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AIDS TREATMENT NEWS Issue #230, September 1, 1995
   phone 800/TREAT-1-2, or 415/255-0588

CONTENTS:

Acupuncture and Chinese Medicine; Interview with Tom 
Sinclair, L. Ac.

Hydroxyurea and ddI: French Study Published

Thalidomide: New Expanded Access for Wasting

d4T Dose Clarification

San Francisco: Viral Load Trial Offers Free Tests

National AIDS Treatment Advocates Forum, October 15-18, Los 
Angeles

National Skills Building Conference, October 19-22, Los 
Angeles

Surrogate Markers Meeting, October 16-18, McLean, Virginia

Next AIDS TREATMENT NEWS Delayed One Week

Health Insurance: Widespread Copayment Abuse


***** Acupuncture and Chinese Medicine; Interview with Tom 
Sinclair, L. Ac.

by John S. James

Thomas M. Sinclair, M.S., L.Ac., Diplomate, National Board of 
Acupuncture Orthopedics, has treated people with HIV for 
eight years. He is executive director of the Immune 
Enhancement Project in San Francisco. AIDS TREATMENT NEWS 
interviewed him August 22, at the IEP office in San 
Francisco's Castro district.

ATN: Where do you have most success with traditional Chinese 
medicine, and where does it not work as well?

Sinclair: Traditional Chinese medicine has been particularly 
successful in treating peripheral neuropathy, sinusitis, 
pain-related problems, night sweats, insomnia, dry skin, 
headache, and low energy, and fatigue.

With digestive problems, we do not always get a person 
functioning back at a normal level. But often acupuncture, 
together with diet changes or medication, can help to return 
the digestion to a more normal state.

What has not worked well? The first condition that comes to 
mind has been Kaposi's sarcoma (KS). We have not had good 
success in that area.

And sometimes in late-stage AIDS it is difficult to make 
dramatic changes, as the body's energy is so depleted.

Finding a Practitioner

ATN: How can somebody go about finding a Chinese medicine 
practitioner, not just in San Francisco but across the U.S. 
How do regulations differ in different states?

Sinclair: Currently in the U.S. there are 27 states where 
acupuncture is licensed and regulated. It goes all the way 
from California, where we function as primary care 
physicians, to some states, even including Illinois, where 
acupuncture is illegal at this point. You need to check with 
the local licensing bodies.

Most importantly, you want to go to somebody who is licensed, 
if licensing exists within your state; that is your assurance 
that you will get at least a minimal level of competency. In 
most states, there is a tendency to regulate only 
acupuncture, as opposed to herbal medicine. In California, 
our license covers both herbs and acupuncture.

There are a number of ways to choose a practitioner: 

* Referral through friends, people who have seen a 
practitioner, is often the best way. You get the most 
personal insight about the practitioner. 

* Check with your physician. We have been developing a much 
better rapport with physicians than in the past. Often 
physicians will have practitioners they send people to.

* Check with local HIV agencies. Often they have listings of 
practitioners.

* Contact programs like the Quan Yin Healing Arts Center, in 
San Francisco, which offers an HIV certification; they have a 
list of practitioners across the country who have taken their 
HIV training. It's quite a good program -- and an assurance of 
a standard.

* Call the state licensing agency (in California, it is the 
Department of Consumer Affairs), and ask them to send you a 
list of licensed practitioners. 

* Also, there is a National Commission for the Certification 
of Acupuncturists, NCCA. They have been accepted as the 
standard in a number of states that do not have their own 
state licensing exam. You can find out if someone has a 
national board certification in acupuncture, and also in 
herbs. For an individual state listing, send $3. to: NCCA, 
P.O. Box 97075, Washington, D.C., 20090-7075; or you can 
order the complete directory for the whole U.S. for $22, 
(which includes postage). You can also order by phone, 
202/232-1404, 9 a.m. through 5 p.m. Monday through Friday 
Eastern time.

Probably the most important question I would ask, if I were 
going to choose an acupuncturist, is how much experience they 
have treating HIV. Choose a practitioner who has as many 
years as possible. HIV is a very complex disease; the same 
underlying problem can look quite different in different 
people.

Private Practitioner Vs. Clinic

ATN: What is the difference between seeing a private 
practitioner, going to a clinic, or going to a teaching-
school clinic?

Sinclair: The advantage of a private practitioner is that you 
get more individualized treatment.

A clinic will cost less, but you may be treated in a group 
setting. It may be a room with as many as ten to twelve 
tables, or just two or three tables. The quality of care is 
largely equal; the difference is the amount of time the 
practitioner can spend with you. 

If you go to a teaching school, you will often be seen by 
students; it's like going to a teaching hospital and being 
seen by medical students. The care certainly can be 
excellent; but you need to realize that you are being seen by 
someone in training, not a seasoned, licensed practitioner, 
but someone on their way there.

