We have long noted that the financial relationships between pharmaceutical and medical device makers and the health care industry have led to enormous controversy. Critics maintain that such relationships create conflicts of interest and could unduly influence everything from research findings to prescribing practices, with patients no longer the primary focus in health care decisions
Now, the federal Center for Medicare & Medicaid Services announced final regulations for the Physician Payment Sunshine Act (PPSA), which mandates drug and medical device firms disclose payments made to physicians, hospitals, and other health care providers, beginning 2014, said The Wall Street Journal. The Act’s intent is to help minimize possible conflicts of interests for physicians or teaching hospitals with potential financial relationships with medical device and drug companies, The Journal explained.
Consider Johnson & Johnson’s DePuy Orthopaedics unit’s ASR metal-on-metal hip implant device. In the first of some 10,000 lawsuits brought over the ASR, a troubling trend was revealed over physicians who were paid consultants to the device maker; startling memos surfaced as part of that first trial. In just one case, noted The New York Times previously, a doctor sent a note to a number of Johnson & Johnson executives stating that one of the firm’s artificial hips was so badly designed, its marketing should have been cut so that the firm could review why the device was injuring patients. The physician consultant wrote the note nearly two years before 93,000 DePuy ASR’s were globally recalled in 2010. The Times also discussed the physician consultants who never went public with what they learned about the ASR to other surgeons and who kept implanting the faulty device.
The Times pointed out that the case has brought into focus a significant medical issue concerning physicians’ ethical duty to warn colleagues about defective drugs and medical devices. “Questioning the status quo in medicine is not easy,” Dr. Harlan Krumholz, a professor at Yale School of Medicine, told The Times recently.
Drug and device makers have long marketed their products using promotion strategies that encourage so-called “consultative” relationships with physicians, bringing them back and paying them to use their products and promote those products to colleagues, said The Journal. In some cases, high physician users were invited to elaborate dinners and as “faculty” at resort destination conferences at no cost to the physicians.
And, while the relationships are forged under the pretext of moving innovation and education forward, they are, in fact, part of broader promotional strategies created to increase sales, The Journal explained.
Physicians believe their clinical judgments is not influenced by these partnerships; however, medical data reveals a different situation and one that endangers patients and drives health care costs. For example, we recently wrote about a New York Times review that revealed that about 25 percent of all physicians have accepted cash from drug and device makers and about 2/3rds have accepted meals in exchange for advice and speaking engagements. Most significantly, the Times also revealed that physicians receiving money from drug makers tend to practice medicine in different ways than physicians who do not accept industry gifts, and that doctors working with industry also tend to prescribe medications in riskier and unapproved ways.
George Loewenstein, a professor at Carnegie Mellon University who has studied medical conflict-of-interest policies also recently told The Times that money can shift a physician’s sense of loyalty. “If someone has been paying you or employing you, it is very difficult to blow the whistle,” said Professor Loewenstein, who teaches economics and psychology. “It offends our sense of loyalty,” he added. Dr. Krumholz also pointed out that these so-called loyalties were between the physician and a firm’s executive, not with the company or its brand, wrote The Times. A doctor may actually see his relationships with these officials as friendships, while companies view these physicians as assets who help create these products and increase sales.
When we last wrote about the Act, which was part of the Affordable Care Act passed in 2010, it was being delayed and Charles D. Rosen, MD, former president and co-founder of the Association for Medical Ethics, along with other physicians, wrote to the White House seeking action. According to the letter, “The administration should implement the Act without any further delay so that it can begin, as soon as possible, to rein in the undue and harmful influence of money on medicine.”