Integrity in Science Watch|
Week of 02/23/2009
Biotech Cos. Thwart GM Crop Research, Scientists Say
Over two dozen university crop scientists told the Environmental Protection Agency that research controls demanded by companies that sell genetically-modified crops are hampering their ability to investigate crop safety and yields, the New York Times reported. The complaint was included in public comments for an EPA scientific advisory panel that meets this week to consider the environmental impact of insect-resistant biotech crops.
Unlike regular seeds, which can be commercially purchased for research purposes, biotech crops are patented and companies maintain strict controls over their use. The scientists said company demands range from reviewing research findings before publication to an outright ban on using GM seeds for research purposes. "If a company can control the research that appears in the public domain, they can reduce the potential negatives that can come out of any research," Ken Ostlie, an entomologist at the University of Minnesota, told the Times.
The statement to the EPA was sent anonymously, although a number of signers agreed to be interviewed by the paper. "People are afraid of being blacklisted," said Elson J. Shields, an entomologist at Cornell University. An official at DuPont, which owns Pioneer Hi-Bred, offered to discuss the issue, which he said arose out of concerns for protecting intellectual property and meeting government regulations. An EPA spokesman told the Times that the government only required management of the crops' insect resistance, and other research controls were company imposed.
NIH, NSF Win Big in Stimulus Plan
The $787 billion stimulus package signed into law last week contained an additional $21.5 billion for government-funded research and development, with the National Institutes of Health's $10.4 billion increase accounting for nearly half the total, according to an analysis by the American Association for the Advancement of Science. The NIH increase, pushed by Sen. Arlen Specter (R-PA), boosted the agency's 2009 budget to $40 billion, a one-third jump.
The National Scientific Foundation also received a sharp increase, receiving $3 billion or nearly a 50 percent increase in its current budget. The Department of Energy's energy programs will receive $3.5 billion for renewable energy, energy conservation and fossil fuel energy research. And the National Aeronautics and Space Administration (NASA) will receive an additional $1 billion for climate change-related satellite missions on top of its regular $17.8 billion budget.
In what turned out to be one of the more controversial elements in the bill, the legislation allocated $1.1 billion for comparative effectiveness research, which compares the relative medical value of competing technologies and treatment approaches. Industry groups led by the pharmaceutical and medical device manufacturers sought language that would limit the research to clinical comparisons and not allow cost comparisons to determine "bang-for-the-buck" from competing and comparable technologies. That wording was removed "without prejudice" in the final bill. An intergovernmental panel will determine research priorities and the Institute of Medicine was granted $1.5 million to draw up a list of potential projects by June. The Center for Science in the Public Interest will push to include public health approaches to preventing disease.
Duke Docs Call for Registering Overseas Clinical Trials
Given the growing number of clinical trials conducted outside the U.S., industry and academic sponsors of clinical research should be required to provide the Food and Drug Administration and international regulators with publicly available copies of their formal research plans and show that study sites are distributed roughly where companies plan to market the drug after approval, a "Sounding Board" survey published last week in the New England Journal of Medicine suggested. The researchers found that since 2002 the number of FDA-regulated investigators outside the U.S. grew 15 percent annually while the overall number of such investigators in the U.S. declined by 5.5 percent since 2002.
While the U.S. still leads the world in clinical trials, a snapshot of 509 industry-sponsored trials underway in November 2007 aimed at eventual FDA approval found that about one-third were being conducted entirely abroad, and that a majority of clinical trial sites are now outside the U.S. The primary driver is costs, with a single case report costing just $1,500 to $2,000 at a first-rate medical center in India compared to ten times that much as a second-tier center in the U.S. To lower costs in the U.S., the Duke University Medical School-affiliated authors suggested streamlining and centralizing the institutional review board (IRB) process for approving clinical trial, and creating an international public registry of all clinical trial sites. The authors also called for a centralized statistical monitoring system "to find unusual data patterns in trial results that raise suspicion of fraud."
The report did not suggest that the U.S. rejoin the Helsinki Declaration for protection of human subjects in clinical trials, which it left last year. Under a midnight Bush administration guidance issued by the FDA, the agency will now accept data from clinical trials conducted abroad without prior registration of those trials as long as the trial sites meet "good clinical practice" guidelines.