Paying for Acupuncture

ATN: In San Francisco, what might people expect to pay for 
Chinese medicine treatment?

Sinclair: To see a private practitioner in the San Francisco 
area, the average cost is about $55 for an hour appointment. 
For a clinic, we try to offer low-cost care, by offering 
package programs. The most common program at our clinic is 
the 12-week program of herbs and acupuncture. The $240 cost 
covers basically all the herbs you need over a three-month 
period, plus an initial consultation and acupuncture session, 
and three more acupuncture sessions. If you need additional 
acupuncture, we charge $25 a session. This is about the going 
rate for clinics that have sliding scales.

In San Francisco there are other payment options. Medi-Cal 
can pay for two visits a month. The Immune Enhancement 
Project, the Bayview-Hunter's Point Foundation, and the 
American College of Traditional Chinese Medicine, all have a 
Ryan White (Federally funded) program that provides free 
herbs and acupuncture to HIV-positive residents of San 
Francisco with income no more that $1,160 per month.

ATN: Will insurance companies pay for acupuncture and herbal 
treatments?

Sinclair: That depends on the company, and on local 
regulation. Call your health-insurance carrier and find out 
what they will cover. We have had good results with companies 
like ITT Hartford, and Aetna. Some Blue Cross and/or Blue 
Shield policies will cover acupuncture, as will some 
Prudential policies. You need to check about your policy, and 
find out if they will pay for treatment with both herbs and 
acupuncture. Often insurance will only pay for acupuncture 
treatment.

ATN: In that case, can you bill for the acupuncture 
separately, so the patient can pay for only the other part?

Sinclair? Yes.

ATN: I have heard that the FDA is about to reclassify 
acupuncture needles. What is the practical meaning of that?

Sinclair: There were five different applications submitted to 
the FDA for uses of acupuncture needles. Currently 
acupuncture needles are classified as an experimental device. 
So a new classification will make it much easier to get 
insurance reimbursement, and open a number of possibilities 
including applying for Medicare reimbursement. Insurance 
companies do not like to pay for things that are regarded as 
experimental procedures, and it has been a real drawback that 
needles were classified this way. I believe the ruling is due 
out sometime in September, and we are pretty certain that 
needles will have one classified use. That will improve the 
whole realm of insurance reimbursement.

Acupuncture, Herbs, Electrical Stimulation, Moxibustion, 
Other Treatments

ATN: Should patients usually take acupuncture and herbal 
treatments together?

Sinclair: When I work with patients, I like to work with 
both. Often I will work on a more long-term, internal basis 
using herbs. They come in decoctions (prepared into a drink 
like a strong tea), or tinctures (herbal extracts in 
alcohol), or raw compressed tablets. Often they have a slower 
effect than acupuncture, but act better over a long time. 
Often I will use the acupuncture treatment for immediate 
symptom relief.

If someone comes in with a headache, or neuropathy, or 
sinusitis, I will probably use acupuncture to treat those 
symptoms. But the underlying condition, the HIV infection, we 
would probably treat more with herbs. This rule has many 
exceptions, of course, in how I work with people.

I think it's best to use both herbs and acupuncture together. 
But some people have certain preferences. Some have a fear of 
needles, or have had bad experiences, or just do not find 
acupuncture pleasant; there is nothing wrong with just using 
the herbs. And some people do not like taking herbs; 
particularly in HIV infection, people are taking so many 
pills, and one of the problems with the herbs is that you 
need to take a lot of product to have an effect -- simply 
because there is a lot of fiber. Look for a practitioner who 
is flexible, to work with you where you're at.

ATN: Can you describe herbal decoctions?

Sinclair: That is the traditional way of taking herbs in 
China. They put together a formula by assembling many loose 
herbs, as roots, barks, seeds, twigs, berries; then that 
mixture is cooked, and the liquid is reduced, and drunk over 
a period of time.

ATN: Is acupuncture painful?

Sinclair: That is a concern for many people. Of course you 
feel a prick as the needle penetrates the skin. What people 
sometimes describe as painful is more the acupuncture 
needling sensation; it's the arrival of chi (also spelled qi) 
at that point. That can feel like a burning, a tingling, 
numbness, a grabbing sensation, an electric sensation. This 
is an appropriate response; it's what we are looking for, it 
means that your body is responding to the stimulation it is 
receiving.

Most people find acupuncture sessions very relaxing, whatever 
we treat. Some patients just have a great sensitivity; 
usually people are much more sensitive when they first start 
treatment. As your body becomes more balanced and more 
adjusted, you will find that the needling sensations are much 
less painful.

ATN: How often does one receive acupuncture?

