The 'Other' Corporate Practice of Medicine

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The 'Other' Corporate Practice of Medicine

Abstract and Introduction

Introduction


AAEM stands strongly against the corporate practice of medicine. Former AAEM president Robert McNamara wrote, "The Corporate Practice of Medicine (CPOM) occurs when a for-profit business entity exerts control over the practice of medicine. CPOM presents a major problem for the specialty of emergency medicine, and for you, the practitioner." Most often, CPOM is discussed in the context of corporate management groups that attempt to control physicians and their care of patients. However, there are other types of business entities that attempt to exert control over the practice of medicine. Pharmaceutical manufacturers continue to increase their efforts to influence the way that physicians practice medicine. Of particular concern is the influence that drug manufacturers have in the development of specific treatment guidelines related to their products.

Consider the issue of using tPA as a treatment for ischemic stroke. The American Heart Association (AHA) Guidelines for the Early Management of Adults With Ischemic Stroke list tPA as a Class I recommendation, the highest possible rating, for the treatment of ischemic stroke. A colleague of mine recently shared a quote from a neurologist who noted, after reading AAEM's position statement on tPA for stroke, that he was surprised that there is still concern over the use of tPA after the elevation of its recommendation by the AHA. So, why is there still controversy?

Unfortunately, there remains question about how corporate support may have influenced the recommendations to use tPA in acute stroke. Genentech is the U.S. producer of tPA. Internationally, the drug is distributed by Boehringer Ingelheim. The disclosures of the AHA Stroke Guideline writing group show that these companies (and a lot of other pharmaceutical manufacturers) have very good representation. We should not assume that any individual knowingly made decisions to support tPA based on corporate influence. However, the ability to make completely unbiased decisions about a drug's effectiveness may be impaired if one is sponsored in any way by the very company that makes that drug.

Most readers of this editorial are probably not surprised to hear that both Genentech and Boehringer Ingelheim also contribute directly to the AHA and its affiliates. According to the American Heart Association, 27.9% of the organization's revenue in 2008–2009 (most recent data available) comes from corporations. The AHA's National Center (not counting affiliate and local offices) received over $17 million in 2008–2009 from pharmaceutical companies and device manufacturers, including Genentech and Boehringer Ingelheim. According to financial documents from the AHA, these two companies alone contributed almost $3.5 million to the AHA National Center from 2004 to 2009.

If the medical community were even close to having a consensus opinion about the use of tPA in acute ischemic stroke, the financial support of these companies might be less of a concern. However, there remains a great divide between supporters and opponents of this drug. It appears that individuals who have any sort of association with the manufacturer usually interpret the evidence to say that tPA's benefits far outweigh its risks. Many others who are not associated with the company interpret the very same evidence much differently, stating that at the very best, the benefits of tPA are minimal compared to the risks. With such diverging opinions over this treatment, why was tPA given a Class I designation, implying that there is "general agreement that the procedure or treatment is useful and effective"? It would seem that tPA deserves, at best, a Class II designation: "Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a procedure or treatment." One must be at least a little concerned that some of the difference in opinions might be due to corporate influence. It is unlikely that physicians knowingly make decisions to support tPA based solely on corporate influence. However, the subconscious effects of corporate influence should not be underestimated.

I am not suggesting the AHA is a bad organization or that all of their recommendations should be abandoned. The organization sponsors very good research and public education about issues like heart disease, smoking cessation, obesity and a lot more. However, providers should not just assume that recommendations from any organization are free of influence from corporate interests. There are many examples of organizations that make recommendations where drug company influence is in question. As a specialty and as individual providers, we have the responsibility to weigh the evidence in as unbiased a manner as possible and present patients with appropriate therapeutic options.

Unfortunately, most clinicians just do not have the time to go through all of the evidence surrounding every controversial topic in medicine. Thus, we rely on experts and guidelines to help give us an idea of what treatments the evidence best supports. If these experts and guidelines are influenced by pharmaceutical companies, though, are we truly providing the best care when following their advice?

With an issue as important as stroke and a treatment option that has a fairly high risk of death, we must make every effort to know what the studies really show and not what the pharmaceutical industry would want us to know. Most of us are aware of the NINDS and ECASS studies, as these are frequently cited by both sides of the issue, albeit interpreted very differently. How many of us have the same level of familiarity with the other trials that do not show benefit to tPA or that show increased morbidity and mortality with tPA? Recently, a Wall Street Journal Health Blog article highlighted an interesting website, "the NNT." Under the topic of thrombolytics for stroke, this site summarizes 11 different trials of tPA for stroke. Four of the listed trials are noted to have been stopped early due to mortality and/or a lack of benefit. Five additional trials are noted to show no benefit. I am not endorsing this website or necessarily supporting all of its conclusions. Rather, I use this as an example to further illustrate the divergence of opinions that exist and encourage clinicians to review the evidence for themselves, rather than rely on any one source of recommendations.

Pharmaceutical companies attempt to influence our practice of medicine from many different angles. Direct-to-consumer advertising, political lobbying, and physician detailing all ultimately impact the way we care for patients. Corporations exist to make money. They would not invest so heavily in these activities if they did not see signifiant increases in the use of their drugs and, in turn, profits. We must always be watchful for any kind of corporate attempt to exert control over the practice of medicine so that we may maintain the integrity of the physician-patient relationship.

My opinions in this editorial are not going to be shared by all. If you feel strongly about any aspect of the information contained herein, please share your thoughts by sending an email to cseditor@aaem.org. Your comments may be featured in an upcoming issue of Common Sense.

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