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April 28, 2008

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Integrity in Science Watch

Week of 04/28/2008

Conflicts Clot HHS Cord Blood Stem Cell Committee

At least 11 of the 25 voting-members of Health and Human Services’ Advisory Council of Blood Stem Cell Transplantation have financial ties to cord blood-banking and transplantation industry despite a committee charter stating that such conflicts should be limited. The council, which meets for the second time today and tomorrow, was formed earlier this year to provide “expert, unbiased analysis and recommendations” on blood stem cell transplantation policy, regulation, and research. The committee’s charter prohibits Council members with financial ties to donor centers, recruitment organizations, transplant centers, or cord blood banks “from participating in any decision that materially affects the center, recruitment organization, transplant center, or cord blood bank.” It also calls on HHS officials to “limit the number of members of the Advisory Council with any such affiliation.” A Center for Science in the Public Interest survey of committee membership found that nearly half of the committee’s voting members have financial ties to the stem cell and blood bank industry.

Members with significant financial conflicts of interest include Charles Sims, the medical director and co-founder of the sperm bank California Cryobank, who is also the chair of the Association of Family Cord Blood Banks, an industry trade group. Fredrick Appelbaum, head of medical oncology at the University of Washington, has relationships with six pharmaceutical companies including Wyeth, Bristol-Myers Squibb, Merck, and Genzyme. Richard Champlin, chairman of the Stem Cell Transplantation and Cellular Therapy at the University of Texas in Houston, serves on the medical advisory board of Stemcyte, a California company that runs public and private banking programs. Champlin also serves as a consultant to Genzyme, AnorMed, and Amgen. The council’s chair, Karl Blume, an emeritus professor of Medicine at Stanford University, also serves with Champlin on the Stemcyte advisory board. Currently, none of these financial ties or the members' conflict of interest waivers are available on the council’s website, although the HHS official in charge of the committee, Remy Aronoff, said he was looking into the issue. According to Aronoff, the initial selection process of the council did not take into account the conflicts of interests of the over 100 applicants, but he added that perhaps for future council appointees "it is a reasonable thing to do." A full list of committee members' conflicts of interest can be found here.

The agenda for the council’s meetings this week includes cord blood bank accreditation programs, insurance reimbursement for stem cell transplants, cord blood access for research, and recruitment practices. Joana Ramos of the Cancer Resources and Advocacy, a private consultant who focuses on improving access to quality cancer and chronic disease treatment for families, said the “stacked” committee makes, “it extremely difficult for the public to have an impact or to shape policy despite having concerns.”

Association Urges Medical Colleges to Ban Gifts

A task force representing the nation’s 125 medical colleges has recommended a ban on gifts and free meals for students and faculty and stricter regulations of industry visits on campus. But the Association of American Medical Colleges, whose executive council will consider the proposal in mid-June, stopped short of calling for prohibiting faculty members from consulting or speaking on behalf of drug and device companies, or for eliminating industry’s role in financing continuing medical education (CME). “Clear and well-though-out guidelines will optimize the benefits inherent in the relationship between academic medicine and industry and minimize the risks,” the report said.

The 30-member task force was chaired by Roy Vagelos, former chairman of Merck, and included the CEOs of Pfizer, Medtronic, Amgen and Eli Lilly. The latter two dissented from the report’s recommendations “strongly discouraging” participation in speakers’ bureaus. The report closely followed a proposal made two years ago by Columbia University’s Institute on Medicine as a Profession with one exception. That report called for academic physicians to abandon participation in industry speakers’ bureaus, which it called “an extension of manufacturers’ marketing apparatus.”

Besides banning gifts, the guidelines called for centralized management of free drug samples or, where that is not possible, some alternative that does “not carry the risks to professionalism with which current practices are associated.” Drug and device salesperson visits with individual physicians should be restricted to non-patient areas and by appointment or invitation only. On speaking and consulting, the report suggested “to the extent that academic medical centers choose to allow participation of their faculty and staff in industry-sponsored, FDA-regulated programs, they should develop standards that define appropriate and acceptable involvement,” which was defined as full transparency and payment “at fair market value.”

