DDMAC promo untitled letter.

The following untitled letter was issued by the Office of Medical Policy Divi-sion of Drug Marketing, Advertising, and Communications (DDMAC). Copies of the letter are available to subscribers from RECORD-RETRIEVE for $7 plus retrieval.

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Guilford Pharmaceuticals, Baltimore, Sept. 29 (DDMAC). FDA objected to a promotional videotape for Gliadel Wafer (polifeprosan 20 with carmustine implant). The agency pointed out that, as stated in the approved product labeling, patients undergoing craniotomy for malignant glioma and implantation of Gliadel should be monitored closely for known complications of craniotomy, including seizures, intracranial infections, abnormal wound heal-ing, brain edema and possible brain hemorrhaging. Moreover, "carmustine," the active component of Gliadel, can cause fetal harm when administered to a pregnant woman. However, the videotape only mentions wound-healing problems, infection, seizures and swelling as the side effects. In addition to failing to communicate significant risks associated with Gliadel, the videotape misleadingly downplays the few adverse effects that are mentioned, and it promotes the use of Gliadel in "combination chemotherapy." The letter pointed out that interactions of Gliadel with other drugs or radiotherapy have not been formally evaluated. Lastly, the agency noted that in clinical studies, there were no statistically significant differences between the Gliadel Wafer and placebo groups with regard to improved patient-reported outcomes or time to neuro-performance deterioration, but among the clinical benefits described on the videotape are claims of "a remarkable improvement in survival," sustenance of neu-rologic function and improvement in quality of life. F-B