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From: [email protected] (David Dodell)
Subject: HICN610 Medical News Part 4/4
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limits of AZT's efficacy and now suggest using the drug either sequentially
with other drugs or in a kind of AIDS treatment "cocktail" combining a number
of drugs to fight the virus all at once. "Treating people with AZT alone
doesn't happen in the real world anymore," said Dr. Mark Jacobson of the
University of California--San Francisco. Also, with recent findings
indicating that HIV replicates rapidly in the lymph nodes after infection,
physicians may begin pushing even harder for early treatment of HIV-infected
patients.
==================================================================
"New Infectious Disease Push" American Medical News (04/05/93) Vol. 36, No.
13, P. 2
The Center for Disease Control will launch a worldwide network to track
the spread of infectious diseases and detect drug-resistant or new strains in
time to help prevent their spread. The network is expected to cost between
$75 million and $125 million but is an essential part of the Clinton
administration's health reform plan, according to the CDC and outside
experts. The plan will require the CDC to enhance surveillance of disease in
the United States and establish about 15 facilities across the world to
track disease.
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April 13, 1993
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"NIH Plans to Begin AIDS Drug Trials at Earlier Stage" Nature (04/01/93) Vol.
362, No. 6419, P. 382 (Macilwain, Colin)
HICNet Medical Newsletter Page 42
Volume 6, Number 10 April 20, 1993
The National Institutes of Health has announced it will start treating
HIV-positive patients as soon as possible after seroconversion, resulting
from recent findings that show HIV is active in the body in large numbers
much earlier than was previously believed. Anthony Fauci, director of the
U.S. National Institute of Allergy and Infectious Diseases (NIAID), said,
"We must address the question of how to treat people as early as we possibly
can with drugs that are safe enough to give people for years and that will
get around microbial resistance." He said any delay would signify questions
over safety and resistance rather than a lack of funds. Fauci, who co-
authored one of the two papers published last week in Nature, rejects the
argument by one of his co-authors, Cecil Fox, that the new discovery
indicates that "$1 billion spent on vaccine trials" has been "a waste of time
and money" because the trials were started too long after the patients were
infected and were ended too quickly. John Tew of the Medical College of
Virginia in Richmond claims that the new evidence strongly backs the argument
for early treatment of HIV-infected patients. AIDS activists welcomed the
new information but said the scientific community has been slow to understand
the significance of infection of the lymph tissue. "We've known about this
for five years, but we're glad it is now in the public domain," said Jesse
Dobson of the California-based Project Inform. But Peter Duesberg, who
believes that AIDS is independent of HIV and is a result of drug abuse in the
West, said, "We are several paradoxes away from an explanation of AIDS--even
if these papers are right."
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April 14, 1993
======================================================================
"Risk of AIDS Virus From Doctors Found to Be Minimal" Washington Post
(04/14/93), P. A9
The risk of HIV being transmitted from infected health-care
professionals to patients is minimal, according to new research published in
today's Journal of the American Medical Association (JAMA). This finding
supports previous conclusions by health experts that the chance of
contracting HIV from a health care worker is remote. Three studies in the
JAMA demonstrate that thousands of patients were treated by two HIV-positive
surgeons and dentists without becoming infected with the virus. The studies
were conducted by separate research teams in New Hampshire, Maryland, and
Florida. Each study started with an HIV-positive doctor or dentist and
tested all patients willing to participate. The New Hampshire study found
that none of the 1,174 patients who had undergone invasive procedures by an
