June 12

Researchers’ Financial Disclosures in the Spotlight

Sen. Charles Grassley

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Conflicts of interest, always an emotional topic, returned to the headlines this week as Sen. Charles Grassley, a longtime critic of the drug industry’s potential influence on research, released new evidence that prominent Harvard University scientists had failed to disclose much of their outside income from pharmaceutical companies over the past eight years.

According to a report in Sunday’s New York Times, Grassley’s office discovered that, among other apparent violations, Joseph Biederman had not reported any income from Johnson & Johnson in 2001, even though the company told the senator’s investigators it had paid him almost $60,000. In total, according to Grassley, the well-known child psychiatrist, along with two colleagues, did not tell the university about more than $4 million in consulting fees, as is required by government rules on conflicts of interest for research supported by federal funding.

Such disclosures are considered especially vital in medical research, where the outcomes of studies can have a sweeping effect on drugs’ commercial usefulness. Biederman and his colleagues’ research has been used in support of the increasing use of antipsychotic drugs for children diagnosed with bipolar disorder, a trend that in itself has generated controversy alongside the scientists’ outside consulting arrangements, some of which were already public.

Harvard’s response to the Times report was a statement that “in certain instances, each doctor may have failed to disclose outside income from pharmaceutical companies and other entities that should have been disclosed.” The researchers are being referred to the university’s conflict of interest committee for a review. The scientists themselves have affirmed their commitment to medical advancement and maintained that they do not take the conflict-of-interest policies lightly.

More names are widely expected to drop as Grassley continues his investigation, which has again raised questions over how federal and university disclosure requirements are enforced. If his Senate office continues to make headlines, pressure could mount for a systemic fix to what some already argue is a widespread problem of oversight. The Iowa Republican backs a legislative remedy called the Physician Payments Sunshine Act, which would require pharmaceutical companies and manufacturers of medical devices to disclose all fees paid to medical doctors in a national registry. The senator, who is the senior Republican on the Senate Committee on Finance, wants to see the legislation attached to a Medicare bill later this year, and already, it boasts support from several industry groups and corporations.

Currently, no such registry exists. Instead, the status quo for disclosure rules at research universities essentially amounts to a strict set of policies that rely on self-reporting by researchers and oversight committees that vary in rigor. Researchers applying for Public Health Service grants — including from the National Institutes of Health, which supplies the largest chunk of academic research funding — must disclose outside income exceeding $10,000 (or equity ownership above a 5 percent stake) to their institutions, which must then review the statements for potential conflicts of interest. If a potential conflict is found, the institution must notify the funding agency and “manage” the interest.

“Managing” a possible conflict of interest can range from remedies as simple as disclosing it in all publications and presentations, to reducing the investigator’s stake, agreeing to oversight or, in more serious cases, resigning. Conflicts of interest must also be disclosed to research subjects.

Marcia Angell, the former editor-in-chief of The New England Journal of Medicine and author of The Truth About the Drug Companies: How They Deceive Us and What to Do About It, said that institutions will always refer to “managing” conflicts, “never to prohibiting them.” Disclosure is “better than nothing,” but in some cases it’s “not good enough,” said Angell, currently a senior lecturer at Harvard Medical School’s Department of Social Medicine. “Essentially the academic medical centers just look the other way and let their faculty stars have as many financial ties as they wish, mainly with the pharmaceutical industry.”

Angell’s implication is that medical institutions have more to gain from powerhouse academic stars (large research grants, prestige) than they have to lose by strictly enforcing their policies. Harvard’s own conflict-of-interest policies note, for example, that even the most frowned-upon relationships described in the document, such as faculty members researching a technology owned by a company they consult for, are “generally not allowable, with certain de minimis exceptions.” Angell and other critics of drug companies’ influence say that such qualifications leave an out for institutions not to dig deeper in investigating conflicts of interest.

