: New York Times (Friday April 6, 2012)
The St. Jude Riata defibrillator is the latest example of a medical implant without proper safety review that harmed a patient.
- More questions about testing, FDA approvals of medical-device implants Source: Dallas Morning News (Friday March 30, 2012)
The Dallas Morning News reports on the new Consumer Reports investigation on Dangerous Medical Devices.
- Untested medical devices, treatments dangerous: Consumer Reports Source: ABC KABC (Wednesday March 28, 2012)
ABC news coverage of Consumer Reports’ Dangerous Medical Devices report, which found that some medical devices may not be clinically tested at all.
- FDA to discuss risks and benefits of metal-on-metal hip replacements Source: FDA (Thursday March 29, 2012)
FDA announces two-day panel to address risks and benefits of metal-on-metal hip replacements
- Probe: Many medical devices not safety-tested Source: Newsday (Wednesday March 28, 2012)
“Despite requirements for pre-marketing review, the investigation found few devices undergo rigorous clinical testing and the standards themselves haven’t changed in a generation.”
- Consumer Reports blasts implant safety Source: Fierce Medical Devices (Wednesday March 28, 2012)
Fierce Medical Devices reports on a new Consumer Reports investigation of untested medical devices that puts patients at risk.
- Report: Medical implants rarely tested Source: CBS News (Wednesday March 28, 2012)
CBS News coverage of Consumer Reports medical devices investigation. A new Consumer Reports investigation shows artificial hips and some other medical devices are rarely rigorously tested to make sure they’re safe.
- Consumer Reports targets medical devices' safety Source: Los Angeles Times (Wednesday March 28, 2012)
The Lap-Band, surgical mesh, metal hips and certain cardiac devices are cited by Consumer Reports, which says the government allows some products to be sold with little or no advance safety testing.
- How Much Will the Medical Device Tax Hurt? Source: Bloomberg (Thursday March 22, 2012)
This Bloomberg article offers a good critique of the medical industry’s claim that the medical device tax included in the health reform law will lead to big industry losses and cause jobs to move overseas.
- Hip Device Phaseout Followed F.D.A. Data Request Source: New York Times (Thursday March 22, 2012)
FDA asked DePuy for safety data just before hip implants phaseout
- Markey targets vaginal mesh manufacturers in new bill Source: Boston Globe (Thursday March 22, 2012)
The Boston Globe reports on Representative Ed Markey’s press conference in DC who stood alongside injured vaginal mesh patient who was left permanently disabled and lives in pain.
- [VIDEO]: March 22, 2012: Victims Speak Out about Dangerous Loophole, Unsafe Medical Devices on the Market Source: Representative Ed Markey (Friday March 23, 2012)
Rep. Markey joined victims, patients, and advocates in a press conference calling for the end of a dangerous loophole at the Food and Drug Administration which has allowed faulty devices to stay on the market.
- Senators Introduce Bipartisan Effort to Make Medical Devices Safer Source: Senator Jeff Merkley (Thursday March 15, 2012)
Today, Oregon’s Senator Jeff Merkley, with Senators Chuck Grassley (R-IA), Michael Bennet (D-CO) and Herb Kohl (D-WI), introduced the bipartisan Ensuring Safe Medical Devices for Patients Act. The bill would give the Food and Drug Administration the tools it needs to improve oversight of medical devices. Defective medical devices have been associated with thousands of deaths in recent years.
- Prone To Failure, Some All-Metal Hip Implants Need To Be Removed Early Source: NPR (Monday March 19, 2012)
NPR story about Susy Mansfield, who had a metal hip implanted and had to get it removed 3 years later because it was eating away at the surrounding bone and soft tissue.
- Markey Calls for Closure of Dangerous Medical Device Loophole Source: Representative Ed Markey (Tuesday March 20, 2012)
Joined by injured patient and surgeon, Markey to release new report highlighting faulty FDA approval process that enables defective medical devices to be implanted in patients, causing serious injury and death
- Consumer Group Says House Draft Bill on Device Fees Should Be Rejected Source: Bloomberg BNA (Wednesday March 21, 2012)
According to Consumers Union, the policy and advocacy arm of Consumer Reports, the House Energy and Commerce Health Subcommittee’s draft bill would significantly weaken device safety oversight and should be rejected.
- Generic Drugs Proving Resistant to Damage Suits Source: New York Times (Tuesday March 20, 2012)
Across the country, dozens of lawsuits against generic pharmaceutical companies are being dismissed because of a Supreme Court decision last year that said the companies did not have control over what their labels said and therefore could not be sued for failing to alert patients about the risks of taking their drugs.
- Markey, Waxman, Schakowsky, DeLauro Introduce Legislation To Close Loophole In Flawed Medical Device Approval Process Source: Congressman Ed Markey (Wednesday February 1, 2012)
To protect patients from defective devices, Reps. Edward J. Markey (D-Mass.), Henry A. Waxman (D-Calif.), Jan Schakowsky (D-Ill.), and Rosa DeLauro (D-Conn.), introduced H.R. 3847, the Safety Of Untested and New Devices Act of 2012 (SOUND Devices Act). This bill closes a major loophole in the device approval process known as the 510(k) by ensuring that a new device is not cleared by the FDA if it is based on an earlier product that was pulled from the market for causing serious harm to patients.
- Believe It Or Not, People Want More Oversight Of Implanted Medical Devices Source: The Consumerist (Tuesday March 20, 2012)
“It seems almost silly to think that anyone would want to scale back the amount of regulatory control on the safety of medical devices, and a new [Consumer Reports] poll shows that an overwhelming number of Americans believe in strong oversight of these products.”
- White House OKs medical device act Source: Cardiovascular Business (Friday March 16, 2012)
White House oks medical device act one month after Consumers Union warned Congress that reauthorizing MDUFMA could lead to a significant increase in the number of unsafe medical devices entering the market.
- For Drugs and Medical Devices, It's Still a Jungle Out There Source: Union of Concerned Scientists (Tuesday March 13, 2012)
The regulation of prescription drugs and medical devices presents new challenges for FDA. Giving FDA the resources it needs to protect the public health will require pressure on Congress from all of us.
- Merkley Backs Bill to Make Medical Devices Safer Source: KTVZ (Thursday March 15, 2012)
U.S. Senators introduce a bipartisan bill that would give the FDA more tools to improve oversight of medical devices. The bill has been endorsed by a number of organizations, including Consumers Union.
- Metal hip joints not worth risk Source: Associated Press (Wednesday March 14, 2012)
British experts at the world’s biggest artificial joint registry said doctors should stop using metal-on-metal hip replacements, citing an analysis showing they have to be fixed or replaced more often than other implants.
- Consumer Reports taps ire over bad medical devices Source: Reuters (Monday March 12, 2012)
Reuters covers Consumers Union’s campaign to improve medical device safety and interviews patients who have had faulty medical devices.
- Artificial hip brings only pain Source: Star Tribune (Monday March 12, 2012)
The artificial devices were thought to be a more durable option for hip replacements, but failure rates are forcing doctors to rethink the option. Terry Wagner-Morley, whose faulty metal-on-metal artificial hip was removed in December, talked about her worries from her hospital room. An infection has forced a delay in implanting a replacement hip, leaving her unable to walk.
- A flawed device brings a tough choice for Riata patients Source: Star Tribune (Saturday March 10, 2012)
Patients weigh what to do about a St. Jude Medical defibrillator with wiring problems. Unlike a defective toaster or recalled automobile, implanted medical devices aren’t easy to take back.
- Report: Hundreds of thousands exposed to toxic compounds from metal-on-metal hip implants Source: MassDevice (Tuesday February 28, 2012)
Hundreds of thousands of patients may have been exposed to toxic chromium and cobalt particles as their metal-on-metal hip implants wear, according to a joint investigation by the British Medical Journal and BBC Newsnight.
- Britain Extends Monitoring for People With Metal Hips Source: New York Times (Tuesday February 28, 2012)
British health regulators said Tuesday that patients in Britain who received a specific type of all-metal artificial hip — one that was also used widely in the United States — should undergo annual examinations for as long as they have the device to make sure they are not suffering tissue damage or other problems.
- Consumer groups protest approval of medical device Source: Washington Post (Wednesday February 29, 2012)
Consumer groups, including Consumers Union, wrote FDA protesting the agency’s approval of a medical device used to address complications from aneurysm treatments on the market. This device carries high risk to patients since it is surgically implanted and potentially life-saving, which is why it should have undergone the FDA’s most rigorous safety testing before it was approved. The safety groups say the device was reviewed under a process that did not require as comprehensive an evaluation and clinical study as other devices that carry low and moderate risks to patients.
- How The Medical Device Industry Lobbies Source: GoozNews (Wednesday February 29, 2012)
Congress is hearing a lot from the medical device industry. Consumers Union is making sure they hear from consumers, too. Merrill Goozner reporting on the recent Public Citizen report entitled “Substantially Unsafe,” about 30 facts that medical device industry lobbyists will probably neglect to tell Congress.
- FDA device regulator calls for more authority Source: Fierce Pharma Manufacturing (Tuesday February 28, 2012)
“Without specifically endorsing legislation introduced by House Democrats, the FDA’s top dog on medical devices has thrown his support behind tougher regulations for approving products that have designs traceable to recalled items.”
- Medical Device Loophole Needs Closing by Congress, FDA Device Chief Says Source: Bloomberg (Tuesday February 28, 2012)
“House Democrats introduced legislation this month to let the FDA reject devices that have designs based on past products that were recalled for safety flaws. The agency now lacks that authority in many cases, creating a ‘loophole’ that’s challenged the credibility of some device approvals, said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.”
- Consumer safety proponents press for tougher standards while firms want faster approvals. Source: StarTribune (Monday February 27, 2012)
Article on the medical device debate in Congress that features Consumers Union’s Safe Patient Project and the stories of real people who have been affected by medical devices that were untested: Steven Baker and Jim Shull.
- Consumer groups, medical device makers spar during MDUFMA III hearings Source: MassDevice (Wednesday February 15, 2012)
Consumer advocates challenged the medical device industry’s calls for speedier clearance pathways at the FDA during a sometimes contentious U.S. House hearing on reauthorizing FDA user fees, arguing that device makers left device safety out of the negotiations with the FDA.
- Consumer Advocates Push House Panel For Stronger Oversight of Device Approvals Source: Bloomberg (Wednesday February 22, 2012)
Consumer advocates told a House panel Feb. 15 that stronger medical device safety oversight is needed, especially now that the Food and Drug Administration has a potential new user fee agreement with industry. Includes quotes by Lisa Swirsky, senior health policy analyst for Consumers Union.
- Hip Maker Discussed Failures Source: New York Times (Tuesday February 21, 2012)
Flawed Depuy hip implant had early FDA notice
- How dirty medical devices expose patients to infection Source: iWatch News (Wednesday February 22, 2012)
An outbreak of infections at a Texas hospital prompted an investigation of the surgical tools used and raised concerns about dirty devices, including possible design flaws that make them difficult to clean.
- Consumer group clashes with medical device industry on Capitol Hill Source: Cardiovascular Business (Tuesday February 21, 2012)
Some coverage of the medical device U.S. House hearing. Features quotes by Consumers Union and Jim Shull, who told about his experience as a patient harmed by synthetic mesh used for a hernia operation.
- Controversy over medical device safety Source: WOAI (Wednesday February 15, 2012)
San Antonio’s WOAI reports on the medical device debate in Congress, including the story of Mike McReynolds who can barely walk these days, because the hip implants he received in 2009 are causing excruciating pain. He recently learned those implants, made by a company called DePuy, were never subjected to clinical trials to prove their safety.
- Consumer Groups: Medical Devices Need More Oversight Source: Fowler Tribune (Monday February 20, 2012)
Colorado publication: Patient safety advocates are asking Congress to step up the regulation of such medical devices as hip replacements and heart stents. Comments by Lisa McGiffert, Director of Consumers Union’s Safe Patient Project.
- St. Jude Device Exposes Safety Monitoring Failures, Doctor Says Source: Bloomberg Businessweek (Thursday February 16, 2012)
Bloomberg story on a defective cable used in heart defibrillators. It is based on an article in the New England Journal of Medicine, which says that the cable is the latest example of a defective medical device that wasn’t spotted quickly enough because U.S. surveillance systems are lacking.
- Hip Implant U.S. Rejected Was Sold Overseas Source: New York Times (Tuesday February 14, 2012)
Background info on the Johnson & Johnson ASR metal hip implant. In March 2010, The Times disclosed that F.D.A. records showed that the agency had received 300 complaints about the ASR, virtually all of them involving patients who had to undergo replacement operation just a few years after getting the device. That number has since reached into the thousands.
- Faulty hip implants may cause long-term health, joint damage Source: USA TODAY (Wednesday February 8, 2012)
Faulty hip joints implanted in tens of thousands of Americans pose adverse health effects in some patients even after removal, according to new research.
- Austin woman, injured by device, lobbying Congress on law Source: Austin American-Statesman (Tuesday February 7, 2012)
Lana Keeton, an Austin woman injured by a medical device, went to Washington DC to meet with her Congress members asking for safety improvements for medical devices. Lana had a synthetic mesh bladder sling implanted in 2001 and has had 17 surgeries and procedures to remove the mesh and has had ongoing medical problems,
- Lawmakers Bid to Close Loopholes on Malfunctioning Med Devices Source: California Progress Report (Wednesday February 15, 2012)
Substantially Unsafe Medical Devices Pose Great Threat to Patients; Safeguards Must be Strengthened, Not Weakened
- Special Report: The French breast implant scandal Source: Reuters (Thursday February 2, 2012)
Reuters story about a defective silicone gel breast implant manufactured by a now defunct French company.