Rather than eliminating industry’s role in financing CME, which now accounts for more than half of the $2 billion industry, the AAMC task force recommended that the money be deposited in a centralized fund. It also recommended establishing school-level audit committees to monitor CME activities to ensure they follow conflict-of-interest guidelines established by the Accreditation Council for Continuing Medical Education. At an Institute of Medicine hearing in March, the Center for Science in the Public Interest urged physicians to pay directly for their own continuing education and eliminate the middlemen since patients and consumers already paid indirectly for CME through higher drug and device prices.

Survey Documents Extensive Political Interference at EPA

A new survey of scientists at the Environmental Protection Agency suggests that political appointees and the White House are interfering with scientific work at the agency and its primacy in regulatory decision-making. The survey, conducted by the Union of Concerned Scientists, found 60 percent of the nearly 1,600 agency scientists who filled out detailed questionnaires had personally experienced pressure from agency political appointees to alter the results of their research over the past five years. Most of the reports came from scientists who work in offices with regulatory responsibilities or those that conduct risk assessments of various chemicals. “The main problem I see is an administration that considers science only if it supports its agenda,” wrote one survey respondent. “Science is used only if it furthers preexisting policy; otherwise it is ignored, marginalized or suppressed (e.g., climate change)."

Many survey respondents cited the increasing role of the White House’s Office of Management and Budget (OMB) in determining EPA regulatory decisions. A Reagan-era executive order gave OMB the power to review and approve all government regulations. In recent years, according to critics, the office has increasingly undermined the science used as a basis for regulation. And in this survey, nearly 100 EPA scientists alleged that OMB’s interference has delayed important public health provisions and has caused rules governing asbestos, ozone, formaldehyde, and particulate air pollution to be altered. “[T]hey want the scientific work to match the preordained conclusions,” said one scientist.

The report prompted Rep. Henry Waxman (D-CA), chairman of the House Committee on Oversight and Government Reform, to demand that EPA Administrator Stephen Johnson offer a public response at a May hearing. An EPA spokesman said that the work of agency scientists was a “valued part of...regulatory action,” and attributed scientists’ responses to their passion about their work which was not always in line with “difficult policy decisions.”

Boxer: EPA Gives Industry More Influence over Science Process

Senator Barbara Boxer (D-CA) last week chastised the Environmental Protection Agency for giving industry the ability to directly input information into the EPA's influential database that catalogues chemical risk information, known as the Integrated Risk Information System (IRIS). The new process lets “the White House and federal polluters derail EPA's scientific assessment of toxic chemicals,” she charged. The new policy, announced April 10 on the agency’s website, will allow industry and the public to contribute information to the IRIS database, which was previously compiled solely by agency scientists. Boxer, chairwoman of the Senate Committee on Environment and Public Works, said the new policy allows for earlier and more extensive involvement by the White House and federal agencies that pollute the environment, such as the Department of Defense.

The risk assessments contained in the IRIS database are used to guide federal, state, and international agencies in crafting public health regulations on drinking water, air pollution, and toxic discharges. Public Employees for Environmental Responsibility said the new rules will increase the influence of industry-funded research, and downplay the role of government research, over policy. The EPA says the changes are simply a means of increasing “transparency and efficiency.”

Report Refutes EPA Assumptions on Ozone

A new report by the National Academy of Sciences calls into question the Environmental Protection Agency’s new standard for ozone issued last month. The new standard, of 0.075 parts per million (ppm), was a reduction from the previous standard of 0.08 ppm but was decried by scientists within the agency’s Clean Air Scientific Advisory Committee as being too high. The scientists had unanimously recommended a standard of 0.06-0.07 ppm over 8 hours, based on studies showing risks to sensitive populations at higher levels. The EPA arrived at the .075 ppm standard as a result of cost-benefit accounting that failed to acknowledge the cost of additional human deaths from the increased levels of pollution. The White House’s Office of Management and Budget had advised the EPA that there was "considerable uncertainty" over the link between ozone levels and deaths.

