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Their concern is based on unpublished research that suggests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,
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