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May 5, 2008

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Integrity in Science Watch

Week of 05/05/2008

Groups, GAO Fault EPA’s Risk Assessment Process

The Environmental Protection Agency’s decision to add a new layer of external review when updating its toxic chemicals registry drew a sharp rebuke from environmental and consumer groups last week. The groups’ protest letters charged that the new process will add extensive delays to the already backlogged assessment program, and will give industry, the Defense and Energy departments more ways to delay important public health protections. Updates to the Integrated Risk Information System (IRIS), the widely-used database that contains information on toxic chemicals and their health effects, have already slowed to a trickle in recent years.

The new procedure, announced April 10, also gave the White House Office of Management and Budget (OMB) greater control of interagency review of the assessments. “We are very concerned that the new process will introduce delays, derail assessments, and institutionalize the growing influence of federal agencies . . . that are among the biggest contributors to toxic Superfund sites,” the letter, whose signers included the Center for Science in the Public Interest, stated. A new Government Accountability Office report found that a majority of the 540 chemicals in the database have outdated assessments, and that the agency has only completed four of a planned 32 assessments in the past two years. The agency’s “low level of productivity jeopardizes the viability of the IRIS database,” the report stated. The GAO also noted that the new procedure lacks transparency, since the OMB shields the interagency and outside reviews from public scrutiny.

Senate Committee on Environment and Public Works committee chairwoman Barbara Boxer (D-CA), who asked for the GAO report, said “EPA scientists are being pushed aside by White House operatives and polluters.” At a hearing last week, Boxer also faulted the entire toxic chemicals regulatory structure in the U.S., saying that the Toxic Substances Control Act requires government to assess a chemical’s risk while Europe’s REACH program “puts the burden on the chemical industry—where it should be.”

FDA Scraps Helsinki Declaration on Protecting Human Subjects

Drug companies got a green light last week to start using data from foreign clinical trials in new drug applications even if the trials only compare new products to placebos instead of best available treatments. The change marks a sharp departure from the 1989 Declaration of Helsinki protecting human subjects in clinical research, the Food and Drug Administration's previous standard. The new rule, which goes into effect next October, was pushed by drug and device manufacturers, but opposed by numerous public interest, patient advocacy, and consumer groups. The Declaration of Helsinki "is the standard-bearer for international research ethics and enjoys particular respect in the developing world," said Peter Lurie, deputy director of Public Citizen's Health Research Group. Its rejection is "in line with other U.S. efforts to flout international mores."

The new rule's substitute standard says foreign trials should follow good clinical practices (GCP) and include a review and approval by an independent ethics committee. A major difference between the Helsinki Declaration and GCP is the former's insistence on using existing treatments instead of placebos if they are available. The Helsinki Declaration had the effect of extending existing treatments to people in poor countries if they participated in clinical trials.

The change is likely to push more clinical trials abroad, where an estimated 35 percent of all trials submitted to the FDA in new drug applications now take place. Unlike trials conducted in the U.S., companies do not have to submit an investigative new drug application (IND) to the FDA before beginning research in foreign countries. The FDA estimates about 575 of the foreign trials submitted to the agency each year as part of new drug applications do not go through the IND process. The FDA rejected the notion that adopting the self-regulating GCP standard and eliminating references to the Helsinki Declaration "will hurt subjects in developing countries or result in less protection for subjects in foreign studies." GCP requires trial sponsors closely monitor trial behavior and report adverse events, the agency noted.

Animal Ag Report Encounters Industry Interference

Industry groups sought to undermine a new report calling for reduced use of antibiotics in meat production and better waste management, the Pew Commission on Industrial Farm Animal Production charged last week. The two-year study found the current system “poses unacceptable risks to public health, the environment, and the welfare of the animals themselves.” The 15-member Commission relied on technical reports written by academic researchers. Pew Commission executive director Robert Martin said many potential contributors had to be disqualified because of their extensive financial ties to industry, and a number of researchers withdrew after industry representatives threatened to withhold research funding from their universities if their findings were critical of industry. “We found significant influence by the industry at every turn; in academic research, agriculture policy development, government regulation, and enforcement,” said Martin. The Commission called for increased public funding of animal agriculture research.

