In my essay “Is This Science or Censorship?” I recounted how new guidelines advising use of cholesterol-lowering drugs called statins (medications like Lipitor, Crestor, Levacor and others) for the primary prevention of heart disease is at the center of heated debate. If the new guidelines are followed, it would put nearly 80 percent of people aged 60 to 75 on statins. This is despite notable concerns about side effects, the potential overestimation of risk, and a lack of evidence that statins actually work to reduce overall death or serious illness for people who have no known risks or history of heart attacks. Independent scientific debate and research should help to clarify the benefits and harms of statins, how these play out for people at varied degrees of risk, and the kinds of information that researchers, clinicians, and patients would need to make clear decisions. Unfortunately, this scenario is itself at risk. The head of one of the groups responsible for the statin guidelines, Rory Collins, called for the retraction of two articles arguing for a more cautious approach. Published in the highly respected international medical journal, The BMJ, these articles are now under scrutiny.
The article by John Abramson and colleagues reanalyzed data from the Cholesterol Treatment Trialists’ Collaboration that Collins heads (one of the groups responsible for the new statin guidelines) and questioned the evidence used to promote statin use in people at low risk of cardiovascular disease. The article by Aseem Malhotra questioned the role of saturated fat in heart disease. Because there was a small but important error in one of the statistics cited in these papers, the authors and The BMJ together published a correction that removed the statistic and explained that it, while technically accurate, did not reflect important caveats. Collins did not find the official correction acceptable and continued to push for retraction.
The Collins controversy caused such uproar that The BMJ appointed an independent panel to review and comment on the process by which the two articles were published, assess how criticisms of the statistic were raised and addressed, and determine whether the papers met the criteria for retraction. The panel is scheduled to complete its review by the end of July. In the meantime, a group of physicians, scientists, and others signed an open letter to The BMJ stating that the calls to retract the two papers are unwarranted and that they should remain part of the ongoing scientific conversation about statins.
The letter to The BMJ, signed by nearly 500 people from 30 countries, was published on the Lown Institute Website. Here is the letter:
“The BMJ stands out among the top medical journals of the world as a beacon in the best tradition of science through its willingness to publish articles and studies that question orthodoxy. Many of these articles question the results of industry-funded research, and while The BMJ publishes its share of industry-funded research, it has also given space and voice to those who question the output of such studies, including those published by The BMJ itself. The journal was among the first to call for open access to clinical trial data, much of which is left unpublished, held secret or misanalysed. The BMJ became one of the first medical journals in history to establish a medical investigative unit geared to understanding when research data represent some of the true and valuable breakthroughs of medicine, and when they are part of the sad history of spin trumping real science.
“This willingness to give voice to careful skeptics, and to insist on data transparency, has triggered the ire of industry and the recipients of its largesse on more than one occasion, leading to accusations and threats against The BMJ. Now, The BMJ is being attacked once again, over a paper involving statins, that should not be retracted as demanded by its critics. The BMJ was correct in publishing the paper, and did what was necessary in correcting an error. We, as doctors, researchers, scientists, patient advocates, journalists and others from around the globe, want to stand with The BMJ in its effort to elevate scientific and honorable dialogue about the issues of the day.”
The BMJ has a solid track record for elevating scientific and honorable dialogue about the issues of the day. Statins are but one topic in an ongoing conversation about the need for evidence–rather than belief, desire, tradition, or protocol–to guide medical decision-making. One of the journal’s recent projects called Clinical Evidence looked at randomized controlled trials to draw conclusions about which treatments work, have benefits that outweigh harms, do not work, or have harms that outweigh benefits. It also identified gaps in evidence to help point researchers in a clear direction for ongoing analysis. After reviewing the existing evidence about 3000 medical practices, the project found slightly more than one-third to be beneficial or likely beneficial. Another 15 percent were unlikely to be beneficial, likely to be ineffective or even harmful, or a wash, offering a close call in the tradeoff between benefits and harms. Half were of “unknown effectiveness.”
An article published by the Mayo Clinic complements The BMJ’s data. Based on a review of more than 2000 articles published from 2001 to 2010 in just one high-impact medical journal, the findings suggest that a high percentage of all medical practices may ultimately be found to have no net benefits. The authors found 146 reversals of established medical practices and concluded that, “When medical practices are instituted in error, most often on the basis of premature, inadequate, biased, and conflicted evidence, the costs to society and the medical system are immense.” Minimizing this harm requires “raising the bar for the approval of new therapies and asking for evidence before the widespread adoption of novel techniques.” The debate over statins guidelines fits squarely within this scenario. If the cart goes before the horse, statins may likely be included in the next decade's round of medical reversals.
As a medical sociologist, I too promote raising the bar for approving new therapies, seeking evidence before instituting protocols, filling gaps in evidence, and changing protocols as bodies of evidence emerge to clarify what works, what doesn’t, and when harms outweigh benefits. The pathway to this goal relies not only on the rigor of research, but also on “elevated scientific and honorable dialogue.” For these reasons I was moved to join the physicians, researchers, and others from 30 countries who signed an open letter to The BMJ to resist the retraction of two important articles on statins. The 13 million Americans at low risk of cardiovascular disease who may be offered a lifetime of statins prescriptions based on the new guidelines deserve unbiased, balanced information on the effectiveness and harms of these drugs. They may also be interested in knowing that 6 of the 15 panelists who authored the new statin guidelines have recent or current ties to pharmaceutical companies that sell or are developing cholesterol-lowering drugs.
After a two-month review, the The BMJ independent review panel has advised The BMJ that its handling of the two articles was appropriate and that its processes were timely and reasonable. The panel unanimously agreed that retraction is unjustified. Here is the report.
© 2014 Gayle Sulik, PhD ♦ Pink Ribbon Blues on Psychology Today