- Allergan Erases Doctor Payment Records Source: ProPublica (Wednesday February 1, 2012)
Drugmaker Allergan best known for its wrinkle-fighting drugs Botox and Juvederm, removes old reports of payments to doctors from its website. Allergan is among 12 pharmaceutical companies that post such payments to the web, either voluntarily or as a result of legal settlements with the U.S. government over allegations of improper marketing and illegal kickbacks to doctors.
- U.K. regulators launch metal hip investigation Source: Fierce Medical Devices (Monday January 30, 2012)
Britain’s Sunday Telegraph writes about the details, including the stark finding that failure rates for the metal-on-metal full hip replacement could be even higher than the estimated 17% national figure.
- Senate Watchdog Targets High-Prescribing Medicaid Docs Source: ProPublica (Tuesday January 24, 2012)
Iowa Republican Charles Grassley sent letters to 34 states Monday asking what steps they had taken to investigate doctors whose prescribing of antipsychotics, anti-anxiety drugs and painkillers to Medicaid patients far exceeds that of their peers. “When these drugs are prescribed to Medicaid patients, it is the American people who pay the price for over-prescription, abuse, and fraud,” wrote Senator Grassley.
- The Rise of Antibiotic Resistance: Consequences of FDA's Inaction
- Plaintiffs allege 'gruesome conditions' at Lap-Band clinics Source: Los Angeles Times (Tuesday January 17, 2012)
At least five patients have died since 2009 after Lap-Band procedures at clinics in Beverly Hills and West Hills that are affiliated with the 1-800-GET-THIN marketing campaign, according to autopsy reports, lawsuits and other public records.
- FDA Misses Deadline in Clash With Device-Makers Over Reviews Source: Bloomberg (Thursday January 19, 2012)
Industry will not agree to sufficient fees required for FDA to adequately review devices.
- J&J Mesh Approved by FDA Based on Recalled Device Source: Bloomberg (Thursday October 27, 2011)
Bloomberg covers safety issues with vaginal mesh implants which the FDA continued approving based on similarity to a device pulled from the market more than a decade ago for safety reasons. The FDA is under increasing pressure to improve medical device safety and oversight.
- New Models of Implants Not Better, Study Finds Source: New York Times (Thursday December 22, 2011)
A new study suggests that the recent technology for artificial hips and knees did not perform any better than older, less expensive designs. Many of the new designs, like metal-on-metal hips, are widely used in the U.S. Those implants are expected to fail prematurely in tens of thousands of patients rather than lasting 15 years or more as artificial joints are supposed to do.
- Changes in medical device information pose lawsuit risks for doctors Source: American Medical News (Monday December 19, 2011)
Kentucky surgeon sued after using a pain pump for an off-label purpose that allegedly injured a patient. The case raises questions about whether doctors are responsible for seeking information about changes to medication instructions or whether device manufacterers should announce updates to physicians.
- Blumenthal Sponsors Bill To Protect Patients From Unsafe Medical Devices Source: Connecticut Health I-Team (Wednesday January 18, 2012)
U.S. Sen. Richard Blumenthal has joined two other senators introducing legislation designed to protect patients from unsafe medical devices. “This bill will help the FDA to get unsafe devices out of the market more quickly and improve tracking and recall procedures,” said Charles Bell, program director with Consumers Union.
- FDA probing J&J delays in reporting serious injuries among users of its Animas insulin pump Source: Associated Press (Wednesday January 11, 2012)
The FDA ordered an insulin pump medical device company to explain by Jan. 20 why it kept selling pumps known to fail and also to submit a plan to rectify its failure to promptly report cases where its device might have caused or contributed to death or serious injury. FDA warned the company that it could face fines and other sanctions if it doesn’t promptly correct the violations.
- F.D.A. Orders Surgical Mesh Makers to Study Risks Source: New York Times (Wednesday January 4, 2012)
The FDA issued an order requiring makers of implantable surgical mesh used to treat urinary incontinence in women to study its risks. This agency move is similar to one it took last year when it ordered producers of all-metal artificial hips to undertake patient studies. The mesh products and the hips belong to a class of implantable devices that manufacturers don’t have to study in patients before they are marketed or closely follow in patients afterward.
- J&J, C.R. Bard Must Study Safety of Vaginal Mesh, FDA Says Source: Bloomberg (Thursday January 5, 2012)
The FDA sent a letter to vaginal mesh device makers ordering them to study rates of organ damage and complications linked to their devices. An FDA report in July found a fivefold jump in deaths, injuries or malfunctions tied to the products.
- It's about time that FDA took action against Lap-Band billboards Source: Los Angeles Times (Wednesday December 14, 2011)
The FDA warned marketing company and clinics that they’re in violation of federal law by promoting the Lap-Band, a weight loss device that has been implanted in thousands of patients, through “false or misleading” advertising.
- Bill Would Require More Monitoring of Implants Source: NY Times (Thursday December 15, 2011)
New bipartisan bill would require postmarket surveillance of medical devices approved through 510(k), the FDA’s fast track approval process that requires no testing on humans and only needs to be similar to a device already on the market.
- Medical devices maker Medtronic agrees to pay $23.5 million to settle kickback allegations Source: Associated Press (Monday December 12, 2011)
Medtronic Inc., the world?s largest maker of medical devices, has agreed to pay $23.5 million to settle allegations that it paid kickbacks to doctors to implant its pacemakers and defibrillators, the U.S. Justice Department said Monday.
- Ventilator errors are linked to 119 deaths Source: Boston Globe (Sunday December 11, 2011)
An analysis of federal safety reports by the Globe shows that at least 119 people died nationwide between 2005 and May 2011 because of such alarm-related problems. And a separate review by the US Food and Drug Administration uncovered about 800 alarm-related adverse events involving ventilator patients in 2010 alone. Many were deemed ?preventable?? or due to ?human error.?? An unknown number resulted in injuries or deaths.
- Analysis: Court tests liability of healthcare executives Source: Reuters (Tuesday December 6, 2011)
3 former medical device executives receive prison sentences for their role in an illegal test of a bone-cement product
- An MS Patient Loses Trust When She Finds Out Her Doctor Is Paid By Drug Companies
As of 2013, a national physician payment database created under the Affordable Care Act will make such information available to all.
- Hospitals Tumble on Medicare Order for Heart Procedure Audit Source: San Francisco Chronicle (Sunday December 4, 2011)
“The Center for Medicare and Medicaid Services will require pre-payment audits on hospital stays for cardiac care, joint replacements and spinal fusion procedures, according to the American College of Cardiology in a letter to members. The program means hospitals won’t receive payment for stays that involve cardiac care or orthopedic treatment until auditors have examined the patient records and confirmed that the care was appropriate.”
- Update: Two ex-Synthes executives, Michael Huggins and Thomas Higgins, get 9 months in prison Source: Philly Pharma (Monday November 21, 2011)
Executives with the device company were sentenced to 9 months jail and $100,000 for sponsoring a clinical trial not approved by the FDA. The illegal clinical tests of bone cements intended for back surgeries. Three study participants died on the operating table.
- 10 HEALTH TECHNOLOGY HAZARDS FOR 2012
10 HEALTH TECHNOLOGY HAZARDS FOR 2012
- Drugs better than stents at preventing 2nd stroke Source: Reuters (Wednesday September 7, 2011)
Stroke patients in a large study who were treated with drugs and a brain stent had more than twice the rate of strokes and death in the month after surgery compared with those treated with drugs alone, researchers said.
- The Money Trail: Erik Paulsen gets financial jolt from medical tech industry Source: The Minnesota Independent (Friday October 21, 2011)
“As co-chair of the House Medical Technology Caucus, U.S. Rep. Erik Paulsen has battled for the medical devices industry since he took office in 2009. Industry Political Action Committees (PACs) and executives have responded to his advocacy with a deluge of campaign donations, helping to make Paulsen the lead fundraiser in Minnesota’s House delegation.”
- Report: Growth in Medical Device Adverse Events Outpaces Industry Growth Source: ASC Review (Wednesday November 2, 2011)
The medical device industry grew 9% annually from 2001-2009; serious harm grew 17% during that same time period, according to an FDA report.
- Venture Capitalists Put Money on Easing Medical Device Rules Source: New York Times (Tuesday October 25, 2011)
As Congress considers reauthorizing a law that sets the fees for medical device makers, venture capitalists are emerging as a rich and influential ally of device companies eager to remove what they say are regulatory roadblocks in the approval process.
- Government Misses Deadline for Rules Forcing Disclosure of Industry Payments to Doctors Source: ProPublica (Wednesday October 12, 2011)
The federal government has yet to write rules — mandated as part of last year’s health-care law — that would force drug and medical-device companies to disclose their gifts, fees and payments to doctors.
- Warning about pelvic mesh Source: WCAX.com (Friday July 15, 2011)
Lana Keeton shares her story about being in constant pain since doctors used plastic mesh on her during pelvic surgery. The FDA approved this medical device for pelvic organ prolapse in 2002, but since it was similar to devices used for decades it did not undergo safety testing.
- Risky pelvic mesh highlights worries about FDA process Source: msnbc.com (Tuesday July 26, 2011)
The FDA has received thousands of adverse event reports related to the mesh in women treated for pelvic organ prolapse or stress urinary incontinence. Janet Holt shares her story about how surgical mesh led to more pain and seven more operations to remove the mesh that had eroded her insides.
- Stenting's Steep Learning Curve Linked to High Mortality Rates Source: HealthLeaders Media (Friday September 30, 2011)
Inexperienced physicians performing carotid artery stenting have alarmingly higher rates of 30-day mortality than more seasoned operators, according to a new report published in the Journal of American Medical Association.
- Remedy Is Elusive as Metallic Hips Fail at a Fast Rate Source: NYT (Friday September 30, 2011)
Metal on metal may be the issue with these implants but research has yet to definitively prove why these artificial hips are failing. But researchers warned more than a decade ago that they release medal debris into the blood system.
- Hospitals readmission rates under scrutiny Source: Austin American-Statesman (Wednesday September 28, 2011)
A new national study indicates that too many hospitals are fumbling and could face penalties if they don’t improve within a year. Texas hospitals respond.
- Doctors Avoid Penalties in Suits Against Medical Firms Source: ProPublica (Friday September 16, 2011)
At least 15 drug and medical-device companies have paid $6.5 billion since 2008 to settle accusations of marketing fraud or kickbacks. However, none of the more than 75 doctors named as participants were sanctioned, despite allegations of fraud or of conduct that put patients at risk, a review by ProPublica found.
- Full Disclosure Needed About Psychiatric Drugs That Shorten Life Source: Psychology Today (Sunday September 4, 2011)
Research Shows Some Psychiatric Drugs Decrease Lifespan
- How Hospitals Harm Us Source: Daily Beast (Wednesday August 31, 2011)
Effective and disturbing graphics and statistics on hospital patient safety performance. (Medical Billing and Coding)
- Half of hospitals buy back-door drugs, new survey shows Source: msnbc.com (Friday August 26, 2011)
Desperation fueled by growing drug shortages creates demand for ‘gray-market’ suppliers. “There are worries that the drugs may be of questionable quality, may not be handled properly or may even be counterfeit or stolen,” said Mike Cohen, president of the Institute for Safe Medication Practices.
- Dangerous Medical Devices: A Personal Story Source: Bioethics Forum blog (Thursday August 25, 2011)
This is an example of a medical device that has been approved through the FDA’s 510(k) fast track process which allows devices that are of “moderate risk” and similar to previously approved devices to go to the market without a rigorous pre-market examination.
- Most pill-mill doctors ‘clear, active’ Source: Healthnews Florida (Friday August 26, 2011)
Florida doctors who have been making millions prescribing narcotics still have a status of clear and active (able to practice medicine) on the Department of Health’s website.
- Insight: DePuy's handling of hip recall sparks questions Source: Reuters (Monday August 22, 2011)
“In a highly unusual move, DePuy has hired a third party — Broadspire Services Inc, which manages workers compensation and other medical claims on behalf of insurance companies and employers — to administer patient claims for out-of-pocket medical costs associated with the recall.”
- If Insulin Pump Can Be Hacked, What Else? Lawmakers Ask Source: ABC (Monday August 22, 2011)
Two lawmakers are requesting a review of the government’s security standards for wireless medical devices after a diabetic discovered how to remotely reprogram his and other people’s insulin pumps.
- Why Drug Companies Are Shy About Sharing On Facebook Source: NPR (Monday August 22, 2011)
When Facebook told drugmakers that they had to start allowing comments on their Facebook pages, some of those pages started disappearing.
- Hip Implant Complaints Surge, Even as the Dangers Are Studied Source: New York Times (Monday August 22, 2011)
An analysis of federal data by The New York Times indicates that the Food and Drug Administration has received more than 5,000 reports since January about several widely used devices known as metal-on-metal hips, more than the agency had received about those devices in the previous four years combined.
- Doctors Take Aim At Antibiotic Resistance From Factory Farming Source: Huffington Post (Tuesday August 16, 2011)
The wide and questionable use of antibiotics in animal factory farming is contributing to antibiotic resistance in humans and a need to create new antibiotics and/or control the use of current antibiotics. Time is running out.
- Video: Certain Antibiotics Spur Widening Reports of Severe Side Effects Source: PBS (Thursday June 16, 2011)
PBS national news segment on antibiotic toxicity. The ten minute PBS video shows that the FDA only picks up one in ten adverse drug reactions.