Sinclair: What I have observed in eight years of treating 
persons with HIV with herbs and acupuncture is that those who 
do the best are those who start early, and those who are very 
consistent. How often you see a practitioner can depend on 
your lifestyle, your economic situation, your commitments. 
The best thing is to be very regular; it may be once a month, 
twice a month, twice a week -- what is important is to stay 
with it over a long period of time. I often tell clients I 
would rather they come in once a month for three years than 
once a week for three months. Treatment with herbs and 
acupuncture is a subtle process which can have dramatic 
changes, but you need to think about the long haul.

As Westerners, as members of a pill-popping society, people 
want to have immediate results. Of course we try to achieve 
that; but you have to temper this goal with the realization 
that Chinese medicine is a long-term therapy. If you are 
going to do it, to get the best results, think of the long 
term.

ATN: Can you explain other procedures, such as moxibustion, 
or electrical stimulation of acupuncture points, or qigong?

Sinclair: In California our license covers the use of herbs, 
acupuncture, and related methods including electric 
stimulation, the application of cups (basically creating a 
kind of suction on the body), and the burning of mugwort 
(which is called moxibustion).

Often moxibustion is used extensively with HIV. Chinese 
medicine looks at the influence of environmental factors, 
such as heat, cold, dampness, wind; often, temperature in the 
body is very important. In HIV we often see a deficiency, 
where the body's energy is very low, the tongue might have a 
white coat, digestion might be poor, there could be diarrhea. 
One of the treatments for that is the use of moxibustion, or 
the burning of mugwort over acupuncture points. The whole 
idea here is to put energy into the body, feed energy into a 
weak and deficient system.

Practitioners use moxibustion in different ways. They may put 
the moxi on an acupuncture needle and burn it. They may burn 
a stick of moxi over the needling site. There are other 
methods, such as applying moxi onto a piece of aconite which 
is placed directly on the body.

ATN: And electrical stimulation?

Sinclair: Often we use that for pain relief; it's a modern 
development in acupuncture. We get very good results, 
particularly with conditions like neuropathy, through the use 
of electrical stimulations.

Chinese and Western Medicine

ATN: How do you integrate Eastern and Western care?

Sinclair: In the last five years we have seen a tremendous 
change in physician attitudes. It used to go from 
indifference to outright hostility; now there is more 
acceptance and, in fact, encouragement of the integration of 
care. 

My philosophy on HIV is to use whatever you can get your 
hands on that is consistent with your belief system. That 
might not be acupuncture -- it might be yoga or spiritual 
work, or meditation, or strictly pharmaceuticals and drug 
trials. There is no one right way with HIV, especially given 
the chronic nature of the disease -- and the limitations of 
Western medicines. Western medicines often have an impact on 
opportunistic infections, but in terms of stopping the 
underlying process, I don't think medical science has 
achieved that yet. It behooves the individual to bring in 
many therapies, and Chinese medicine is a very useful option.

It's important that you have a good working relationship with 
your physician; and it's even more important that your 
physician supports your integrating Chinese medicine, herbs 
and acupuncture, into your treatment program.

If you are having trouble with neuropathy, for example, there 
is no entirely satisfactory Western medication to treat it; 
doctors have amitriptyline and a few other drugs. The 
physician could refer you to acupuncture to treat the 
neuropathy, which may be induced by drugs like d4T or ddI or 
ddC; that is a valuable synthesis right there. Or if you have 
digestive upset, you might have parasite cultures, an 
endoscopy, sigmoidoscopy -- standard Western procedures. They 
may not identify a pathogen; then you may choose to treat 
with Chinese medicine. This is another opportunity to 
integrate both models.

The question comes up about the use of AZT, 3TC, or other 
antivirals. Here I come back to the philosophy that you need 
to use everything you can to stay healthy and stay alive.

I used to feel that if one pill is good, ten pills is much 
better. I'm coming to see that an important principle with 
HIV is to use the minimum amount of treatment to achieve the 
maximum effect. I have seen people come into this clinic who 
are on Neupogen and Procrit because they have poor bone 
marrow reserves; they are combining ganciclovir, hydroxyurea, 
multiple nucleosides, and they wonder why they have problems 
with bone marrow.

Other Aspects

ATN: What is "Qigong" -- and how does it relate to "Tai Chi," 
a term more familiar to our readers?

Sinclair: Both are variations of each other. Each is a 
systematic series of movements that serve to enhance the 
body's energy. Qigong tends to be slower; it is less of a 
martial art. Tai Chi can be a defensive martial art, even 
though it also is gentle and soothing.

Each gives one a profound sense of relaxation. What I hear 
constantly from our clients who do Qigong or Tai Chi is that 
they have increased energy. It does not take a lot of 
technology or training to learn the basic form; then it's up 
to you to practice.

ATN: You mentioned that the practitioner can act as client 
advocate, can help the client be informed about lifestyle, 
diet, stress, and alternative/complementary treatments. Can 
you give some examples?

