kdavis@rainbow.UUCP (Ken Davis) (09/07/89)
AZT Proves Useful Given Earlier, at Lower Doses
Mail-Order Pharmacies: Saving Money on Prescription Drugs
Hypericin Notes
Baltimore/Washington: Intravenous Dextran Sulfate Study
Needs Volunteers
Baltimore/Washington: AZT/Probenecid Study Needs Volunteers
New York/New Jersey Clinical Trials Directory
Report from Conference on AIDS and Minorities
1978-1980 San Francisco VD Clinic Patients Sought for Study
*****
AZT PROVES USEFUL GIVEN EARLIER, AT LOWER DOSES
by Denny Smith
Three separate announcements in less than six weeks may
change the course of the AIDS epidemic for thousands of people,
and confirm the value of a treatment approach already in use by
many with HIV. Reports from three clinical trials, when combined,
have shown that AZT (Zidovudine), even at low doses, can slow the
progression of HIV infection in people with moderately low helper
cells but with few or no symptoms, and may be less toxic the ear-
lier it is initiated. (The indications for AZT therapy approved
so far by the Food and Drug Administration have been limited to
people with a T4-helper cell count below 200 or a diagnosis of
AIDS.) Following is a brief description of the details and
sequence of recent developments, and the questions they raise
about lack of access to health care for AIDS, and in the U. S.
generally.
Lower Dose Shown Effective
On July 14 AIDS TREATMENT NEWS #83 reported preliminary
results of an AZT/acyclovir study still in progress at the
University of California in San Francisco. This is a small trial
combining a low dose of AZT with two different amounts of acyclo-
vir (Zovirax), testing the possibility that acyclovir enhances
the activity of AZT, and simultaneously suppresses the threat of
active herpes, shingles and perhaps CMV infections. Several simi-
lar studies combining AZT and acyclovir were presented at the V
International Conference on AIDS in Montreal last June, most of
them suggesting that the combination was better than AZT alone.
The anti-clotting drug dipyridamole (Persantine) may also extend
the effectiveness of AZT (see AIDS TREATMENT NEWS #79), as well
as the anti-gout medication probenecid, but neither has been
tested with AZT enough to establish safety.
Although the UCSF study was designed to measure toxicity and
not efficacy, we noted that AZT appeared to be more easily
tolerated and more effective in reducing HIV activity when ini-
tiated before helper cells were seriously depleted or symptoms
appeared. We added that such results had been predicted by some
physicians, and would support the HIV early intervention strategy
proposed by Project Inform, a San Francisco-based AIDS advocacy
organization.
In the same article, we mentioned the July 12 announcement
of results of a much larger trial conducted by the National
Institute of Allergy and Infectious Diseases (NIAID) demonstrat-
ing that survival rates for people taking a low dose of AZT (100
mg every four hours) were equal to those obtained by a high dose
(250 mg at the same frequency). All of the 572 participants had
experienced one episode of Pneumocystis carinii pneumonia (PCP)
prior to entering the study; blood toxicities were less common in
those receiving the lower dose. The researchers are continuing to
evaluate the trial's data to identify the degree of neurologic
improvement and the rate of development for new opportunistic
infections. The principle investigator of that study was Mar-
garet Fischl, M. D., of the University of Miami. On August 3 Dr.
Fischl announced results of another important AZT trial, known as
Protocol 016, which found that AZT delayed progression from the
symptoms of ARC to infections of AIDS in a significant number of
people.
Benefits of Treatment Determined For ARC
Protocol 016 began in August of 1987 and eventually
recruited 713 individuals who met the study's parameters of a
T4-helper count between 200 and 800 and one or two symptoms of
ARC. The participants were randomized to receive either 200 mg of
AZT every four hours or a placebo on the same schedule. They
were followed to observe any progression to "endpoints" -- which
for this trial were defined as new or worsening ARC symptoms or
development of AIDS-defining infections.
