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March 30, 2009

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Integrity in Science Watch

Week of 03/30/2009

Federal Disclosure Would Help Editors Find Cheats

The Center for Science in the Public Interest last week called the Journal of the American Medical Association's effort to silence whistleblowers who officially complain when JAMA authors fail to report conflicts of interest an "unwarranted assault on freedom of speech and the press." In a letter sent to all members of the Senate Finance Committee, CSPI called for passage of the Physician Payments Sunshine Act, which would require industry to post all payments to physicians greater than $500 in a federal database. The legislation, sponsored by Herb Kohl (D-WI) and Charles Grassley (R-IA), would give medical journal editors an easily accessible database for checking the financial conflict-of-interest disclosure information submitted by authors and reviewers and make JAMA's misconceived policy unnecessary, the letter said. A 2004 CSPI pilot study of four leading journals showed a persistent failure by authors to disclose conflicts of interest, with JAMA having the worst record among the four.

Earlier this month, JAMA's editors were publicly embarrassed by reports in the Wall Street Journal that they had sought to squelch public discussion of a complaint that an author had failed to disclose relevant conflicts; complained to the dean at the medical school where the whistleblower worked; and made disparaging comments to the newspaper about the whistleblower's professional credentials. In an editorial posted online on March 20, JAMA's editors denied making the disparaging comments to the newspaper, admitted contacting the school, and instituted a policy requiring anyone who reports to the editors that a JAMA author failed to properly disclose financial ties must remain silent while the allegations are investigated. The Wall Street Journal reported Saturday than an American Medical Association oversight committee will investigate whether JAMA's top editors threatened the whistleblower, Jonathan Leo of Lincoln Memorial University in Harrogate, Tenn.

Another Question for the Editors of JAMA

Last January, the Journal of the American Medical Association published a study of the low use of mammography later in life by female childhood cancer survivors who'd received radiation therapy. The study, co-authored by Leslie L. Robison of St. Jude Children's Research Hospital in Memphis, Tenn., concluded that the results provided a "foundation for targeted interventions involving both clinicians and cancer survivors." The previous month, Robison disclosed in an article in Pediatric Radiology covering the same issue across a range of cancers that he served on a scientific advisory board for Eli Lilly, which manufactures raloxifene (Evista) for, among other things, prevention of breast cancer.

In an email communication, Robison explained that his relationship with Eli Lilly involved post-marketing surveillance of the company's growth hormone products, which have been implicated in cancer recurrence. "The article published in JAMA is on breast cancer screening, which has no relationship to growth hormone," he wrote. Do the editors agree that a relationship with a company involving one of its products does not have to be disclosed by an author when publishing research that could impact another one of that company's products?

Grassley Aide Punted from Tufts Panel

Tufts University last week rescinded an invitation to the aide to Sen. Charles Grassley (R-IA) who has been investigating academic researcher-drug industry ties, the Boston Globe reported. Sheldon Krimsky, co-chairman of the ethics committee and a professor of environmental policy at Tufts, said university administrators refused to allow anyone from the school's administration to serve on a May 13 ethics panel with someone who was simultaneously investigating the school.

The Boston Globe reported that Grassley recently requested detailed information on the relationship between Tufts infectious disease professor Helen Boucher and all pharmaceutical companies. In a 2006 continuing medical education disclosure, Boucher, who received $276,000 in grants from the National Institutes of Health that year, revealed she has consulted for Aspreva Pharmaceuticals, Cubist Pharmaceuticals, Pfizer and Schering-Plough; served on the speakers bureau of Pfizer; received honoraria from Cubist and Pfizer; and owned Cubist stock.

Obama, FDA Muddy Whistleblower Waters

President Obama and the Acting Commissioner at the Food and Drug Administration recently issued directives that could limit federal employees' right to release information to Congress and the public. The president's signing statement on this month's $410 billion budget bill said the legislation would not limit his power to control the flow of certain information to lawmakers, according to the New York Times. Seperately, the FDA's Frank Torti warned agency employees that releasing draft guidances and proposed rules that may contain commercial information could "result in disciplinary sanctions and/or individual criminal liability." Critics called the Torti memo overly broad.

