Newspaper Page Text
Southern Voice/April 25, 1991
27
AIDS
Bristol-Myers to Seek Marketing
Approval for New AIDS Drug
by Dave Gilden
AIDS NEWS SERVICE
Bristol-Myers Squibb Company has
announced that it has filed a new drug applica
tion with the FDA seeking approval to market
ddl. When the drug gets the official nod, ddl
will be the first new direct anti-AIDS drug
since AZT.
Like AZT, ddl is a nucleoside analog. It is
a defective version of one of the repeated sub
units, in this case adenosine, that makes up the
DNA in a cell's genetic material.
When the AIDS-triggering HIV virus
invades a cell and tries to insert a copy of its
genes into a human cell's DNA, taking up an
AZT or ddl molecule breaks the new DNA
chain the virus is forming. The attempt at
infecting the cell fails.
Past experience has shown that AZT loses
effectiveness after someone has taken it for a
year or two. Side effects such as anemia and
muscle weakness accumulate, and the HIV in
the person's body seems to become resistant to
the drug.
As people live longer with HIV and AIDS,
and begin taking AZT earlier in the disease
cycle, alternatives to AZT have become des
perately needed. For many people with AIDS,
their time on AZT is running out.
ACT UP, Project Inform in San Francisco
and other groups across the country have con
ducted a vigorous campaign since last August
to accelerate approval of ddl and the related
ddC. Target dates of December 1 and then
March 1 had been set for their approval.
The biggest surprise in Bristol-Myer's
announcement was that the company was
seeking approval for a very wide spectrum of
use—in anyone with symptomatic HIV infec
tion. Previously, the rumor had been that
Bristol-Myers was going to request approval
for prescribing ddl only to PWAs who were
failing on AZT and to children with AIDS.
In March, Martin Delaney of Project
Inform told AIDS News Service, "We were
pushing for the broadest indications for ddl,
but they said that would delay approval."
Bristol-Myers will not yet comment on
what data caused the company to change its
mind. More than 23,000 people worldwide are
now taking the drug, either in official trials or
through the company's free compassionate use
As people live longer with HIV and
AIDS, and begin taking AZT earlier
in the disease cycle, alternatives to
AZT have become desperately needed.
For many people with AIDS, their
time on AZT is running out."
program, making for a very large body of
experience to draw upon.
FDA approval under Bristol-Myers' terms
should make the drug readily available to
everyone, including those who want to experi
ment with combined ddl-AZT therapy. But
ddl's price may be a major stumbling block.
According to Bristol-Myers spokesperson
Susan Yarin, "It is premature to speculate on
the cost of the drug." It is clear, though, that
the exceptional costs of distributing ddl free to
23,000 people will be reflected in its final
price.
Another big question is how long the FDA
will take to review the licensing application
for the drug. In a statement issued April 10,
Roland G. Chesemore, FDA Associate
Commissioner for Regulatory Affairs,
promised, "We have assigned the highest pri
ority to review and evaluation of ddl."
But according to AIDS authority Dr.
Donald Abrams, the FDA Antiviral Advisory
Committee, of which he is a member, has
scheduled a meeting to discuss ddl in "June or
July". Since the advisory committee does not
have the final say on the drug, it is likely that
approval of ddl is still many months off.
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L. S’- WELCH
Cont'd from page 11
Aging. She was, in fact, on the verge of
coming out when she learned that Project
Open Hand was looking for an Executive
Director. Karen landed the position and
began work last December. She calls the
sequence of events and change in jobs,
"really just coincidental." And then with
a smile she says it's also, "one of the best
things I've ever done for me.. .it's been
good for my mental health."
Karen is all the way out at Project
Open Hand. This particular career move
has enabled her to strip away a layer of
anxiety. She believes she worries less
and trusts her own judgment more. She
knows how difficult it is to be a woman
and a lesbian in the workplace, but "not
at Project Open Hand," she says.
Karen Boyles is obviously happy
about the direction her life has taken
recently, but now at 40, admits, "if I
could do it over, I would have done it
sooner.. .1 wish I'd been more coura
geous.”
Karen's already making up for lost
time on the courage issue. Not long ago,
a former coworker from the Council on
Aging who didn’t know Karen is a les
bian, applied for a position at Project
Open Hand. At the end of the interview,
Karen just told the applicant, Roberta,
the truth, and asked if that would be a
problem. Since it wasn't a problem,
Roberta now works there and happily
agreed to be quoted. "It doesn't matter to
me. I'm glad to have a job."
Rebecca Hart is 39, attends church
regularly, loves cycling and sells Mary
Kay Cosmetics for extra income. For
over two years now she has worked as a
Graphic Designer at CNN alongside
David Salyer. Rebecca says she can't
even remember how or when she real
ized David was gay. However it hap
pened she says, "I guess I wasn't shocked
or surprised." Does she remember work
ing with any other openly gay men in the
past? "Are you kidding," she laughs,
"I'm from Conservativetown, U.S.A."
Last spring Rebecca and David grew
closer during simultaneous break ups
with boyfriends and discovered they
were able to talk candidly with one
another. Having survived Bruce and
Scott, Rebecca and David like to talk
about thirtysomething now. But some
times they still like to talk about men.
Rebecca believes working with an
openly gay man like David has made her
more aware of the problems gay people
face. She says, "it must take a lot of
courage to come out because you're
going against the norm." Then, after a
pause, Rebecca adds, "courage is an
admirable quality in anybody."
Next issue: "Out of the Darkness"
turns to the spiritual and religious choic
es that open lesbians and gay men make.
This installment of "Out of the Darkness"
is part three of a seven-part series.
It Isn't Easy Being Green
But knowing who to talk to makes a big difference.
We understand your concerns. You don't need to have a problem
to come in for information, a check-up, or expert advice about
staying healthy.
Our job is to keep you in bloom. And we know how. Call us. Soon
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