kdavis@lll-crg.llnl.gov (Ken Davis) (11/16/89)
AIDS TREATMENT NEWS Issue number 90, November 3, 1989
Contents:
U. S. Videotape Explains Cooking and Food Preparation for
Persons with AIDS
Hypericin Study Needs Help to Finish
AZT Now Available Free for Children
Information on HIV in Pregnancy and Pediatrics
Germanium Danger: British Government Warns Physicians
Aerosol Pentamidine Newsletter Publishes Treatment Price
Comparison
Call for Information: Your Experience Applying for ddI Access
San Francisco: ddI Public Forum November 15; New Issue of
BETA
San Francisco: Quan Yin Recruiting for New Herbal Study
Nurse Needed for San Francisco AIDS Research
AIDS TREATMENT NEWS 1990 Publication Schedule
Proposal: An Ombuds Office for Promising Treatments and
Public Policies
*****
U. S. VIDEOTAPE EXPLAINS COOKING, FOOD PREPARATION FOR PERSONS
WITH AIDS
Persons with immune deficiencies are in serious danger of
food-borne diseases. Proper selection, cooking, and handling of
food can greatly reduce the risk. Now two Federal agencies --
the Food and Drug Administration, and the Centers for Disease
Control -- have produced the first videotape to alert people to
this danger, and explain how they can protect themselves.
The 15-minute videotape includes information on foods to
avoid, proper cooking, avoiding contamination in the kitchen,
eating in restaurants, and travel abroad.
Individuals and organizations can obtain the tape without
charge from the CDC's National AIDS Information Clearinghouse
(NAIC). To order a copy, call NAIC at 800/458-5231; or send a
written request to NAIC, P. O. Box 6003, Rockville, MD 20850.
*****
HYPERICIN STUDY NEEDS HELP TO FINISH
by John S. James
The hypericin monitoring study by San Francisco's Community
Research Alliance has enrolled 33 patients, and is collecting
some of the best data anywhere on anti-HIV use of hypericin,
which may be one of the most promising antivirals. (For back-
ground see AIDS TREATMENT NEWS #63, #74, and later issues.) Now
we need the community's help to finish the study, and to start
other rapid, low-cost trials of promising treatments.
The Community Research Alliance (of which this writer is a
co-founder) is not the only group researching hypericin, but it
was able to begin its study early. The leading academic team
studying the drug is now planning animal toxicity tests required
for FDA approval before its human trials can begin. But the Com-
munity Research Alliance could start its study last June, because
people with HIV were already trying hypericin, found in herbal
extracts which have been in human use for years for other medici-
nal purposes. Because the organization does not give anybody a
drug, but is only doing blood work and other data collection on
patients who obtain their own treatment from buyers' clubs or
health-food stores, the study could proceed immediately. Data is
being collected as in university clinical trials, under a proto-
col designed in advance and approved by the organization's scien-
tific advisory committee and institutional review board. It took
only two weeks to recruit enough study volunteers, partly because
the Community Research Alliance was created by the PWA Coalition
and other grassroots AIDS organizations in San Francisco, and
partly because this study does not ask patients to give up any
other treatment or otherwise change what they would be doing any-
way.
The Community Research Alliance helped pioneer this kind of
prospective monitoring study. While this study will not obtain
the more definitive data of a randomized controlled trial, it has
the advantage of taking weeks instead of years to get into opera-
tion. And because all patients have blood work and other tests
under a protocol designed in advance to answer important ques-
tions -- and all are tested at the same intervals and by the same
lab, to obtain comparable results -- this trial can produce far
better information about an available treatment (in this case,
hypericin-containing herbal extracts) than anecdotal reports, or
any data collected from patients who were not following a uniform
protocol. In short, this low-cost, rapid, and flexible kind of
trial, which does not ask patients to make any sacrifices in
their treatment, can produce the best data available for years --
and if it shows promising trends, it could stimulate interest in
more formal trials, so that they would be organized sooner than
if the observational study had not been done.
In New York, the Community Research Initiative plans a simi-
lar study of hypericin. It will be larger and better funded, but
it has not started yet. The importance of the San Francisco
study is that it started in June and its data collection will be
finished next month.
