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March 31, 2008

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Integrity in Science Watch

Week of 03/31/2008

Lung Cancer Researcher Took Funds from Tobacco Company

Two prominent lung cancer researchers took several million dollars in financial support from tobacco giant Ligget & Myers and failed to report that conflict of interest when their controversial study appeared in the New England Journal of Medicine, the New York Times reported last week. Claudia Henschke and David Yankelevitz of Weill-Cornell Medical College in New York disclosed at the end of their 2006 research article promoting routine CT scans to detect early stage lung cancer that their study was funded in part by the Foundation for Lung Cancer: Early Detection, Prevention & Treatment. However the authors failed to disclose that the foundation received $3.6 million--nearly all of its funding--from Vector Group, the parent company of Ligget & Myers.

Henschke, Yankelevitz and other prominent officials from Weill-Cornell Medical College served on the foundation, with Henschke serving as president. The Vector Group issued a press release at the end of 2000 announcing the company's intention to give $2.4 million for Henschke's research. Her research ultimately produced a 2006 study that claimed giving smokers routine CT scans could prevent 80 percent of lung cancer deaths. "You have to ask yourself the question, 'Why did the tobacco company want to support her research?" Dr. Jerome Kassirer, a former editor of NEJM and author of "On the Take," told the Times. "They want to show that lung cancer is not so bad as everybody thinks because screening can save people; and that's outrageous."

The Cancer Letter previously reported that Henschke and Yankelevitz failed to disclose to NEJM, the Journal of the American Medical Association and other journals that they hold a patent licensed to General Electric on interpreting CT scans. Lasts week, JAMA published a corrected conflict of interest disclosure that included all previously unreported financial disclosures of Henschke and Yankelevitz. JAMA, which had published a 2006 study and a 2007 letter to the editor by the researchers, noted the authors' patent and patent applications were relevant and would have been published if they were known. Last month, the NEJM admitted that the journal's editors knew about the authors' conflicts of interest on the patent, but felt that they were not relevant to the study.

Group Demands Protection for 681 Species

WildEarth Guardians last week demanded that the U.S. Fish and Wildlife Service finalize Endangered Species Act listing decisions for nearly 700 species of rare or dwindling wildlife and plants in the western United States. The lawsuit challenges the agency's failure to issue findings in response to two petitions the group filed last summer. The 681 species named in the suit were selected from the Natureserve database, which compiles information on species status from a network of international biological inventories and which is used by the FWS to make listing decisions. "We need to elevate the pace on obtaining federal protection for our nation's wildlife and plants," said Nicole Rosmarino, the group's conservation director. "Too many species are slipping through the cracks as the extinction crisis escalates."

The Washington Post reported last week that the Bush Administration has made it substantially harder for species to obtain protection under the Endangered Species Act. FWS political appointees, according to the article, have changed the standards used to determine whether a species is in jeopardy and limited the sources of scientific data that can be used to make that determination. "One of the biggest threats facing species is the very agency that is supposed to be protecting them," said Rosmarino. A FWS spokeswoman attributed the slowdown in listings to extra work caused by lawsuits by conservation groups.

Industry Studies Informed FDA Finding on BPA

An investigation by the House Committee on Energy and Commerce has revealed that the Food and Drug Administration relied on two industry-funded studies to determine that the chemical bisphenol-A poses little risk to humans. The studies behind the FDA's ruling last November came from the Society of the Plastics Industry, a subsidiary of the American Chemistry Council. One of the studies had never been published nor peer reviewed. The other was based on flawed experimental methods, according to the Environmental Working Group. Both studies said that the low levels of BPA to which humans are exposed caused no adverse effects in rodents. A National Toxicology Program report on BPA has also been controversial because it relied on data compiled by an industry consulting group. BPA, which is found in plastic containers and the linings of metal cans, has been found in the urine of 93 percent of Americans.

Odds and Ends

A Harvard University study published in the New England Journal of Medicine found that drugs approved right before review deadlines set by the Prescription Drug User Fee Act are more likely to cause safety problems than drugs approved well before deadlines. The FDA rejected the study's results. . . . The British government announced last week that it will force drug companies to disclose all safety data generated by clinical trials of their products. The move to strengthen current regulation comes after an investigation by the British Medicines and Healthcare Products Regulatory Agency concluded that GlaxoSmithKline delayed releasing information on the risk of suicide in teens from its anti-depressant Seroxat . . . . Eli Lilly, maker of the anti-psychotic Zyprexa, which has been linked to diabetes and heart disease, settled the first of many lawsuits with states around the country. Lilly, which was accused of concealing the risks of Zyprexa from the public, agreed to pay Alaska $15 million.

Cheers and Jeers

  • Cheer to Jennifer Cutraro of the Boston Globe for disclosing that Steve Sloan, director of pediatric transfusion medicine at Children's Hospital Boston, had done work for ZymeQuest Inc., a biotech company currently working on technology to convert all blood into type O, the universal donor. The article discussed methods to combat inventory shortages at blood banks across the country.