Aspirin as Vioxx?

vioxx12.jpgIn one of my earlier posts about the Merck/Vioxx case, I observed somewhat facetiously that the risks associated with aspirin would probably deter any pharmaceutical company today from making the investment necessary to bring the drug to market. In this Medical Progress Today piece, pharmaceutical expert Derek Lowe confirms that my speculation is almost certainly correct:

[I]f you were somehow able to change history so that aspirin had never been discovered until this year, I can guarantee you that it would have died in the lab. No modern drug development organization would touch it.

Thanks in part to advertisements for competing drugs, people know that there are some stomach problems associated with aspirin. Actually, its use more or less doubles the risk of a severe gastrointestinal event, which in most cases means bleeding seriously enough to require hospitalization. Lower doses such as those prescribed for cardiovascular patients and various formulation improvements (coatings and the like) only seem to improve these numbers by a small amount. Such incidents, along with others brought on by other oral anti-inflammatory drugs, are the most common severe drug side effects seen in medical practice.
It doesn’t take too long to see these effects in a research program. Aspirin causes gastric lesions in rats and dogs, which are the standard small and large animal models for drug toxicity. This side effect occurs at levels which would raise red flags for any new compound. What would a present-day research organization do about it? If we stipulate that they could determine that aspirin worked by inhibiting cyclooxegenase enzymes, they would surely try to break the vascular effects of the drug apart from its anti-inflammatory effects. They would try to find new compounds that selectively inhibited only one of the enzyme subtypes. They would, in other words, produce Vioxx, and Celebrex, and the other COX-2 inhibitors, and this is just why these drugs were developed.

Read the entire piece. By the way, the third Vioxx trial against Merck cranks up this week in Houston federal court. And Ted Frank wonders why Mark Lanier has still not moved for entry of a judgment on the $253 million jury verdict in the Ernst case?

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