ddodell@stjhmc.fidonet.org (David Dodell) (04/25/91)
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J O H N J A M E S writes on A I D S
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copyright 1991 by John S. James;
permission granted for non-commercial use.
AIDS TREATMENT NEWS Issue #124, April 5, 1991
phone 800/TREAT-12, or 415/255-0588
CONTENTS: [items are separated by "*****" for this display]
Treatment Strategies: Interview with Larry Bruni, M. D.
Clarithromycin: Abbott Seeks Compassionate Access
for MAC (MAI)
Eleven Percent Entirely Healthy Ten or More Years
After HIV Seroconversion
CMV: Oral Ganciclovir Studies Open
First National Children with HIV/AIDS Awareness Day
Lawsuit Challenges AZT Patent
Announcements:
* International AIDS Conference: Free Passes for
Persons with HIV; Apply by April 12
* San Francisco: Chinese Herbal Protocol Starts
April 17; Lecture April 11
* National AIDS Update, San Francisco: Deadline
Extended
* International Conference Assistance Requested
*****
Treatment Strategies: Interview With Larry Bruni, M. D.
by Denny Smith
To help support strategic, individualized programs for
controlling HIV disease, we interviewed Larry Bruni, M. D., a
Washington, D. C., physician who has maintained a large HIV
practice for several years. Dr. Bruni is known as an innovator
in the care of his patients; a Cable News Network (CNN) interview
with him should air later this month.
* * *
DS: For people who are still above 500 T-helper cells, what
do you look for to make decisions about intervention in the
progression of HIV?
LB: The various blood markers aren't very useful at that
point, so I look carefully at the clinical picture. I've come to
regard anything except a broken bone as possibly related to HIV.
That may be a fallacious assumption, but better to be too
vigilant, rather than trivialize something like a rash or
headaches that could be tied into disease progression. I don't
dismiss anything. When people worry that they are being
hypochondriacal, I tell them that they're not. By just recording
patients' complaints in their charts, I can sometimes discern a
pattern of symptoms. Small things that would ordinarily go
unnoticed may be significant. For example, when I examine the
ears, I look for small bubbles behind the eardrums. These can be
caused by infections of mycoplasma, which sometimes colonize the
middle ear. I'm more willing to try doxycycline than to tell the
patient "don't worry about it."
DS: When do blood markers become noteworthy?
LB: Well, the T-4 helper cell counts and percentages are
important because, of course, progressive depletion of helper
cells is the hallmark of HIV infection. But you can't rely on
this alone, partly because the methods of counting the cells are
not absolutely precise; there are many calculations involved in
deriving the final "count."
DS: That's a good point, because I think a lot of people,
including myself, don't understand all the calculations involved
in lab results. We often assume that the total blood cell
population is ordinarily stable, so any variation in one
component is alarming.
LB: No one should be alarmed by small variations. Also,
the percentage of T-helper cells is more revealing than the
absolute count.
DS: When someone who is on AZT experiences a drop in T-
helper cells, is that ever attributable to a drop in the overall
white count, which can in turn be attributed to AZT?
LB: Yes. So I don't routinely put people on nucleoside
analogs [AZT, ddI, ddC] for T-helper cell counts above 500. But
there are circumstances that may warrant the use of AZT in that
range, particularly clinical symptoms that indicate disease
activity. For example, if someone is having repeated bouts of
genital warts.
DS: In other words, a relatively minor problem which is
resistant to normally successful treatment may be a signal of HIV
activity.
LB: Not only that, but I think HIV would be a rather
indolent [slow to change] infection if it weren't for all the
other infections our bodies have to process at the same time. I
don't really make a distinction between opportunistic infections
and the idea of cofactors. I teach my patients that HIV disease
is a slow process if not for other things that push it, such as
other infections, exposure to sunlight, etc. And infections can
transactivate each other. While the warts are allowed to recur
by HIV, HIV is stimulated by the wart virus. So for both
practical and theoretical reasons, we need to control this cycle
by controlling any problem that is potentially chronic, like
bronchitis or adenovirus colitis.
DS: In light of that, what are some of the things you look
for in patients who would ordinarily think of themselves as
asymptomatic?
