DSM-5 Comments Close
The American Psychiatric Association reported that it received 6,400 comments on its draft of the DSM-5. About a quarter of the comments were general, another quarter were on neurodevelopmental disorders, 15% dealt with anxiety disorders, 11% were on psychoses, and 10% concerned sexual and gender-identity disorders. The remainder was split among nine other classes of mental disorders. The comments probably will result in revisions, according to the APA. In fact, the DSM-5 Work Group on Eating Disorders already has proposed revisions to criteria for anorexia nervosa and bulimia nervosa. Now that comments have closed, the APA will test the proposed diagnostic criteria in clinical settings and then refine them. Final publication is planned for May 2013.
New Tobacco-Science Chief
The Food and Drug Administration has named a director for the Office of Science within its new Center for Tobacco Products. Dr. David L. Ashley will assume the position in June. Currently, he is the chief of the Emergency Response and Air Toxicants Branch of the Centers for Disease Control and Prevention's National Center for Environmental Health. Dr. Ashley also is a member of the World Health Organization's study group on tobacco regulation. At the center, he will oversee science, product review, epidemiology and metrics, and social and behavioral sciences, according to the FDA.
$153 Billion Wasted on Medications
Americans are wasting $153 billion a year on medications, primarily because of lack of adherence to prescriptions, estimates the pharmacy-benefit management company Express Scripts. The company came up with this tally as part of its annual report on drug spending. In 2009, $106 billion in waste was caused by nonadherence, $51 billion by failure to use lower-cost alternatives, and $6 billion from people choosing retail over mail order delivery, said the Express Scripts. (It has a mail order subsidiary.) The biggest medical area of waste is in treating high cholesterol, followed by hypertension, ulcer disease, and depression, according to the company. It said that 35% of the annual spending on lipid medications could be saved if people behaved better. Overall, drug spending rose 6.4% in 2009, which reversed a downward trend over the past few years. Spending for specialty drugs–for conditions such as rheumatoid arthritis, cancer, and multiple sclerosis–rose by 11%, driven largely by price increases.
Sales of Generics Still on Rise
More introductions of lower-cost generics dampened sales of brand name prescription drugs last year, but overall sales were still up 5%, according to IMS Health. U.S. sales grew to $300 billion, with 3.9 billion prescriptions dispensed in 2009. Generics made up 75% of dispensed prescriptions, an increase of almost 6% since 2008. Prescriptions dispensed as branded products decreased by almost 8%. There were 32 novel drugs introduced in 2009, but those “drove a limited increase in drug spending,” IMS Senior Vice President Murray Aitken commented in a statement. The top-selling class was antipsychotics, whose $14 billion in sales equaled the 2008 total. Proton pump inhibitors were second, hitting $13.6 billion in sales last year. Lipid regulators accounted for $13 billion in sales, a figure held down by generics, and antidepressants were fourth largest in sales at $9.9 billion.
Pfizer Details Pay to Physicians
As part of a settlement with the federal government, Pfizer Inc. has posted its first report detailing how much it pays health care professionals for consulting and other duties, including clinical trial participation. No other drug company has detailed trial payments. The data, which are posted at
Reform Was Lobbying Cash Cow
Lawyers, professional societies, and other organizations spent $1.2 billion lobbying Congress and the White House on health reform and other issues in 2009, according to a report by the Center for Public Integrity (CPI), a Washington-based watchdog group. How much went to health reform is not known, but if it was even 10%, that would be record lobbying for a single issue in 1 year, according to the CPI. The group estimates that 1,750 entities spread the money around. In addition to making use of its own lobbyists, Pharmaceutical Research and Manufacturers of America, for instance, hired 25 outside firms, CPI said.
FDA Proposes New Ad Rules
The Food and Drug Administration wants manufacturers to detail more of the contraindications and potential side effects of drugs in radio and television direct-to-consumer advertisements. The proposed rule would require that an ad's major statement on side effects and contraindications “be presented in a clear, conspicuous, and neutral manner.” The new rule would require manufacturers to present the information in both the audio and visual components of a video ad and make sure that it isn't overshadowed by other parts of either type of ad. The FDA will accept comments on the proposed rule until June 28.