Lots of people like free food and free baubles—physicians are no different. But what happens if accepting free swag from drug companies somehow influences your clinical decision making? Is it worth taking a freebie if it comes with implicit bias? You may be under the impression that some laws exist to govern the gifts that pharmaceutical companies and medical device makers can bestow upon physicians. However, no such laws exist. The Sunshine Act The Physician Payments Sunshine Act (“the Sunshine Act”), which some people think targets pharma gifts, was instead created to improve transparency regarding the financial relationships between physicians, teaching hospitals, and manufacturers of drugs, medical devices, and biologics. Under the Sunshine Act, drug and device manufacturers must now submit data annually to the government, reporting any money paid to physicians or the monetary value of gifts. The Centers for Medicare & Medicaid Services (CMS) then makes this information available via the Open Payments Program. What gifts are out there? In 2002, the Pharmaceutical Research and Manufacturers of America (PhRMA), which represents the interests of the country’s leading biopharmaceutical research companies, adopted a voluntary ethical code in an effort to regulate the types of gifts given to physicians. This decision followed increased scrutiny from the American Medical Association (AMA) regarding pharmaceutical marketing practices in light of increasing drug costs. By 2009, PhRMA issued new recommendations prohibiting non-educational and practice-related gifts (eg, pens and notepads), but still permitting company-sponsored meals, drug samples, and other educational gifts worth fewer than $100 (eg, an anatomical model for use in an examination room). But gifts can come with bigger price tags in some instances. Gifting money for research or educational opportunities, for example, is permitted. Furthermore, physicians may participate in company-sponsored drug talks, which can pay handsomely. Peddling influence In one study, researchers found that less than 10% of physicians believe that the small gifts they receive from pharma influence their prescribing practices. Patients, however, are more suspicious, with nearly 40% believing that these gifts may be influential. Other researchers have also shown that, despite what physicians may think, they are most likely influenced by pharma gifts. In a 2017 study published in the BMJ, prescribers in Washington, D.C., who received gifts from drug companies wrote more than twice as many prescriptions than their peers who didn’t partake. Furthermore, these prescriptions were for more expensive and brand-name drugs. In the study, 2,873 licensed physicians, nurse practitioners, physician assistants, and other healthcare professionals wrote prescriptions under Medicare Part D. In 2013, nearly 40% of these prescribers reported receiving gifts amounting to $3.9 million in total, with ticket prices for individual items ranging from $7 to $200,000. What does the AMA say? The AMA Council on Ethical and Judicial Affairs has issued an opinion on gifts from industry given to physicians. Here are some highlights from the guidelines: gifts should primarily be beneficial to patients and should not be too pricy. Items like textbooks and modest meals in the context of an educational function are acceptable, but cash payments are not permitted. Individual gifts related to a physician’s work, such as pens and notepads, are permissible. Conferences or meetings with food provided are allowed, as long as the focus of such events is educational. Subsidies underwriting the costs of continuing medical education (CME) or defraying conference registration fees are permissible. Money should not be accepted by a physician to pay for conference lodging, travel, or for the physician’s time. No gift should be accepted on condition of the physician’s prescribing practices. Some subsidies for scholarship by medical students, residents, and fellows may be permissible as long as funds are distributed by the academic or training institution. Pushback An increasing number of stakeholders are no longer on board with pharma freebies. Several states have considered bans on industry gifts. In Minnesota, for instance, pharmaceutical manufacturers cannot give gifts with a combined annual retail value in excess of $50. Notably, the statute exempts: drug samples, payments to sponsors of education programs, honoraria and payment of members who serve on the faculty of education programs, compensation for research consulting, and educational materials. Many academic centers have restricted exposure to pharmaceutical marketing—banning pharm reps from the floors. These institutions follow guidance laid out in a 2006 policy proposal that, in part, recommends: “All gifts (zero dollar limit), free meals, payment for time for travel to or time at meetings, and payment for participation in online CME from drug and medical device companies to physicians should be prohibited. A complete ban on these activities by eliminating potential gray areas greatly eases the burden of compliance.” Georgetown University Medical Center set up a program called PharmedOUT that “advances evidence-based prescribing and educates healthcare professionals and students about pharmaceutical and medical device marketing practices.” In part, this organization researches how pharma influences prescribing practices. It also encourages physicians to choose pharma-free CME. Sentiment among the certification boards regarding free gifts from pharmaceutical companies is also negative. “Our foundation has written about [gift practices],” said Richard J. Baron, MD, president and chief executive officer, American Board of Internal Medicine (ABIM) and the ABIM Foundation in an exclusive interview with MDLinx. “Personally, as a physician, I don’t think we should be accepting any gifts from pharma. I don’t think we should be accepting pens, or pads, or lunches, or any of it. We are all in a position to buy pens, pads, and lunch. There’s no good reason to accept those gifts.” Ultimately, the decision as to whether to take free swag from drug reps is a personal one. But it is important to remember that in the pharmaceutical industry, there’s no such thing as a free lunch. During the past several years, congressional investigations, federal prosecutions, and class-action lawsuits have all demonstrated how pharmaceutical companies often cross the line in favor of profits over patient welfare. Source
