Like so much in life, Norvir (ritonavir) never lived up to its early hype. First, Abbott Labs' protease inhibitor caused serious liver toxicity and boosted triglycerides. Then a mysterious manufacturing glitch put a halt to capsules, which were then supplanted by a nasty-tasting liquid form. But just as Norvir hit its nadir, fate tossed out a finding that gave it a new lease on life: The compound hikes blood levels of other PIs, offering a leg up on resistance.
But bad luck is back. In a warning letter from the Food and Drug Administration (FDA) last summer, Abbott was reprimanded for failing to report two incidents of Norvir side effects in a timely manner. Per its custom, the FDA does not identify which side effects, only that they were "serious and unexpected." Alerted by doctors to the adverse reactions in February 2000 and again a year later, Abbott was required to notify the FDA within 15 days; instead it took five months in one case, two months in the other.
Abbott rep Nicole Wesley blamed the delays on corporate "systems changes," adding that the FDA action "had nothing to do with the safety and effectiveness of Norvir."
Stephen Fried, author of the best-seller Bitter Pills, an investigation into pharma scandals, said that "Abbott has a reputation at the FDA for not being as forthcoming about safety information as consumers might like."
But ultimately, advocates say, the issue is less with Abbott than with the industry in general -- in particular its failure to conduct follow-up studies on drugs fast-tracked through approval by the FDA. As Anthony Fauci, MD, head of the National Institute of Allergies and Infectious Diseases, told POZ, "The accelerated drug-approval process works well if there is a commitment to post-marketing -- and the capability of reversal of approvals when the drugs do not work as expected." At present, the feds lack the will -- or the stick -- to prod the industry to fulfill its commitments.