Protease Inhibitor Approvals: Will People Be Cut Off Drug? Followup Studies Proposal Needs Support

The PWA Health Group, the largest AIDS buyers' club in New York, is circulating a sign-on consensus letter asking the FDA, when it approves Merck's Crixivan(R) (indinavir) and Abbott's Norvir(TM) (ritonavir), to require the companies to obtain long-term followup data, by allowing people currently receiving the drugs (in clinical trials, or in the expanded-access lottery programs) to continue their treatment in long-term followup studies.

This proposal addresses two problems. For those now receiving either of these experimental treatments, it would prevent involuntary interruption of therapy if they cannot pay for the drugs when they go on sale. Interruption of therapy might be especially problematic with these drugs, because of concern that it might help a person's virus become resistant to most or all protease inhibitors, greatly reducing the value of this class of drugs for that person.

The other problem -- lack of long-term data -- concerns everybody who uses these drugs. It is widely expected that one or both of them will be approved soon -- as almost everyone wants -- perhaps in the next several weeks. Then thousands are likely to start using them.

But very few people have taken these drugs for more than a year. The fastest way to get the needed long-term data now is to allow those who have already been using the drugs to continue, with monitoring in a followup study. Then, in case some long-term safety problem develops after two or three years of use, the many thousands of people who started the drug when it was approved would have advance warning, and could probably avoid the problem by interrupting or changing therapy if necessary. But there is widespread concern that unless the FDA requires these studies, the companies will stop providing free drug once they can sell it instead, and the studies will not be done.

You can help by signing the consensus letter, and if relevant, getting your organization to do so. To sign on, or for more information, including a copy of the statement, contact Sally Cooper at the PWA Health Group, 212/255-0520 or fax 212/255-2080.