HIV-positive orthopedic surgeon contracted HIV. In Maryland, 413 of 1,131
patients operated on by a breast surgery specialist at Johns Hopkins Hospital
were found to be HIV-negative. Similarly in Florida, 900 of 1,192 dental
HICNet Medical Newsletter Page 43
Volume 6, Number 10 April 20, 1993
patients, who all had been treated by an HIV-positive general dentist, were
tested and found to be negative for HIV. The Florida researchers, led by
Gordon M. Dickinson of the University of Miami School of Medicine, said,
"This study indicates that the risk for transmission of HIV from a general
dentist to his patients is minimal in a setting in which universal
precautions are strictly observed." Related Story: Philadelphia Inquirer
(04/14) P. A6
======================================================================
"Alternative Medicine Advocates Divided Over New NIH Research Program" AIDS
Treatment News (04/02/93) No. 172, P. 6 (Gilden, Dave)
The new Office of Alternative Medicine at the National Institutes of
Health has raised questions about the NIH's commitment to an effort that uses
unorthodox or holistic therapeutic methods. The OAM is a small division of
the NIH, with its budget only at $2 million dollars compared to more than $10
billion for the NIH as a whole. In addition, the money for available
research grants is even smaller. About $500,000 to $600,000 total will be
available this year for 10 or 20 grants. Kaiya Montaocean, of the Center for
Natural and Traditional Medicine in Washington, D.C., says the OAM is afraid
to become involved in AIDS. "They have to look successful and there is no
easy answer in AIDS," she said. There is also a common perception that the
OAM will focus on fields the NIH establishment will find non-threatening,
such as relaxation techniques and acupuncture. When the OAM called for an
advisory committee conference of about 120 people last year, the AIDS
community was largely missing from the meeting. In addition, activists'
general lack of contact with the Office has added suspicion that the epidemic
will be ignored. Jon Greenberg, of ACT-UP/New York, said, "The OAM advisory
panel is composed of practitioners without real research experience. It
will take them several years to accept the nature of research."
Nevertheless, Dr. Leanna Standish, research director and AIDS investigator
at the Bastyr College of Naturopathic Medicine in Seattle, said, "Here is a
wonderful opportunity to fund AIDS research. It's only fair to give the
Office time to gel, but it's up to the public to insist that it's much, much
more [than public relations]."
======================================================================
"Herpesvirus Decimates Immune-cell Soldiers" Science News (04/03/93) Vol. 143,
No. 14, P. 215 (Fackelmann, Kathy A.)
Scientists conducting test tube experiments have found that herpesvirus-
6 can attack the human immune system's natural killer cells. This attack
causes the killer cells to malfunction, diminishing an important component in
the immune system's fight against diseases. Also, the herpesvirus-6 may be a
factor in immune diseases, such as AIDS. In 1989, Paolo Lusso's research
found that herpesvirus-6 attacks another white cell, the CD4 T-lymphocyte,
which is the primary target of HIV. Lusso also found that herpesvirus-6 can
HICNet Medical Newsletter Page 44
Volume 6, Number 10 April 20, 1993
kill natural killer cells. Scientists previously knew that the natural
killer cells of patients infected with HIV do not work correctly. Lusso's
research represents the first time scientists have indicated that natural
killer cells are vulnerable to any kind of viral attack, according to Anthony
L. Komaroff, a researcher with Harvard Medical School. Despite the test-tube
findings, scientists are uncertain whether the same result occurs in the
body. Lusso's team also found that herpesvirus-6 produces the CD4 receptor
molecule that provides access for HIV. CD4 T-lymphocytes express this surface
receptor, making them vulnerable to HIV's attack. Researchers concluded that
herpesvirus-6 cells can exacerbate the affects of HIV.
======================================================================
April 15, 1993
====================================================================
"AIDS and Priorities in the Global Village: To the Editor" Journal of the
American Medical Association (04/07/93) Vol. 269, No. 13, P. 1636 (Gellert,
George and Nordenberg, Dale F.)