By July of this year it was clear that those participants
getting a placebo had progressed to endpoints in markedly greater
numbers than those getting AZT -- 36 versus 14. The bulk of pro-
gression was concentrated among those participants who entered
the trial with helper cells below 500. And within this subgroup
the contrast between placebo and active drug outcomes was sharper
than in the group who entered with helper cells over 500. Addi-
tionally, side effects were experienced by only 5% of the parti-
cipants, substantially less than the nearly 50% of people with
AIDS who cannot tolerate AZT.
The researchers interpreted these results as showing that
people who have ARC and who have less than 500 helper cells can
benefit from AZT. They felt that the data are not sufficient to
show benefit of AZT if helper cell counts are above 500, but
nevertheless recommend testing for HIV antibodies to anyone who
may be at risk. Those who test positive "should seek early
treatment as appropriate."
These studies confirmed the approach used for over two years
by many physicians and their patients: if AZT slows HIV activity
in people with AIDS, but only for those who can tolerate the side
effects, then why not begin the intervention at lower, less toxic
doses, and before early symptoms advance to life-threatening
infections? The next logical question to ask is whether people
without any observable symptoms can intervene in the progression
of HIV to prevent deterioration of their immune systems. The
most recent AZT developments suggest that the answer is yes.
Value Seen in Treating Before Symptoms
On August 17 a study known as Protocol 019 of the AIDS Clin-
ical Trials Group (ACTG), conducted by NIAID, was interrupted
because it found growing evidence that AZT delayed progression to
illness in many people who are HIV+ but asymptomatic. This trial
began more than two years ago, in July of 1987, and was still
recruiting until July of this year. A total of 3,200 partici-
pants were recruited. All of these entered the trial without
symptoms, but about 1,300 entered with a T4-helper cell count of
less than 500.
The participants were randomized into three arms of the
trial: one third received 1500 mg of AZT daily, another third
received 500 mg a day, and the remainder got a placebo. Signifi-
cantly, but to many observers not surprisingly, participants with
helper cells under 500 were twice as likely to progress to ARC or
AIDS if they got the placebo than if they received AZT. In the
same group, disease progression was about the same in patients
receiving 500 mg or 1500 mg of the active drug, and side effects
of both doses were minimal. The principal investigator, Paul
Volberding, M. D., of San Francisco General Hospital and the
University of California, said that now all of the participants
with fewer than 500 helper cells will be offered AZT. The study
will continue for the group of participants with helper cells
over 500, since among them the progression to symptoms was negli-
gible. Protocol 019 is the largest AIDS clinical trial ever con-
ducted.
The question of when to begin antiviral treatment if helper
cells are declining but remain over 500 is being clarified by the
growing refinement of prognostic indicators. In addition to an
uneven decline in the number of T4-helper cells, HIV infection
over time usually results in anemia (low red cells or hemoglo-
bin), thrombocytopenia (low platelets), and increases in serum
neopterin, beta 2 microglobulin, and p24 antigenemia. AZT has
been connected with reversals of all of them, but singly they do
not always indicate that AZT or any antiretroviral is warranted.
When analyzed in combination they provide a more accurate picture
from which to consider treatment intervention.
For example, some people may have consistently low helper
cell counts (under 500) for several years without any external
symptoms. In this situation, many physicians have not initiated
AZT therapy unless the level of p24 antigen is high or rising,
suggesting that the system may soon be destabilized by current
HIV activity. A study at the University of California in Los
Angeles found a strong correlation between elevated neopterin
levels in HIV+ individuals and their subsequent progression to
AIDS, and when neopterin levels were considered together with
helper cell counts, the prognosis value was much greater than
either gave alone (Melmed and others, 1989). Since helper cells
can fluctuategreatly, two or even three counts must be charted
over the course of several months to be meaningful. So testing
for neopterin levels could hasten the process of identifying
viral activity in an individual, or of determining the effective-
ness of a new anti-viral treatment.
P-24 antigenemia and helper cell counts may be useful tools
for monitoring asymptomatic seropositive people, but a study at
the Northwestern University School of Medicine found that these
tests did not predict the course of AIDS during treatment with
AZT (Steinberg and others, 1989). Instead, decreased hemoglobin
and platelets often predicted an increased chance of AZT-related
toxicities in people who have had an opportunistic infection.
