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Automate the COI disclosure and management process.
As a psychiatrist, Dr. Pies delves more deeply than some into matters of the mind. He quotes ethicist James DuBois as saying: “…an induced COI is said to exist when a researcher knowingly creates situations of financial or other types of dependency that may compromise judgment,” but then points out that “…physicians and other researchers are not always aware of their own COIs, and are truly surprised when an outside observer points it out to them; thus, not all COI is conscious or ‘knowing.’”
In hospitals and academic medical centers, much of the focus on COI is on disclosure and reporting requirements related to the federal government, particularly for reporting to the NIH (for research) and to the IRS (for the form 990). There is, however, another important area where, (to quote Arthur Miller) “attention must be paid!” That is in procurement. Executives and compliance officers have a responsibility to assure that the resources of their institutions are protected, by guarding against conflicts of interest in the procurement process.
On August 1st, Pharmaceutical and Medical Device manufacturers will be required to begin collecting data on payments to physicians and other providers under the “Physician Payment Sunshine” provisions of the Affordable Care Act. Physicians are being urged, by professional societies, the American Hospital Association, the AMA and others to educate themselves on the “Sunshine” provisions so that they can accurately track and, if necessary, correct the payment information that will be reported in public databases in September 2014.
In July, 2008, The Pharmaceutical Research and Manufacturers of America (PhRMA), the trade association and lobbying group for the pharmaceutical industry, updated their Code of Interactions with Healthcare Professionals. This was followed in July, 2009 by an update to the AdvaMed Code, which provides the same function for the Medical Device industry. In both of these documents, the industry went further than ever before in recommending limits on the marketing efforts of their members.
The “Sunshine” provisions were designed to increase transparency in industry’s formal and informal relationships with medical providers. Ever since astute observers noticed that physicians could be influenced by financial considerations (the Stark anti-kickback laws date to the 1980’s) there has been concern that industry largesse could unduly influence research results, prescribing patterns, continuing medical education, and even practice patterns. The thinking is, to paraphrase Justice Brandeis, “Sunshine is the best disinfectant”.
A pair of researchers in the Cal psychology department staged an experiment. They began by grabbing students, as lab rats. Then they broke the students into teams, segregated by sex. Three men, or three women, per team. Then they put these teams of three into a room, and arbitrarily assigned one of the three to act as leader. Then they gave them some complicated moral problem to solve: say what should be done about academic cheating, or how to regulate drinking on campus.
Most involved parties agree that Conflicts of Interest – both financial and non-financial – carry the risk of adversely influencing medical treatment and research decisions. For this reason steps have been taken by public and private entities alike to require the identification and management of such conflicts.
Much attention has been paid to the new NIH disclosure rules, which went into effect on August 24th. The rules require that institutions obtain disclosure of “Significant Financial Interests” from all those conducting or in a position to influence research, and have a process in place to identify and disclose what they determine to be “Financial Conflicts of Interest”. Much of the discussion about the rules has centered on how conflicts of interest might impact the design, conduct or presentation of funded research.
There is something inherently human about being blind to your own faults. There is a psychological term called “cognitive dissonance” which describes the uncomfortable feeling caused by holding two opposing ideas or beliefs simultaneously. The idea that “I am a good and ethical person” clashes with the idea that “my decisions and actions may be affected by a conflict of interest”. It would be very easy to come to the conclusion that “I would not be affected by a conflict because I am a good and ethical person”.
The decision this morning by the Supreme Court to uphold the key provisions of the Affordable Care Act leaves in place the “Physician Payment Sunshine Act” elements, which will require pharmaceutical and medical device companies to disclose payments to physicians. These disclosures will eventually be posted on publicly available web sites.
Can anyone really evaluate their OWN conflicts of interest? It is so natural for people to rationalize their behavior, to convince themselves that their decisions would not be influenced by financial (or even intangible) benefits that would accrue to them if they move in one direction versus another. I question whether anyone can be completely confident in their own impartiality. As such, my initial reaction when I see a real or potential conflict is to ask how it is being mitigated.
It has been more than three years since several high profile cases put conflicts of interest in medicine on the front pages of the New York Times. Eminent physicians from top medical schools were discovered to have been paid millions of dollars by pharmaceutical companies, while at the same time evaluating or touting those companies’ drugs.