Drug Safety (182 items)

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Drug Safety (182 items)

Consumers Union Documents

  • Consumers Union petitions the FDA on drug safety (January 31, 2008)
  • Avandia and the Commerical Impact of FDA’s Credibilty Gap (September 13, 2007)
  • Testimony of Jim Guest President, Consumers Union, before the House (June 15, 2007)
  • Summary of Testimony of Jim Guest (June 14, 2007)
  • Putting patient safety first & fixing our drug safety system (May 18, 2007)
  • Further Actions Needed to Improve FDA’s Postmarket Decision-making Process (May 9, 2007)
  • Getting Seniors, Taxpayers the Best Deal on Prescription Drugs through Medicare Part D (March 14, 2007)
  • FDA witholds important safety information from its own advisory panel, Senator says (December 15, 2006)
  • Improvements needed in FDA’s oversight of direct-to-consumer advertising, new study finds (December 15, 2006)
  • Information you should have before your next doctor visit (November 1, 2006)
  • When Clinical Trials Are Compromised: A Perspective from a Patient Advocate (February 14, 2006)
  • Grassley, Baucus seek more details of drug company grant money (January 17, 2006)
  • Mandatory public clinical drug trial registry needed to help ensure prescription drug safety, IOM panel told (June 28, 2005)
  • Maine first state in nation to require public clinical trials (June 13, 2005)
  • Food and Drug Administration Safety Act S.930 (PDF) (June 3, 2005)
  • Statement of CU regarding report on the FDA’s failure to ensure the safety of rapidly approved drugs (May 31, 2005)
  • Recommended reforms to Institute of Medicine panel (PDF) (May 25, 2005)
  • Lower-cost heart drugs could help expand treatment to millions of Americans (PDF) (March 29, 2005)
  • Sen. Chuck Grassley’s take on the FDA’s drug safety program (March 14, 2005)
  • Consumer Reports Best Buy Drugs (March 3, 2005)
  • A Rudderless, Leaderless FDA (February 15, 2005)
  • Requiring Drug Companies to Disclose Marketing Expenditures to Physicians (January 27, 2005)
  • Fact Sheet: Disclosing Relationships Between Pharmacy Benefit Managers and Drug Companies (January 27, 2005)
  • About Institutional Review Boards (December 8, 2004)
  • FDA official’s testimony about drug safety (November 18, 2004)
  • Q&A; on the Fair Access to Clinical Trials Act (November 10, 2004)
  • FDA’s proposed changes to drug safety program (November 5, 2004)
  • Avoiding Hospital Blunders (Knowing the Risks and Speaking Up Can Help You Stay Safe) (September 15, 2003)

Laws and Legislation

  • Read the text of HR 2900, the House drug safety bill (July 3, 2007)
  • HR 2900 continued (July 3, 2007)
  • HR 2900 continued to end (July 3, 2007)
  • Strong drug safety legislation goes to US House floor for a vote (June 22, 2007)
  • How did your Senator vote on drug safety? (May 18, 2007)
  • Battle for drug safety moves to House floor (May 18, 2007)
  • Text of S. 1082 Senate Drug Safety Bill (May 18, 2007)
  • Text of H.R. 1561 (May 16, 2007)
  • Food and Drug Administration Safety Act S.930 (PDF) (June 3, 2005)
  • Fact sheet on federal bill S. 470 (June 3, 2005)
  • Pharmaceutical Market Access and Drug Safety Act of 2005, S.334 and H.R.700 (PDF) (May 9, 2005)
  • CU Model Clinical Trials Bill (January 27, 2005)
  • CU Model Pharmacy Benefit Managers Bill (PDF) (January 27, 2005)
  • CU Model Pharmaceutical Company Marketing Disclosure Bill (PDF) (January 27, 2005)
  • State-Based Mandates Requiring Registry and Reporting (PDF) (January 27, 2005)

Consumers Union News Releases

  • Drug safety bill moves to Conference Committee; send strong bill to the President! (July 17, 2007)
  • Human face on weak prescription safety laws (June 12, 2007)
  • Clinical trial registry analysis shows company secrecy continues (January 3, 2006)
  • Drug companies manipulate research findings (December 27, 2005)
  • Amendment passes that will create greater transparency in drug safety advisory panels (September 28, 2005)
  • Drug safety board needs real independence, authority (February 15, 2005)
  • In Light of Celebrex News, Consumer Reports Best Buy Drugs Urges Patients to Talk to Their Doctors about Alternatives (December 22, 2004)

