Battle of the Brits: BMJ, Lancet Continue Sniping Over Statins


Top editors of the BMJ and the Lancet are sparring over how the UK’s Committee on Publication Ethics (COPE) responded to questions about the BMJ’s handling of two papers that contained statements exaggerating the risks of statin therapy. The latest volley in the war of words has come from BMJ Editor-in-Chief Fiona Godlee. 

Last week, the Lancet published a review led by Rory Collins, FMedSci (University of Oxford, England) meant to provide a definitive overview of the risks and benefits of statin therapy. It was accompanied by a comment from Lancet Editor-in-Chief Richard Horton noting that the review is intended as a response to misleading claims about the safety of the drugs. Horton argues that “publication of disputed research and tendentious opinions about statin use among people at low risk of cardiovascular disease in 2013” led many patients to stop treatment, a direct reference to the two BMJ papers in question.

This week Godlee, in a September 14, 2016, rapid response to one of her own editorials on the subject, asserts that Horton also made “inaccurate statements” regarding COPE’s involvement in the affair.

The history of this spat dates back to 2013 when the BMJ published two papers containing a claim tied to the same source that statins cause side effects in about 20% of patients. Shortly after, Collins alerted the journal that the adverse event rates were overstated and subsequently called for retraction of the papers. The journal corrected the articles to withdraw the inaccurate figures, but Godlee left the decision about retraction up to an independent panel convened in June 2014. The panel ultimately concluded—in August 2014—that the papers did not meet COPE criteria for retraction.

Then, in October of that year, a group of investigators including Collins and other authors of the recent Lancet review lodged a complaint with COPE about how BMJ handled the papers.

In his recent comment, Horton writes that “after 2 years of frustrating exchange, including a direct request that COPE conduct an independent investigation, COPE declined to act further, emphasizing that it is a charitable member organization, not a regulatory authority.”

But that, Godlee says this week in her piece, is not accurate. She links to documents from COPE showing that the body did act, by calling for the researchers filing the complaint and the BMJ to work together to settle any unresolved issues. Included was a letter dated April 15, 2016, from COPE to Collins et al that reads: “We believe that the BMJ acted appropriately by completing an internal investigation and audit to a high standard, and promoted transparency by making information on the process publicly available.”

Godlee concludes, “We hope that publication of the documents relating to the complaint will serve to correct the public record.”

Independent Review Needed

The ongoing fracas speaks to a larger issue hovering over this controversy—the growing calls for an independent review of statin trial data, something Godlee herself called for in an editorial published September 15, 2016.

The Lancet review was meant to “bring an end to a dangerous debate,” but, she says, “not everyone agrees.

Though the benefits of statins for secondary prevention or in people at high risk of cardiovascular disease are undisputed, proposals to offer them to large numbers of people at lower risk remain controversial, much to the frustration of the statin trialists who authored the Lancet review,” Godlee says.

She points to an editorial by Harlan Krumholz, MD (Yale School of Medicine, New Haven, CT), which highlights some of the limitations of the existing data, including the dearth of data on people older than 80 years, uncertainty about how comparable adverse event data across trials are, and the paucity of head-to-head comparisons of individual statins. There is also uncertainty about whether the trials are applicable to current patients with cardiovascular disease, Krumholz suggests.

“Independent third party scrutiny of the statins trial data remains an essential next step if this increasingly bitter and unproductive dispute is to be resolved,” Godlee says. “I have now written to England’s chief medical officer, Sally Davies, asking her to call for and fund an independent review of the evidence on statins. As Krumholz concludes, sharing the individual patient-level data from the statins trials would send ‘a strong message that no single person or group should have exclusive access to data’ that are so important for public health.”

Although Collins’ group, the Cholesterol Treatment Trialists’ Collaboration, has announced that it is undertaking a detailed review of adverse events using trial data, Krumholz—in an email to TCTMD—said: “I don’t think you could consider them independent . . . since they were funded to do many of the trials.”

 


 

 

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Todd Neale is the Associate News Editor for TCTMD and a Senior Medical Journalist. He got his start in journalism at …

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Disclosures
  • Krumholz reports being involved in research agreements from Medtronic and Johnson & Johnson (Janssen), through Yale University, to develop methods of clinical trial data sharing; receiving a grant from the US Food and Drug Administration and Medtronic to develop methods for postmarket surveillance of medical devices; working under contract with the Centers for Medicare & Medicaid Services to develop and maintain performance measures; chairing a cardiac scientific advisory board for UnitedHealth; and being the founder of Hugo, a personal health information platform.

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