Sinclair: I look at the relationship between the practitioner 
of Chinese medicine and the client as a prevention strategy. 
Particularly with a well-trained practitioner, they can 
recognize early danger signs. For example, in this clinic, we 
have seen patients come in with a splitting headache, they 
are sensitive to light, they have a stiff neck -- these are 
signs of meningitis. A number of times we have referred 
people immediately to the emergency room. Sometimes we will 
treat, and then have the patient call their physician, or go 
into the emergency room to be treated.

Patients usually see their acupuncturist much more frequently 
than they see their Western physician. It is important that 
you pick a practitioner who is experienced, so he or she can 
be a sentinel for early danger signs, and knows when to refer 
you to a Western provider.

The relationship that develops is often intimate, informal. 
It's a good opportunity for the practitioner to talk to you 
about lifestyle decisions you are making, stress, coffee, 
activity, exercise, drug use. Acupuncture has an aspect of 
disease prevention; certainly we see that in the reduction of 
colds and flu. If we accept the theory that you want to 
prevent the immune system from being stimulated (to avoid 
stimulating the growth of HIV), Chinese medicine may have a 
beneficial effect.

HIV can be very overwhelming; it is difficult for people to 
make a lot of choices. A well-informed practitioner can talk 
to you about clinical trials, about Western medications, 
about other alternative therapies, about nutrients and 
supplements. Certainly at our clinic, everyone is very well 
trained in these areas.

ATN: You mentioned coffee. Do you think it is best avoided?

Sinclair: My philosophy is that we need to be realistic. Yes, 
it's probably good to stop coffee, stop staying up late, 
don't smoke, don't do drugs, avoid stress, get appropriate 
exercise. But that's not always realistic for the ways people 
exist in the real world. I much prefer to see people do 
gradual changes over time, changes they are going to stick 
with. If someone is drinking ten cups of coffee a day, there 
is a reason why they are drinking so much, and they need to 
look at that. But I think one or two cups is fine -- although 
there are practitioners who will disagree with me. I like to 
take a realistic approach; I never want to lecture to my 
patients. Generally people know what they should do. It is 
not from lack of information (that they don't do it); it is a 
number of other factors that influence people's decisions.

Research in Traditional Chinese Medicine

ATN: What research are you doing at the Immune Enhancement 
Project?

Sinclair: We received funding through the National Institutes 
of Health Office of Alternative Medicine to do a study 
comparing the use of antibiotics to herbs and acupuncture for 
treating HIV-related sinusitis. It's an eight-week trial with 
a four-week washout. We tried to design it to be as objective 
as possible, so we are looking at objective measures such as 
nasal resistance, nasal air flow, smell testing; and we are 
doing paranasal CT scans to show whether the therapy is 
having an impact. This study is randomized, with 20 people in 
each arm of the study.

ATN: Is the study full, or are you still recruiting?

Sinclair: We are still actively seeking patients. Recruitment 
is going much slower than we originally anticipated. Part of 
the problem is that by the time people have tried all the 
antibiotics, they are ready to do acupuncture; but what this 
study offers them is a randomized choice. 

ATN: Is there a cost to participate in the study?

Sinclair: There is no cost. And whichever group you are in, 
you get a lot from it. You will have a complete ENT exam by 
the physician, Kelvin Lee, M.D. Also you will get pre- and 
post-treatment paranasal CT scans, as well as either eight 
weeks of herbs and acupuncture, or eight weeks of antibiotic 
therapy.

For more information about volunteering for this trial, see 
AIDS TREATMENT NEWS # 225, June 16, 1995, or call Tom 
Sinclair at the Immune Enhancement Project, 415/252-8711.

There is a growing interest in research on traditional 
Chinese medicine within the U.S. We have a long way to go; 
but we have come a long way already, in being able to 
document and show the benefit of these therapies.

Immune Enhancement Project History

ATN: How did the Immune Enhancement Project begin?

Sinclair: The original concept of the Immune Enhancement 
Project was developed in 1983. IEP was organized at our 
present location in 1990, and incorporated as a non-profit in 
July 1992. Our function is to provide low-cost care, to 
educate the public about the benefits of traditional Chinese 
medicine, and to conduct research. That is our mission, and 
that's what we do.

ATN: What are some of the other major centers in San 
Francisco?

Sinclair: We are very fortunate in San Francisco that there 
are many options. In teaching clinics, there is the American 
College of Traditional Chinese Medicine; it has been a leader 
in the field of HIV treatment. There is also the Meiji 
School; I don't know if they have an HIV program. In terms of 
the clinics, there is the Immune Enhancement Project, and 
also the Quan Yin Healing Arts Center.

Misha Cohen (the founder of Quan Yin, now in private 
practice) should also be acknowledged. We all owe her much 
credit. Over the years she has been a pioneer in treating 
HIV, in providing education about how to treat HIV, and in 
providing access to low-cost care.

