The Latest Of-All-the-Nerve Award

This month's Of-All-the-Nerve Award goes to Steven Ferris, PhD of New York University; Douglas Galasko, MD of UC-San Diego, and Louis Kirby, MD of Provista Life Sciences in Phoenix.

Back in April, JAMA published a paper on ghostwriting, based on revelations from the Vioxx litigation and the resulting disclosure of internal Merck documents (see previous post, http://brodyhooked.blogspot.com/2008/04/jama-to-pharma-and-its-allies-enough.html). As an example of a ghostwritten paper with academic "guest authors," Ross et al. discussed in some depth a paper (Thal et al. 2005) listing these gentlemen as co-authors. The three awardees thereupon wrote an angry Letter to the Editor to JAMA denouncing their inclusion in the article as guest authors.

They insisted that all had had "substantial roles" in designing and carrying out the trial. They then admitted: "The paper was initially drafted by Merck coauthors in August 2003, after discussion of the results had previously taken place with Dr Thal and Dr Ferris in June and July 2003. Drs Thal, Ferris, and Kirby were formally approached about being coauthors on the paper and an associated abstract in September 2003. Each critically reviewed the complete statistical report and contributed to revising the final manuscript."

Having this conceded the major point of the accusation against them--that a Merck ghostwriter had in fact been the real "first author" and that they had seen the paper only after it was sent to them, virtually already completed, by the company--Ferris, Galasko, and Kirby went on to complain: "This unsubstantiated allegation of guest authorship raises questions about flawed methodology in the study by Ross et al. It is poor science to draw broad conclusions about pharmaceutical practices from limited and highly selective information. Moreover, neither the authors nor JAMA contacted the presumed guest authors for comments or clarification regarding this material or the allegation of guest authorship prior to publication. A change in author names does not necessarily mean that those added were not involved: such name changes occur frequently as research manuscripts are revised."

"Unsubstantiated"? Ross et al., in their reply to the Letter, remind the readers that as part of their analysis, they had compared the draft prepared by the Merck ghostwriter with the published article, and found only minor changes in wording and organization--so much for the "contributions" to revising the final manuscript.

It may be of some significance that in order to disclose all of their financial relationships with industry, Ferris et al. required 22 lines of fine print following their Letter.

I guess their theory is that the best defense is a good offense. When caught red-handed passing off a ghostwritten paper as your own work, attack the methodology of the expose.

(Thanks to Roy Poses at the Health Care Renewal blog for guiding my attention to this letter.)

Ferris S, Galasko D, Kirby L. Guest authorship, mortality reporting, and integrity in rofecoxib studies (letter). JAMA 2008; 300(8):901-2.

Ross JS, Hill KP, Egilman DS, Krumholz HM. Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation. JAMA 299:1800-12, April 16, 2008.

Thal LJ, Ferris SH, Kirby L; et al. A randomized, double-blind, study of rofecoxib in patients with mild cognitive impairment. Neuropsychopharmacology. 2005;30(6):1204-1215.

How Is Merck Faring in Vioxx Lawsuits? Very Well, Thank You

If ever a company looked as if it was all set to lose its shirt in court, it was Merck, when it was finally forced to withdraw Vioxx from the market in 2004. The published evidence, in hindsight, was crystal clear that the company should have known about the risks of heart attack as far back as the late 1990s, and internal company documents only confirmed the company's awareness of the risks. Yet Merck continued not only to sell the drug, but to market it heavily--and as a first line choice, not merely for those thought to be at higher risk of stomach bleeding (the purported main advantage of the class of drugs).

So now it's three years down the road. And, as Alex Berenson reports in the New York Times, the liability risk once estimated to be as high as $25 billion has shrunk to $5 billion. And after Merck stock plunged at the first adverse jury award, it has since regained 80 percent of its value.

How has Merck done it? It has simply decided to use its financial muscle ($1 billion so far spent on legal fees) to fight each case individually, and to appeal every adverse ruling all the way up. The courts have helped by insisting that each case be tried separately and opposing any class action suits.

The medical facts work in Merck's favor in such a setting. We can know, on a population basis, that there may have been as many as 140,000 excess heart attacks in the U.S. during the five years that Vioxx was on the market after the risks were clear. The problem is to translate that number into the reasonable certainty that John Doe of Podunk, East Dakota was one of those heart attacks--that he had his particular heart attack when he did because he took Vioxx, and that his high blood pressure, high cholesterol, or other risk factors had nothing to do with it. So far, in most cases that have come to court, Merck lawyers have managed to create reasonable doubt that Vioxx was the cause of the heart attack. And, in the case of Robert Ernst, where the jury found against the company and demanded $253 million, the case is still tied up in appeals and the Ernst family lawyer predicts that if they see any money at all, it won't be until 2010.

I'm no legal expert, but it seems from this vantage point that if you want to have your day in court in the U.S., having an extra billion or so dollars in your pocket does not hurt.

Berenson A. Plaintiffs find payday elusive in Vioxx cases. New York Times, Aug. 21, 2007.