The Safe Patient Project is a Consumers Union campaign focused on eliminating medical harm, improving FDA oversight of prescription drugs and promoting disclosure laws that give information to consumers about health care safety and quality.
Most medical implants have never been tested for safety. A new investigation by Consumer Reports reveals that while tens of millions of American consumers live with medical devices implanted in their bodies, many of these 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. In fact, because of our broken regulatory system, in such cases the only safety “testing” that occurs is in the bodies of unsuspecting patients.
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: Americans support stricter safety standards for medical devices, according to a new Consumer Reports poll. More than eight of 10 people in the survey said it was more important to prevent safety problems in the devices than it was to encourage innovation or avoid delays in getting them to market.
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.
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.
Several congressional bills have introduced bills that would relax conflict of interest rules for the Food and Drug Administration (FDA) advisory committee members.
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.
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.
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.
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.
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.
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.
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.
“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.”
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.
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.
Consumer Groups preliminary MDUFA suggestions to improve the agency’s performance in terms of ensuring that consumers have access to safe and effective medical devices, and to guarantee the scientific integrity of the safety review process.
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.
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.
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.
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.
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
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
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.
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 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.
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.
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.
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.
GAO found that FDA lacked clear and effective processes for making decisions about, and providing management oversight of, postmarket drug safety issues.
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.
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.
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.
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.
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.
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.
Statement of Consumers Union Bill Vaughan, Senior Policy Analyst On Congressman Ed Markey’s Report on the FDA’s Failure to Ensure the Safety of Rapidly Approved Drugs May 31, 2005
Rep. Markey and his staff have done a remarkable job in
Consumers Union has drafted two alternative model bills for use by state legislatures that wish to address the problem of inadequately disclosed clinical trials.
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.
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.
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.
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.
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.
“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.”
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.
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’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).
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.
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.
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.
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.
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.
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!
The IOM released a report last week reviewing the 510(k) medical device approval process. The report finds that the current FDA process “lacks the legal basis to be a reliable premarket screen of the safety and effectiveness” of devices.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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?
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
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.
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.
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..
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.
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.
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.
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.
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.
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.
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.
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.
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…
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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:
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.
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.
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.
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, 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.
“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.
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.
An article just published in the Archives of Internal Medicine echoes the growing consensus of physicians and other experts calling for major FDA reform.
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.
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.
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.
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.
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?
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 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.
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.
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.
“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.”
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.
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.
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.
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.
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.
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.
“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.”
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.
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.
“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.”
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
“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.”
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.”
“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.”
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 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 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.
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.
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.
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.
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.
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.
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 joints implanted in tens of thousands of Americans pose adverse health effects in some patients even after removal, according to new research.
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,
Source: MN Star Tribune (Saturday February 11, 2012)
The report from the U.S. General Accounting Office — which turned up a difference of more than $8,000 for one cardiac device alone — found that confidentiality clauses in sales contracts keep even the physicians who decide which devices to use in the dark about prices. A study of device charges has been requested by Sen. Max Baucus.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.”
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.
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.
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.”
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
“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.”
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.
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.
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.
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.
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.
“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.”
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.
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 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.
“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.”
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.”
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.
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.
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.
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.
In a shift still evolving, federal enforcers are targeting individual executives in health care fraud cases that used to be aimed at impersonal corporations.
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.
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.
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.
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.
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.
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.
Audio interview featuring ProPublica journalist Charles Ornstein on the drug and medical device industry’s heavy presence at medical society conventions.
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.
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.
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.
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.
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.
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.
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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).
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.”
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 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).
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.
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.
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.
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.
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.”
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.
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.
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.
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.
Nearly three-quarters of medical device recalls that could have caused injury or death from 2005-2009 went through the 510(k) pre-market notification process at the Food & Drug Administration, according to a new report from the Archives of Internal Medicine.
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.
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.
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.
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.
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.
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.”
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.
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.
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.
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.
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.
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.
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.
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.
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.
“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.”
“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.”
“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.”
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.
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.”
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.”
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
“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 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.
“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.”
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.
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.
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.
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.
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.
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.
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.
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.
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.
“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.”
Betsy Imholz of Consumers Union challenges the decision the California Pharmacy Board has signaled it will adopt regarding presription drug labeling standards.
“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. “
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.
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.
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.”
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.”
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.
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.
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.
“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.”
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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.”
“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.”
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.
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. “
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.
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.”
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” 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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.”
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.
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.
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.
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.
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.
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.
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.
comprehensive ban on drug company gifts to doctors will end the troubling financial conflicts of interest that undermine the quality of care to patients.
The Iowa Republican, in a series of hearings and investigations, has focused on financial ties between the drug industry, doctors and academic institutions.
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.
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.
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.
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.
An inappropriate analysis of clinical trial data by researchers at GlaxoSmithKline obscured suicide risks associated with paroxetine, a profitable antidepressant, for 15 years.
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.”
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.
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.
Prescription drugs would be monitored more closely for side effects under legislation the Senate approved aimed at staving off future high-profile drug withdrawals.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.”
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.
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.
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
Source: New England Journal of Medicine (Tuesday February 14, 2012)
“In our view, the greatest challenge facing U.S. device regulation is the evaluation of high-risk devices through pathways intended for lower-risk devices, such as the 510(k) process.”
IOM report: Thousands of medical devices are allowed to go on the market without proper testing for safety. FDA should develop a new framework for ensuring the safety and effectiveness of these devices.
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.
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.
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.
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.
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.
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.
The GAO determined the scope and collection of available data limited the agencies ability to determine a national estimate of hospital associated infecdtions related to medical devices. However, experts report medical staff practices as a significant factor.
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.
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.
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.
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.
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.
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.
Kim Witczak and Eric Swan take the fight for good information about prescription drugs very seriously.
In 2003, Kim’s husband and Eric’s brother-in-law, Woody, filled a new prescription from his family doctor for the antidepressant, Zoloft to reduce insomnia and “help manage the stress of a new job.” Woody had just taken a position as Vice President of Sales with a start up company about 2 months prior.
After 5 weeks of being on the drug–Woody took his own life. He had no history of mental illness, depression or any other problem. Woody was not warned about the need to be closely monitored when first going on the drug or when the dose was increased…
My mother had hip surgery during which the doctor, unbeknownst to my mother or her rehab crew, severed a nerve. After several months of my mother not getting the mobility or correct walking gait back, the doctor insisted it would only take more rehab.
The surgeon in California, who originally did a hip replacement on my right hip, used a laser to assure that both my legs were the same length. When the liner broke (13 years later), the orthopedic surgeon replaced the ball with a larger ball. This resulted in my right leg (where hip replacement was) being longer than left leg. I now limp because the left leg is approximately 3/4″ shorter.
98,000 people die each year needlessly because of preventable medical harm. Efforts to reduce this are few and fragmented. With little transparency and no public reporting (except where hard fought state laws now require it), scarce data does not paint a picture of real progress.
In this report (PDF)
we give the country a failing grade on progress on select recommendations we believe necessary to create a health-care system free of preventable medical harm.
Glossary
Medicare keeps costs down through broad spreading of risks throughout the large pool of covered persons, coupled with universal participation. Other essential elements of the program include freedom of choice of doctor, accountability for high quality of care, and fair payment to health care providers to ensure broad participation. Areas for improvement in Medicare include limitations on out-of-pocket costs, a buy-in program for people aged 55 -65, and giving the program the ability to negotiate lower prescription drug prices.
The Safe Patient Project is a Consumers Union campaign focused on eliminating medical harm, improving FDA oversight of prescription drugs and promoting disclosure laws that give information to consumers about health care safety and quality.
