A Question of Ethics: An Expert Interview With Amy Brodkey, MD

Pippa Wysong

Disclosures

December 11, 2009

Medicine is fraught with questions relating to the ethics of relationships between physicians and industry. Should doctors accept gifts from industry, and does it matter if it's something small like a pen or free lunch? At what point can interactions with industry representatives become a conflict of interest or influence practice? Is it ethical to give patients free drug samples? These and other questions were posed to Amy Brodkey, MD, an adjunct associate professor of psychiatry at the University of Pennsylvania who has studied the relationship between physicians, industry representatives, and conflict of interest. She is also on the board of No Free Lunch, a nonprofit organization encouraging greater distance between physicians and industry. Medscape's Pippa Wysong spoke to her.

Medscape: What is the definition of conflict of interest?

Amy C. Brodkey, MD: In brief, it's a competing interest. A physician's primary fiduciary duty is to patients and their well-being. A competing interest can lie in accepting gifts, payment above the normal salary, or doing anything else for self-gain that conflicts with your duty to patients, students, or the public's health. The effects of conflicts of interest are often subtle, and a doctor may not even realize that it is affecting how he or she practices.

Industry's aim is to make money for their stockholders. Relationships with industry can conflict with a doctor's duty. Numerous studies show that industry influence on physicians frequently leads to harm -- not only to patients, but also to trainees, the public, and the profession.

Medscape: Will you expand on that?

Dr. Brodkey: Studies show that physicians who interact more with pharmaceutical representatives prescribe more expensively, sometimes inappropriately, and sometimes more dangerously than physicians with fewer interactions. They're influenced to think that new drugs are better even though an older drug might be more appropriate.

Medscape: Industry often funds continuing medical education (CME) workshops and activities. Is this a problem?

Dr. Brodkey: Industry funds 60%-80% of all CME activities. CME is often put together by medical education and communication companies (MECC), most of which are for-profit companies that have as their explicit goal to increase industry profits. Many are credentialed to offer ACCME [Accreditation Council for Continuing Medical Education]-accredited programs.

Several studies show that sponsored CME activities are often biased when compared with nonsponsored CME. Industry's take-over of medical education has affected what medicine is, what our interests are, and what defines the profession. One Scottish study looked at what happened when government funding of CME was slowly replaced with more industry sponsorship. The researchers found that over the years, the topics narrowed from a wide range, including services and other areas of patient care, to focusing more on drug management of disease. The dominance of pharmacologic therapy, not just in psychiatry, has changed medicine.

A number of years ago, in an attempt to decrease conflict of interest, the APA [American Psychiatric Association] placed resident monitors at industry-sponsored symposia to assess whether the talks were biased. The effort was ineffective -- the monitors had a tough time judging the accuracy of the information and sanctions were rare.

Medscape: But aren't drugs more effective these days?

Dr. Brodkey: Pharmaceuticals certainly have an important place in medicine, but medicine is so much more than that. In psychiatry, we've seen a trend of fewer psychiatrists offering psychotherapy. Managed care, decreased funding for medicine, and to some extent the development of more effective pharmaceutical agents all play a role. However, the public perception that medicine has become just giving pills is more prevalent, largely due to industry influence.

Medscape: Is there a checklist that physicians can use to assess whether they are practicing ethically or being influenced?

Dr. Brodkey: The problem with conflict of interest is that people are often unaware of how it influences them. Receiving a gift in any form can subtly alter behavior or create bias -- even unconsciously. Many physicians don't meet with pharmaceutical representatives anymore, because they're marketers, not educators. The best way to reduce conflicts of interest is to distance oneself as much as possible.

Medscape: Some physicians argue that if they attend one symposium that is biased, and then another that is biased differently, it balances out. How do you respond?

Dr. Brodkey: There is also the opinion that if someone speaks for several drug companies, you can trust them more. The reality is that the content of a talk under a single sponsor is often vetted by the sponsor beforehand. The question is absurd. Why should you get your information from sources that you know are biased?

