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January 29, 2007

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Integrity in Science Watch

Week of 01/29/2007

NKF Cloaks Conflicts on Eve of Crucial Meeting

The non-profit National Kidney Foundation is refusing to release the final roster of the expert panel that meets in Dallas on Saturday to re-evaluate its anemia guidelines for people suffering from chronic kidney disease. Recent studies show that raising red blood cell counts to meet targets established in the 2006 NKF guidelines increases strokes and heart attacks for people on dialysis, and hastens the onset of dialysis for people with chronic kidney disease. Eleven of the 16 members of the committee behind those guidelines, which were underwritten by Amgen Inc., had ties to firms that sell drugs to alleviate anemia, which are Amgen, Roche and Johnson & Johnson. The government's Medicare program currently spends over $2 billion a year for these drugs.

The current roster on the NKF website lists 12 of 18 members with ties to those three firms. A spokesman for the group refused to answer questions about possible changes to the committee in the wake of recent criticism in The Lancet attacking both the guidelines and conflicts of interest in the NKF guideline-writing process. "We've decided to keep the membership anonymous," said Bryan VanSteenbergen, a spokesman for NKF.

In an article in the current issue of the Clinical Journal of the American Society of Nephrology, Daniel W. Coyne of Washington University School of Medicine in St. Louis blasted the committee's decision last year to ignore unpublished data showing excess mortality even though the NKF was aware of the results. "In whose interest was it not to delay release of the guidelines until the results of these studies were available," he asked. In a written response, five physicians from the committee, four with ties to the drug makers, said reviewing only published studies "served as a safeguard against bias."

Coyne also attacked Medicare reimbursement policy, which rewards dialysis clinics for increased use of the drugs, and called on NKF to prohibit or "greatly limit" physicians with conflicts of interest from serving on its guideline-writing panels. "There are many physicians in academia with few or no ties to industry who are well trained to evaluate evidence from clinical trials and capable of writing guidelines," he told Integrity in Science Watch. "By not restricting corporate conflicts of interest among guideline panel members, the NKF has sometimes chosen physicians clearly favored by their sponsoring corporations, and effectively encourages those companies to attempt to influence all panel members." In the written response to his article, the NKF committee members said prohibiting physicians with conflicts from sitting on the panel "although attractive in theory, is unrealistic." They called instead for greater transparency.

Journals Fight Open-Access Movement

The Association of American Publishers has hired the "pit bull of public relations" to fight the open-access movement, which campaigns to make scientific research freely available, Nature reported last week. Eric Dezenhall, whose clients have included former Enron chief Jeffrey Skilling and ExxonMobil, spoke to officials from Elsevier, Wiley and the American Chemical Society last summer about a possible campaign that would include messages such as "public access equals government censorship" and would cost an estimated $300,000 to $500,000.

Mark Patterson, director of publishing for open-access publisher Public Library of Science (PLoS), said the PR campaign shows the strength of the open access movement. "There has been huge progress towards open access over the past year in particular, and comprehensive open access is now inevitable," he wrote in an e-mail exchange.

PLoS is part of a group of scholarly publishers that is urging the European Commission to support open access by guaranteeing public access to publicly funded research shortly after publication. The group's petition has garnered more than 12,000 signatories so far.

EPA OKs Charity Promos on Bleach

The Environmental Protection Agency has decided to allow Clorox Co. to advertise a pledge that it will donate a small percentage of the retail purchase price of its bleach products to the Red Cross. EPA guidelines regulating the content of labels for registered pesticides, rat poisons, fungicides and anti-microbial agents emphasize safety and usage information and discourage any "symbols implying safety or nontoxicity, such as a Red Cross or a medical seal of approval." But the agency has decided to allow placement of the phrases "Dedicated to a healthier world" and "Help Clorox raise $1M for the Red Cross," as well as the use of the Red Cross logo on both the front and back panels, on five Clorox products, according to documents released last week by Public Employees for Environmental Responsibility (PEER).

Clorox spokeswoman Mary O'Connell noted that the company has a long history of working with the Red Cross and its sister organizations, especially during natural catastrophes such as the recent hurricanes and tsunamis, because of bleach's disinfectant properties. "Bleach has saved more lives than any other substance made by man," she said.

PEER Executive Director Jeff Ruch said his group is concerned that the decision would allow manufacturers of pesticides and other commercial poisons to feature similar tie-ins with charitable organizations and marketing slogans on their product labels. "EPA realizes that once they have made allowances for Clorox, they have to make comparable allowances for anyone else that wants them," he said. EPA officials confirmed that the agency is developing guidance on charity labeling.

