Merck used ghostwriters for studies and misled FDA on Vioxx dangers

Ghost Hunters

The Ghosts of Vioxx Past just won’t stop showing up on Merck’s doorstep.

How annoying is that!

Actually, it’s quite gratifying. Because no one deserves it more than Merck executives. And this time, the ghosts are real.

Naming names

Earlier this month, the Journal of the American Medical Association (JAMA) spilled the beans.

With two articles and an editorial, researchers offered precise details about Merck’s very aggressive Vioxx sales strategy, which included a practice that’s not well known among the general public: ghostwriting.

Many of the drug studies and reviews that appear in the most prestigious medical journals are actually written by drug company employees or ghostwriters in medical publishing firms. The drug companies then pay prominent academics in return for simply placing their names among the authors. In some cases, the academics really do review the studies, make changes, and then add their names to the author list.

The researchers of the JAMA articles found clear evidence of this practice when they examined court documents related to the thousands of lawsuits brought against Merck after Vioxx was pulled from the market in 2004 because of increased risk of heart attack and stroke. This past November, Merck paid close to $5 billion to settle those lawsuits out of court.

Yes, you read that correctly – that’s five billion, with a B. That’s the kind of money a giant drug company can spare to make an inconvenient problem go away.

Crime wave

Beyond the fact that Merck used ghostwriters for clinical studies and reviews of Vioxx that appeared in several prominent medical journals, a MUCH more disturbing trend is revealed by the JAMA articles: further evidence that safety information was withheld.

In the second of the two articles, the authors write, “In April 2001, the company’s internal intention-to-treat analyses of pooled data from these 2 trials identified a significant increase in total mortality. These mortality analyses were neither provided to the FDA nor made public in a timely fashion.” The authors also noted that in a 2001 Safety Update Report for the FDA, Merck “minimized the appearance of any mortality risk.”

The JAMA editorial calls the two articles “a glimpse of one company’s apparent misrepresentation of research data and its manipulation of clinical research articles and clinical reviews.”

Steven Nissen of the Cleveland Clinic is quite a bit more direct. He described the revelations to HealthDay News as “a very ugly picture of medicine really at its worst.” And he summed up the true scandal: “The thing that you can’t lose in all of this, amid the corporate misconduct story, is that patients were harmed.”

But let’s be even more direct: They weren’t harmed, they were killed. And let’s call Merck’s actions what they really are: criminal.

“Guest Authorship and Ghostwriting in Publications Related to Rofecoxib” Journal of the American Medical Association, Vol. 299, No. 15, 4/16/08,
“Reporting Mortality Findings in Trials of Rofecoxib for Alzheimer Disease or Cognitive Impairment” Journal of the American Medical Association, Vol. 299, No. 15, 4/16/08,
“Impugning the Integrity of Medical Science” Journal of the American Medical Association, Vol. 299, No. 15, 4/16/08,
“Key Vioxx Research Was Written by Merck, Documents Allege” Amanda Gardner, HealthDay News, 4/15/08,