This study suggests that the range of tests useful for predicting
or monitoring the course of an HIV infection is narrowed as symp-
toms progress and immune functions become more impaired. In
other words, the sooner HIV is confronted, the more tools may be
available to assess questions of when and how much to treat.
One warning offered by Professor David Cooper, Director of
AIDS Epidemiology & Clinical Trials at the University of New
South Wales, and also by Marcus Conant, M. D., of the University
of California, San Francisco, is to avoid swallowing AZT capsules
dry, without water or juice, since the drug is caustic enough to
create ulcerations in the esophagus, which could then be misdiag-
nosed. On the other hand, an old caution to avoid combining AZT
with acetaminophen (Tylenol) has been largely dismissed.
To improve AZT therapy further, trials continue which com-
bine AZT with acyclovir, alpha interferon, DDC, interleukin II,
granulocyte macrophage-colony stimulating factor (GM-CSF), and
other drugs. NIAID is also sponsoring trials at the University
of Miami and the University of California Los Angeles to deter-
mine if AZT given to seropositive women during the last trimester
of pregnancy can prevent HIV transmission to their infants.
Vindication of the Early Treatment Strategy?
When all of these studies are considered together, they sup-
port the premise that the benefits of AZT can be obtained with
lower, less toxic doses, and that these benefits decrease in pro-
portion to immune deficiency.
Protocols 016 and 019 resulted in real advances for under-
standing how to interrupt the course of HIV. But they also veri-
fied the "underground" strategy of earlier, and therefore easier,
treatment for HIV. The idea of intervening early in HIV infection
is nearly as old as the epidemic, championed by many long-term
survivors with HIV, both symptomatic and asymptomatic, by many
progressive physicians, and by the persistent activism of Project
Inform and ACT UP. The medical establishment has historically
promoted early detection and treatment in other diseases, such as
cancer, heart disease, diabetes, hypertension. But for the years
preceding these recent announcements, people with HIV were
dismissed with false pessimism in the media and inappropriate
Federal regulations, and told to wait.
In light of the above studies, the original recommendations
for using AZT may have been too much, too late, and too expen-
sive. Now many researchers and activists agree that AZT, at
least, is effective earlier, and in lower amounts, than the FDA
approval indicated. The controversy regarding the optimal dosage
and timing for AZT has long simmered in public discussions as
well as medical literature, usually framed in a way which begged
the question: "Why should asymptomatic patients be given a drug
which may poison and impoverish them? " This view of the issue
permitted thousands of asymptomatic people to drift aimlessly
into illness.
Others have instead questioned the high cost of the only
approved treatment for HIV, questioned the regulatory structure
which discouraged the idea of informed choice for people with few
choices, questioned a research process which sought recruits for
AZT/placebo studies as late as July of 1989, and questioned the
continuing dominance of AZT in the treatment landscape.
References
R Melmed, R N and others. Serum neopterin changes in HIV-
infected subjects: Indicator of significant pathology, CD4 T-
cell changes, and the development of AIDS. Journal of Acquired
Immune Deficiency Syndromes, volume 2, number 1, pages 70-76,
1989.
Steinberg, J P and others. Predictors of outcome in AIDS
patients receiving zidovudine. Journal of Acquired Immune Defi-
ciency Syndromes, volume 2, number 3, pages 229-234, 1989.
Jacobson, M. How does zidovudine effect virologic immunologic
markers of HIV activity? AIDS Medical Report, volume 2, number
2, pages 13-14, 1989.
Oskenhendler, E and others. Zidovudine for Thrombocytopenic Pur-
pura Related to Human Immunodeficiency Virus (HIV) Infection.
Annals of Internal Medicine, volume 110, number 1, pages 85-86,
1989.
*****
MAIL-ORDER PHARMACIES: SAVING MONEY ON PRESCRIPTION DRUGS
by John S. James
The new information supporting the value of early treatment
with AZT, together with the unconscionable price of that drug,
has focused attention on the problems of paying for treatment.