Also, in terms of detox, there are treatment programs 
available at the Haight Ashbury Free Clinic, and Walden 
House. Also the Bayview-Hunter's Point Foundation has Ryan 
White funding.

For More Information

ATN: What newsletters or other information about Chinese 
medicine can you suggest?

Sinclair: The Immune Enhancement Project publishes a 
quarterly newsletter. We try to appeal to general clients; 
also, we try to have articles which will be useful to 
practitioners working with people who are HIV-positive. [A 
sample issue of the newsletter is free; a year's subscription 
(4 issues) costs $12. Send a request for a free issue, or a 
check or money order for a subscription, to IEP, Newsletter 
Subscription, 3450 16th St., San Francisco, CA 94114. Or call 
the Immune Enhancement Project at 415/252-8711.]

There is a growing field of journals of alternative medicine. 
Some have come out in the last year, and have a number of 
well-written articles.

* * *

Tom Sinclair suggested the following books and journals on 
traditional Chinese medicine. They can be ordered through 
bookstores, or directly from the publisher. AIDS service 
organizations which maintain a library could use these to 
begin a section on Chinese medicine.

Books

* CHINESE MEDICINE AND HIV, short booklet by Gene London, 
1995. $1, Impact AIDS, San Francisco, phone 415/861-3397; 
also available from the Immune Enhancement Project, where the 
author is a practitioner.

* BETWEEN HEAVEN AND EARTH: A GUIDE TO CHINESE MEDICINE, by 
Harriet Beinfield and Efrem Korngold, 1993. $14, Ballantine 
Books, New York.

* TREATING AIDS WITH CHINESE MEDICINE, by Mary Kay Ryan and 
Arthur Shattuck, 1994. $29.95, Pacific View Press, Berkeley, 
California, 510/849-4213.

* THE WEB THAT HAS NO WEAVER; UNDERSTANDING CHINESE 
MEDICINE, by Ted J. Kaptchuk, 1983. $19.95, Congdon and Weed, 
New York.

* AIDS AND ITS TREATMENT BY TRADITIONAL CHINESE MEDICINE, 
by Huang Bing Shan, 1991. $24.95, Blue Poppy Press, Boulder, 
Colorado, 303/447-8372 (or place orders at 800/487-9296), 9 
a.m. to 2 p.m. Mountain time Monday through Friday.

* NINE OUNCES: A NINE-PART PROGRAM FOR THE PREVENTION OF 
AIDS IN HIV-POSITIVE PERSONS, by Bob Flaws, 1992. $9.95, Blue 
Poppy Press, Boulder, Colorado (see phone information above).

* AIDS AND CHINESE MEDICINE, by Qingcai Zhang, M.D., 1993. 
$19.95, Oriental Healing Arts Center, Long Beach, California, 
310/431-3544.

Journals

* ALTERNATIVE THERAPIES IN HEALTH AND MEDICINE. Bimonthly, 
$48 per year. Aliso Viejo, California; phone 800/899-1712.

* ALTERNATIVE/COMPLEMENTARY THERAPIES. Bimonthly, $79 per 
year plus shipping. Mary Ann Liebert Publications; phone 
914/834-3100, ask for customer service.

* THE AMERICAN JOURNAL OF ACUPUNCTURE. Quarterly, $60 per 
year. Capitola, California; phone 408/475-1700.


***** Hydroxyurea and ddI: French Study Published

by John S. James

The long-awaited French study of hydroxyurea plus ddI 
appeared August 28 in the JOURNAL OF ACQUIRED IMMUNE 
DEFICIENCY SYNDROMES AND HUMAN RETROVIROLOGY. It reported 
good antiviral activity and CD4 count improvement in a 90-day 
trial with 12 patients who started with a high CD4 count.

Viral load (measured by plasma HIV RNA) fell with a median 
decline of 1.71 log (about 98%) in six of the 12 patients; in 
the other six, plasma HIV RNA fell to undetectable levels, so 
the exact decline could not be computed. At the same time, 
the 12 patients had a median CD4 increase of 120.

The 12 patients had to be asymptomatic, with CD4 count over 
250, to enter this trial. Their median starting CD4 count was 
343.

There were some side effects which might have been due to 
hydroxyurea, but none severe enough to cause anyone to 
discontinue the treatment. However, other publications have 
reported that the drug can cause serious side effects.

Comment

We have heard a few greatly mixed reports on hydroxyurea, 
which has been used for decades in cancer treatment and is 
available by prescription. Generally the good reports have 
been from persons in earlier stages of HIV disease; many have 
had CD4 counts in the high 200s or more. One person who 
started with a CD4 count just under 300 reported tremendous 
improvement. But we have also heard two reports from people 
with advanced AIDS and very low counts who found no benefit 
at all and serious side effects; one thought the drug had 
caused him lasting harm. Hydroxyurea may work better in 
earlier than in later illness, although there is not enough 
information yet to know for sure.

