FAUCI PROPOSES "PARALLEL TRACK" TREATMENT ACCESS

Anthony Fauci, M.D., the head of the largest AIDS clinical trials program at the U.S. National Institute of Allergy and Infectious Diseases, proposed a "parallel track" system whereby patients not able to enter clinical trials would be allowed to use some drugs which had passed safety tests but had not yet completed efficacy testing. The proposal, made public June 23 at a talk in San Francisco, was prominently reported in The New York Times and other newspapers the following Monday, June 26.

Although no new laws are required, Dr. Fauci stressed that this plan would work only if the FDA, the drug companies involved, and the scientists running the trials agreed. He cannot make it happen by his decision alone.

The way the plan could work is that when a clinical trial is being designed, the parties involved -- the FDA, the drug company, and NIAID -- would discuss whether a parallel track could be implemented. If all agreed, then the study protocol could specify that certain patients not eligible for the trial could be treated with the drug through the parallel track. Examples of those ineligible might be persons who had used AZT but had to stop because of the toxicity, if the particular trial excluded people who had ever used AZT. Others might be allowed in the parallel track because the study was full, or because there was no trial available in their area. Fauci emphasized that this parallel access must not interfere with the main trial needed to get scientific data about the drug -- presumably meaning that those able to enter the trial would not be allowed to choose parallel-track access instead.

At a press conference after his San Francisco announcement, Fauci suggested that the parallel track would also be designed to collect data useful for evaluating the drug -- and that community-based clinical trials might be ideal for conducting such studies.

Discussions on possibly implementing a parallel track are now going on with the FDA and with several drug companies.

Comment

We commend Dr. Fauci for an excellent proposal, which could speed both access to drugs and final approval. However, there are important obstacles which might prevent the idea from being carried out.

For a parallel track to happen, three organizations must agree: Fauci's NIAID (if the trial is in the NIAID system), the FDA, and the pharmaceutical company which owns the rights to the drug. NIAID will be no problem, and the FDA seems willing to accept the idea, at least if the parallel track is able to generate scientifically sound data, as well as providing treatment access to the drug.

Most people familiar with the parallel-track concept think that the biggest problem will be with the drug companies. They will probably be expected to pay for the parallel track -- since the government will not want to pay for it, and there would be problems in allowing patients to do so. The question, then, is what incentives the companies have to support this access to their drug?

What drug companies want above all is approval of their NDA (New Drug Application), meaning final permission to market the drug. If the parallel track will generate data likely to help them get the NDA sooner, then most companies will probably be willing or eager to have a parallel track when their drug is tested.

The key to the parallel track therefore depends on the FDA. If the FDA only halfheartedly permits it, then drug companies will know that paying for treatment access will do little or nothing for them in getting their drugs approved, and they will not agree. But if it is clear that the parallel track can collect data which the FDA is likely to accept as supporting the NDA, then the idea can work.

And even aside from the question of whether the parallel-track idea is ever implemented, the fact that Fauci proposed it has already furthered debate and consensus-building around the issue of earlier access to treatment for life-threatening conditions. For example, in private discussions of the idea before its public announcement, Fauci heard objections that drug companies would not accept the parallel track because they were afraid that what happened to Syntex with ganciclovir would happen to them. Syntex provided the drug free to thousands of patients on a compassionate basis, saving them from blindness, and it has been widely believed in the pharmaceutical industry that they were punished by the FDA for doing so. Fauci answered these objections by clarifying that Syntex got into trouble not for providing compassionate access to persons with AIDS, but for failing to conduct clinical trials early.

Fauci's suggestion is important in another way. As the U.S. government's leading AIDS researcher, he is the one most clearly qualified to challenge the unfortunate idea that providing wider access to treatment will make scientific trials difficult or impossible. By so doing he removes the issue from the realm of science, which most people consider themselves incompetent to think about, to the realm of cost and feasibility, where the public can address the issues on their merits.