News and Articles
FAA bans anti-smoking drug Chantix for pilots, air controllers LA Times (May 22, 2008)
The Federal Aviation Administration on Wednesday banned pilots and air traffic controllers from using a popular anti-smoking drug after a study found that it had apparently contributed to auto accidents and other problems that posed risks to both users and others.
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A Healthier FDA LA Times (May 22, 2008)
A proposal to increase funding for the financially starved watchdog agency deserves approval
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FDA Panel Considers Toll-Free Number for TV Drug Ads Washington Post (May 17, 2008)
Direct-to-consumer drug ads on television should include a toll-free phone number that would allow consumers to report adverse side effects, U.S. health experts suggested Friday.
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Ban Urged on Medical Giveaways New York Times (April 28, 2008)
Drug and medical device companies should be banned from offering free food, gifts, travel and ghost-writing services to doctors, staff members and students in all 129 of the nation’s medical colleges, an influential college association has concluded.
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The FDA Needs Help Washington Post editorial (April 27, 2008)
The heparin scare revealed problems the agency says it can fix. But it won't tell Congress how much that will cost.
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TV ads oversell drugs, skimp on risks LA Times (February 11, 2008)
For now at least, Vytorin, the controversial cholesterol-lowering drug under investigation by Congress and state attorneys general, will remain on the market. But its TV ads will not. |
Did GSK trial data mask Paxil suicide risk? New Scientist (February 8, 2008)
An inappropriate analysis of clinical trial data by researchers at GlaxoSmithKline obscured suicide risks associated with paroxetine, a profitable antidepressant, for 15 years. |
Editorial: The FDA in Crisis: It Needs More Money and Talent NY Times (February 3, 2008)
The FDA is supposed to be Americans’ main line of defense against tainted food, drugs, medical devices and other products. So it was especially chilling last week to hear the agency’s former chief counsel, Peter Barton Hutt, tell a Congressional panel that the F.D.A. was “barely hanging on by its fingertips.” |
NY subpoenas Merck and Schering-Plough over Vytorin KTEN (January 27, 2008)
NY AG has subpoenaed Merck & Co (MRK.N) and Schering-Plough Corp (SGP.N) for documents and information to see whether the companies hid the results of a study on their cholesterol drug Vytorin. |
White House Vetting Product-Safety Candidates Washington Post (January 26, 2008)
The White House is considering a scientist who has frequently testified and written on behalf of the energy, pesticide and tobacco industries to chair the nation's chief product-safety regulator. |
FDA Confirms Infant-Meds Recall Business Week (January 17, 2008)
Months after drugmakers pulled infant cold remedies from most pharmacy shelves, the FDA warns consumers of their life-threatening side effects |
Antidepressant Studies Unpublished NY Times (Jan 17, 2008)
The makers of antidepressants like Prozac and Paxil never published the results of about a third of the drug trials that they conducted to win government approval, misleading doctors and consumers about the drugs’ true effectiveness, a new analysis has found. |
After a Trial, Silence NY Times (November 21, 2007)
Prescriptions for the cholesterol-lowering drugs Zetia and Vytorin are written for almost 800,000 Americans every week, at a cost this year of about $4 billion. Yet it still is not clear how well the drugs work. |
Human face on weak prescription safety laws
Today, Patricia Slingo appears in a full page USA Today advertisement as part of our national push to finally pass strong drug safety reform. |
FDA scientist says she was reprimanded for warning USA Today (June 12, 2007)
Johann-Liang found herself in the media spotlight. The popular diabetes drug Avandia began making headlines because a prestigious medical journal aired concerns about its safety. She took her staff's advice and recommended in Feb. 2006 that Avandia get a "black box" warning about congestive heart failure. |
US House drug safety bill has additional review Reuters (March 19, 2007)
U.S. regulators would have to conduct an additional review of a prescription drug's risks seven years after approval under a bill introduced on Monday that expands on a Senate measure requiring evaluations for the first three years. |
FDA Is Criticized Over Drugs' Safety Problems Washington Post (April 24, 2006)
The Food and Drug Administration is sometimes too slow in picking up safety problems once drugs are on the market and in responding to emerging danger signals, a federal study concluded in a report to be released today. |
Ethics for Sale Salon.com (Dec. 13, 2005)
For-profit ethical review, coming to a clinical trial near you. |
Where drug advertisements often cross the lines USA Today (May 30, 2005)
The Food, Drug and Cosmetic Act requires that drug promotions present accurate information and fairly represent a drug's benefits and risks. Here are the most frequent ways the Food and Drug Administration says drug marketers overstep. |
How marketing drives the pharmaceutical industry San Francisco Chronicle (May 1, 2005)
Federal prosecutors charged last year that Neurontin's multibillion-dollar market arose from illegal strategies such as paying doctors to promote it off label for dozens of conditions, from back pain to psychiatric illnesses. The case was settled with a $430 million fine and guilty pleas by a Pfizer unit. |
FDA Is Flexing Less Muscle Washington Post (Nov. 18, 2004)
In the past four years, the Food and Drug Administration has taken a noticeably less aggressive approach toward policing drugs that cause harmful side effects. It has some leading some lawmakers, academics and consumer advocates complaining that the agency is focused more on bolstering the pharmaceutical industry than protecting public health. |
Veil of secrecy to lift on drug tests Christian Science Monitor (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.
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Prescription for reform? USA TODAY (September 13, 2004)
Against a backdrop of spiraling prescription drug costs, questions are mounting about whether drugmakers — and the doctors who test and prescribe their products — always have patients' best interests in mind. Increasingly, critics say, money, not medicine, drives drug development and use.
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Taking drugs on faith (Chicago Sun-Times May 27, 2001)
Receiving any treatment is an act of faith: faith in the integrity of the researchers who say it works. |
Rezulin To Be Withdrawn From The Market HHS NEWS (March 21, 2000)
U.S. Department of Health and Human Services
FDA asked the manufacturer of Rezulin (troglitazone) -- a drug used to treat type 2 diabetes mellitus-- to remove the product from the market. The drug's manufacturer, Parke-Davis/Warner-Lambert, has agreed to FDA's request.
FDA took this action after its review of recent safety data on Rezulin and two similar drugs, rosiglitazone (Avandia) and pioglitazone (Actos), showed that Rezulin is more toxic to the liver than the other two drugs. Data to date show that Avandia and Actos, both approved in the past year, offer the same benefits as Rezulin without the same risk.
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