Over the past several years, there have been several well-publicized episodes highlighting the apparent lack of disclosure of COIs in medicine. Many of these disturbing affairs have come to light due to the efforts of Senator Charles E. Grassley of Iowa. As the ranking Republican member of the U.S. Senate Judiciary Committee, he has led dozens of Congressional probes into undisclosed relationships between academic medical centers (AMCs) and physicians on the one hand and pharmaceutical and device companies on the other. He has been the driving force behind the passage of the Physician Payments Sunshine Act (PPSA). For our foreign readers, please note this act is not a meteorological decree that the sun should shine whenever doctors are paid! It refers to sunshine being the best antiseptic, a quote attributed to former U.S. Supreme Court Justice Louis D. Brandeis. The Sunshine Act requires all drug and device manufacturers to disclose payments to physicians and teaching hospitals that exceed $100 annually. It also assigns the Center for Program Integrity, the antifraud division of the U.S. Department of Health and Human Services (HHS), to establish a searchable website that makes the information publicly available. The Sunshine Act was supposed to have been implemented by now, but enforcement has been delayed due to a lack of consensus about some key definitions of what constitutes a payment. More about that later.
“There are known knowns. These are things we know that we know. There are known unknowns. That is to say, there are things that we know we don’t know. But there are also unknown unknowns. There are things we don’t know we don’t know.”
Show Me The Money
Let’s first examine some of the opaque financial arrangements between doctors and sponsors that first attracted Sen. Grassley’s attention. In 2008, the Senate Judiciary staff identified eight psychiatrists at five major academic centers who had significantly under-reported to their universities and medical centers, their actual earnings from the pharmaceutical industry.3 For example, the chairman of psychiatry at one major academic university had filed a COI form with his university stating that the value of the shares he owned in a company that was conducting a drug trial based at the university was “greater than $100,000.” Technically, he was telling the truth, since that income level was the highest listed option available. The reality was starkly different. His shares of the company were determined to be worth $6,000,000. The chairman of psychiatry at another major university was found to have received, but failed to report, payments from one drug company totaling at least $500,000 over 4 years. Throughout this time, he was the principal investigator of a National Institutes of Health (NIH)–sponsored clinical trial studying the efficacy of this company’s drug for the treatment of depression. Yet he failed to disclose these payments to the NIH.