 

  • Medical Mistakes show on Oprah (March 13, 2009)
  • Old Blood for Halloween (October 31, 2008)
  • You Score Higher Marks than Doctors (June 17, 2008)
  • What you should ask your doctor (June 16, 2008)
  • Common sense shouldn’t take two years – unless it’s the FDA (May 21, 2008)

News

  • Grassley Probes Financing of Advocacy Group for Mental Health

    The Iowa Republican, in a series of hearings and investigations, has focused on financial ties between the drug industry, doctors and academic institutions.

  • Vytorin Ad Shame Taints Entire Marketing Industry

    Pharma’s compromised credibility

  • Supreme Court rules against Wyeth in liability case

    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.

  • Test Drug Does Well Against Hospital Infection

    A new antibiotic being developed by a small San Diego company fared well in a clinical trial, holding promise in treating an intestinal superbug that is commonly spread in hospitals and is becoming more deadly.

  • MRSA Rates Tied to Hospital Understaffing

    “The drive toward greater efficiency by reducing the number of hospital beds and increasing patient throughput has led to highly stressed health-care systems with unwelcome side effects,” the researchers wrote.

  • FDA Panel Considers Toll-Free Number for TV Drug Ads

    Direct-to-consumer drug ads on television should include a toll-free phone number that would allow consumers to report adverse side effects, U.S. health experts suggested Friday.

  • The FDA Needs Help

    The heparin scare revealed problems the agency says it can fix. But it won’t tell Congress how much that will cost.

  • TV drug ads should list FDA hotline, lawmakers say

    The information would allow consumers to report serious side effects from prescription medication.

  • Strong Medicine: What’s Ailing the FDA?

    Special report takes a look at pharmaceutical manufacturing and how new drugs receive FDA approval.

  • Off-label Botox use linked to serious side effects

    Botulinum toxin injections, best known for smoothing wrinkles, have been linked to cases of serious reactions, including death, the FDA announced.

  • Did GSK trial data mask Paxil suicide risk?

    An inappropriate analysis of clinical trial data by researchers at GlaxoSmithKline obscured suicide risks associated with paroxetine, a profitable antidepressant, for 15 years.

  • Editorial: The FDA in Crisis: It Needs More Money and Talent

    The FDA is supposed to be Americans’ main line of defense against tainted food, drugs, medical devices and other products. So it was especially chilling last week to hear the agency’s former chief counsel, Peter Barton Hutt, tell a Congressional panel that the F.D.A. was “barely hanging on by its fingertips.”

  • FDA Confirms Infant-Meds Recall

    Months after drugmakers pulled infant cold remedies from most pharmacy shelves, the FDA warns consumers of their life-threatening side effects

  • FDA approves blood test for ‘superbug’

    Rapid test will enable faster treatment, containment of resistant staph germ

  • A Policy Study of Clinical Trial Registries and Results Databases

    As evidence that pharmaceutical companies have suppressed unfavorable study results has grown, the need for publicly available clinical trial registries and results databases has gained increasing public currency.

  • FDA scientist says she was reprimanded for warning

    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.

  • Under the Influence: How Lobbyists Wrote and Bought the Rx Drug Bill

    60 Minutes tells the story of how pharmaceutical industry lobbyists literally wrote the historic Medicare Prescription Drug Bill and twisted arms to get the necessary votes to have it passed in the middle of the night.

  • US House drug safety bill has additional review

    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.

  • FDA Is Criticized Over Drugs’ Safety Problems

    The Food and Drug Administration is sometimes too slow in picking up safety problems once drugs are on the market and in responding to emerging danger signals, a federal study concluded in a report to be released today.

  • Ethics for Sale

    For-profit ethical review, coming to a clinical trial near you.

  • Female and Elder Consumers and Payers Sue Pfizer Over Deceptive Marketing of Lipitor (R)

    Plaintiffs Allege Promotional Scheme to Boost Sales of World’s Best-Selling Drug by Misleading Women and Seniors About Link Between the Drug and Heart Disease

  • New Antibiotics in clinical trials show promise of success against Superbugs

    The misuse and overuse of antibiotics has led to the rise of so-called superbugs–bacteria that have developed a resistance to widely used antibiotics and pose a threat to public health.

