November 28, 2012

The Tale of Avandia and Big Pharma: Why Critical Skepticism Matters as We Review Drug Studies

The front page of Sunday’s The Washington Post featured an article by Peter Whoriskey titled “As drug industry’s influence over research grows, so does the potential for bias.”

In a nutshell, the writer tells the story of how in 2006 Big Pharma giant GlaxoSmithKline (GSK) managed to land a glowing 17-page report about their diabetes blockbuster Avandia in the prestigious New England Journal of Medicine (NEJM), even though:
  • there was apparently clear evidence linking Avandia to increased risk of heart attack and death, 
  • the drug trial had been funded by GSK, 
  • all 11 authors of the report received money from GSK. 
Four years later, in 2010, Avandia had disappeared from American drugstores. An FDA scientist estimated that while doctors in this country prescribed Avandia – propelled by laudatory reports like NEJM’s – 83,000 people using the drug suffered heart attacks or died.

A Washington Post review found that the NEJM published 73 articles about new drugs between August 2011 and August 2012. Here’s how Whoriskey characterized the literature over those 12 months:
Of those articles, 60 were funded by a pharmaceutical company, 50 were co-written by drug company employees and 37 had a lead author, typically an academic, who had previously accepted outside compensation from the sponsoring drug company in the form of consultant pay, grants or speaker fees.
My sense of smell is non-existent these days, but even I get a whiff of something unsavory here. Is Big Pharma’s drive for profit superceding public welfare?

In decades past, the government conducted more of these studies, presumably concerned only with drugs’ efficacy and side effects. Big Pharma’s role in these drug studies has grown sharply, begging the obvious question of conflicting interests. Last year, NIH spent $31 billion on drug studies; Big Pharma ponied up $37 billion.

It’s a long article, worth reading.

In fairness, the Post also published a response from GSK to Whoriskey’s article. That response includes this comment:
With regards to Avandia, we firmly believe we acted responsibly in conducting the clinical trial program, in marketing the medicine, in monitoring its safety once it was approved for use and in updating information in the medicine’s labeling as new information became available. 
No question, the Avandia story is a cautionary tale. It made me recall another article – a “Consumer Reports Insights’ -- I saw in the Post several weeks ago, titled “Add a healthy dose of skepticism.” It, too, is worth reviewing, since we win when we’re more informed and critically aware as we read new reports about drugs we just might take.

In short, here are the bullet points:

Check the background
  • Was the study published? 
  • Who paid for it? 
  • What’s the context? 
Examine the Methodology
  • Was it a controlled clinical trial or an observational study? 
  • Did it address “confounders”? 
  • How long was the study? 
Grade the Journalism
  • Are harms mentioned as well as benefits? 
  • What do other sources say? 
  • Who’s quoted? 
Determine What the News Means
  • Do the findings apply to you? 
  • Do you have access to the care that the study participants did? 
  • What does your doctor think? 
Good questions for all of us to keep in mind.

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