The Baltimore Sun carried an article last week titled “Learning the hard lessons of Vioxx: All drugs pose risks, experts warn, and newest products demand extra caution.”
The gist of the article is that, despite what you might think the FDA is supposed to be doing regarding drug safety, you’re pretty much on your own. There’s a concept in economics for this: caveat emptor. Buyer beware.
The article reports that experts say doctors and patients need to understand that approval by the FDA has very limited meaning. The FDA approves drugs with benefits that seem to outweigh the risks based on very limited clinical trials. Long term risks are complete unknowns. And as we know, in many cases such as Vioxx, known risks are sometimes actively suppressed by the drug companies.
These experts also say we can’t really expect the FDA to do much, given their Congressional mandate. And we certainly can’t expect the drug companies to do anything, given the demands of competition. So that leaves you and me and our physicians holding the bag, according to these experts.
Who are these experts? Former FDA officials who now work as lobbyists for the pharmaceutical industry.
The big news in reform reported by the Sun is that a great Congressional upwelling of indignation might put limits on advertising drugs to consumers. But only new drugs. And only for the first year. Maybe. The article is silent on reforms that affect physicians, despite a recent editorial piece in the Public Library of Science by a former editor-in-chief of the British Medical Journal titled “Medical journals are an extension of the marketing arm of pharmaceutical companies.”
To cut to the chase, we are all contaminated by the oil slick of drug money. Tinkering with advertising is close to laughable. The problem here is much more fundamental.
The public has a great interest in what drug companies do. That’s how we justify the FDA. But the drug companies can devote a lot more attention to the FDA than you or me or our doctors can. Let me introduce another concept from economics which I think explains itself: regulatory capture.
How is it that drug companies have more money than God? Because they pack huge research and development costs into their price and are able to charge for it based on exclusive rights under US patent law. And most of that R&D is for variations on old themes, not for genuinely new pharmocology.
Maybe it’s just because I’m a political economist, but the solution here seems obvious to me. Instead of more regulation, the answer is, first, have all drug research and development conducted by public agencies and universities, second, place the science in the public domain, and third, license drug-making to the drug companies. The FDA’s approval of a drug would be entirely separate from the fortunes of the drug companies.
Right. Unthinkable.
So back to holding the bag. You don’t have to take the bag that’s handed to you. You can make drugs the last, not the first thing on the list of what you do about your health. Instead of insisting that your doctor give you the drug you just saw TV, insist that he or she find a non-pharmaceutical solution. And, of course, you’re a citizen. Vote for people who will do more than limit ads for new drugs.
Twenty years ago, single payer health care was unthinkable. Now its very thinkable. Why not public pharmaceuticals?
The issues in this article are developed (with references) in issue #4 of the Progressive Health Observer in a review article titled “Fit to Print? A review of The Truth About the Drug Companies and Critical Condition.”
Related resources are available on the Health Politics page.
