Integrity in Science Watch|
Week of 09/04/2007
FDA Waives Three Conflicted Docs onto EPO Safety Panel
The Food and Drug Administration revealed late last week that three physicians participating in the September 11 advisory committee meeting that will evaluate the safety of red blood cell stimulating agents used in dialysis have financial conflicts of interest. A joint meeting of the Cardiovascular and Renal Drugs and Drug Safety advisory committees will review new clinical trial data that led the FDA last March to slap a black box warning on Amgen's Aranesp and Epogen and Johnson & Johnsonís Procrit, known collectively as EPO. The trials, reviewed in this Journal of the American Medical Association editorial, showed excessive EPO use increases the risk of heart attack, stroke and premature death.
After the FDA issued its warning, the Center for Medicare and Medicaid Services, which pays for most dialysis patients in the U.S., instituted a monitoring and payment policy that will cut EPO use. Amgen, whose stock price fell 25 percent since March, spent over $9 million on lobbyists in the first half of 2007 - nearly as much as it spent in all of 2006. The National Kidney Foundation's anemia management committee, the president of the Renal Physicians Association, and the American Association of Kidney Patients - which all have extensive financial ties to Amgen or J&J - have issued guidelines and lobbied for measures that could lead to EPO use at or above the maximum level suggested on the FDA label. A provision in the House version of the Children's Health Insurance Program bill would grant $300 million in incentive payments to dialysis clinics over the next three years if they maintained relatively high levels of EPO use. A provision in the House version of the Prescription Drug User Fee Act renewal would limit conflicts of interest to one per committee.
Voluntary Industry-Government Toxics Testing Program Falls Short
The chemical industry fell far short of its promise to produce data on the toxic properties of widely-used chemicals, a new report from Environmental Defense showed. The Environmental Protection Agency established the voluntary testing program in 1998 in collaboration with the American Chemistry Council and Environmental Defense. The idea was to generate voluntary data disclosure for regulatory actions under the federal Toxic Substances Control Act (TSCA) since the law limited the EPAís ability to demand hazards data to just 200 of the 80,000 chemicals on the TSCA inventory list. The industry's self-imposed deadline for producing toxics data for an additional 2,200 chemicals on the inventory was 2004. To date, industry has produced data for less than half that number. The U.S. lags far behind the regulatory toxics testing programs in the European Union and Canada.
Psychiatrists Lead Buck-raking Pack in Minnesota
Drug manufacturers paid Minnesota physicians over $73 million between 2002 and 2006 with psychiatrists receiving over 10 percent of the payouts, more than twice any other specialty, a new report shows. Minnesota requires drug companies disclose their payments to doctors, which often involves their speaking at sessions promoting the companies' drugs. An analysis of the latest data by the St. Paul Pioneer Press showed that disclosure has failed to stem the tide of industry grants. Psychiatrists, for instance, collected $2.1 million in 2006, a 50 percent jump over the year before. Eli Lilly, whose best-selling drug is the atypical anti-psychotic Zyprexa, led the pack among corporate donors with over $11 million in payouts over the five-year period. One psychiatrist, John Simon, who sits on the state's Medicaid formulary committee, received $570,000, most of that from Eli Lilly, according to the report. "Most of the psychiatrists who are really good have ties to industry," Simon told the paper.
NIH Director Charged with Bungling Schwartz Ethics Probe
Senator Chuck Grassley (R-IA) last week charged National Institutes of Health Director Elias Zerhouni with failing to investigate charges of misconduct by National Institute of Environmental Health Sciences director David Schwartz. Schwartz recently stepped down from the directorís post amid charges that he testified in asbestos cases while director; acquired government computers for his family's personal use; and inappropriately made staffing decisions involving Duke University, his former employer. Grassley's letter charged that the investigation conducted by the NIHís Office of Management Assessment has "missed and/or ignored" extensive evidence of misconduct uncovered by Grassleyís investigation, and accused Zerhouni of inadequate responsiveness to ongoing requests for information.
Meanwhile, Representative Henry Waxman (D-CA) told the head of the National Toxicology Program (NTP) at NIEHS that its internal study of conflicts of interest among contractors is invalid because it was based on the contractors' own self-assessments. "The working group's reliance on contractor reports is a questionable way to assess conflicts of interest," the letter charged. The internal review was prompted by revelations in March that NTP's review of the carcinogenic compound bisphenol A had been run by a consulting firm with financial ties to the company that makes the chemical.
Science Invoked to Justify Continued Whale Kills
Iceland's recent decision to suspended commercial whaling because of falling demand has not ended that nationís ongoing slaughter of endangered whales for "scientific research." The research whaling takes place under an exemption in the 1986 International Whaling Commission ban on commercial whaling. However, Iceland's whaling fleet intends to capture and kill the last 6 of the 200 whales allowed under the research exemption even though the meat is piling up in warehouses. Whaling, whether for research or commercial purposes, still exists to meet demand for the meat in Japan. But Japanese whale consumption has declined in recent years due to consumer fears about toxic chemicals building up at the top of the ocean food chain.
Odds and Ends
The Center for Biological Diversity said it will sue the Department of the Interior for systematically ignoring agency scientists while making 55 endangered species decisions under the leadership of Julie MacDonald, who resigned April 30 following an Inspector General report charging her with leaking sensitive documents to industry lobbyists, browbeating U.S. Fish and Wildlife scientists, and illegally overturning scientific recommendations in order to squelch protections for endangered species. . . A Dutch primatologist faces jail time in Brazil for keeping orphaned monkeys at his Amazonian sanctuary without the proper permits; scientists and activists speculate that his arrest was prompted by bribes from the timber and soy industries due to the scientist's outspoken efforts to protect the Amazon rainforest.
Cheers and Jeers
to the American Medical Student Association for offering the nationís 68,000 physicians-in-training a one-year free subscription to the non-profit Medical Letter to combat the "advertisements and sales representatives of the (drug) industry." The Medical Letter, published biweekly, provides drug reviews and prescribing recommendations that "are completely independent of the pharmaceutical industry."
to the Washington Post for exposing the infant formula industryís successful campaign to pressure the Health and Human Services Department to tone down ads promoting the health benefits of breast feeding. According to the report, Rep. Henry Waxman is investigating allegations that former Surgeon General Richard Carmona was blocked by political appointees at HHS, including a former drug industry lobbyist, from participating in the breast-feeding advocacy effort.
- Jeer: to WebMD and Reuters for failing to disclose that one of the authors of a new study linking throat cancer to human papilloma virus (HPV), which recommended vaccination for boys, had ties to a vaccine manufacturer. Paul Cinciripini of the University of Texas M.D. Anderson Cancer Center consults for GlaxoSmithKline, maker of the HPV vaccine Cervarix, which competes with Merckís Gardasil.