- Lupron verdict in Las Vegas trial deals blow to victims Source: KTNV-TV (Wednesday August 10, 2011)
A major defeat in federal court today for women across the country who say their life and health has been destroyed by a drug that’s supposed to relieve pain.
- Pfizer: Nigeria drug trial victims get compensation Source: BBC News (Thursday August 11, 2011)
In 1996, 11 children died and dozens were left disabled after Pfizer gave them the experimental anti-meningitis drug, Trovan as part of a clinical trial.
- J&J To Settle Criminal Charge Over Risperdal Marketing, While 40 States Plan Lawsuits Source: Pharmalot (Wednesday August 10, 2011)
“As Johnson & Johnson attempts to resolve a raft of litigation and government investigations related to Risperdal marketing, attorney generals from approximately 40 states are deciding whether to pile on as they pursue a coordinated civil investigation into potential consumer fraud violations, according to a filing with the Securities and Exchange Commission.”
- How Safe Are Medical Devices? Source: New York Times (Thursday August 4, 2011)
New York Times editorial on medical devices, following the Institute of Medicine report released last week that found that the FDA process for approving medical devices to market is flawed and does not ensure the safety or effectiveness of most devices.
- Patient Safety America Newsletter
The newsletter includes great information about the safety of drug devices.
- Trial for 'overpriced poison' Lupron begins in Las Vegas federal court Source: KTNV Las Vegas (Monday August 1, 2011)
Lupron, a man-made form of a hormone that regulates many processes in the body, is under trial in Las Vegas in a federal case concerning the drug’s harmful side effects.
- Oregon doctors, hospitals and patients wrestle with growing drug shortages Source: The Oregonian (Saturday July 9, 2011)
Oregon cancer patient affected by drug shortages of his chemotherapy. Drug shortages are a growing national problem, and as a result, patients are getting late treatments, substitute medications, or decreased drug doses for serious illnesses.
- FDA is urged to revamp its review process for medical devices Source: Los Angeles Times (Friday July 29, 2011)
“The National Academy of Sciences says in an FDA-commissioned report that thousands of medical devices are allowed to go on the market without proper testing for safety. The FDA disputes the finding.”
- Useless Studies, Real Harm Source: New York Times (Thursday July 28, 2011)
Carl Elliott: “In a typical seeding trial, a pharmaceutical company will identify several hundred doctors and invite them to take part in a research study. Often the doctors are paid for each subject they recruit. As the trial proceeds, the doctors gradually get to know the drug, making them more likely to prescribe it later.”
- Study of Medical Device Rules Is Attacked, Unseen Source: New York Times (Wednesday July 27, 2011)
The medical device industry is crawling over Washington in an attempt to discredit an upcoming Institute of Medicine report that could propose a tougher approval process for a wide range of devices like hip implants, hospital pumps and external heart defibrillators.
- FDA Medical-Device Approval Studies Targeted by Journal Editors Source: Bloomberg (Wednesday July 20, 2011)
Studies concluding U.S. reviews of medical devices made by companies such as Medtronic Inc. (MDT) lag behind those in Europe and drive up costs for makers are flawed, according to editors of three medical journals.
- Diabetes Drug Dapagliflozin Rejected by F.D.A. Panel Source: New York Times (Tuesday July 19, 2011)
FDA rejects diabetes drug due to a possible increased risk of breast and bladder cancers.
- Citizen Petition Filed by Pharma Likely to Delay Indefinitely the Issuance of FDA Social Media Guidance Source: Pharma Marketing Blog (Wednesday July 6, 2011)
Pharma companies file “citizen petition” to stall FDA guidance on social media marketing.
- Health News: Medical devices debated in Congress; controversies surface; Oregon connection Source: The Oregonian (Tuesday July 5, 2011)
A sampler of articles on the issue of fees for medical device manufacturers, a debate heating up in Washington DC.
- FDA probes new death, infections tied to tainted wipes Source: msnbc.com (Friday July 1, 2011)
Man, 66, died of bacterial infection after being treated for skin cancer, diabetes, report says
- Op-ed: Think Inside the Box Source: New York Times (Monday July 4, 2011)
The government should follow through on proposals to require fact boxes, similar to those that appear on food packaging, in every ad drug makers produce and along with every package of medication they sell.
- Editorial: Shattered trust Source: Journal Sentinel (Wednesday June 29, 2011)
Federal regulators had ample opportunity to take enforcement action against a Hartland company but dragged their feet. They should explain why. Federal regulators found evidence of contamination by the bacterium Bacillus cereus as well as numerous other serious problems at this drug company’s plant.
- More Scrutiny for Doctors Profiting From Medical Devices They Use Source: ProPublica (Friday June 10, 2011)
Five senators are calling for an investigation into a system that gives surgeons a financial stake in the devices they use on their patients.
- The Markingson Files: Conflicts of interest in clinical trials should be transparent Source: Reporting on Health (Monday June 6, 2011)
Conflicts of interest in clinical trials should be transparent.
- Flacking for Big Pharma
Harriet Washington: “Drugmakers don’t just compromise doctors; they also undermine top medical journals and skew medical research.”
- In Shift, Feds Target Top Execs For Health Fraud Source: Huffington Post (Tuesday May 31, 2011)
In a shift still evolving, federal enforcers are targeting individual executives in health care fraud cases that used to be aimed at impersonal corporations.
- How Seroquel, a Risky Antipsychotic, Became a "General Purpose" Mental Health Drug Source: BNET (Friday May 27, 2011)
Report on medical harm linked to Seroquel when it is used for unapproved or “off-label” purposes such as depression. The drug is only approved for schizophrenia, mania and bipolar disorders.
- Heart-valve rings slip through FDA loophole Source: Chicago Tribune (Tuesday March 22, 2011)
Permanently implanted devices OK’d without clinical studies
- Data raise questions on FDA oversight Source: Chicago Tribune (Saturday May 21, 2011)
Flawed statistics paint murky picture of rings’ safety record
- Medical Data Mining Strengthens Drug Safety Source: InformationWeek (Monday May 16, 2011)
Data mining of the medical literature could help uncover drug side effects before they cause serious harm to patients, a new study suggests.
- Some Info On Utah Doctors Hard To Get Source: Connect2Utah.com (Tuesday May 2, 23)
Utah’s top medical regulator says you should be given more information about doctors, licensed to practice medicine in the state.
- Metal Artificial Hips May Need A Hip Check Source: NPR (Wednesday May 25, 2011)
Consumers want to be informed about the longevity and error rate of joint implants.
- During Mitch Daniels' decade at Eli Lilly, the drug giant paid billions in fines and settled thousands of lawsuits Source: iWatch News (Monday May 9, 2011)
Over the years, drugmaker Eli Lilly downplayed Zyprexa’s harmful side effects, putting patients at risk.
- Most States Do Not Protect Patients From Substandard Physicians, Public Citizen’s Annual State Medical Board Ranking Finds Source: Public Citizen (Saturday March 12, 2011)
Public Citizen’s analysis found that the rate at which doctors are disciplined by state medical boards has declined significantly over the past 10 years, and some of the worst states have been consistently poor performers.
- The murky world of academic ghostwriting Source: Macleans.ca (Friday May 6, 2011)
Ghostwriting–when academics sign their name to papers that were actually written by writers hired by the pharmaceutical company–continues to be a problem that promotes misleading information about medical treatments.
- After five hip replacement surgeries, Travis County woman sues company Source: American-Statesman (Monday May 2, 2011)
Jane Rogers has had hip replacement surgery five times in four years. The financial analyst says she thinks the manufacturer knew about a high failure rate by the time of her second surgery.
- Highlighting Drug Industry Influence, Watchdog Says Overmedication in Nursing Homes Is Troubling Source: ProPublica Blog (Tuesday May 10, 2011)
Nursing homes are unnecessarily administering powerful antipsychotic drugs to many elderly residents, including residents with dementia, according to a new report by the Health and Human Services inspector general.
- How flimsy research gets inferior drugs to market Source: The Guardian (Saturday May 7, 2011)
Most of the drugs studies are done on highly unrepresentative patients, skewing data that we rely on to treat patients.
- Special report: Big Pharma's global guinea pigs Source: Reuters (Friday May 6, 2011)
The globalization of drug industry clinical trials raises drug safety problems. The U.S. FDA inspected 0.7 percent of foreign clinical trial sites in 2008, against 1.9 percent of domestic sites.
- Influencing Doctors Source: KQED (Friday May 6, 2011)
Audio interview featuring ProPublica journalist Charles Ornstein on the drug and medical device industry’s heavy presence at medical society conventions.
- Financial Ties Bind Medical Societies to Drug and Device Makers Source: ProPublica (Thursday May 5, 2011)
ProPublica investigation reveals nearly half of the Heart Rhythm Society’s annual revenues come from corporate sponsorships, exhibits or grants. Last year corporate sponsors spent $5 million on product placement at one cardiologists’ conference.
- Board Disciplines 3 Doctors Source: New York Times (Tuesday May 3, 2011)
The Board of Medical Examiners in New Jersey, which is responsible for licensing doctors practicing in the state, said on Tuesday that it had disciplined three orthopedic surgeons because they did not disclose their personal financial interests in the success of an artificial spinal disk they were studying in clinical trials that were used by federal regulators to approve the disk.
- Prescription meds killing more than illegal street drugs, Travis officials say Source: American Statesman (Sunday May 1, 2011)
More people in Travis County died last year from taking medications such as pain pills and muscle relaxants than from using illegal drugs, including heroin and cocaine, officials with the medical examiner’s office have found.
- Rx side effects causing more hospitalizations Source: American Medical News (Monday May 2, 2011)
The number of hospitalizations due to medication side effects jumped by more than half between 2004 and 2008, according to an Agency for Healthcare Research and Quality report released in April.
- Forest Labs CEO to challenge HHS move Source: Associated Press (Wednesday April 13, 2011)
In April, the U.S. Department of Health and Human Services sent a letter to the drug company CEO of Forest Labs indicating they could potentially exclude him from participating in federal health care programs for wrongdoing.
- 'Use Only as Directed' Isn't Easy Source: The Wall Street Journal (Tuesday April 26, 2011)
Self-inflicted medication mishaps are on the rise, in part due to confusing labels. WSJ’s Informed Patient columnist Laura Landro highlights some new efforts to make medicine labels easier to understand.
- FDA: Hand Sanitizers Carry Unproven Claims to Prevent MRSA Infections Source: Food and Drug Administration (Wednesday April 20, 2011)
Some hand sanitizers and antiseptic products come with claims that they can prevent MRSA infections. Don’t believe them. These statements are unproven, says the Food and Drug Administration (FDA).
- GAO renews critique of FDA medical device system Source: Associated Press (Thursday April 14, 2011)
“Government investigators say the Food and Drug Administration is putting patients at risk by approving sensitive medical devices such as hip joints and heart defibrillators under the same streamlined system intended for power wheelchairs, stitches and catheters.”
- Tipping the Odds for a Maker of Heart Implants Source: New York Times (Saturday April 2, 2011)
95 percent of patients at University Medical Center of Southern Nevada who had a heart device implanted there got one made by Biotronik. Company documents reviewed by the New York Times revealed that, in mid-2008, Biotronik hired several cardiologists who implant heart devices at the Las Vegas hospital as consultants, paying them fees that may have reached as high as $5,000 a month.
- FDA: CDC And ADPH Investigate Outbreak At Alabama Hospitals; Products Recalled Source: FDA (Tuesday March 29, 2011)
FDA announces product recall after outbreak in Alabama hospitals. The Alabama Department of Public Health is investigating an outbreak of Serratia marcescens bacteremia in six Alabama hospitals. On March 16, ADPH was notified that an outbreak had occurred in two of these hospitals among patients receiving TPN (total parenteral nutrition).
- Video: More known about who got sick after Al. IV bag contaminations Source: Alabama's 13 (Wednesday March 13, 30)
A rare bacteria found in six Alabama hospitals is blamed for the deaths of nine people.
- Obesity Lap Bands Cause More Complications Than Weight Loss, Study Finds Source: Bloomberg (Monday March 21, 2011)
Almost half of patients undergoing gastric banding for obesity needed to have the device removed, often because of erosion, according to a study that found the treatment caused more complications than weight loss.
- FDA Official: Another Tainted Drug Is Inevitable Source: Pharma Blog (Tuesday March 15, 2011)
The complex drug chain spreads around the world and most overseas drug manufacturers are not inspected.
- Q&A with Dr. Carl Elliott, Part 2: Finding fault with his own university after patient's death Source: Reporting on Health (Monday March 14, 2011)
Part 2 of Q&A with Dr. Carl Elliott; a bioethicist with an MD, Elliott took on powerful interests at his own university on behalf of a woman he barely knew and a patient he could not save.
- Q&A with Dr. Carl Elliott: Making patient protection a priority for clinical trials Source: Reporting on Health (Thursday March 10, 2011)
A bioethicist with an MD, Elliott took on powerful interests at his own university on behalf of a woman he barely knew and a patient he could not save.
- MGH faces suit over drug error that killed woman Source: Boston Globe (Thursday March 10, 2011)
Massachusetts woman dies from drug overdose in the hospital. The hospital staff gave her a large dosage of blood thinner which resulted in internal bleeding and ultimately death.
