News

Majority of panelists on controversial new cholesterol guideline have current or recent ties to drug manufacturers

BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f6989 (Published 21 November 2013) Cite this as: BMJ 2013;347:f6989
  1. Jeanne Lenzer
  1. 1New York

The chairman and one of two additional co-chairs of the working panel that wrote the controversial cholesterol guidelines on reducing cardiovascular risk, released last week,1 2 had ties to the drug industry at the time they were asked to lead the panel. And, in all, eight of the 15 panelists had industry ties.

The chairman, Neil J Stone, professor of medicine at the Feinberg School of Medicine, Northwestern University, Chicago, told the BMJ, “When I was asked by NHLBI [the National Heart, Lung and Blood Institute] to chair the [cholesterol] panel, I immediately severed ties with all industry connections prior to assuming my role as chair.”

He severed those ties in May 2008. Later he had to complete a disclosure statement regarding financial ties to industry, and in response to the question regarding his ties from 2008 to 2012 he wrote “None.”

David Newman, a physician researcher at the Icahn School of Medicine at Mt Sinai in New York City, told the BMJ that dropping industry ties on taking up such roles without declaring these previous ties was against the spirit of competing interests declarations.

Stone acknowledged to the BMJ that before being empanelled he had financial ties to Abbott, AstraZeneca, Merck, Pfizer, Sanofi-Aventis, and Schering-Plough, and he had served as a consultant to Abbott, AstraZeneca, Merck, Pfizer, Reliant, Schering-Plough, and Sonaste. All six corporations to which Stone had financial ties make drugs to treat hyperlipidemia. Stone said that he would “definitely” not take any industry funding for two years after release of the guidelines.

Jennifer Robinson, the other of the committee’s two co-chairs, disclosed in the committee’s report her financial ties to several drug companies, including manufacturers of statins, which she held during her service on the panel from 2008 to 2013. Six of the remaining panelists also disclosed ongoing financial ties to drug makers during their service on the panel. Stone told the BMJ that although the panelists with industry connections recused themselves from voting, he did vote.

No disclosures were published for any of the panelists regarding ties to drug makers before 2008, when the committee was empanelled. Stone’s ties were discovered during an investigation by the BMJ.

Newman told the BMJ that the panelists’ financial ties violate the Institute of Medicine’s recommendation that “whenever possible, guideline development group members should not have conflicts of interest . . . and the chair or co-chairs should not be a person(s) with conflicts of interest.”3 He said that the International Committee of Medical Journal Editors regards any active or relevant prior financial relationships as pertinent, as well as any other financial relationships that patients would likely want to know about. Newman said that treating ties to industry prior to empanelment as irrelevant to patients was “quite unusual.”

Jerome Hoffman, emeritus professor of medicine and emergency medicine at the University of California, Los Angeles, agreed with Newman, saying that failure to report prior financial ties represented a “fundamental distortion” of the concept of a conflict of interest.

Hoffman said, “Being in a ‘public service’ position—for an explicitly temporary period—gives greater clout to any industry friendly position such a person takes and thus makes his pronouncements even more valuable to industry, and to him. As long as such a person hopes to renew his financial relationship with industry in the future, any position he currently takes has a great effect on his own future bottom line.

“So, unless the decision to sever financial ties represents a fundamental change of heart—and is accompanied by an absolute pledge not to take money from industry in the future—this type of revolving door relationship between ‘public service’ and [industry] is about as clear a model of conflict of interest as I can imagine.”

The new guidelines on cardiovascular risk, drawn up by panels from the American Heart Association, the American College of Cardiology, and the Obesity Society, have been subject to fierce criticism over the past few days, with a number of experts claiming that millions more people would be pushed to take statins. Criticisms include a Lancet commentary that found the algorithm overestimated the observed risks by 75% to 150%.4 5

Barbara Roberts, a cardiologist and associate clinical professor of medicine at the Alpert Medical School of Brown University in Providence, Rhode Island, said that the new guidelines are a “big kiss to big pharma.” Roberts told the BMJ, “According to the new risk calculator all African American men aged 65 and up with normal blood pressure and normal cholesterol levels should be on statins. That’s an outrage and is unsupported by clinical evidence.”

Stone disagreed that the guidelines were industry friendly, saying that “about 30% of the relevant population is now on statins” and that the new guidelines would result in an “estimated 33% of people taking statins.” He said that some people who were currently on the drugs shouldn’t be, while others who weren’t on them should be.

However, John D Abramson, a lecturer at Harvard Medical School, and Rita F Redberg, a cardiologist at the University of California San Francisco Medical Center and the editor of JAMA Internal Medicine, wrote in an opinion article in the New York Times that they believed that the new guidelines would result in a “vastly expanded class of healthy Americans” to whom statins would be recommended.6

Abramson, who serves as an expert in litigation involving drugs and medical devices, including a case involving a statin, told the BMJ that by reducing the risk threshold to include people who had a 10 year cardiovascular risk of between 7.5% and 9.9% the new guidelines would increase the number of Americans for whom statins are recommended by 7.5 million. Removing the LDL cholesterol threshold of ≥130 mg/dL for people with two or more risk factors and with a 10 year risk of between 10% and 20% would increase the number by another six million, he said. Therefore, the new guidelines, he estimated, could increase the number of people for whom statins are recommended by 150%—potentially putting an additional 13.5 million more healthy Americans on statins.

Newman said he was disturbed that the committee relied on relative risks to make claims about benefits without balancing those proportional benefits with harms. He said, “Relative risk reductions are meaningless to patients. Even 16 year old girls will see a reduction in heart attacks, but they virtually never have heart attacks to begin with. And the problem is compounded by the committee’s failure to offset those putative benefits with the harms of testing and treatment.”

Newman concluded, “We need to tell patients the actual numbers. For patients without diabetes or a prior heart attack or stroke who are treated with statins for five years, 98% will see no benefit; 1.6% will be spared a heart attack and 0.4% a stroke—and importantly, there will be no difference in overall mortality. At the same time, 2% of individuals treated with statins will develop diabetes and 10% will have muscle damage.

“We need to be honest and tell patients all of this and let them decide if the benefits outweigh the harms for them.”

Notes

Cite this as: BMJ 2013;347:f6989

Footnotes

  • bmj.com Analysis: Should people at low risk of cardiovascular disease take a statin? (BMJ 2013;347:f6123, doi:10.1136/bmj.f6123.

References