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May 19, 2008

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Integrity in Science Watch

Week of 05/19/2008

After Negative AHRQ Review: Medicare May OK Drug Guide with Non-Disclosure Disclosures

Medicare is nearing approval of three additional drug compendia that can be used to justify reimbursement for the off-label use of anti-cancer drugs, including one that clearly violates the agency’s guidelines on conflict-of-interest disclosure. The National Comprehensive Cancer Network’s Drugs and Biologics Compendium, drawn from its trademarked Clinical Practice Guidelines, fails to disclose the corporate ties of the 20 to 24 experts who sit on each of its 44 guideline-writing panels. Instead, it lists all the companies which gave money or research support to any of the committee members without reference to any specific member or the amount given. In 2006, the Medicare Evidence Development and Coverage Advisory Committee recommended that any new compendia approved by the Center for Medicare and Medicaid Services carry public identification of “potential conflicts of interest of the compendia’s parent and sibling organizations, reviewers, and committee members.”

The NCCN Clinical Practice Guidelines and Compendium, published by a consortium of 21 of the nation’s leading cancer treatment centers, follow the same non-disclosure disclosure policy as the American Society of Clinical Oncology, which holds its high-profile annual meeting in Chicago starting May 30. Companies financially involved with any of the researchers behind any of the hundreds of studies released at the meeting are listed on the disclosure form. But the disclosure does not reveal which company gave money to which researcher or how much.

In addition to the NCCN drug registry, CMS early next month may approve Elsevier’s Clinical Pharmacology and Thomson Healthcare’s DrugDex and its companion DrugPoints. The Elsevier publication relies on in-house scientist-writers who are prohibited from accepting any “gifts or benefits” from the drug industry. Thomson uses outside experts supervised by its Oncology Advisory Board, many of whom have ties to industry that are disclosed on the company’s website. For instance, Thomas Marsland, a Florida community oncologist who chairs the advisory board, reports owning stock in Genentech, maker of the anti-cancer drug Avastin.

But the NCCN website does not disclose that Robert J. Motzer, an investigator at Memorial Sloan-Kettering Cancer Center in New York who chairs the NCCN kidney cancer guideline writing committee (registration required), receives research support from Genentech. The NCCN Compendium listing for Avastin (generic name: bevacizumab) was recently updated to include its use in slowing tumor progression in kidney cancer. The Food and Drug Administration has not approved it for that indication and it has not been shown to prolong life. Avastin, which blocks blood vessel formation, can cost as much as $8,800 a month.

All three compendia received a scathing review from the Agency for Healthcare Research and Quality’s technology assessment program, which analyzed the compendia's reviews of 14 on- and off-label indications for commonly used anti-cancer drugs. An estimated 60 percent of anti-cancer drugs are used off-label. "Compendia claim to use evidence-based methods in their evaluation of therapeutic agents, (but) cited literature was often neither the most recent nor the most valid in terms of study design," the reviewers noted. DrugDex was more likely than the others to list off-label indications, while the NCCN compendium was scored for failing to discuss adverse effects.

NCCN, a free-standing non-profit created by prestigious medical centers like Sloan-Kettering, M.D. Anderson Cancer Center in Houston, and the Fred Hutchinson Cancer Research Center in Seattle, acknowledged “support from many companies.” It had a $15.5 million budget in 2005. It lists 25 drug company supporters on its website, but not the amounts given.

The drug industry’s financial role in NCCN's program drew a heated response from Thomas Kaye, senior pharmacy director at Passport Health Plan, which serves 155,000 Medicare and Medicaid beneficiaries in Kentucky. “There’s an inherent bias in an organization that gets the majority of its funding from pharma,” the Louisville-based pharmacist said. “Negative things do not get published. We deal a lot with access to care issues, and when we have limited dollars, we want to make sure we’re providing the most value for what we have. I would not like to see NCCN become an official compendium because of possible bias.”

The consulting firm IMS Health projects global sales of anti-cancer drugs will grow at an annual rate of 12 to 15 percent to $75 to $80 billion by 2012. A number of recent news stories have focused on cancer patients who are having problems affording the co-pays on their increasingly pricey chemotherapy regimens. NCCN CEO William McGivney was traveling last week and unavailable for comment.

FDA Commissioner Finally Asks for More Money

The Food and Drug Administration commissioner Andrew C. von Eschenbach wrote Congress last week urging an immediate $275 million to beef up its saftey monitoring of imported foods, drugs and medical devices. Von Eschenbach asked for an immediate $125 million to finance food safety, $100 million for medical product and drug safety activities, $40 million for modernizing FDA’s work force, and $10 million to upgrade the agency’s facilities. The letter marked a sharp departure for von Eschenbach, a presidential appointee who previously supported President Bush’s budget request for the agency. The White House asked for a budget bump of $50.7 million, which does not cover projected salary increases. Two weeks ago, Eschenbach told Congress the FDA couldn’t absorb a $375 million addition in its budget.