  • FDA races to keep up with drug ads that go too far

    The TV commercial for the drug Enbrel was upbeat, engaging and, the Food and Drug Administration said, misleading.

  • How marketing drives the pharmaceutical industry

    Federal prosecutors charged last year that Neurontin’s multibillion-dollar market arose from illegal strategies such as paying doctors to promote it off label for dozens of conditions, from back pain to psychiatric illnesses. The case was settled with a $430 million fine and guilty pleas by a Pfizer unit.

  • FDA Is Flexing Less Muscle

    In the past four years, the Food and Drug Administration has taken a noticeably less aggressive approach toward policing drugs that cause harmful side effects. It has some leading some lawmakers, academics and consumer advocates complaining that the agency is focused more on bolstering the pharmaceutical industry than protecting public health.

  • Veil of secrecy to lift on drug tests

    Gregory M. Lamb, Staff writer of the Christian Science Monitor

    Firms are under pressure to release results of all their clinical trials, including the negative ones. The result could be a new level of industry openness.

  • Prescription for reform?

    Against a backdrop of spiraling prescription drug costs, questions are mounting about whether drugmakers — and the doctors who test and prescribe their products — always have patients’ best interests in mind. Increasingly, critics say, money, not medicine, drives drug development and use.

  • Rezulin To Be Withdrawn From The Market

    U.S. Department of Health and Human Services
    FDA asked the manufacturer of Rezulin (troglitazone) — a drug used to treat type 2 diabetes mellitus– to remove the product from the market. The drug’s manufacturer, Parke-Davis/Warner-Lambert, has agreed to FDA’s request.
    FDA took this action after its review of recent safety data on Rezulin and two similar drugs, rosiglitazone (Avandia) and pioglitazone (Actos), showed that Rezulin is more toxic to the liver than the other two drugs. Data to date show that Avandia and Actos, both approved in the past year, offer the same benefits as Rezulin without the same risk.

Research and Reports

  • Grassley Probes Financing of Advocacy Group for Mental Health

    The Iowa Republican, in a series of hearings and investigations, has focused on financial ties between the drug industry, doctors and academic institutions.

  • Senate hearing: Direct to consumer advertising

    Senate Special Committee on Aging hearing on “Marketing or Medicine: Are Direct-to-Consumer Medical Device Ads Playing Doctor?”

  • Representative Markey questions drug industry lobbyist

    During a hearing of the House Energy and Commerce Subcommittee on Health, Representative Edward J. Markey (D-MA) questioned PhRMA representative, Dr. Caroline Lowe, senior vice president of scientific and regulatory affairs, about PhRMA’s opposition to Markey’s proposal for a stronger FDA drug safety system.

  • Grassley says FDA problems need sunshine, calls on Commissioner to reverse chill factor

    Sen. Chuck Grassley said that statements by the Commissioner of the FDA discourage agency employees and scientists from speaking up about problems with the way the FDA monitors drug safety.

  • Institute for Healthcare Improvement touts lives saved by its hospital campaign

    Group says 60,500 lives have been saved in the first nine months of its one-year campaign to prevent unnecessary deaths at hospitals, including fatalities from infections.

  • New England Journal of Medicine chastises Merck for hiding data

    Recent findings regarding inaccuracies in data in the report of the VIGOR (Vioxx Gastrointestinal Outcomes Research) study by Bombardier et al.1 that raise concern about certain conclusions in the article.

  • Too Sweet to be True

    In a trenchant postmortem to the Rezulin story published in the British medical journal Lancet, Dr. Edwin Gale, an English diabetes specialist wrote, “Access to information about new drugs is closely retained by the companies, and post-marketing studies are dictated by marketing policy. . . . One lesson from [Rezulin] is that the public interest is not well served by the current system of drug development.”  a nonprofit supporting public interest research.

  • Suicidality in pediatric clinical trials

    GlaxoSmithKline (GSK) performed an analysis of suicidal behaviors in their paroxetine pediatric clinical trial database, and found that there was a statistically significant increase in suicide-related adverse events for paroxetine-treated subjects compared to placebo.

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