LB: Sinus infections, skin rashes, fungal infections of the
toenails, athlete's foot that is persistent, prostate infections,
and of course, headaches and fatigue. Headaches, especially, are
too often chalked up to "tension," but since stress can
contribute to immune dysfunction, and to emotional dysphoria, I
think even a tension headache may deserve intervention.
DS: You mentioned sunlight as a cofactor.
LB: Yes, even before studies were published about its
effect on HIV, sunlight was known to provoke herpes outbreaks.
Strong sunlight, probably the ultraviolet rays, can impair immune
response. You don't have to worry about the regular exposure
during daily activities. I'm talking about laying out in the
sun, or playing volleyball in your swimsuit for hours at a time.
T-helper cell counts drop almost invariably after someone spends
a long weekend at the beach.
DS: I understand that you favor the empirical use of
antibiotics, when a set of symptoms is eluding any particular
diagnosis or treatment. Is there a concern that antibiotic drugs
could suppress the immune system further?
LB: I haven't really seen any systemic damage from
antibiotics. Indeed, my own experience is that a course of
antibiotics frequently perks up the immune picture. The first
antibiotic I tried on an empirical basis was doxycycline, in
1988, based on Stephen Caiazza's ideas.
DS: Since HIV isn't affected directly by antibiotics, this
must be a way of dealing with cofactors in hiding.
LB: It often seems that something else is driving the
infection. The notion that latent syphilis may be treated this
way is interesting. I can't think of any topic in medical school
that professors were more smug about than syphilis treatment.
"We know everything there is to know about this disease," they'd
say. Reminds me of the character in Voltaire's Candide.
DS: Dr. Pangloss!
LB: Yes, as though we live in the best of all possible
worlds, and we know everything we need to know. But meanwhile,
one treatment they were using to treat syphilis failed to cross
the blood/brain barrier, and those people may be chronically
infected with syphilis, including many people with HIV.
DS: So the cerebrospinal fluid could be "reseeding" the
body, and doxycycline may be dealing with it?
LB: I've had some excellent results with doxycycline;
tetracycline, as well, will cross the blood/brain barrier. I try
it in people who have a residual indicator of syphilis in their
blood. And now we know that we could be treating mycoplasma
infections empirically, too. I have actually seen rises in T-
helper cells in some patients during treatment with doxycycline.
DS: How do patients and physicians make judgment decisions
together?
LB: Physicians need to be willing to make some intuitive
judgments, because we won't find advice in the medical journals,
whose reports invariably end with something like "not
statistically conclusive, more investigations needed." Patients
can be limited by their preconceptions. I still get patients who
say to me, "I'll try anything except AZT. " "Why won't you try
AZT? " "Because it's poison." Yet studies clearly show that
when we use AZT correctly, we can improve the quality and the
length of life.
DS: So you're trapped between patients who do not like the
primary option available, and a medical establishment which
cannot seem to improve the options.
LB: Well, I'm really happy now that we have ddC, even if
people have to use the "gray market" version. I think ddC works,
without horrible side effects. Now routinely, when I start
people on AZT, after three months I tell them it's time to switch
to ddC. Another three months, we return to AZT, and I continue
alternating like that.
DS: What's the rationale for rotating instead of using them
together?
LB: Well, it takes about three months for AZT side effects
to appear, at the current low doses. This dosing may avoid
indefinitely those predictable drops in white cells and
hemoglobin. By using them separately, you can also see how each
drug affects each patient.
DS: You've mentioned AZT and ddC, but not ddI.
LB: For a year and a half, our office has been overwhelmed
by the paperwork associated with ddI. And the manufacturer's
criteria for ddC eligibility are ridiculous. I'm ready to forego
all that if patients can reliably obtain ddC through the buyers'
clubs.
DS: Are there other important treatments that patients can
get through the buyers' clubs?
LB: In addition to ddC, I'm glad to see the clubs carrying
levamisole [a potential immunomodulator] and clarithromycin [a
new antibiotic]. I started recommending levamisole to patients
last November, before it was approved by FDA for use in colon
cancer. When it became available by prescription, I started
slowly, not being familiar with its use and wishing to avoid
toxicities. Now I give it to people who do not improve on more
standard therapies. I think it holds great promise as an
immunomodulator.
DS: Is clarithromycin still looking promising for treating
MAI, cryptosporidiosis, or toxoplasmosis?
