4 MONTROSE VOICE/JANUARY 20, 1987
Federal Panel Recommends
Licensing AIDS Drug
By Celia Hooper
United Press International
WASHINGTON-A federal panel has
recommended a new AIDS-fighting
drug be approved for some patients with
the fatal disease, but the chairman says
it may amount to "a genie" let out ofthe
bottle too soon.
The Food and Drug Administration
panel voted 10-1 Friday, Jan 16, to
recommend approval of the drug for
limited prescription sale to AIDS
patients who have a certain type of
pneumonia and to patients with an
advanced AIDS-like condition.
The recommendation was made after
the panel reviewed the results of limited
testing of the drug azidothymidine by
its manufacturer, Burroughs-Wellcome
The recommendation now goes to
FDA Commissioner Frank Young for
The panel chairman. Dr. Itzhak
Brook, professor of pediatrics and
surgery at the Uniformed Service University of Health Sciences, cast the lone
dissenting vote, saying it was too early
to recommend approval.
"AZT may be a genie that we're letting out of the bottle after too little
data," he said.
But the committee concluded, "The
controlled clinical trial sponsored by
AZT's ability to prolong the short-term
survival of AIDS patients with recently
diagnosed Pneumocystis carnii pneumonia and certain advanced patients
with AIDS-related complex."
In its test, the company gave 145
patients the drug and 137 received a
dummy drug. One AZT patient died, as
opposed to 19 on the placebo.
In addition to lowering the death
rates of the study's patients with
acquired immune deficiency syndrome,
AZT reduced infections and improved
nerve and brain functioning in some
When the study ended, the government allowed the company to expand
experimental use of AZT. More than
3000 of the 13,000 Americans who have
AIDS are currently receiving the drug
free of charge.
Despite the results, the panel said it
had a number of reservations about
AZT. The drug has serious side effects,
including anemia and supression of
bone marrow production of some types
Members of the panel said
researchers had not studied the side
effects sufficiently and said they lacked
information on the long-term toxicity of
the drug, the best dosage, the interactions of AZT and other drugs prescribed
to AIDS patients, how long the drug is
effective and exactly which AIDS
patients will benefit from taking the
Panel members said they were concerned that increased availability ofthe
drug would lead doctors to prescribe
AZT for AIDS patients for whom the
drug had risks but no known benefits.
Brook said approval ofthe drug would
deter researchers from collecting new
"If we approve AZT today, it may
limit collection of new data. If we wait,
there will be more data and we can be
more sure that we're prescribing it for
the right patients."
Dr. David Barry, Burroughs-
Wellcome's vice president for research,
said the company was committed to
continued research and tightly controlled distribution of the drug.
Barry said experimental prescription
of the drug is "a tremendous burden to
the FDA, physicians and patients. The
paperwork is staggering and the delays
significant," adding the company has
spent $80 million producing and testing
The panel's recommendation does not
guarantee AZT will go on the market.
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Not Hurt by
By Elaine S. Povich
United Press International
WASHINGTON (UPI)-The nation's
two top doctors are insisting to skeptical
senators that proposed federal budget
cuts in scientific research and delays in
hundreds of research grants will not
hurt the war on AIDS.
In his fiscal 1988 budget, President
Reagan recommended increasing funds
by 28 percent for AIDS research and
education, but called for a one-year postponement of 700 basic medical research
grants at the National Institutes of
Health to save $325 million.
"It's not going to affect AIDS," Surgeon General C. Everett Koop told
reporters following a hearing Thursday, Jan. 15, by the Senate Labor and
Human Resources Committee on
acquired immune deficiency syndrome.
"The cutbacks we will be asking Congress for this spring are postponing
decisions on 700 new grants," said
Robert Windom, head of the public
health service. "All the present research
But Committee Chairman Edward
Kennedy, D-Mass., said the tactic of cutting back on basic medical research
while increasing funding for AIDS is
"robbing Peter to pay Paul."
Sen. Lowell Weicker, R-Conn.. noting
that one treatment for genital herpes
came out of dental research, said, "We
don't know where the breakthroughs
are going to come from. We can't abandon basic research. Especially with
something as flaky as AIDS."
Koop's report on AIDS, released in the
fall, predicted there will have been
270,000 cases ofthe incurable disease in
the Untied States by 1991 and that
179,000 victims will have died.
Koop said Thursday the risk for infection is increasing dramatically and the
public, especially teenagers, needs more
information on how to protect itself.
AIDS is spread by sexual contact and
can affect anyone, he said. He recommended limited sexual partners, using
condoms and avoiding sex with intravenous drug users.
The hearing set the stage for what is
expected to be an effort by the new
Democratic-led Congress to add money
to federal programs on AIDS research
and other scientific programs. Kennedy
has already said AIDS is among his top
five issues for the year.
Sen. Paul Simon, D-Ill., said he hoped
that the administration's plan to
increase funds for AIDS research would
not mean a "pull-back on cystic fibrosis,
cancer, and arthritis" research.
Koop stressed his reports show AIDS
cannot be contracted by casual nonsexual contact.
You don't get it from using the same
towels, by sharing the same bed, by
using the same telephone or even the
same toothbrush," he said, adding that
there is still a lot of misunderstanding
about the disease.