Psych Working Group Again Rife with Conflicts of Interests

More than half the 28 new members of writers of the next edition of the American Psychiatric Association's (APA) Diagnostic and Statistical Manual of Mental Disorders (DSM) have ties to the drug industry. The conflicts of interests were posted online by the APA last week. They ranged from small to extensive. Leading the pack was William Carpenter, Jr., director of Maryland Psychiatric Research Center at the University of Maryland, who over the past last five years worked as a consultant for 13 drug companies, including Pfizer, Eli Lilly, Wyeth, Merck, Astra Zeneca, and Bristol-Myers Squibb. APA President Carolyn B. Robinowitz claimed that "we have made every effort to ensure that DSM-V will be based on the best and latest scientific research, and to eliminate conflicts of interest in its development." The fifth DSM, produced in conjunction with the National Institute of Mental Health, will be published in 2012. It is used by mental health professionals to classify mental illnesses.

Agency Hedges on Great Lakes Pollution Link to Health

Reversing the conclusions of its draft report, the Agency for Toxic Substances and Disease Registry’s (ATSDR) final report on the health impacts of environmental contamination in the Great Lakes claims the data is inadequate to prove the pollution poses a threat to human health. The February draft report authored by former ATSDR toxicology director Christopher DeRosa found a link between contaminant levels and a broad spectrum of health concerns. DeRosa was reassigned following release of the controversial study, which was delayed seven months. The new report concludes simply that more research is needed to define the health impacts of Great Lakes contamination. The public has 60 days to comment on the new report.

Groups Protest FIFRA Panel Nominees

The Center for Science in the Public Interest and Natural Resources Defense Council last week protested the lack of disclosure and industry ties of four nominees for two open positions on a seven-member advisory panel established under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The panel conducts peer reviews on pesticide-related issues for the EPA's Office of Prevention, Pesticides and Toxic Substances. The groups objected to the nominations of James Bruckner, who was a paid expert witness for Lockheed Martin; Mark Harwell, whose firm, Harwell Gentile & Associates, LLC consults for such entities as Exxon-Mobil; Wanda Haschek-Hock, who has received research funding from numerous industries; and Curtis Klaassen, who has worked for nearly 20 years with the industry-backedInternational Life Sciences Institute. "This failure to disclose relevant conflicts of interest compromises the ability of the public to comment intelligently on the nominations and the Agency's ability to convene a panel without financially conflicted members," the letter stated. "Panelists who are or often have been employed by industry, or frequently consulted for industry, are at risk of harboring pro-industry bias."

Odds and Ends

The Union of Concerned Scientists disclosed a new document showing that the White House delayed a rule that would protect the North Atlantic right whale. Rep. Henry Waxman (D-CA) demanded that the Office of Management and Budget release the rule, which would slow shipping speeds along the Atlantic coast. The White House pressure on behalf of the shipping industry was first brought to light by Public Employees for Environmental Responsibility. . . . Twelve conservation groups filed a lawsuit challenging the removal of the northern Rockies gray wolf population from the endangered species list. The US Fish and Wildlife Service delisted the wolf in late February. . . . A federal judge has ordered the Interior Department to decide by May 15 whether the polar bear should be listed as a threatened species because of global warming. . . . More than half the 110 people and organizations signing a “Patient Declaration” that asked the World Health Organization (WHO) to include patient group input into intellectual property policy reform deliberations get financial support from drug companies, Essential Action, a non-profit organization working on public health and corporate accountability, revealed in a report last week.

Cheers and Jeers

  • Jeer to Steven Sternberg of USA Today for failing to disclose that Ethel Siris, a professor of clinical medicine at Columbia University and president of the National Osteoporosis Foundation, served as a consultant and speaker for several drug companies, including Merck. In the story, Siris downplayed the findings of a new study published in Archives of Internal Medicine that linked the Merck osteoporosis drug, Fosamax, with increased risk of heart conditions in women. Sternberg also failed to note that the foundation has received donations from Merck.
  • Cheer to Elizabeth Williamson of the Wall Street Journal for her article and on-line video detailing the farming industry’s efforts to undermine the Pew Commission on Industrial Farm Animal Production, which released a report calling for more regulation of industrial farming. Williamson’s article described the industry influence on commercial farming and food safety policy, as well as agriculture research done at universities and land grant colleges.