EPA Wanted Tougher C8 Limits
An internal briefing paper from the Environmental Protection Agency suggests that the agency's scientists originally sought a much tougher standard for the toxic chemical C8 than was included in a nationwide health advisory issued last month, the Charleston Gazette reported last week. More than three years ago, EPA staffers proposed that the agency rewrite a deal with DuPont, the maker of the chemical, to mandate a C8 limit of 0.2 parts per billion, according to the internal document. EPA senior toxicologist Christopher Weiss later explained that animal studies demonstrated C8's "potential for developmental toxicology, including mortality" justified the 0.2 parts per billion limit. This recommendation was changed, however, to 0.5 ppb limit as "the result of a calculation error," EPA regional drinking water chief Karen Johnson said. In early January, the EPA revised the limit again to 0.4 ppb.
FDA Admits Lilly Questioned Adviser's Role on Committee
The Food and Drug Administration has confirmed that Eli Lilly officials called the agency to question the inclusion of a prominent safety expert on an advisory panel considering the new anti-coagulation drug pasugrel for acute coronary syndrome, which is jointly manufactured by Lilly and Daiichi Sankyo, according to heartwire. The admission came after Public Citizen questioned the removal of Sanjay Kaul, a Los Angeles cardiologist at Cedars-Sinai Heart Institute, from the Feb. 3 FDA Cardiovascular and Renal Drugs advisory committee meeting, which voted overwhelmingly in favor of approving prasugrel. Kaul, a regular member of the committee, had raised questions about the drug at a prior scientific meeting. The committee voted overwhelmingly in favor of the drug despite safety and cancer concerns raised by Public Citizen and Kaul. Kaul's removal "significantly limited critical discussion of the safety of this drug," the group wrote last week to Janet Woodcock, head of the Center for Drug Evaluation and Research.
Odds and Ends
Environmental Protection Agency Administrator Lisa Jackson will review a memo issued by her predecessor Stephen Johnson that said greenhouse gas emissions could not be considered in federal decisions to authorize new coal-fired power plants. The Sierra Club had petitioned EPA to reconsider the earlier policy. ... The conservationist group Wild Earth Guardians called for abolishing the federal government's Wildlife Services program, calling the program's approach to wildlife management "biologically unsound." ... Rep. Henry Waxman (D-CA), chair of the House Energy and Commerce committee, and Rep. Bart Stupak (D-MI), chair of the subcommittee on oversight and investigations, are continuing an investigation into the safety and effectiveness of Vytorin, a prescription drug manufactured jointly by Schering-Plough and Merck. In a letter last week to Schering-Plough CEO Fred Hassan and Merck CEO Richard Clark, the congressmen requested information about the decisions by the Data Safety Monitoring Boards to "unblind" the interim data from the SHARP and IMPROVE-IT trials.
Cheers and JeersJeer to Gina Kolata of the New York Times for failing to disclose that a study on bone drugs used to fight breast cancer was sponsored by AstraZeneca and Novartis, and that the quoted lead author, Michael Gnant of the Medical University of Vienna, consults for those as well as many other pharmaceutical firms. The article cited a study published (subscription required) in the New England Journal of Medicine concluding that "the addition of zoledronic acid to adjuvant endocrine therapy improves disease-free survival in premenopausal patients with estrogen-responsive early breast cancer." Novartis makes the zoledronic acid drug. AstraZeneca makes the breast cancer drugs goserelin and anastrozole, which were used in the study.
Jeer to Virginia Postrel and Atlantic Magazine for failing to disclose in an article entitled "My Drug Problem" that oncologist John Glaspy of the University of California, Los Angeles, who was quoted saying physicians were "guessing" when they gave a shorter course of Genentech's Herceptin (trasutuzumab) for post-breast cancer adjuvant therapy with Herceptin (trastuzumab), receives research support from Roche, owner of Genentech, as well as Amgen and Johnson & Johnson. Studies appearing in the New England Journal of Medicine have shown both a nine-week course and a one-year course of therapy to be similarly effective in reducing the risk of breast cancer recurrence.
Last week, Integrity in Science Watch published an article on a District of Columbia water study that suggested the editors of Environmental Health Perspectives had reached a conclusion on whether the study's author, Tee Guidotti of George Washington University, had agreed to publication controls over his research. It should have stated that EHP editor "Hugh Tilson asserts that if the allegations are proven, the agreement [between Guidotti and DC Water and Sewer Authority] is a violation of the journal's policy on competing interests." Neither Tilson nor the journal's advisory board have made any conclusions regarding these allegations. We apologize for the error.