NIMH Director Denies Conflict
Dr. Thomas R. Insel, director of the National Institute of Mental Health, is denying a report in the Chronicle of Higher Education that he assisted a former colleague in securing a new position after the person was removed as principal investigator on an NIMH-funded grant because of conflicts of interest. The story alleged that Dr. Insel helped Dr. Charles B. Nemeroff get a new position at the University of Miami after he left Emory University and that Dr. Insel helped Dr. Nemeroff avoid sanctioning by the National Institutes of Health. Dr. Nemeroff is under investigation for not disclosing payments from GlaxoSmithKline while he was leading studies of the company's drugs escitalopram and duloxetine at Emory. Dr. Insel has been leading the NIH's latest effort to weed out conflicts among employees. In a post on his “Director's Blog” in mid-June, he said that “Having been one of the most outspoken proponents for developing tougher conflict of interest policies at NIH, the allegations that I would help anyone avoid penalties struck me as surreal.” He added, “I realize that my tenure at Emory and a previous association with Dr Nemeroff will, for some, be 'guilt by association.' To avoid such allegations, I recused myself from all matters involving Dr. Nemeroff during the conflict of interest investigation at NIH… and from future applications or NIH matters involving Dr. Nemeroff.”
APA Beefs Up Conflict Policy
The American Psychiatric Association has approved a new code of conduct to govern its relationships with other organizations. The policy requires that any financial relationship with any entity that develops educational programs or subsidizes research should be clearly stated by APA staff and members working on behalf of the organization. It also requires all APA educational programs follow the American College of Continuing Medical Education standards for independent and unbiased presentations. A new conflict of interest committee will be charged with overseeing the organization's relationships with industry and other groups. The code is available at
www.psych.org/Resources/Governance/Disclosure-of-Interests-and-Affiliations/APA-Code-of-Conduct.aspx
Judge Hands Down Topamax Fine
Ortho-McNeil Pharmaceutical LLC, a subsidiary of Johnson & Johnson, recently pleaded guilty to one misdemeanor count of violating the Food, Drug & Cosmetic Act, for the illegal promotion of Topamax for psychiatric uses. Under a sentence delivered by a U.S. District Court judge in Boston last month, the company will pay a criminal fine of $6.14 million. The sentence is consistent with an agreement the company reached with the Justice Department in April. Prosecutors alleged that Ortho-McNeil used a program called “Doctor for a Day” to promote the epilepsy and migraine treatment Topamax among psychiatrists for off-label uses. The company paid physicians to accompany sales representatives meeting with psychiatrists. In its plea, the company acknowledged promoting the drug for certain unapproved uses between 2001 and 2003, but it said that it voluntarily discontinued the program before receiving the first subpoena in the government's investigation.
Tobacco Coverage to Be Broader
The Centers for Medicare and Medicaid Services is proposing to cover tobacco counseling services for all adults and pregnant women who are entitled to benefits under Part A or Part B of Medicare. Such counseling has been covered only for people with signs or symptoms of tobacco-related disease. Under the new plan, anyone who uses tobacco or desires the counseling would be entitled to two counseling “attempts” per year, which would include a maximum of eight intermediate (3-minute) or intensive (10-minute) sessions per year. A final coverage decision is pending, after comments on the proposal were taken through late June.
House Probes Home Gene Testing
Three key House lawmakers have launched an investigation into personal genetic testing kits that are being marketed directly to the public. The investigation, spearheaded by House Energy and Commerce Committee Chairman Henry A. Waxman (D-Calif.) and supported by Rep. Joe Barton (R-Tex.), Rep. Bart Stupak (D-Mich.), and Rep. Michael C. Burgess (R-Tex.), has targeted the companies 23andMe Inc., Navigenics Inc., and Pathway Genomics Corp. The companies already offer their tests to consumers by phone or online, and San Diego-based Pathway announced that it is seeking to sell testing kits in retail locations, despite concerns from the scientific community about the accuracy of test results. In letters to the companies, the lawmakers said they want information on how the companies analyze test results and identify potential genetic risks. The three lawmakers also want to know how the companies collect, store, and process individual genetic samples collected from consumers.