It turns out every new medical drug should contain a warning: “The FDA approved this medicine. Watch out.”
Perhaps the warning should be more extreme: “If you’re taking this drug, have an emergency medical crew on stand-by.”
A new study, published in the Journal of American Medical Association, examined all 222 drugs approved by the FDA between 2001 and 2010. The finding? Years after approval, roughly a third of the medicines were then labeled with warnings about serious adverse effects; and some of those warnings indicated life-threatening complications. For example, cancer and liver damage. For example, death—which, the last time I looked, is life-threatening.
The Washington Post reports: “Among the drugs with added warnings [years after the drugs were approved, as safe, for public use]: Humira, used for arthritis and some other illnesses; Abilify, used for depression and other mental illness; and Pradaxa, a blood thinner. The withdrawn drugs [taken off the market] and the reason: Bextra, an anti-inflammatory medicine, heart problems; Raptiva, a psoriasis drug, rare nervous system illness; and Zelnorm, a bowel illness drug, heart problems.”
A pharma trade-group spokeswoman told the Post: “Even with rigorous clinical studies and regulatory review it may be impossible to detect certain safety signals until several years after approval, once the medicine is in broader use.”
No doubt. And that’s why the public is subjected to the luck of the draw, a roll of the dice, a spin of the roulette wheel.
Of course, as I never tire of pointing out, a landmark review (July 26, 2000) in the Journal of American Medical Association, by Dr. Barbara Starfield, found that, every year in the US, FDA approved drugs kill 106,000 people. Extrapolating to a decade, that would be a million deaths.
The new study confirms only a small part of the overall problem.
And the overall problem is what major media don’t want to report on—and what the federal government doesn’t want to touch with a 10-foot pole.
The new study is what intelligence agencies would call a limited hangout, which is a public admission of part of a problem or scandal that is, in fact, much bigger. The huge scandal, in this case, is the routine death-by-medicine numbers every year—which is ignored by the press and the government.
106,000 Americans killed by FDA approved medicines every year. That’s the big one. That remains hidden and unacknowledged.
NOTE: under Trump, the FDA is urged to speed up the drug-approval process. It’s good for business. For patients, it’s a disaster on top of the already existing disaster.