In a December letter sent to pharmaceutical manufacturer AstraZeneca LP, the U.S. Food and Drug Administration said the company "promoted misleading efficacy information" and "minimized the risks" associated with their drug Nolvadex (tamoxifen citrate). The letter was sparked by a print advertisement that appeared in the September 2001 issue of InTouch, a magazine aimed at cancer patients and distributed in cancer treatment settings.
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In addition, the agency maintained that the ad minimized serious risk information concerning uterine cancer and blood clots and misrepresented other side effects such as hot flashes, vaginal discharges, and irregular periods as "relatively mild," even though they occurred with "much higher" frequency among those receiving Nolvadex compared to a placebo.
The FDA ordered the manufacturer to "immediately cease distribution of this and other similar promotional materials for Nolvadex that contain the same or similar claims or presentations" as well as submit a written response with a compliance plan by Jan. 3.
While not denying the FDAs assertions, AstraZeneca spokesperson Mary Lynn Carver points out that the ad in question was aimed primarily at breast cancer patients in a 2-year promotional campaign involving the cancer specialty magazines InTouch, MAMM, and others.
"The real issue is exactly what can consumers be expected to understand," said Carver. "You have to look at a wide range of consumers. These folks (breast cancer patients) are extremely savvy about their diseases and their risks; they are very well informed. The readership of these publications is patients, their loved ones, or support folks and they are distributed almost entirely in oncologist offices."
Carver said while the Nolvadex ad is no longer being used, like virtually all drug promotional materials used in the United States it was developed in conjunction with patient advocacy groups and underwent "extensive" corporate review. At present AstraZeneca is targeting only the "direct-to-patient" cancer market and is not engaged in "direct-to-consumer" general audience campaigns, she added.
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