We will cover policy questions on cost of care in later issues;
this article discusses filling prescriptions by mail to reduce
costs -- whether or not one has insurance which includes drug
coverage.
Mail-order pharmacies are high-volume operations which can
locate where costs are low, and can negotiate good prices from
suppliers. Also, they compete with each other mainly on price,
because location doesn't matter, whereas traditional corner drug-
stores may have a captive market. Therefore they usually (but
not always) have the lowest prices available. AIDS TREATMENT
NEWS published price comparisons in issue #64, September 9, 1988.
For this article we briefly surveyed customer satisfaction,
by asking people to tell us their own experiences with mail-order
pharmacies. We did not ask the pharmacies to recommend customers
for us to interview; instead we called AIDS organizations and
spoke to anyone who had information, and also asked physicians
and other knowledgeable people whom we were contacting anyway for
other reasons. Everyone we talked to who had experience with
mail-order pharmacies (about ten people in all) was completely
satisfied; most of them only knew about a single one, because
they were happy with the first one they tried and did not need to
look further.
Yet many of the people we contacted did not know of any
source for prescription drugs, even though they had talked with
tens or hundreds of persons with AIDS or HIV. It seems that fil-
ling prescriptions is usually a solitary or personal activity,
one which patients seldom talk about. Therefore, information
about money-saving options does not circulate in the AIDS commun-
ity as freely as it should. We hope this article helps to fill
that communication gap.
In our interviews we did not name specific pharmacies, but
let the interviewees volunteer the names. Only two mail-order
prescription vendors were mentioned more than once: American Pre-
ferred Plan (APP), and Family Pharmaceuticals of America. Both
had excellent references from customers. Others may be equally
good; but we did not have time to make this short article into a
complete list.
[Note: Readers should know that several months ago AIDS
TREATMENT NEWS received an unsolicited donation of $500 from one
of the companies (APP) which appears in this article. We con-
sidered returning the money in order to avoid any questions about
our objectivity in future reporting. Instead we decided to
accept the donation, but use it only for contributions to non-
profit AIDS organizations, not for our own operations. Because of
the urgent needs in the AIDS community, we felt it was better to
handle the contribution this way than to return it. We also felt
we should disclose the matter to our readers.]
For most mail-order pharmacies:
* Physicians can call in prescriptions, avoiding the need to
wait for the mail, if patients can pay by credit card, or if the
prescription is fully paid by insurance (see below). The pharma-
cies we talked to send the drugs by two-day express, unless over-
night delivery is necessary. Delivery can be to a different
street address (such as a friend's, or a work address), so that
nobody needs to stay home to receive the medicines. (The couriers
used, such as UPS and Federal Express, do not deliver to post-
office boxes. Also, we have not heard of deliveries outside of
the United States and its possession.)
* The pharmacy should bill insurance directly and handle the
paperwork. The ones we interviewed seldom or never require
patients to front the money which will be paid by insurance. Some
other mail-order pharmacies require full payment from the
patient, with the insurance company reimbursing the patient for
the percentage it pays -- a process which can take months. (For-
tunately it is only necessary to pick up the phone to reach a
mail-order pharmacy which does not require this money up front.)
* Patients can, of course, get price and other information
by phone.
* Drugs like alpha interferon which need to be refrigerated
can be shipped overnight in insulated containers. Make sure the
shipper includes some kind of cold pack, such as "blue ice", able
to keep the medicine cold even if a delivery is missed. (While
we have heard only good reports about mail-order pharmacies, the
fact remains that they are relatively new and not adequately
regulated by government agencies; therefore uniform standards
about such matters as shipping refrigerated drugs cannot be
assumed, and patients and physicians should be vigilant.)
* While prices are usually lower at mail-order than at trad-
itional pharmacies, they are not always lower, and it does pay to
shop around.
