New at Reason

Tim Cavanaugh | January 3, 2005

David R. Henderson and Charles L. Hooper prescribe a dose of Vioxx reality.

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|1.3.05 @ 8:22PM|#

The thing that really pisses me off is that a drug like marijuana or MDMA (Ecstasy), which have very low, if non-existant, mortality issues, are illegal and villified. Ridiculous.

|1.3.05 @ 9:32PM|#

I don't see how Merck can run the company and deal with all this litigation. The plaintiff's bar will bleed the company much as it tried to bleed the gun manufacturers.

I can't even imagine how this would be playing out if the tort lawyer was elected VP.

|1.3.05 @ 9:42PM|#

Lowdog, please, let's not drag illicits into every conversation about drugs. Fenfluramine, a substituted amphetamine, is chemically similar to MDMA. It was approved by FDA in 1993 as a slimming pill. The normal regimen was daily long-term usage. A few years later, it was taken off because of cardiovascular risks (heart valve defects). The same risk applies to MDMA. You can find these studies at Medline. As an aside, at the FDA hearings, Ricaurte's imploring to reject Fen because he believed it had the same neurotoxic effect as MDMA, was rejected on the basis of the evidence being weak and GFAP levels which are considered an accurate indicator of neurotoxicity, indicating that MDMA/Fen are *not* neurotoxic. Sorry for the long rant.

Anyway, the main problem here is fundamental. Since our medical sciences are still probabilistic and crude at their core. We still don't have a bottom-up view of all the intricacies that make life tick. Using extensive correlations to form plausible mechanisms, we figure out problems and rough solutions, but medicine still is a (systematic) art. As long as that remains sufficiently true, all medical products will have risks. You can't eliminate them all by design, only by luck. All this outrage over pharmas solely after profits is misplaced. OTOH, if Merck withheld pertinent info, then going after them for that is fine.

|1.4.05 @ 8:51AM|#

"Emory University economist Paul Rubin reports an estimate that FDA regulation saves between 500 and 1,000 injuries (not deaths) per year but costs between 2,100 and 12,000 lives annually. That's not a good tradeoff. The last thing we need is further hurdles to new drug development."

However, what the authors neglect to mention is the simple fact that the FDA is basically "the man on the inside" for the large Pharma corps. The authors note that "the greatest scandal of all [...] is not Vioxx but the dozens of new drugs that will never be developed because the cost of clearing the FDA's superconservative hurdles make those drugs not worth developing." Yet, while they are standing in the ring for Pharma giant Merck, they refuse to acknowledge the fact that it is this "superconservative" FDA approval regime that supports and reinforces the relative monopoly that the big companies enjoy. Those "hurdles" are, as they note, hard enough for the giants to overcome. To get through the clinical trials and FDA beaurocratic paper maze, it takes years of massive capital investment with zero return. Only the largest companies can afford to embark on such an endeavour. And so, the FDA's hurdles, more than anything else, protect the Pharma giants from small competition. It's a small tradeoff for someone like Merck. You might get screwed out of a few drugs making it to market (see: Imclone), but on other hand, those very same hurdles protect you from upstart competition. Still a pretty sweet deal.

The real losers are the consumers, especially the American consumer. In a world of socialized medicine and drug price controls, the US is an island of relatively free-market drugs. In essence, the high prices we pay for drugs subsidize the price-controlled nations' drug supply. The pharma companies make relatively small profits from socialized price-controlled markets; because the FDA makes it so expensive to develop a legal drug, they have to take their profits where they can get them, and that is from the American consumer.

Couple that with, as the authors noted, the amount of people who live in pain or die because the FDA blocks the sale of a drug, and you have one sad situation. Remember ImClone, the Martha Stewart thing? Underneath all that stock "scandal" bullshit was an actual injustice. ImClone had developed a drug that helped mitigate the effects of chemotherapy in cancer patients. However, because of some sort of beaurocratic red-tape screwup, the FDA blocked the drug from the market. Incidentally, this is what led to the stock drop that eventually led to Martha's incarceration. Anyway, ImClone went back and filled in the paperwork correctly, and a year later, the drug was approved by the FDA, in its original form. So, in effect, the FDA's paperwork maze ended up killing untold hundreds of people.

It's high time that the FDA's power was cut back. Instead of being able to block a drug from the market, their sole purpose should be to enforce the disclosure of any and all known negative effects of drugs. Then, the people, instead of some beaurocratic pile of shit, could make their own decisions about whether the it's worth the risk. A new drug would show up on the market, and, like any other consumer product, the market would sort it out. If a drug relieved headaches, but had a 1 in 5 chance of stroke or heart attack, my guess is that it wouldn't be profitable. But if a drug mitigated the effects of AIDS, and only had a 1 in 5000 chance of death, then I would think it could be successful.

All in all, it's time to take the risk/reward decisions out of the hands of the FDA, and put it back where it belongs: in the hands of those people who are actually taking the risk.

|1.4.05 @ 10:17AM|#

Back from traveling, and need to scream!

Gawd, how cute an article, but it only contains half the truth, you might almost think they were paid to write it by merck itself.

My I suggest, for your edification, you read the following warning letter issued to Merck all the way back in '01 (back when those of us in the various cox-2 R&D programs were already aware of the slight but documentable risk).

http://www.fda.gov/foi/warning_letters/g1751d.htm

Merck did know, and did lie to doctors. That's why Vioxx is off the shelves and Celebrex is still on them. Merck got caught lying, and the bottom line...that is the liability here.

Jeez louise, lets only tell part of the story, reading this article was like listening to Dan Rather talk about memos.

For those who wish to know the liabiltiy risk that Pfizer faces should read up on the history of the only half published CLASS study. That one is interesting, I believe a pharmocology student on the west cost is the one who realized that something was missing from that one (the whole second half of the study) I think that the editor of JAMA still hasn't forgiven the Celebrex researchers for that bait and switch.