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This blog is written by Canadian journalist Donna Laframboise. Posts appear Monday & Wednesday.

Financial Conflicts & the Retracted COVID Research

Lead author, paid by drug companies, gives the all-clear to products those companies sell. World’s leading medical journal fails transparency test.

Mandeep Mehra is a professor at Harvard Medical School, and the medical director of a Boston hospital department. That city being a coronavirus hotspot, life hasn’t been normal there for some time.

He’s also the lead author of two COVID-19 research papers that were retracted shortly after being published in prestigious medical journals. Lancet boss Richard Horton calls the one published in his journal a “monumental fraud.”

The other, which has received less attention, appeared in the New England Journal of Medicine (NEJM). Titled Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19, it runs to seven pages and was retracted because its authors now admit the data on which it relies cannot be validated.

During this pandemic, physicians have been desperate for information to help guide their decisions. Eric Rubin, editor-in-chief of the NEJM, recently explained to the New York Times,

I’m an infectious disease doctor, I treat Covid-19 patients. I’ve been in the hospital recently treating patients, and we have no idea what to do. I’m the primary driver at the journal of saying, ‘We have to get data out there that people can use.’ [bold added]

Many hypotheses have been advanced. Many questions remain unanswered. For example, there’s uncertainty about whether some widely prescribed medications might be complicating the picture. Are people who take high blood pressure pills – ACE inhibitors and ARBs (angiotensin receptor blockers) – at higher risk? Should they switch to alternatives until the pandemic is over (see here, here, and here)?

Similarly, should people on cholesterol-lowering statins follow advice published in the British Medical Journal and stop taking these drugs if they develop a serious case of COVID-19? Statins are, after all, prescribed for preventative purposes, to help avert heart problems longer term.

Mehra’s paper claimed to have examined patient records from three continents and to have found no evidence that any of these drugs increase the death rate of those who had heart issues prior to the coronavirus. Indeed, it declares that “the use of ACE inhibitors, and the use of statins were associated with a better chance of survival” in women.

But even if this data was 100% reliable, there would still be two enormous problems with this research:

#1: The lead author has financial ties to companies that sell those drugs.

#2: Neither the authors nor the journal informed us of this salient fact up front, in a transparent manner.

The paper reports, on page 1, that the research was “Funded by the William Harvey Distinguished Chair in Advanced Cardiovascular Medicine at Brigham and Women’s Hospital.”

Mehra’s Harvard e-mail address also appears on page 1. Readers are told that’s where reprint requests should be addressed (reprints are frequently distributed to third party doctors by drug companies as marketing material, and can be a considerable source of revenue for medical journals).

At the very end of the paper, on page 7, in fine print, we’re reminded that the research was supported by the William Harvey Distinguished Chair. Only then are we advised that “Disclosure forms by the authors are available with the full text of this article at NEJM.org.”

One must go to the trouble of tracking down the online version of the paper, and downloading that separate 16-page PDF, to discover the lead author has a serious conflict of interest. There, on page 12, we read:

Dr. Mehra reports personal fees from Abbott, personal fees from Medtronic, personal fees from Janssen, personal fees from Mesoblast , personal fees from Baim Institute for Clinical Research, personal fees from Portola, personal fees from Bayer, personal fees from Triple Gene, personal fees from Leviticus, personal fees from NupulseCV, personal fees from FineHeart, other from Riovant, outside the submitted work;. [sic, bold added]

Abbott Laboratories sells statins and ACE inhibitors. The company is described as a “top key player,” a “major giant,” and a “leading player” in those global marketplaces.

Likewise, Bayer AG is a major global player in the ARB market.

So a lead author who has financial relationships with two companies that sell certain classes of drugs took the time, during a pandemic, to give those drugs an all-clear.

On it’s website, the New England Journal of Medicine calls itself “the world’s leading medical journal.” Why did it choose to bury this vital piece of information?

 

 

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LINKS:

  • The database on which this NEJM paper relies has been vociferously critiqued by third parties (see my previous commentary, Retracted Papers Written by Journal VIP). In this context it’s worth noting that the paper itself spends a full page (one-seventh of its total length) telling us how robust the data is. It says manual data-entry was “used for quality assurance and validation.” That data was “validated against financial records and external databases.” And that all the authors “vouch for the accuracy and completeness of the data provided.”

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This entry was posted on June 22, 2020 by in health and tagged , .
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