Do Endangered Species Have a Chance?

The House Natural Resources Committee holds a hearing this Wednesday on the politicization of the Endangered Species Act entitled “The Danger of Deception: Do Endangered Species Have a Chance?” The hearing features the testimony of activists and scientists who continue to experience obstacles to obtaining science-based protections for endangered species. Conservationists contend that despite the removal of the Interior Department’s Julie MacDonald last year following allegations that she altered the decisions of scientists, agency officials continue to block protections for endangered species. Scott Black, a scientist with the Xerces Society, which seeks to protect invertebrates, notes that biologists within the agency are working to get species listed but are encountering resistance. “Decisions are not being made from a scientific perspective,” said Black. “Science teams are coming up with decisions and those decisions are then summarily watered down or reversed.” Others testifying at the upcoming hearing include the Government Accountability Office, which the FWS recently asked to review the eight endangered species decisions that the agency determined had been influenced by MacDonald; Jerry Franklin, a spotted owl scientist who was involved in the Clinton-era plan to recover the owl and who has been critical of the plan’s recent update; and Francesca Grifo of the Union of Concerned Scientists, which has documented longstanding “manipulation and distortion of scientific information at the Interior Department.”

Genetically-Engineered Embryo Sparks Unease

Cornell University researchers have genetically engineered an embryo, sparking fears that “designer babies” are just around the corner. The scientists inserted a gene for a fluorescent protein into the single-celled human embryo to see if the embryo’s daughter cells would contain the fluorescent protein gene. Three days later, all of the resulting cells in the embryo glowed. Zev Rosenwaks, director of Cornell’s Center for Reproductive Medicine and Infertility and one of researchers involved in the study, said the embryo was never meant to be viable. However, critics attacked the work as a dangerous step that has not been appropriately vetted by the public. “It’s an important ethical boundary that scientists have been observing,” Marcy Darnovsky, associate director of the Center for Genetics and Society, a watchdog group in Oakland, told the New York Times. “These scientists, on their own, decided to step over that boundary with no public discussion.” The study, which was originally presented last fall at an American Society for Reproductive Medicine meeting, came to light last week in the London’s Sunday Times.

Odds and Ends

The Fish and Wildlife Service finally listed the polar bear as an endangered species due to global warming. Critics charged the delay was politically motivated. . . . Senate investigators want EPA administrator Stephen Johnson to explain why Chicago region chief Mary Gade was forced out of her job after telling Dow Chemical to clean up dioxin-contaminated sites near the company’s Michigan plant. . . . Universities and physical science researchers failed to convince the House of Representatives to beef up funding for the National Science Foundation and the Department of Energy’s Office of Science. Plans for playoffs at the Energy Department’s national labs are proceeding. . . . The Heartland Institute, a Chicago-based think tank that receives funding from ExxonMobil, sent thousands of brochures and DVDs to schools in Canada, urging lesson plans questioning human’s impact on climate change, according to the National Post. . . . Hwang Woo-suk, the South Korean stem cell scientist who falsified data on human embryo cloning in 2004, has started a firm that specializes in cloning pets. . . . Washington Gov. Chris Gregoire’s controversial pick of a former Dow Chemical scientist for a state panel tracking pesticide exposures has resigned, but the governor is sticking by her decision not to reappoint toxicologist Steve Gilbert, a board member with the anti-pesticide Washington Toxics Coalition. . . . David Michaels, a former Energy Department official now at George Washington University, told a Senate panel investigating agency and business meddling in the EPA’s risk assessment process: “We would never allow the EPA, in secret, to delay military activities. Why should we permit a system in which DOD, in secret, has the ability to block EPA efforts to protect human health and the environment?”

Cheers and Jeers

  • Jeer to Liz Szabo of USA Today for failing to disclose the numerous conflicts of interests of authors of a recent study boasting the effectiveness of ultrasounds in detecting breast cancer. Nine of 16 authors of the study published in the Journal of American Medical Association disclosed financial relationships with companies that manufacture ultrasound machines, including MediPattern, Siemens, Hologic, and General Electric
  • Cheer to Carla Johnson of the Associated Press for noting that some authors of a recent study claiming Aleve and Celebrex can slow mental decline in the elderly received consulting fees from Pfizer, the maker of Celebrex. The research article, published online in the Archives of Neurology, included a full list of conflicts of interest of its authors.
  • Jeer to Jad Mouawad of the New York Times for failing to disclose that the Energy Policy Research Foundation (EPRINC) is funded by over 30 oil companies. Mouawad quoted an economist from EPRINC in a story detailing the impact of decreasing public consumption of gas due to hike in prices.
  • Jeer to Dick Armey and the Washington Times for failing to disclose in an op-ed touting a new alcohol content labeling rule that could give distilled liquors a marketing edge over beer and wine that Armey’s law firm, DLA Piper, is a registered lobbyist for Diageo, a major importer of distilled spirits.