The Institute of Medicine recently proposed eliminating all industry sponsorship of CME. Industry has no business educating physicians and most people don't realize the extent to which industry has taken over that function. Industry influences professional standards of practice both directly and indirectly.

Medscape: Who should fund CME events?

Dr. Brodkey: Academic medical centers ought to rely on local talent. It used to be an honor to be asked to give a talk. It has been suggested that industry should pool resources and offer them to medical centers for CME programs. Interestingly, the APA decided to eliminate industry-sponsored symposia from their meetings. That move is going to cost the association $1.5 million. Generally, there is movement toward more accountability and more disclosure.

Medscape: Are free drug samples a problem?

Dr. Brodkey: Yes, but there is a dilemma. For those of us who work in impoverished areas and take uninsured patients, samples are tempting. Most community psychiatrists accept samples, but many have ambivalent feelings about it. Consider, 50% of marketing budgets in industry are for drug samples.

There are harms to using drug samples. Drug companies don't sample generic or older products; they sample the newest and most expensive medications. Studies show that samples are rarely the doctor's first choice. If you give those out, patients will probably stay on the same medication once they become insured, running up healthcare costs. Not as much is known about the long-term safety of new drugs. Also, studies show that a large portion of samples are actually used by healthcare workers and their families, and don't reach patients.

Medscape: You are on the board of No Free Lunch, an organization encouraging doctors not to accept gifts from industry. How big of an issue are gifts, and do small things like free lunches really affect doctors?

Dr. Brodkey: There is no evidence that larger gifts are any more influential than smaller gifts. Gifts of any sort establish a mutual obligation. A relationship does the same thing , which is another reason to avoid drug representatives . Doctors sometimes feel that they are mistreated all around, so a friendly representative can be very influential.

Trainees are an interesting case in point. I was involved in a study published in JAMA about the extent of medical student involvement. It was considerable, and trainees tend to be relatively naive. Drug companies target them when their habits are just forming. In terms of the moral development of trainees, if they take gifts from industry they may feel obligated to reciprocate, which is not good. Or, they may feel that they've gotten something for nothing, which leaves an unhealthy sense of entitlement. It's lose-lose for them.

Medscape: Does disclosure solve the problem of conflict of interest?

Dr. Brodkey: Disclosure is important, but we know very little about its effects. Often, disclosure is ignored and people don't know what to disclose. Even at the annual APA conference, where disclosures are supposed to be listed, many don't bother. Plus, what does disclosure mean to audience members? If you're in a lecture listening to someone who takes industry money, disclosure doesn't help you interpret the effect of the conflict.

Psychology research shows that biased advice is frequently unintended and unconsciously motivated. Some people who speak and who disclose may exaggerate claims, or they may feel less responsible for accuracy because they disclosed. It may temper skepticism in the audience. Some evidence suggests that people often underestimate how severely conflict of interest affects them.

Medscape: What should be done?

Dr. Brodkey: One proposal is to have disclosures make everything transparent -- any financial and other relationships, payment for specific services, total compensation, all relationships between the person and the company, board memberships , consultancies, research funding, and investments. Still, because we know so little about the effects of disclosure, I don't have solid reasons to believe that this is an adequate solution.

Obviously, doctors may interact with industry in different ways. I'm saying we need to have as much transparency and as much distance as possible -- increase the firewall between industry and the profession.

Medscape: Do all these issues reflect poorly on the profession as a whole?

Dr. Brodkey: Yes. There is a perception by the public that psychiatrists just want to medicate people, and that we are arm-in-arm with drug companies, even in inventing diseases. Consider social anxiety disorder. It's a genuine condition, but about 10 years ago there was a huge advertising campaign to get people with the disorder to use Paxil®. At one point, it was claimed that the prevalence of social anxiety disorder was about 15%, which is ridiculous. When does normal shyness become social anxiety disorder? I’m not saying that psychiatrists want to medicate every person who is shy, but the public perception is that psychiatry is in bed with industry. That discredits our profession.

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