LB: I've replaced all the old MAI drugs with clarithromycin
and ciprofloxacin. The dose we're trying is eight pills [250 mg
each] of clarithromycin daily, which unfortunately is expensive.
I'm seeing some weight gain, and reduced fevers. These patients
feel it's working. I'm trying the related drug azithromycin to
treat toxoplasmosis in several patients who were obviously
failing the pyrimethamine/sulfa combination. It's too early in
follow-up to say for sure, but I think it will work. I'm also
advocating some prophylaxis in people who have been exposed to
Toxoplasma, and who have dropped below 200 T-helper cells. I
believe azithromycin and clarithromycin probably will become the
best drugs with which to treat toxo or prevent active infections.
Anecdotally, two of my patients with cryptosporidiosis found
complete relief from the diarrhea within five days on
azithromycin, and after ten days of treatment they maintained
normal bowel function and regained all their lost weight for
months.
DS: Something we have been hearing a lot about lately is
gall bladder inflammation and bile duct obstructions. Is this
becoming a common HIV-associated trouble?
LB: Very common. This is usually a condition called
acalculous cholecystitis, meaning an inflammation which is not
caused by gallstones. The cause could be any of a number of
pathogens, like CMV, cryptosporidiosis, or other parasites. But
the drugs we give to treat those infections do not penetrate the
gall bladder very well, making it sort of a reservoir of
infection. The signs are abdominal pain, often connected with
diarrhea. Since this tends to persist and not respond to
antibiotics, the best treatment seems to be removal of the gall
bladder. You can get along nicely without a gall bladder, and
the surgery should improve both appetite and nutrient absorption.
DS: Getting back to the empirical use of treatments, you
have found IVIG [intravenous immune globulin] useful, haven't
you?
LB: It can be very helpful, also very expensive. It's
valuable for treating the kind of recurring bacterial infections
that a healthy immune system ordinarily handles, especially sinus
infections. It is also a good complement to use with ganciclovir
when treating CMV pneumonia or colitis. Adding it to therapy for
retinitis does not help much, according to studies which have
been completed.
DS: Can you make immune globulin specific, engineer it to
be concentrated in certain antibodies?
LB: It's not engineered so much as graded for counts of
particular antibodies. I use Gammagard, made by Baxter, because
it has the highest concentration of anti-CMV antibodies.
DS: Do you have any advice about nutritional supplements?
LB: I have recommended a short list of supplements for
several years, and have recently added NAC and coenzyme Q-10 to
that list.
DS: Why has interest in coenzyme Q been revived recently?
[Note: do not confuse coenzyme Q with compound Q.]
LB: It might be helpful for countering some of the heart
muscle degeneration being reported now in connection with HIV
infection.
DS: I saw one such report that alerted physicians to the
possibility of HIV cardiac abnormalities, and that some symptoms
casually attributed to lung involvement, like fatigue and
shortness of breath, instead could be implicating the heart.
Research Politics
DS: What are some of the politics affecting the clinical
care picture today?
LB: I see the Food and Drug Administration and the National
Institutes of Health as having a symbiotic relationship with the
pharmaceutical industry. They are in a codependent relationship.
People on both sides have their complaints, but they do not
seriously analyze themselves. Congress plays along with the
game, too, funding and regulating the relationship. And as in
codependency, something like a disaster has to happen for a real
change to occur. No one is presently in charge of an overall
plan for AIDS. But you watch -- five years from now, when
straight teenagers are dropping like flies, then AIDS will become
a national priority. Of course, we will probably have a new
administration by then, too. Meanwhile, we need clinicians and
researchers to talk to each other, to try to build solutions to
the problems of HIV disease. Instead of obsessing on basic
research, we must constructively analyze what the problems are,
and start acting on priorities toward the solution. Plan the
work and work the plan. No organization in the world is doing
that now.
DS: Perhaps we should aim for solutions that fit the
problem, instead of problems that fit someone's solution.
LB: Exactly right. And we need innovators. More AZT
studies are not innovative. The non-innovative answers are not
solutions. They are solutions in search of problems, as you said.
And all the while researchers around the world traipse around
their own little garden path, doing their own personal research.
By contrast, we could harness that creative thinking, and
integrate this research chaos into a bigger picture. One model
I've worked with is the National Community Research Initiative,
in Washington, D. C. We began by developing computer software,
called CRIS, to let physicians keep up with each other's
experiences, to correlate all the raw data of our practices.
