Center for Science in the Public Interest

For Immediate Release: April 2, 2007

Integrity in Science Watch

Week of 04/02/2007

Inspector General To Reexamine NIH Conflict-of-Interest Cases, Oversight

The Health and Human Services department is reexamining the cases of 103 scientists exonerated by the National Institutes of Health after they failed to disclose their outside financial ties to private industry, the Associated Press reported last week. The inspector general’s investigation will include a review of the agency’s new conflict-of-interest rules, which were adopted in the wake of a 2003 Los Angeles Times investigation. That report turned up a half dozen senior scientists at NIH who earned hundreds of thousands of dollars a year from their outside dealings with private drug and medical device companies. At least one, Trey Sunderland, who headed the agency’s geriatric psychiatry branch, last December pleaded guilty to failing to report over $500,000 in outside income from Pfizer Inc. He agreed to forfeit $300,000 while spending two years on supervised probation.

Meanwhile, Inspector General Daniel Levinson told Rep. John Dingell, chairman of the House Energy and Commerce Committee, that he will also investigate NIH’s oversight of conflict-of-interest policies at the universities and non-profit research institutions that receive 80 percent of the agency’s $28 billion budget. While NIH requires institutions receiving grants to adopt such policies, the agency conducts virtually no oversight and has no rules regulating the behavior of government grant recipients who double dip on industry payrolls.

FDA Okays Conflicts on Committee Considering Merck’s New Pain Pill

The Food and Drug Administration last week gave three scientists, including two with financial ties to Merck, permission to serve on an advisory committee and to vote on the fate of the company’s new Cox-2 inhibitor pain pill. The Arthritis Drugs Advisory Committee will consider Arcoxia (etoricoxib) when it meets later this month. Preliminary clinical trial data released by the company last year indicated Arcoxia raises blood pressure in some patients, but does not result in the same heart attack risk as Vioxx, the Cox-2 inhibitor Merck removed from the market in late 2004.

According to agency documents that were released last week, the committee will include Robert Levine, a gastroenterologist at the State University of New York, who owns between $25,000 and $50,000 in Merck stock. The FDA identified four gastroenterologists willing to take the slot, but two had more extensive conflicts than Levine. The FDA also granted a waiver to Kenneth Saag, a rheumatologist at the University of Alabama at Birmingham, who receives somewhere between $10,000 and $50,000 a year from Merck. Saag, the FDA said, is expert in analyzing large databases (Merck has tested the drug in over 35,000 patients) and the agency “was unable to find anyone as qualified.” However, the agency admitted that it only scrutinized its current roster of advisers and employees of the National Institutes of Health to identify candidates. Committee chair Dennis Turk, an anesthesiology professor at the University of Washington, also received a waiver for the $10,000 a year or less he earns from a company that competes with Merck on unrelated issues.

All will be allowed to vote, according to the agency. The FDA recently issued a draft guidance that would ban scientists earning over $50,000 a year from private firms from serving on advisory committees. The guidance also would prohibit those earning less from voting, although they could be granted a waiver to serve. A recent analysis showed less than 10 percent of the outside scientists granted conflict-of-interest waivers by the FDA earn more than $50,000 a year from their corporate activities.

Interior IG: Top Wildlife Official Censored Endangered Species List

The Interior Department’s Inspector General has confirmed allegations that Julie MacDonald, a 2002 Bush administration appointee who now runs the Fish, Wildlife, and Parks division, tampered with the Endangered Species Act listings generated by agency scientists. The charges by internal whistleblowers first surfaced in a Washington Post report last October that was based on documents obtained by the Union of Concerned Scientists. IG Earl Devaney told Congressional investigators that MacDonald, an engineer by training, “bullied, insulted, and harassed the professional staff of the U.S. Fish and Wildlife service to change documents and alter biological reporting regarding the Endangered Species program.” The IG also accused MacDonald of disclosing “nonpublic” information to the conservative Pacific Legal Foundation, which mounts legal challenges to implementation of the Endangered Species Act.

Double Duty: Many Academic Leaders also Direct Health Care Corporations

A majority of U.S. medical schools have leaders or faculty members who sit on boards of for-profit health care corporations ranging from drug companies and biotechnlogy start-ups to hospital chains, a new study shows. Scientists associated with the Foundation for Integrity and Responsibility in Medicine surveyed the boards of 164 publicly traded health care companies and found 200 board members who held faculty or administration positions at 65 of the nation’s 125 medical schools. Individuals who sit on the boards of publicly-traded companies have a fiduciary responsibility to maximize the profits of those organizations. That could pose conflicts with their roles as researchers or administrators of research programs at the nation's medical schools, especially when research may threaten the interests of the private corporations. “Severe conflicts of interest may be more prevalent at U.S. academic medicine than was heretofore appreciated,” noted the abstract for the paper, which will be presented later this month at the annual meeting of the Society of General Internal Medicine.

Odds and Ends

The Japanese health ministry is removing two conflicted researchers from a study group analyzing Tamiflu’s side effects, Nature (subscription required) reports. . . The Environmental Protection Agency’s Scientific Advisory Board wants nominees for an outside panel to review the agency’s forthcoming acrylamide risk assessment. The carcinogen is present in low levels in many fried foods.

Cheers and Jeers