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HIV from patients than vice versa. In the United States, some surgical
personnel may be facing a 2 percent per year risk of contracting HIV. Over a
professional lifetime of 35 years, more than half such surgeons would become
infected with HIV. The U.K. General Medical Council's recommendations that
doctors who discover that a colleague is HIV-positive should report the
result to the authorities violates patient confidentiality. Therefore,
doctors' civil liberties are jeopardized, concludes Ellis.
====================================================================
"HIV {*filter*} Test Counseling" American Medical News (03/22/93-03/29/93) Vol. 36,
No. 12, (special insert)
The American Medical Association (AMA) has developed its second edition
of physician guidelines for HIV {*filter*} test counseling. The guidelines urge
physicians to educate the public and provide patients with specific
counseling on the HIV antibody {*filter*} test. The AMA says that the ELISA
(enzyme-linked immunosorbent assay) is the most widely used HIV test. But
for someone to be considered to be HIV-positive, results of three tests
conducted on the same serum specimen must be reactive. These confirmatory
tests include the Western Blot, the radioimmuno precipitation assay (RIPA),
and the indirect immunofluorescence assay (IFA). The AMA states that HIV
tests should be readily available for anyone requesting testing. Also,
doctors should encourage voluntary HIV testing for anyone whose history or
clinical status suggests risk for HIV infection. Pretest procedures include
providing HIV education; providing information about the test; conducting
risk assessment, including sex and drug history; and counseling about risk
reduction. The pretest counseling should be conducted face-to-face and
should involve the discussion of the medical, psychological, and social
implications of HIV testing. Adolescents and women have special
considerations regarding HIV that should be addressed, such as women's more
ambiguous manifestations of HIV infection. The AMA supports routine HIV
testing, which is the testing of all patients regardless of their risk. But
Health InfoCom Network News Page 42
Volume 6, Number 9 April 10, 1993
such testing should involve consent that can be provided as part of the
general consent for treatment. Every patient should subsequently be informed
of his or her test results, according to the AMA.
====================================================================
April 7, 1993
=====================================================================
"Army to Test AIDS Drug Despite Objections" Washington Post (04/07/93), P. A1
(Squires, Sally)
The Department of Defense yesterday confirmed that it expects to test a
therapeutic AIDS vaccine made by MicroGeneSys of Meriden, Conn., even though
federal health officials and top AIDS researchers objected to the trial.
Yesterday marked the deadline for preventing the controversial $20- million
trial of the vaccine from being conducted. The vaccine, gp160, is a
substance made from part of the outer coating of HIV. The Defense Department
has a large system of medical facilities, and plays a key role in AIDS drug
research, including trials on civilians. However, the choice of which {*filter*}
to test is traditionally made by researchers at the National Institutes of
Health (NIH). But in the case of gp160, Congress bypassed NIH last fall and
approved both the vaccine and the funding level to be used in the trial. The
trial was subsequently mandated by an amendment to the defense appropriations
bill passed last fall. The amendment stated that the trial should proceed
unless the NIH director, the commissioner of the cooking.net">food and Drug Administration,
and the secretary of defense unanimously decide not to allow it within six
months of the bill's passage. Last Thursday letters were sent to Defense
Secretary Les Aspin and House Appropriations Committee Chairman William H.
Natcher (D-Ky.) from NIH Director Bernadine P. Healy and FDA Commissioner
David A. Kessler, who recommended that the trial be conducted only if it
involved testing of other therapeutic vaccines now under development.
However, Army spokeswoman Sgt. Dawn Kilpatrick said yesterday that regardless
of the recommendations, "the Army has decided to test only the gp160
[MicroGeneSys] vaccine."
