Chicago Tribune - November 2, 2004
Bruce Japsen, Tribune staff reporter

This time, the FDA told Abbott that it inflated the benefits for Kaletra, the nation's most popular protease inhibitor in the fight against the HIV virus. The drug has been a blockbuster for Abbott since it won U.S. approval four years ago, and is projected to generate more than $800 million in worldwide sales this year.

The FDA ordered Abbott immediately to cease circulating the ads, which have run in one national magazine directed toward the HIV community and posters often displayed in restrooms. Abbott wouldn't disclose further where the ads have appeared.

"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 an Oct. 29 letter that was posted Tuesday on its Web site. "Therefore, the promotional materials misbrand the drug (under federal law)."

The ads, one of which appeared in Poz magazine, feature a healthy-looking man in each photograph with captions indicating the photos were taken in various years dating back to 2000. One caption indicates the HIV virus is "still undetectable."

The FDA said the ads are misleading because Kaletra was approved based on data from patient trials over 48- and 72-week periods.

"FDA is not aware of substantial evidence or substantial clinical experience to support claims of survival, good health, undetectable HIV RNA levels and disease control for five years," FDA said. "The (print) ad implies that the man shown in the photographs has been healthy over the past several years and that this positive outcome is a direct result of taking Kaletra. The ad implies that patients taking Kaletra can expect to survive and be healthy for at least five years."

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

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

Consumer groups say Abbott's price hike of Norvir, which is used as a booster to Kaletra rival drugs made by other companies, was designed in part to win prescriptions for Kaletra, the company's next-generation protease inhibitor.

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.

For its part, 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 the company of falsely marketing health risks and costs of that drug. In that case, the FDA criticized Abbott brochures for marketing Norvir as the lowest priced protease inhibitor. Norvir's 100-milligram dose is a booster for other drugs and would not be taken on its own.

"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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