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March 17, 2008

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Integrity in Science Watch

Week of 03/17/2008

Cancer Letter: Researcher Failed to Disclose Patent during CME

In the wake of allegations that a prominent lung cancer researcher failed to disclose a patent licensed to General Electric on interpreting CT scans in an article that claimed early CT scanning could substantially reduce lung cancer mortality, the New England Journal of Medicine last month ruled the patents “not relevant” to the subject of the article and refused to print a correction. Now, a follow-up investigation by the Cancer Letter (subscription required), an industry newsletter, uncovered numerous instances when Weill Medical College researcher Claudia Henschke failed to disclose the patents in a series of continuing medical education (CME) seminars, including one held by the Radiological Society of North America (RSNA) a month after the article appeared in October 2006. The NEJM article could also be read for CME credit.

The Accreditation Council for Continuing Medical Education in 2005 adopted strict rules for disclosing granted and pending patents held by any presenter at a CME activity. “Royalties by themselves establish the financial relationship of the person with a commercial interest and create the potential for conflict of interest. Therefore, the relationship is relevant in CME,” Murray Kopelow, the chief executive of ACCME, told the Cancer Letter. The Center for Science in the Public Interest later this week will ask the ACCME to order all the CME providers where Henschke failed to disclose to send proper disclosures to anyone who participated in those activities. And Sen. Charles Grassley (R-IA) said he plans to launch a Congressional inquiry in physician patenting activity. “It’s becoming clear that patents and royal payments to doctors deserve a lot more scrutiny from Congress, the FDA, professional journals and other watchdogs,” Grassley said.

Need for Independent Drug Info Detailed

Legislation that would send government-funded educators into doctors’ offices with independent information about prescription drugs received a boost last week at a Senate Committee on Aging hearing. “Pharmaceutical sales reps (known as detailers) are currently one of the only ways doctors can learn about the latest drugs on the market,” said Sen. Herb Kohl (D-WI). “These sales reps often confuse educating with selling, and evidence shows that doctors’ prescribing patterns can be heavily influenced by the biased information often put forth by these sales representatives.” Experimental programs that send scientific professionals with clinical training into physicians’ office to provide them with objective, unbiased information – sometimes known as academic detailing – are now underway in five states and the District of Columbia. Kohl and Sen. Dick Durbin (D-IL) will introduce legislation that would create a federal academic detailing program later this spring.

The program is a potential money saver for the federal government, which added a senior citizen drug benefit to Medicare in 2003 and spent an estimated $47 billion on the program last year. Pennsylvania’s academic detailing program reduced the total cost of patient prescription by $60 per physician in the six months after an academic detailer’s visit, according to Nora Dowd Eisenhower, head of the state’s Department of Aging. Jerry Avorn of Harvard Medical School told the committee that an experimental academic detailing program that reached 400 doctors in four states saved $2 for every $1 in costs. “Research has shown that when doctors have full access to comprehensive and unbiased data on all the drugs available, they prescribe the best drug--not just the newest one--and healthcare spending is lowered,” said Kohl. The pharmaceutical industry spends an estimated $7 billion a year on direct-to-physician marketing, employing over 80,000 detailers to reach the nation’s 700,000 practicing physicians. A drug industry group, the Coalition for Healthcare Communication (CHC), responded to the hearing by saying that while it does not oppose Sen. Kohl’s proposal, it does question whether the government should have a role in drug promotion. “The First Amendment provides everyone with a right to speak, including Uncle Sam,” said John Kamp, executive director of CHC. “But I question whether the federal government needs to be in the business of countering pharmaceutical sales.”

EPA to Post Coal Wastes Analysis

The Environmental Protection Agency has promised to post its draft risk assessment for the health and environmental risks of coal combustion wastes after an environmental group charged the agency was violating government rules for conducting peer review of scientific documents. EPA and OMB guidelines require public posting of documents up for peer review. As of late last week, however, the “Human Health and Ecological Risk Assessment of Coal Combustion Wastes” had not been posted on the agency’s website, nor was there any plan for allowing public comment, according to Earth Justice. “These guidelines are in place to maximize the potential for public participation,” said Lisa Evans, an attorney with the group. “When the agency violates its own rules, that participation is in danger.” The draft risk assessment considers the health and environmental risks of coal combustion wastes, which are often left in open landfills and have been found to leach arsenic, selenium, and other heavy metals. An EPA spokesman said the omission was an oversight, and the website will be updated shortly.