All health-care workers are obligated and responsible for not only
ensuring that politicians understand the dimensions of certain health
problems, but also to be committed to related policies, write George Gellert
and Dale F. Nordenberg of the Orange County Health Care Agency, Santa Ana,
Calif., and the Emory University School of Public Health in Atlanta, Ga.,
respectively. Dr. Berkley's editorial on why American doctors should care
about the AIDS epidemic beyond the United States details several reasons for
the concerted interest that all countries share in combating AIDS. It should
be noted that while AIDS leads in hastening global health interdependence, it
is not the only illness doing so. Diseases such as malaria and many
respiratory and intestinal pathogens have similarly inhibited the economic
development of most of humanity and acted to marginalize large populations.
Berkley mentions the enormous social and economic impact that AIDS will have
on many developing countries, and the increased need for international
assistance that will result. Berkley also cites the lack of political
aggressiveness toward the AIDS epidemic in its first decade. But now there
is a new administration with a promise of substantial differences in approach
to international health and development in general, and HIV/AIDS in
particular. Vice President Al Gore proposes in his book "Earth in the
Balance" a major environmental initiative that includes sustainable
international development, with programs to promote literacy, improve child
survival, and disseminate contraceptive technology and access throughout the
developing world. If enacted, this change in policy could drastically
change the future of worldwide health.
====================================================================
"AIDS and Priorities in the Global Village: In Reply" Journal of the American
HICNet Medical Newsletter Page 45
Volume 6, Number 10 April 20, 1993
Medical Association (04/07/93) Vol. 269, No. 13, P. 1636 (Berkley, Seth)
Every nation should tackle HIV as early and aggressively as possible
before the disease reaches an endemic state, even at a cost of diverting less
attention to some other illnesses, writes Seth Berkley of the Rockefeller
Foundation in New York, N.Y., in reply to a letter by Drs. Gellert and
Nordenberg. Although it is true that diseases other than AIDS, such as
malaria and respiratory and intestinal illnesses, have similarly inhibited
economic development in developing countries and deserve much more attention
than they are getting, Berkley disagrees with the contention that AIDS is
receiving too much attention. HIV differs from other diseases, in most
developing countries because it is continuing to spread. For most endemic
diseases, the outcome of neglecting interventions for one year is another
year of about the same level of needless disease and death. But with AIDS
and its increasing spread, the cost of neglect, not only in disease burden
but financially, is much greater. Interventions in the early part of a
rampantly spreading epidemic like HIV are highly cost-effective because each
individual infection prevented significantly interrupts transmission. Berkley
says he agrees with Gellert and Nordenberg about the gigantic social and
economic effects of AIDS and about the need for political leadership. But he
concludes that not only is assertive political leadership needed in the
United States for the AIDS epidemic, but even more so in developing countries
with high rates of HIV infection and where complacency about the epidemic
has been the rule.
HICNet Medical Newsletter Page 46
Volume 6, Number 10 April 20, 1993
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AIDS/HIV Articles
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First HIV Vaccine Trial Begins in HIV-Infected Children
H H S N E W S
********************************************************************
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
March 29, 1993
First HIV Vaccine Therapy Trial Begins In HIV-Infected Children
The National Institutes of Health has opened the first trial of experimental
HIV vaccines in children who are infected with the human immunodeficiency
virus (HIV), the virus that causes AIDS.
The trial will compare the safety of three HIV experimental vaccines in 90
children recruited from at least 12 sites nationwide. Volunteers must be HIV-
infected but have no symptoms of HIV disease.
HHS Secretary Donna E. Shalala said this initial study can be seen as "a
hopeful milestone in our efforts to ameliorate the tragedy of HIV-infected
children who now face the certainty they will develop AIDS."
Anthony S. Fauci, M.D., director of the National Institute of Allergy and
Infectious Diseases and of the NIH Office of AIDS Research, said the trial "is
the first step in finding out whether vaccines can help prevent or delay
disease progression in children with HIV who are not yet sick." If these
vaccines prove to be safe, more sophisticated questions about their
therapeutic potential will be assessed in Phase II trials.
The Centers for Disease Control and Prevention estimates 10,000 children in
the United States have HIV. By the end of the decade, the World Health
Organization projects 10 million children will be infected worldwide.
