TCPR: Dr. Appelbaum, you are the chair of a work group of the American Psychiatric Association (APA) that focuses on the relationships between doctors and industry. Can you tell us about that group?
Dr. Appelbaum: The Work Group on Relationships Between Psychiatrists and Pharmaceutical and Medical Device Industries is a subgroup created by the Board of Trustees (BOT) that was appointed by then-president Nada Stotland in 2008. There are represen- tatives from the BOT, from the Assembly, from the Ethics Committee of the APA, and from doctors with a background working with pharmaceutical and device companies.
TCPR: And what has the group been up to?
Dr. Appelbaum: After a number of meetings last year, we came up with recommendations for members of the APA in dealing with pharmaceutical and medical device companies.
TCPR: Please take us through what the work group’s recommendations are.
Dr. Appelbaum: You can divide the recommendations into two sets: those for all psychiatrists and those specifically for doctors involved in research.
TCPR: Okay. What are the general recommendations for all psychiatrists?
Dr. Appelbaum: The group recommends that psychiatrists should not accept gifts of any value from industry, including food and other refreshments, regardless of the venue in which those are supplied. However, we make an exception for medication samples, which can be accepted but should be limited to situations in which their use is clearly in the interest of patient care. Psychiatrists should be aware that the purpose of samples is to increase market share of a particular medication.
TCPR: Do you have any suggestions for what we should do to ensure we are dealing with samples in the way you recommend?
Dr. Appelbaum: Insofar as possible, we recommended that psychiatrists who work in larger settings should set up mechanisms for centralized receipt and distribution of samples to reduce the reliance of any individual psychiatrist on a relationship with a market- ing person for the pharmaceutical industry.
TCPR: So you mean that drug reps should be going to the office manager or secretary to talk about samples instead of seeing the psychiatrist?
Dr. Appelbaum: Yes. Someone—other than the physician—who is legally allowed to accept samples, or the pharmacy in a clinic or hospital some centralized location.
TCPR: You also offer some recommendations regarding continuing education. Please tell us about those.
Dr. Appelbaum: We recommend that psychiatrists should go to educational sessions sponsored by industry only if they are ACCME-accredited or otherwise have procedures in place that ensure that sponsoring drug companies have not influenced the content of their presentations. Presenters at industry-supported educational programs should participate only when they control the content of their presentations. In addition, payment for travel and lodging to attend CME programs should be considered gifts and therefore should not be accepted in compliance with the recommendation for gifts.
TCPR: So are you saying that psychiatrists should not participate in non ACCME-accredited so-called “promotional talks?”
Dr. Appelbaum: Yes.
TCPR: Can you explain why you make this recommendation?
Dr. Appelbaum: In most cases, the psychiatrist presenter of a promotional talk is not allowed to come up with the material him- or herself, but instead has to work from a slide-set that was produced by the drug company. Attendees at these promotional talks may not know that what they are hearing is not the medical opinion of the presenter.
TCPR: What about consulting arrangements?
Dr. Appelbaum: We’ve all heard reports of sham consulting arrangements that are set up by industry essentially as a way of funnel- ing money to physicians. Because of these, we recommended that psychiatrists avoid participating in consulting arrangements in which they are unlikely to make substantive contributions, and that payments for legitimate activity should be proportional to the actual time and effort that are expended in them.
TCPR: Not all consulting arrangements are shady, though. There are legitimate consulting arrangements. How do you deal with this issue?
Dr. Appelbaum: We recognize that there are plenty of legitimate reasons for physicians, including psychiatrists, to act as consult- ants to industry. These can range from consultation regarding the symptoms that could constitute appropriate targets for new med- ications, to the likely utility of a proposed new compound, to the design of preclinical and clinical studies of that compound, etc. But we are concerned that sometimes under the guise of consultation, pharmaceutical companies assemble meetings with groups of practitioners who prescribe their products, often in resort locations, where people are essentially paid not to give substantive consultation, but as a reward and incentive for further prescribing, and to be the audience for what are essentially promotional presentations.
TCPR: What are your recommendations for dealing with pharmaceutical and device reps?
Dr. Appelbaum: We recommend that psychiatrists be aware that the role of these representatives is to market their company’s products. Studies have shown that they can have a substantial influence on physicians’ prescribing practices, and we ask that psychiatrists seriously consider those issues and their implications for patient care before deciding whether to interact with pharma- ceutical and other industry representatives.
TCPR: Any other recommendations?
Dr. Appelbaum: Yes, one more for all psychiatrists, and this is one that deals with disclosure of relationships with industry. We think physicians need to dis- close this information on a yearly basis. We recognize that currently physicians, particularly in academia, get multiple requests for disclosures of varying sorts that often result in seemingly conflicting information out in the public realm that really does no one very much good. So we encourage the development and adoption of uniform and accessible formats and content for disclosures.
TCPR: You presented these recommendations to the Assembly of the APAin May 2008. How were they received?
Dr. Appelbaum: There was resistance, though not from every speaker, to thenotion that well-meaning and dedicated physicians would ever have their pre-scribing practices influenced by an interaction that they might have with the pharmaceutical industry. It is very difficult for physi- cians, including psychiatrists, to accept the substantial body of data that suggest that interactions can have effects beyond the awareness of the prescriber.
TCPR: What other type of feedback did you receive?
Dr. Appelbaum: There was the sense from some commenters that as a professional organization the APA shouldn’t be telling its members what to do—that people are and should be free to make their own decisions. I think it is fair to say that many of the speakers saw the idea that the APA might offer recommendations with regard to these decisions as offensive.
TCPR: But doesn’t the APA already offer some type of ethics guidelines to its members?
Dr. Appelbaum: Yes. The APA has adapted the AMA Principles of Medical Ethics with a set of annotations that define ethical behav- ior for psychiatrists in quite clear terms. APA members can be susceptible to ethics proceedings against them for violating those guidelines. Interestingly, the proposal of our workgroup is not for a set of binding ethics guidelines, but for a set of recommenda- tions regarding behaviors.
TCPR: Where do you think all the resistance was coming from?
Dr. Appelbaum: I think the resistance reflects just how sensitive physicians are about these issues. Some physicians resent what appears to be the suggestion that they are being bought off by industry and consciously taking bribes in order to change their behavior, even when this is not really what the recommendations say. I don’t think this is an issue of physicians being bought off; it’s the unconscious influences on behavior that are of concern. If you look at the surveys of physicians asking what they believe the impacts of their relationships with industry are, you will see that, by and large, physicians deny that there could be any impacts on them, although they are markedly more willing to respond that other physicians might well be affected by such relationships.
TCPR: So where do your recommendations stand now, in terms of acceptance by the APA?
Dr. Appelbaum: The Assembly Executive Committee recently voted to recommend to the Assembly that the draft be approved, and it will be going to the Assembly during the annual meeting in New Orleans this May. I think this is a good set of recommendations. It reflects mainstream thought today about how physicians should be interacting with industry. This is where American medicine, at least at this point, should be positioning itself, and I would be proud to see APA publicly move in this direction as well.
TCPR: Thank you, Dr. Appelbaum.
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