Remune Bites the Dust… Again
by Enid Vázquez
This is what happens
when you get into bed with the devil, says Martin Delaney.
The founding director of Project Inform, a well-respected
HIV service organization based in San Francisco, says the
demise of the experimental HIV treatment called Remune is
long overdue. The therapeutic vaccine for HIV (meant to control
disease progression, not to prevent infection) has shown disappointing
results from its beginning.
Now, in a move that could
leave people with HIV and researchers hanging, Pfizer Inc.
announced that it would end its partnership with the Immune
Response Corporation (IRC) to develop Remune (generic name
HIV-1 immunogen). The giant Pfizer recently purchased Agouron
Pharmaceuticals, which a couple of years ago had teamed up
with IRC to pursue Remune. Agouron is a small company that
produces Viracept (nelfinavir), an HIV protease inhibitor.
The Pfizer pullout may effectively end Remune’s development,
since IRC is a small firm with little money of its own.
But doctors had already warned
people not to enroll in any Remune trials that may still be
open. As the new Remune crisis unfolded, another HIV specialist
contacted Positively Aware asking that readers be warned
not to be “duped” into enrolling in the vaccine’s trials.
“Aside from showing
a lack of benefit, what was worse is the spin that IRC put
on its vaccine,” says Delaney. Even when Remune was introduced
at the Ninth International AIDS Conference, held in Berlin
in 1993, scientists jumped all over a company presentation,
contending that the data did not justify the conclusions that
this particular product was a good one to pursue. That was
followed over the years by actions that infuriated advocates
of people with HIV, including a meeting with the Food and
Drug Administration (FDA) that was misrepresented by the company
to get people to come, Delaney said.
A more recent controversy
was the lawsuit IRC filed seeking millions of dollars in damages
against a group of Remune researchers. Daniel Berger, MD.,
reported on the findings of a large-scale clinical trial involving
Remune in the March/April issue of Positively Aware.
The researchers published a report in the prestigious Journal
of the American Medical Association (JAMA) stating that
clinical trial results failed to demonstrate that the vaccine
had any effect on HIV progression-free survival or clinical
improvement (actual good health). In fact, that trial was
stopped early because it failed to show beneficial results.
It was largely believed that the introduction of potent anti-HIV
combination therapy made the vaccine unable to muster outstanding
results above and beyond what the trial participants were
already taking. (Either Remune or a placebo—fake medicine—was
being added to people’s HIV therapy.)
IRC claimed that data not
presented in the JAMA report would show some efficacy
from Remune. The researchers said that the data omitted was
inconsequential and that the company refused to turn over
other data that they had requested. The University of California,
home of the JAMA report’s lead researcher, in turn
filed its own lawsuit against IRC.
Soon after Pfizer’s announcement
on July 6, the Weiss & Yourman law firm in Los Angeles
announced it had filed a class action complaint on behalf
of all people who acquired IRC securities between May 17,
1999 and July 6, 2001. The complaint charges IRC and Agouron
with violations of federal securities laws. According to a
press release from the firm, “The complaint charges that Immune
and Agouron withheld the results of Remune’s major clinical
trial, and instead hyped the prospects of Remune, even though
defendants knew during the Class Period that Remune had no
effect upon people with HIV and AIDS. The complaint further
alleges defendants’ false misrepresentations worked to artificially
inflate the price of Immune stock.” (Visit www.wyca.com.)
The New York Times
on July 9 reported that IRC shares dropped 44% the day of
the Pfizer announcement, down $2.01 to $2.58. According to
the report, IRC planned to continue its Remune trials, but
with only enough money for about six months. Company executives
told the Times that money from investors may be hard
to come by following Pfizer’s decision.
HIV treatment advocate and
longtime Remune supporter David Scondras, founder of Search
for a Cure, in Boston, is struggling to either get Agouron
to state a scientific reason for dropping out of the Remune
trials, or to continue funding trials looking for another
potential role for the therapy. These trials seek to determine
whether using Remune during a Strategic Treatment Interruption
(STI) can increase the amount of time that a person can be
off drug and remain below a predetermined HIV viral load (the
amount of HIV in the blood). Scondras’ own partner is in a
clinical trial looking at this issue. According to Reuters
Health news service, Agouron based its decision on data from
several studies.
The thought of a pharmaceutical
company callously stopping a trial midway outraged many advocates.
But Delaney claims that the truth is, the STIs trial were
still in preliminary stages and have not actually started,
and that the 10 people in Boston signed up have not yet been
given Remune. (Scondras says his partner did receive
a Remune injection already.) Delaney says one of the big dangers
now would be a public perception that immune-based therapies—the
stimulation of people’s own immune system to fight HIV—don’t
work, rather than that Remune doesn’t work.
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