The study will enroll children ages 1 month to 12 years old. NIAID, which
funds the AIDS Clinical Trials Group network, anticipates conducting the trial
at nine ACTG sites around the country and three sites participating in the
ACTG but funded by the National Institute of Child Health and Human
Development.
Preliminary evidence from similar studies under way in infected adults shows
that certain vaccines can boost existing HIV-specific immune responses and
HICNet Medical Newsletter Page 47
Volume 6, Number 10 April 20, 1993
stimulate new ones. It will be several years, however, before researchers
know how these responses affect the clinical course of the disease.
The results from the pediatric trial, known as ACTG 218, will be examined
closely for other reasons as well. "This trial will provide the first insight
into how the immature immune system responds to candidate HIV vaccines," said
Daniel Hoth, M.D., director of NIAID's division of AIDS. "We need this
information to design trials to test whether experimental vaccines can prevent
HIV infection in children."
In the United States, most HIV-infected children live in poor inner-city
areas, and more than 80 percent are minorities, mainly black or Hispanic.
Nearly all HIV-infected children acquire the virus from their mothers during
pregnancy or at birth. An infected mother in the United States has more than
a one in four chance of transmitting the virus to her baby. As growing
numbers of women of childbearing age become exposed to HIV through injection
drug use or infected sexual partners, researchers expect a corresponding
increase in the numbers of infected children.
HIV disease progresses more rapidly in infants and children than in adults.
The most recent information suggests that 50 percent of infants born with HIV
develop a serious AIDS-related infection by 3 to 6 years of age. These
infections include severe or frequent bouts of common bacterial illnesses of
childhood that can result in seizures, pneumonia, diarrhea and other symptoms
leading to nutritional problems and long hospital stays.
At least half of the children in the trial will be 2 years of age or younger
to enable comparison of the immune responses of the younger and older
participants. All volunteers must have well-documented HIV infection but no
symptoms of HIV disease other than swollen lymph glands or a mildly swollen
liver or spleen. They cannot have received any anti-retroviral or immune-
regulating drugs within one month prior to their entry into the study.
Study chair John S. Lambert, M.D., of the University of Rochester Medical
School, and co- chair Samuel Katz, M.D., of Duke University School of
Medicine, will coordinate the trial assisted by James McNamara, M.D., medical
officer in the pediatric medicine branch of NIAID's division of AIDS.
"We will compare the safety of the vaccines by closely monitoring the children
for any side effects, to see if one vaccine produces more swollen arms or
fevers, for example, than another," said Dr. McNamara. "We'll also look at
whether low or high doses of the vaccines stimulate immune responses or other
significant laboratory or clinical effects." He emphasized that the small
study size precludes comparing these responses or effects among the three
HICNet Medical Newsletter Page 48
Volume 6, Number 10 April 20, 1993
products.
The trial will test two doses each of three experimental vaccines made from
recombinant HIV proteins. These so-called subunit vaccines, each genetically
engineered to contain only a piece of the virus, have so far proved well-
tolerated in ongoing trials in HIV-infected adults.
One vaccine made by MicroGeneSys Inc. of Meriden, Conn., contains gp160--a
protein that gives rise to HIV's surface proteins--plus alum adjuvant.
Adjuvants boost specific immune responses to a vaccine. Presently, alum is
the only adjuvant used in human vaccines licensed by the Food and Drug
Administration.
Both of the other vaccines--one made by Genentech Inc. of South San Francisco
and the other by Biocine, a joint venture of Chiron and CIBA-Geigy, in
Emeryville, Calif.--contain the major HIV surface protein, gp120, plus
adjuvant. The Genentech vaccine contains alum, while the Biocine vaccine
contains MF59, an experimental adjuvant that has proved safe and effective in
other Phase I vaccine trials in adults.
