Tuesday, February 10, 2009

What is the effect of pharmaceutical industry promotion?

Early in my blogging days I reviewed the literature on this topic, concluding that the evidence was soft. That situation had not changed, even as recently as the evidence reviews I presented in our two most recent Medscape Roundtables on physician-industry relations. However, a new development this month warrants a brief revisit.

First a little background. The extensive literature on this subject has been spun by the No Free Lunchers and others as proving that industry promotion is harmful to patients. That conclusion goes far beyond what the evidence warrants. The main points of said evidence are as follows:

Promotions are biased.
Promotions influence attitudes.
Promotions influence prescribing behavior.
Individual doctors, in surveys, believe their colleagues are influenced but tend to underestimate their own susceptibility.

That’s about as far as it goes. Not what you’d call hard clinical endpoints, eh?

Now I don’t consider myself an expert but I’ve followed this literature closely for 10 years. As a participant on the No Free Lunch listserv for several years I heard and examined every argument---over and over again---against industry promotion.

But, hey, don’t take my word for it. It’s easy to check the primary sources. Virtually everything that’s been written on the subject is compiled and nicely organized in a huge repository, the Drug Promotion Database. And, although the web site appears to have an anti-industry bent the conclusion based on its literature review is circumspect. You can read the summary pages here and here and note the conspicuous absence of any evidence about promotional effects on patient outcomes. That’s because there wasn’t any.

Until now.

Yes, there’s finally evidence of the effect of an industry promotion on patient outcomes. And what’s really interesting is it’s one of the most maligned and heavily criticized industry promotions in all of medicine. It’s the Surviving Sepsis Campaign, which has been under extremely heavy fire for its ties with Eli Lilly and Edwards Lifesciences.

This NEJM perspective piece accused the campaign of being a marketing strategy disguised as evidence based medicine. Health Care Renewal (read here and here) and other bloggers heaped on more criticism and, predictably, the popular media jumped into the fray.

So what’s the new evidence?

Recently at the Society of Critical Care Medicine 38th Critical Care Congress the results of a 2 year multicenter study of the effects of the campaign were presented:

"Resuscitation compliance increased from 10.9% at baseline to 30.1% after 2 years," Dr. Levy said. "There was an almost linear increase [in compliance]. It was statistically significant with every quarter."

"Mortality dropped from 37% at baseline to 30% after 2 years," Dr. Levy reported. Although absolute risk reduction was 7%, relative risk reduction was 19% (P less than .01), he added.

To analyze the significance of the drop in mortality, the investigators assessed the baseline mortality on hospital admission.

"Baseline mortality did not change, which suggests a true drop in mortality," Dr. Levy said. "The findings showed us 2 things. One, that we were able to change clinical practice and that we were able to facilitate a knowledge transfer; and 2, that there was a real change in mortality."

Sure enough, industry promotion does influence doctors, and this influence was for the good. It saved lives. What’s interesting is that although guideline adherence almost tripled as a result of the campaign it was still only 30% at study end. It was encouraging that the trend was one of increasing influence over time, suggesting further improvement, and a more robust decline in mortality, had the campaign continued.

Despite these results many critics of physician-industry relations will continue their appeal to ridicule. It’s time to shift to an appeal to evidence.

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