Consulting Firm Delayed Removal of Harmful Drug for Years

An ongoing congressional investigation into a D.C.-based scientific consulting firm found it boasted to potential clients that it had delayed removal of a dangerous drug from the market for 10 years, ABC News revealed last week. The House Energy and Commerce Committee, which launched an investigation into the Weinberg Group last month, accused the firm of generating false uncertainty about scientific research that cast a negative light on their clients’ products. After showing deleted pages from the Weinberg Group's website boasting about its work for two pharmaceutical clients, the committee demanded the firm hand over documents naming the drug, the drug manufacturer and the experts used to prevent the drug’s ban. The group has also been accused of working to cast doubt on research linking a brand name hair dye to cancer and the impact of chlorofluorocarbons on the ozone layer. More recently, it has come to the aid of the chemical industry in downplaying the dangers of Bisphenol A, a chemical found in many plastic bottles and shown in some studies to harmful to public health.

Yellowstone Bison Management under Fire

Retired Yellowstone National Park backcountry ranger Bob Jackson recently accused Park administrators of succumbing to political pressures and overriding science in their approach to bison management. Since the mid-1980s Yellowstone has culled bison within the park in response to political pressures from ranching interests concerned about brucellosis transmission to livestock. Jackson said that Yellowstone's administrators have ignored scientific research that downplays the risk. A spokesman for Yellowstone said that the bison management plan used by the park was informed by extensive scientific research.

Odds and Ends

The Environmental Protection Agency last week recommended 60 to 70 parts per billion. Administrator Stephen L. Johnson also said he would push for a rewrite of the Clean Air Act to allow for a balancing of economic costs with health benefits of restricting air pollutants, which is currently prohibited by the law. The House Committee on Oversight and Government Reform, chaired by Henry Waxman (D-CA) has announced that it will hold a hearing on the role of the White House in setting the ozone air quality standards. . . .The Centers for Disease Control and Prevention asked the Institute of Medicine to review an internal study editorial in Nature magazine this month says that the Environmental Protection Agency has lost its credibility, and accuses administrator Stephen Johnson of sabotaging the agency. The editorial says that Johnson has protected business interests rather than the environment, and “has done so with reckless disregard for law, science or the agency’s own rules — or, it seems, the anguished protests of his own subordinates.” The editorial refers to the agency’s denial of California’s Clean Air Act waiver and complaints by EPA unions that Johnson has repeatedly ignored the agency’s own Principles of Scientific Integrity. . . . CSPI last week joined a coalition of public interest groups led by Government Accountability Project in sending a letter to Congressmen in support of H.R. 4047, the Private Sector Whistleblower Protection Streamlining Act of 2007. The bill would provide protection to non-Federal employees who speak out about threats to public safety or violations of the law, specifically with regard to drug safety. The bill’s sponsor is Representative Lyn Woolsey (D-CA).

Cheers and Jeers

  • Cheer to Andrew Pollack of the New York Times for disclosing that Pramod Mistry, a professor of internal medicine at Yale University, receives research funding from Genzyme, the manufacturer of Cerezyme. Mistry was quoted in article discussing the high cost of Cerezyme, which is used to treat Gaucher disease and costs per patient more than $300,000 a year.
  • Jeer to Julie Steenhuysen of Reuters for failing to note that Paul Goss, director of breast cancer research at Massachusetts General Hospital, worked as a consultant for GlaxoSmithKline, Novartis, Pfizer, Schering, AstraZeneca, Eli Lilly, and Ortho Biotech. The article described Goss’s study on the long-term benefits of Novartis’s breast cancer pill Femara.