=====================================================================
"Laser {*filter*} Test" Associated Press (04/05/93)
Little Rock, Ark.--Because taking a {*filter*} sample can be quite risky,
Russian and American researchers say they have devised a way to take a sample
by substituting a laser beam for the sharp steel lancets. Charles Vestal,
chairman of Venisect Inc. of Little Rock, Ark., said, "We're going to change
the whole industry." The company refined a device that was once a Soviet
military secret. Although lasers are currently used in surgery, the new
technique allows a laser to make a minuscule opening--up to 0.5 millimeters
in diameter and 0.5 millimeters deep. The hole is large enough to permit the
Health InfoCom Network News Page 43
Volume 6, Number 9 April 10, 1993
collection of a small {*filter*} sample, and it heals exactly like other tiny
punctures. The researchers claim the laser, which would not touch {*filter*}, may
help allay fears about spreading disease through needles and other sharp
objects. Dr. Milton Waner, clinical director of the University of Arkansas
for Medical Sciences Biomedical Research Laboratory, said that if a patient
is infected with a {*filter*}-borne disease like HIV, "the contaminated lancet or
needle poses a serious threat to others who come in contact with it." But
the laser is much safer and cheaper than steel lancets. The laser was first
invented in the late 1970s by scientists at the General Physics Institute of
the Russian Academy of Sciences. Last year, Vestal discovered that the
technique was available for commercial development in the West.
=====================================================================
"Where the AIDS Virus Hides Away" Nature (03/25/93) Vol. 362, No. 6418, P. 287
(Maddox, John)
Because of the new findings that HIV replicates in the lymph nodes while
in the so-called latent period, Professor Peter Duesberg of the University of
California--Berkeley may want to change his position, writes John Maddox of
Nature. Duesberg has held that drug taking is responsible for AIDS, and not
HIV. Most viruses are DNA viruses, which ordinarily replicate within cells
by hijacking the preexisting machinery of DNA transcription and translation.
But the genomes of retroviruses, like HIV, by contrast, consist of RNA.
Those of the lentiviruses, of which HIV is one, come equipped with a gene
specifying a reverse transcriptase (for converting RNA into the complementary
DNA). While the RNA genome may be used, as if it were one of the infected
cell's own messenger molecules, to generate the proteins that would allow an
intact virus particle to be regenerated, by far the more efficient means of
replication is that DNA complementary to the viral RNA should be incorporated
in the genome of the cell, where it will serve as a template for the
production of its own genomic RNA and thus for intact viral particles.
Duesberg claims that it is difficult to recover helper T lymphocytes, whose
attrition for many patients indicates the onset of overt AIDS, virus particles
that might plausibly infect others. The new findings show that the virus is
alive and well in the lymph nodes, among other locations, of those infected
with HIV. The recent revelations suggest that, nevertheless, the alternatives
for AIDS patients are even less justifiable than seemed likely a few years
ago. Duesberg should now admit the possibility that he has been mistaken,
concludes Maddox.
=====================================================================
"Where Has HIV Been Hiding?" Nature (03/25/93) Vol. 362, No. 6418, P. 292
(Temin, Howard M. and Bolognesi, Dani P.)
The two new studies published in Nature which found that HIV replicates
in the lymph nodes while in the asymptomatic period stress that HIV infection
is a very complicated process and that it will require the perseverance of
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Volume 6, Number 9 April 10, 1993
science to gain sufficient knowledge to control the virus, write Howard M.
Temin and Dani P. Bolognesi of the University of Wisconsin--Madison and Duke
University Medical Center in Durham, North Carolina, respectively. The study
conducted by Pantaleo et al. used polymerase chain reaction (PCR) to show
that in asymptomatic HIV-infected patients there are many infected cells in
the lymph nodes. Embretson et al. complete their earlier work combining PCR
and in situ hybridization with autoradiography to demonstrate that a high
fraction of cells, about a quarter, in germinal centers of lymph nodes are
infected, and that these cells tend not to be expressing viral RNA. The
issue of the percentage of latently infected cells notwithstanding, it can be
concluded from the reports that secondary lymphoid organs are solidly infected
with HIV. Both reports also point out that virus particles are carried
probably passively by follicular dendritic cells but in a form that is likely
to be infectious for other HIV target cells, especially T-cells, that
circulate through these organs. In addition, these reports suggest that a
more centralized AIDS research effort should examine cohorts of HIV-positive
persons and carefully quantify, in different tissues at different times
after infection, cells containing infectious provirus, cells containing
defective provirus, cells containing early viral RNA, cells containing late
viral RNA, and the load of free virus, conclude Temin and Bolognesi.
