Integrity in Science Watch|
Week of 06/02/2008
Exxon Announces Cutoff for Warming Skeptics – Again
ExxonMobil last week announced for the second consecutive year that it will cut funding to nine groups fueling climate science skepticism, including the Capital Research Center, Committee for a Constructive Tomorrow, Frontiers of Freedom Institute, the George C. Marshall Institute, and the Institute for Energy Research. Each group continued to receive Exxon funding in 2007 after the company’s first announcement that it would discontinue the payments. Exxon did not immediately return calls seeking comment on how serious it was in following through on its plans.
The renewed promise to cut financial aid to skeptic groups preceded a shareholder meeting where activist shareholders offered several green resolutions, including ones that would have stripped CEO Rex Tillerson of his chairmanship, pushed the company toward greater investment in alternative energies, and committed the company to firm greenhouse gas reduction targets. The resolutions, proposed by descendants of Exxon founder John D. Rockefeller, were all rejected by shareholders.
Meanwhile, the government’s Climate Change Science Program last week released its long-awaited report on the impacts of climate change in the U.S. A federal court ordered “Effects of Climate Change on Agriculture, Land Resources, Water Resources, and Biodiversity” after environmental groups sued the Bush Administration over suppression of information on climate change. The report predicted extensive drought, food shortages, and reduced biodiversity throughout the U.S. These findings have “been well-understood in the science community and in the government for some time,” said Rick Piltz, Director of the Government Accountability Project’s Climate Science Watch program.
Study: Health Journalists Get F in Reporting
HealthNewsReview.org monitors the top 50 most widely-circulated newspapers in U.S., the Associated Press, TIME, Newsweek, and U.S. News & World Report, as well as the morning and evening news broadcasts of ABC, NBC and CBS. Stories are evaluated by 10 criteria including whether the journalists appropriately describe the benefits of intervention, judge the supporting evidence critically, and provide conflict-of-interest information about the sources in the story. Schwitzer did note that when reporters were approached with feedback, most were receptive but were limited by a lack of time to research, space in the publications, and scientific training. “We think that our project’s findings should be cause for reflection by all parties involved in the dissemination of news and information to journalists covering health and medicine—including medical journals, government agencies, industry, academic medical centers, and individual clinicians and researchers,” Schwitzer wrote.
A new study published in PLOS Medicine criticized the media’s coverage of health stories as potentially dangerous to consumers and offered suggestions on how the press could improve its reporting. Gary Schwitzer, the paper’s author and a University of Minnesota journalism professor, collected and analyzed two years' worth of data from his website, HealthNewsReview.org, which evaluates health news stories and provides journalists with feedback. Out of more than 500 stories evaluated, 62 percent to 77 percent failed to adequately address costs, harms, benefits, the quality of evidence and the existence of other options when covering health care products and procedures, according to the paper.
Private Food Safety Labs Hide Negative Tests
Some private U.S. laboratories are under investigation by the House Committee on Energy and Commerce for withholding samples of tainted food and allowing importers to continue to bring their contaminated products into the U.S., the Chicago Tribune reported last week. A letter by the Congressional committee to the labs suggests that importing companies pressured them to toss out results that failed Food and Drug Administration standards. “We're gathering information from both the FDA and private industry about the labs almost being complicit in helping importers game the system,” investigations subcommittee chairman Bart Stupak (D-MI) told the Tribune. “Someone told us you pay for the result you want to get from the labs."
Earlier this year, CEO David Eisenberg of Anresco Laboratories, a private lab that tests imported food, told the subcommittee that private labs sometimes withhold negative test results. "If the importer tells us not to submit the information to the FDA, the FDA never sees it," Eisenberg testified. "We are not employed by the FDA, and the FDA has no authority over private labs that are generating imported-food test results, so we have to follow the advice of our customer." The Center for Science in the Public Interest is supporting a bill currently in the House of Representative that urges increased government regulation of food safety testing. The bill allows the FDA to give third-party certification to private labs only if they uphold FDA standards for testing.
Medtronic Settlement Provides Strong Whistleblower Protections
Potential whistleblowers at Medtronic Spine LLC will be granted broad protections as part of the company’s $75 million settlement with the Justice Department for defrauding Medicare. The settlement was announced earlier this month. The settlement required Medtronic to enter a Corporate Integrity Agreement (CIA) with the Department of Health and Human Services' Office of the Inspector General to ensure compliance with HHS regulations. In their CIA, Medtronic detailed a disclosure program that provides a toll-free compliance telephone line where potential whistleblowers can anonymously air their concerns with someone other than a direct supervisor. Compliance officers are required to begin inquiries in response to concerns and make a record of any corrective action. Non-retribution and non-retaliation were also emphasized in the disclosure program.
