US drug agency admits death rates from licensed drugs

This has been found on the Food and Drug Administration (FDA) website. 

Why Learn about Adverse Drug Reactions (ADR)?

Institute of Medicine, National Academy Press, 2000

Lazarou J et al. JAMA 1998;279(15):1200–1205

Gurwitz JH et al. Am J Med 2000;109(2):87–94

• Over 2 MILLION serious ADRs yearly

• 100,000 DEATHS yearly

• ADRs 4th leading cause of death ahead of pulmonary disease, diabetes, AIDS, pneumonia, accidents and automobile deaths

• Ambulatory patients ADR rate—unknown

Nursing home patients ADR rate—350,000 yearly

Source: John Rappaport. Rappaport is very excited about this chance find on the FDA website. It shows awareness in the FDA that an untold number of deaths are caused by legally prescribed drugs.

What it doesn't point out 

• that the FDA is itself responsible for the licensing of these drugs;
• that the safety of these drugs is indicated by the publication of the results of clinical trials in medical journals. The trials are sponsored by drug manufacturers, who then write up the results and seek publication.

Publication bias plays a part. This is how it might work:

A final note: The august editors of medical journals have a game they can play. Suppose a drug company has just finished writing up the results of a clinical drug trial and has submitted the piece to a journal for publication. The editor knows the company carried out a half-dozen other such trials on the same drug…and they didn’t look good. The drug caused wild fluctuations in blood pressure and blood sugar. There were heart attacks. Strokes. But this ONE study, the one submitted for publication, looks very positive. The editor knows if he prints it and forgets about “ethics,” the drug company will order re-prints of the piece from him and distribute them to doctors all over the world, and to reporters, professors, government officials. The drug company will order and pay for so many re-prints, the medical journal can make $700,000 from publishing THAT ONE STUDY. Let’s see. In one hand, the editor sees: I won’t publish it=no money. In the other hand, he sees: I’ll publish it=$700,000. What to do?

The fact that the web page shows clear FDA knowledge that its own drug safety regime fails disastrously has led Rappaport to speculate that FDA contains a rogue element who has posted it in the hope that it reaches the wider public.

The FDA knowingly exposes the US public to dangerous pharmaceutical preparations on a gargantuan scale.

This revelation should be considered in the light of the fact that the FDA also persecutes small farmers and dairy operations in the US ostensibly on safety grounds. Like health agencies everywhere, it maintains an unhealthy interest in the dangers of smoking, but should really clean up its own act before coming after tobacco companies.