However, there is another point worth noting. Of the 15 panelists that authored these new guidelines, six reported having recent or current ties to drugmakers that already sell or are developing cholesterol medications. And among the half dozen who disclosed these relationships was one of the two panel co-chairs, which contradicts an Institute of Medicine suggestion about managing conflicts and leadership roles on such panels.
Each of the six panelists disclosed they worked as a consultant and received funding for personal research. And among the 10 expert reviewers, half listed consulting relationships. Among the companies cited are
The financial ties may concern some, while others may shrug off the disclosure. Certainly, the issue of financial conflicts of interest has been debated for some time, although fears persist that such relationships may unduly influence decision makers whose recommendations hold considerable sway over medical practice. For this reason, the IOM two years ago updated standards to guide expert panels.
To be specific, the Institute of Medicine wrote 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.” The Institute of Medicine also wrote that members with conflicts should not represent a majority (here is the IOM report).
“One of the reasons the IOM recently recommended eliminating rather than ‘managing’ financial conflicts of interest in guideline development groups is because of concerns about implicit bias,” says Lisa Cosgrove, an associate professor at the University of Massachusetts and Network Fellow at the Edmond J. Safra Center for Ethics at Harvard University. “When individuals have commercial ties they are vulnerable to developing subtle, but sometimes powerful, pro-industry ways of thinking.
“On one hand, you can see the lower threshold for cholesterol as more conservative and demonstrating more concern with patient-centered outcomes,” she adds. “But the fact that so many panelists have ties is deeply problematic. As you know, there’s been a lot of discussion – professionally and publicly – about transparency, which can actually worsen the problem, because some people think simply disclosing a tie relieves any moral concern.”
A study published last year in the Archives of Internal Medicine found that, as of June 2011, information on conflicts of interest was provided by fewer than 130 guidelines that were selected randomly for compliance with earlier IOM standards. And, of those, conflicts were present in more than two thirds of committee chairs and 90 percent of committee co-chairs (this is the abstract).
Meanwhile, it should be noted the Institute of Medicine updated standards also acknowledged that, “in some circumstances, a panel may not be able to perform its work without members who have conflicts, such as relevant clinical specialists who receive a substantial portion of their incomes from services pertinent to the clinical practice guidelines.” This may explain why some panelists were chosen.
In response, the AHA and ACC offered this statement: "The policies adopted by the writing panels to manage authors’ relations with industry are outlined in the methods section of each panel report. These policies were in effect when this effort began under NHLBI (the National Heart, Lung and Blood Institute) in 2008 until the process was transferred to ACC/AHA in 2013.
"In the interest of transparency, the ACC/AHA requested that panel authors resubmit RWI disclosures as of July 2013. Relationships relevant to these guidelines are disclosed in Appendix 1 of each report. None of the ACC/AHA expert reviewers had relevant relationships with industry."] Spokespeople for both organizations were asked to define "relevant," but did not respond.
Of course, some drugmakers with which the various panelists – both authors and reviewers – have ties are likely to fare better than others as a result of the new guidelines. Some of the biggest-selling cholesterol pills of the past two decades, such as Pfizer’s Lipitor and Merck’s Zocor, are off-patent and generics are available.
However, AstraZeneca does not face generic competition for its Crestor treatment until 2016 after the drugmaker reached a patent settlement earlier this year with Actavis. And Philip de Vane, executive director of US medical affairs for AstraZeneca (AZN) released a statement saying how “pleased” the drugmaker is with the new recommendations.
Conversely, Merck may be a loser. The drugmaker sells Zetia, which is not a statin, and the new guidelines say such pills should not be used “in the routine prevention of events,” because they have not demonstrated an ability to prevent heart attacks or strokes. This raises questions about a drug that generated $2.6 billion in sales last year, a 6 percent increase.
Similarly, drugs sold by AbbVie - Tricor, Trilipix and Niaspan - may also be hurt, since these are not statins. Then there is a forthcoming batch of injectable drugs called PCSK9 inhibitors that are being developed by Amgen (AMGN), Roche, Merck (MRK), Sanofi and Pfizer (PFE). Longer studies have not been completed showing these reduce the risk of heart disease and death, but the FDA says cardiovascular outcomes trials will not need to be completed prior to approval.
