The Food and Drug Administration (FDA) has the responsibility of making sure drugs put on the market by the drug manufacturers are safe for use. Most folks probably believe the FDA is properly funded by Congress, that it has adequate staffing, that it tests all drugs before they hit the market, that it monitors drugs after they are approved and put on the market, and that the agency has authority to demand what drug labels contain. Unfortunately, none of the above is accurate.
Public Citizen’s health research group, which was founded by Dr. Sidney Wolfe 41 years ago, has done a much better job of protecting consumers in this country than has the FDA. Public Citizen has done that which the FDA does not always do and that is to protect consumers from unsafe or ineffective medications. Hundreds of thousands of people are needlessly harmed each year by the very medications that are supposed to be helping them. If the American people knew how ineffective the regulation by the FDA of the politically powerful drug industry has been over the years, they would be outraged.
Dr. Wolfe and Public Citizen put out a publication, Worst Pills, Best Pills, each month. The publication is a tremendous resource for consumers. In fact, every consumer in the U.S. would be well-served to have access to this publication. In this publication, Dr. Wolfe and his staff at Public Citizen don’t pull any punches. They don’t hedge their bets and they tell folks exactly what drugs they should stay clear of and why. Public Citizen, in Worst Pills, Best Pills, puts out DO NOT USE warnings that often come many months, and sometimes years, before unsafe drugs are withdrawn from the American market. The following drugs are prime examples of how bad drugs get on the market and have to be pulled later on:
• -MERIDIA (sibutramine). In 1998 Public Citizen warned folks not to take this diet drug for safety reasons: it increases blood pressure and heart rate in many people (and weight loss is meager). In 2002, Public Citizen petitioned the FDA to remove the drug from the market, but it took 12 years (October 2010) for the manufacturer to pull the drug after finally being pressured by the FDA.
• -ZELNORM (tegaserod). Public Citizen warned readers about this drug in June 2004. The drug was withdrawn in April 2007-nearly three years later.
• -VIOXX (rofecoxib). In April, 2001, Public Citizen issued a DO NOT USE warning for VIOXX. The drug was finally removed from the market – but only in September 2004 after it had done great damage to thousands of innocent and uninformed users.
• -BEXTRA (valdecoxib). At the time VIOXX was removed from the market, Public Citizen issued a DO NOT USE warning for BEXTRA, another NSAID, because of serious safety problems. In April, 2005, the manufacturer agreed to stop marketing the product and recommended that patients stop taking it.
• -PROPULSID (cisapride). Public Citizen warned readers about the drug in August, 1998. It was withdrawn a year and a half later.
• -REZULIN (troglitazone). Public Citizen warned its readers in March 1998 about Rezulin. It was withdrawn in August of 2001-over two years later.
• -BAYCOL (cerivastatin). Public Citizen warned its readers in March 1998 about Baycol. It was withdrawn in August of 2001-over three years later.
• -EPHEDRA. Public Citizen warned its readers in August 2001 about this drug. In September, 2001, Public Citizen petitioned the FDA to ban it. The regulatory agency finally did-over two years later!
While the above information should shock most of our readers, I doubt many knew about Public Citizen’s efforts to keep these drugs off the market. The Vioxx story alone would be enough to shock even a Tea Party zealot. I would encourage all of our readers to subscribe to Worst Pills, Best Pills. You can go to Citizen.org or Worstpills.org for more information on this publication.
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