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Thursday, January 19, 2017

Conflict of Interest in Medicine--Why should we care?

This weeks issue if the JAMA (Journal of the American Medical Association) reads like an expose. At least 3 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 sometimes 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% of  patient advocacy organizations such as the American Diabetic Association, the Multiple Sclerosis Foundation and March of Dimes, 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 organization 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 overdose. In response to this problem healthcare 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 US opiate epidemic, but misinformation propagated by the pharmaceutical industry was definitely 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 definitely 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 the 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 healthcare 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 entirely 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.

1 comment:

herbert said...

It's interesting to me that a woman is the lead- or shares the lead- on every one of these articles... because it's possibly a function of challenging a "status quo" in the medical industry where until relatively recently, women have not had much voice.

I'm in a bind of my own choosing, in a way, with regard to a couple of issues here: I have HepC (since 1968); and I'm seeing a cardiologist for congestive heart failure, where he was responsive enough to allow me to continue taking red yeast rice capsules in place of a statin. My cholesterol has come down... probably as much a result of cutting down on butter as much as the power of red years rice... but, whatever. Giving up beef because of the way its grown) 25 years ago is also a contributor to my fairly good health, despite the erratic heartbeat.

I'm on Medicare, and never signed up for Part D, because there was no funding to cover it when it was introduced. (I buy my own red yeast rice and lisinopril with cash.)

While I could have been treated for the Hep C with the new "Wonder drug", I'm sort of holding my own... and it's another case of not wanting to suck up resources for a guy whose almost at the "average life expectancy point" anyhow. (I've lived a long time, compared to your average Hippie.) $70-$80,000 for my 'cure' would go a long way to pay for more useful things, in the Big Picture... and I'm also interested to see what kind of a difference my relatively clean and nutritious life style can provide, when dealing with the chronic bug in my liver (no smoke, no drink for 34 years, now... not easy for a fellow who loved making wine and home brew).

I DO appreciate my doc wanting to "fine tune" my treatment for the heart problem... and the labs required to "check my levels", periodically. I also appreciate that he listens to what I have to say... and hasn't scolded me (yet). From our conversations I've gotten an inkling of what affects him, with regard to "outside pressures" beyond simply being aware of the incredible amount of information available- about Everything- these days! On some level, I'm probably a guinea pig... since I have a chronic condition. I don't mind that. It's a pretty good trade-off, the way I see it. (And I may leave my cadaver to the local med school, to be useful beyond my ability to pay my bills.)
Thanks, as always, for your observations on ethics- and "common sense"- in medicine. Honesty isn't always easy, or comfortable. But, given the culture we have lived in, it's so much simpler to put one's body/mind at ease, when one has a sense of WHAT facts and situations are most important to one's physician. ^..^