Chicago Tribune - November 3, 2004
Bruce Japsen, Tribune staff reporter

The FDA recently ordered Abbott to immediately stop circulating print advertisements for its drug Kaletra, the nation's most popular protease inhibitor for people with HIV, accusing the company of inflating the drug's benefits.

Some ads, which have run in several publications targeting the HIV community and on restroom posters, show a multiyear sequence of pictures of a healthy-looking man and ask, "Where do you see yourself in five years?" One caption indicates that HIV is "still undetectable."

"These promotional pieces overstate the effectiveness of Kaletra, and omit the indication and material information about the risks associated with Kaletra in the treatment of HIV infection," the FDA wrote in a letter dated Friday and posted Tuesday on its Web site. "Therefore, the promotional materials misbrand the drug [under federal rules]."

Kaletra, which has become a blockbuster for North Chicago-based Abbott since it won U.S. approval four years ago, is projected to generate more than $800 million in worldwide sales this year. The drug, a protease inhibitor, blocks an enzyme and appears to stop HIV from reproducing and spreading in the body.

But the FDA said the ads are misleading because Kaletra was approved by regulators based on data from patient trials during 48- and 72-week periods. The agency said it is not aware of substantial evidence or substantial clinical experience to support claims of survival, good health and disease control for five years.

"The ad implies that patients taking Kaletra can expect to survive and be healthy for at least five years," the FDA said.

For its part, Abbott agreed to pull the ads and "respond to the FDA in the requested time frame, which is Nov. 15," Abbott spokeswoman Laureen Cassidy said. Abbott had no further comment.

The FDA's letter is the latest controversy surrounding Abbott's efforts to increase sales of its AIDS drugs. Abbott has been under fire from AIDS patients, consumer groups and state prosecutors over the 400 percent price increase it imposed last December for its first-generation AIDS drug, Norvir.

Consumer groups say Abbott's price increase on Norvir--which is used as a booster with drugs made by other companies--was designed, in part, to win prescriptions for Kaletra, the company's next-generation protease inhibitor. Kaletra includes Norvir as an ingredient and therefore does not require a booster.

By raising the price of Norvir to $8.57 a day from $1.71, consumer groups say, Abbott was also boosting the price of other companies' drugs much higher than Kaletra. The price increase is still under scrutiny from at least two state prosecutors.

Abbott has denied wrongdoing and has said the Norvir price increase was justified. The company said Norvir's use as an HIV treatment had been undervalued in the market.

In June, the FDA scolded Abbott for its marketing of Norvir, accusing it of falsely marketing health risks and costs of that drug. At that time, the FDA criticized Abbott brochures for promoting Norvir as the lowest-priced protease inhibitor.

In reality, Norvir's 100-milligram dose is used as a booster for other drugs that in combination would not constitute the lowest-priced protease inhibitor, industry price guides confirm. Abbott complied with the FDA's request and stopped using the brochures touting Norvir as the lowest priced.

"It is unbelievable, that when the FDA just wrote Abbott a letter about Norvir, that they would try to pull something with Kaletra," said Lynda Dee, a Maryland attorney and member of the drug-development committee of the AIDS Treatment Activist Coalition. "Do they think no one is watching?"

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