TCPR: In recent years greater attention has been paid to relationships between practicing physicians and industry, specifically pharmaceutical companies. What are some ways that practicing physicians might have relationships with industry?

Dr. Appelbaum: Physicians may be the recipients of gifts from industry, including food and other items of value, whether they have an educational focus—like a textbook—or not. They may receive samples of products for distribution to their patients, or be invited to attend educational sessions, whether formally accredited for CME purposes or not. They may receive research support for studies; or be compensated for serving on advisory committees or in other consultant capacities for pharmaceutical companies; or have equity in pharmaceutical companies, by owning stock options or some other share of ownership.

TCPR: How may these types of relationships create a conflict or ethical dilemma for a practicing physician?

Dr. Appelbaum: There are data showing that rates of prescriptions of promoted medications after interactions with pharmaceutical representatives or attendance at educational presentations increased both for indicated and nonindicated purposes (Wazana A, JAMA 2000;283(3):373–380). The data suggest that the alterations in prescribing practices are being made in response to the receipt of benefits—these interactions with pharmaceutical companies—rather than objectively and on the basis of patients’ particular needs.

TCPR: But many physicians argue that these relationships don’t affect their prescribing practices.

Dr. Appelbaum: Multiple surveys of physicians have shown that overwhelmingly physicians do not believe that their prescribing behavior is affected by their interactions with industry. And yet those same physicians, when asked whether they believe that their colleagues’ behavior might be affected by interactions with industry, are much more willing to acknowledge that possibility. So what we have here is recognition of the biasing impact of such interaction, but a sense of denial that it could affect them as well. Undercutting that denial is a huge amount of data—both pointing to the mechanisms by which industry influence tends to have its effect, including by evoking a sense of reciprocity on the part of physicians who receive gifts and food and other sorts of benefits, and also showing directly that industry gets what it pays for. That is, physician behavior actually does change, and these techniques are quite effective. Whether we want to believe it or not, all of us are susceptible to being influenced by industry if we continue to engage in these relationships with them.

TCPR: You mention drug samples as an example of a relationship with industry. Is there evidence that giving out samples in one’s practice influences prescribing habits?

Dr. Appelbaum: Yes, physicians say that they are more willing to prescribe medications for which they have samples available, and studies have shown that, in fact, they do prescribe such medications more frequently. The problem with this is that samples distributed by pharmaceutical representatives are typically of a company’s more recent and more expensive medications—medications that are still under patent and therefore exclusive to a particular company, often when there are much less expensive and equally or more effective generic medications available. They do this because they know that once patients have been stabilized on a medication and samples are no longer available, both patients and physicians will be reluctant to switch to alternative medications, and hence they now have a long-term customer for that particular drug.

TCPR: Most of us who are in practice have noticed that the drug companies have voluntarily cut back on the gifts, meals, and other perks they provide to physicians, and this is related in some way to the Sunshine Act. Can you explain the Sunshine Act for us?

Dr. Appelbaum: The Physician Payment Sunshine Act, which is part of the Patient Protection and Affordable Care Act legislation, went into effect in August 2013 and requires pharmaceutical manufacturers to report to the Federal government any benefits that they have provided to physicians or teaching hospitals in excess of 10 dollars in value. There are some exclusions to that rule, but in general, many of the kinds of benefits that physicians previously received, from textbooks to dinners to compensation for participation in surveys or direct payments for consultation or for research purposes, all must now be reported to the federal government.

TCPR: And what is the government doing with that information?

Dr. Appelbaum: By September 2014, the government will place the information on a publicly available website. So the public and anyone else who is interested in knowing if a particular physician has received payment or benefit from a pharmaceutical company will be able to track that information down easily.

TCPR: Can practitioners opt out of this to have their individual data not reported to the government?

Dr. Appelbaum: There is no option for practitioners to opt out of reporting. There are some categories of benefit that don’t have to be reported, including drug samples and patient-education materials, but most other forms of benefits—including textbooks purchased by a drug company as a gift to a doctor—must be reported.

TCPR: In your opinion, how do you think this data will be used? 