- Op Ed: Hospital acquired infection is the gorilla in the room Source: Minute Man News Service (Wednesday March 9, 2011)
“I guess America’s present “Wild West” health care system does allow lots of folks to make a handsome profit. But the rest of us are suffering from high health insurance premiums and unacceptably high fatality rates caused by medical errors.”
- HealthGrades study finds patients are 46% less likely to experience error in top-rated hospitals
The study finds there is a significant gap in the probability of experience a patient safety event between hospitals with good patient safety records and those with lower patient safety performance standards.
- Colo. hospital blew whistle on contaminated wipes Source: MSNBC.com (Monday March 7, 2011)
Spate of serious infections caused by rare bacteria sparked massive recall, investigation
- Do expensive buildings improve health care? Source: Concord Monitor (Thursday March 3, 2011)
Patient safety advocate Lori Nerbonne argues that the $1billion spent on new hospital buildings in New Hampshire since 2000 has not resulted in better quality care.
- FDA warning: Topamax can cause risk of cleft lip or palet Source: FDA (Friday March 4, 2011)
Topomax is prescribed for seizures and migraines. Pregnant women should consult a physician before using this drug.
- How the FDA Got the Markingson Case Wrong Source: Bioethics Forum blog (Thursday March 3, 2011)
“There is simply very little protection for human subjects in privately-sponsored clinical trials.”
- Dan Markingson's mother blasts U of M vice president's suicide comments Source: City Pages (Wednesday March 2, 2011)
Mother enters a heated debate on how the University of Minnesota should handle controversy surrounding the 2004 suicide of her son, Dan Markingson. Dan was involved in a drug study at the U of M.
- FDA knew of problems at plant that made tainted alcohol wipes Source: msnbc.com (Tuesday February 22, 2011)
Documents show sterilization issues as early as 2009; dozens may have been sickened
- Released hospital patients' many unhappy returns Source: San Francisco Chronicle (Wednesday February 16, 2011)
http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2011/02/16/MN4K1HCMNU.DTLA new study found that 20 percent of California patients were readmitted to the hospital within 30 days at an annual cost of $250 million. The study blames poor discharge planning but also patient complications, which we know can often be the result of infections and medical errors. The report by the California Discharge Planning Cooperative can be found here.
- Should FDA Hold 'Me-Too' Drugs To A Higher Standard? Source: NPR (Tuesday February 15, 2011)
NPR weighs in on “me-too” drugs; drugs that are similar to already known drugs.
- Study finds FDA's less stringent medical device approval process faulty
A recent study on mdical device recalls by the National Research Center for Women & Families found the majority of recalled medical products were approved without testing. The FDA’s 510(K) process that only requires medical devices be similar to another device on the market to be approved. Find the study in the Archives of Internal Medicine here.
- Parents blame toddler's death on tainted alcohol wipes Source: MSNBC (Tuesday February 15, 2011)
Millions of pads, swabs recalled because of same bacteria that killed 2-year-old boy
- FDA Orders TMJ Implant Studies Source: Milwaukee Journal Sentinel/MedPage Today (Monday February 7, 2011)
The FDA has ordered a review of the performance of temporomandibular joint (TMJ) implants after finding a substantial number of problems with the products in recent years.
- FDA Panel Urges Stricter Standards for Cancer Drugs Source: MedPage Today (Tuesday February 8, 2011)
Earlier on Tuesday, the panel and FDA officials questioned representatives of six drug companies about their failure to complete follow-up studies that were part of the deal by which they received accelerated approval.
- Dollars for Docs Adds Payouts from HIV Drug Maker Source: ProPublica (Monday February 7, 2011)
A firm that specializes in HIV medications has become the eighth pharmaceutical company to disclose the payments it has made to U.S. health professionals for speaking and consulting.
- Podcast with drug safety activist Kim Witczak Source: News Talk WTCM (Tuesday January 18, 2011)
Kim Witczak discusses the effects of psyche drugs and tell the story of her husband Woody, who died of a Zoloft-induced suicide in 2003.
- Deadly Medicine
“More and more clinical trials for new drugs are being outsourced overseas and conducted by companies for hire. Is oversight even possible?”
- Should A Paxil Journal Article Be Retracted? Source: Pharmalot (Monday January 24, 2011)
Two years ago, two academics argued for a medical journal article to be retracted due because they argue it is misleading. So far, though, their call has gone on unheeded.
- Spine surgeons fighting over future royalties Source: Louisville Courier Journal (Monday January 17, 2011)
Doctor’s file suit over claims that a new agreement violates a 2001 agreement among five surgeons to equally share rights to their inventions for Medtronic. That included any “improvements and enhancements” of the devices, and “any future systems, devices or techniques developed by their efforts.”
- MN-Based St. Jude Medical Pays U.S. $16 Million to Settle Claims that Company Paid Kickbacks to Physicians Source: DOJ (Tuesday January 19, 2010)
Department of Justice press release regarding the use of kickbacks to encourage doctors to use the company’s pacemakers and defibrillators.
- FDA plans modest changes to medical device system Source: Washington Post (Wednesday January 19, 2011)
FDA takes delays decision on granting the government more authority to police medical device makers.
- Dollars for Docs Sparks Policy Rewrite at Colorado Teaching Hospitals Source: ProPublica (Wednesday January 19, 2011)
The University of Colorado Denver and its affiliated teaching hospitals have launched an overhaul of conflict of interest policies after a ProPublica database revealed extensive ties between its faculty and pharmaceutical companies.
- 43 million packages of Tylenol, Benadryl, Sudafed and Sinutab recalled Source: Consumer Reports Health Blog (Tuesday January 18, 2011)
Johnson and Johnson’s McNeil Consumer Healthcare announced late last week a recall of more Tylenol as well as Benadryl, Sudafed, and Sinutab products—about 43 million packages in all.
- Toward a 21st-Century Regulatory System Source: Wall Street Journal (Tuesday January 18, 2011)
President Obama mentions hospital infections and medical devices in his op ed re cutting red tape.
- Top Ten Legal Drugs Linked to Violence Source: TIME (Friday January 7, 2011)
A new study from the Institute for Safe Medication Practices has identified 31 drugs that are disproportionately linked with reports of violent behavior towards others.
- Glaxo Whistle-Blower Lawsuit: Bad Medicine Source: CBS News (Sunday January 2, 2010)
Interview about the recent Glaxo Smith Kline guilty plea to distributing adulterated drugs.
- DOJ Indicts Former GlaxoSmithKline Lawyer Source: CBS News (Tuesday November 9, 2010)
The Department of Justice has indicted a former top corporate lawyer for the pharmaceutical giant GlaxoSmithKline on charges of obstructing justice and making false claims about the unapproved promotion of a drug for weight loss purposes.
- Ruling Is Upheld Against Executives Tied to OxyContin Source: New York Times (Wednesday December 15, 2010)
A federal district judge in Washington has upheld the disbarment of three former top executives of the company that made the prescription painkiller OxyContin, ruling that they should still be prohibited from involvement in any government-financed health care program.
- Dozen Stanford physicians under fire for speaking at gigs paid for by drugmakers Source: MercuryNews.com (Monday December 20, 2010)
A dozen physicians at Stanford University’s School of Medicine are under investigation by the school’s disciplinary board for their too-cozy relationships with drug companies.
- ProPublica and "Dollars for Docs" Source: The Oregonian (Tuesday December 21, 2010)
The Oregonian takes a look at local policies governing doctor-pharma relationships after a ProPublica investigation.
- Drug-firm fees to UM doctors are questioned Source: The Miami Herald (Monday December 20, 2010)
ProPublica, a nonprofit investigative group, is reporting that more than dozen University of Miami doctors did not properly report their earnings from drug companies as required by a medical school policy.
- U. of Minnesota profs demand investigation of drug trial death Source: MedCity News (Monday December 6, 2010)
A group of University of Minnesota professors want the board of regents to investigate the suicide of a patient enrolled in a university-run drug study.
- Med Schools Flunk at Keeping Faculty Off Pharma Speaking Circuit Source: ProPublica (Sunday December 19, 2010)
An ongoing ProPublica investigation finds conflict of interest activity at some of the nation’s top medical schools.
- Drug Companies Take Their Pitch to Social Media--Carefully Source: TIME (Friday December 17, 2010)
There are no FDA guidelines on how drug companies can market drugs through social media, such as disclosing information about a drug’s known risks. This month, however, the FDA is expected to issue guidelines on how drug companies market drugs, from Viagra to Ambien, on outlets such as Twitter, Facebook and Google.
- U.S. cracks down on dangerous supplements Source: CBC News (Thursday December 16, 2010)
Herbal products containing drugs and banned substances a big problem
- Panel Votes to Expand Surgery for Less Obese Source: NYT (Friday December 3, 2010)
The FDA approved the use of lap bans for people who are not obese.
- Drug Maker Wrote Book Under 2 Doctors' Names, Documents Say Source: New York Times (Monday November 29, 2010)
An example of the behavior of ghostwriting by the drug industry and the influence of companies’ marketing on medical practices.
- Drug industry ties to doctors weaken as disclosure, gift rules spread Source: American Medical News (Monday November 29, 2010)
More physicians are saying no to free lunches, drug reps and consulting relationships, new data show.
- FTC Urged To Probe Online Health Marketing Source: Pharmalot (Tuesday November 23, 2010)
“The move comes as the FDA grapples with formulating rules for how the pharmaceutical industry can adopt social media.”
- Investigators: Junk Joints Source: Fox 9 (Sunday November 9, 8)
“Chances are you or someone you know is going to be a candidate for joint replacement. How much will you know about the device that’s surgically implanted in your body? Well, let’s just put it this way, it might be easier to track the performance record of the parts that go in your car.”
- No Standard for the Placebo? Source: ScienceDaily (Tuesday October 19, 2010)
“A paper published in the October 19 issue of Annals of Internal Medicine — entitled “What’s In Placebos: Who Knows?” calls into question this foundation upon which much of medicine rests, by showing that there is no standard behind the standard — no standard for the placebo.”
- Glaxo to Pay $750 Million for Sale of Bad Products Source: New York Times (Tuesday October 26, 2010)
“GlaxoSmithKline, the British drug giant, has agreed to pay $750 million to settle criminal and civil complaints that the company for years knowingly sold contaminated baby ointment and an ineffective antidepressant — the latest in a growing number of whistle-blower lawsuits that drug makers have settled with multimillion-dollar fines.”
- HealthKey: Database details pharmaceutical payments to doctors Source: Baltimore Sun (Sunday October 24, 2010)
$6 million went to Maryland medical professionals in 2009-2010
- When big pharma breaks the law, prosecute the CEO Source: New Scientist (Tuesday October 19, 2010)
Patient safety will remain at risk until big pharma’s top executives are brought to book for their companies’ actions, says Paul Thacker.
- Consumers wary of doctors who take drug-company dollars Source: Consumer Reports Health (Tuesday October 19, 2010)
A recent poll conducted by Consumer Reports found that most Americans are skeptical of financial arrangements between doctors and drug companies.
- Doctors on Pharma Payroll Have Blemished Records, Limited Credentials Source: Propublica (Tuesday October 19, 2010)
An investigation by ProPublica reviewed records of doctors on seven drug company payrolls. It uncovered “hundreds of doctors on company payrolls who had been accused of professional misconduct, were disciplined by state boards or lacked credentials as researchers or specialists.” They have also posted a database so you can look up doctors who work for drug companies.
- Are We Giving Our Soldiers Drugs That May Make Them Kill Themselves? Source: AlterNet (Sunday October 10, 2010)
Violent and bizarre behavior of people affected by antidepressants..who is paying attention?
- When Drugs Cause Problems They Are Supposed to Prevent Source: New York Times (Saturday October 16, 2010)
“In the past month, the Food and Drug Administration has concluded that in some cases two types of drugs that were supposed to be preventing serious medical problems were, in fact, causing them…The difficulty is in figuring out how to assess the safety of drugs that will be taken for decades, when the clinical trials last at most a few years.”
- Public 'misled' by drug trial claims Source: BBC (Wednesday October 13, 2010)
Researchers said “there has been a publication bias and this had overestimated the benefit of reboxetine and underestimated potential harm. And, they said, it was a widespread problem that applied to many of the drugs in use today.”
- F.D.A. Says It Approved Device in Error After Official Pressure Source: New York Times (Thursday October 14, 2010)
The Food and Drug Administration vowed Thursday to reverse the approval of a patch for injured knees that it granted in 2008 after being pressured by four New Jersey congressmen and its own commissioner. Read the FDA’s report here.
- FDA Determines Knee Device Should Not Have Been Cleared for Marketing Source: FDA (Thursday October 14, 2010)
The U.S. Food and Drug Administration today announced that an orthopedic device used in the knee should not have been cleared for marketing in the United States. The announcement follows a re-evaluation of the scientific evidence that was undertaken after a September 2009 agency report identified problems in the agency’s review of the device.
- FDA: Possible Fracture Risk With Osteoporosis Drugs Source: FDA (Wednesday October 13, 2010)
The Food and Drug Administration (FDA) is warning there is a possible risk of a rare type of thigh bone (femoral) fracture in people who take drugs known as bisphosphonates to treat osteoporosis.
- Weight-loss drug Meridia pulled from market due to heart attack, stroke risk Source: Consumer Reports Health Blog (Friday October 8, 2010)
The weight loss drug Meridia (sibutramine) has been removed from the market because it has been linked to an increased risk of heart attack and stroke, the Food and Drug Administration said Friday.
- Side Effects May Include Lawsuits Source: New York Times (Saturday October 2, 2010)
Article about the surge in antipsychotic prescriptions and the aggressive marketing tactics that’s fueled such growth.
