The San Francisco Examiner - Wednesday, October 22, 1997
Lisa Krieger, Examiner Medical Writer

IL-2, an immune regulatory protein called a cytokine, has been shown in preliminary tests to boost the number of immune system CD4 cells in sick patients.

But there is no evidence that the immune boost created by IL-2 treatment offers actual improvement in health - in stark contrast to anti-viral combination drug therapy, where a CD4 increase is closely correlated with positive clinical effects. For reasons that are not well understood, CD4 increases induced by IL-2 don't seem to be a good marker of future health and longevity.

So it is impossible to say, based on current data, that a CD4 count of 1,000 achieved with IL-2 treatment signifies better immunologic health or improved prognosis than does a CD4 count of 200, without IL-2 treatment.

According to the manufacturer, Chiron, based in Emeryville, these cell count improvements are persuasive enough evidence for them to move forward with plans to apply to the federal Food and Drug Administration for accelerated approval of the agent.

But the federal National Institutes of Health wants better proof that IL-2 helps immune system recovery - and more important, whether this immune system recovery translates into clinical benefit, as marked by a delay in disease progression or improved survival.

The upcoming NIH-sponsored trial will seek to enroll 3,700 people around the world with CD4 counts above 350, half of whom will receive twice-daily injections of IL-2 for five days every eight weeks, according to a new report of the study by Gay Men's Health Crisis in New York City. The other half will receive an inactive placebo.

There are challenges, practical and ethical, in the proposed study.

For instance, there is the possibility that participants will stay so healthy due to new anti-viral combination drug treatments, with or without IL-2, that not enough people will progress to AIDS to prove whether the immune-based therapy helps.

So the study protocol team has proposed enrolling large numbers of patients in undeveloped countries where prognosis is poor and anti-viral therapy is not available. But this raises several serious ethical questions: Why test a therapy in populations that will never have access to it? And what if IL-2 boosts levels of the AIDS virus, as some fear - and patients are without the protection of proven anti-viral therapy?

Journal resignations

It was a similar ethical question - should studies be carried out in populations that will never receive the fruits of the research? - that has created turmoil at the prestigious New England Journal of Medicine in Boston.

Two top AIDS scientists quit their advisory posts on the Journal because its editor did not consult them before printing a strong editorial last month that criticized a U.S.-sponsored AIDS drug trial as unethical.

Dr. David Ho of the Aaron Diamond Research Center in New York and Dr. Catherine M. Wilfert of Duke University School of Medicine are supporters of a study in which some African pregnant women who have HIV receive AZT, while others get a placebo.

The editorial, written by the journal's executive editor Dr. Marci Angell, said that the rationale for the study was "ethical relativism" that "could result in widespread exploitation of vulnerable Third World populations for research programs."

Ho and Wilfert were angered because the Journal failed to consult with the board before publishing the editorial. In response, the Journal said it is not its policy to have board members review editorials or other opinion pieces before publication.

Events

Community groups and people with HIV are holding a public forum Tuesday to discuss what they perceive as the "bureaucratization" of The City's AIDS service organizations. The forum will be Oct. 28 at 7 p.m. at the Metropolitan Community Church, 150 Eureka St.

"People with AIDS have little to no input at most of the big AIDS service organizations," asserted Jeff Sheehy of the Harvey Milk Democratic Club, a sponsor of the forum. "These agencies handle tens of millions of dollars that theoretically benefit people with AIDS - yet when actual people with AIDS ask where the money goes or how decisions are made, we are consistently stonewalled."

Activist Hank Wilson agreed: "Too many of the organizations conduct business in closed meetings, not open to the community, and the boards are entirely self-perpetuated. The closed-door mentality and secrecy has got to stop."

Organizers plan to create a set of "sunshine principles" for AIDS groups, requiring open board meetings, annual public meetings, community election of board members, public access to information that does not violate client or employee confidentiality and electronic publication of organization records.

They will ask San Franciscans not to give money to nonprofits that do not adhere to these principles and will ask the San Francisco Board of Supervisors to deny city contracts and funding to nonprofits that do not adopt similar policies.

For information, call (415) 252-9200.

Dr. Robert Gallo, director of the Institute of Human Virology in Baltimore; former director of the San Francisco Department of Health Dr. Sandra Hernandez, and Project Inform's Martin Delaney will be the featured speakers at Project Inform's annual "Evening of Hope" benefit dinner on Friday, Nov. 7 at the Westin St. Francis at Union Square. Call (415) 864-6397 for ticket information.

The toll

Matthew Perry, 46, a manager in the early days of the Jaguar Bookstore and owner of a successful tax preparation and bookkeeping service . . . Manuel Lago, 55, who was born in Cuba, studied comparative literature, and was an ardent Francophile who wrote on the composers of the Impressionistic era . . . Reuven Closter, 46, who in the late 1970s was active in San Francisco's lesbian and gay Jewish organization The Lost Tribe, in New York City.

Date Cases Deaths reported

S.F.. . . 10/1 24,682 16,900

Calif.. . 10/1 103,056 65,744

U.S.. . . 10/1 612,078 379,258

WHO 10/1 8.4 mil 6.4 mil

Figures are cumulative since June 1981.

Note: AIDS statistics can no longer be updated weekly due to a decision by city, state and federal epidemiologists to release new data only four times a year.

To contribute to AIDSWEEK, call (415) 777-7867.
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