AACE Nominates Officers, Board
The American Association of Clinical Endocrinologists has nominated a preliminary slate of officers and board members for 2007. Officer nominees include Dr. Daniel S. Duick as president-elect, Dr. Jeffrey R. Garber as vice president, Dr. Daniel Einhorn as treasurer, and Dr. Yehuda Handelsman as secretary. The 11 candidates for 9 open positions on the AACE board of directors are Dr. Myriam Z. Allende-Vigo, Dr. Pauline M. Camacho, Dr. Alan J. Garber, Dr. Daniel L. Hurley, Dr. Jonathan D. Leffert, Dr. Harmeet S. Narula, Dr. Eric A. Orzeck, Dr. Victor L. Roberts, Dr. K.M. Mohamed Shakir, Dr. Fred A. Williams, Jr., and Dr. Farhad Zangeneh. If Dr. Handelsman, who is currently on the board of directors, becomes secretary, there will be a 10th open board slot to fill his unexpired term. Winners will be announced at the AACE annual business meeting on April 14 in Seattle.
Lilly Reaches Zyprexa Settlement
The drugmaker Eli Lilly & Co. has agreed to pay up to $500 million to settle approximately 18,000 claims related to its atypical antipsychotic Zyprexa (olanzapine). Most of the claims stated that, before September 2003, the Zyprexa package insert did not adequately display the risk of hyperglycemia and diabetes. In September 2003, the Food and Drug Administration required a label change for all atypical antipsychotics that added information about a relationship between diabetes and this type of medication. Zyprexa has been approved for the treatment of schizophrenia and bipolar disorder. “While we remain confident that these claims are without merit, we took this difficult step because we believe it is in the best interest of the company, the patients who depend on this medication, and their physicians,” Sidney Taurel, CEO of Eli Lilly, said in a statement. The settlement also means that any claims in which physicians are named as codefendants will be dismissed, according to Eli Lilly. Approximately 1,200 Zyprexa claims were not included in the settlement.
New Osteoporosis Health Claims
FDA officials are proposing to allow a new health claim stating that foods and dietary supplements containing both calcium and vitamin D have the potential to reduce the risk of osteoporosis. The FDA currently allows manufacturers to make only health claims linking calcium intake to a reduced risk of osteoporosis. The new proposal would also broaden the health claim that can be made for products containing calcium by dropping references to sex, race, and age. The change is being proposed based on an FDA review of the scientific evidence, including the 2004 Surgeon General's report on bone health and osteoporosis.
Malpractice DB for Washington
The Washington City Council has passed a law requiring physicians there to report any adverse malpractice actions to a local database. According to the law, the database, which will be maintained by the city's Board of Medicine, “shall include, but not be limited to, a complete list of licensees and accurate and timely information regarding the licensees' license status and education, hospital privileges, loss of hospital privileges and cause, areas of specialization, board certifications, prior criminal convictions, prior convictions of the charge of medical malpractice in a court of law, malpractice claims settled out of court, and disciplinary action taken against the licensee by the Mayor or Board of Medicine.” The purpose of the database—from which reports will be made—is to reduce medical errors and improve health care delivery, according to the law. Dr. Peter Lavine, board chair of the Medical Society of the District of Columbia, noted in a statement that the measure included “vague, over-reaching, physician-reporting language” but added that “the devil will be in the details.” The database is scheduled to go into effect on July 1; it was part of a package that also included medical malpractice reform measures.
Unique New Drugs on Decline
The FDA approved only 18 new molecular entities last year, on par with the previous year but close to a historic low. Throughout the 1980s and 1990s, the agency approved at least 20–30 NMEs annually. Among the 18 were 4 biologic therapies and 4 new vaccines. The paltry number of approvals and a Government Accountability Office report issued in December may point to a decline in new drug development, according to Rep. Henry Waxman (D-Calif.), Sen. Richard Durbin (D-Ill.), and Sen. Edward Kennedy (D-Mass.). The legislators requested the GAO report, which found that huge increases in drug industry research and development from 1993 to 2004 were not accompanied by a similar rise in new drug applications—especially for NMEs—to the FDA.