What We Need Now
The hypericin study needs your help. The Community Research
Alliance needs $10,000 to finish it -- for laboratory costs, data
entry and analysis, and to pay the principal investigator and a
staff assistant. Few foundations have ever funded any AIDS pro-
ject -- and of those who have, almost none will touch research.
(The one major exception, the American Foundation for AIDS
Research -- AmFAR -- has already given $30,000 to the Community
Research Alliance.)
In the future, the Community Research Alliance hopes to con-
duct similar studies of treatment possibilities which may be
important, but will not otherwise be researched promptly. For
example, when a potentially important antiviral might be obtained
from an edible plant (such as the sulfolipids in blue-green
algae -- see AIDS TREATMENT NEWS #87, September 8, 1989) academic
and commercial researchers spend the time to prepare the pure
chemical, with associated laboratory and animal tests, before any
human trial can start. Only pure chemicals, not plant products,
have academic and commercial value in the United States. But in
appropriate cases, a prospective monitoring trial of a natural
product could begin very quickly, avoiding years of delay. The
Community Research Alliance has already done one such study, and
is well positioned to do others.
The government will not pay for this kind of research, foun-
dations will not pay for it, the pharmaceutical industry will
not. Unless the community supports this work, it will not hap-
pen. In the future, we hope to find one or more sponsors for
each study -- a community-minded individual or business who could
contribute the relatively small amount, usually under $20,000,
required for this kind of trial. People are more willing to con-
tribute when they know exactly what their money will pay for,
what they will make possible that would not happen otherwise.
If you might be able to help in any way, call the Community
Research Alliance at 415/626-2145; the best times are 10 AM to 6
PM on weekdays. If you can send a contribution, mail it to Com-
munity Research Alliance, 273 Church St., San Francisco, CA
94114.
The Community Research Alliance has shown that it can organ-
ize studies very quickly. But at least for now it gets little
support from established research institutions, which have their
own ways of doing business, ways which cannot respond quickly to
the AIDS emergency. The work of this organization, and of other
community-based AIDS research, depends on you.
*****
AZT NOW AVAILABLE FREE FOR CHILDREN
Until recently, it has been very difficult for physicians to
give AZT to children, for two reasons. First, the drug was not
approved for children, as the early dosage, safety, and efficacy
trials only recruited adults. Physicians could legally prescribe
AZT for children, but without official guidance, most were reluc-
tant to do so, and if they did, insurers were unlikely to pay.
Also, the drug only came in capsules designed for adults; these
had to be opened and their contents divided to obtain the right
dose for a child.
On October 4, Burroughs Wellcome announced that AZT would be
available in syrup form in a few weeks -- allowing dose adjust-
ment for children, and also making the drug more accessible to
adults who cannot swallow capsules.
On October 26, the Department of Health and Human Services
announced that the FDA had approved a "treatment IND" application
from Burroughs Wellcome, allowing the company to distribute the
drug free for children who meet certain medical requirements.
AZT had already been given to at least 200 children in clinical
trials; it seemed to be no more or less toxic to them than to
adults, and it seemed clearly beneficial in some cases, espe-
cially in treating dementia. For more information about the
treatment IND, physicians can call Burroughs-Wellcome at
800/829-PEDS.
While the drug is free, we do not know how associated costs
will be paid -- especially the cost of blood tests to detect tox-
icity, and of any treatment required for side effects. Many
children with AIDS come from poverty backgrounds and are unlikely
to have insurance. State Medicaid programs ought to cover these
costs, but we do not know if they will do so.
*****
INFORMATION ON HIV IN PREGNANCY AND PEDIATRICS
The standards of medicine applied to children, infants and
pregnant women are often different and more complex than those
for other populations. Some treatments which are ordinarily safe
can be dangerous during pregnancy, and drugs approved by the Food
and Drug Administration are assigned a rating according to the
Pregnancy Risk Category. Drug doses for newborns and pediatric
patients are not arrived at by simply lowering the recommended
adult dosage, because the mechanisms through which childrens'
bodies absorb, metabolize and excrete drugs are qualitatively
different. Consequently, when questions of treatment for HIV and
AIDS have been addressed for non-pregnant adults, they have
remained largely unanswered for children and women in pregnancy.
