PAGE 4 T Q-Notes ▼ January 24, 1998
Rights stakes may be highest in ’98
by Peg Byron
Special to Q-Notes
NEW YORK—Lambda Leg^ Defense and
Education Fund staff are predicting that the
coming year will bring a record number of gay
and AIDS-related concerns to the country’s
highest courts.
“The United States Supreme Court and
other high-level courts are expected to address
employment, the military, disability protec
tions, family and other fundamental constitu
tional issues for lesbians, gay men and people
with HIV in 1998,” said Lambda Legal Direc
tor Beatrice Dohrn.
“Never have the stakes been so high for the
civil rights of our community. We expect an
unprecedented number of decisions from top-
level state as well as federal courts, and they are
Last fall, a three-judge federal
panel disregarded the Supreme
Court’s ruling against Colorado’s
Amendment 2 and upheld
Cincinnati's Issue 3.
likely to affect the way lesbians and gay men
are treated across the country for many years
to come,” she added.
In 1998, among more than 50 cases on its
docket. Lambda expects a ruling from Hawaii’s
highest court that may make civil marriage
available to lesbian and gay couples for the first
time in this country. State by state. Lambda
also is fighting child custody and adoption rul
ings that discriminate against lesbian and gay
families. In one such case, being fought in
North Carolina, the state’s highest court is ex
pected to rule on whether Fred Smith, who is
gay, can have his two sons returned to his care,
since his ex-wife won custody because of his
sexual orientation.
In the US Supreme Court this spring.
Lambda is coordinating amicus briefs challeng
ing a Maine dentist’s refusal to treat a woman
with asymptomatic HIV. The case, Bragdon v.
Abbott brought by the Gay and Lesbian Advo
cates and Defenders, could determine whether
the Americans with Disabilities Act covers hun
dreds of thousands of people who are infected
with HIV but show no sign of illness.
Lambda awaits a Supreme Court ruling in
another employment-related case, Oncale v.
Sundowner Offshore Services, Inc., for which it
authored an amicus brief joined by the leading
women’s organizations as well as gay and other
civil rights groups. In this same-sex sexual ha
rassment case, heard by the Court December
3, Lambda argued that the federal law against
sexual harassment at work should be applied
without regard to the sex or sexual orientation
of the harasser or victim.
Another challenge to the widespread prob
lem of anti-gay employment discrimination is
one of the first cases to test California’s protec
tion for lesbian and gay
workers. Argument against
California Causality
Management’s firing of sales
man Dan Kovatch is ex
pected before a state court of
appeals this spring.
In the only active federal
appeal of “Don’t Ask, Don’t
- Tell,” Lambda, with the
ACLU, has just filed its brief in v. USA. A
district-level court rejected the policy as uncon
stitutional in July; the US Court of Appeals for
the Second Circuit is expected to hear the
government’s appeal early in 1998.
In a renegade decision last fall, a three-judge
federal panel disregarded the Supreme Court’s
ruling against Colorado’s Amendment 2 and
upheld Cincinnati’s nearly identical Issue 3,
which would prohibit legislators from approv
ing discrimination protections for lesbians, gay
men and bisexuals. Determined to put an end
to the nation’s last remaining anti-gay ballot ini
tiative, Lambda and co-council have appealed
for a hearing by the entire Sixth Circuit Court.
Lambda, which celebrates its 25 th anniver
sary this year, itself was born of a court batde.
It incorporated in 1973 after defeating a New
York state court j udgment that found there was
“no demonstrated need” for a non-profit group
defending lesbian and gay civil rights. T
Two groups propose live
HIV vaccine trials
by Dan Van Mourik
Q-Notes Staff
NEW YORK—The media has recently fo
cused a great deal of attention on volunteers
who have stepped forward to submit themselves
to live attenuated (weakened) HIV vaccine tests.
However, researchers warned of the risks posed
by the studies and a US company said it could
be two years before a product was even ready
for testing. At the same time, an Australian
research team said human studies could begin
within 18 months.
The flurry of activity surrounding live at
tenuated HIV vaccines began when the Chi
cago-based International Association of Physi
cians in AIDS Care (lAPAC) announced that
more than 50 individuals had volunteered to
participate in a study of a live attenuated vac
cine, first described by Ronald Desrosiers of the
Harvard Medical School.