The government alleged that the Medtronic division, formerly known as Kyphon, submitted fraudulent claims for surgeries treating spine factures from osteoporosis, cancer or lesions. By convincing healthcare providers to perform the minimally invasive surgeries as an inpatient rather than outpatient procedure, the company successfully over-billed Medicare for years. The company’s fraud was revealed in 2005 by Craig Patrick and Chuck Bates, reimbursement manager and regional sales manager of Kyphon, respectively. Patrick left the company after his complaints about Kyphon’s actions went unheeded.
CSPI Protests Adding Sub-Standard Payment Guides at CMS
The Center for Science in the Public Interest has asked the Center for Medicare and Medicaid Services (CMS) to postpone adding three pharmaceutical compendia to its roster of drug reference guides that can be used to justify reimbursement for off-label use of anti-cancer drugs. Being listed in a compendium could greatly enhance sales of a drug. CMS last February received requests from the National Comprehensive Cancer Network Compendium, Elsevier’s Clinical Pharmacology, and Thomas Micromedex’ DrugPoints and DrugDex to be included on that roster. As reported two weeks ago in Integrity in Science Watch, the NCCN compendium fails to meet criteria established by a CMS advisory committee in March 2006 that drug reference guides have a publicly transparent process for evaluating therapies and identifying potential conflicts of interests. The letter also cited an Agency for Healthcare Quality and Research technology analysis that found that the three compendia failed to meet rigorous scientific standards when they added potential off-label uses to their drug listings.
Odds and Ends
At an international gathering of alcohol policy and public health researchers in Dublin two weeks ago, attendees decided that for the legitimacy and integrity of alcohol research, financial relationships with the alcohol industry should be avoided. The decision, called the Clarion Declaration, was adopted in response to fears that the industry was limiting and influencing alcohol research, the Alcohol, Drugs and Development program reported . . . . Low levels of lead exposure can lead to permanent brain damage and has been linked to violent crime arrest, according to the first study examining lead exposure from childhood to adulthood. The paper’s authors argued that lead continues to be problem despite by government efforts to minimize exposure . . . . Pfizer last week began an advertising and public relations campaign to counter concerns about the company anti-smoking drug, Chantix. The tobacco cessation medication, which has come under the scrutiny of Sen. Charles Grassley, has been linked to heart irregularities, seizures, dizziness, depression, and suicide.
Cheers and Jeers
- Jeers to Carla K. Johnson of the Associated Press for quoting Charles Reynolds, a psychiatrist at the University of Pittsburgh, without disclosing his financial relationships Forest Laboratories and GlaxoSmithKline, makers of antidepressants. In the article Reynolds encouraged doctors to prescribe preventive antidepressants to stroke patients.
- Cheers to Ed Silverman of Pharmalot for his article questioning two conflict-of-interest-waivers issued by the FDA to Gary Lyman and Maha Hussain for the agency’s meeting on Promacta, an experimental treatment for chronic Immune Thrombocytopenic Purpura (ITP). Promacta is manufactured by GSK and Ligand Pharmacueticals. Lyman earns less than $10,000 from a rival company while Hussain holds between $5,000 to 25,000 in stock in eight drug companies, including one of the drug companies sponsoring the meeting.
- Jeer to the Wall Street Journal for failing to disclose all potential conflicts of interest of Mark Thornton, author of an op-ed attacking Senator Charles Grassley’s (R-IA) request to the General Accountability Office to launch an inquiry into the FDA decision to grant accelerated approval for Genentech’s cancer drug, Avastin. Although the WSJ noted that Thorton is a former medical officer at the FDA’s Office of Oncology Products and president of the Sarcoma Foundation of America, the newspaper failed to disclose that Thornton is also the Senior VP of Clinical Development at GenVec and holds over $150,000 worth of the company’s stock. As noted by Pharmlot, GenVec is a small pharmaceutical company developing cancer medications.
- Jeer to Maia Szalavitz of MSN Health & Fitness for failing to disclose that Madhukar H. Trivedi, an associate professor of psychiatry at the University of Texas Southwestern, has received financial support from over a dozen pharmaceutical companies, including Bristol-Myers Squibb, Pfizer, Eli Lilly and GlaxoSmithKline. The article, which discussed the effectiveness of antidepressants, included a quote from Trivedi extolling of value of antidepressants.
With this issue, Integrity in Science Watch begins its bi-weekly summer schedule. The next issue will be posted online on June 16th.