Allen.Uebele@p0.f69.n154.z1.fidonet.org (Allen Uebele) (07/19/90)
Parallel Track Policy
National AIDS Program Office
200 Independence Avenue, SW
Room 738-G
Washington, DC 20201
July 13, 1990
It has come to my attention that you are currently entertaining
comments from concerned people with regard to your Parallel
Track policy. I write to you therefore to urge you to continue
and expand your use of PT as an alternative therapy.
For people with AIDS and ARC, an experimental drug is frequently
the only hope of therapy. It would be cruel to deny people this
hope. The magnitude of the AIDS crisis demands policies like PT
that permit the use of investigational drugs by people with no
alternatives.
The original draft for PT permitted any interested party to go
before the AIDS Research Advisory Committee (ARAC) to petition
that a drug be put on PT. Now however, the regs require that a
petition be made by a drug sponsor. Considering that drug
companies make decisions at times on the basis of their own
vested interests, I urge you to do the following: First, change
the regs back to the original language so that any interested
person can make the petition; Second, since ARAC has community
representation it should be up to them to decide what
constitutes standard therapy.
Beyond these changes I would like to congratulate you on the
innovation of PT and urge you to expand it so that those who use
PT will be able to have a choice in their therapy. There are
many ways in which expansion could occur. One such way would be
to allow community-based research organizations to collect data
on a PT drug's effectiveness. Another would be to develop a
track that would parallel a clinical trial which tests two or
more AIDS drugs at the same time.
Perhaps the single greatest need which the current policy must
address is its inability to reach those who are uninsured or
underinsured. I urge you to address this grievous situation
with innovative programs such as PT as soon as possible. It is
the right of every person in this country to receive adequate
health care regardless of their insurance status. It is the
obligation of our government to see that they do.
Sincerely,
--
Uucp: ...{gatech,ames,rutgers}!ncar!asuvax!stjhmc!154!69.0!Allen.Uebele
Internet: Allen.Uebele@p0.f69.n154.z1.fidonet.org