Also, it is unclear what dose should be used. The French 
study used "200 mg ddI twice daily on an empty stomach, and 
500 mg hydroxyurea twice daily taken at least one hour after 
the ddI." The 500 mg twice daily dose seems to be fairly 
common in the community, although some people suspect that 
lower doses should be used.

This new report of a small trial may give needed momentum to 
additional research with this drug, which should have been 
studied in HIV treatment long before now. But it seems clear 
that hydroxyurea is not a drug for everyone, and does have 
safety concerns that must be addressed.


***** Thalidomide: New Expanded Access for Wasting

by John S. James

Thalidomide has already been available through a 
compassionate-use program for treatment of certain cases of 
aphthous ulcers, and some other conditions. But until now 
patients could not obtain the drug through this program for 
the treatment of HIV-related wasting syndrome, where 
thalidomide might also be effective.

Now the FDA has authorized an expanded-access program for 
AIDS-related wasting. This program, conducted by Celgene 
Corporation of Warren, New Jersey, will randomize patients to 
one of two doses, 50 mg or 200 mg (the most common community 
dose so far has been 100 mg); this randomization will allow 
researchers to determine if there is a dose response in 
either safety and/or effectiveness of the treatment. Response 
to therapy will be measured after four weeks, and those 
failing the smaller dose can switch to the larger dose at 
that time. Patients may continue the therapy indefinitely.

This program will require that physicians get local IRB 
(institutional review board) approval to participate -- which 
can be a serious obstacle to patients who obtain their 
treatment in public hospitals and clinics. Also there will be 
cost recovery, meaning that the company, which is small, can 
charge for the cost of the program. The cost has not yet been 
set, but we have heard that it is likely to be about $1,000 
per year -- not a few thousand dollars per year as quoted in 
The WALL STREET JOURNAL on August 29.

Entry Criteria

As we go to press on August 30, the protocol is not yet 
entirely final. But according to Dr. Sol Barer of Celgene, 
the major criteria are likely to be the following:

* Those who are qualified for the separate double-blind 
controlled trial of thalidomide which is still recruiting 
cannot enter this program, unless they live more than an hour 
away from any trial site (by public transportation). Those 
who have entered and completed that trial may enter this 
program.

* Those ineligible for the controlled trial because of 
opportunistic infections, malignancies, IV feeding, diarrhea 
or use of other anti-wasting agents -- which includes many 
people -- may enter the expanded-access program. In addition, 
those who have lost more than 20 percent of body weight can 
enter immediately.

* Exclusion criteria are pregnancy, serious peripheral 
neuropathy, major abnormalities in blood chemistry, or if the 
physician feels the treatment is not appropriate.

* Women of childbearing age can enroll, but must use 
specified birth-control methods to prevent any chance of 
pregnancy.

For more information about this program, call 800/896-6766, 
or after Monday September 4 call 800/253-1596, during 
business hours Eastern time.


***** d4T Dose Clarification

by John S. James

Our interview with Dr. Conant published in issue #228, August 
4, 1995, left some readers confused about the d4T dose Dr. 
Conant is using. For some patients, he increases the dose 
until it is twice the dose recommended by the FDA in the 
product labeling. The following statement in the interview is 
correct:

"Dr. Conant: If there is evidence of disease progression, we 
are first treating many patients with very high dose d4T. The 
dose I usually start with is 20 mg. twice a day; then I have 
the patient increase it by 20 mg. each week, until they get 
neuropathy, or until we get to 80 mg. twice a day. That is 
twice the FDA-recommended dose."

But then the next paragraph includes the statement, "So if 
patients can tolerate the dose, I go all the way up to 80 mg 
per day." This should have read "80 mg per dose," not "per 
day." AIDS TREATMENT NEWS regrets the confusion.


***** San Francisco: Viral Load Trial Offers Free Tests

Chiron Corporation is sponsoring a small trial to observe how 
viral load, measured by their branched DNA (bDNA) test, 
responds to various treatment changes. Participants must plan 
to make a change in their HIV treatment (either starting or 
stopping either a mainstream or alternative treatment) -- but 
get the first viral load test through the program before they 
do so. Several other tests will be run after the treatment 
change.

Blood will be drawn at Davies Medical Center in San 
Francisco. This program is intended for persons who otherwise 
have no way to pay for viral load tests.

To register, call Healing Alternatives, 415/626-4053, noon to 
6 p.m. Pacific time Tuesday through Friday, or noon to 5 p.m. 
Saturday.


