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Date: Sat, 20 Sep 1997 19:04:55 -0400 (EDT)
From: Iamcsquid@aol.com
Message-ID: <970920190227_-495857015@emout03.mail.aol.com>
To: ignition-point@majordomo.pobox.com
Subject: IP: some news matters
i am not sure what my stand is on the AIDS experiments, but i think herbal
aand other remedies (including "essiac tea") should be more rigorously
investigated, as over against expensive remedies like AZT.
The reuters also contains an interesting item about illness in a cruise ship.
All my best in our struggle,
Craig E. Gibson
iamcsquid@aol.com
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NYT, Science, Thursday, september 18th, 1997
U.S. AIDS Research in Poor Nations Raises an Outcry
By SHERYL GAY STOLBERG
WASHINGTON -- For the past two years, the United States has been conducting
experiments on pregnant women infected with HIV in Africa, Thailand and the
Dominican Republic, in which some women are given drugs that can prevent
transmission of the deadly AIDS virus to their babies and some receive only
dummy pills.
The studies are so controversial that even some of the government's own
scientists have questioned whether they are ethical. Now, one of the nation's
most prestigious medical journals has thrown a harsh spotlight on the
research, with an editorial that likens it to the notorious Tuskegee
experiment, in which poor black men suffering from syphilis were left
untreated.
The AIDS studies, which involve 12,211 women in seven countries and are
paid for by the National Institutes of Health and the Centers for Disease
Control and Prevention, aim to help the developing world find a cheap,
effective method of preventing transmission of HIV to babies. The research is
based on one of the most dramatic discoveries of the AIDS epidemic: that
women who take the drug AZT during pregnancy can cut the risk of transmission
by two-thirds.
But the drug regimen, as used in the United States, costs about $1,000 per
mother, so public health officials want to know if there are less expensive
ways to use AZT to achieve the same benefit. Half the foreign women in the
experiments receive AZT, at varying levels that differ from the amounts used
in the United States. The other half get the dummy, or placebo, pills.
As a result, critics say, more than 1,000 infants will contract the AIDS
virus, infections that the studies' detractors say could be prevented.
"We have turned our backs on these mothers and their babies," complained
Dr. Peter Lurie of Public Citizen, an advocacy group that has condemned the
research.
Federal officials counter that the use of dummy pills is the only way to
get a quick, reliable result, and that it is not depriving women of therapy
they would have otherwise received, since AZT is not affordable in the Third
World. But some critics suggest that this argument is reminiscent of defenses
offered for the Tuskegee experiment, in which researchers watched the ravages
of syphilis while saying that the subjects of their study, poor black men
from rural Alabama, would not have been treated in any case.
"Some of the same arguments that were made in favor of the Tuskegee study
many years ago are emerging in a new form in the AZT studies in the third
world," Dr. Marcia Angell, the executive editor of The New England Journal of
Medicine, said in an interview this week. In Thursday's issue of the journal,
Dr. Angell writes that the current AIDS research represents a "retreat from
ethical principles."
The use of dummy medication has always been controversial in medical
research, but never more so than with studies involving AIDS. In the United
States, advocates for AIDS patients have all but eliminated
placebo-controlled clinical trials by demanding that every patient have
access to some kind of drug therapy.
But the same is not true in the developing world, where many can barely
afford aspirin, let alone expensive medicines like AZT.
Nonetheless, the journal editorial has touched off an intense debate about
whether the mother-to-infant transmission studies should continue. Several
experts in medical ethics said they had urged officials at the health
institutes and the disease-control centers to abandon the studies, or at
least reconsider. The National Bioethics Advisory Commission may address the
matter when it meets in Washington this week.
"If you tried to do this study in the U.S., you would have to do it through
a throng of demonstrators and a sea of reporters," said Dr. Arthur Caplan,
director of the Center for Bioethics at the University of Pennsylvania. "I
wouldn't do this study without a design that would let me run it without a
placebo. I think you owe that to your subjects, even if they are not educated
enough, savvy enough to demand it from you."
Still, Caplan says, the Tuskegee analogy is inappropriate because the
Alabama men were falsely told that they were getting treatment. Others agree,
and say that that there is nothing wrong with U.S. researchers' tailoring
their studies to the health care systems of other nations, without regard to
standards here.
"The facts are different in different places," said Dr. Norman Fost,
director of the medical ethics program at the University of Wisconsin.
At the health institutes in Bethesda, Md., and the disease-control centers
in Atlanta, officials scrambled Wednesday to defend the experiments, saying
that officials in the foreign countries chose to use dummy medication in the
studies, and that U.S. standards simply could not be translated overseas.
