Hoffman-La Roche, maker of saquinavir (Invirase), stands accused of shoddy, if not shady, R&D. In August’s Tagline. The Treatment Action Group’s newsletter, Mark Harrington charges that even as the FDA approved its protease inhibitor in late 1995, the Swiss company was sitting on damaging data: The drug’s licensed dose—600 mg three times a day—is too low for optimal suppression of HIV and can quickly cause resistance.
“Had saquinavir become the drug of choice, a public-health disaster might well have resulted,” Harrington writes. “If cross-resistance became widespread, many would not be able to benefit from the later introduction of more potent protease inhibitors.”
The bigger blunder? Roche’s refusal to alert doctors and patients that only by quadrupling the dose is the drug safe and effective. But Roche calls the TAG rag’s tongue-lashing so much Monday-morning quarterbacking. “It’s easy to say how we might have done things better,” said medical director Dr. Laurent Fischer. “Saquinavir was the first protease inhibitor, and there was a demand for expanding access. It saved lives. Now we’re improving it.”
A tiger in the test tube, saquinavir has absorption hitches that earned it a rep as the runt of the protease litter. So Roche got busy developing a soft-gel-capsule that delivers eight times more drug. But now, says Harrington, a 1997 MacArthur “Genius” Fellowship winner, it’s payback time. Led by TAG and Project Inform, activists nationwide demand that Roche pull the ads for its current formulation, slash the price by seven-eights to reflect its actual potency and compensate cross-resistant consumers.
At presstime, the drug giant was a soft-gel-cap ad campaign and reportedly lobbying to get the new formulation named a first-line protease in the just-out federal standard-of-care guidelines.