New heart medication study was “too flawed for publication”, says former journal editor

As a heart attack survivor, I’d love to believe that when my doctors read medical journal articles, what they’re reading about new drugs is true. But I might be wrong. Consider, for example, the criticisms aimed at a study published recently in the New England Journal of Medicine by the journal’s own former editor. Dr. Arnold Relman, professor emeritus at Harvard Medical School, not only points out a couple of glaringly obvious omissions in this published research, but he also claims that he would have never have accepted such an article for publication during his NEJM tenure.

The study focused on an anticoagulant drug called apixiban (brand name: Eliquis) and it was entirely funded by drug giants Bristol Myers Squibb and Pfizer, who happen to jointly manufacture Eliquis.  Quelle surprise . . .  The drug companies claim that Eliquis helps prevent blood clots from forming following major surgery like knee replacement, and may prevent strokes in patients with the heart arrhythmia condition called atrial fibrillation.

But wait, warns author and investigative health journalist Alison Bass She reminds us that drug studies funded by the very companies who make the drug, and then conducted by researchers who disclose financial ties to those companies may actually present skewed research results that favour expensive new drugs over low-cost yet effective generics. A number of recent studies on this controversy, including this one last year from Germany that found up to half of clinical trials investigated that are financed by pharmaceutical companies are never published if their conclusions are not positive towards their drug being studied. These researches concluded:

“Clinical drug trials financed by pharmaceutical companies yield favorable results for company products more often than independent trials do. Moreover, pharmaceutical companies have been found to influence drug trials in various ways.”

Alison Bass points out, for example, the immediate concerns about the Eliquis study:

“It featured a lengthy roster of authors, many of whom have extensive financial ties to the drug industry (in the form of speaking and consulting fees). At least three of the authors were Bristol Myers Squibb employees, as the fine print at the end of the study disclosed.”

Alison also explains the issue Dr. Relman had raised:  how these financial conflicts may have influenced the way the paper itself was skewed in favour of the drug.

He noted two major omissions in the discussion section of this published study:

  • One was the fact that the anticoagulant showed no efficacy over the much cheaper warfarin generic in the 7,000 patients recruited in Europe (this was a multi-centre trial involving 18,000 patients from the U.S., Latin America, Asia and Europe).
  • Secondly, 35% of the patients on warfarin were not taking a therapeutic dose of the drug, which could explain why these patients had a higher rate of blood clotting and stroke than patients taking the Eliquis.

Yet neither of these key limitations were mentioned in the study’s discussion, a glaring omission according to Dr. Relman. He said that the journal itself was remiss in publishing the study without mentioning these limitations:

“This study was not well peer-reviewed. Neither [Dr. Marcia Angell, also a former editor of NEJM] nor I would have accepted this paper for publication.”

Yet as a result of its publication, many cardiologists will now be steered toward prescribing a much more expensive drug when the cheaper generic would do just as well in many cases.

The study, according to Dr. Relman, was a prime example of why the disclosure of conflicts of interest (which most leading medical journals now require) is not enough to curb bad or biased science.

He suggested that medical institutions should simply prohibit their faculty from doing research on drugs when they are receiving lucrative speaking and consulting payments from the drug industry.

“The real solution is for medical institutions to get rid of these unethical practices. Disclosure is not a solution.”

Please read the original Alison Bass article about Dr. Relman’s perspectives.

And for more information on research showing the demonstrated link between a company funding a drug trial and favourable results for that company’s drug, see here and here. Alison Bass is a Pulitzer Prize nominee and author of Side Effects: A Prosecutor, a Whistleblower and a Bestselling Antidepressant on Trial, which won the NASW Science in Society Award.

2 thoughts on “New heart medication study was “too flawed for publication”, says former journal editor

  1. This is yet one more instance of “FDA science”. The FDA doesn’t vet the “science” conducted by folks beholden to the pharmaceutical and medical device industry, so what else would you expect? Everybody seems to have their hand in the till, leaving the consumers in the dirt of ignorance and exploitation.

    No wonder the 99% are protesting the corruption of our institutions!

    Like

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