The policy states: “These classifications are not intended to serve as a rigid or comprehensive code of conduct or to define ‘black letter’ rules with respect to conflict of interest. It is expected that the guidelines will be applied in accordance with the spirit of the mission of Harvard Medical School in education, research and patient care. By this process, it is expected that a common institutional experience in the application of these guidelines will gradually evolve. The complexity of the subject matter is such that the current guidelines and their ensuing interpretations should be formally reviewed on a periodic basis.”

All universities that conduct federally funded biomedical research must abide by the same basic disclosure guidelines, but relatively few have found a researcher in violation of the rules, suggesting either that the current system already sufficiently encourages transparency — or that oversight mechanisms are not rigorous enough, or effectively nonexistent.

“I think it is rare,” said Julie Gottlieb, assistant dean for policy coordination at the Johns Hopkins University School of Medicine, where an investigator was taken through a formal misconduct process several years ago. “I think if the Sunshine Act passes, there will be more tools for institutions to compare, as was done in the Harvard case by Sen. Grassley ..., the payments made by industry to the investigators.”

Many universities, in addition to abiding by the federal rules, also uphold similar standards for privately funded research, although such policies vary. Other institutions also must follow state regulations, if they exist, resulting in a patchwork of sometimes confusing rules. But the institutions themselves have been at the forefront of calls for better enforcement: A 2001 Association of American Medical Colleges task force on conflicts of interest in clinical research concluded that oversight was necessary for both investigators and their institutions.

“What the existing federal financial disclosure regulations do not require is a comprehensive system of disclosure and oversight, pursuant to which institutions would collect and carefully review information on all significant financial interests in human subjects research, whether such research is federally-funded or privately sponsored. Equally important, federal financial disclosure regulations do not mandate special scrutiny of financial interests in human subjects research, nor do they acknowledge the unique obligations that attend research involving human beings,” the report stated.

“Mindful of these obligations, the Task Force asserts that academic medicine must look beyond the scope of current federal financial disclosure requirements and delineate more fully the bounds of acceptable conduct for those who conduct research with human subjects. Some institutions have made exemplary efforts in this regard. For others, revising policies and practices in the manner that we recommend might require a significant investment of time and resources, and perhaps a discomfiting change in institutional culture. We are convinced nonetheless that all institutions can rise to this challenge.”

Many attribute problems of enforcement — including uneven oversight by committees charged with evaluating financial disclosures — to a lack of resources. “I think it’s a very rare university that has the resources to actually follow up to see if their management strategy is being implemented,” said Lisa Bero, a pharmacologist at the University of California at San Francisco and chairwoman of the campus’s conflict of interest committee.

Bero co-wrote a 2004 article in the journal Health Affairs that found widely varying standards and implementation, even among the several campuses of the University of California. For example, some campuses went beyond the federal standard in not allowing consulting fees worth less than $10,000, while others did not. They also differed on whether investigators may consult for companies sponsoring clinical trials as those trials are being conducted. Beyond the policies themselves, some conflict of interest committees emphasized certain management strategies, such as disclosure, over others.

“In the absence of a clear and consistent definition of conflict of interest, individual committees have developed their own sets of standards in evaluating financial disclosures,” the article states. “Those standards appear to be based on specific institutional values that the committees felt were important to protect. Thus, as noted above, some campuses put the protection of students at the forefront of their standards; others evaluated clinical trials according to a different standard. Similar cases were interpreted and managed differently, depending in part on the orientation of the committee to these values or standards as well as the specific details of each case. It is important to note that all of these values are considered commonly held within academic communities.”

Bero added that committees can also vary in their makeup, from consisting mainly of fellow researchers who may be reluctant to criticize colleagues’ work to those whose composition includes a variety of stakeholders, including members of the lay public.

“There are limits to the resources that we have to verify information, certainly if there’s a reason to suspect a problem I’m sure any one of our peer institutions, and we, would pursue that,” said Gottlieb of Hopkins. “But again, a lot of this is about doing the right thing, and moral suasion, and inculcating a culture of integrity. Transparency is really essential to getting there.”

— Andy Guess

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