Diabetics beware, and don't count on the U.S. Food and Drug Administration (FDA) to cover your back. People taking the drug Avandia have a 43% higher risk of heart attack than people taking other diabetes drugs or no drugs, according to a study published in the New England Journal of Medicine.
The FDA reportedly knew of the risks for years but refused to include them on Avandia's labels. Even studies by Avandia's maker, GlaxoSmithKline, have shown a 30% higher risk of heart attack.
Senator Charles Grassley (R-Iowa) sent a letter to the FDA, demanding explanations. For years, Grassley has pushed for FDA reform because this is not the first time the FDA has been molasses-slow in alerting the public to drug risks . . . .
Even before the FDA approved Merck's painkiller Vioxx, studies linked that drug to heart attacks. Yet, the FDA waited nearly two years to require Vioxx labels to list that risk. Meanwhile, the manufacturer spent millions marketing Vioxx to doctors and consumers who were clueless about the dangers.
An FDA scientist confirmed the Vioxx-heart-attack link and urged FDA higher-ups to remove high-dose Vioxx from the market: higher-ups turned on that scientist like a pack of pit bulls, pressuring him to change his conclusions and refusing to let him publish his study. FDA higher-ups also refused to take Vioxx off the market.
After looming lawsuits and bad press, the manufacturer voluntarily took it off the market--four years after the risks became evident. Twenty-million Americans took Vioxx while it stayed on the market.
The FDA similarly mishandled the anti-impotence drug Viagra. In 2002, studies linked Viagra to a rare form of blindness. In 2004, an FDA scientist urged higher-ups to add blindness risks to Viagra labels. The FDA waited a year to do it. I don’t know how many men went blind during that year.
Antibiotic Ketek has been linked to eye-, circulatory- and liver-problems. Last year, Grassley investigated allegations that the FDA approved Ketek for public sale based on a study that the FDA knew was fraudulent. Still, the FDA cited the fraudulent study when telling the public that Ketek wasn’t all that dangerous. Despite reportedly knowing the dangers of Ketek, the FDA also approved experimentation on children as young as six months old.