When it comes to health, I’ve been very fortunate: most of my problems have been limited to colds, occasional stomach bugs and stubbed toes. I say fortunate, because the few times I’ve ever run to the medicine cabinet, I’ve experienced nasty side effects.
Aspirin hurts my stomach. Painkillers dehydrate me. Penicillin causes my shoulders and neck to break out in a rash.
So I rarely take drugs. I even avoid vitamins. Still, it’s good to know that modern science provides a slew of options should I need them. Insulin for diabetes and antibiotics really work.
Because of this, most of us believe that antidepressants and anti-cholesterol drugs work as well. Perhaps we are mistaken.
It turns out that pharmaceutical companies never bothered to publish the full story about antidepressants, reports The New York Times:
In published trials, about 60 percent of people taking the drugs report significant relief from depression, compared with roughly 40 percent of those on placebo pills. But when the less positive, unpublished trials are included, the advantage shrinks: the drugs outperform placebos, but by a modest margin, concludes the new report, which appears Thursday in The New England Journal of Medicine. …
(The researchers) found that 37 of 38 trials that the FDA viewed as having positive results were published in journals. The agency viewed as failed or unconvincing 36 other trials, of which 14 made it into journals.
But 11 of those 14 journal articles “conveyed a positive outcome” that was not justified by the underlying FDA review, said the new study’s lead author, Dr. Erick H. Turner, a psychiatrist and former FDA reviewer who now works at Oregon Health and Sciences University.
The upshot? There has been a bias toward reporting positive results for other drugs as well.
Newer cholesterol drugs are being questioned, but for different reasons, reports The New York Times. There are two points to consider: 1. Despite the widespread use of these drugs, heart disease is still the No. 1 killer in the United States. 2. Experimental new anti-cholesterol drugs are making it to the market before proving that they reduce heart attacks.
You see, the FDA considers existing anti-cholesterol drugs effective at lowering bad cholesterol AND reducing heart disease. Ergo, any new drug that reduces cholesterol is treated by the FDA as effective at lowering heart disease, reports The Times.
The problem: Some of these new drugs lower bad cholesterol, but not necessarily heart disease:
Pfizer stopped development of its experimental cholesterol drug torcetrapib in December 2006, when a trial involving 15,000 patients showed that the medicine caused heart attacks and strokes. That trial – somewhat unusual in that it was conducted before Pfizer sought FDA approval – also showed that torcetrapib lowered LDL cholesterol while raising HDL, or good cholesterol.
Torcetrapib’s failure, Dr. (Allen) Taylor said, shows that lowering cholesterol alone does not prove a drug will benefit patients.
Then, on Monday, Merck and Schering-Plough announced that Vytorin, which combines Zetia with Zocor, had failed to reduce the growth of fatty arterial plaque in a trial of 720 patients. In fact, patients taking Vytorin actually had more plaque growth than those who took Zocor alone.
Oops. This is important because drug makers continue to seek approval of anti-cholesterol drugs, even if pharma hasn’t proven they reduce heart-attack risk. In other words, we, the patients are the study subjects.