Badpuppy Gay Today

Monday, 27 October 1997

SIX YEAR FEDERAL STUDY LAUNCHED ON IL-2
To Find if Interleukin-2 Helps Prolong Lives of HIV Patients
$30 Million International Study on Immune Regulatory Protein

By Corrine Hicks



 

Last week the federal government announced it was launching a $30 million six-year global study to measure more precisely the effectiveness of IL-2 (Interleukin2), a controversial immune-based therapy. There are claims that the regulatory protein boosts the numbers of CD4 cells in sick patients.

The government-sponsored study will determine whether IL-2 prolongs the lives of HIV patients.

Currently, it appears, there is no strong data, which proves IL-2 to be undeniably effective in promoting healthy effects and CD4 counts. This lack of pertinent data stands in contrast to the obvious life-prolonging powers of anti-viral combination drug therapy.

Chiron, the pharmaceutical company that is attempting to speed IL-2 approval by the federal Food and Drug Administration, says IL-2 is responsible for remarkable cell count improvements which should help to persuade the FDA on its behalf.

The government's health-watch agencies, however, are, in the case of IL-2, not likely to be stampeded. The National Institutes of Health isn't convinced and wants hard data to prove the agent to be a needed weapon against untimely deaths.

Beyond this demand, NIH also wants proof that IL-2 does more than raise CD4 cell levels. It also wants to know if the rise in those levels adds to a patient's healthiness and his or her life span.

The trial studies, sponsored by NIH, will enroll 3,700 people worldwide, all of whom must have CD4 counts over 350. Half of the enrollees, according to the Gay Men's Health Crisis in New York, will be given a placebo injection twice daily while the remaining half will get IL-2 for five days every 8 weeks.

Once again the question of "placebo morality" figures into the new studies. Should half of a study group be denied a potentially life-saving substance?

But an even more ungainly problem will continue to plague IL-2 studies. Because many HIV patients are presently taking combination anti-viral therapy, the success of IL-2 may become hard to measure due to the success of the " combo cocktail" method.

Once again "undeveloped countries"— a euphemism for the world's economic midgets—the poor-- are being chosen for tests where the new and expensive combination therapy is unknown.

There are those who believe that IL-2 precipitates rather than retards the AIDS virus. If this is so, they argue, it becomes unethical to worsen infected patients, take them to a cliff and offer them no life-saving "cocktail" ropes.

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