Friday, February 18, 2005

The return of VIOXX?

In a surprising announcement late Thursday, a Merck executive hinted that the company may begin reselling Vioxx -- a painkiller that generated billions of dollars in sales -- after yanking it off the market last September due to cardiac risks.
While this is an interesting development, I'm wondering what clinician would take the risk of prescribing a drug that was on again-off again in terms of recall. Even pharmacists could get drawn into litigation on cases of people who were prescribed a once-recalled drug and then suffered a cardiac event. The possibilities for litigation seem endless.

It would, at the very least, require extensive surveillance of the COX-2's as a whole, the kind of surveillance that current systems (such as FDA Medwatch) are likely incapable of. A more proactive system would be needed, such as the EMR on a wider scale, perhaps on a pilot basis for surveillance reporting at a number of large medical centers.

Feb. 19 - addendum:

Panel OKs Merck's Vioxx Return to Market

This panel's decisions raise some interesting informatics and legal questions in my mind.

Should clinicians be required to submit outcomes data to the manufacturers on patients for whom they prescribe COX-2 drugs? There still is significant debate on the the cardiovascular risks of these drugs.

Should specific guidelines for prescribing these drugs be crafted to create a standard of practice? Without this, I would fear that clinicians might be at risk unless they document carefully that they explained to patients that these drugs may be risky, and that the true risk is still under debate.

If I were still in practice, I'd require patients to sign a waiver releasing me from liability before I'd prescribe under these circumstances. But that's just the 'Medical Informatics' me remembering the former 'Medical Programs Manager/Substance Abuse Review Officer for a Huge City Transit Authority With Litigation Left-and-Right' me.

-- SS

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