HHS OIG: Legal Issues Affecting Academic Medical Centers and Other Related Institutions
Late last month, Daniel R. Levinson, Inspector General of the Department of Health & Human Services, made remarks regarding conflicts of interest (COI) for a Keynote Address given at a Conference of the American Healthcare Lawyers Association. The conference was titled “Legal Issues Affecting Academic Medical Centers and Other Related Institutions.”
His focus was on “COIs and the challenging aspect of managing, reducing, and eliminating conflicts under the current regulatory framework and system where reliance is placed primarily on individuals, researchers, and institutions.” Mr. Levinson noted that the ongoing debate centers on what “extent to which government regulation should place oversight and verification responsibility on Federal agencies.”
Seemingly, while his ideas are not new, the fact that he addressed health care lawyers about how “subtle and often hard to detect” COIs are, is a bit concerning. His speech uses hypothetical language about the nature of COIs, stating that “what may appear to be an appropriate arrangement between a researcher and a drug manufacturer may actually raise potential COI issues that could taint the results of a clinical trial.”
Such uncertainty should never be cause to go after scientists and doctors who are changing the way patients are treated and making them healthier, and it should especially not be given to lawyers whose livelihood depend on 50.1%–what it takes for a jury to determine a favorable verdict.
Mr. Levinson asserted that undetected COIs may expose people who volunteer in trials to unnecessary risk; deprive them of beneficial therapies; unsafe or ineffective drugs or devices may enter the US market; patients may receive inferior therapies when safer or more effective therapies are available; and the public may waste limited Medicare and Medicaid dollars to pay for this inappropriate treatment.
All of these concerns do not outweigh the clear benefit that industry has provided academics and researchers over the past few decades as evidenced by breakthroughs in heart disease, cancer, diabetes, HIV and numerous other chronic diseases.
Moreover, unsafe or ineffective drugs or devices will not ever enter the
COI Regulation
Mr. Levinson’s brief history lesson of COIs talked about the early 2000s, when the NIH Director established a “Blue Ribbon Panel on COI policies to look at whether the COI policies for intramural research were sufficient to uphold agency standards and maintain public trust in NIH and its activities.
The Panel found an extremely complex set of rules governing COIs at NIH.” No wonder today there is so much of a debate or controversy around COI: no one knew then what to do, and now politicians and media are going about an individual crusade against doctors who simply make mistakes interpreting “extremely complex sets of rules.”
As a result, today’s politicians are having hearings on oversight to determine what information should be disclosed and who—individual, government or institution—should bear the responsibility for monitoring and managing potential COIs.
The 2010 Omnibus Appropriations Act, will also require the Secretary of HHS to amend Federal regulations to strengthen government and institutional oversight of financial conflicts of interest by May 1, 2010.
Such hearings and legislation have become standard practice as government employees like Levinson believe that the “relationships between the private sector and investigators have become more complex and that the collaborations may generate an increased potential of investigators to hold financial interests in multiple sources.”
Such complexity is cause for OIG to believe that “if not reported and appropriately managed, reduced, or eliminated, these relationships could introduce bias into the conduct of their research.”
Levinson told his crowd of lawyers that HHS has “recommended that NIH use its current authority to request further information about reported COIs where basic information about the COI is missing and, at the same time, revise the current regulation to require grantees to report certain details to NIH about their reported COIs.”
Similar recommendations were made in the agency’s report on FDA’s oversight of clinical investigators’ financial interests, even though it was “found that only 42 percent of marketing applications were missing financial information.”
Mr. Levinson acknowledged that such recommendations were necessary based on a few examples (although totally unrelated to CME) of recent enforcement actions related to COIs in medical education. He even stated directly in his speech that “these cases did not involve AMCs,” but he felt that “AMCs could learn important lessons from these examples in terms of ensuring the integrity of educational sessions they host, responsible partnerships with co-hosts or industry funding sources, and appropriate behaviors and industry relationships for medical staff serving as faculty or filling the audience for educational events.” He used examples of drug companies who resolved charges relating to off-label promotion, no where near an accredited CME course or program.
Conclusion
Since Mr. Levinson himself noted that “the nature and amount of information that should be reported and disclosed, and where responsibility should be placed for reviewing and verifying the information, remains a constant subject of debate,” more research and discussion is needed before attempting to implement recommendations within the life-sciences community and the Federal Government.
As he also indicated, because “the vast majority of physicians and scientists are ethical and honest and committed to the welfare of their patients,” approaching new ways to manage COIs should carefully consider the “special role academic medical centers (AMCs) play in health care.”
Mr. Levinson specifically indicated that AMCs are “responsible for educating and training the next generation of physicians, nurses, and other types of health care workers; advancing clinical care for the sickest patients; and advancing basic science in pre-clinical research and participate in clinical trials to develop new technology.” With such a crucial role in making our health care system function, Mr. Levinson needs to consider where AMCs would be with industry support today and where funding would come from without it.
Accordingly, Mr. Levinson is certainly right that more “research on COIs and COI policies can provide a stronger evidence base for policy design and implementation.”
Until such research and evidence is found, we encourage him to follow his own words and engage “physicians, researchers, and medical institutions in developing conflict of interest policies and consensus standards” instead of distracting researchers from creating the next generation of treatments.