- Feds reopen probe into medical scanner approvals Source: Associated Press (Tuesday September 28, 2010)
Federal inspectors have reopened an investigation into complaints by Food and Drug Administration scientists who say they were pressured by their managers to approve high-tech medical scanners that could pose harm to patients.
- Drug Shortages Are Causing Safety Problems: Survey Source: Pharmalot (Friday September 24, 2010)
An ongoing number of shortages of prescription meds is wreaking havoc among health care practitioners who work in hospitals and patients are at risk, yet little or no information is available from the FDA or drugmakers, according to a new survey.
- FDA restricts use of risky diabetes drug Avandia. What are safer options? Source: Consumer Reports Health Blog (Thursday September 23, 2010)
The Food and Drug Administration Thursday limited the diabetes drug rosiglitazone (Avandia, Avandamet, and Avandaryl) to people who can’t use other medications due to concerns it could cause a heart attack or stroke.
- What Will Happen to Abbott's Meridia? Source: Wall Street Journal Health Blog (Monday September 13, 2010)
On Wednesday an FDA advisory committee will consider whether Meridia, Abbott’s weight-loss drug, should remain on the market or be yanked — as it was in Europe earlier this year.
- Editorial: Licensing drugs for diabetes Source: BMJ (Monday September 6, 2010)
Surrogate end points are not enough, robust evidence of benefits and harms is needed
- Rosiglitazone: what went wrong? Source: BMJ (Monday September 6, 2010)
Over 10 years after the diabetes drug rosiglitazone was approved by regulators, and despite studies on tens of thousands of people, questions remain about its cardiovascular safety. An investigation by the BMJ looks at why this happened.
- UK Regulator Says Avandia Should Go Source: Pharmalot (Monday September 6, 2010)
The UK’s Medicines and Healthcare products Regulatory Agency says the GlaxoSmithKline drug Avandia “no longer has a place on the UK market.”
- Allergan Settles Charges It Went Too Far Marketing Botox Source: NPR (Wednesday September 1, 2010)
Allergan to Pay $600 Million in Botox Cases
- FDA To Baxter: Start Telling The Truth Source: Pharmalot (Tuesday August 31, 2010)
FDA has sent a third warning to Baxter regarding its Aralast NP emphysema treatment brochure that contains misleading efficacy claims.
- Maine Voices: Doctors and patients don't have to rely on TV for drug information Source: The Portland Press Herald (Tuesday August 31, 2010)
Physicians have better sources than salesmen and advertisements to guide prescribing choices.
- U.S. Inquiry of Drug Makers Is Widened Source: NYT (Friday August 13, 2010)
Concern about payments to doctors to encourage prescribing drugs and paying doctors in other countries to oversee clinical trials, has led US prosecuters to investigate a number of drug manufacutres. The vast majority of clinical trials take place outside the U.S.
- Consumer and manufacturing groups back bill to protect US drug supply Source: Pharmacy News EU (Monday August 16, 2010)
A new bill sponsored by Senator Michael Bennet (D-CO) would give the the FDA additional regulatory authority to monitor pharmaceutical supply chains.
- Solo Slim, Solo Slim Extra Strength: Recall - Undeclared Drug Ingredient Source: FDA (Monday August 9, 2010)
FDA just issued a new alert regarding yet another supplement for weight loss.
- Revivexxx Extra Strength: Recall - Undeclared Drug Ingredient Source: FDA (Monday August 9, 2010)
FDA releases a new alert regarding yet another supplement for sexual dysfunction.
- FDA moves toward tighter medical device oversight Source: Associated Press (Wednesday August 4, 2010)
Makers of X-ray machines, drug pumps and other medical devices would have to submit more safety information to win federal approval under a proposal designed to tighten regulation of thousands of products reviewed each year.
- Ghostwriting and Academic Medicine Source: The Chronicle of Higher Education (Monday July 19, 2010)
You’ve seen drug commercials but there are other sneaky ways drug companies try to sell their products: ghostwritten manuscripts, composed by the employees of pharmaceutical companies in cooperation with their marketing departments and then published under the byline of academic researchers.
- Massachusetts Gift Ban For Doctors Remains Intact Source: Pharmalot (Monday August 2, 2010)
“An effort in Massachusetts to repeal a controversial law that prohibits drugmakers from giving gifts and meals to doctors and other healthcare professional has apparently ended.”
- The Avandia dilemma: When is a drug too risky to stay on the market? Even the FDA is unsure Source: AP (Thursday July 1, 2010)
“The arthritis pill Vioxx was withdrawn but menopause hormones were not, even though both were tied to heart risks. A multiple sclerosis medicine was pulled and later allowed back on.
- Beef up rules on prescription drugs, inquest urges Source: The Globe and Mail (Monday June 28, 2010)
Coroner’s inquest into suicide of Ontario teen recommends sweeping changes to drug safety regulations
- Avandia a test for U.S. FDA on drug safety Source: Reuters (Tuesday June 29, 2010)
“Safety questions around the diabetes pill Avandia pose a major test for the U.S. Food and Drug Administration’s leadership and how it will handle drug risks under President Barack Obama.”
- I Predicted It: Social Media Guidance Likely To Be Split Into Multiple Documents Source: Pharma Marketing Blog (Friday June 18, 2010)
FDA social media guidelines for regulating online drug ads to be broken up into multiple documents
- Doctors' role in drug studies criticized Source: Journal Sentinel (Sunday May 30, 2010)
Drug company funded medical studies often skew the truth about drugs, putting patient safety at risk.
- Drug Maker Seen as Uncooperative on Inquiry Source: New York Times (Thursday June 10, 2010)
Major drug company is resisting investigation by Congress and FDA for the recent recall of children’s Tylenol and pediatric medications.
- Storm over J&J's child drug recall only grows Source: Rueters; May 27. 2010 (Thursday May 27, 2010)
Investigation into Johnson and Johnson’s Drug recall for variouis children’s over the counter medication reveals problems in the manufacturing process.
- Is it Time for the FDA to Chime in on Drug Company Tweets? Source: Xconomy (Wednesday May 26, 2010)
Some drug companies are using Twitter to promote their products and overplay the benefits versus the risks. The FDA is now asking drug companies and other interested parties to submit opinions on how it might regulate the promotion of products using social media and the Internet.
- FDA May Disclose More Details On Drug, Food Safety Source: AP (Wednesday May 19, 2010)
Responding to charges that the agency is too slow to disclose drug safety issues, the FDA is proposing to reveal more information about drugs and devices under review.
- Antibiotic Resistance Called Growing Threat to Human Health Source: Voice of America (Tuesday May 18, 2010)
The World Health Organization calls antibiotic resistance one of the three greatest threats to human health.
- US urges doctors to report misleading drug pitches Source: Rueters (Wednesday May 12, 2010)
The FDA monitors consumer ads but has not, until now, tried to track the effacacy of direct to doctor promotion. The industry spends nearly three times as much on this than direct to consumer advertising.
- What do patients want? And why it matters for Sunshine
This Community Catalyst blog discusses the Physician Payments Sunshine Act passed in the health care reform legislation. It creates a national public website where drug and device companies will report payments and gifts to doctors. Consumers will be able to search the site.
- J&J to Pay $81 Million, End Federal Cases on Topamax Source: Business Week (Thursday April 29, 2010)
Two subsidiaries of Johnson & Johnson have settled with the Justice Department for civil and criminal claims concerning the illegal promotion of Topamax, an epilepsy drug, for psychiatric use.
- New Web Site Invites Patients To Report on Adverse Medical Events Source: ModernHealthcare.com (Monday April 26, 2010)
The Empowered Patient Project has created a patient oriented survey on adverse medical events. Aggregate information from the surveys will be posted on their website.
- VT: Drug Samples Thorny Issue at Statehouse Source: NLARx (Monday April 26, 2010)
The Vermont health care bill provision requiring drug companies to report when they give free medication samples to doctors is being misinterpreted as a ban on all free samples.
- Patient Advocates Announce Website to Collect Medical Error Stories
- FDA's Center for Devices and Radiological Health (CDRH) Source: FDA (Monday April 19, 2010)
FDA’s device transparency page: Information about the medical device approval process.
- 10 Things Drug Companies Won't Say Source: Smart Money (Monday April 26, 2010)
Heavy direct marketing of drugs to doctors may have more of an effect on prescription practices than you think.
- Op-ed: Off-label drug marketing puts consumers at risk Source: New York Times (Wednesday April 14, 2010)
Even though it’s illegal to market drugs for unapproved uses, according to this article about one in five prescriptions in the US are for an off-label use.
- Overactive bladder? You might think so after seeing Toviaz ad Source: Consumer Reports Health Blog (Wednesday April 7, 2010)
From the Consumer Reports AdWatch team
- Patient Safety Report Shows Medical Errors Continuing in NJ Hospitals Source: Atlantic Hightland Herarld (Thursday April 1, 2010)
AARP: Older Adults Still the Most Affected by Dangerous Medical Errors
- Child's Death Raises More Questions About Blood-Thinner
“Nebraska health officials have admitted that 23-month-old Almariah Duque may have died from an overdose of the blood-thinner heparin, raising more questions about the use of the drug on infants.”
- Viewpoints: Fine print on Rx labels spells danger Source: Sacramento Bee (Saturday April 3, 2010)
Betsy Imholz of Consumers Union challenges the decision the California Pharmacy Board has signaled it will adopt regarding presription drug labeling standards.
- Health System Bears Cost of Implants With No Warranties Source: NYT (Friday April 2, 2010)
“When a car breaks, a computer fails or a toaster flames out, the manufacturer is often liable under the product warranty. But that is not how the multibillion-dollar orthopedics industry tends to work, according to doctors, industry experts and three of the biggest device makers. “
- Dallas toddler dies after heparin overdose at Nebraska hospital Source: Dallas Morning News (Thursday April 1, 2010)
A 23 month old died from an overdose of blood thinner while in the hospital to be treated for an infection.
- Health reform can cut errors Source: Times Union (Thursday April 1, 2010)
More reforms are needed to protect patients from preventable medical harm, but the new health reform law creates a solid foundation that will help ensure that the health care we are paying for is safe.
- Pfizer Paid Doctors, Hospitals $35 Million Source: Wall Street Journal (Wednesday March 31, 2010)
Drug company giant reveals the amount it paid to doctors and hospitals during the second half of last year. The health overhaul passed recently requires disclosures of certain physician payments starting in 2013.
- What If, God Forbid, Sally Field Broke Her Leg? Source: Pharma Marketing Blog (Saturday March 27, 2010)
Many patients report experiencing bad side effects taking BONIVA, including broken bones, which BONIVA drug marketers claim it prevents.
- Let The Sun Shine In Source: Gooznews on Heatlh (Tuesday March 23, 2010)
“Drug and device companies will soon have to report payments to physicians in a national database, thanks to a little noted section of the health care reform bill called the Physician Payments Sunshine Act.”
- Transparency and the health-care reform bill Source: Washington Post (Sunday March 21, 2010)
Merrill Goozner points out another little-noticed provision in the bill: “Drug and device companies will soon have to report payments to physicians in a national database, thanks to a little noted section of the health care reform bill called the Physician Payments Sunshine Act.”
- The Worst Time for a Hospital Visit Source: NYT Health blog (Thursday March 18, 2010)
According to a study published this month in the journal Medical Care hospital occupancy, weekend admissions, nurse staffing and the seasonal flu are major factors that increase the risk of dying in a hospital.
- Video: The Faces of Medical Errors...From Tears to Transparency
The following films from Transparent Learning are the first in a series of educational stories that feature patient safety advocates including Helen Haskell, Rosemary Gibson and Dr. Lucian Leape.
- Transparency and Public Reporting Are Essential for a Safe Health Care System Source: Commonwealth Prespectives on Health Reform Brief (Wednesday March 17, 2010)
Leading patient safey advocate Dr. Lucian Leape released report. He makes a strong statement on public reporting: “Transparency is an idea whose time has come and both hospitals and the public will be better off because of it.” His statement and report are online now.
- Electronic Prescriptions Reduce Errors by Seven-Fold Source: Newswise (Friday February 26, 2010)
“Should doctors around the country use e-prescribing to decrease prescription errors? A study led by physician-scientists from Weill Cornell Medical College found that health care providers using an electronic system to write prescriptions were seven times less likely to make errors than those writing their prescriptions by hand.”
- Are Veterans Being Given Deadly Cocktails to Treat PTSD? Source: Alternet (Saturday March 6, 2010)
A combination of drugs is being prescribed to treat post traumatic stress disorder (PTSD) in returning soldiers including Seroquel, an anti-psychotic, despite a disturbing number of veteran deaths associated with the treatment. Seroquel has not been approved for PTSD by the FDA.
- Are Veterans Being Given Deadly Cocktails to Treat PTSD? Source: AlterNet (Saturday March 6, 2010)
AstraZeneca has been linked to the deaths of soldiers returning from war.
- Drug Company Gifts To Doctors Should Be Disclosed And Limited, Ct AG Urges Source: CTWatchdog.com (Monday March 1, 2010)
Legislation in CT this year would require limits on drug company compensation to doctors instead of an outright gift ban. A 2009 gift ban bill was strongly opposed and failed to pass.
- Why Psychiatry Needs Therapy Source: Wall Street Journal (Saturday February 27, 2010)
Patients who seek psychiatric help today for mood disorders stand a good chance of being diagnosed with a disease that doesn’t exist and treated with a medication little more effective than a placebo.