A low dose of each product will be tested first against a placebo in 15
children. Twelve children will be assigned at random to be immunized with the
experimental vaccine, and three children will be given adjuvant alone,
considered the placebo. Neither the health care workers nor the children will
be told what they receive.
If the low dose is well-tolerated, controlled testing of a higher dose of the
experimental vaccine and adjuvant placebo in another group of 15 children will
begin.
Each child will receive six immunizations--one every four weeks for six
months--and be followed-up for 24 weeks after the last immunization.
For more information about the trial sites or eligibility for enrollment, call
the AIDS Clinical Trials Information Service, 1-800-TRIALS-A, from 9 a.m. to 7
p.m., EST weekdays. The service has Spanish-speaking information specialists
available. Information on NIAID's pediatric HIV/AIDS research is available
from the Office of Communications at (301) 496- 5717.
NIH, CDC and FDA are agencies of the U.S. Public Health Service in HHS. For
press inquiries only, please call Laurie K. Doepel at (301) 402-1663.
HICNet Medical Newsletter Page 49
Volume 6, Number 10 April 20, 1993
NEW EVIDENCE THAT THE HIV CAN CAUSE DISEASE INDEPENDENTLY
News from the National Institute of Dental Research
There is new evidence that the human immunodeficiency virus can cause disease
independently of its ability to suppress the immune system, say scientists at
the National Institues of Health.
They report that HIV itself, not an opportunistic infection, caused scaling
skin conditions to develop in mice carrying the genes for HIV. Although the
HIV genes were active in the mice, they did not compromise the animals'
immunity, the researchers found. This led them to conclude that the HIV
itself caused the skin disease.
Our findings support a growing body of evidence that HIV can cause disease
without affecting the immune system, said lead author Dr. Jeffrey Kopp of the
National Institute of Dental Research (NIDR). Dr. Kopp and his colleagues
described their study in the March issue of AIDS Research and Human
Retroviruses.
Developing animal models of HIV infection has been difficult, since most
animals, including mice, cannot be infected by the virus. To bypass this
problem, scientists have developed HIV-transgenic mice, which carry genes for
HIV as well as their own genetic material.
NIDR scientists created the transgenic mice by injecting HIV genes into mouse
eggs and then implanting the eggs into female mice. The resulting litters
contained both normal and transgenic animals.
Institute scientists had created mice that carried a complete copy of HIV
genetic material in l988. Those mice, however, became sick and died too soon
after birth to study in depth. In the present study, the scientists used an
incomplete copy of HIV, which allowed the animals to live longer.
Some of the transgenic animals developed scaling, wart-like tumors on their
necks and backs. Other transgenic mice developed thickened, crusting skin
lesions that covered most of their bodies, resembling psoriasis in humans. No
skin lesions developed in their normal, non-transgenic littermates.
Studies of tissue taken from the wart-like skin tumors showed that they were a
type of noncancerous tumor called papilloma. Although the papillomavirus can
cause these skin lesions, laboratory tests showed no sign of that virus in the
animals.
Tissue samples taken from the sick mice throughout the study revealed the
presence of a protein-producing molecule made by the HIV genetic material.
HICNet Medical Newsletter Page 50
Volume 6, Number 10 April 20, 1993
Evidence of HIV protein production proved that the viral genes were "turned
on," or active, said Dr. Kopp.
The scientists found no evidence, however, of compromised immunity in the
mice: no increase in their white blood cell count and no signs of common
infections. The fact that HIV genes were active but the animals' immune
systems were not suppressed confirms that the virus itself was causing the
skin lesions, Dr. Kopp said.
Further proof of HIV gene involvement came from a test in which the scientists
exposed the transgenic animals to ultraviolet light. The light increased HIV
genetic activity causing papillomas to develop on formerly healthy skin.
Papilloma formation in response to increased HIV genetic activity proved the
genes were responsible for the skin condition, the scientists said. No
lesions appeared on normal mice exposed to the UV light.
