Tuesday, November 23, 2010

FDA: Gilead ad for Truvada 'misleading'

Editor's Note: I would recommend that you do some research about any new medication on the market, even those approved by the FDA considering the close relationship which exists between the FDA and the Pharmaceutical industry. A revolving door exists between many drug companies and the FDA. I also recommend that you watch the video below in which a scientific researcher admits that AIDS was developed by the U.S. during the development of the polio vaccines.

Regulators have warned Gilead Sciences Inc. about direct-to-consumer print advertising for its HIV drug, Truvada.

The Food and Drug Administration said Gilead's ad for Truvada touts the drug as "better or more effective than has been demonstrated." It asked Foster City-based Gilead (NASDAQ: GILD) to "immediately cease" the ads.

Specifically, the FDA takes issue with ads that show photographs of a woman who takes Truvada as part of her HIV combination therapy — at graduation, in an office setting and as a married woman sitting on a sofa — and appears to be happy and in good health. The headline above the images states, "HIV doesn't have to change the hopes and dreams I have now." Among the claims below the images is the line, "With once a day Truvada for my HIV, I can plan for long-term success."

"The print ad is false or misleading because it overstates the efficacy of Truvada, makes unsubstantiated claims and minimizes the risks associated with the drug," the FDA regulatory review officer Aline Moukhtara said in a letter to Joyce Acbay, Gilead's director of regulatory affairs.

The FDA said the "totality of these claims and presentations misleadingly suggests" that patients using Truvada can manage their HIV-1 RNA levels, or viral load, and increased CD4 cell count on a long-term basis. That, however, "has not been demonstrated by substantial evidence or substantial clinical experience," the FDA said.

Gilead does note in the ad — "in small, non-prominent font," the FDA said — that Truvada was evaluated "through 3 years of a clinical study" and "proven over the long term … in 3 years of a clinical study."

"However, this contextual information does not mitigate the overwhelming impression created by the prominent images and claims in the print ad, which suggest that patients can expect long-term treatment success with Truvada as they achieve their hopes and dreams, such as graduation, a career and marriage," the FDA said in its letter. "Any of these goals can easily take more than three years to accomplish."

Biogen Idec also was warned by the agency for a webcast promoting the multiple sclerosis therapy Tysabri.

Read more: FDA: Gilead ad for Truvada 'misleading' | San Francisco Business Times

The following video suggests that the AIDS epidemic in the United States was deliberately created by Dr. Robert Gallo: