(Circulation. 2001;103:e9003.)
© 2001 American Heart Association, Inc.
Cardiovascular News
Conflicting Desires
It did not really start with Jesse Gelsinger, the first known casualty of the battle to perfect gene therapy, but the altruistic 19-year-old gave the problem a face. That face generated a firestorm of publicity that brought to the fore a potential problem that most in medicine would prefer not to confront—conflict of interest in an era of growing industry investment in the development of new drugs and treatments.
The reasons that most scientists and physicians prefer not to confront these issues is that they think that the monetary and professional interests involved do not taint their work and their concern for the research subjects who become their patients. As Catherine D. DeAngelis, MD, MPH, editor of the Journal of the American Medical Association, said in her November 1, 2000, editorial, "It is vitally important that these institutions develop conflict of interest policies, have oversight mechanisms in place, and continuously monitor the relationships of faculty with sponsoring companies and agencies. Without these policies and procedures, the academic institutions where most clinical research is based and their faculty members who perform the research are in gave danger of losing the support and respect of the public. Without this support and respect, trust in new medical discoveries and their applications will not be forthcoming. Without trust, medical research is doomed" (JAMA. 2000;284:2237–2238).
In the New England Journal of Medicine, Joseph B. Martin, MD, PhD, and Dennis L. Kasper, MD, of Harvard Medical School note that "current Harvard Medical School policy prohibits investigators from having a financial interest above de minimis levels in a company whose technology and products they are studying, regardless of the funding source. In addition, the policy prohibits laboratory investigators from having an equity interest, above de minimis levels, in a company that supports their research" (N Engl J Med. 2000;343:1646-1649).
They argue that such restraints are necessary because "we have entered a time of unprecedented opportunity for the prevention and treatment of human disease, as was recently highlighted by the sequencing of the human genome. To exploit this opportunity fully, we will need to ensure greater interdependence of those ‘uneasy bedfellows,’ academia and industry. The pressures and potential conflicts that will inevitably accompany this more porous interface demand that its operations be clearly evident to the public."
In an article in the same issue of that journal, Baruch Brody, PhD, and his coauthors at Baylor College of Medicine in Houston found a shocking inconsistency and inadequacy in conflict of interest requirements among research universities, professional journals, and even funding agencies (N Engl J Med. 2000;343:1621–1626). They found that 14 of 250 medical schools and research institutions receiving >$5 million in federal funding annually had no policies on conflict of interest and one had a policy that dealt only with the situation in which an investigator accepted work outside of his or her full-time responsibilities.
The conflict of interest disclosure requirements among the remaining institutions varied widely, with some meeting federal guidelines and others falling below it. Policies about disclosing familial and trust ownership also varied among the institutions. Fewer than 10% of the institutions required disclosure of conflicts to research sponsors or funding agencies, and even fewer required disclosure to institutional review boards, journals, or collaborating researchers. Only 3 institutions required disclosure to patients involved in studies. Penalties varied from a reprimand to termination of research funding or employment; however, most penalties were nonspecific and their application was discretionary.
Even more surprising was the response of federal agencies. Of the 11 agencies that reported funding outside research, only 4 (the Public Health Service [PHS], National Science Foundation [NSF], the Food and Drug Administration [FDA], and the Department of Agriculture) had policies specific to extramural researchers. These also varied widely. The PHS and NSF require institutions to obtain periodic disclosures of conflicts of interest from investigators and to develop a policy to manage such conflicts. "They must report to the agency the existence of both a conflict of interest and a strategy for managing it, but they are not required to report the details of either the conflict or its management," Dr Brody and his colleagues reported.
The FDA is more stringent, requiring that research sponsors submit to it information about conflicts of interest involving investigators and about strategies to minimize possible bias. "If the disclosure raises questions about the integrity of the data, the FDA may audit the data, require further analyses or studies, or refuse to use the data," according to Dr Brody and his colleagues. Of 20 journals surveyed, all required disclosure of conflicts of interest on the part of authors, but only 5 required that authors disclose possible conflicts involving spouses, partners, or children.
Dr Brody and his coauthors made the following suggestions.
- All federal agencies adopt a common conflict-of-interest
rule.
- Research institutions report to federal agencies such conflicts and how they will be managed.
- Journals require disclosure of conflicts and publish the information routinely.
