Developments, news and strategies for drug development specific to phase I through Phase III global clinical trial management, execution, project management and outsourcing. Go→
News, articles and issues specific to clinical trial practice and implementation at the investigative site level. Go→
Strategies and innovations related to how clinical professionals are utilizing technology internal and external to their organizations to advance clinical trials. Go→
News, articles and issues specific to laboratories role in the clinical trial, including ECG, imaging, genotyping, tissue samples and more. Go→
News, developments and strategies for clinical trials conduct in relation to the FDA, EMEA and other global regulatory authorities overseeing the drug development industry. Go→
News, articles and strategies related to clinical trial design which impact postmarketing studies, therapeutic areas, adaptive trials, statistics, protocols and more. Go→
For any Brit involved in medical publishing, The BMJ is the holy grail. So it came as a huge shock when editor-in-chief Fiona Godlee, MD, admitted last week that important—and seemingly quite basic—mistakes were made in a key paper on statins. Worse still, she didn’t appear particularly remorseful, humble, or gracious.
The offending article was published on October 22, 2013 and written by John Abramson, MD, and colleagues from the Department of Health Care Policy, Harvard Medical School, Ipswich, Massachusetts. It questioned the evidence behind new proposals to extend the routine use of statins to people at low risk of cardiovascular disease, but the authors made an error due to a misreading of data from an observational study. The mistake was not picked up by the peer reviewers or editors, and was repeated in another article published in the same week in The BMJ.
The alarming fact is that it took nearly seven months to withdraw the incorrect statement. On May 15, when the correction was officially made, Rory Collins, PhD, professor of medicine and epidemiology at the Clinical Trial Service Unit at the University of Oxford, UK, said on BBC Radio 4’s Today program that he sent an e-mail to Godlee straight after the paper was published, informing her about the error, and then met her for lunch in December.
On the same program, Godlee said she disputed Collins’ recollections of the timing, but it still seems she didn’t act with any great decisiveness or speed. Whilst she deliberated, Abramson (the author of “Overdosed America: The Broken Promise of American Medicine,”) repeated the false claims, according to Collins. For example, on November 13, 2013, he published an article in the New York Times, “Don’t give more patients statins”, which urged people to read the BMJ paper.
Everybody makes mistakes, of course, but surely Godlee should have issued the correction much sooner. Collins is hardly a nobody; he was knighted in 2011 for services to science.
The whole incident has caused not only serious harm to The BMJ’s international credibility but also immeasurable damage to patients. In some people’s eyes, it is no longer the holy grail.
Editor's Note Since this blog was written, the BMJ has established an independent panel to review statin articles, and further details are available here.