Privately, they worried that the outcry would force them to cancel the
research, a move that they said would cripple their efforts to control AIDS
in countries where it takes its most devastating toll.
"This wasn't something that we did behind closed doors," said Dr. Helene
Gayle, who directs the AIDS program at the disease-control centers. "This was
done with a lot of discussion from the international community, following
international codes of ethics. Part of doing ethical trials is that you are
answering questions that are relevant for those countries."
If HIV-infected women are not treated with AZT in pregnancy, roughly 25
percent of their babies will be born infected with the virus. If they are
treated with the drug, the figure falls to 8 percent or lower. In the United
States, roughly 8 percent of all babies born to HIV-infected women -- fewer
than 500 a year -- are born infected. But the disease-control agency
estimates that around the globe, more than 1,000 infants are born infected
every day.
"In our wards, 30 percent of children admitted each day are HIV-positive,"
said Dr. Glenda Gray, a pediatrician in South Africa who is taking part in
similar studies paid for by the United Nations. "I've buried hundreds of
children. I'm seeing their mothers die. We need to find a magic bullet for
every woman in the world."
Finding that magic bullet will not be simple, Dr. Gray and others say. In
the United States, AZT is given during the final 12 weeks of pregnancy. Women
also receive an intravenous infusion of the drug during delivery, and their
babies take the medicine for six weeks after birth. This is commonly called
the 076 regimen, which gets its name from the number assigned to the federal
study that proved it effective.
But the regimen has problems in developing countries. Aside from the cost,
many nations do not have the equipment to administer AZT intravenously. And
most mothers in the Third World breast-feed, a practice that can spread the
virus to infants and that can counteract the benefits of taking the drug
during pregnancy.
Thus in 1994, after the results of the 076 study were published, officials
at the World Health Organization, the United Nations, the National Institutes
of Health and the disease-control centers gathered in Geneva to design
clinical trials suitable for overseas. In the absence of any standard of
care, said Dr. Joseph Saba, a U.N. AIDS official, they settled on comparing
different courses of AZT to dummy medications.
Almost from the outset, there was controversy. In January 1995, government
records show, CDC investigators in the Ivory Coast wrote to the agency's
headquarters in Atlanta to say that several of their African collaborators
"do not feel comfortable with the use of placebo."
At the same time, Marc Lallemant, a Harvard University investigator working
in Thailand on behalf of the health institutes, insisted he would not use
dummy medication. Dr. Troyan Brennan, head of the Harvard University ethics
panel that reviewed the study, said in an interview that because the Thai
government had indicated that it could offer AZT to pregnant women, his
committee did not consider dummy medications "ethically appropriate." None of
the Thai women in the institutes' study receive placebo. But some Thai women
in a disease-control agency's study get the dummy pills.
Then, in April, Public Citizen wrote to the secretary of health and human
services, Donna Shalala, to argue that it would be just as scientifically
valid, albeit more expensive, to compare a short course of AZT to the longer
076 regimen. Lurie argues that when scientists work in another country, they
have an obligation to give their patients the best care possible, regardless
of what the local standards of care are. In an interview, Dr. Angell
supported that view.
"If you say it's all right to have a different standard in the Third
World," she warned, "that is opening the door to a real slippery slope."
Yet Dr. Gray, the South Africa pediatrician, said there was a far more
pressing concern. If the current studies, which are to be completed in six
months to a year, find that a short course of AZT is effective, she asked,
will the authorities who financed them pay for women in her country to get
the drug? "If they're really concerned about the ethics of placebo," she
said, "they should put their money where their mouth is."
Other Places of Interest on the Web
The New England Journal of Medicine
<A HREF="http://www.nejm.org/">http://www.nejm.org/</A>
Copyright 1997 The New York Times
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Reuters Hourly News Summary
Justice Opens Clinton Probe
The Justice Department says it's reviewing allegations that President Clinton
made improper fund-raising phone calls from the White House, seeking to
decide whether to appoint a special prosecutor. The president has said he
does not remember whether he made any political fund-raising phone calls, and
the White House believes that Clinton is exempt from the law barring federal
employees from soliciting campaign contributions on federal property. Sources
say the preliminary 30-day review of allegations against Clinton began
sometime in the past five days and was approved by Attorney General Janet
Reno. After the 30 days are up, Reno must decide whether to proceed to a
formal 90-day investigation of the matter.
Clinton Threatens Veto on Tests
President Clinton today bluntly warned Congress he will veto legislation that
fails to fund his efforts to create voluntary national education testing
standards. Clinton, whose ideas to promote education reform have encountered
increasing opposition in the House and Senate, used his weekly radio address
to issue his strongest threat yet that he intends to fight for his education
agenda. Republicans in Congress bridled at Clinton's veto threat and promised
to hold firm in their opposition to the plan. ``By taking this position, I
think the president is telling parents and teachers, 'I don't trust you,'''
Sen. Slade Gorton of Washington said.