***** National AIDS Treatment Advocates Forum, October 15-18, Los 
Angeles

NMAC, the National Minority AIDS Council, is sponsoring a 
National AIDS Treatment Advocates Forum, October 15-18 at the 
Century Plaza Hotel & Tower, Los Angeles. (Note that this 
meeting is just before the 1995 National Skills Building 
Conference, October 19-22, in the same Los Angeles hotel.)

Topics tentatively scheduled include antiviral drugs, immune-
based therapies, treatments for opportunistic infections, 
malignancies, women's health,  basic science workshops, 
research policy and legislation, and treatment education. 
This forum is to "foster dialog and exchange of information 
and ideas, and facilitate the development of leadership that 
can advocate for better treatments and educate people with 
AIDS and their caregivers on the latest treatment advances." 

Co-sponsors are the AIDS Action Council, AIDS Project Los 
Angeles, American Foundation for AIDS Research, Gay Men's 
Health Crisis, National Association of People with AIDS, 
National Minority AIDS Council, Project Inform, and the 
Treatment Action Group.

Conference registration is $100 if received by September 29, 
$150 later. Single or double occupancy rooms at the Century 
Plaza Hotel & Tower are $89 per night for this meeting, if 
reserved by September 29. For more information, contact David 
Barre at National Minority AIDS Council, 202/483-6622, fax 
202/483-1135, or email NMAC1@aol.com.

National Skills Building Conference, October 19-22, Los 
Angeles

The fifth National Skills Building Conference will take place 
October 19-22 at the Century Plaza Hotel & Tower in Los 
Angeles. Registration is $330 for members (persons from a 
community-based organization which is a dues-paying member of 
one of the three host organizations -- AIDS National 
Interfaith Network, National Association of People with AIDS, 
and National Minority AIDS Council), $450 nonmembers, until 
September 29; later or on-site registration is $550. Single 
or double occupancy rooms at the Century Plaza Hotel & Tower 
are $89 per night for this meeting, if reserved by September 
29. (Note: As we go to press, the Century Plaza Hotel sold 
out for October 18th and 19th; for information on overflow 
hotels, call Craig Wilkinson, 202/483-1124 ext. 312.)

Last year's meeting, with over 1800 participants, was named 
1994's Best Community Service Education Program by the 
American Society of Association Executives.

For more information, call the National Skills Building 
Conference, 202/483-1124.

Surrogate Markers Meeting, October 16-18, McLean, Virginia

Surrogate Markers & Clinical Outcomes of HIV: Strategies for 
Selection and Use, a conference on the use of "surrogate 
markers" such as viral load and CD4 counts in clinical trials 
and perhaps in patient management, will be held October 16-
18, at the Ritz Carlton Tysons Corner hotel, in McLean, 
Virginia. This meeting is organized by Cambridge Healthtech 
Institute, which organized a similar meeting in October 1994. 
Prices range from $395 to $895, plus hotel ($135 single or 
double per night, if reserved before September 25). 

"An analysis of currently available information surrounding 
the selection, validation, and efficacy of HIV surrogate 
markers and clinical outcomes will be the focus of Day One's 
presentations. In this newly formatted open three-day forum, 
the panel, consisting of the Executive Scientific Advisory 
Committee members, will review the data and analyses 
presented by prominent AIDS researchers and participate in 
several open workshops focusing on novel investigations in 
clinical research."

For more information, contact Cambridge Healthtech Institute, 
617/630-1300.

Comment

This writer attended last years' meeting, and plans to go 
again this year. We were disappointed in the outcome last 
year, however, when a pre-appointed committee met privately 
and wrote the recommendations of the meeting -- 
recommendations which later were widely ignored. This year it 
appears that there will again be a pre-appointed committee, 
only it will meet openly.

We were concerned that the recommendations were and may again 
be too conservative, as committee products by their nature 
are likely to be. We believe that the best way to save lives 
is to move rapidly to use viral load and other tests of HIV 
disease status as well as we can, for clinical management of 
individual patients as well as for clinical trials to test 
new drugs. But academic committees want to see data first. 
People do not agree on what data should be required, however; 
and some want data that will take a very long time to obtain. 
The result is gridlock, with no company applying to the FDA 
for approval of its viral load test, because no one has 
decided what standards the tests must meet.

We believe that the key needs now are: (1) better information 
on how best to use viral load clinically -- information which 
we believe will develop much faster from clinical experience 
in addition to trials, than from clinical trials alone; (2) 
consensus on what standards must be met before viral load is 
officially recommended for routine clinical use -- since 
official approval would help greatly in lowering the price of 
the test (by allowing routine use of test kits at reference 
labs), and also in getting the cost of the test reimbursed 
for patients; and (3) attention to developing immune-function 
measures which are feasible for widespread clinical use -- 
especially immune function tests based on flow cytometry, 
such as the new FastImmune* (CD69) system from Beckton 
Dickinson. If this year's meeting can help with these issues, 
it will make an important contribution.

