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June 16, 2008

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Integrity in Science Watch

Week of 06/16/2008

NCCN Expands Disclosure Policy after CSPI Protest

The Center for Medicare and Medicaid Services (CMS) earlier this month added the National Comprehensive Cancer Network (NCCN) Compendium to its roster of drug reference guides that oncologists may use to claim reimbursement for the off-label use of anti-cancer drugs. CMS’ approval came just one day after NCCN promised to expand its flawed conflict-of-interest disclosure policy. NCCN pledged that starting in July it will disclose the individual financial ties to drug companies of the oncologists who write its clinical practice guidelines. The change in policy came one week after the Center for Science in the Public Interest asked CMS to deny NCCN’s request because its guidelines’ disclosure statements failed to list which guideline writers received industry cash (see Integrity in Science Watch, June 2). NCCN currently lists the companies that gave money to any of members of its guideline-writing committees, but not the names of the committee members themselves. “Historically, the NCCN has disclosed the names of companies with whom there are relationships,” said Dr. William McGivney, CEO of the NCCN said in a press release. “We now will apply that to individuals so that the public may better use the scientific, evaluative information that we provide.

Harvard Shrinks Shrank from Disclosing Consulting Fees

A group of leading Harvard researchers failed to tell their university about millions of dollars in consulting fees collected from drug companies, according to an investigation by Sen. Charles Grassley (R-IA). Child psychiatrist Joseph Biederman underreported at least $1.6 million received from drug companies between 2000 and 2007, as did his colleague Timothy E. Wilens. Another Harvard researcher, Thomas Spencer, reported earning at least $1 million after being pressed by congressional investigators. Their research, some of which was funded by federal grants administrated by Massachusetts General Hospital, supported controversial use of antipsychotic drugs in youths with bipolar disorder, a mental disease once considered limited to adults.

The financial relationship between the researchers and drug companies violated both federal and Harvard policies governing conflict-of-interest disclosure. For example, the National Institutes of Health requires researchers to disclose consulting fees over $10,000 from drug manufacturers if the researchers are studying those companies’ products in a federally-financed clinical trial. According to Eli Lilly, Biederman in 2000 accepted more than $10,000 from the company while conducting NIH-funded clinical trials in children using Strattera, Eli Lilly’s attention deficit disorder medication. Biederman told Harvard that he received less than $10,000 from the company that year. While universities ask professors to self-report conflicts of interest, they rarely verify the accuracy of the disclosures. Grassley uncovered the discrepancy by comparing the university’s financial disclosure forms to the pharmaceutical companies’ lists of payments to the researchers between the years 2000 to 2007.

Grassley said these discrepancies demonstrate profound flaws in the oversight of researchers’ financial conflicts and the need for a national registry, which he has proposed as part of the Physician Payments Sunshine Act currently before the Senate. However, a number of the payments to the Harvard physicians would not have been covered by the proposed law because they were funneled through private firms that sponsor continuing medical education seminars.

Tough EU Chemical Regulation Could Have Global Impact

Strict new laws passed by the European Union could have a significant impact on the U.S. chemical industry’s manufacturing practices, the Washington Post reported. The regulations, which are in sharp contrast to current weaker U.S. regulations, require industry to disclose any health risks associated with chemicals used in everyday products before they enter the market. In the U.S., regulators are responsible for showing that a chemical is harmful before taking a chemical off the market or restricting its use. Under the European scheme, known as REACH (Registration, Evaluation, Authorization and Restriction of Chemicals), the chemical industry will also be required to study possible risks from certain chemicals and make the results available to the public. Additionally, chemicals suspected of causing serious health problems will be placed on “substances of very high concern” list and will require EU permission before use by manufacturers.

The REACH laws, which will be phased in over the next ten years, have been fiercely opposed by the Bush administration and the U.S. chemical industry, which complains the regulations are burdensome, unnecessary, and will raise costs. However, if U.S. companies do not meet Europe’s new law, they will lose access to markets in 27 countries with over 500 million consumers. "This is going to compel companies to be more responsible for their products than they have ever been," Daryl Ditz, senior policy adviser at the Center for International Environmental Law, told the Post. "They'll have to know more about the chemicals they make, what their products are and where they go."