Desrosiers and other research teams have
shown that live attenuated SIV (Simian Immu
nodeficiency Virus) vaccines could provide
impressive protection in monkeys. But con
cerns began to mount with reports that some
newborn and adult monkeys developed simian
AIDS fi'om die vaccines.
These reports led some researchers, includ
ing Anthony Fauci, director of the National
Institute of Allergy and Infectious Diseases
(NIAID), and Barry Bloom, chair of the
’’Further delays are unethical”
— Dr. Charles Farthing
UNAIDS Vaccine Advisory Committee, to
publicly suggest that human studies should not
begin at this time. ^
To date, at least four research groups repon
monkeys that show signs of immune suppres
sion after receiving a live attenuated SIV vac
cine.
Proponents of the live attenuated trials met
with officials at the US National Institutes of
Health (NIH) to explore ways of “moving the
live attenuated approach forward.” According
to participants, a number of key questions, be
yond safety concerns, were identified. These
questions included: 1) whether any company
would be willing to produce a live attenuated
HIV vaccine; 2) whether the US Food and
Drug Administration (FDA) would approve a
manufacturing plan and clinical trial protocol
for such a vaccine; 3) how an informed con
sent process might be developed that would
accurately describe the potential risks from the
trial; and 4) what party would be responsible
for adverse events caused by the vaccine.
lAPAC proposed a trial that would use a live
vaccine designed by Desrosiers that contains
HIV with at least four genes deleted. Initially,
five individuals would be vaccinated. If these
individuals maintain low levels of HIV after six
months, the trial would be expanded. John
Sullivan, a researcher at the University of Mas
sachusetts Medical School, has proposed that
the first study should be in terminal cancer
patients. The study would last 6-12 months
and only patients with solid tumors for which
there is no therapy would be enrolled. Accord
ing to Sullivan, since many terminal cancer
patients have competent immune systems, im
portant information could be obtained from
the trial.
But no matter what trial plan might be
adopted, producing a suitable vaccine could
take several years. Even then, there is no guar
antee of FDA approval for testing in humans.
In the past, the FDA has been reluctant to ap
prove the use of transformed T-cell lines (one
proposed method of producing the vaccine).
However, this policy is currendy under review.
While lAPAC officials suggested they would
go ahead with a trial, even without FDA ap
proval, Dennis Panicali, president of Therion
Biologies, said his company “would not, under
any circumstances, produce a product for hu
man tesdng without full FDA approval.”
Researchers at Macfarlane Burnet Centre in
Australia may be farther along in preparing for
a human study. The Australian team, led by
John Mills, is pursuing a different strategy than
the US researchers. It is attempting to pro
duce a live vaccine that mimics an apparendy
weakened HIV strain found in a group of long
term non-progressors. The vaccine will be pro
duced from infectious DNA clones capable of
causing infection rather than the live virus that
lAPAC is proposing. Mills believes that infec-
tious DNA will be less expensive
to produce, store and administer
than live anenuated HIV. If all
goes well. Mills suggests that hu
man trials would begin within 18
months.
Although most AIDS researchers have ex
pressed admiration for the potentid courage of
the lAPAC volunteers, many appear to agree
with Fauci and Bloom that it is too early to test
a live attenuated HIV vaccine in humans.
Safety concerns are unquestionably the
greatest hurdle to human studies. While not
dismissing the need for safety, Desrosiers ex
plained that “it is unrealisdc to expect any live
attenuated vaccine to be absolutely, 100 per
cent safe. Every live vaccine used in people has
some adverse events associated with it. For ex
ample, the live polio vaccine is associated with
a very small number of paralyde poliomyelitis
cases. But society accepts this risk because of
the overall benefits of the vaccine. Similarly,
the likelihood of adverse events from an HIV
vaccine must be weighed against the frequency
of new infecdons and disease in a target popu
lation.”
Charles Farthing, a Los Angeles physician
and lAPAC member who has volunteered for
the trial, says “it is wrong to require an AIDS
vaccine to meet US safety and efficacy stan
dards when 8500 individuals are infected with
HIV every day around the world.” Given the
enormity of the crisis, says Farthing, “further
delays are unethical.” He does recognize, how
ever, that “our willingness to test the vaccine
on ourselves is useless without the support of
the decision makers in the US, the UN, the
scientific community and the biotechnology
companies.” ▼
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