AIDS Treatment News #339

Date: Mar 17 2000 (712 lines)

Copyright 2000 by John S. James;
permission granted for non-commercial use.

AIDS TREATMENT NEWS #339, March 17, 2000
phone 800-TREAT-1-2, or 415-255-0588

CONTENTS:  [items are separated by "*****" for this display]

** Treatment Models from India:  Interview with Shashank
Joshi, M. D.
An HIV specialist in India describes an evolving standard of
care, when only a few patients can afford the antiviral
regimens common in richer countries.  Dr. Joshi's approach
include nutritional support for the immune system,
intermittent HAART for some, herbal treatment, de-worming,
and sometimes drugs to reduce intestinal inflammation and
therefore possibly lower viral load.

** Testosterone Cream Available at CPS; Gel Approved by FDA
A major HIV-specialist pharmacy is now carrying a compounded
testosterone cream for topical application, avoiding the
shots or patches otherwise used to deliver this drug.
Meanwhile, the FDA has approved a testosterone gel -- but this
gel will not be widely available for several months.

** Anabolics, Exercise, Nutrition, Supplements:  New Book
Available
BUILD TO SURVIVE, by the editors of the newsletter
MEDIBOLICS, discusses anabolic steroids, exercise, nutrition,
and supplements for preventing or treating muscle wasting in
AIDS.

** Vaccine News, March 2, 2000
Much is happening to accelerate development of vaccines,
especially for AIDS, tuberculosis, and malaria.  Major
initiatives were announced at a meeting of the President's
Millennium Vaccine Initiative, March 2 at the White House.

** Fluconazole:  Pfizer Asked to Lower Africa Price
Pfizer, Inc. 's fluconazole costs almost 15 times as much in
South Africa, where it is patent protected, than in Thailand
where it is generic.  The result is that many Africans die of
cryptococcal meningitis and other fungal infections because
they cannot obtain the patented drug at Pfizer's price.  In
South Africa, a coalition of major organizations has asked
Pfizer to either reduce the price to the Thailand level, or
voluntarily license the patent so that the treatment could be
made available.

** Dietary Supplement Regulation:  FDA Public Hearing April 4,
Written Comments Due May 4
Problems in how the U.S. regulates "foods" vs.  "drugs" could
eventually block access to low-cost and natural treatments.

** FDA Drug-Approval Background:  New Web Pages
An FDA Web site explains the details of how drugs are
regulated.

** African Americans and AIDS:  Highlights of 2nd Annual
Washington Conference
Treatment and prevention experts look at how to respond to
the epidemic among African Americans, who are much more
likely than whites to have HIV and AIDS.


*****

Treatment Models from India:  Interview with Shashank Joshi,
M. D.

by John S. James

     Shashank R. Joshi, M. D., president of the HOPE
Foundation in Mumbai, India, is an HIV specialist in a
public hospital system with more than 36,000 patients with
HIV; in addition, he follows over 500 HIV patients in his
private practice, and more than 180 HIV-discordant couples.
We asked Dr. Joshi to share information and experiences that
might be useful to physicians or patients elsewhere.

An Evolving Standard of Care in India

     AIDS TREATMENT NEWS:  How to you approach HIV care in
India, where few patients have access to triple-drug
combination antiretroviral treatment?

     Dr. Joshi:  We are developing low-cost treatment models
in the Indian population, because of the high cost of
antiretroviral drugs.

     A few of my private patients can afford some triple
therapy with a protease inhibitor and two nucleoside
analogs, but not continuously.  So for some patients, we
suggested triple therapy on alternate months, one month on a
HAART combination and the next month without
antiretrovirals.  At the end of a year we have a small
cohort of 26 patients who have done very well on this
treatment; all of them have undetectable viral load -- below
20 copies on the Roche Ultrasensitive test -- and their
average CD4 count has improved.  It is important to note
that all of these patients started this regimen with a CD4
count over 300.  NIH is critically looking at this cohort.
We are now trying to validate these results, and are working
with other researchers, including in the U.S.

     We are looking at other low-cost models as well.  We do
not have ddI in India, so often I use d4T, 3TC, and
hydroxyurea, in an antiretroviral-naive population.  [Note:
Hydroxyurea, an inexpensive drug usually used in cancer
treatment, may improve the activity of certain
antiretrovirals, especially ddI -- but can also increase the
toxicity of the regimen.]  This combination is working very
well in a small but significant number of cases, reducing
viral load and inducing CTL responses.  Significantly, we
have had no mitochondrial toxicity in these patients --
perhaps because we are giving them appropriate
immunonutrition, including multivitamins, antioxidants, and
certain other micronutrients.  This nutritional therapy may
be particularly important in the Indian population, because
wasting is a major problem.  [Note: Some researchers believe
that mitochondrial toxicity -- a condition recognized
elsewhere in medicine -- may caused by nucleoside analog
drugs -- and may be responsible for much of their toxicity,
as well as some but not all of the body-shape changes often
attributed to protease inhibitors.]

     We are planning to study the product ImmunoCal, a
nutritional supplement derived from whey protein, as a
source of glutathione.  It is believed that mitochondrial
toxicity, which the nucleoside analog drugs and hydroxyurea
may have, is mediated through the glutathione pathway.  If
you give patients a natural source of glutathione, maybe
this problem can be prevented, and you may not see the liver
toxicity, lactic acidosis, or other problems which might
otherwise occur.  We want to see if improved nutrition can
improve the catabolic cachexia [wasting], and also we want
to look for any antiretroviral effect.  I understand that a
small but significant number of patients have dropped their
viral load by a log, after treatment with nutritional
regimens designed to support the immune system.