The October issue of Focus, published by the AIDS Health
Project in San Francisco, contained two good overviews of these
questions: "Pregnancy and HIV", by Laurie B. Hauer, R. N. who is
the Coordinator of the Bay Area Perinatal AIDS Center at San
Francisco General Hospital, and "Caring for Children with HIV
Infection", by Ellen R. Cooper, M. D., Medical Director of the
Pediatric AIDS Program at Boston City Hospital. To obtain a copy
of this issue, (volume 4, number 11, October 1989), write to
Focus, UCSF AIDS Health Project, Box 0884, San Francisco, CA
94143. Single issues are $3.00.
The Children's Hospital AIDS Program (CHAP) of Children's
Hospital of New Jersey published a useful guide for families with
HIV+ children called The Child with AIDS. The guide discusses
blood tests, opportunistic infections, medications, nutrition,
and emotional dilemmas for parents, siblings and legal guardians.
CHAP also houses the National Pediatric HIV Resource Center. The
Center provides telephone consultations to health professionals
regarding drug trials, home care, school issues and child welfare
agencies. Both CHAP and the Pediatric HIV Resource Center can be
reached at 201/268-8251.
We will report on more resources for parents and children
with HIV in an upcoming issue.
*****
GERMANIUM DANGER: BRITISH GOVERNMENT WARNS PHYSICIANS
by John S. James
In an unusual letter dated October 10, the British govern-
ment warned all doctors in England of health risks from use of
germanium compounds, which have been widely sold in health-food
stores. The warning followed an article on germanium toxicity by
well-known investigative reporter Duncan Campbell, published Sep-
tember 8 in New Statesman & Society, London. The official letter
to physicians begins as follows:
"The purpose of this letter is to alert you to a potential
health hazard caused by germanium, found in certain dietary sup-
plements which can cause nephropathy, leading in some cases to
renal failure and death. Other complications include cardiomyo-
pathy and peripheral myopathy. (The letter references T. Matsu-
saka and others, "Germanium-induced nephropathy: report of two
cases and review of the literature," Clinical Nephrology (West
Germany), December 1988, volume 30 number 6, pages 341-345.) In a
review of 10 cases, pathological changes occurred following
ingestion of germanium, 50 to 200 mg per day, for periods of four
to 18 months. Death occurred in two cases."
The letter went on to express concern that persons with AIDS
and chronic fatigue were especially likely to use germanium. It
said that the Department of Health had no evidence that the sub-
stance had any nutritional value or health benefit, and urged
physicians to have their patients stop using it.
Except for occasional mentions in lists of treatments, we
have not previously covered germanium in AIDS TREATMENT NEWS.
Another View
We spoke with Parris Kidd, Ph.D., founder of the Germanium
Institute of North America (which he has since closed). Dr. Kidd
told us that there are no published cases of toxicity from the
germanium compound which is supposed to be in the capsules,
namely germanium sesquioxide, also called Ge-132. He believes
that the toxicity is due either to another compound, germanium
dioxide, or to an unknown contaminant. (This information is con-
sistent with what we have seen in the published literature; how-
ever, we know of no proof that even the pure product would be
safe.)
Dr. Kidd explained that it is difficult and expensive to
test for potentially dangerous contaminants -- and that because
of lack of uniform testing, no one can be confident of the safety
of germanium compounds.
He also told us that while there were no controlled human
trials, he has heard many anecdotal reports suggesting that ger-
manium sesquioxide might be helpful in treating various condi-
tions, including chronic viral infections. He also told us that
germanium is not known to be a nutrient, as no deficiency condi-
tion has been established.
There has been a little research published in medical jour-
nals on possible medical uses of germanium sesquioxide; we have
not seen any related to AIDS. (A different compound, spiroger-
manium, has been widely tested as a potential cancer treatment.)
Our conclusion, based on the evidence we have seen so far,
is that germanium compounds available today may be dangerous, and
that no benefit has been proven.
*****
AEROSOL PENTAMIDINE NEWSLETTER PUBLISHES TREATMENT
PRICE COMPARISON
A newsletter published by PANT (Patient Advocates for Neces-
sary Treatment) gives prices for monthly aerosol pentamidine
treatment at 18 different hospitals, clinics, and physicians
offices in San Francisco. The prices, which range from $175
(University of California San Francisco Medical Center) to $280
(tie between St. Mary's Hospital, and Pacific Presbyterian Medi-
cal Center) can also help to establish reasonable price ranges
elsewhere.