In the future, more of this kind of work will be shifted to 
computer conferences, where everyone can participate, at 
little cost and on their own schedules. Face to face meetings 
will always be necessary, but they will be better focused 
when they do not have to cram everything into three pressure-
packed, expensive days.


***** Next AIDS TREATMENT NEWS Delayed One Week

The next issue of AIDS TREATMENT NEWS will be delayed one 
week so we can cover the important ICAAC conference (Inter-
Science Conference on Antimicrobial Agents and Chemotherapy) 
in San Francisco. We will publish issue #231 on September 22 
instead of September 15.

Issue #232 will appear on schedule on October 6.


***** Health Insurance: Widespread Copayment Abuse

by John S. James

A newly exposed health-insurance abuse, run by some of the 
biggest companies in the business, is costing policyholders 
billions of dollars a year, according to expert estimates. 
Anyone who pays a copayment (usually 20%) for health care is 
potentially at risk. The scheme was described in a page 1 
article in The WALL STREET JOURNAL, August 21.

The way it works is that the companies sell standard 
insurance contracts in which they agree to pay 80 percent of 
certain medical costs. But then they negotiate secret deals 
with doctors and hospitals, by which they receive huge 
discounts over the nominal price -- often more than 50 
percent. This way the insurance company ends up paying much 
less than the 80 percent agreed to in its contract.

In some cases discounts can be more than 80 percent. This 
means that not only did the insurance company pay nothing, it 
actually got a rebate from the physician, out of the 
patient's copayment.

The insurance companies then use the fictitious 80-percent 
amounts to tell people that they have reached their policy 
maximum, when the company has actually paid far less than the 
amount agreed in the contract.

Meanwhile, all this is concealed from the patients by 
contracts with the doctors and hospitals, requiring them to 
keep the information confidential.

The WALL STREET JOURNAL article described the case of one 
company, Trigon Blue Cross Blue Shield, in Virginia. The 
state forced it to abandon such practices and pay millions of 
dollars in civil fines and restitution. (Technically a not-
for-profit, Trigon has accumulated a surplus of more than 
$650 million, and pays its chief executive an annual 
compensation of $895,000.) 

Meanwhile, similar practices continue in other companies 
across the country. Activists could help by getting 
documentation from friendly physicians and hospitals, or 
their employees, to the attention of regulatory agencies and 
the press. Doctors and hospitals know if they are billing 
your insurance for more than they are really being paid. 
Another approach might be to urge medical societies to 
develop ethical codes governing such practices, which could 
not exist without collaboration by healthcare providers.

Note: A different approach to reforming healthcare abuses was 
suggested in an interview with Lonnie Bristow, the new 
president of the American Medical Association, published in 
the SAN FRANCISCO CHRONICLE, August 20. He said that after 
the loss of health-care reform, managed care, which can be 
legitimate, had often become "managed profiteering." The 
interview lacked details, but Dr. Bristow protested that 
Federal antitrust laws discourage doctors from competing with 
healthcare corporations by providing their services directly 
to employers, etc., at lower cost, while maintaining the 
integrity of the doctor-patient relationship. It may be 
illegal for doctors to collectively price their services, 
while legal for a corporation to hire the same doctors and 
set the same prices. (Doctors can start their own healthcare 
corporation -- and are doing so in California -- but this can 
be difficult.) Federal law may have unwittingly created 
special privileges for corporate healthcare, helping it take 
billions of dollars out of the healthcare system without 
providing comparable value in return.

***** AIDS TREATMENT NEWS
      Published twice monthly

Subscription and Editorial Office:
   P.O. Box 411256
   San Francisco, CA 94141
   800/TREAT-1-2  toll-free U.S. and Canada
   415/255-0588 regular office number
   fax: 415/255-4659
   Internet: aidsnews@aidsnews.org
Editor and Publisher:
   John S. James
Reader Services and Business:
   Richard Copeland
   Thom Fontaine
   Denny Smith
   Tadd Tobias

Statement of Purpose:
AIDS TREATMENT NEWS reports on experimental and 
standard treatments, especially those available now. We 
interview physicians, scientists, other health 
professionals, and persons with AIDS or HIV; we also 
collect information from meetings and conferences, 
medical journals, and computer databases. 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.

Subscription Information: Call 800/TREAT-1-2
   Businesses, Institutions, Professionals: $230/year.
   Nonprofit organizations: $115/year.
   Individuals: $100/year, or $60 for six months.
   Special discount for persons with financial difficulties:
   $45/year, or $24 for six months. If you cannot afford 
   a subscription, please write or call.
   Outside North, Central, or South America, add air mail 
   postage: $20/year, $10 for six months.
   Back issues available.
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ISSN # 1052-4207 

Copyright 1995 by John S. James.  Permission granted for 
noncommercial reproduction, provided that our address 
and phone number are included if more than short 
quotations are used.