We've developed a database that can work as a total clinical
management system. We can directly download results of bloodwork
from the laboratory by modem into the database. This technology
could help to share statistics, to generate statistically valid
correlations. In my office we will soon have a computer work
station in each patient examination room, so we can have the
patient's history and treatment experiences and all lab work at
our fingertips.
DS: It would seem that physicians in different countries,
using different therapies, could use the database to learn from
each other.
LB: Yes, this information is eminently exportable.
Communication technology is an innovative, useful approach.
***** Clarithromycin: Abbott Seeks Compassionate
Access for MAC
by John S. James
Abbott Laboratories has contacted the U. S. Food and Drug
Administration (FDA) and proposed a draft protocol for
compassionate use of clarithromycin for persons with AIDS who
have mycobacterium avium complex (MAC, also called MAI).
Clarithromycin, a new broad-spectrum antibiotic approved in
20 countries but not yet in the United States, has quickly become
a major concern of treatment activists. MAC is one of the most
widespread opportunistic infections, and conventional treatment
(usually a "cocktail" of four or five antibiotics) is often
unsatisfactory. Early research results and practical experience
both suggest that clarithromycin is much more promising than any
of the standard treatments. Persons with MAC have imported the
drug, but it is expensive, and often financially burdensome or
unavailable, since unapproved drugs are seldom covered by
insurance. It is hoped that some form of compassionate treatment
access can fill the gap until the drug can be financed in the
same way as other medical care. We do not know how long it will
take for Abbott's preliminary proposal for compassionate use to
be completed and implemented.
Clarithromycin was first developed for uses not related to
AIDS. For these purposes the drug is less critical, because other
satisfactory treatments are available. Clarithromycin has the
advantage of broad-spectrum activity; according to Abbott's April
1 news release, it "has been shown to be active against all
significant respiratory pathogens as well as against the full
range of community-acquired skin and gastrointestinal
infections."
For more information on clarithromycin, see AIDS TREATMENT
NEWS #109 (August 17, 1990) and #113 (October 19, 1990). Also see
the interview with Larry Bruni, M. D., in this issue. For
information about obtaining the drug now, call the PWA Health
Group, 212/532-0280, or LABC/Staying Alive, 213/748-1295.
***** Eleven Percent Entirely Healthy Ten or More Years
After HIV Seroconversion
by John S. James
A major San Francisco study of AIDS progression is finding
that about 11 percent of persons infected with HIV are completely
healthy ten or more years later; they not only have no HIV-
related symptoms, but also have normal T-helper counts. A formal
report on intensive studies of some of these patients is being
prepared for publication. Meanwhile, a March 25 article in the
San Francisco Examiner brought current findings to wider public
attention. Researchers are trying to find out why the disease
progresses very slowly (if at all) in some people; such knowledge
might be useful in developing treatments.
The data is emerging from the Clinic Study, conducted by the
San Francisco Department of Public Health (DPH) and the U. S.
Centers for Disease Control. The Clinic Study began as research
on sexually-transmitted hepatitis B, before AIDS was known; 6,705
gay or bisexual men who visited San Francisco's sexually-
transmitted disease clinic from 1978 to 1980 were recruited, and
frozen blood samples were saved. Later it was found that 489 of
them were either HIV positive when they entered the study, or
became positive at a known time between 1978 and the present.
Because the approximate time of seroconversion is known, this
cohort is providing some of the best information anywhere on how
AIDS develops.
Of the 489 whose time of seroconversion is known, 341 were
found to be HIV positive more than ten years ago, between 1977
and 1980. As reported last November1, 49 percent of these men
had died of AIDS, ten percent currently had AIDS, 19 percent had
ARC, 3 percent had lymphadenopathy but no other symptoms, and 19
percent had no clinical symptoms of AIDS or HIV. [Note:
Survival is almost certainly better today; these percentages are
for persons infected by 1980, years before antiretrovirals,
pneumocystis prophylaxis, and other treatment improvements were
in use.] Today more than half of that 19 percent -- 11 percent of
the 341 -- not only have no symptoms, but also have normal T-
helper counts.