We called the two companies named by our interviewees and
asked them what advantages they offered to customers:
Family Pharmaceuticals of America, 800/922-3444 (in South
Carolina only, call 803/881-3444):
This mail-order pharmacy has been in business since 1981; we
first mentioned it in AIDS TREATMENT NEWS issue #46, December
1987. It is "AIDS sensitive", having long sought business in the
AIDS community. It competes mainly on price but also has a good
reputation for service.
In our recent interview, president John Richards, M. D.,
told us about new home services including intravenous medications
and TPN (total parenteral nutrition). Family Pharmaceuticals has
affiliated with a home-care company to deliver such treatment
anywhere in the country, at what it claims are significant sav-
ings; Dr. Richards said that the first 20 patients put on this
system showed savings totalling $200,000 per year, compared to
what they had spent previously. Family Pharmaceuticals provides
a "turnkey" system, meaning that it arranges for nursing and
other necessary support, so that patients do not need to make
these arrangements themselves.
Medications delivered this way can include ganciclovir,
intravenous antibiotics, and aerosol pentamidine. The company
also supports the "cassette" system for pain-control and other
medications. This system uses a small computer-controlled pump
to inject medication continuously or on a pre-programmed
schedule. The apparatus and medicines can be worn on the arm;
the self-contained unit is about the size of a cigarette pack.
Alpha interferon is a special case, in that suppliers have
announced a cap of about $9800 that a single patient will have
to pay for the drug in one year. Family Pharmaceuticals has made
arrangements so that its customers do not have to front the money
after this annual limit is reached.
Patients or physicians interested in home care with
intravenous medications should call a special number, 800/232-
3003 and ask for William J. Taylor, Pharm. D. (Dr. Taylor,
incidentally, is also chair of the pharmacology committee of the
Physicians' Association for AIDS Care.) Patients calling to fill
ordinary prescriptions should call Kim Richardson at 800/922-
3444.
American Preferred Plan (APP), 800/227-1195 (in New York
State only, call 800/445-4519):
This company is technically not a pharmacy but a membership
organization; it places orders with a pharmacy, and specializes
in covering the 20 percent copayment (which many insurance poli-
cies require) for its members. In most cases, APP will accept
the 80 percent insurance coverage as payment in full, and the
patient does not need to put out any money, or do any paperwork
after they have joined the organization. There is no fee to
join.
APP is very similar to Preferred Rx, which was covered in
AIDS TREATMENT NEWS issue #66, October 7, 1988. However, Pre-
ferred Rx (800/365-2646; in Ohio 216/661-1977) requires a $25
membership fee every 12 months. Both Preferred Rx and APP were
started by Ron English, who is also well known as a board member
and major fundraiser for the Community Research Initiative in New
York.
After our interviews with customers, we interviewed Ron
English and Ellie Adiel at APP. This company focuses exclusively
on working with people with AIDS; besides filling prescriptions,
it can refer callers to organizations, agencies, legal and emo-
tional support services, and sources of free medications.
Patients with insurance which covers 80 percent or more of
the cost of pharmaceuticals should be able to fill prescriptions
through APP without paying any money out of pocket. Patients
without insurance can also use APP, but for them it has no spe-
cial advantage over other mail-order pharmacies. Patients should
compare prices on the drugs they need.
Other Options
This article does not cover free or subsidized medical care,
a very important area which needs to be discussed elsewhere.
Also, it does not cover any form of underground market in
prescription or other pharmaceuticals.
In some locations non-profit pharmacies have been set up to
reduce drug prices for persons with AIDS or other chronic
diseases. We did not find any in this brief survey, but patients
should know that such organizations exist.
A few traditional pharmacies have sold AZT at cost, as a
public service; therefore their price is lower than that of
mail-order pharmacies. We do not have a list of these pharma-
cies; persons should check with local AIDS support groups, which
may know any in their area.
One pharmacy in Los Angeles goes beyond paying the 20 per-
cent insurance copayment and offers cash rebates in certain
situations. Will Basso at Bob's Pharmacy (6136 Venice Blvd; it
also sells by mail, phone 213/838-7292) said that rebates have
been as high as $300 per month, but are more typically in the
range of $100 to $150, if patients are using full-dose AZT and
other drugs in addition. Potential customers can learn by phone
what their rebates should be before they place their orders.