- Study: Costly Health Care Not Necessarily Best Source: NPR; WBUR (Thursday February 25, 2010)
For some medical conditions, the cost of care does not directly correlate to the quality of care according to a study in the Archives of Internal Medicine.
- Doctor Training Aided by Drug Industry Cash Source: NYT (Tuesday February 2, 2010)
Drug industry funding of more than half of US medical residency programs, calls into question conflicts of interest.
- Doctors, Officials Fight Against Prescription Drug Addiction Source: WMUR Manchester (Monday February 22, 2010)
New Hampshire ranks fourth in the nation for deadly methadone overdoses, and health professionals and law enforcement are battling to keep it and other prescription drugs out of the wrong hands.
- Glaxo, Merck disclose how much they're paying U.S. doctors Source: Miami Herald (Saturday January 23, 2010)
Responding to a continuing push from lawmakers to reveal how much the pharmaceutical industry is influencing America’s doctors, two more major drug makers have made public their payments to physicians, but an industry expert says the data are of limited value.
- Popular Drugs May Help Only Severe Depression Source: New York Times (Tuesday January 5, 2010)
Some widely prescribed drugs for depression provide relief in extreme cases but are no more effective than placebo pills for most patients, according to a new analysis released Tuesday in the Journal of American Medical Association.
- F.D.A. to Seek New Standards on Human Test Data Source: New York Times (Tuesday December 29, 2009)
The Food and Drug Administration is developing guidelines that will set tougher scientific standards for data from tests on humans that makers of medical devices submit when seeking approval of their products, a top agency official said.
- Popular Drugs May Help Only Severe Depression Source: New York Times (Tuesday January 5, 2010)
Some widely prescribed drugs for depression provide relief in extreme cases but are no more effective than placebo pills for most patients, according to a new analysis released Tuesday.
- Sens. move to block drugmakers from mining Rx data Source: AP (Thursday December 10, 2009)
A proposed amendment to the Senate health care bill would prohibit drug companies from mining pharmacy records in order to craft their marketing to a doctor’s prescribing history.
- Millions Take Aspirin to Prevent Heart Attacks Based on a Typo; "Immodest" Bayer Site Not Helping Source: BNET (Friday December 11, 2009)
“Millions of people are needlessly popping an aspirin every day in the false belief that it will ward off heart attacks and strokes, according to HeartWire.”
- FDA Dislikes Canadian Drugs; Is OK With Chinese Drugs Source: BNET (Thursday December 10, 2009)
“Drugs made in China are imported legally to the U.S. as if they were “American” drugs. The drug industry merely opposes allowing Americans to buy the same Chinese-made drugs from Canada, where price controls have rendered them cheaper.”
- Negative Pressure Wound Devices Draw FDA Notice, Advice Source: FDA Consumer Update (Friday December 11, 2009)
Wound therapy devices can have adverse outcomes, leading to injuries or death. The FDA has recommendation for proper use.
- FDA, Congress move to counter expansion of prescription drug ads Source: Missouri Post Dispatch (Wednesday December 9, 2009)
Major drug makers are pushing for online advertising flexibility. Congress is considering new advertising laws that will limit on line ad claims that exaggerate drug capabilities and eliminating the corporate tax deductions for drug promotion.
- FDA Has Failed To Make Safety Changes: GAO Source: Pharmalot (Wednesday December 9, 2009)
The Government Accountability Office report “finds the agency FDA continues to give the bulk of its decision-making power to scientists who approve new drugs, rather than those who monitor the side effects of drugs on the market. “
- Advertising to Consumers May Raise Drug Prices Source: Healthday.com (Tuesday December 8, 2009)
With Plavix as an example, study finds no added use but higher costs.
- Kent Hospital (RI) settles suit with Woods family Source: The Providence Journal (Wednesday December 2, 2009)
James Woods, his mother and the hospital president announced the withdrawal of the lawsuit and a new joint effort by the hospital and the family to improve patient care.
- Critics Say Social-Media Should Be Off Limits for DTC Drug Ads Source: Advertising Age (Friday November 13, 2009)
FDA Urged to Maintain Strict Risk-Disclosure Rules for Web 2.0
- Who Wants to Talk to the FDA About Google and Facebook? Source: Wall Street Journal Health Blog (Wednesday November 11, 2009)
The FDA is holding a meeting this week to get input on “making policy decisions on the promotion” of drugs and medical devices on “the Internet and social media tools. PhRMA, the drug industry trade group, recommends that FDA adopt some kind of standardized online warning language, such as “All drugs have risks. Click here for more information from the manufacturer.”
- Film explores broken health care system Source: Dead By Mistake (Saturday October 31, 2009)
A new documentary film, “Money-Driven Medicine”, tackles the economic underpinnings of an American healthcare system that kills four times as many people through medical error and preventable infections as die in highway accident. Consumers Union has encouraged activists to view this film and take action to make our health care system safer.
- Money-Driven Medicine Watch-In!
“Money-Driven Medicine” examines the medical industrial complex, and what’s wrong with our healthcare system. Watch the movie for free here until November 10 and sign our petition for reform.
- Drug Industry Lobbyists Kept Clinical Trial Results Secret Source: Huffington Post (Wednesday October 28, 2009)
Time reported earlier this month that the pharmaceutical industry has spent more than any other segment of the medical industry lobbying for health care legislation in 2009. Drug companies and their trade organizations spent more than $110 million, or $609,000 a day, to craft health care policy to their liking.
- How Congress and Special Interest Kept crucial crinical trial data secret
Lobbyist for the pharmaceutical device industry lobbied hard to keep results from clinical trials secret.
- MRI die can lead to fatal disease for some Source: Business Week (Friday October 16, 2009)
Many MRI patients are injected with a GE dye to enhance images. If they have weak kidneys, they might develop a rare and sometimes fatal disease.
- Physician's group wants new drug labeling, 2-year DTC moratorium Source: MM&M (Friday September 25, 2009)
The American College of Physicians (ACP) ACP argues that FDA should be authorized to require that new drugs carry labeling indicating their new-to-market status and that DTC advertising be restricted for the first two years a drug is on the market: Improving FDA Regulation of Prescription Drugs.
- More Than Half Million Kids Get Bad Drug Reactions Source: The Associated Press (Monday September 28, 2009)
Study Shows Side Effects, Bad Drug Reactions Send Half a Million US Kids to The Doctor Each Year
- F.D.A. Reveals It Fell to a Push by Lawmakers Source: NYT (Thursday September 24, 2009)
The Food and Drug Administration said Thursday that four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees, an approval it is now revisiting.
- Health Concerns Over Popular Contraceptives Source: NYT (Friday September 25, 2009)
Critics say popular birth control drugs Yaz and Yasmin put women at higher risk for blood clots, strokes and other health problems than some other birth control pills do.
- Lilly Paid Doctors to Prescribe Zyprexa, Notes Show Source: Bloomberg.com (Tuesday September 8, 2009)
Eli Lilly & Co. paid doctors in South Carolina for participating in a speakers’ program in exchange for prescribing the antipsychotic Zyprexa.
- "Dr. Nobody" Slams JAMA Again; Prophylactic Antidepressant Use Is Real Issue, Says Leo Source: BNET (Wednesday September 9, 2009)
Dr. Jonathan Leo has again taken JAMA to task over its failure to disclose links between researchers publishing studies in its pages and Forest Labs, which funded them.
- Pfizer to pay record $2.3B penalty over drug promotions Source: San Francisco Chronicle (Wednesday September 2, 2009)
Federal prosecutors hit Pfizer Inc. with a record-breaking $2.3 billion in fines Wednesday and called the world’s largest drug maker a repeating corporate cheat for illegal drug promotions that plied doctors with free golf, massages, and resort junkets.
- Pharma's misguided TV pitches Source: Los Angeles Times (Wednesday July 22, 2009)
Pharma’s misguided TV pitches — Commercials for vanity pharmaceuticals are worse than insulting — they divert attention from serious medical problems, increase healthcare costs and warp research priorities
- FDA Approves New Blood Thinner Source: WSJ (Saturday July 11, 2009)
The drug ( Effient ) must carry the agency’s sternest warning because of its bleeding risks.
- Senator Moves to Block Medical Ghostwriting Source: The New York Times (Tuesday August 18, 2009)
From NYT:: A growing body of evidence suggests that doctors at some of the nation’s top medical schools have been attaching their names and lending their reputations to scientific papers that were drafted by ghostwriters working for drug companies — articles that were carefully calibrated to help the manufacturers sell more products.
- How Do You Ask Your Doctor if He Gets Paid by the Drug Industry? Source: The Wall Street Journal Health Blog (Tuesday August 18, 2009)
Do you want to know whether your doctor is influenced by drug or device makers? It’s okay to ask, but you may also want to do some research ahead of time.
- Saying 'No' to Drug Ads Source: The New York Times (Saturday August 8, 2009)
A New York Times commentary, Room for Debate, ran a discussion about prescription drug ads asking whether if they should or should not be reined in as some in Congress have suggested. Of the more than 300 comments the forum generated, it’s official: the overwhelming majority would like to see these ads altered or banned altogether.
- Medication errors harm millions each year Source: St. Louis Today (Sunday August 2, 2009)
Despite efforts to prevent medication errors, mix-ups like this are occurring across the country with alarming frequency.
- Basic Patient Safety Reforms Would Save 85,000 Lives and $35 Billion a Year, Public Citizen Report Says Source: Public Citizen (Thursday August 6, 2009)
The report, “Back to Basics,” analyzed the results of scientific studies of treatment protocols for chronically recurring, avoidable medical errors.
- Should Prescription Drug Ads Be Reined In? Source: The New York Times (Tuesday August 4, 2009)
The New York Times features several differing viewpoints on prescription drug direct-to-consumer advertising.
- Medical Papers by Ghostwriters Pushed Therapy Source: The New York Times (Tuesday August 4, 2009)
Newly unveiled court documents show that ghostwriters paid by a pharmaceutical company played a major role in producing 26 scientific papers backing the use of hormone replacement therapy in women, suggesting that the level of hidden industry influence on medical literature is broader than previously known. The articles, published in medical journals between 1998 and 2005, emphasized the benefits and de-emphasized the risks of taking hormones to protect against maladies like aging skin, heart disease and dementia.
- Lawmakers Seek to Curb Drug Commercials Source: New York Times (Sunday July 26, 2009)
New York Times (July 26, 2009)
- Editorial: Health Care’s Infectious Losses Source: New York Times (Sunday July 5, 2009)
Former Treasury Secretary Paul O’Neil comments on reducing health care costs: “The president says he likes audacious goals. Here is one: ask medical providers to eliminate all hospital-acquired infections within two years.”
- FDA panel calls for crackdown on acetaminophen Source: Consumer Reports Health Blog (Wednesday July 1, 2009)
The blog offers advice on how to take acetaminophen, a video on overusing OTC painkillers, and if you have concerns about your medications, take a look at some questions to ask your pharmacist. You can also read Consumer Reports Health’s coverage of recommendations in May from an FDA working group to improve the safety of acetaminophen-containing products.
- Ban Is Advised on 2 Top Pills for Pain Relief Source: The New York Times (Wednesday July 1, 2009)
A federal advisory panel voted narrowly on Tuesday to recommend a ban on Percocet and Vicodin, two of the most popular prescription painkillers in the world, because of their effects on the liver.
- U.S. Health Care System Fails to Protect Patients From Deadly Medical Errors
Consumers Union Assesses Lack of Progress Ten Years After Institute of Medicine Found Up To 98,000 Die From Preventable Errors
- Report: about 98,000 Americans still die annually from medical errors Source: China View (Friday May 22, 2009)
The Consumers Union report said lawmakers largely have failed to enact patient safety reforms recommended by a 1999 report by the Institute of Medicine that found that medical errors cost the U.S. as much as 29 billion U.S. dollars a year.
- Preventable Medical Errors Still Kill Thousands, Cost Billions as Employers Foot Bill Source: Workforce Management (Wednesday May 20, 2009)
Despite a landmark report a decade ago detailing the deadly nature of the U.S. health care system, a consumer group finds that little has been done to prevent errors that cost the nation $17 billion to $29 billion and kill as many as 100,000 patients annually.
- Deadly Medical Errors Still Plague U.S.
Report Shows 10-Year Effort to Curb Medical Errors Yields Few Results
- U.S. group sees little progress on medical errors Source: Rueters (Tuesday May 19, 2009)
Despite a decade of promises, little has been done to fix the problem of preventable medical errors that kill nearly 98,000 people in the United States each year, a consumer group said on Tuesday.
- Vermont Enacts Sweeping Gift Ban; Affects Drug, Device, Biologics Manufacturers Source: NLARX (Monday May 11, 2009)
A bill passed by the Vermont House and Senate will close the loopholes in the state’s existing gift disclosure law by requiring full disclosure of allowable gifts to physicians, health care organizations, non-profit groups and state-funded academic institutions.
- Group Advises Stopping Flow of Gifts to Doctors Source: The New York Times (Wednesday April 29, 2009)
In a scolding report, the nation’s most influential medical advisory group said that doctors should stop taking much of the money, gifts and free drug samples that they routinely accept from drug and device companies. Supports Grassley/Kohl legislation legislation that would require drug and device makers to publicly disclose all payments made to doctors.
- End Drug Company Gifts To Doctors Source: Hartford Courant (Tuesday April 7, 2009)
comprehensive ban on drug company gifts to doctors will end the troubling financial conflicts of interest that undermine the quality of care to patients.
