CMS Adds Geriatric Code
The Centers for Medicare and Medicaid Services has established a new physician specialty code for geriatric psychiatry. The code, 27, will go into effect April 1, 2010, the agency announced in late October. CMS directed all its contractors to recognize the new physician specialty code on all claims.
Dr. Nemeroff Lands in Miami
Dr. Charles B. Nemeroff, who was hounded by charges of conflicts of interest in his biological studies of neuropsychiatric disorders, has left Emory University, Atlanta, for the University of Miami. He will be professor and chairman of the department of psychiatry and behavioral sciences. While at Emory, Dr. Nemeroff was accused of failing to disclose $800,000 in payments from GlaxoSmithKline while he was directing National Institutes of Health studies that used some of that company's products. Emory subsequently stripped him of his psychiatry chairmanship and blocked him from seeking NIH grants for 2 years. It also prompted Emory to revise its conflict rules. According to a statement from Miami's Miller School of Medicine, Dr. Nemeroff plans to work on mental health and aging, HIV, drug abuse, and links between depression and cancer and heart disease.
Shire Receives OIG Subpoena
The British-based pharmaceutical company Shire plc has received a subpoena from the Office of the Inspector General of the U.S. Department of Health and Human Services seeking documents related to the sales and marketing of Adderall XR (amphetamine/dextroamphetamine), Daytrana (methylphenidate), and Vyvanse (lisdexamfetamine). Shire disclosed the subpoena in a statement with its third-quarter 2009 earnings announcement, which said sales of Adderall XR dropped 74% in the quarter. But Vyvanse sales continued to grow, partly because of the Food and Drug Administration's rejection of a generic competitor earlier this year and partly because of a 10% growth in the market for attention-deficit/hyperactivity disorder treatments, Shire said. The company also said it is about to launch its latest drug for ADHD, Intuniv (guanfacine).
Huge Seroquel Settlement
AstraZeneca will pay $520 million to settle several legal proceedings relating to its atypical antipsychotic Seroquel (quetiapine). The settlement was for two federal investigations and two whistleblower (qui tam) suits. In its third quarter–2009 earnings filing, the company said that the qui tam suits were related to two investigations by the U.S. Attorney's Office in Philadelphia. One concerns off-label sales and marketing, and the second is about “selected physicians who participated in clinical trials involving Seroquel,” the company said. AstraZeneca reached an agreement in principle to resolve the investigations in September, which included the payout. Meanwhile, Seroquel sales continue to rise. Compared with those last year, sales increased 16% in the United States for the 9 months ending Sept. 30, 2009, totaling $2.5 billion. Sales in the rest of the world increased 9%, to $1 billion, despite a 73% decline in Canada because of the introduction of a generic.
Risperdal Litigation Grows
There are now 425 cases pending against Johnson & Johnson's Ortho-McNeil-Janssen Pharmaceuticals Inc. alleging various damages from the atypical antipsychotic Risperdal (risperidone). The figure was disclosed in the company's third-quarter earnings statement. The company also said attorneys general in eight states and the Office of General Counsel of Pennsylvania are seeking reimbursement for public funds spent on off-label prescriptions and to treat adverse reactions. The Texas attorney general has joined a whistleblower suit seeking similar relief. More may be coming: Attorneys general in 40 other states have taken an interest in such litigation and have secured a ruling that stays the statute of limitations while they investigate. Six union health plans also have sued to recover alleged overpayments and have sought certification for a class action. Meanwhile, Risperdal sales dropped 60% in the first 9 months of 2009, partly because of generic competitors. But those sales are being replaced by the company's Risperdal Consta, which had revenues of $1 billion from January to October.
More Autism Grants From AARA
The NIH has awarded 50 grants for autism research totaling $65 million. The funds were provided by the American Recovery and Reinvestment Act (ARRA), known popularly as the economic stimulus package. A statement from the National Institute of Mental Health said all the grants were awarded based on how well they met short-term research objectives outlined in a plan devised by Interagency Autism Coordinating Committee. Much of the data from the studies will be available to other researchers through the National Database for Autism Research. NIMH's director, Dr. Thomas R. Insel, said the studies “hold the best promise of revealing what causes autism, how it might be prevented, what treatments are effective, and how service needs change across the lifespan.”