We asked Susan Buchbinder, M. D., of the AIDS Office of DPH,
whether the statistics on disease progression suggest that some
of the 11 percent would never become ill, or if they were only
the extreme end of the statistical distribution of slow disease
progression. She said that no one knows at this time -- but that
in either case, information about why HIV infection behaves
differently in these people might help in developing treatments.
One of the major theories being studied now in conjunction
with the San Francisco City Clinic is that certain blood cells,
perhaps CD8 lymphocytes, secrete an unknown substance which helps
to keep the virus in check. The group at the University of
California San Francisco Medical Center, headed by virologist Jay
Levy, M. D., has been investigating this possibility for several
years. Other researchers, including Dr. Buchbinder and Alison
Mawle, Ph.D., of the U. S. Centers for Disease Control, are
investigating another kind of white blood cell, the cytotoxic
lymphocyte.
Dr. Buchbinder asked us to let our readers know that any gay
or bisexual men who visited San Francisco's STD clinic from 1978
to 1980, and have not already been in contact with the research
team, could call to see if they have frozen blood stored. They
must give permission for their blood to be used for research.
Persons who participate in research can learn about their own
health history and status, and also they will be contributing to
knowledge which could help to improve HIV treatments. Those who
may have blood stored can call Paul O'Malley at the Clinic Study,
415/554-9030.
References
1. Rutherford GW, Lifson AR, Hessol NA and others. Course of
HIV-I infection in a cohort of homosexual and bisexual men: an
11 year follow up study. British Medical Journal November 24,
1990; volume 301, pages 1183-1188.
***** CMV: Oral Ganciclovir Studies Open
by Michelle Roland
Two clinical trials testing oral ganciclovir in people with
CMV infection have recently opened at seven centers around the
United States. The larger study is for people with newly
diagnosed CMV retinitis. The second trial is designed to
evaluate the effects of food on the absorption of oral
ganciclovir. It will last eight days and is open to people with
a past or present CMV infection (documented by a positive CMV
culture or the presence of antibodies against CMV) without any
evidence of CMV-related disease. Note that most people have been
exposed to and infected with CMV at some time in their lives, but
only some will develop symptoms related to that infection.
Background on CMV Treatments
Intravenous (IV) ganciclovir (also called DHPG, or Cytovene)
is currently the only FDA-approved treatment for CMV retinitis, a
sight-threatening infection of the eye. People who have been
diagnosed with CMV retinitis are generally given ganciclovir
twice a day for two to three weeks (induction phase) followed by
daily infusions five to seven days a week for the rest of their
lives (maintenance phase). If a person experiences a progression
of their disease during the maintenance phase, they are generally
re-induced with twice a day ganciclovir for another two to three
weeks.
If the treatment fails to prevent progression of the
retinitis after repeated inductions, or if the side effects of
the ganciclovir are too serious to continue treatment, people may
choose to try the experimental drug foscarnet. Although this
compound is not yet FDA-approved, it is usually available to
people in these situations through an expanded access program.
Foscarnet is also an IV drug.
Several oral and other experimental anti-CMV drugs are
currently in various stages of development. The oral compound
which has been studied most is ganciclovir. In early studies it
was found that the drug was not well absorbed; therefore,
quantities much larger than the IV dosage must be taken to
achieve concentrations high enough to be effective.
CMV Retinitis Study
The new study in people with CMV retinitis will compare oral
and IV ganciclovir as maintenance treatment, after all
participants have received a three week induction course with IV
ganciclovir. This is an extremely important study because it
will answer questions about the relative safety and efficacy of
the oral and IV formulations. If the oral compound is found to
be about as safe and effective as the IV drug, data from this
study may lead to FDA licensing of oral ganciclovir.
To be eligible for this study, the CMV retinitis must have
been diagnosed, and no anti-CMV drugs may have been used, within
one month of enrollment. Participants cannot have persistent
diarrhea or other gastrointestinal symptoms, because these are
some of the potential side effects of oral ganciclovir.
Participants must be at least 13 years old. Because this drug
causes birth defects in animals, both males and females will be
required to use birth control, and women will be required to have
a negative pregnancy test.
Initiation or resumption of AZT will be allowed after the
first five weeks of the study. ddI may be initiated or continued
at any time during the study. ddC is not yet allowed, but an
amendment may be written to include ddC and/or combination
antiretroviral therapy at some point during the study as more
data becomes available about the efficacy of these treatment
approaches.