For a copy of the newsletter (vol. 1, no. 2), send a self-
addressed stamped envelope to: Morgan Fine, PANT, 4302 19th
Street, San Francisco, CA 94114.
*****
CALL FOR INFORMATION: YOUR EXPERIENCE APPLYING FOR DDI ACCESS
Lambda Legal Defense and Education Fund is collecting infor-
mation about the process of applying for access to ddI. It espe-
cially wants to hear from anyone who has had difficulty or been
rejected. If you have information, phone David Barr, a staff
attorney who is working on AIDS issues, at Lambda Legal,
212/995-8585.
*****
SAN FRANCISCO: DDI PUBLIC FORUM NOVEMBER 15; NEW ISSUE OF BETA
On Wednesday, November 15, speakers from the National Cancer
Institute, Bristol-Myers Squibb and San Francisco General Hospi-
tal will discuss recent developments concerning the drug ddI at a
public forum sponsored by the San Francisco AIDS Foundation, the
County Community Consortium, and the San Francisco Medical
Society. The forum begins at 8 p.m. at the San Francisco Medi-
cal Society Auditorium, 250 Masonic, near Turk St.
Physicians are invited to an earlier meeting, 5: 30 at the
same address, to discuss monitoring their patients on ddI and the
administrative requirements of ddI access.
The latest (fourth) issue of BETA (the Bulletin of Experi-
mental Treatments for AIDS) will soon be released by the San
Francisco AIDS Foundation. It should be available at the ddI
forum.
*****
SAN FRANCISCO: QUAN YIN RECRUITING FOR NEW HERBAL STUDY
The Chinese Herbal Treatment Program of San Francisco's Quan
Yin Healing Arts Center is again open to enrollment for a twelve
week HIV research and treatment protocol. The cost is $190.00
and includes required lab work. The program is structured for
all seropositive persons, with or without symptoms. Participants
must already have a primary physician, and other treatments and
medications can be continued. The deadline for enrollment is
Friday, November 24, and the program begins the following Thurs-
day, November 30. For information, call David at 415/861-4963.
Another, more intensive program sponsored by the Healing
Arts Center is the San Francisco AIDS Alternative Healing Pro-
ject, and begins December 4. This program also runs for twelve
weeks and will include acupuncture, psychotherapy, chiropractic,
hypnosis, massage and nutritional counseling as well as herbal
treatments. For more information call Amanda at 415/861-4964.
Both the Quan Yin Herbal Program and the AIDS Alternative Healing
Project approach HIV as a manageable chronic viral syndrome.
*****
NURSE NEEDED FOR SAN FRANCISCO AIDS RESEARCH
A registered nurse is needed for community-based AIDS
research in San Francisco. Duties include providing research
support and monitoring clinical trials conducted in physicians'
offices and in clinics in the Bay Area. HIV experience is
strongly preferred, but prior research experience is not
required.
For more information, call Carroll Child, County Community
Consortium, 415/821-3144.
*****
ERRATA
Two errors appeared in our last issue, #89:
(1) In the article about the upcoming hemophilia conference and
the difficulty of participants entering the United States, we
gave the wrong state of Senator Jesse Helms. The correct state
is North Carolina.
(2) The editorial contrasting the response to the earthquake and
the response to AIDS suggested that there have been over 2,000
AIDS-related deaths in San Francisco. In fact there have been
over 4,700 deaths in San Francisco -- hundreds of times the toll
of the earthquake.
*****
AIDS TREATMENT NEWS 1990 PUBLICATION SCHEDULE
On January 1, AIDS TREATMENT NEWS will start publishing
twice a month, on the first and third Fridays, instead of pub-
lishing every two weeks. Therefore a one-year subscription will
be 24 issues, instead of 26 as currently.
The individual and reduced-rate subscription prices will
stay the same. However, as there will be fewer issues, the cost
per issue will be about 8 percent higher. Any new subscription
or renewal which we receive through the first week in January
will be credited at the rate of 26 issues per year. Subscrip-
tions received later will be counted as 24 issues per year.
