Medical Device Daily Washington Editor

WASHINGTON — The Institute of Medicine (IOM; Washington) held a press briefing yesterday to discuss its proposal for disclosure requirements for drug and device makers on one side and academic researchers and physicians on the other, but the effect of the report on the federal government may be limited, given that the Physician Payment Sunshine Act of 2009 (S. 301) is already on ink and paper, and a congressional staffer is on record as describing the bill as "a smart and strong piece of legislation" (Medical Device Daily, Jan. 26, 2009).

Andrew Pope, who serves on the board of healthcare policy for the National Academy of Science (Washington), told Medical Device Daily after the session that he cannot say whether Kohl and Grassley are interested in tweaking their bill based on the findings in the report. "We've been in touch with them in a one-way" manner, he said, but noted that he has received no feedback indicating their views. The possibility exists, however, that the report will spur more action on the parts of states, which are not pre-empted by S. 301 from imposing more stringent reporting requirements.

Harvey Fineberg, MD, President of IOM, said in his opening remarks, "every week it seems you open the newspaper" to find a story depicting something suggesting a profound conflict of interest, adding that the phenomenon is "not a new problem, but seems to be coming forward with ever-increasing force" and perhaps greater frequency.

"This report takes a broad look at conflict of interest," and "sets a new standard for comprehensiveness," Fineberg said, remarking that he was "pleased ... at the attention paid to prevention" rather than chasing events after the fact.

Also on the panel was Bernard Lo, MD, director of the program for medical ethics at the University of California San Francisco (San Francisco), who said, "this is a vital issue that goes to the heart of a patient's trust that they're getting the best medical advice." He said not all relationships between industry and physicians "are problematic," and noted that such relations can speed the arrival of vital therapeutics. However, conflicts of interest can erode trust, he said.

The IOM report details concerns on the parts of the authors on a number of issues, including the results of clinical trials and the interpretation of those results, but the report relies on fairly dated information in some instances. According to the report, a survey from 1993 indicated that the results of genetics studies were more likely to be delayed by six months or more if industry funding backed the project. The report also notes that a review of new drug applications indicated that the results of trials that concluded favorably were about twice as likely to be published than those that gave the drug a middling or negative score.

The report also recommends that physicians be prohibited from accepting any gift from industry at any monetary value level, a recommendation that conflicts with that of the Medicare Payment Advisory Commission, which recommended to Congress that the threshold for reporting by $100. This is also the set-point used by the authors of the Physician Payment Sunshine Act of 2009.

Panelist Eric Campbell, PhD, a health policy professor at Harvard Medical School (Boston), tackled relations between industry and universities and other institutions. "Virtually every large medical institution ... has some sort of relationship with industry," he noted, adding that institutional review boards (IRBs) "have a fair way to go" where disclosure is concerned, perhaps a swipe at Coast IRB (Colorado Springs, Colorado), which has had to suspend its further participation in clinical trials after falling prey to a sting operation by the Government Accountability Office.

On the other hand, the drug and device industries have made enormous contributions to healthcare today, and Campbell said as much. "Research suggests that virtually all the drugs and devices on the market today would not exist" without close collaboration between industry and physicians working inside and outside of academe. "These relationships are vital to the next generation of drugs and devices," he remarked.

Regarding the idea of industry funding for studies of physician practice guidelines, Lo said that even indirect funding "can have subtle influences." All the same "there is not enough current funding" for independent practice guidelines, he said, without pointing out that the billions set aside for comparative effectiveness research would essentially fill in this gap.

Rounding out the panel was James Childress, PhD, professor of ethics at the University of Virginia (Charlottesville, Virginia), who remarked of publishers and editors of medical journals: "One thing that's quite striking about medical journals is the enormous variety of standards" for disclosure. "We call on journals and other organizations to ... reinforce the idea that disclosure has to be made and has to be specific." He called on the World Association of Medical Editors (Shiraz, Iran) to publish a list of which journals hew to the standards of the medical societies they represent.

One of the questions from the audience was whether the IOM committee is aware of any evidence that such disclosure will blunt undue industry influence. Campbell said "it's hard to come up with other industries in which relationships ... are so pervasive." He said that umpires don't get free lunches from the New York Yankees (Bronx, New York) acknowledging immediately it was a poor comparison. Campbell said that he is indeed unaware of any such information but held his ground, stating that disclosure is "essential because you can't manage what you don't know about."

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