Federal Watch Dog Doesn’t Bark

Almost 100 years ago Congress passed the Pure Food and Drug Act, setting the stage for federal regulation of medications. Americans had become sick and tired of fraudulent advertising and ineffective or dangerous drugs.
Times have changed, but some of the same issues plague American consumers. The FDA that is supposed to protect us from deceptive products or dangerous drugs seems to have let down its guard.
Instead of itinerant medicine peddlers with snake oil potions, we now have Internet purveyors of penis enlargers. Open your email and you will find offers for diet pills, powerful pain medicine, breast enhancers and erection pills. The FDA seems powerless to halt the flood of bogus products.
Even more alarming, though, is the agency’s failure to protect the public from drug disasters. The sudden removal of Vioxx is an indictment of the FDA’s regulatory oversight. The agency did not require the maker to take Vioxx off the market. Instead, it waited until Merck made the decision to pull the drug voluntarily. The company determined that the drug posed too great a risk of heart attack and stroke.
Cardiologist Eric Topol, MD, of the Cleveland Clinic chastised both the agency and the company in The New England Journal of Medicine: “This represents the largest prescription-drug withdrawal in history, but had the many warning signs along the way been heeded, such a debacle could have been prevented.
“Neither of the two major forces in this five-and-a-half-year affair – neither Merck nor the FDA – fulfilled its responsibilities to the public.”
Unfortunately, this is not the only instance in which the FDA has let America down. The feds learned that there were significant quality control problems at Chiron in June 2003. But the FDA was still taken by surprise when British regulators revoked Chiron’s license, creating a major shortage of flu vaccine.
Just a month prior to this disaster, the agency was hearing about suicide attempts in children and teenagers taking antidepressant drugs. Here again, British regulators had led the way, banning the use of many such antidepressants in youngsters and warning about suicidal thoughts and behaviors. The FDA was more than a day late and a dollar short.
The diabetes drug Rezulin was yanked off the market in 2000 after hundreds of deaths due to liver damage. Here again, the agency was reluctant to take action even when staff members urged the product’s withdrawal.
Other drug disasters that seem to have caught the FDA off guard include the cholesterol-lowering drug Baycol and the diet pill duo phen-fen. The agency was very slow to act on the popular antihistamines Seldane and Hismanal, even though these drugs caused heart rhythm irregularities in combination with other medicines.
Most Americans believe that our medicines are safe and effective because of FDA oversight. Just as a watchdog guards a home, so the agency should be vigilant against fraudulent or dangerous products.
Tens of millions of people were exposed to Vioxx, and countless heart attacks and strokes may have resulted from the agency’s inaction. Until the FDA demonstrates it has both a bark and a bite, physicians and patients will need to be far more vigilant.