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www.fdanews.com/articles/75847-wyeth-starts-support-program-for-patients-on-effexor-xr

WYETH STARTS SUPPORT PROGRAM FOR PATIENTS ON EFFEXOR XR

August 29, 2005

Wyeth has launched a unique support program for patients taking the firm's antidepressant Effexor XR. The program aims to improve patient and physician communications.

Wyeth's program, "The Dialogues: Time to Talk," is the first initiative of its type to use telephone outreach counseling, according to a Wyeth spokesman. "We implemented the education and support program to help [patients] stay the course and lead them to better clinical outcomes, which is our hope," spokesman Christopher Garland told FDAnews.

The program, which includes printed materials, a magazine and health-related reminder items, stems from the FDA's requirement last fall to strengthen labeling on all antidepressant drugs. The new labeling recommends patients be "observed closely" during the first few months of therapy and states that "additional contact by telephone may be appropriate between face-to-face visits."

Patients who enroll in the program can opt to receive three telephone calls from nurses contracted by Wyeth. The nurses will assess the patients' progress on Effexor XR (venlafaxine HCl) through a series of questions examining topics such as mood, appetite, sleep patterns and energy level. Patients will then have opportunity for an expanded discussion to provide more detail on how they are feeling, Garland said. Patients may also call a Wyeth-sponsored hotline at any time.

One industry observer says Wyeth's decision to facilitate telephone counseling is unique, but that such initiatives are part of an overall trend in the industry. Drug company activity in this area typically involves disease management programs, said Joshua Cohen, senior research fellow at the Tuft Center for the Study of Drug Development.

"Since around 1990, drug firms have been officially promoting their products through disease management programs," he told FDAnews. "The focus is on patient and provider education, particularly emphasizing compliance."