After the first three weeks of twice daily IV infusions of
ganciclovir, participants will be randomized to receive either
oral ganciclovir (two capsules six times a day while awake) or IV
ganciclovir (once a day, seven days a week). Some patients
treated outside of this study would only receive IV ganciclovir
five days a week after the first two to three weeks, depending on
blood counts and the preference of the patient and the physician.
Randomization to the IV arm of this study may therefore require
more infusions than is common in some physicians' clinical
practices.
The study lasts for a total of 23 weeks. The ganciclovir
and all clinic visits and lab work required by the study will be
provided free of charge. If the drug still appears to be safe at
the end of the study, all participants will be eligible for oral
ganciclovir through another Syntex protocol, as long as they are
willing to be followed on the protocol.
At press time the study drugs have been shipped to the seven
sites listed below. We have confirmed that the study is open in
Boston, Miami, and San Francisco/Davies. The Washington, D. C.,
site will not be enrolling patients until early May for the
retinitis study, but is currently accepting participants for the
food absorption study described below. We were not able to
contact the San Francisco (Children's Hospital) or Galveston
sites before going to press, but have been told by the clinical
research associate at Syntex that they are all ready to enroll
patients.
Chicago: Rush-Presbyterian-St. Luke's Medical Center. Contact
person: Pam Urvanski, 312/942-5865.
Boston: Beth Israel Hospital. Contact person: Jocelyn Loftus
or Mary Ann Lee, 617/735-4103.
Miami: Miami Veteran's Administration Medical Center. Contact
person: Tommy Stapleton, 305/324-3267, or Debra Fertel, M. D.,
305/324-4455. Please note that because this is a Veteran's
Administration hospital, all veterans are eligible for the study,
and individual non-veterans will be considered.
San Francisco: Davies Medical Center. Contact person: Ed
Freeman, 415/565-6617.
San Francisco: Children's Hospital. Contact person: Jaime
Geaga or Toby Dyner, M. D., 415/750-6529, or David Busch, M. D.,
415/923-3883.
Galveston: University of Texas Medical Branch. Contact person:
Karen Waterman, 409/761-4979.
Washington, D. C.: Georgetown University Hospital. Contact
person: Cari O'Leary, 202/687-6845, or Anne Byrne, 202/687-
8087, or James P. Lavelle, Jr., M. D., 202/687-8826.
Additional sites in San Francisco, New York , Detroit, and
San Diego are expected to receive the study drug and start
enrolling patients within the next few weeks. For more
information on the current status of the trial in these areas,
call 800-TRIALS-A. Syntex will be updating information available
through that number on at least a monthly basis.
Study of the Effect of Food on Absorption
This study is open to people who have been infected with CMV
at some time in the past but do not have any signs of CMV
disease. Participants must have a T-helper count above 200. The
study lasts only eight days. It requires multiple blood samples
on two days, single blood samples on several other days, regular
telephone contact, and strict timing of medication and meals.
Participants must be willing to stop taking most drugs, including
all antiretrovirals, for 12 days. Because this study is not
expected to provide any benefit to the participants, and does
entail a significant amount of travel and inconvenience,
participants will be paid $300 at the completion of the trial.
This is also an important study; it is crucial to learn how
to maximize the absorption of oral ganciclovir, while minimizing
its side effects. The trial is being conducted at the San
Francisco (Davies Medical Center only) and Washington, D. C.,
sites listed above, both of which are currently enrolling
participants.
***** First National Children with HIV/AIDS Awareness Day
by Michelle Roland
The First National Children with HIV/AIDS Awareness Day will
be held on the Mall near the Capitol Building in Washington, D.
C., on Tuesday, June 11, 1991. This event is being spearheaded
by the Sunburst National AIDS Project, an organization which
sponsors a summer camp for HIV-positive children and their
families. Supporting organizations include the Names Project,
the U. S. Department of Maternal and Child Health, the National
Education Association, the Children with AIDS Project of America,
the Parents' Pediatric AIDS Coalition of California, the Children
with AIDS Foundation in Boston, the AIDS Resource Foundation for
Children in New Jersey, and the Minnesota AIDS Project. Newman's
Own is the first corporate sponsor to offer its support.
