I’m not a big fan of the Food and Drug Administration. This isn’t just because I used to have a friend who got involved with a pugnacious woman who worked at the FDA and who believed that being a doctor gave her a leg up in the smarts department regardless of who else was involved in the conversation.
No, I’m not a big fan of the FDA because as an agency it acts in a particularly reckless and endangering manner. It concentrates on things that don’t matter and ignores things that do to the possible fatality of the average American citizen. Take direct-to-consumer drug advertising: no, really, take it, please.
DTC advertising was, according to Greg Crister author of Generation Rx a book which should be required reading for everyone in the U.S., made possible by the perfect storm of Naderite meddling, Reagan deregulation, incentivization of government agencies, cost cutting by insurance companies, and BigPharma profit sniffing to give us an environment where:
- advertising by multi-billion dollar corporations is protected as free speech just the same as your right to criticize the government
- up to 90% of continuing medical education in the U.S., which is required for all physicians, is funded by pharmaceutical companies who spend millions of dollars a year to “detail” doctors through a quasi-illegal process that gives these companies access to physicians’ prescribing habits
- insurance companies would rather have you take multiple pills than have your doctor spend 10 extra minutes talking with you (the pills are cheaper)
- a government agency is dependent upon fees from the very industry it is supposed to be regulating.
Yes, that’s right: the FDA is dependent for a good chunk of its budget on fees paid by pharmaceutical companies to expedite the review of new drug applications. You can thank Ronald Reagan and his push to maintain big government while cutting the Federal budget for that little boil on the ass of American safety regulations.
The FDA’s patent inability to protect us isn’t entirely the direct fault of the people responsible for reviewing new drug applications. A complicated agency, it’s not as if an application goes in, a pharmacologist reviews objective clinical trial data and then determines whether or not a drug is “safe” and approved for sale or not. No, there are committees. There are committees that review the work of other committees. I’m utterly convinced that there are robes and a secret handshake and possibly candles with things embedded in them atop big, wrought iron stands which are lit by half-seen slightly deformed minions with great ceremony.
What is it that convinces me that the FDA might be actively trying to kill us? It’s not that there are drugs released on to the market that lately have been shown to have little effectiveness as was Zetia made by Merck/Schering-Plough Corp (approved in May 2006). Nor is it that the FDA has approved a drug which has massive side effects to treat a condition doctors aren’t really sure is an actual disease. Again, drug approval is a complicated, slimy process that allows “senior officials” to overrule reviewers’ concerns about side effects and efficacy.
What’s convinced me that the FDA is actively trying to kill us is not just that they have approved cloned meat for human consumption but that they have done so with absolutely no labeling requirements.
So all of this, the FDA’s slide from consumer protection agency which began with a lawsuit designed to give the consumer free access to drug pricing information brought by Ralph Nader’s Public Citizen Litigation Group in 1976 to industry’s butt buddy ends in 2008 with me not being allowed to make an informed choice about whether or not I want to buy a product because the industry isn’t required to tell me a damn thing about it. We won’t discuss BigPharma’s ability to suppress clinical trial results that reflect unfavorably on their products; it’s just to scary.
If nothing else the FDA makes it clear why one of the most frightening string of words in the English language is “I’m from the government and I’m here to help you.”
Resources:
Potentially Inappropriate Medications for the Elderly According to the Revised Beers Criteria
- The list itself
- A handy guide with explanations of side effects
Drug Interactions and Liver Toxicity (because your liver takes the first hit if a drug is really bad for you)
- A primer on cytochrome P450
Consumer information about pharmaceuticals
- Public Citizen (it’s the least they can do to put this together but the site is still by subscription only)