translation agency

San Francisco Examiner
Controversy raging over AIDS vaccine
Lisa M. Krieger of the Examiner Staff
December 24, 1997
THIS WEEK, the debate continues over the wisdom of the doctors who have volunteered to be injected with a controversial AIDS vaccine.

"Don't Die Of Recklessness," warns the headline of an editorial in the British journal New Scientist.

"Such trials may seem noble and courageous but in practice they are a thoroughly bad idea," the journal asserts. "We now know that the vaccine is potentially far more dangerous than anyone thought.

"Incredibly, it seems that these doctors were - and still are - prepared to put themselves and their colleagues at risk without first consulting the people who have been testing similar vaccines in animals."

Their concern is based on unpublished research that suggests that the "live attenuated" vaccine, reputed to be incapable of causing disease, could lead to infection by HIV.

This approach to vaccine development, pioneered by Ron Desrosiers at Harvard Medical School's New England Primate Center in Southborough, Mass., is based on the presumption that the injected virus - live but "attenuated" because it has three genetic deletions - cannot reproduce.

But Ruth Ruprecht, a researcher at the Dana-Farber Cancer Institute in Boston, has released new data from experiments on adult monkeys that cast serious doubts on the safety of the proposed human trial.

Previously, Ruprecht has shown that up to 90 percent of newborn monkeys exposed to an attenuated version of SIV, the monkey AIDS virus, show signs of immunodeficiency. Desrosiers has dismissed this finding, saying it occurs only if the monkeys are given very high doses of the vaccine. Moreover, he says, the vaccine is safer in adults.

Ruprecht has now found that one of 18 adult rhesus monkeys infected two years ago with an attenuated SIV has developed AIDS. Another is showing early signs of immune deficiency, New Scientist reported.

The volunteers could be faced with much bigger dangers than they realize, according to Ruprecht. "Weakening the virus' ability to replicate is not a safe vaccine strategy," she asserts.

Even before her announcement, others were criticizing the doctors' plans.

The trial "is not going to answer the substantial questions," said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. Like Ruprecht, Fauci worries about long-term problems and says more work must be done with animals before scientists can tell whether a human trial is justified.

Who should go first?

Sir George Pickering, professor of medicine at Oxford University, once said: "The experimenter has one golden rule to guide him as to whether the experiment is justifiable. Is he prepared to submit himself to the procedure?"

The story of medicine's self-experimenters was told for the first time in 1983 by Jon Franklin and Dr. John Sutherland in their book "Guinea Pig Doctors: The Drama of Medical Research Through Self-Experimentation," published by Morrow. It was followed in 1987 by a book by New York Times reporter Dr. Lawrence Altman, entitled "Who Goes First? The Story of Self-Experimentation in Medicine," by Random House.

When to volunteer?

When is it appropriate for anyone - scientist or physician or HIV patient - to take the risk of volunteering for a study?

These are some questions to ask if you are asked to take part in a medical study:

*Is volunteering the best course for me? If you weren't doing this research, what would you say is best for me?

*What are my alternatives if I don't take part?

*Why are you doing this study? What do you hope to learn?

*Have there been previous studies? How many of the patients (or animals) benefited?

*What are my obligations in time, travel or expense? Will I be reimbursed?

*Will I actually be getting the drug (or vaccine) under study? Or is this a "blinded" study, in which some patients are randomly assigned to receive an inactive placebo?

*What are the possible complications or risks? Will there be pain?

*What if I do suffer harm - who will pay for the care? Will you pay for me for as long as I am affected - or only for as long as I am here?

*Who do I call if I have questions or problems?

*If I withdraw from the study, will you treat me anyway or must I seek care elsewhere?

*If the study cannot help me personally, can my participation help others? How?

It is noble to contribute to the betterment of medicine. The courage, commitment and cooperation of patients has propelled HIV research to where it is today.

But in a letter to the New England Journal of Medicine, Dr. Dennis Moritz of Walter Reed Army Medical Center wrote: "It is easy to forget the sacrifices and decisions we often ask our patients to make in the hope of advancing medical science.

"The published article can never reflect the harsh reality of repeated venipunctures, arterial sticks, lumbar punctures, central lines, various tubes and other invasive procedures."

The toll

Fritz Shultz, born and raised in Lodi, a 1978 UC-Santa Cruz graduate, music lover, and an active member of Bethany Methodist Church in Noe Valley for 15 years . . . Jon Patrick Rollins, 43, director of music at San Francisco's St. Francis Lutheran Church and former director of the Portland Gay Men's Chorus, who began organ studies in high school and was former assistant organist at the Cathedral of St. John the Divine in New York, in Palm Springs.

. . . . . .Date . Reported Cases. . Deaths

S.F.. . . .12/1 24,881 16,974

Calif.. . .12/1. . .103,056 65,744

U.S.. . . .12/1 . .612,078 379,258

WHO(rprtd) 12/1 8,400,000 6,400,000

Figures are cumulative since June 1981. Government officials now compile and release statistics quarterly, not monthly. To contribute to AIDSweek, call (415) 777-7867.

AIDSweek columns are available on the Internet at www.examiner.com / aidsweek / aidsweek.html



www.aegis.org