The transgenic mice used in this study were developed at NIDR by Dr. Peter
Dickie, who is now with the National Institute of Allergy and Infectious
Diseases.
Collaborating on the study with Dr. Kopp were Mr. Charles Wohlenberg, Drs.
Nickolas Dorfman, Joseph Bryant, Abner Notkins, and Paul Klotman, all of NIDR;
Dr. Stephen Katz of the National Cancer Institute; and Dr. James Rooney,
formerly with NIDR and now with Burroughs Wellcome.
HICNet Medical Newsletter Page 51
Volume 6, Number 10 April 20, 1993
Clinical Consultation Telephone Service for AIDS
H H S N E W S
********************************************
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
March 4, 1993
HHS Secretary Donna E. Shalala today announced the first nationwide
clinical consultation telephone service for doctors and other health care
professionals who have questions about providing care to people with HIV
infection or AIDS.
The toll-free National HIV Telephone Consulting Service is staffed by a
physician, a nurse practitioner and a pharmacist. It provides information on
drugs, clinical trials and the latest treatment methods. The service is
funded by the Health Resources and Services Administration and operates out of
San Francisco General Hospital.
Secretary Shalala said, "One goal of this project is to share expertise
so patients get the best care. A second goal is to get more primary health
care providers involved in care for people with HIV or AIDS, which reduces
treatment cost by allowing patients to remain with their medical providers and
community social support networks. Currently, many providers refer patients
with HIV or AIDS to specialists or other providers who have more experience."
Secretary Shalala said, "This clinical expertise should be especially
helpful for physicians and providers who treat people with HIV or AIDS in
communities and clinical sites where HIV expertise is not readily available."
The telephone number for health care professionals is 1-800-933-3413, and
it is accessible from 10:30 a.m. to 8 p.m. EST (7:30 a.m. to 5 p.m. PST)
Monday through Friday. During these times, consultants will try to answer
questions immediately, or within an hour. At other times, physicians and
health care providers can leave an electronic message, and questions will be
answered as quickly as possible.
Health care professionals may call the service to ask any question
related to providing HIV care, including the latest HIV/AIDS drug treatment
information, clinical trials information, subspecialty case referral,
literature searches and other information. The service is designed for health
care professionals rather than patients, families or others who have alternate
sources of information or materials.
When a health care professional calls the new service, the call is taken
by either a clinical pharmacist, primary care physician or family nurse
practitioner. All staff members have extensive experience in outpatient and
inpatient primary care for people with HIV-related diseases. The consultant
asks for patient-specific information, including CD4 cell count, current
medications, sex, age and the patient's HIV history.
This national service has grown out of a 16-month local effort that
HICNet Medical Newsletter Page 52
Volume 6, Number 10 April 20, 1993
responded to nearly 1,000 calls from health care providers in northern
California. The initial project was funded by HRSA's Bureau of Health
Professions, through its Community Provider AIDS Training (CPAT) project, and
by the American Academy of Family Physicians.
"When providers expand their knowledge, they also improve the quality of
care they are able to provide to their patients," said HRSA Administrator
Robert G. Harmon. M.D., M.P.H. "This project will be a great resource for
health care professionals and the HIV/AIDS patients they serve."
"This service has opened a new means of communication between health care
professionals and experts on HIV care management," said HRSA's associate
administrator for AIDS and director of the Bureau of Health Resources
Development, G. Stephen Bowen, M.D., M.P.H. "Providers who treat people with
HIV or AIDS have access to the latest information on new drugs, treatment
methods and therapies for people with HIV or AIDS."
HRSA is one of eight U.S. Public Health Service agencies within HHS.
AIDS Hotline Numbers for Consumers
CDC National AIDS Hotline -- 1-800-342-AIDS
for information in Spanish - 1-800-344-SIDA
AIDS Clinical Trials (English & Spanish) -- 1-800-TRIALS-A
HICNet Medical Newsletter Page 53
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