=====================================================================
April 8, 1993
=======================================================================
"Wellcome's Defense Fails to Dispel Doubts About AZT" Journal of Commerce
(04/08/93), P. 7A
The manufacturer of AZT defended the drug Wednesday with data indicating
that early use in HIV infection could enhance the chances of survival.
However, Burroughs Wellcome's effort only incited controversy. Wellcome's
investors, unimpressed with the company's contentions, dropped shares again
as a result of fears of another round of negative publicity for the drug.
Peter Cartwright, pharmaceutical analyst at stockbroker William de Broe,
said, "They didn't come up with anything very new, nor did they put on a
knock-out defense of their position. They handled it very badly." These
incidents follow the "Concorde" study, published in The Lancet last week,
which indicates that AZT has no significant effect on the development of
AIDS. Paul Fiddian, Wellcome's clinical virology head, claimed that a full
analysis of the Concorde study conducted in Europe would demonstrate that
early treatment with AZT could improve survival rates in AIDS patients.
However, industry experts said Wellcome's argument surrounds its on-going
belief that the level of CD4 cells is a conclusive marker in the progression
of the disease. Preliminary results of the study showed patients taking AZT
before full-blown AIDS had more CD4 cells, but it found no proof that they
Health InfoCom Network News Page 45
Volume 6, Number 9 April 10, 1993
lived longer. Concorde researchers said their discoveries raise questions
on the validity of CD4 cell counts to measure benefits of AIDS treatments.
Professor Richard Peto of the Clinical Trial Service Unit in Oxford said it
would probably take several more years and more extensive trials to reach
final conclusions about the net effects of early use of AZT. Related Story:
Investor's Business Daily (04/08) P. 3
=======================================================================
"Is AZT a False Hope?" Time (04/12/93) Vol. 141, No. 15, P. 25
Although the AIDS drug AZT is given to asymptomatic HIV-positive
patients to delay the onset of full-blown AIDS, it may not have to be
prescribed so early in the course of disease. Several studies have
demonstrated that AZT can postpone the onset of symptoms, though it does not
prevent or cure the disease. But the largest and longest-term study ever
conducted has found the opposite to be true. A three-year European study
reported in the current issue of the Lancet discovered that patients infected
with HIV who take AZT even though they exhibit no symptoms of AIDS progress
at the same rate of disease as those who do not take AZT early on. But the
discovery does not question AZT's benefits for those who already have
symptoms, and it is being examined with skepticism by some AIDS researchers.
Moreover, a single study won't change conventional therapeutic regimens. But
it does raise questions about prescribing such an expensive drug, and
indicates that the search for new AIDS {*filter*} will be pursued more vigorously
than ever.
=======================================================================
April 9, 1993
====================================================================
"Controversial Plan to Test Single AIDS Drug Said to Be Canceled" Washington
Post (04/09/93), P. A4 (Squires, Sally)
The Defense Department plan that spurred controversy over a $20 million
trial of an experimental AIDS vaccine has apparently been canceled, sources
say. The scheduled drug trial had angered many researchers because Congress
bypassed the advice of federal scientists and required that the Army test
only VaxSyn, made by MicroGeneSys, after an extensive lobbying effort by the
drug company. On Tuesday, the deadline for stopping the project expired.
But White House officials called a meeting on Wednesday morning involving
Edward Martin, acting assistant secretary for health affairs at the Defense
Department, as well as National Institutes of Health Director Bernadine Healy
and cooking.net">food and Drug Commissioner David A. Kessler. The meeting, held at the
Pentagon, addressed how to expand the clinical trials to include other
therapeutic AIDS vaccines now in the pipeline. Health and Human Services
Secretary Donna E. Shalala said yesterday at a news briefing that an
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Volume 6, Number 9 April 10, 1993
announcement describing the new agreement would be provided in 24 hours.