To continue building national awareness of pediatric AIDS
issues, a joint resolution is being submitted to both Houses of
Congress to designate June 10-16 as Pediatric AIDS Awareness
Week.
The organizers of the National Children with HIV/AIDS
Awareness Day plan to educate the public about the various modes
of pediatric AIDS transmission, the all-inclusive range of ethnic
and social groups affected, and the ever-increasing number of
babies, children, and teenagers with AIDS. They hope that this
attention will influence Congress to allocate more funding for
AIDS research and direct services. Finally, the Day's events
will provide support to families affected by AIDS, and
remembrance of children who have died from AIDS-related
conditions.
The organizers are looking for professional athletes and
celebrity speakers, fundraising assistance, and additional
corporate sponsors. Volunteers to help in Washington on June 11
are also needed. The Sunburst AIDS Project is requesting
participation of school systems throughout the country to
increase awareness about children with HIV/AIDS and to support
the Awareness Day; four states (California, Minnesota,
Mississippi, and Tennessee) have already endorsed this program,
called the Butterfly Project. Local Congressional
representatives may be contacted by phone or mail to support the
Pediatric AIDS Awareness Week (H. J. Resolution 91). If you
would like to help in any area, or would like more information,
call Sunburst National AIDS Project in Brooklyn at 718/763-8095,
or in Petaluma, California, at 707/769-0169, or write to 148
Wilson Hill Road, Petaluma, CA 94952.
***** Lawsuit Challenges Patent on AZT
A lawsuit prepared by Public Citizen, a nonprofit public
interest group founded by Ralph Nader, has challenged Burroughs
Wellcome's 1988 patent on AZT (brand name Retrovir). The lawsuit
claims that the patent is invalid because "the company did not
conceive, develop or demonstrate the utility of the drug, nor did
it name all of the inventors in its patent application,"
according to a March 19 press release from Public Citizen. "This
lawsuit will establish the public's right to a fair price, and it
gives the government a vehicle to challenge Burroughs Wellcome's
monopoly." Plaintiffs include the PWA Health Group in New York,
and two individuals in Washington, D. C., who are using AZT.
Burroughs Wellcome's press release of the same date claimed
that its scientists "were the first to conceive the use of the
chemical AZT for the treatment of HIV infection in humans" -- the
basis of the company's use patent, and that challenging the
patent now, "more than five years after its filing...could have a
chilling effect on innovation in the United States and could
discourage future AIDS research." The press release also states
that the company has supported "in whole or in part, more than 90
Retrovir-related clinical trials involving some 10,000 patients
worldwide," and that the current price of approximately $2,200
per year for the dose of 500 mg per day "represents a 70 percent
reduction in cost of therapy as a result of price decreases and
reduced dosage since the drug was first marketed in 1987."
***** Announcements
** International AIDS Conference: Free Passes for Persons
with HIV; Apply by April 12
The VII International Conference on AIDS, June 16-21 in
Florence, Italy, is offering free passes to persons with HIV who
would like to attend the Conference but cannot afford the
registration fee. Requests should be received by April 12,
although they will still be considered after that deadline, if
possible.
As stated in the March 12 announcement, "People with HIV who
are interested in applying for free passes to the Conference can
write a letter stating that they are HIV+, with a brief statement
of why they want to attend the Conference and how they have been
involved in the fight against AIDS (activist, volunteer, service
provider, etc.) . Priorities will be given to people from
developing countries, women, and people of color. Letters should
be sent to the Community Relations Department (address below) by
April 12."
Two hundred free scholarships are available: one third for
Italians, one third for North Americans, and one third for
persons from the rest of the world, with an emphasis on
developing countries. Unfortunately, the Conference cannot
provide travel or free housing; it will help people find low-cost
housing in Florence. Italy has no immigration restrictions on
persons with HIV.
To apply for the free passes, or if you have questions about
this program, contact Laura Thomas or Benjamin Junge at the
Community Relations Department by fax, phone, or mail (we suggest
fax):
FAX: (39 6) 44.53.369
phone: (39 6) 44.57.888
Community Relations Department
VII International Conference on AIDS
Laboratory of Virology
Istituto Superiore di Sani
Viale Regina Elena, 299
00161 Rome, Italy
[Organizations note: the Conference will also provide a
small number of exhibition booth spaces to non-governmental and
community-based organizations at greatly reduced rates: Lit.