Basso assured us that rebates are completely legal -- "We can do
what we want with our profits" -- and that they have not had com-
plaints or problems. (AIDS TREATMENT NEWS has not yet inter-
viewed anyone who has used this service.)
This article could not be comprehensive, and obviously many
good sources for prescription drugs have not been listed. Instead
of providing a list, we gave examples to show some of the options
available, and to show some of the creative ways that have been
developed to reduce the cost of drugs.
*****
HYPERICIN NOTES
Our hypericin survey (published in AIDS TREATMENT NEWS # 80,
June 2, 1989) is taking longer than expected to analyze, but we
plan to have a report in the next issue. Meanwhile we must pass
on recent information about potential side effects.
We previously published reports of several people who had to
stop taking extracts of St. John's wort (the herb which contains
hypericin) because blood-chemistry panels showed elevated levels
of liver enzymes. Recently we heard of three more such cases.
The two for whom the best data is available showed gradual rises
over a two-month period while they used the herb. There is no
proof that the St. John's wort caused the abnormal liver function
tests, but until more is known, persons using the herb should
have a blood-chemistry panel (such as SMA 25) which includes
liver-function tests. Physicians usually recommend that patients
stop all medicines, temporarily at least, if these tests become
seriously abnormal.
Also, St. John's wort may act like a kind of antidepressant
called an MAO inhibitor -- although no one knows for sure. MAO
inhibitors are dangerous if combined with certain other drugs,
and even any of a long list of foods and beverages. In AIDS
TREATMENT NEWS #74, we pointed out that this problem was possi-
ble, although it seemed remote.
But recently we heard of one case where this interaction
might have occurred. The patient combined St. John's wort with a
tricyclic antidepressant (a kind of drug which must not be com-
bined with an MAO inhibitor) and suffered rapid heart beats,
skipped beats, and anxiety. This is the only case we have heard
of such a problem. But since this reaction is dangerous, the
physician who brought this case to our attention suggested that
St. John's wort extracts should not be combined with prescription
antidepressants, and possibly not with certain foods either.
More information can be found in medical reference books,
which list foods and drugs which must not be combined with MAO
inhibitors, and symptoms which may occur is they are combined.
It is possible that these problems with St. John's wort
extracts -- if they exist at all -- are caused not by hypericin,
but by some other chemicals in the plant. In that case, the
problems could be overcome by using pure hypericin, from which
the other chemicals had been removed.
*****
BALTIMORE/WASHINGTON: INTRAVENOUS DEXTRAN SULFATE STUDY NEEDS
VOLUNTEERS
Johns Hopkins University Medical Center needs volunteers for
a small study of intravenous dextran sulfate. Participants must
be p24 positive, not using AZT, and not using certain other drugs
unless they could go off them for the two weeks of the study.
Ten to 12 volunteers are being sought. They will need to
spend two weeks in the hospital research center, described as a
comfortable setting. There is no expense involved, and
volunteers will receive much free laboratory testing and medical
attention. The study's purpose is to follow the effect of
intravenous dextran sulfate on p24 levels, and also to find the
best ways to administer the drug. One patient has already com-
pleted the study; the effect on p24 is not yet known, however, as
the blood samples were frozen and will be tested together as a
batch in order to improve accuracy.
Dextran sulfate shows very good anti-HIV activity in the
test tube. But when taken by mouth it seems to be poorly
absorbed in its active form. The small studies conducted so far
have shown little evidence of antiviral efficacy of the oral
drug, although anecdotal reports suggest that some people may
benefit. Because of the drug's good laboratory results but poor
oral absorption, the intravenous test is an obvious next step,
and one which has long been awaited.
Intravenous dextran sulfate has routinely been used in
Japan. However, the intravenous product there (for example, MDS
Kowa A) has a different sulfur content (three to six percent)
than the oral version which had been tested against HIV (17 to 20
percent). Therefore it has been unclear whether or not the
intravenous drug in use in Japan would have antiviral activity.
