Important note: Information in this article was accurate in 2003. The state of the art may have changed since the publication date.
San Francisco Chronicle - Saturday, August 9, 2003
Bernadette Tansey, Chronicle Staff Writer
The FDA warned Gilead for the second time in just over a year that its sales representatives were downplaying the risks and exaggerating the benefits of its HIV drug, Viread.
The FDA ordered Bristol-Myers to replace misleading advertisements about its cholesterol drug Pravachol with corrective announcements -- an unusually strong enforcement measure. The agency said the ads, which appear in general- interest publications such as Good Housekeeping, falsely proclaimed that Pravachol was the sole drug proven to prevent stroke in certain patients.
In a speech Friday, FDA Commissioner Mark McClellan said the agency has been cracking down on deceitful over-promotion of pharmaceuticals and nutritional supplements.
"I consider it a public health hazard when people are misled by false claims," said McClellan, according to the Associated Press.
The FDA has been under fire recently from critics who claim that the agency has slacked off on disciplining drug companies. Late last year, U.S. Rep. Henry Waxman, D-Los Angeles, complained that FDA actions against deceptive drug ads had dropped by 70 percent during the Bush administration.
The FDA denied such charges in a June white paper, maintaining that enforcement measures were increasing. The agency pointed to a dozen warning letters issued this year to major drug companies, including Amgen of Thousand Oaks (Ventura County), the world's largest biotechnology company, and the pharmaceutical giant GlaxoSmithKline.
In a letter made public this week, Thomas Abrams, director of the FDA's drug marketing division, said a Gilead sales representative falsely claimed Viread was safer than other HIV drugs at a Miami AIDS conference in April. Abrams said the spokesman didn't disclose that the drug has been associated with side effects that, though rare, can be fatal.
"This conduct is particularly troubling because the more than 1,500 attendees of this conference included social workers, AIDS educators, and patients with HIV/AIDS, and you had previously been warned not to engage in such activities," Abrams wrote.
The FDA had faulted Gilead last year for similar statements by four sales representatives at a 2001 conference. One described Viread as a "miracle drug" that was effective for unproved uses.
Gilead spokeswoman Amy Flood said the firm had tried to correct the problem after the first warning and took the second "very seriously." Flood said she did not yet know why it recurred.
"We're investigating it," she said. "We do believe this also is an isolated event and we're going to ensure there is retraining on our promotional policies."
The FDA ordered Gilead to demonstrate that its second retraining effort will succeed better than the first. It also required the firm to send corrected information to attendees at the Miami conference.
The agency's reprimand had little effect on Gilead shares, which lost 38 cents, or 0.61 percent, to close at $62.25. Soaring Viread sales have made Gilead's fortune since the drug's approval by the FDA in 2001. Sales could reach $600 million in 2003, the company estimates.
E-mail Bernadette Tansey at btansey@sfchronicle.com.
The Associated Press contributed to this story.
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