Remune Bites the Dust . . . Again
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, M.D., 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 the 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 trials were still in preliminary stages and had not actually started, and that the 10 people in Boston signed up had 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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