Most Med Schools’ Conflict of Interest Policies Get Failing Grade

A majority of medical schools across the country are failing to monitor money, drug samples, and gifts given to doctors and students by pharmaceutical companies, the American Medical Student Association (AMSA) reported earlier this month.  Out of 150 medical schools ranked by AMSA, only 21 scored a B or higher while 60 got a failing grade. AMSA, which represents more than 68,000 students, interns, residents, and physicians, spent six months evaluating colleges’ conflict-of-interest policies and industry interaction guidelines with the Boston-based Prescription Project before announcing their rankings. The top-rated schools included Mount Sinai School of Medicine in New York and the University of California medical schools in Los Angeles, Davis, and San Francisco. “By eliminating the gifts and the misleading information that pharma reps currently bring into our schools, hospitals, and academic medical centers, physicians will be able to better practice evidence-based medicine. And that translates into better care for our patients,” said Brian Hurley, president of AMSA. In response to the AMSA assessment, several schools have submitted updated conflict-of-interest policy for review.

FDA Panel Issues Several Conflict of Interest Waivers

The Food and Drug Administration issued conflict of interest waivers for three members of the Ophthalmic Devices Panel for its meeting last week. On June 10, the panel reviewed several contact lenses and contact lens care products. Donald G. Ahearn, an emeritus professor at Georgia State University, received a waiver after receiving more than $100,000 from a manufacturer of contact lens products for work as a speaker and consultant. Timothy McMahon, professor of ophthalmology at the University of Illinois at Chicago, received a waiver because he also served as a consultant for contact lens manufacturer. Loretta B. Szczotka-Flynn, associate professor of ophthalmology at Case Western Reserve University, received a waiver because of a grant of less than  $100,000 from a contact lens manufacturer.

Odds and Ends

A congressional hearing held last week failed to reach a resolution on bisphenol A (BPA), a chemical used in plastics that has been linked to developmental problems. While the department of Health and Human Services’ National Toxicology Program has released a report linking BPA to health risks, an FDA panelist argued that based on current research there is no reason for consumers to stop using products with BPA. Some consumer groups and Democratic senators have pushed for a ban of the chemical in children’s products. . . .The University of Pittsburgh Medical Center is investing $20 million with General Electric to launch an imaging company named Omnyx LLC. The non-profit hospital is hoping the new imaging company will create a virtual microscope whose images can be stored electronically. . . . Chemicals offered as a substitute to the toxic chemical C8 used in manufacturing cookware, waterproof clothing, and grease-resistant food packaging, are similar to C8 and have their own deleterious effects on health, according to a new report by the Environmental Working Group (EWG). Within the report, EWG accused the government and industry of withholding information about C8 replacements by redacting scientific studies. C8 is a perfluorochemical (PFCs), which are persistent in the environment, toxic to aquatic life, cross the placenta to contaminate children before birth, lower fertility, lead to birth defects, and cause death, according to EWG.


"Rejuvenating Public Sector Science" is July 11, 2008

Don't Miss the Center for Science in the Public Interest's conference on Rejuvenating Public Sector Science, July 11, 2008 at the Ronald Reagan International Center in Washington, DC. The conference will throw a spotlight on the need for independent regulatory science and protecting public sector scientists from political meddling and corporate influence.
For more information and to register, call (202) 777-8348 or visit our website at http://cspinet.org/integrity/conflictedscience_conf.html.>

Also don't miss GAP's upcoming conference on The Emerging Era in Whistleblower Rights and the Public's Right to Know, June 23 at the AU Washington College of Law. For a full agenda and to register see http://www.whistleblower.org/template/page.cfm?page_id=213

Cheers and Jeers

  • Jeer to Edward J. Calabrese of the University of Massachusetts, Amherst for failing to disclose in numerous articles and letters, including a 2007 article in Toxicology and Applied Pharmacology, that Belle (Biological Effects of Low Level Exposures), which he runs, in 2007 received a $150,000 grant from ExxonMobil. Calabrese’s articles argue that low level exposure to some toxic chemicals may be beneficial. 

  • Cheerto Andrew Pollack of the New York Times for disclosing that Eric L. Matteson, chairman of rheumatology at the Mayo Clinic, has consulted for many companies developing arthritis medication. Matteson is author of a recent study examining the link between various arthritis medications and cancer.

  • Jeer to Audrey Grayson of ABC News’ Medical Unit for failing to note that Michael J. Manos, head of the Pediatric Behavioral Health Center at the Cleveland Clinic’s Children’s Hospital, consulted and served on the speakers’ bureaus of Eli Lilly, McNeil Consumer and Specialty Pharmaceuticals, and Shire US. Manos was quoted supporting use of pharmaceuticals to treat Attention Deficit and Hyperactivity Disorder rather than St. Johns Wort.

  • Cheer to Marilynn Marchione of the Associated Press for disclosing that Michael Gnat, a professor at the Medical University of Vienna, consults for Novartis, AstraZeneca, and other breast cancer drug makers. Earlier this month, Gnat announced results of his recent study showing Novartis’ bone drug, Zometa, can slow the spread of breast cancer.