According the the Johns Hopkins group, the version they are
using, from Ueno Fine Chemicals, Ltd. in Japan, has been tested
for anti-HIV activity, and also has been in human use in that
country.
Persons interested in volunteering can call Linda Nerhood at
301/955-7703, or Charles Flexner, M. D., at 301/955-9712.
*****
BALTIMORE/WASHINGTON: AZT/PROBENECID STUDY NEEDS VOLUNTEERS
Probenecid, an inexpensive prescription drug used for gout,
has been found to inhibit the elimination of AZT from the body.
A small human study reported at a scientific meeting last
October, and recently published in The Lancet (and also reported
in the news media), suggested that probenecid may allow only half
as much AZT to be used, greatly reducing the financial cost. Pro-
benecid may also allow medication to be taken every eight hours,
avoiding the inconvenience of the four-hour schedule. Probenecid
is not believed to provide any medical benefit besides the finan-
cial one. It was, incidentally, used for the same purpose during
the early history of penicillin, when that drug was scarce and
expensive due to limited manufacturing capability.
But the combination of AZT and probenecid has not been pro-
ven safe. The new Johns Hopkins study will monitor patients dur-
ing a 30-day trial to assess safety.
This study needs only eight participants. They must be able
to tolerate AZT -- either 100 or 200 mg, five or six times a day.
They must have reasonably normal blood chemistries, and cannot be
using any other antiviral, or certain other drugs including gan-
ciclovir, interferon, or dapsone. While this is an outpatient
study, volunteers will need to spend three days in the medical
center for testing: one day when they start, one day after a
week, and the third at the end of the 30-day study.
Persons interested in volunteering should call Linda Nerhood
at 301/955-7703, or Charles Flexner, M. D., at 301/955-9712.
*****
NEW YORK/NEW JERSEY CLINICAL TRIALS DIRECTORY
A very complete list of AIDS/HIV clinical trials in New York
and New Jersey has been published by AIDS Treatment Registry
(ATR), a New York AIDS service organization. About 40 different
drugs and 40 different trial sites are listed, and the directory
is republished six times a year to keep the information current.
ATR's Directory of AIDS/HIV Clinical Trials Open in New York
and New Jersey does not describe the drugs themselves, except in
a glossary; it recommends the AIDS/HIV Experimental Treatment
Directory, published by the American Foundation for AIDS Research
(AmFAR), for this information. But ATR's directory gives very
complete coverage to all-important details of each trials, such
as inclusion and exclusion criteria, trial sites with contact
persons and phone numbers, whether hospitalization is required,
whether PCP prophylaxis is allowed (almost always the answers is
yes, at least with aerosol pentamidine), and where to get further
information.
ATR has published a companion volume, Deciding to Enter an
AIDS/HIV Drug Trial. Besides general background, this booklet
includes checklists of dozens of questions which potential
volunteers may want answered before they decide to enter a study.
These questions are relevant anywhere in the U. S., of course,
not only for the New York/New Jersey trials.
Note: ATR urgently needs financial help. Potential donors
should know:
* ATR has been instrumental in building the knowledge base
which enabled the AIDS community to be effectively represented in
the DDI/parallel track negotiations;
* It's founder and scientific director, Iris Long, Ph.D.,
was honored in "A Salute to Everyday Heros" published in
Newsweek, July 10 of this year;
* In one case, the trial information saved the life of a
patient. The patient's hospital did not know that it had the
experimental drug trimetrexate. ATR proved that it did, and the
patient received the treatment.
Copies of the directory, or the booklet on deciding whether
to enter a trial, can be obtained from AIDS Treatment Registry,
P. O. Box 30234, New York, NY 10011-0102, phone 212/268-4196.
There is no charge, but contributions, which are tax-deductible,
are requested from those who can afford them.
*****
REPORT FROM CONFERENCE ON AIDS AND MINORITIES
Washington, D. C. was the site of "Prevention and Beyond: A
Framework for Collective Action," a conference August 13-17 spon-
sored by the Department of Health & Human Services to discuss the
impact of the AIDS epidemic on ethnic and racial minorities in
the U. S., and to create a plan of action to combat HIV transmis-
sion and create access to services and treatment in these commun-
ities.