The report by the National Academy’s National Research Council finds that short-term exposure to ambient ozone conclusively leads to premature deaths especially among children, the elderly, and those with heart and lung disease. The OMB could not be reached for comment on the NAS study’s findings.

IOM to Evaluate Great Lakes Study

The National Academy of Science’s Institute of Medicine is forming a committee to evaluate the controversial study on Great Lakes environmental toxins released in February. The study proposed a link between industrial releases of toxic substances in the Midwest and elevated levels of cancer, low birth weights, and infant mortality, and was originally planned for release by the Center for Disease Control’s Agency for Toxic Substances and Disease Registry (ATSDR) last July. Christopher Derosa, lead author of the study and former director of ATSDR’s division of toxicology and environmental medicine, was demoted last December following criticisms from ATSDR’s chief Howard Frumkin that the study was “well below expectations.” Several members of Congress led by House Committee on Science and Technology Chair Bart Gordon wrote to CDC Director Julie Gerberding in February demanding that the agency explain the delay and “protect Dr. DeRosa from retaliation for whistle blowing.” The IOM committee will, at the request of the CDC, review whether the scientific evidence in the study supports its conclusions.

Redacted Climate Change Testimony Delivered

A senior official at the Centers for Disease Control has come forward with the information missing from the censored climate change testimony that CDC Director Julie Gerberding delivered last October. When Gerberding testified before the Senate Committee on Environment and Public Works, The Associated Press revealed that her remarks had been censored by the White House Office of Management and Budget to play down the public health risks of climate change. But on April 9, senior CDC official Howard Frumkin revealed most of that information in testimony before the House Select Committee on Energy Independence and Global Warming. Global warming will increase heat and severe weather events, and will increase the incidence of disease and pathogens sensitive to weather conditions, Frumkin said.

Gov't. Grant Used to Allegedly Fabricate Sludge Data

A University of Georgia professor and former Environmental Protection Agency scientist is suing officials at the University of Georgia for publishing allegedly fraudulent research funded by the federal government. David Lewis, an adjunct professor in UGA’s department of ecology, filed a False Claims lawsuit against the university Board of Regents, the university research foundation, and five faculty members. According to court documents, Lewis accused the scientists of publishing fabricated data on the safety of sewer sludge from wastewater treatment plants in Augusta, Ga. The sludge was used as a replacement for commercial fertilizer on farms in the area.

Last month U.S. District Court judge Anthony Alaimo ruled that sludge treated in Augusta’s facilities had metals concentrations thousands of times over allowed toxicity levels. Although the judge noted that the UGA report on those facilities was “faulty and incomplete,” Alaimo did not accuse the scientists involved in the study of knowingly submitting false information. Lewis has investigated the harmful side affects linked with the sludge since 1998 and argued in 2005 that his research led to his firing from the EPA. UGA is one of five institutions up for National Bio and Agro-Defense Facility grants to study emerging terrorist and natural disease epidemics.

Odds and Ends

An audit requested by a Sourcewatch volunteer editor has revealed that more than $500,000 in contributions to University of Toronto research accounts was routed to Friends of Science, which then used the funds to purchase advertisements to urge inaction on global warming. . . . The University of Cincinnati will continue to investigate and watch corporate research funding received by Melissa DelBello, a professor of psychiatry, the Cincinnati Enquirer reported last week. AstraZeneca paid DelBello over $330,000 from 2003 to 2007 for her work on the company's bipolar medication for children but told the university that she received significantly less. The discrepancy came to light after Senator Charles Grassley (R-IA) cited the professor and the university, which received $8.7 million in funds from industry last year, as examples of growing conflicts of interest within science research. . . . The University of North Carolina and the Hamner Institute announced that the two organizations will collaborate on future biomedical research and public health projects. The Hamner Institute is a non-profit research institute that receives funding from a range of chemical, drug, and oil companies including 3M, Bayer CropScience, GlaxoSmithKline, Procter & Gamble, Chevron, and ExxonMobil. The institute also receives money from industry trade association such as the American Chemistry Council, American Forest & Paper Association, and American Petroleum Institute.