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Two candidates for FDA commissioner identified

BY Alaric DeArment

WASHINGTON The head of the Baltimore Health Department may become commissioner of the Food and Drug Administration under President-elect Barack Obama, the Wall Street Journal reports.

The Journal described Joshua Sharfstein as a critic of the pharmaceutical industry who would likely strengthen regulations and who persuaded the FDA to forbid sales of OTC cough and cold medicines to children, but he also supports vaccinations of children.

Steven Nissen, who is in charge of cardiovascular medicine at the Cleveland Clinic, is another candidate for the post, and he has hurt GlaxoSmithKline’s and Merck’s sales by calling the safety of the respective diabetes drug Avandia (rosiglitazone maleate) and the cholesterol drug Vytorin (ezetimibe and simvastatin) into question.

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Management shakeup continues at Sanofi-Aventis

BY Jim Frederick

PARIS Drug maker Sanofi-Aventis SA said Wednesday that its top legal and financial officer has stepped down, extending a management shuffle that led to the appointment of a new chief executive, GlaxoSmithKline PLC veteran Chris Viehbacher, Dec. 1.

In the latest change, Sanofi announced the abrupt resignation yesterday of Jean-Claude Leroy, a 23-year company veteran who last served as executive vice president of finance and legal affairs. As of Dec. 10, His replacements are Laurence Debroux, senior vice president and chief financial officer, and Karen Linehan, senior vice president of legal affairs and general counsel.

Both have been named to Sanofi-Aventis’ executive committee and group management committee, and will report directly to the company’s new CEO, the French-based pharmaceutical firm announced.

Before coming to Sanofi, Viehbacher was president of North American pharmaceutical operations for GSK, and co-chairman of that company’s Portfolio Management Board, which oversees strategic decisions for research and development. At Sanofi, he’s expected to lead efforts to recharge the company’s drug-development pipeline and marketing prowess amid today’s difficult economic climate.

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Report calls for better adolescent health care

BY Antoinette Alexander

WASHINGTON Reform is needed in health care services for adolescents, who often engage in risky behavior, as the services and providers that are needed and used by adolescents are often fragmented, resulting in gaps in care, according to a new report from the National Research Council and Institute of Medicine.

While most U.S. adolescents (those aged 10 to 19) are healthy, many engage in risky behavior, develop unhealthy habits and have physical and mental conditions that can jeopardize their health. 

“As policymakers discuss how to restructure the way healthcare is delivered in the U.S., the distinct problems faced by adolescents‹such as risky behavior‹deserve particular attention. And because adolescence is a critical period for developing habits that build a strong foundation for health throughout one?s entire life, services need to focus on promoting healthy behaviors, preventing disease and managing health conditions,” stated committee chair Robert Lawrence, professor of environmental health sciences and health policy at the John Hopkins Bloomberg School of Public Health. 

Furthermore, the various services and providers that are needed and used by adolescents are often fragmented, resulting in gaps in care. For example, specialty services in mental health, sexual health, oral health and substance abuse treatment are not accessible to most adolescents.

The report suggests that a system be developed that fosters coordination between primary and specialty care; it should also include opportunities for primary care services to reach adolescents through safety-net settings, such as hospitals and community health centers and programs. Also, a stronger focus is needed on meeting the needs of adolescents who may be especially vulnerable to risky behavior or poor health‹for example, those who are poor, recent immigrants or those in foster care.

Federal and state policy makers also should develop strategies to ensure that all adolescents have comprehensive, continuous health insurance coverage, the report states. More than five million Americans aged 10 to 19 are uninsured and they use care less often and are less likely to have a regular source of primary care than those young people who are insured.

To improve the skills of health professionals to interact effectively with this age group, the report recommends that regulatory bodies incorporate competencies in adolescent care in their licensing, certification and accreditation requirements. Also, public and private funders should provide financial support to expand and sustain interdisciplinary training programs in adolescent health.

It is also recommended that, as an overarching principle, adolescents give their own consent before their health information is shared with others, even their parents, according to the report.

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