Tuesday, September 13, 2005

FDA in the Spotlight

From: The Daily Aztec, San Diego State University
http://www.thedailyaztec.com/media/paper741/news/2005/09/12/Opinion/Drug-Prescriptions.Lethal.To.Americans-981085.shtml
Drug prescriptions lethal to Americans
By Ari Whitten, Contributing Columnist
Published: Monday, September 12, 2005

Media Credit: KRT Campus
Vioxx is responsible for thousands of deaths since its approval.There's a new killer in America: it isn't the result of an unhealthy diet or lifestyle, nor is it an obscure new disease. Yet, it ranks within the top-five causes of death in America each year, along with cancer, heart disease and stroke.
Adverse reaction to prescription drugs is the fourth leading cause of death in the United States, according to the American Medical Association. This doesn't include deaths and injuries that result from drug abuse or prescribing errors, and the AMA notes that "reactions to prescription and over-the-counter medications kill far more people annually than all illegal drug use combined."
The question is: Why are so many Americans dying from drugs that are intended to help them? After all, the U.S. Food and Drug Administration is "responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs," according to its mission statement. However, recent occurrences force me to question just how devoted to protecting the public health the FDA really is.
Consider the case of Vioxx, an anti-inflammatory drug usually prescribed to arthritis patients and recently re-approved by the FDA. Vioxx is responsible for more than 55,000 deaths and 160,000 heart attacks since its approval by the FDA in May 1999, according to Dr. David Graham, an associate director of the FDA's Office of Drug Safety. In September 2004, its manufacturer, Merck, voluntarily pulled Vioxx from the market because research data showed patients taking the drug faced twice the risk of heart attack compared to those taking placebo. Incredibly, an FDA advisory panel recently voted to allow Vioxx to return to the market with full FDA safety approval.
In November 2004, before Congress, Graham - who had warned about the heart risks of Vioxx - called the FDA's actions "a profound regulatory failure," according to Reuters. Several government watchdog groups now claim the FDA is attempting to censor and intimidate Graham. With its decision to deem one of the most lethal drugs to ever hit the U.S. market as safe for consumers, the FDA has made its safety approval policy entirely meaningless.
Among the many other dangerous drugs the FDA has knowingly allowed to remain on the market is Rezulin, which lowers blood sugar in Type II (adult onset) diabetics. Rezulin has been directly linked to a number of serious, life-threatening side effects, including severe injury to the heart and liver and death. Warner-Lambert, the manufacturer of the drug, has been blamed in dozens of deaths from liver failure and thousands of other cases of liver damage reported from 1997 to 2000. In December 1997, Rezulin was removed from the British market but despite its obvious dangers, the FDA allowed the drug to remain on the U.S. market for more than two years.
Tragically, the FDA's failures to ensure the health of the American public go far beyond its inability to ensure drug safety, but also extend to efficacy.
According to the International Journal of Neuropsychopharmacology, "the majority of antidepressant trials conducted by drug companies have found that sugar pills, or placebos, produce results similar to or better than antidepressant drugs."
To make matters worse, recent research has demonstrated that people who take SSRI antidepressants - the popular selective serotonin reuptake inhibitors such as Prozac and Zoloft - are more likely to attempt suicide, compared to users of placebo or other therapeutic interventions, according to the British Medical Journal. Sadly, depression afflicts roughly 19 million Americans and it's these dangerous, marginally effective drugs, which the FDA willfully allows to remain on the market, that remain the treatment of choice.
Clearly, the FDA is more interested in protecting the interests of the pharmaceutical industry than protecting American consumers. According to Graham, the reason for this conflict of interest is the FDA "views industry as its client, and the client is someone whose interest you represent."
Unfortunately, the industry is more concerned with profit than with health. Until the FDA realizes that our interests are not adequately represented by the industry, Americans will continue to pay for it with their lives.
-Ari Whitten is a kinesiology senior.

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