AIDS Treatment News #161, October 16, 1992
John S. James
This program is for patients who have T-helper counts under 300 and have failed both AZT and ddI -- either because they could not tolerate those drugs, or because their condition continued to worsen despite treatment with each.
The drug's sponsor is Bristol-Myers, which also sponsored the expanded-access program for ddI before that drug was approved. The d4T program has been designed to involve less paperwork for physicians than the ddI program, to be more accessible to patients receiving their care at public clinics, and to give somewhat more leeway to physicians who believe that their patient should be in the program.
Incidentally, the way that drug "failure" (for AZT and ddI) is defined makes it easy for persons with T-helper counts under 50, who have been treated with those drugs, to qualify for the d4T program.
Comment
d4T might be less toxic than AZT or ddI, and at least as effective in raising T-helper counts. However, much less is known about it than about the approved drugs.
Meanwhile, the reports we are hearing about ddI continue to be good; persons who are not doing well on AZT and have no contraindications for ddI should consider switching. More information about ddI should be available in the next few months.
The new parallel-track program for d4T seems to be a good as we can hope for at this time. However, we believe a better policy would be to allow urgently-needed drugs which are ready for parallel track to be marketed instead, under conditional approval, and reimbursed by public or private insurance like other approved drugs. Such a system would (1) give more control of medical decisions to physicians and patients, (2) allow earlier access to drugs like peptide T which do not have a major developer able to afford parallel track, (3) be at least as equitable across social classes as "free" distribution which requires physician time and laboratory tests commonly paid for out of the patient's pocket -- or the physician's; (4) allow faster learning about new treatments under conditions of practical use, and (5) permit small companies to bring out the most important new advances (such as tat inhibitors) when big companies are not aggressive or not effective in doing so.
We do not think this approach would endanger the public, because it would only apply to drugs already considered safe enough for release to thousands of patients under parallel track. And, like parallel track, it would only apply for serious and life-threatening conditions when there was a compelling need for the drug.
But politics is "the art of the possible." Decades of struggle between liberal (consumer protectionist) and conservative (pro business) positions, neither of which serves the public interests very well, hardened into rigid battle lines with both sides reluctant to give up ground. And the current inefficiencies favor big business, which finances most of the leading researchers, who are accepted uncritically as authorities by the press, politicians, and policy experts, who seldom have the scientific background for an independent evaluation. Problems persist because the system does not generate much constituency for doing things better. Until more of the public gets involved in AIDS and related activism, we will be stuck with second best.
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