- Grassley Probes Financing of Advocacy Group for Mental Health Source: Bloomberg News (Monday April 6, 2009)
The Iowa Republican, in a series of hearings and investigations, has focused on financial ties between the drug industry, doctors and academic institutions.
- Vytorin Ad Shame Taints Entire Marketing Industry Source: Advertising Age (Monday January 21, 2008)
Pharma’s compromised credibility
- Supreme Court rules against Wyeth in liability case Source: Reuters (Wednesday March 4, 2009)
The U.S. Supreme Court ruled against the drugmaker Wyeth, holding that pharmaceutical companies can be held liable for harm from medicines that carry warnings approved by federal regulators.
- FDA should ban BP in childrens' products
FDA should ban BP in childrens’ products
- Test Drug Does Well Against Hospital Infection
A new antibiotic being developed by a small San Diego company fared well in a clinical trial, holding promise in treating an intestinal superbug that is commonly spread in hospitals and is becoming more deadly.
- MRSA Rates Tied to Hospital Understaffing Source: U.S. News and World Report (Tuesday June 24, 2008)
“The drive toward greater efficiency by reducing the number of hospital beds and increasing patient throughput has led to highly stressed health-care systems with unwelcome side effects,” the researchers wrote.
- FDA Panel Considers Toll-Free Number for TV Drug Ads Source: Washington Post (Saturday May 17, 2008)
Direct-to-consumer drug ads on television should include a toll-free phone number that would allow consumers to report adverse side effects, U.S. health experts suggested Friday.
- The FDA Needs Help Source: Washington Post editorial (Sunday April 27, 2008)
The heparin scare revealed problems the agency says it can fix. But it won’t tell Congress how much that will cost.
- TV drug ads should list FDA hotline, lawmakers say Source: LA Times (Thursday April 3, 2008)
The information would allow consumers to report serious side effects from prescription medication.
- Strong Medicine: What's Ailing the FDA?
Special report takes a look at pharmaceutical manufacturing and how new drugs receive FDA approval.
- Off-label Botox use linked to serious side effects Source: USA Today (Sunday February 10, 2008)
Botulinum toxin injections, best known for smoothing wrinkles, have been linked to cases of serious reactions, including death, the FDA announced.
- Did GSK trial data mask Paxil suicide risk? Source: New Scientist (Friday February 8, 2008)
An inappropriate analysis of clinical trial data by researchers at GlaxoSmithKline obscured suicide risks associated with paroxetine, a profitable antidepressant, for 15 years.
- Editorial: The FDA in Crisis: It Needs More Money and Talent Source: NY Times (Sunday February 3, 2008)
The FDA is supposed to be Americans’ main line of defense against tainted food, drugs, medical devices and other products. So it was especially chilling last week to hear the agency’s former chief counsel, Peter Barton Hutt, tell a Congressional panel that the F.D.A. was “barely hanging on by its fingertips.”
- FDA Confirms Infant-Meds Recall Source: Business Week (Thursday January 17, 2008)
Months after drugmakers pulled infant cold remedies from most pharmacy shelves, the FDA warns consumers of their life-threatening side effects
- FDA approves blood test for 'superbug' Source: Greenville News (Thursday January 3, 2008)
Rapid test will enable faster treatment, containment of resistant staph germ
- A Policy Study of Clinical Trial Registries and Results Databases Source: Public Citizen (Tuesday July 17, 2007)
As evidence that pharmaceutical companies have suppressed unfavorable study results has grown, the need for publicly available clinical trial registries and results databases has gained increasing public currency.
- FDA scientist says she was reprimanded for warning Source: USA Today (Tuesday June 12, 2007)
Johann-Liang found herself in the media spotlight. The popular diabetes drug Avandia began making headlines because a prestigious medical journal aired concerns about its safety. She took her staff’s advice and recommended in Feb. 2006 that Avandia get a “black box” warning about congestive heart failure.
- Senate OKs drug-safety bill Source: AP (Thursday May 10, 2007)
Prescription drugs would be monitored more closely for side effects under legislation the Senate approved aimed at staving off future high-profile drug withdrawals.
- Under the Influence: How Lobbyists Wrote and Bought the Rx Drug Bill
60 Minutes tells the story of how pharmaceutical industry lobbyists literally wrote the historic Medicare Prescription Drug Bill and twisted arms to get the necessary votes to have it passed in the middle of the night.
- US House drug safety bill has additional review Source: Reuters (Monday March 19, 2007)
U.S. regulators would have to conduct an additional review of a prescription drug’s risks seven years after approval under a bill introduced on Monday that expands on a Senate measure requiring evaluations for the first three years.
- U.S. Drug Safety Laws Must Be Tougher, Families Say Source: Bloomberg.com (Thursday March 8, 2007)
More than a dozen families organize in Washington to lobby Congress today and tomorrow for tougher U.S. drug safety laws.
- Former F.D.A. Chief Is Charged With Conflict Source: New York Times (Tuesday October 17, 2006)
Lester M. Crawford, former chief of the FDA was charged yesterday with conflict of interest and lying about stock he and his wife owned in companies the agency regulates.
- FDA Is Criticized Over Drugs' Safety Problems Source: Washington Post (Monday April 24, 2006)
The Food and Drug Administration is sometimes too slow in picking up safety problems once drugs are on the market and in responding to emerging danger signals, a federal study concluded in a report to be released today.
- Ethics for Sale Source: Salon.com (Tuesday December 13, 2005)
For-profit ethical review, coming to a clinical trial near you.
- Female and Elder Consumers and Payers Sue Pfizer Over Deceptive Marketing of Lipitor (R) Source: PR Newswire (Wednesday September 28, 2005)
Plaintiffs Allege Promotional Scheme to Boost Sales of World’s Best-Selling Drug by Misleading Women and Seniors About Link Between the Drug and Heart Disease
- New Antibiotics in clinical trials show promise of success against Superbugs Source: ScientificAmerican.com (Tuesday August 30, 2005)
The misuse and overuse of antibiotics has led to the rise of so-called superbugs–bacteria that have developed a resistance to widely used antibiotics and pose a threat to public health.
- FDA races to keep up with drug ads that go too far Source: USA Today (Monday May 30, 2005)
The TV commercial for the drug Enbrel was upbeat, engaging and, the Food and Drug Administration said, misleading.
- How marketing drives the pharmaceutical industry Source: San Francisco Chronicle (Sunday May 1, 2005)
Federal prosecutors charged last year that Neurontin’s multibillion-dollar market arose from illegal strategies such as paying doctors to promote it off label for dozens of conditions, from back pain to psychiatric illnesses. The case was settled with a $430 million fine and guilty pleas by a Pfizer unit.
- FDA Is Flexing Less Muscle Source: Washington Post (Thursday November 18, 2004)
In the past four years, the Food and Drug Administration has taken a noticeably less aggressive approach toward policing drugs that cause harmful side effects. It has some leading some lawmakers, academics and consumer advocates complaining that the agency is focused more on bolstering the pharmaceutical industry than protecting public health.
- Veil of secrecy to lift on drug tests Source: Christian Science Monitor (Monday September 13, 2004)
Gregory M. Lamb, Staff writer of the Christian Science Monitor
Firms are under pressure to release results of all their clinical trials, including the negative ones. The result could be a new level of industry openness.
- Prescription for reform? Source: USA TODAY (Monday September 13, 2004)
Against a backdrop of spiraling prescription drug costs, questions are mounting about whether drugmakers — and the doctors who test and prescribe their products — always have patients’ best interests in mind. Increasingly, critics say, money, not medicine, drives drug development and use.
- Rezulin To Be Withdrawn From The Market Source: HHS NEWS (Tuesday March 21, 2000)
U.S. Department of Health and Human Services
FDA asked the manufacturer of Rezulin (troglitazone) — a drug used to treat type 2 diabetes mellitus– to remove the product from the market. The drug’s manufacturer, Parke-Davis/Warner-Lambert, has agreed to FDA’s request.
FDA took this action after its review of recent safety data on Rezulin and two similar drugs, rosiglitazone (Avandia) and pioglitazone (Actos), showed that Rezulin is more toxic to the liver than the other two drugs. Data to date show that Avandia and Actos, both approved in the past year, offer the same benefits as Rezulin without the same risk.
Research and Reports
- Patient Safety America Newsletter (March 2013) Source: Patient Safety America (Monday March 4, 2013)
John James, Ph.D., Patient Safety America: “This month I’ve tried to put some important things in perspective for you. Ben Goldacre’s book called “Bad Pharma,” which I reviewed, is a worth-while read. Gun violence is compared with “medical violence” as far as they affect our children’s lives. The cheap, effective medical care received in Cuba is summarized as a lesson for us, and then I pound on the dangers of drugs and the unstoppable overpricing of medical care in our country. Finally, you’ll learn what post-hospital syndrome is and how to manage it to remain out of the hospital.”
- FDA Safety Communication: Metal-on-Metal Hip Implants Source: FDA (Thursday January 17, 2013)
Today the U.S. Food and Drug Administration (FDA) issued a Safety Communication on metal-on-metal hip implants which includes recommendations on imaging a patient with a metal-on-metal hip implant.
- NEJM Perspective: The 510(k) Ancestry of a Metal-on-Metal Hip Implant Source: New England Journal of Medicine (Thursday January 10, 2013)
Using FDA documents obtained from the agency’s database and Freedom of Information Office, authors traced the ancestry of the ASR XL back more than five decades, through a total of 95 different devices (including femoral stems), including 15 different femoral heads and sleeves and 52 different acetabular components (see figure, and the interactive graphic, available with the full text of this article at NEJM.org).
- AARP's drug savings tool: Helping you get the most value for your healthcare dollar Source: Consumer Reports (Saturday December 1, 2012)
Have you ever wondered if the medication you’re taking is really the best one for your condition? Is there a less expensive, but equally effective medication you can use instead? Or is there a comparable drug with fewer side effects? AARP’s Drug Savings Tool, powered by CR Best Buy Drugs, can help you get the most value for your prescription drugs and learn more about the medications you take.
- Patient Safety America Newsletter (January 2013) Source: Patient Safety America (Tuesday January 1, 2013)
John James, Ph.D., Patient Safety America: “This month I address the discriminatory medical care system in this country. Why are the poor left behind when they need competent medical care? Next – why does Medicare keep spending your tax dollars on procedures that are not “necessary and reasonable?” What is behind the 29+ deaths that resulted from injection of the fungal-contaminated medication from a compounding company? The answer might surprise you. On the controversial front, I summarize an article critical of overuse of mammography screening. Why do prescription pain killers kill at least 16,000 Americans per year? How can a medication be dispensed to you when your doctor has ordered it stopped? Be wary of these potentially dangerous practices.”
- Top 10 Health Technology Hazards For 2013 Source: ECRI Institute (Thursday November 1, 2012)
ECRI lists the top 10 health technologies that may potentially harm patients.
- Patient Safety America Newsletter (November 2012) Source: Patient Safety America (Wednesday October 31, 2012)
Review of book “Unaccountable” by Marty Makary, MD. The first two articles deal with medical errors – the first on diagnostic errors and the second on errors of omission. On page 3 I take a look at recent misdeeds of big Pharma, and then deal with ethical issues associated post-marketing drug testing on patients. A business model suggests that providers should start giving us what we really want – health – not medical care. Finally, we have a look at why hospital prices continue to escalate.
- Editor's Choice: The scandal of medical device regulation Source: BMJ (Wednesday October 24, 2012)
“Try describing Europe’s system for regulating medical devices and, as Peter McCulloch says in his editorial this week, the response from your audience will be incredulous.”
- RECALL: Methylprednisolone Acetate Injections Related to Multistate Meningitis Outbreak Source: California Department of Public Health (Monday October 15, 2012)
CDPH received a list of the recalled methylprednisolone acetate lots shipped to California facilities on September 28, 2012, and immediately notified the three local health jurisdictions where the lots had been received, including the names of the four facilities in those jurisdictions that may have administered the recalled medication. The facilities are in the process of notifying affected patients under the oversight of local health departments. No related cases of meningitis have been identified to date in California. Nationally, the illness has only been associated with one of the three lots that were initially recalled, and all of the California facilities that were identified as recipients have already been notified.
- ISMP Medication Safety Alert: Sterile Compounding Tragedy is a Symptom of a Broken System on Many Levels Source: ISMP (Thursday October 18, 2012)
Includes Table of Selected Pharmacy Sterile Compounding Misadventures
- BeSafeRx: Know Your Online Pharmacy Source: FDA (Wednesday October 10, 2012)
FDA BeSafeRx is a national campaign to raise awareness of the dangers of buying prescription medicines from fake online pharmacies.
- Frequently Asked Questions For Patients: Multistate Meningitis Outbreak Investigation Source: CDC (Thursday October 11, 2012)
CDC link on advice to patients
- CDC Map of health facilities who received contaminated steroid injections Source: CDC (Monday October 8, 2012)
Healthcare Facilities which Received Three Lots* of Methylprednisolone Acetate (PF) Recalled from New England Compounding Center on September 26, 2012
- The Assertive Patient Source: The Assertive Patient (Monday September 10, 2012)
A Guide to Speaking Up When You Are Dissatisfied With A Health Care Experience by Health Care For All.
- FDA Public Meeting on Medical Device Postmarket Surveillance System, September 10, 2012 Source: FDA (Tuesday September 4, 2012)
The Food and Drug Administration (FDA) is announcing a public meeting entitled: “Strengthening the National Medical Device Postmarket Surveillance System.” The purpose of this meeting is to solicit public feedback regarding FDA’s proposal to strengthen the national medical device postmarket surveillance system. The meeting will be webcast.