392,700 (approximately U. S. $350). During the Conference, the
booths must be attended at all times. Inquiries on booth space
should be addressed Centro Servizi Segreteria, FAX: (39 55)
660236, phone: (39 55) 670182, address: Via A. Lapini, 1, 50136
Firenze, Italia.]
** San Francisco: Chinese Herbal Protocol Starts April 17;
Lecture April 11
The Immune Enhancement Program (IEP) will begin a new 12-
week herbal therapy research program on April 17; a lecture and
orientation meeting will be held April 11 at 7:00 p.m. The
program, subsidized by Subhuti Dharmananda's Institute for
Traditional Medicine (ITM), costs $190 for the 12 weeks,
including herbal tablets, herbal consultations, monthly
acupuncture visits, and blood work, including T-helper counts.
The formulas emphasize ganoderma (a mushroom used in Oriental
medicine), and also include astragalus and other herbs.
The Immune Enhancement Program, located at 3450 16th Street
in San Francisco, began in October 1990. The herbal formulas
used are based on several years' work by ITM, in cooperation with
other organizations, in developing herbal combinations for
persons with HIV.
For more information, call the Immune Enhancement Program,
415/252-8711.
** National AIDS Update, San Francisco: Deadline Extended
The National AIDS Update Conference (May 19-22 in San
Francisco; see notice in our last issue) has extended the $145
early-registration deadline to May 10 for AIDS TREATMENT NEWS
readers only; this is a savings of $50. To qualify, write "ATN
Reader" on the registration form.
This conference (on care and services, education and
prevention, policy and administration, and treatment) provides
AIDS education for health-care providers, service organization
administrators, government representatives, and others.
For more information, contact AIDS Conference Registrar,
phone: 415/255-1297, FAX: 415/255-8496.
** International Conference Assistance Requested
AIDS TREATMENT NEWS sent five staff members to both the V
International Conference on AIDS in Montreal in 1989, and the VI
International Conference in San Francisco in 1990, greatly
expanding our coverage of the Conference, background for future
articles, and contacts with international and other
organizations. In 1991, however, we can only afford arrangements
for one person, our editor John S. James, to attend the VII
International Conference in Florence in June. We are asking if
readers can contribute money so that we could send one or two
more writers to this Conference, and/or have a literature table
at this meeting, which is especially important for making
international contacts.
Please send donations (not tax deductible) payable to "ATN
Publications" and marked "Conference Fund," or call Tim Wilson at
415/255-0588 for additional information.
***** Statement of Purpose
AIDS TREATMENT NEWS reports on experimental and
complementary treatments, especially those available now. It
collects information from medical journals, and from interviews
with scientists, physicians, and other health practitioners, and
persons with AIDS or HIV.
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 per year for 24 issues ($100 for nonprofit
organizations, $200 for businesses and institutions), or $40
reduced rate for persons with AIDS or related conditions who
cannot afford the regular rate, to: ATN Publications, P. O. Box
411256, San Francisco, CA 94141. A six-month subscription (12
issues) is $55 for individuals or nonprofits, $110 for businesses
and institutions, or $20 reduced rate. For subscription
information and a sample issue, call 800/TREAT-12 (800/873-
2812), or 415/255-0588.
To order back issues, send $18 for issues #1 through #75,
plus the per-issue cost for each later issue you need. The per-
issue cost is $1 reduced rate, $2 individual or nonprofit rate,
and $4 for businesses and institutions (Note that issues 1
through 75 are also available through bookstores, at a retail
price of $12.95.) The back issues include articles on ddI,
compound Q, clarithromycin, azithromycin, fluconazole, AZT,
aerosol pentamidine, ganciclovir (DHPG), diclazuril, DHEA,
peptide T, passive immunotherapy, hypericin, and many other
treatments.
Outside North America, add $20 per year for airmail postage,
$6 airmail for back issues #1 through #75, and $.50 for each
additional issue. Outside U. S. A., send U. S. funds by
international postal money order, or by travelers checks, or by
drafts or checks on U. S. banks.
To protect your privacy, we mail first class without
mentioning AIDS on the envelope, and we keep our subscriber list
confidential.
Copyright 1991 by John S. James. Permission granted for
non-commercial reproduction, provided that our address and phone
number are included if more than short quotations are used.
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