Panel on Hormone Guidelines Rife With Conflicts

Almost five years after alarming data from the Women's Health Initiative study on hormone therapy showed an increased risk of cardiac problems for older women using the drugs, the North American Menopause Society has released a new set of guidelines that recommends use of hormone therapy to younger women and says use of estrogen and progestin drugs may help pre-menopausal and postmenopausal women's heart and bones. The decision makers on the NAMS committee are heavy with conflict of interests. Out of 14 members, only 5 do not have obvious financial ties to pharmaceutical companies. Notable among those with financial conflicts of interest is NAMS Executive Director Wulf Utian, who led the advisory committee.

NAACP Touts High-Cost Heart Drug After Contribution

The National Association for the Advancement of Colored People is demanding that Medicare pay for BilDil, the first cardiac medication tested and approved solely for African-Americans. The strongly worded letter came after the NAACP received $1.5 million in contributions from NitroMed, the drug's manufacturer, the Wall Street Journal (subscription required) reported. The American Heart Association and American College of Cardiology say there is no difference between taking BilDil and its two generic components. Medicare says taking the two generics instead of BilDil would save consumers or their insurers between $1,300 and $2,700 a year. In its letter, the NAACP said the generics are no substitute because patients on generics need to swallow more pills, thus reducing compliance, and some would have to split pills to get the proper dose.

Hearing To Examine Political Influence on Climate Change Scientists

The House Oversight Committee will hold a hearing tomorrow on political interference in the work of government climate change scientists. In preparation for the hearing, Chairman Henry A. Waxman (D-Calif.) and Ranking Republican Tom Davis (R-Va.) have asked the White House Council on Environmental Quality to provide documents related to allegations that officials edited scientific reports and took other actions to minimize the significance of climate change.

Researchers Who Get Pharma Funding More Likely to Back Nicotine Replacement Therapy

A Canadian study has found that researchers with drug company funding are more likely to conclude that nicotine replacement therapy has a better chance of helping people quit than those who do not take money from pharmaceutical companies, CanWest news service reported last week. Paul McDonald, a health studies professor at the University of Waterloo, who conducted the study, said "the overwhelming majority of the studies that are being conducted are being conducted in whole or in part with private-sector funding or pharmaceutical funding." The results will be made public at a conference in Texas next month.

Cheers and Jeers

  • Jeers: Dr. Phillip J. Rosenfeld of the University of Miami was quoted in a New York Times article last week defending the drug Lucentis, but the article did not disclose that Rosenfeld sits on the scientific advisory board of the drug's manufacturer, Genentech.
  • Jeers: A story in last week's National Post that reported on new findings by Dr. Pierre Blier that showed a cocktail of drugs are more effective in treating depression than Prozac alone failed to disclose that Blier has ties to numerous pharmaceutical companies, including Prozac manufacturer Eli Lilly, Pfizer, Merck, Bristol Myers Squibb, GlaxoSmithKline and Wyeth Ayerst.
  • Jeers: An Associated Press article critiquing the latest report from the Intergovernmental Panel on Climate Change cited University of Alabama at Huntsville professor John Christy's belief that Greenland will not melt as fast as the report expects, but failed to report Christy's ties to numerous organizations that receive funding from ExxonMobil, including the Independent Institute and the Marshall Institute.
  • Jeers: The Washington Times included a commentary last week by prominent global warming skeptic Patrick J. Michaels that accused the New York Times of misleading its readers about the effects of climate change in Greenland. Michaels was identified as an author and senior fellow at the Cato Institute, but the article did not mention Michaels' well-established ties to industry groups including the Intermountain Rural Electric Association and Western Fuels Association.
  • Jeers: Michaels was also cited in a Richmond Times-Dispatch story last week on a new report outlining the dangers of global warming for Virginia. He was identified only as a University of Virginia climatologist.

Odds and Ends

Newly appointed University of California Regent Bruce D. Varner co-owns an energy firm that does business with the University of California at Riverside, but Varner said he would recuse himself from decisions that might affect the firm, the Riverside Press-Enterprise reported last week. ... Adriane Fugh-Berman of the Georgetown University School of Medicine and several colleagues recently launched PharmedOut, a Web site aimed at doctors seeking continuing medical education programs free of industry funding. The program is funded through a grant program created as part of a 2004 settlement between Warner-Lambert and the attorneys general of 50 states and the District of Columbia regarding its marketing campaign for the drug Neurontin. ... Although EPA officials have decided who they want on the NOx and SOx Primary Review Panel, the membership of the panel will not be announced until later next month, agency spokesman Fred Butterfield said last week.