The subscription price for organizations will change, from
the current $150.00 per year, to $100.00 for nonprofits and
$200.00 for businesses and institutions.
The cost for back issues will be greatly reduced, as issues
1-75 are being published (by Celestial Arts, Berkeley, CA) with
an extensive, updated index, and a resource list with current
addresses and phone numbers. We will announce the book when it
is available, probably by the end of this year. If you want to
order back issues now, see "How to Subscribe to AIDS TREATMENT
NEWS," below.
There will be no issue on December 29 of this year. All
subscriptions will be extended one issue to compensate.
Our regular and reduced-rate subscription prices have had no
important changes in our three years of publication, although the
average length of each issue has almost doubled. Our goal is to
keep prices unchanged at least through 1990.
*****
PROPOSAL: AN OMBUDS OFFICE FOR PROMISING TREATMENTS AND PUBLIC
POLICIES
by John S. James
Note: We submitted this suggestion to the Mayor's HIV Task
Force, San Francisco, which requested our comments on clinical
trials and the parallel track. One of the other invited speakers
challenged our characterization of ddI as a relative success in
drug development. He pointed out that the anti-HIV activity of
ddI was discovered at almost the same time as that of AZT, and
that if ddI had been developed promptly the clinical trials could
have been finished, and ddI approved two years ago. (We should
note that Bristol-Myers Squibb and others now working with ddI
were not involved at that time.)
We left the statement below as we submitted it, but the
point is a good one.
The Problem
The mainstream, national response to the earthquake shows
what can and should be done in responding to a disaster. But
AIDS has killed hundreds of times as many people, both in San
Francisco and nationally, without calling forth even a shadow of
the response to the earthquake. The Federal failure to support
San Francisco's model AIDS programs illustrates the lack of
national mobilization, the fact that the United States has backed
into the epidemic and still does not have a coherent, rational
AIDS program.
How can San Francisco increase its impact on national pol-
icy?
Lost Opportunities: An Example
Our three and a half years of publication has documented a
catalog of lost opportunities -- both particular treatments, and
broader public policies -- largely neglected when they clearly
deserved feasible, cost-effective research or other followup.
The example of ddI shows that while Federal policies have
significantly improved, they are still unable to respond effec-
tively to the epidemic:
* ddI has been handled with unprecedented speed and unpre-
cedented communication between AIDS advocates, industry, and the
FDA -- all very much for the good.
* But this rapid mobilization applies only when the public's
imagination is engaged. For example, the related antiviral DDC
appears to be about as good as ddI, but cost hundreds of times
less to manufacture. It could be developed as a treatment avail-
able to all, anywhere in the world, regardless of ability to pay.
But our initial inquiries indicate that no one anywhere is
developing this treatment option -- a critical lack when many
people have no treatment available at all, and little prospect of
treatment in the future, since only the expensive treatment pos-
sibilities are being developed.
* The current clinical trials of ddI will probably take over
two years to complete -- obviously not acceptable for the pur-
poses of public health. Clinical trials are still being designed
under business as usual, without mobilization of top scientific
and statistical talent to re-examine the underlying assumptions
of trial design in view of the current emergency.
Questions about the two-year delay are usually dismissed
with the comment that those who need the drug in the meantime can
get it through parallel access. But --
* The parallel-access system now developing for ddI will
work only for those who have aggressive primary-care physicians,
and who can afford the extensive paperwork and laboratory tests
required. Insurance will probably refuse to pay for these costs,
meaning that we will have parallel access only for those with
money.
Yet ddI is the success story. Hundreds of promising treat-
ment and policy options have been overlooked for lack of atten-
tion and advocacy. One systematic problem is that the interests
and views of impacted jurisdictions like San Francisco, which are
called on to provide medical care of last resort when others
institutions have walked away, are not represented when decisions
are made.
What Can San Francisco Do?
Inadequate national response to the AIDS/HIV epidemic is
creating intolerable burdens in impacted areas. The recent
earthquake will make the financial strain even worse. How can
San Francisco affect national policy through programs which cost
little or no money?
One way would be to apply the concept of an ombuds office --
which usually serves individuals -- to serving PROPOSED POLICIES
instead.