Diana's Driver Laid to Rest
Three weeks after the car crash that killed Princess Diana and her companion,
Dodi Al Fayed, their driver Henri Paul was laid to rest today in his hometown
of Lorient, France. About 200 people attended the funeral as police kept a
crowd of reporters and onlookers at bay outside the church. Paul's funeral
was delayed to allow autopsies, which showed that he was legally drunk at the
time of the Aug. 31 accident. In London, British media today praised Prince
Charles for being more open. In an impromptu speech yesterday, Charles
thanked the world for the outpouring of support after Diana's death and said
he was incredibly proud of the way his sons, William and Harry, handled the
tragedy.
Air Force Investigates B-1 Crash
U.S. Air Force officials are investigating the sixth crash of a military
aircraft in a week -- this one involving a B-1 bomber that went down
yesterday in southeast Montana. All four crew members aboard the Air Force
B-1B bomber were killed when the plane crashed, leaving a trail of debris
several hundred feet long in the Montana prairie. In all 16 Americans have
died in random U.S. military crashes since Sept. 13. Officials at Ellsworth
Air Force Base, where the plane was assigned, told a news conference on this
afternoon they are still hunting for clues to explain why the B-1 crashed 25
miles north of Alzada, Montana.
Workers Search Train Wreckage
Salvage workers today are sifting through the wreckage of Britain's worst
train crash in almost a decade, and investigators are focusing on what
happened to the trains' signalling network. Six people were killed and 13
seriously injured when an express train packed with 500 passengers slammed
into a freight train yesterday afternoon in the western suburbs of London.
The driver of the express train was released on bail early today after being
arrested by police conducting a manslaughter inquiry.
Probe of IRS to be Released
Senate Finance Committee is set to present the results of a six-month probe
into the Internal Revenue Service which found a quota system that rewarded
agents who brought in the cash. The committee will hold three days of
hearings next week intended to take a look at the tax collection agency from
the inside out. The atmosphere will have a touch of cloak-and-dagger with one
panel of IRS agents testifying behind a screen to keep their identities
secret. The investigation found many taxpayers complained the IRS did not
listen to them and assumed they were guilty and wanted to cheat on their tax
returns.
U.S., Japan Discuss Trade
Finance ministers from the Group of Seven rich nations today in Hong Kong
after the United States and Japan had frank bilateral talks over Tokyo's
growing trade surplus and its weaker-than-expected growth. U.S. officials
later said they had kept up pressure on Japan to rein in its ballooning
surplus and kick-start domestic demand to boost flagging growth rates and
prevent undue fluctuations on the world's foreign exchange markets. The G7
ministers said in a statement at the end of their talks: ``We agreed that
exchange rates should reflect economic fundamentals and that excess
volatility and significant deviations from fundamentals were undesirable.''
'Flu Cruise' Docks in New York
A cruise ship hit by an outbreak of the flu and a flurry of media attention
on its journey from Montreal docked in New York today with health officials
assuring the public the situation is under control. Of the 1,400 passengers,
most of them senior citizens, and 600 crew, 53 crew members and 43 passengers
suffered respiratory infections similar to influenza A. Doctors at the U.S.
Centers for Disease Control and Prevention and the Canadian national health
service had joined the Holland America ship Westerdam in Boston Harbor and
monitored the outbreak along with the ship's doctors.
Gunman Kills Seven in Latvia
A gunman used an automatic hunting rifle to kill seven people, including two
women, and seriously injure one man in Latvia today as they were harvesting
potatoes in a field. The man fled on foot with his rifle and police are
hunting for him in and around nearby farmsteads. The Baltic News Service
reported that the killings were an apparent revenge attack as the man had
accused his victims of setting fire to his house. Latvia television quoted
eyewitnesses as saying the victims were chased around the field by the
murderer in his car and the killer picked them off one by one.
Old Gems, New Home
Some of the world's most famous and infamous gems returned to public view
today in their newest setting in Washington. The infamous Hope diamond and
other gems are now ensconced in the Janet Annenberg Hooker Hall of Geology,
Gems and Minerals, which officially opened today. The supposedly cursed Hope,
all 45.52 carats of it, stands guard just inside the entrance to the hall
within the National Museum of Natural History. It is in good company, with
diamond earrings that belonged to Marie Antoinette. But even the grandest
stones get stiff competition from a grey lump known as ALH84001. It's a
meteorite born on Mars 4.5 billion years ago that hurtled to Earth. It shows
signs of what some scientists believe is fossilized evidence of life on Mars.
18:23 09-20-97
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