- Congressman Ed Markey and Senator Merkley Letter to FDA on 510(k) database Source: U.S. Congressman Ed Markey (Wednesday August 15, 2012)
U.S. Rep. Ed Markey and U.S. Sen. Jeff Merkley write a letter to FDA asking them to update the 510(k) medical device database to provide better information about devices recalled for serious design flaws and to help avoid future injuries.
- 2012 Meeting Materials of the FDA Metal on Metal Hip Panel Source: FDA (Monday July 30, 2012)
Meeting materials from the FDA’s metal on metal hip panel, June 27-28, 2012.
- Patient Access to Medical Devices — A Comparison of U.S. and European Review Processes Source: New England Journal of Medicine (Thursday August 9, 2012)
A study comparing how high-risk devices are approved in the US versus Europe.
- California Joint Replacement Registry Source: California Joint Replacement Registry (Tuesday August 7, 2012)
The California Joint Replacement Registry (CJRR) is an effort by the California HealthCare Foundation (CHCF), Pacific Business Group on Health (PBGH), and the California Orthopaedic Association (COA) to collect and share information about hip and knee replacement surgeries performed in the state.
- Failure rates of stemmed metal-on-metal hip replacements Source: The Lancet (Tuesday March 13, 2012)
Analysis of data from the National Joint Registry of England and Wales. Findings: Metal-on-metal total hip replacement systems failed at high rates. Interpretation: Metal-on-metal stemmed articulations give poor implant survival compared with other options and should not be implanted. Comments on this study can be found at http://www.thelancet.com.
- Report: Shining Light On The "Gray Market" Source: Senate Committee on Commerce, Science and Transportation; Senate Committee on Health, Education, Labor, and Pensions; House Committee on Oversight and Government Reform (Wednesday July 25, 2012)
An examination of why hospitals are forced to pay exorbitant prices for prescription drugs facing critical shortages
- Fact Sheet: Medical Device User Fee Amendments of 2012
List and brief description of medical device amendments contained in the FDA Safety and Innovation Act.
- FDA Safety and Innovation Act Source: FDA (Monday July 9, 2012)
Includes FDA’s description of MDUFA III.
- Big Pharma's Big Fines Source: ProPublica (Tuesday July 3, 2012)
ProPublica takes a look at six recent multi-million dollar fines that drug companies have agreed to pay for inappropriately, and in some cases illegally, promoting prescription drugs.
- Statement of Dr. Diana Zuckerman Regarding Metal on Metal Hip Implants Source: Diana Zuckerman (Wednesday June 27, 2012)
Diana Zuckerman (president of the National Research Center for Women & Families) statement before the FDA June 27, 2012 panel on metal-on-metal hip implants.
- NEJM: Delays and Difficulties in Assessing Metal-on-Metal Hip Implants Source: New England Journal of Medicine (Wednesday June 20, 2012)
NEJM reports on unanswered safety questions about metal-on-metal hip implants and foreseeable challenges for stakeholders.
- Video: FDA 2012 Patient Network Annual Meeting Source: FDA (Friday May 18, 2012)
4-part video series of the May 18, 2012 FDA event to get patient input on perceived risks and benefits related to medical products.
- Video: Health Subcommittee Hearing on FDA User Fees Source: Committee on Energy & Commerce (Wednesday April 18, 2012)
Webcast video of Subcommittee on Health hearing on Wednesday, April 18, 2012, at 10:15 a.m. in 2123 Rayburn House Office Building entitled “FDA User Fees 2012: How Innovation Helps Patients and Jobs.”
- House Energy & Commerce Health Subcommittee April 18, 2012 Hearing on FDA User Fees Source: U.S. House Energy & Commerce Committee (Tuesday April 17, 2012)
House Energy & Commerce Subcommittee on Health will hold a hearing on April 18, 2012 at 10:15am to discuss FDA User Fees, including the Medical Device User Fee Act (MDUFA). The hearing will also be webcast on the committee website.
- FDA and ISMP Work to Prevent Medication Errors Source: FDA (Thursday April 5, 2012)
FDA and ISMP Work to Prevent Medication Errors
- The Eleven Most Implanted Medical Devices In America Source: 24/7 Wall St (Monday July 18, 2011)
24/7 Wall St. has examined National Health Survey data, multiple professional physician services, peer-reviewed journals, and SEC filings to complete a list of the most frequently implanted medical devices today. While many of these are life saving, controversy swirls around several others.
- Congressman Edward Markey report: Defective Devices, Destroyed Lives SOUND Act Report Source: Representative Ed Markey (Thursday March 22, 2012)
Congressman Ed Markey issued a report highlighting faulty FDA approval process that enables defective medical devices to be implanted in patients, causing serious injury and death.
- Support for the SOUND Act of 2012 Source: Congressman Ed Markey (Wednesday February 1, 2012)
Consumers Union signs on to legislation introduced in Congress that will protect the public from avoidable harms caused by unsafe devices that should never have been cleared for sale in the first place. It will also help to ensure that decisions on device safety are based on more reliable information.
- Survey: Despite Progress, FDA Scientists Feel Political and Industry Pressure Source: Union of Concerned Scientists (Wednesday March 7, 2012)
Despite progress, FDA scientists feel political and industry pressure
- FDA Scientist Survey Shows Progress, But Problems Remain Source: Union of Concerned Scientists (Wednesday March 7, 2012)
The survey shows FDA scientific reviewers trusted the latest leaders of the FDA but still feel the agency is overly influenced by special interests. “FDA scientists express concern on several fronts, including their right to publish research and communicate with the public, the degree of corporate and political influence on regulatory decisions, and the overall transparency and accountability of the agency’s decision making.”
- Ongoing problems with metal-on-metal hip implants Source: BMJ (Tuesday February 28, 2012)
Authors examine what has gone wrong with hip implants
- Lifelong checks are needed for patients fitted with dangerous hip implants Source: BMJ (Wednesday February 29, 2012)
Access requires subscription or payment. UK health agency announced that around 49 000 UK patients with metal-on-metal hip implants will need follow-up tests for the rest of their lives. A BMJ investigation found problems with metal-on-metal implants caused by metal ions leaking into the body.
- Watchdog group says “massive lobbying effort” by medical device industry threatens public health Source: BMJ (Tuesday February 28, 2012)
Access requires subscription or payment. Public Citizen says that the medical device industry has lavished millions of dollars on US politicians in a “massive lobbying effort” to promote legislation that will weaken oversight of the industry and endanger the public.
- How safe are metal-on-metal hip implants? Source: BMJ (Tuesday February 28, 2012)
Deborah Cohen examines the evidence of risk from metal-on-metal hips, the manufacturers’ inadequate response, and how the regulatory bodies failed to give doctors and patients the information they need to make informed decisions
- 30 Things You Need to Know About Medical Devices: Approvals, the Industry, and Safety Source: Public Citizen (Monday February 27, 2012)
All of the facts below and additional information are compiled in the Public Citizen report, Substantially Unsafe, available at http://pubc.it/rMDUFA.
- Testimony of James Shull Before U.S. House Committee on Energy and Commerce/Subcommittee on Health
James Shull of Brown Mills, NJ testifies before U.S. House Energy and Commerce Committee, Health Subcommittee on medical devices
- FDA Should Enhance Its Oversight of Recalls Source: GAO (Tuesday June 21, 2011)
GAO report on medical device recalls
- FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process Source: GAO (Thursday January 1, 2009)
GAO report on Class III medical devices and the 510(k) process.
- GAO: FDA Should Enhance Its Oversight of Recalls
Government Accountability Office; June 21, 2011
- Shortcomings in FDA's Premarket Review, Postmarket Surveillance, and Inspections of Device Manufacturing Establishments Source: GAO (Wednesday February 18, 2009)
GAO found that FDA does not review all class III devices through its most stringent premarket review process.
- FDA's Premarket Review and Postmarket Safety Efforts Source: GAO (Wednesday April 13, 2011)
Government Accountability office report
- Patient Safety America Newsletter (December 2011)
Monthly patient safety newsletter by John T. James, Ph.D. of Houston, TX.
- Dollars for Docs
Look to see if your doctor has ties to drug and medical device companies.
- MedWatch: The FDA Safety Information and Adverse Event Reporting Program
Go here to report adverse or harmful events resulting from medications or medical devices.
- Report: After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drug
This report describes the problems associated with an increasingly globalized market for manufacturing prescription drugs.
- Maryann Napoli: Most Drugs Don't Work
A new Cochrane review of all relevant studies found that the most common statistical terms for expressing drug study results—in medical journals and the media—are misunderstood by doctors and consumers alike. In fact there was no difference in understanding between physicans and the lay public.
- Medicare Atypical Antipsychotic Drug Claims for Elderly Nursing Home Residents
For the period January 1 through June 30, 2007, the OIG found errors in 51 percent of Medicare claims for atypical antipsychotic drugs, amounting to $116 million. The OIG also found unnecessary antipsychotic drug use in nursing homes.
- Pharmaceutical and Medical Device Manufacturer Code of Conduct
This page provides information relating to the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct (PCOC) regulation. Reports on drug and medical device industry gifts to physicians.
- Drug Safety: FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed
The GAO has written a report on the FDA’s progress on foreign drug inspections since 2008. In 2008, the GAO found that FDA had inspected relatively few foreign establishments and had inaccurate information in its databases from 2002 through 2007.
- Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report
A committee was convened to assess the regulatory clearance process for certain medical devices held a workshop to glean insights and data from a range of invited experts. The information presented at the workshop and summarized in this report will help inform the committee’s ongoing deliberations. This summary does not contain reactions or statements by members of the study committee, whose findings and recommendations will be recorded in a report to be publicly released in 2011.
- A Prenatal Treatment Raises Questions of Medical Ethics
There is no data on how many mothers receive prenatal dex (dexamethasone), but according to the odds, 7 of 8 may be taking medication unnecessarily.
- Drug shortages: National survey reveals high level of frustration, low level of safety
ISMP survey: More than 1,000 near misses, errors, and adverse outcomes due to drug shortages in the US.
- FDA Safety Alerts for Drugs and Devices
FDA Medwatch Safety Information
- Making a Killing
Clinical trials have become marketing exercises for Big Pharma–and cash-strapped universities are helping make the sale. Article begins on page 54.
- QuarterWatch report on Adverse Drug Events (4th Quarter 2009)
Reported patient deaths increased by 14% in 2009 from adverse drug events.
- FDA 2010 Warning Letters to Drug Companies
FDA warning letters and untitled letters to drug companies for marketing and communications violations.
- QuarterWatch: Monitoring MedWatch Reports
ISMP QuarterWatch (Quarter 4 and 2009 totals) – Reported patient deaths increased by 14% in 2009. QuarterWatch is an ISMP program used to monitor adverse drug events (ADEs) in the US. During the most recent period of monitoring, ISMP analyzed 116,174 serious, disabling, and fatal ADEs reported to FDA during 2009. A 2.8-fold increase in reports has been observed since 2000. The volume of reports from health professionals has been relatively stable since 2004, while consumer reports have risen steadily since 2000.
- Truthful Prescription Drug Advertising and Promotion (Bad Ad Program)
New FDA website allows for reporting of misleading drug ads.
- Medwatch: The FDA Safety Information and Adverse Event Reporting Program
Report adverse drug or device reactions and read the latest safety information.
- Federal Register on FDA's proposed study about toll-free number on TV drug ads
Federal Register on FDA’s proposed study about adding the government’s toll free number on direct-to-consumer TV ads.
- Senate hearing: Direct to consumer advertising
Senate Special Committee on Aging hearing on “Marketing or Medicine: Are Direct-to-Consumer Medical Device Ads Playing Doctor?”
- Representative Markey questions drug industry lobbyist
During a hearing of the House Energy and Commerce Subcommittee on Health, Representative Edward J. Markey (D-MA) questioned PhRMA representative, Dr. Caroline Lowe, senior vice president of scientific and regulatory affairs, about PhRMA’s opposition to Markey’s proposal for a stronger FDA drug safety system.
- Grassley says FDA problems need sunshine, calls on Commissioner to reverse chill factor
Sen. Chuck Grassley said that statements by the Commissioner of the FDA discourage agency employees and scientists from speaking up about problems with the way the FDA monitors drug safety.
- Institute for Healthcare Improvement touts lives saved by its hospital campaign
Group says 60,500 lives have been saved in the first nine months of its one-year campaign to prevent unnecessary deaths at hospitals, including fatalities from infections.
- New England Journal of Medicine chastises Merck for hiding data
Recent findings regarding inaccuracies in data in the report of the VIGOR (Vioxx Gastrointestinal Outcomes Research) study by Bombardier et al.1 that raise concern about certain conclusions in the article.
- Too Sweet to be True
In a trenchant postmortem to the Rezulin story published in the British medical journal Lancet, Dr. Edwin Gale, an English diabetes specialist wrote, “Access to information about new drugs is closely retained by the companies, and post-marketing studies are dictated by marketing policy. . . . One lesson from [Rezulin] is that the public interest is not well served by the current system of drug development.” To purchase the book, please visit www.powerfulmedicines.org, a nonprofit supporting public interest research.
- Suicidality in pediatric clinical trials
GlaxoSmithKline (GSK) performed an analysis of suicidal behaviors in their paroxetine pediatric clinical trial database, and found that there was a statistically significant increase in suicide-related adverse events for paroxetine-treated subjects compared to placebo.