d4T Parallel-Track Program Begins

The parallel track program for the anti-HIV treatment d4T
(described in AIDS TREATMENT NEWS #159, September 18) obtained
FDA approval on October 5. Physicians can call 800/842-8036 for
information and instructions for enrolling patients.

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.