Both policies appear to contradict the president's January 21 call for greater transparency in government, according to Amanda Hitt of the Government Accountability Project. Sen. Charles Grassley (R-IA) called Obama's signing statement "overly broad" and said it would "undoubtedly chill whistleblowers who might otherwise come forward to report waste, fraud or abuse to Congress."

FDA Ordered to Lift Some Restrictions on Plan B

A federal judge last week ordered the Food and Drug Administration to reconsider its 2006 ruling limiting over-the-counter access to the "morning after" contraception pill to women over the age of 18. U.S. District Court judge Edward R. Korman in Brooklyn, N.Y., instructed the agency to make the so-called Plan B pill available to 17-year-olds within 30 days and review whether the emergency contraceptive should be available to all ages without a doctor's order, according to the Washington Post. The court's decision in Annie Tummino v. Frank M. Torti, Acting Commissioner of the Food and Drug Administration repeatedly criticized the FDA for "arbitrary and capricious" decisions that were influenced by "political and ideological" considerations imposed by the Bush administration. Korman ruled that then-Acting Commissioner Lester Crawford wrested decision-making control from staff; stacked an advisory committee, and then ignored its recommendations; and responded to outside political pressure by denying some non-prescription access before FDA's scientific review staff had completed its review.

FDA Inspectors Ignore Whistleblower; Five Die

The Food and Drug Administration ignored an employee's complaints about unsanitary conditions at a North Carolina syringe manufacturing plant for at least six months, resulting in hundreds of illnesses and at least five deaths among syringe users, the North Carolina News & Observer reported. In June 2007, a whistleblower alerted the FDA in an email to unsterile conditions in the AM2PAT's "clean" room in Angier, N.C. The whistleblower also complained that the company's managers "just ignore the complaints from employees." Two months later an FDA inspector visited the plant, noted it had "significant objectionable conditions," but failed to act despite the FDA having written a prior report citing the company for failing to maintain a sterile environment. Only in December 2007, after 20 cases of bacterial infections had been traced to the plant, did inspectors return and shutter the facility. Last month, two employees were charged with falsifying records. The company president, wanted on ten charges, appears to have fled the country.

Odds and Ends

The U.S. Justice Department last month sued Forest Laboratories, maker of the antidepressants Celexa (citalopram) and Lexapro (escitalopram), for illegally promoting the off-label use of the drugs in children, the British Medical Journal reported. The Journal of the American Medical Association study by University of Iowa psychiatrist Robert Robinson that failed to report his ties to Forest Labs (see lead story above) involved the use of escitalopram in post-stroke depression. ... The American Psychiatric Association announced it will end medical education seminars and meals sponsored by drug companies at its annual meetings. ... Brooke Gladstone, the host of National Public Radio's "On The Media," retracted a report that claimed former NPR producer Bill Lichtenstein of "The Infinite Mind" knew that show host Frederick K. Goodwin had conflicts of interest never mentioned on the program. Goodwin, a psychiatrist, reportedly earned at least $1.3 million from 2000 to 2007 giving marketing lectures for drugmakers. ... The journal Current Medical Research and Opinion will institute a new transparency policy that publicly reports any relevant financial relationships of its staff, editor-in-chief, editorial board members, international advisory board members, authors and peer reviewers. ... Former top EPA lawyer Jon Cannon withdrew from consideration as the agency's deputy administrator because of an investigation into the nonprofit America's Clean Water Foundation (ACWF), where he once served on the board of directors. An EPA inspector general's report claimed the now defunct ACWF mismanaged more than $25 million in federal grants by allowing a subsidiary of the National Pork Producer's Council to conduct clean-water assessments on hog farms. ...

Cheers and Jeers

Cheer to Tom Avril of the Philadelphia Inquirer for reporting how chemical industry giant Rohm & Haas funded research to downplay concerns that indoor pollution had led to at least a dozen brain cancers at its main research facility in Spring House, PA.