The Black, Latino, Asian/Pacific Islander, and Native Ameri-
can communities were well represented at the conference, with a
cross-section of disciplines from each community. The conference
addressed issues such as the double and triple oppressions which
minorities face, the need for language/culture-specific litera-
ture to explain HIV transmission, racist tilting of epidemiologi-
cal and budgeting statistics, low-income families receiving infe-
rior overall health care (if any at all), and the inadequate
access to early diagnosis and treatment options for HIV and AIDS.
A group of concerned attenders interrupted the conference
proceedings at one point in an effort to dramatize some of the
deficiencies of the conference. The future of the epidemic is
bleak unless dramatic changes are made in the manner information
is disseminated and the way health care is delivered, or not
delivered, in the U. S. Even if an effective treatment and/or
vaccine is found, who will get it? Will money or skin color or
language or geography or gender decide? Two staff members from
AIDS TREATMENT NEWS attended and participated in discussions of
these problems and possible solutions. We will report again when
the statements from the various conference caucuses are com-
pleted.
*****
1978-1980 SAN FRANCISCO VD CLINIC PATIENTS SOUGHT FOR STUDY
Men who used the old Fourth Street VD clinic in San Fran-
cisco between 1978 and 1980 are urgently needed for an important
scientific study.
The Clinic Study, by San Francisco City Clinic, began as a
study of hepatitis, before AIDS was known. 6,700 men were
screened, and frozen blood samples and medical interview informa-
tion were saved. Later, scientists realized that they had unk-
nowingly collected some of the most valuable data in the world
for studies of the epidemiology and progression of AIDS.
Under California law, the frozen blood cannot be tested for
HIV without the consent of the donor. So far the researchers
have been unable to reach 2,000 of the 6,700 men to ask for their
consent. They estimate that about two thirds of them are still
living in the Bay Area, and that about 10 to 15 percent have
moved to Southern California.
Anyone who used the clinic in the years mentioned above
could contribute to AIDS research by contacting the clinic at the
number listed below. Those who were part of the hepatitis study
may also be asked if they can come in for further tests. Partici-
pants can also obtain information of personal benefit, such as
free lab work, and information about their HIV status in the
past.
Persons concerned about confidentiality should know that
this study has a Federal certificate of confidentiality, which
will protect the information against disclosure under future
state, local, or Federal laws. The clinic is of course discreet
in all phone and mail communication. And persons who choose not
to know their own antibody status can still participate in the
study, and ask not to be told their test results.
Anyone who visited the Fourth Street clinic between 1978 and
1980 should call Paul O'Malley, the program coordinator, at the
San Francisco City Clinic, 800/537-3722 (from California), or
415/554-9030 (from out of state -- call collect), to see if their
participation is needed.
*****
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.
HOW TO SUBSCRIBE TO AIDS TREATMENT NEWS BY MAIL
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 subscrip-
tion (13 issues) is $55.00 ($80.00 for businesses or organiza-
tions), or $16.00 reduced rate. For subscription information and
a sample issue, call (415) 255-0588.
For the complete set of over 70 back issues, send $75.00 ($18.00
for persons with AIDS or ARC) to the above address. The back
issues include information on hypericin, dextran sulfate, foscar-
net, passive immunotherapy, DTC (Imuthiol), naltrexone, DHEA,
lentinan, propolis, coenzyme Q, monolaurin, egg lecithin lipids,
fu zheng herbal therapy, DNCB, aerosol pentamidine, fluconazole,
ganciclovir (DHPG) and other experimental or complementary treat-
ments.
To protect your privacy, we mail first class without mentioning
AIDS on the envelope, and we keep our subscriber list confiden-
tial.
Outside North America, add $20.00 per year for airmail postage,
and $18.00 airmail for back issues. 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.
Copyright 1989 by John S. James. Permission granted for non-
commercial reproduction.
--
Ken Davis - W6RFN San Francisco, California
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