A recent issue of the Journal of the American Medical Association (JAMA) reads like an expose. Well, at least three of the research articles do. So exciting! I don’t want medicine — my field — to be ethically unsavory, but it is sometimes. It makes me proud to see that it polices itself and that such information is published in a high profile journal.
The first article is entitled “Patient Advocacy Organizations, Industry Funding and Conflict of Interest” by Susanna Rose of the Cleveland Clinic along with colleagues of hers from the University of Chicago. It turns out that 67 percent of patient advocacy organizations — like the American Diabetic Association, the Multiple Sclerosis Foundation and March of Dimes and organizations that support patients with various diseases — receive support from industry. Specifically, “industry” means organizations that make money by selling products related to health. More than one in 10 of these organizations received over half of their support from industry. Nearly 8% of the leaders of advocacy groups surveyed admitted to feeling pressure to conform to the wishes of their corporate donors. Since this is a hard thing to admit, that number probably vastly underestimates the true impact.
The Institute of Medicine has written extensively on conflicts of interest and how to manage them. Financial conflict of interest occurs when the primary aim of an organization, in this case to advocate for patients’ best interests, is in competition with a secondary goal such as promoting a product for a company that pays your bills. It is hard to quantify just how these conflicts of interest play out. Big drug and device companies have tremendous amounts of money, expertise and resources to strengthen an organization, but they also are primarily motivated by making money. If they wish to sell a product that is of questionable benefit to patients, an advocacy group could be a powerful ally in marketing. Patients think of their advocacy organizations as representing their interests, sometimes in opposition to the medical establishments. There are no disclaimers for them to read such as “this organization supported by the makers of patented titanium bone screwdrivers or magic diabetes-be-gone pills.”
The next article by Dora Lin and colleagues from The Johns Hopkins School of Public Health looked at the organizations and individuals who argued with the US Centers for Disease Control’s (CDC) guidelines for prescribing opioid pain medication for chronic pain. Unless you have lived under a rock, you have probably observed that prescriptions for pain medication in the opiate class increased dramatically for several years, followed by all of us noticing that there was increasing numbers of patients addicted and also dying of an overdose. In response to this problem health care advisory groups have recommended prescribing these drugs less often, at lower doses and discontinuing them sooner along with offering non-opiate options for pain control that are less dangerous and probably more effective. When the CDC’s recommendations came out, there were criticisms and so there was a period of invited comment before the final release. It turns out that the majority of criticisms came from organizations with ties to opiate manufacturers and none of them mentioned this in their comments. There are many reasons for the U.S. opiate epidemic, but misinformation propagated by the pharmaceutical industry was an important one.
The third article was even more concerning from a financial standpoint. In the last few years, we have seen major changes in the way we treat hepatitis C and elevated cholesterol levels. Guidelines released in 2013 by the American Heart Association recommended that we extend the number of people who will be treated with cholesterol-lowering “statin” drugs to anyone with a 10-year risk of atherosclerotic cardiovascular disease (heart attacks and the like) of over 7.5%. Guidelines released in 2015 for the treatment of hepatitis C, a chronic liver disease caused by a blood-borne virus, suggested that we treat everyone with hepatitis C with extremely expensive drugs which, kudos to pharmaceutical researchers, can cure the disease.
The price tag is the reason that this last article (by Akilah Jefferson and Steven Pearson of the National Institute of Health and the Institute for Clinical and Economic Review) is of greatest concern. Statin drugs, which are good for some people, especially those with known heart disease, are set to reach over $1 trillion in worldwide sales by 2020. The new hepatitis C drugs can run over $1000 a pill, or $80,000 and up for a treatment course and will account for about 10 billion dollars of healthcare spending in 2015. It turns out that a significant number of physicians in both of the groups who were responsible for developing these guidelines had support from the manufacturers of the drugs they directed to be used so extensively. The Institute of Medicine made some pretty clear recommendations about conflicts of interest in 2009, and neither of the organizations responsible for producing these very influential guidelines followed these recommendations.
So it’s good that we are talking about this but not good that it is happening. The problem with conflicts of interest isn’t that they necessarily lead to bad decisions, but that they probably do and that we don’t know. We as physicians try to do good, and we’ve been told in the last many years that we can do the best for our patients by following guidelines. These guidelines, we are led to believe, are based on the best of scientific evidence and, lacking time to read all of the literature and keep up with the astounding amount of new data that comes out every year, we would do well to follow them. But if the people who create the guidelines work for the companies that stand to benefit financially from the outcomes of those guidelines, we would do better to question them. At the level of populations, the decision to recommend that all patients receive a treatment rather than a smaller group of patients who would more clearly benefit makes a huge difference. Our individual budgets as well as our nation’s budget for health care are limited. A choice to use an expensive medication is also a choice not to do something else that might benefit us more.
Conflicts of interest are common and part of the human condition. It is not possible to eliminate them in any situation. In cases such as guideline development and patient advocacy groups in which patients are vulnerable to influences which do not have their best interests as a guiding force, we should be especially sensitive. Physicians should try hard to recuse themselves from making important decisions in which they have a conflict of interest. We should honestly recognize that bias in the form of industry connections may make it impossible to be truly objective.
Janice Boughton is a physician who blogs at Why is American health care so expensive?
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