Dr. Appelbaum: Some patients may care enough to track down the information, but frankly I think the major impact will come less from patients who use this information to choose a physician and more from physicians’ knowledge that the information will be publicly available. They may be reluctant to have their names associated with receipt of benefits from pharmaceutical companies, and may be unwilling to face the questions that might be raised about the objectivity of their decisions. I am already seeing many physicians who might otherwise casually have attended dinners or accepted small payments for survey participation now deciding to decline those opportunities to keep their name off the website.

TCPR: Some physicians say that some of the perks like dinners out are just part of how salespeople do business. They argue that politicians and others take money from special-interest groups, so why are doctors being singled out? 

Dr. Appelbaum: There is a strong societal interest in assuring that decisions about treatment are not made on the basis of any interest but the patient’s. And there is a similarly strong interest in holding down the cost of medical care, and since data suggest that both promotional activities and financial benefits distributed by the pharmaceutical industry are effective in altering prescribing patterns in the direction of prescription of more expensive medications, it is not surprising that medicine has been singled out for much closer focus. Physicians are willing and often eager to see themselves as part of a profession with a higher calling. So in many respects, the efforts to reduce pharmaceutical influence on physician behavior is doing nothing more than holding physicians to their own deeply-held, traditional concept of what makes medicine different.

TCPR: Another argument some critics of the Act make is that visits from pharmaceutical reps or talks and seminars is perhaps their only way of getting information about new drugs on the market.

Dr. Appelbaum: It may once have been true that contact with pharmaceutical representatives or attendance at educational events sponsored by the companies was a necessary way of learning about the latest advances in treatment. But the Internet has brought us readily available informational programs and access to publications that enable every physician, no matter how busy or remote from major academic medical centers, to remain up to date on the latest aspects of medical care.

TCPR: Who’s covered by the Sunshine Act?

Dr. Appelbaum: It includes MDs, DOs, dentists, podiatrists, optometrists, and interestingly, chiropractors, but not other classes of prescribers. It doesn’t apply to nurses with prescribing privileges, for example, or to prescribing psychologists in the two states where they have such privileges. And it doesn’t apply to physicians in training—either medical students or residents.

TCPR: So a psychiatric nurse practitioner, who is still susceptible to pharmaceutical company marketing, will not be reported if he or she receives a gift or a meal?

Dr. Appelbaum: No, not at present. I tend to view this as an oversight on the part of the drafters of the legislation who simply were unaware of the important role that nurse prescribers, physician assistants, and others who aren’t included in the current list play in modern medical care. My guess is that at some point that loophole will be closed, but at the moment it does look to be a significant loophole.

TCPR: We are talking here about mainly relationships with pharmaceutical companies because medications are a key part of today’s psychiatry. But other tools are marketed to us, as well, such complementary and alternative medicines, some psychotherapies and treatment programs, and pharmacogenetic tests. Do those count?

Dr. Appelbaum: No, the reporting is limited to pharmaceutical and device manufacturers. This law was designed in response to some high-profile scandals involving the cozy relationships between some of these entities and physicians.

TCPR: What would you say from an ethical standpoint to physicians who complain that the Sunshine Act interferes with their autonomy and undermines their intelligence and their profession?

Dr. Appelbaum: I would respond in two ways. First, the Sunshine Act still allows physicians to continue accepting payments and other benefits from pharmaceutical companies—they just basically have to be prepared for patients and others to be aware that that is exactly what they are doing. So for physicians who believe strongly that there is nothing wrong with what they have been doing and that the benefits they accept don’t affect their prescribing practices, they are free to continue accepting those benefits. Second, on the other hand, we can’t ignore the large body of data showing that industry influence can evoke a sense of reciprocity on the part of physicians who receive gifts, foods, and other benefits.

TCPR: In December 2013, GlaxoSmithKline announced they would no longer compensate doctors for promoting their products, and they have also made changes to how they compensate their field representatives. How do you feel about this decision?

Dr. Appelbaum: I think this is a positive step because it will eliminate some of the most problematic practices, including physician promotion of products that, in the past, often went beyond authorized indications and included promotion of questionable off-label usage. The other change that Glaxo announced was that they will no longer compensate their drug reps on the basis of prescribing activity by the physicians whom they visit. Representatives will now have less incentive to pressure physicians to prescribe particular medications regardless of indication; that too is a positive step. Whatever the motive and however this affects other drug companies, it is a positive step that I think should be applauded.

TCPR: Thank you, Dr. Appelbaum.