The Gayly Oklahoman (Oklahoma City, Okla.), Vol. 9, No. 8, Ed. 1 Monday, April 15, 1991 Page: 16 of 24
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AIDS UPDATE
by Larry Prater, M.D.
Bristol-Myers Squibb Co. of New York has
filed a new drug application—a major hurdle in
the drug approval process — for dideoxyinosine
(ddl) with the Food and Drug Administration.
Currently, Bristol-Myers is making the drug
available for free to AIDS patients who have no
other treatment options and who cannot take part
in the traditional tests required for drug approv al.
More than 17,000 people have received ddl
through the special “expanded access’* program
and another 2,300 got ddl in traditional tests,
company officials said. But AIDS activists
contend even more patients would be able to get
the drug if it was approved for general marketing
and have called on the FDA to make a decision on
ddl as quickly as possible. Since March 1987,
there has been only one government-approved
drug (ACT) to directly fight the AIDS virus.
Both ACT and ddDI work by interfering with an
enzyme the virus needs to reproduce. “It’s high
time that some other drugs came down the
pipe... let’s hope it stalls a price war,” said Mark
Harrington of AIDS Coalition to Unleash Power
(ACT-UP) in New York, ddl is chemically
similar to ACT, but appears to have different
toxic side effects. Consequently, patients who
cannot tolerate ACT may be able to take ddl.
Many patients have to stop taking ACT due to
severe anemia and bone marrow suppression,
ddl has been associated with a potentially fatal
inflammation of the pancreas and can trigger a
painful nerve disorder in the hands and feel. Brad
Stone, an FDA spokesman, would not speculate
how quickly ddl could be approved, but noted it
took only three and a half months between the
time AZT’s new drug application was filed and
final approval. “We review any application for
any AIDS drug as quickly as possible. But it is
impossible to say how long it will take for ddl,”
Mr. Stone said. In its application, Bristol-Myers
asked for permission to market ddl under the
A
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Want
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The Gay & Lesbian
HELPLINE
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Wednesday - Monday
(4U5) 642-4297
tradename VIDEX for treating both children and
adults who have symptoms stemming from in-
fection with HIV. Mark Harrington said he was
pleased Bristol-Myers was pushing for a “broad
indication” for ddl, not just recommending the
drug only for people who cannot tolerate ACT.
“That means it could be taken in combination
with ACT, which should have the best therapeutic
effect," he said. Dr. Mervyn Silverman, president
of the American Foundation for AIDS Research
in New York said, “We hope the (FDA review)
will be expedited to the greatest degree possible
and as many people as possible will benefit from
this.” Dr. Silverman said ddl probably will be
priced more affordably than ACT, which costs
about $10,000.00 annually per patient when it
was first approved. However, he said he does not
expect ddl to push ACT off the shelves because
the two drugs will most likely be used together in
treatment strategies. Susan Yarin, a spokeswoman
for Bristol-Myers Squibb Co., said about 3% of
patients receiving ddl in tests developed in-
flammation of the pancreas, called pancreatitis.
Of the patients with ddl-linked pancreatitis, about
10% died in the first eight months of testing, but
that death rate has since declined to about 5.4%,
Ms. Yarin said. Early tests of the drug showed it
boosted levels of key immune cells, called T-4
cells, and promoted weight gain, Ms. Yarin said.
The company spokeswoman refused to comment
on results of later tests or predict when ddl might
be approved or how much it would cost. Another
experimental drug related to ddl, dideoxycy tidine
or ddC, is at a similar stage of testing. ACT-UP
has charged that the maker of DDC, Hoffman-
LaRochelnc., ofNutley, N.J., is dragging its feet
in providing ddC to HIV-infected people.
Two government agencies are sponsoring a
study to determine the effectiveness of a drug that
may be useful in treating mental dysfunction
caused by HI V. At least 150 people infected with
HIV will be enrolled in the trial sponsored by the
National Institute of Mental Health and the Na-
tional Institute of Allergy and Infectious Diseases.
The drug, Peptide T, was developed by NIMH
and has been through an initial round of trials
testing its safety. AIDS activistshad been pressing
the National Institute of Health to begin Phase II
studies even though Peptide T has no drug
company sponsoring it, said Anna Blume of
ACT-UP/New York. The second phase of study
is designed to determine whether Peptide T can
safely reduce AIDS-caused problems of con-
centration and memory, and whether it is safe and
effective when used with ACT. Peptide T is an
artificially produced protein that blocks the at-
tachments of HIV to human cells.
Fill out Sc return
the Gayly Survey
on page 8 and get a FREE
Gayly Bumper Siickeri
AIDS SUPPORT PROGRAM, INC.
2236 NW 39th Street, Oklahoma City, OK 73112
(405) 525-6277
Serving persons with HIV/ARC/AIDS
and those who love and care for them
Support Groups • Emergency Transportation • Visitation
The Winds Residence • Food Basket • Clothes Closet
Buddy Program • Massage Therapy • Names Project
Counseling • Referrals • Information
Free, Anonymous HIV Counseling and Testing Site
every Thursday, 7:00 - 8:30 p.m., ASP office
Anonymous testing by appointment from 9 to 5, Monday - Friday
(no name necessary to make appointment)
staffecnD^ASPvolunteJmvhoarecertifiedb^^
Page IS ▼ThelfcAYLy A April 15,’91
• • ,Z! A. ' V+S F *
DEAR DR. W.,
Doctor Wlodover is a board certified special-
ist in infectious diseases at the Oklahoma City
Clinic, and manages their AIDS/STD clinic.
