Friday, December 17, 2004

Another Cox-2 Takes a Fall

Hot off the press are wire-service reports that an ongoing trial of Pfizer's Celebrex showed a greater than two-fold increase in risk of myocardial infarction (heart attack) for patients taking the drug versus placebo. Celebrex, like Vioxx, another Cox-2 inhibitor, has been heavily promoted for general use as an analgesic and anti-inflammatory, not just as a niche drug for patients who cannot tolerate standard non-steroidal anti-inflammatory drugs (NSAIDS).
In fact, there has been evidence around for a while that both widely used Cox-2 inhibitors had important rates of adverse effects. A meta-analysis published in 2002 in the Canadian Medical Association Journal warned that both drugs produced statistically insignificant increases in total mortality compared to conventional NSAIDS (whereas, if their main difference with conventional drugs was decreased risk of gastrointestinal side effects, one would expect the Cox-2 inhibitors to yield the same, or lower mortality rates as do regular NSAIDS). ("Statistically insignificant" here means that the differences in mortality could have been produced by chance differences between the patients taking different drugs.) More strikingly, both drugs also produced statistically significant increases in serious adverse events.
If nothing else, maybe this will alert the public to be skeptical of all those expensive "direct to consumer" advertisements now epidemic on US television. Such skepticism would make it easier for physicians to persuade their patients that they don't necessarily need the newest, and most heavily promoted drug for every ailment.

4 comments:

Egan said...

>If nothing else, maybe this will alert the public to be
> skeptical of all those expensive "direct to consumer"
> advertisements now epidemic on US television. Such
> skepticism would make it easier for physicians to
> persuade their patients that they don't necessarily
> need the newest, and most heavily promoted drug for
> every ailment.

I agree. It is a strange arrangement as it is: advertising to consumers who cannot buy your product without a highly complex process involving a highly trained and highly regulated middle-agent, i.e. a physician. Other industries obviously use middle-men that either perform a service or install a product that the consumer has no practical want or ability to perform her/himself. But physicians and the complex matrix of the healthcare system that the former are confined to make healthcare a unique realm in terms of market niche.

And that niche raises questions: how much is healthcare really analogous to other markets? Can we regulate advertising in this niche? Just what forces and components comprise a free market (e.g. as with VCRs) and do these exist in healthcare?

Egan

InformaticsMD said...

Could ossified thinking about retrospective reviews of patient data be impairing earlier detection of these problems?

Pharma, it may be time to revamp thinking about clinical trials and support widespread EMR implementation, especially in large medical centers, with adaptations for post-marketing surveillance.

-- SS

Egan said...

You raise some good points.

I would raise another related point: data ownership. HMOs and pharma have been keepers of their "own" data for much longer than physicians/healthcare institutions. As an informatics person this lack of owning my own data is what drove me to medical informatics in the first place. We physicians are the last to the data table, if you will. And we are paying the price!

Egan

Russ Maulitz said...

LOVELY JUXTAPOSITION

Well, the quasi-inevitable Celebrex news takes top honors today both here and at MedRant.

Funny: on my tabletop today I espy two interesting publications, carelessly placed on atop the other.

One is the above-the-fold in today's Philly _Inquirer_ (http://www.philly.com/mld/inquirer/10444692.htm).

The other is a CD that fell out of that august publication from Elsevier, _Internal Medicine News_. Title: "The Pulse of Current Cardiovascular Concern: Anti-Inflammatory Meedications." Logo prominently displayed: "Educatinal Grant from Pfizer."

So the questions arise. Do I bother to place CD into computer? Is the world a delightfully perverse place? Would this make a good coaster?