The traditional ombudsman hears problems from individuals,
and helps get these problems addressed as well as possible by
existing agencies or other institutions. The ombuds office may
advise the individual on how to proceed, or may call officials
and others to help clear up snafus; but it does not substitute
for the agencies, or do their work itself. Therefore a small
effort can have a great impact, by overcoming just those problems
which the experienced ombuds office can easily deal with, and
getting the existing system to work as well as it can. Later,
statistics generated by the ombuds program can be used to guide
legislation or other institutional improvements.
San Francisco could develop a highly leveraged impact on
national policy by creating an ombuds function which receives
PROMISING PUBLIC POLICIES instead of individuals -- and helps
shepherd them through existing systems, as the traditional
ombudsman helps individuals. The proposed ombuds office would
receive complaints or suggestions from anyone, then investigate
and prioritize the problems and decide which ones it might handle
most effectively. It could help to resolve simple snafus through
telephone calls to Federal, state, local, or other government
officials, to corporate officials, to the media, etc. It could
make recommendations to City departments, but would have no power
except persuasion. And of course it could refer persons who
brought problems, complaints, or suggestions to anyone else they
should be talking to.
A key to the success of such an ombuds office is that it
could address any problem that impacts on San Francisco's ability
to respond to the epidemic -- medical research, standards of
care, insurance reimbursement (private, Federal, or state), fund-
ing for services, organizational snafus. Some problems can be
resolved quickly by bringing the right people into communication.
Problems which cannot be resolved easily can be articulated with
cogent analysis and well-justified recommendations.
*****
STATEMENT OF PURPOSE
AIDS TREATMENT NEWS reports on experimental and complementary
treatments, especially those available now. It collects informa-
tion from medical journals, and from interviews with scientists,
physicians, and other health practitioners, and persons with AIDS
or ARC.
Long-term survivors have usually tried many different treatments,
and found combinations which work for them. AIDS TREATMENT NEWS
does not recommend particular therapies, but seeks to increase
the options available.
We also examine the ethical and public-policy issues around AIDS
treatment research and treatment access.
HOW TO SUBSCRIBE TO AIDS TREATMENT NEWS
Send $100.00 per year for 26 issues ($150.00 for businesses and
organizations), or $30.00 reduced rate for persons with AIDS or
ARC who cannot afford the regular rate, to: ATN Publications, P.
O. Box 411256, San Francisco, CA 94141. A six-month subscription
(13 issues) is $55.00 ($80.00 for businesses or organizations),
or $16.00 reduced rate. For subscription information and a sam-
ple issue, call 415/255-0588.
To order back issues, send $18.00 for issues #1 through #75, plus
the per-issue cost for each later issue you need. The per-issue
cost is $1.00 reduced rate, $2.00 individual or nonprofit rate,
and $4.00 for businesses and institutions. Issues #1 through #75
are out of print and will be backordered until they are available
in the new paperback book. We will mail the more recent issues
immediately and send the book when it is available, sending
both by first-class mail. (Note that issues 1 through 75 will
also be available in bookstores, at a retail price of $12.95.)
The back issues include articles on DDI, compound Q, fluconazole,
AZT, aerosol pentamidine, ganciclovir (DHPG), diclazuril, DHEA,
lentinan, peptide T, passive immunotherapy, hypericin, and
many other treatments.
Outside North America, add $20.00 per year for airmail postage,
$6.00 airmail for back issues #1 through #75, and $.50 for each
additional issue. Outside U.S.A., send U.S. funds by inter-
national postal money order, or by travelers checks, or by
drafts or checks on U.S. banks.
For the complete set of over 80 back issues, call AIDS TREATMENT
NEWS for information. The back issues include articles on DDI,
compound Q, fluconazole, AZT, aerosol pentamidine, ganciclovir
(DHPG), diclazuril, DHEA, lentinan, peptide T, passive immunoth-
erapy, and many other treatments.
To protect your privacy, we mail first class without mentioning
AIDS on the envelope, and we keep our subscriber list confiden-
tial.
Copyright 1989 by John S. James. Permission granted for non-
commercial reproduction.
--
Ken Davis - W6RFN San Francisco, California
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