- Institutional Research Boards and patients participating in research studies be informed about conflicts of interest as a routine matter.
- Research institutions report to federal agencies such conflicts and how they will be managed.
In a companion article, Bernard Lo, MD, Leslie E. Wolf, JD, MPH, and Abiona Berkeley of the University of California at San Francisco describe their analysis of the policies governing conflicts of interest at the 10 US medical schools that receive the largest amount of research funding from the National Institutes of Health. These schools are Baylor College of Medicine, Columbia University College of Physicians and Surgeons, Harvard Medical School, Johns Hopkins University School of Medicine, the University of Pennsylvania School of Medicine, the University of California at Los Angeles School of Medicine, the University of California at San Francisco School of Medicine, the University of Washington School of Medicine, Washington University School of Medicine at St Louis, and Yale University School of Medicine (N Engl J Med. 2000;343:1616–1620).
All 10 universities require disclosure of financial interests by faculty members, but only 4 required disclosure by all members of the research staff. Five universities required disclosure of all financial interests, even those that fall below federal requirements. Six required disclosure to Institutional Research Boards and to a committee on conflicts of interest or a university official. One university prohibits investigators from having stock, stock options, consulting agreements, or decision-making positions involving a company that sponsored the research being undertaken. Another prohibited researchers from trading stock or stock options in a company that sponsored research or sold the product or device under study.
Dr Lo et al concluded, "We suggest that university-based investigators and research staff be prohibited from holding stock, stock options, or decision-making positions in a company that may reasonably appear to be affected by the results of their clinical research. Of the 10 medical schools we studied, only 1 had a policy that was close to this standard."
Both JAMA and the New England Journal of Medicine dealt with issues of conflict of interest in November. The Association of American Medical Colleges convened a meeting on the issue at the end of October. However, little has been decided in either federal policy or private agreements.
Privacy Rules
On December 20, 2000, the US Department of Health and Human Services (HHS) released new regulations to assure the privacy of medical records. "For the first time, all Americans—no matter where they live, no matter where they get their health care—will have protections for their most private personal information, their health records. Gone are the days when our family doctor kept our records sealed away in an office file cabinet. Patient information is now accessed and exchanged quickly. With these standards, all Americans will be able to have confidence that their personal health information will be protected," said HHS Secretary Donna Shalala, PhD, in a released statement.
The new regulations cover all paper, oral, and electronic information and limit the use and release of private information without the consent of the patient. Patients receive new rights to see their medical records and to know who else has seen them. They are also able to restrict how their information can be disclosed, limiting it to the minimum needed to accomplish a particular task. The rules also establish new criminal and civil penalties for the improper use or disclosure of such information. They also establish new requirements for researchers seeking to use records for their work.
Providers will have to get patient consent for the routine use and disclosure of medical records and for unusual requests for disclosure. Patients will have to be given detailed, written information on their privacy rights and told how their information will be used.
The rules also protect against the unauthorized use of medical records for employment purposes. In other words, employers who provide health benefits will not be able to access the personal health information from their sponsored plan to use for employment-related purposes, unless the employee agrees.
The civil penalties for noncriminal violations of the privacy standards range from $100 per violation to as much as $25 000 per year. Criminal penalties impose up to $50 000 in fines and a year in prison for obtaining and disclosing protected health information, up to $100 000 and as many as 5 years in prison for obtaining or disclosing protected health information under "false pretenses," and as much as $250 000 and as many as 10 years in prison for obtaining protected health information with the intent to sell, transfer, or use it for commercial advantage, personal gain, or malicious harm.
HHS officials said the privacy regulation will cost an estimated $17.6 billion; however, this amount will be offset by the $29.9 billion in savings projected from recent electronic claims regulation, which is expected to streamline the nation’s health claims processing.
In response, Chip Kahn, president of the Health Insurance Association of America, said the industry supports rules that would protect against the inappropriate disclosure of health information. "However, the sweeping new rules released today by the President contain administrative provisions that will add complexity, confusion, and cost to maintaining medical records confidentiality... Additionally, the ‘minimum necessary’ provisions in the new rules will make it more difficult for health plans to maintain services that help consumers, such as disease management programs and the dissemination of wellness and preventive information to policyholders. This, in turn, could have long-range implications by impinging upon insurers’ ability to reduce costs by improving health care quality."
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