Reader’s Digest Special Report on the FDA

I’m not a regular reader of Reader’s Digest, but this special report on the FDA provides a good examination of all the ways that the agency has become so compromised that they are barely doing the job they were set up to do. From the article:

Recent headlines have uncovered one shocking lapse after another at the Food and Drug Administration: A popular diabetes drug can sharply increase the risk of heart attack, a finding the agency knew but took two years to reveal. An FDA-approved antibiotic can destroy your liver in just five days. And despite mounting concerns about the safety of Chinese-made drugs, the agency had only enough field inspectors last year to check a mere 13 of the 714 Chinese factories that produce medicines for U.S. consumers.

Many of the nation’s leading doctors, scientists and lawmakers now agree that the FDA is in crisis. Lurching from one disaster to another, the 102-year-old agency learns of dangers too late and then moves too slowly to remedy them. Insiders say it’s woefully underfunded, dangerously understaffed and fractured by bitter internal tensions. Instead of depending on the FDA, Americans are doubting it — and for good reason.

The FDA is expected to regulate $1.5 trillion in food, drugs, vaccines, medical devices, blood and tissues, radiation-emitting machines, animal feeds and drugs, cell phones, dietary supplements, biotechnology and gene therapy — and, post-9/11, sniff out any food-borne terrorist plot. Yet the agency’s annual funding, $2 billion, is about what Fairfax County, Virginia, pays for its public schools.

“Think your pacemaker, heart valve, microwave oven or morning vitamin was inspected?” asks former associate commissioner William Hubbard. “Dream on.” [full text]

There is also a good related story about the drug Ketek, which somehow got through FDA approval even though it was so unsafe that it could ruin your liver in five days. The story provides frightening text from an FDA official’s email in which the official encouraged the drug makers to cover up the fact that many of the supposed participants in the clinical trials for the drug were fabricated.

The good news is that the public’s growing awareness of the problems with the FDA has finally led to some proactive change. But the changes are coming slowly and corporate influence still plays a major role in what drugs get to market and how fast. So for the time being, it’s every drug consumer for him/herself. Remember to use the tools available to you, particularly the internet and second opinions, in order to make informed decisions about medication use.

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One response

  1. this is frightening stuff if you use prescription drugs or a medical device. i have injected heparin into lots of people, but never knew that a main ingredient is pig intestines scraped in a chinese garage.
    and the pig intestines and the low-tech manufacturing were not the problem. the problem is corrupt lab owners substituting cheap and dangerous ingredients. drugs are so outsourced and international it’s hard to see how the FDA can guarantee anything.
    still, prescription drugs can save lives and health, so if you need it, take it, and try to get the best you can.

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