Please send your questions to him c/o The
Gayly Oklahoman, or make an appointment
for a private consultation by calling
(405) 271-2717.
Dear Dr. W,
I am HIV positive, fortunately still
asymptomatic. Last year my doctor told me to
take ACT. I was hesitant since I was feeling well,
but he said it was the right thing to do. Nowafew
weeks ago I heard that it doesn’t work unless you
are already feeling bad. You can see I’m confused.
Please help clarify.
— S.S.
Dear S. S.,
In 1989, data was reported that ACT post-
poned progression to AIDS in HIV positive,
asymptomatic persons, if their T4 lymphocyte
count was less than 500. At that point, the
message seemed clear. x
However, more recent data indicates that
although ACT may delay the onset of symptoms
for the asymptomatic, HIV positive individual, it
does not prolong life. A group of 338 HIV
infected persons were randomized to receive
ACT either immediately, or to wait until their
immune system further deteriorated. The study
ran for three years. Over this period, for white
men, 14 of 107 who immediately took the drug
developed symptoms, compared to 32 of 113
who waited. However, there was a 30% mortal-
ity, regardless of whether ACT was started earlier
or later. In a group of Hispanic and black indi-
viduals, the drug did not postpone symptoms. On
the other hand, ACT continued to show its benefit
when symptoms did develop, consistent with
previous studies.
We must remember that HIV infection and
ACT treatment is very complex. There are mul-
tiple factors, beyond simply HIV and ACT, which
affect how a person is going to do. Recall also
that ACT was virtually rushed through the FDA
testing procedures, for the obvious reason of
urgency in getting a drug to infected persons as
soon as possible. Studies such as the ones in 1989
which showed ACT to be beneficial to the HIV
positive, asymptomatic individual, were reported
before progression to death was known. We still
know relatively little about HIV and ACT. Sim-
ply stated, we need more data.
At this point, should an HIV positive,
asymptomatic individual take ACT? If the T4
lymphocyte count is less than 500, and he can
tolerate it without adverse side effects, I would
still say “yes” for the following reasons: ACT
still seems to postpone symptoms if not prolong
life. The relatively lower doses now in vogue are
causing less side effects. And if side effects
develop, ACT can always be discontinued.
From a psychological standpoint, some pa-
tients and their prescribing physicians are prone
to medications, others rely more on time, pa-
tience and nature. The best place to be is prob-
ably somewhere in between.
NEW SERVICE FOR PWAs
The Robert Wood Johnson Foundation,
which has funded many AIDS-related projects,
has announced the beginning of “Let’s Talk,” a
free telephone support group for rural Oklahoma
PWAs and HIV-positive persons. The support
group is coordinated by a mental health facilitator
skilled in working with these persons. Meeting
each week via teleconference call, persons in
isolated areas with no access to support groups
can freely discuss feelings and problems, hear
updates from professional health care experts in
the field, and connect with others with the same
problems in an anonymous, confidential format.
For more information about joining a group,
call Diane Farris, new project coordinator, at 1 -
800-256-2828.
PREVENT A LITTER
Each year in Oklahoma City alone, over
50,000 homeless pets are destroyed in animal
shelters; and of course countless others wander
forlorn and abandoned until hunger, illness, or
injury overtake them.
To help combat this appalling situation,
Volunteers for Animal Welfare and numerous
veterinary clinics in the OKC area are sponsoring
a reduced-cost spay and neuter campaign. These
veterinarians are offering a variety of reduced
sterilization fees for a limited time. Call VAW at
; (405) 842-7882 or (405) 843-4755 for a list of the
| participating veterinary clinics.
WANT TO FEEL AND BE HEALTHIER?
Non-sexual Full Body Therapeutic Massage
One Hour at your home. $30.00
Personalized Fitness Instruction
One Session - Home or Gym $20.00
Stephen Scott
Health & Wellness Specialist
since 1984
call: (405) 236-FITT for appt.
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405 / 848-5429
Shirley CM* Dhmler, lM£JL
LICENSED PROFESSIONAL
COUNSELOR
EMPHASIS ON THE PROBLEMS
OF GAY PEOPLE
5009 N. PENN
SUITE 102 • OKC, OK
E. V. Johnson,
D.D.S.
General Comprehensive
Dentistry
Night & Sunday Practice
Emergencies Welcome
5009 N. Penn, Ste. 103
OKC • (405) 840-5410
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Shaffer, Ron & Hawkins, Don. The Gayly Oklahoman (Oklahoma City, Okla.), Vol. 9, No. 8, Ed. 1 Monday, April 15, 1991, newspaper, April 15, 1991; Oklahoma City, Okla.. (https://digital.library.unt.edu/ark:/67531/metadc824406/m1/16/: accessed April 18, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting Oklahoma Historical Society.