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January 26, 2009

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Integrity in Science Watch

Week of 01/26/2009

Mandatory Medical Disclosure Gains Traction

Sens. Charles Grassley (R-IA) and Herb Kohl (D-WI) last week introduced legislation requiring manufacturers that sell goods to government health care programs to report payments to physicians greater than $100 in a publicly-available Internet database. The disclosures made under the Physician Payments Sunshine Act would detail the value and date of the payments and include consulting, honoraria, food and entertainment, research support and stock ownership. The legislation echoes recommendations included in a perspective in the New England Journal of Medicine (subscription required) last week.

The proposed law does not extend to requiring companies or others sponsors of clinical trials to report conflict-of-interest information to the FDA before physicians begin enrolling their patients in the trials. Such reporting is necessary, according to a new Health and Human Services inspector general's report, if the agency is going to monitor "the potential for bias that may compromise the safety of human subjects and the integrity of research data." The report found just one percent of nearly 30,000 investigators listed on new drug and device applications in 2007 reported conflicts of interest to the agency, despite estimates in the Journal of the American Medical Association that "between 23 percent and 28 percent of academic researchers had financial interests in medical companies," according to the inspector general's report.

Meanwhile, the voluntary movement among academic medical centers toward greater disclosure accelerated last week when Harvard Medical School Faculty Dean Jeffrey S. Flier announced he will chair a committee to review the current Faculty of Medicine Policy on Conflicts of Interest and Commitment, according to the Harvard Crimson. Cleveland Clinic and Duke are among the medical schools that have recently begun disclosing all faculty members' corporate ties on their websites. And Park Nicolett, a health care provider in Minnesota with more than 8,100 employees, will begin disclosing their physicians financial ties to medical device and drugmakers, the Minneapolis Star Tribune reported.

COIs Found on IOM Vitamin D-Calcium Committee

At least two members of the committee proposed by the Institute of Medicine to reevaluate intake guidelines for calcium and vitamin D have potential conflicts of interest, a Center for Science in the Public Interest investigation found. Clifford Rosen, a senior scientist at the Maine Medical Center's Research Institute, last year disclosed that he had received research support from Novartis and Eli Lilly and served on the speaker's bureau for Procter & Gamble. The three companies produce vitamin D supplements, which are used to help build bone mass. The IOM did not reveal those conflicts of interest on its website because its disclosure policy only considers financial ties that are active and ongoing.

Another proposed committee member with recent conflicts of interest is J. Christopher Gallagher, a professor of medicine and chief of the bone metabolism section at Creighton University Medical Center in Omaha. In a telephone interview Gallagher said he was not currently working with any pharmaceutical companies, but he has recently disclosed previous financial relationships with GlaxoSmithKline, Organon and Wyeth, which make vitamin D supplements. CSPI considers relevant for disclosure purposes any financial payments received within the past five years, the standard adopted by the Journal of the American Medical Association. Gallagher disclosed those relationships in a 2006 guideline on calcium intake sponsored by the North American Menopause Society, where he was listed as a member of the board of trustees. The guideline development process was funded by GlaxoSmithKline, which sells the vitamin D supplement Oscal.

The study, sponsored by the US Departments of Health and Human Services, Agriculture and Defense and by Health Canada, will meet March 26-27 in Washington. The proposed committee roster is open for public comment until Jan. 29.

Obama Moves Quickly to Roll Back Bush Rules

President Obama's first official act in office froze all proposed Bush Administration rule changes that have not gone into effect. The memorandum issued by Obama Chief of Staff Rahm Emanuel allowed the new administration to review any rules that raise "substantial questions of law or policy." Agencies may now review rules that have not been published in the Federal Register and postpone for 60 days the effective date of those that have. The move may result in the restoration of protections removed from the Endangered Species list this month, against the advice of scientists, such as for northern Rocky Mountains gray wolves.

The freeze will have no effect on Bush Administration rules that have already gone into effect, although the new Director of the Office of Management and Budget Peter Orszag has indicated that department heads may choose not to defend these rules in the case of legal challenge. Many of the Bush Administration's controversial midnight rule changes, including the effort to remove wildlife scientists from endangered species decisions, have already been challenged by conservation groups. A new report from the Center for American Progress outlines possible strategies that the new Administration and the public may undertake to reverse many of the midnight rule changes.

