Myth of the innocent drug company

Christoph Westphal is a very intelligent person, otherwise he would not have been granted an MD/PhD from Harvard and a BA (Phi Beta Kappa) from Colombia. And he wouldn’t have founded various biotech companies or been named to head GSK’s venture arm. Yet it doesn’t take someone with an advanced degree to realize something is wrong with his op-ed (The myth of the perfect drug) in yesterday’s Boston Globe.

Here’s how it starts:

When it comes to prescription drugs, patients expect benefits but appear intolerant of risks. What would happen in a world that accepts no risks in its pharmaceuticals? We would have very empty medicine cabinets.

The rest of the piece describes how patients have over-reacted to the risks of Vioxx, and repeats the tired assertion that “it is possible that aspirin would not be approved today by the FDA, so dramatic is the shift in society’s risk-benefit views regarding pharmaceutical products.” (I first heard that line back in 1994.)

Three times in the space of two columns, Westphal writes of the benefits of Vioxx in “severe arthritis.” He keeps warning that “society” is making a mistake by over-weighting the risks relative to the benefits.

In placing the blame on “society” for shifting its view of the risk/benefit tradeoff, Westphal is ignoring a number of important elements in the Vioxx saga. In particular, Merck, medical journals and the medical profession are to blame:

  • Merck heavily promoted the drug beyond patients with “severe arthritis.” One of my relatives (also Harvard educated, but just a Master’s degree) was prescribed Vioxx for moderate arthritis pain. She didn’t ask her doctor for the prescription; he prescribed it based on its presumably benign profile. In fact, when Vioxx was originally approved one of the big marketing pitches was that it was safer than over the counter pain relievers. My relative was livid when she found out about the dangers, and rightly so
  • The New England Journal of Medicine published a flawed article on the VIGOR trial, which played up the benefits of Vioxx and downplayed the risks. When issues were pointed out after publication, the Journal argued that it didn’t have the resources to ferret out problems in articles. Meanwhile, the Journal sold more than 900,000 reprints of the article –more than one for every practicing physician in the country– and most of those were purchased by Merck. I’m sure they weren’t all given to docs prescribing for “severe arthritis.” I’ve proposed a “100,000 reprint rule” that says journals should spend more effort on follow-up of especially popular articles
  • Some physicians have allowed their trust and authority to be co-opted by pharmaceutical companies. By accepting promotional items and free CME, by allowing articles to be ghost written, by relying on drug reps to educate them on medications, they have not lived up to the standards that society expects. Certain drugs are available by prescription-only because doctors are supposed to be looking out for the patient. Sadly sometimes physicians have failed us

In light of these behaviors, it’s entirely reasonable for consumers (i.e., society) to become more risk-averse and for the government to step in. It’s odd that Westphal wrote a whole article blaming society without once acknowledging the role his industry and profession have played in getting us to this point. A little bit of introspection is called for here.

For the record, I am in favor of allowing even medications with dangerous side effects and potential for abuse on the market. But we need pharma companies to be ethical, journal editors to be diligent, and doctors to put patients first. Get those things straight and then we can talk about societal issues.

June 29, 2010

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