As if the new cholesterol guidelines needed more controversy, the BMJ reported that the chair of the panel responsible for the new advice, which many see as favorable to the cholesterol-lowering drugs known as statins, had previous ties to a number of drug makers that manufacture those very same medications. Did it influence the final outcome?
Dr. Neil Stone, professor of medicine at the Feinberg School of Medicine at Northwestern University, chaired the 15 member committee, which was convened by the National Heart, Lung and Blood Institute to update advice on how doctors should screen and treat high cholesterol levels. At the time he was asked to helm the panel, Stone had been paid by a number of pharmaceutical companies, all of whom made statins.
In an interview with TIME, Stone says that any financial ties to those companies were in the form of honoraria he accepted to speak on lipids. “I always said the [lectures] had to be educational, I did not give promotional talks, and the slides were mine,” he says.
When NHLBI approached him to chair the panel in 2008, Stone says he verbally informed the representative that he had accepted honoraria in the past, but would no longer do so. He says the NHLBI official reassured him, also in conversations, that committee chairs should have no financial ties to industry for just one year prior to serving for the Institute. “I mentioned it over and over again, and kept saying, ‘Are you sure this is okay?’” says Stone. “They said the rule was one year.” A spokesperson for the NHLBI verified that the initial letter of invitation to panel members asked for conflict of interest information over the past 12 months. When the committee convened for the first time in March 2009, Stone was asked about any financial ties to industry in the prior year through 2012, and wrote that he had none.
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Does that make Stone unbiased? Some experts feel such conflict of interest rules only pay lip service to the idea of being free of influence. The Institute of Medicine (IOM), an independent organization of scientists that analyzes available data and provides advice on medical issues, recommends that chairs of guideline committees should have no conflicts of interest if possible, and that the entire panel should also be free of ties to industry; if that’s not possible, then at least half of the members should meet this criterion. The cholesterol guidelines committee just met this threshold; of the 15 members on the committee, seven reported both current and past ties to industry (they recused themselves from the final vote on the guidelines). The International Committee of Medical Journals Editors, a group of journal editors who suggest policies for how studies should be reported, edited and published, advise that guidelines panelists be free of ties to industry for at least 36 months to ensure any unintentional biases don’t influence their decisions.
Those policies stem from studies suggesting that biases do creep into people’s behaviors, whether consciously or not. In one study published earlier this year, for example, scientists compared the guidelines proposed by two different groups of experts for treating a blood clotting disorder; the panel in which 73% of members reported connections to pharmaceutical companies suggested stronger recommendations for turning to drug-based treatments compared to a panel in which none of the members had ties to industry. “It doesn’t mean that everybody is biased, but the potential is there,” says Dr. David Newman, associate professor of emergency medicine at the Icahn School of Medicine at Mount Sinai.
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What’s concerning, says Newman, is that data increasingly show that doctors may not be aware of any potential biases that influence their medical decisions. While physicians recognize that having a relationship with industry can affect prescribing patterns, they almost always deny they would be influenced by such things as an honorarium, or even a pen emblazoned with the name of a drug.
Stone says that while he no longer had any connections to industry during his tenure as chair of the committee, he was fully aware that about half of his panel members did. While Newman calls that “egregious,” Stone says of the conflicts, “You can’t have a panel without it.” Anyone who was involved in a clinical trial to study cholesterol-lowering drugs, he says, is considered a consultant. “Who doesn’t have ties if they ran a clinical trial? And you can’t have expertise without having done clinical trials.”
But the IOM notes that panel members who are charged with coming up with guidelines don’t necessarily have to be experts in the field. Because their mission involves parsing through existing studies and vetting them for their methodological and statistical soundness, actual clinical experience with patients can be helpful, but is not essential.
To prevent any single view or individual from dominating the discussion, Stone says panel members were called upon at random to comment or review data. “I thought it was an excellent tack he took,” says Alice Lichtenstein, a professor of nutrition at Tufts University and co-chair of the panel. Lichtenstein reported no financial ties to industry during her service on the panel, and says the professionalism of experts she has encountered throughout her career should be sufficient to avoid conflicts of interest, and “supercede everything.”
Still, Newman believes stricter criteria for committee members, particularly those that develop guidelines for treatment, are needed. “I don’t think anybody intends to deceive,” he says. “But we are all trying to get to a place where there is more transparency.”