Meanwhile, Obama limited the role of lobbyists and corporate special interests in his administration. The new rules bar former lobbyists from taking jobs in agencies they sought to influence, prohibit employees of the Obama administration from going on to work in the same area they once regulated, and prohibit lobbyists from giving gifts to any member of the administration.

And in a complete reversal of Bush administration secrecy policy, the new administration ordered agency officials who process freedom-of-information act requests to err on the side of disclosure when they had discretion to do so. In 2001, then Attorney General John Ashcroft ordered agencies to withhold information from the public whenever they had the option of doing so. The new guidance must be published in the Federal Register before it can go into effect. In a second directive, the White House ordered OMB, the Chief Technology Officer, and the General Services Administration to draw up an "Open Government Directive" within 120 days to apply to almost all executive agencies.

Health Care Firms Fund New Kennedy Institute

Drug companies, hospitals and health insurance firms helped amass the $20 million needed to finance a new nonprofit educational institute in Boston that will honor Sen. Edward Kennedy, the Boston Globe reported. The largest donation came from the biotech firm Amgen,which gave $5 million. Kennedy chairs the Senate Committee on Health, Education, Labor and Pensions, where he is in the process of developing major changes in healthcare policy. Kennedy has kept his distance from the process, particularly the fund-raising, to avoid any ethical concerns, according to the article. "What we intend to do is be perfectly transparent in what we've received in donations," said Paul Kirk, a former Kennedy staffer who helped organize the fundraising drive for the John F. Kennedy Library Foundation.

Study: Politics Said to Influence Who Wins NIH Grants

Researchers working in states with influential Members of Congress received a disproportionate share of National Institutes of Health grants, according to new study from the University of California at Berkeley's Haas School of Business. Deepak Hegde and David C. Mowery, writing in last week's Science Magazine (subscription required), claim $1.7 billion of the $37.4 billion awarded by NIH to extramural researchers in 2002 and 2003 was directly related to their having representatives who sit on the health subcommittee of the House Appropriations Committee. Looking back over two decades, having a single member on the House subcommittee was associated with 5.9% increased overall NIH funding in that member's district, with public universities seeing 8.8 percent greater funding and grants to small businesses 10.3 percent greater funding, according to the study. Senate Appropriations Committee members were less prone to using their influence with one exception: "New York Sen. Alfonse D'Amato, a member of the SAC from 1983 to 1994, significantly increased NIH funding for performers in New York State," Hegde and Mowery wrote. "The exercise of such influence clearly mediates the effects of rigorous peer review."

Odds and Ends

The Obama administration will give states the right to regulate greenhouse gas emissions, and will push up the date for raising average fuel efficiency standards to 35 miles per gallon, according to press reports. The moves, which reverse Bush administration policies, follow both "science ... and law," according to Frank O'Donnell of Clean Air Watch. ... Scientists celebrated President Obama's vow in his inaugural address to "restore science to its rightful place," the New York Times reported. ... A study in the New England Journal of Medicine reports that reductions in air pollution in the U.S. between 1979 and 2001 accounted for as much as 15 percent of the increase in life expectancy over that period, even after controlling for factors like smoking habits and socioeconomic status. The improvement translated into an additional .77 years of life for every 10 micrograms per cubic meter reduction in air pollution. ... The North American Spine Society, responding to revelations from lawsuits by former industry employees, will require researchers to reveal their financial ties to medical device companies, including dollar amounts, according to press reports. ...

Cheers and Jeers

  • Cheer to Bill Gleason and the Minnesota Daily for calling on the University of Minnesota to "repair the credibility damage done by the Furcht appointment and other disclosure issues." Leo Furcht, the chairman of lab medicine and pathology at the university, was reprimanded for a "serious violation" of the university's conflict-of-interest policy in connection with a grant from Baxter Healthcare for stem cell research at the Medical School.

  • Jeer to Roni Caryn Rabin of the New York Times for failing to disclose that a study about drug-resistant ear, nose and throat infections was supported by Alcon Laboratories, which claims to be the market leader in developing eye and ear drugs and glaucoma treatments. The study was published in the Archives of Otolaryngology - Head and Neck Surgery.