According to some sources, the trial will be expanded to include two other
therapeutic vaccines and a placebo. The appropriations amendment approved by
Congress last fall required that the trial proceed unless the NIH director,
the commissioner of the FDA, and the secretary of defense unanimously agreed
not to proceed within six months of the bill's passage. On April 1, Kessler
and Healy wrote letters to Defense Secretary Les Aspin suggesting that the
trial be expanded to include other {*filter*}. Yesterday, Healy's spokeswoman
said "all three parties seemed to be headed in the same direction." Related
Story: Washington Times (04/09) P. A4
====================================================================
"{*filter*} Milk May Transmit HIV, Journal Reports" Reuters (04/07/93)
London--HIV-positive mothers could transmit the infection to their
babies through {*filter*} milk, according to a study published Thursday in The
Lancet. However, these women should not discontinue {*filter*}-feeding their
babies, another report said. The first report discovered that if a mother's
milk contained HIV-positive cells, it was likely her baby would also become
infected. Dr. Philippe Van de Perre of the AIDS Reference Laboratory in
Kigali examined the {*filter*} milk of 215 HIV-positive women who had just given
birth. "Presence of HIV-infected cells in milk taken 15 days after birth was
strongly predictive of HIV infection in children," the report said. However,
this did not conclusively mean that {*filter*} milk transmitted HIV to the child.
"Because there is no way of distinguishing HIV infection acquired in the
uterus from that acquired during or after birth, this study can only report
an overall risk of transmission from mother to baby," the study added. In a
separate report, Dr. Jacqueline Mok of City Hospital in Edinburgh said
{*filter*} milk is important for protecting children against malnutrition and
infectious diseases. She said it was imperative that women in countries
where malnutrition and infection lead to child deaths continue {*filter*}-feeding
their babies.
====================================================================
"AIDS Moves to 5th Place as Killer of Young People" United Press International
(04/09/93) (Taylor, Charles S.)
Atlanta--AIDS is now the fifth leading cause of premature death of
Americans aged 65 and under, according to a report by the Centers for Disease
Control. The federal agency said Thursday that during 1991, the last year
for which statistics are available, AIDS replaced birth defects as the number
five cause of premature death for younger Americans. Previously, AIDS had
been ranked sixth as an early cause of death, or, as the CDC considers it,
the cause of "years of potential life lost before age 65." The disease
appeared for the first time in national health statistics in 1987, when it
was categorized as a major cause of death of young people. It ranked seventh
that year and moved up to sixth place in 1988. It remained there until
Health InfoCom Network News Page 47
Volume 6, Number 9 April 10, 1993
moving to fifth place in 1991. Between 1989 to 1990, the largest increases
in premature deaths were for HIV/AIDS, at 12.7 percent, and suicide/{*filter*},
at 6.5 percent. The CDC reports that there have been 253,448 cases of AIDS in
the United States and 171,890 deaths as of Dec. 31, 1992.
====================================================================
"Tuberculosis Prevention in Drug-Treatment Centers and Correctional
Facilities--Selected U.S. Sites, 1990-1991" Morbidity and Mortality Weekly
Report (03/26/93) Vol. 42, No. 11, P. 210
About 87,000 inmates released each year from U.S. drug treatment centers
(DTCs) and 133,000 federal and state correctional facility inmates (CFs) may
have latent tuberculosis infection, according to the Centers for Disease
Control. The CDC awarded money to 25 state and city health departments in
1989 to support TB testing and administration of preventive therapy, as well
as with HIV counseling and testing in DTCs and CFs. The project found that
among the 40,823 persons enrolled in the target facilities from program
initiation through December 1991, 30,808 were from 114 DTCs and 10,015 were
from six CFs in the 23 areas for which data was available. The CDC project
detected 26 previously unreported active TB cases and 145 persons with
suspected TB. All 21 people with active TB cases and with known HIV status
were HIV-positive. Among the 124 persons with suspected TB for whom HIV
status was known, 61 were HIV-positive. The report found that the prevalence
of skin-test positivity was higher among HIV-negative persons, suggesting
that HIV-induced anergy might be obscuring the true prevalence of tuberculin
positivity among those clients tested. The CDC concludes that since there is
such a high risk of HIV infection in person in DTCs and CFs, there is a need
for longer preventive therapy among HIV-infected persons, and HIV counseling
and testing should be offered to all persons in these settings.
Health InfoCom Network News Page 48
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