     So an evolving standard of care in India is that we
offer patients antiretroviral therapy with two nucleoside
analogs and a protease inhibitor; if they cannot afford
that, they can try structured treatment interruption, one
month on and one month off of the triple therapy; if they
cannot afford that, we look into an option like d4T and 3TC
and hydroxyurea.  In any case, treatment includes
multivitamins and antioxidant supplements, psychological
support, and meditation and yoga.

     Our protocol always includes vitamin E and vitamin C.
We try to get the vitamin E from natural sources; we do not
use the synthetic pills because they are derived from
petrochemical intermediates, and some believe that these
preparations might be pro-oxidant as well as antioxidant.
So we use extracts from wheat germ, usually 200 IU to 400
IU. We also include B-complex vitamins, selenium, and other
minerals.

Herbal Treatments for Antiretroviral or IL-2 Effects

     Dr. Joshi:  We are also using certain herbal
medications -- some of which increase the body's natural
production of IL-2.  We presented a poster on this approach
in 1998, at the 12th World AIDS Conference in Geneva
["Effect of unique herbal formulation in Indian HIV
patients:  A pilot study," 12th World AIDS Conference,
Geneva, June 28 - July 3, 1998, abstract #42385].  We have
compiled an herbal booklet, listing each ingredient, with
references to studies showing antiviral activity, or
increases in the natural production of IL-2.

De-Worming, and Other Treatment for Intestinal Inflammation

     Dr. Joshi:  We are also giving a weekly dose of
albendazole to patients who have intestinal parasites.  We
have seen that if we de-worm patients routinely, after six
months to a year there is a reduction of viral load.  Indian
patients traditionally have higher viral set points than
European patients; this might be related to the parasites.
Deworming might assist mucosal immunity in the gut, and
improve the CTL response against HIV.  Also, in a couple of
patients, I am trying mesalamine, a drug used to reduce
intestinal inflammation.

Side Effects of Antiretroviral Regimens

     Dr. Joshi:  We have not had problems with mitochondrial
toxicity -- perhaps because of our nutritional therapy, or
perhaps because we do not have ddI in India.  I also believe
that immunonutrition helps to some extent with
lipodystrophy.

     But we are seeing lipodystrophy.  And we are also
seeing other side effects which have been reported
elsewhere, including osteoporosis, and aseptic necrosis of
the femur, in people on protease-inhibitor regimens in
India.  So there is considerable concern about these drugs,
and we are looking at PI-sparing regimens.  Nevirapine is
now available in India, and we will be using it for this
purpose.

*****

Testosterone Cream Available at CPS; Gel Approved by FDA

by John S. James

     On March 2 the Community Prescription Service, a mail-
order pharmacy associated with POZ magazine and specializing
in HIV, announced that it is selling a compounded
testosterone cream.  This product is not generally available
in pharmacies.  ("Compounded" means that it is specially
prepared by a pharmacist at the direction of a physician,
not a packaged pharmaceutical product; compounded products
do not have to pass most of the FDA requirements for
approval of pharmaceuticals.)  Topical testosterone has long
been available (see Testosterone Cream and Gel Available;
Prices Vary Greatly,"  AIDS TREATMENT NEWS #307, November
20, 1998), but usually only through certain pharmacies which
specialize in compounding.

     With the CPS product, the physician specifies the
starting dose per application, and the cream is made up
accordingly.  According to CPS, for most people, an
appropriate starting dose is 12.5 mg of testosterone per
application.  The same controlled-substance regulations
apply to topical testosterone as to the injected or patch
forms of the drug.

     For more information about this testosterone cream,
call CPS at 800-842-0502.

     Note:  On February 29 Unimed Pharmaceuticals, Inc.
announced that the FDA had approved its AndroGel(TM) 1%
testosterone gel "for replacement therapy in males for
conditions associated with a deficiency or absence of
endogenous testosterone" -- the first time the FDA has
approved such a product.  However, AndroGel is not expected
to be widely available in pharmacies until mid summer.
Apparently AndroGel will deliver a somewhat higher dose of
testosterone than the CPS cream.

     Comment:  We expect that the main practical difference
between the products is that the AndroGel will be much more
expensive.

*****

Anabolics, Exercise, Nutrition, Supplements:  New Book
Available

by John S. James

     BUILD TO SURVIVE, by AIDS treatment advocates Michael
Mooney and Nelson Vergel, covering anabolic steroids,
exercise, nutrition, and popular supplements (especially for
preventing or treating HIV-related wasting), was published
February 2000.  Mooney and Vergel are also editors of the
MEDIBOLICS newsletter, http://www.medibolics.com

     The book includes sections on AIDS wasting, BIA
(bioelectrical impedance analysis), testosterone replacement
therapy, different kinds of anabolic steroids, legality of
anabolic steroids in medicine, lipodystrophy and potential
approaches for management, side effects and guidelines for
anabolic steroids, human growth hormone, orthomolecular
nutrition, popular food supplements, various diet plans,
food safety, diarrhea, blood tests to use before starting a
nutritional program, exercise programs, recommended reading,
references, and testimonials.

     BUILT TO SURVIVE is published by PoWeR (Program for
Wellness Restoration), a nonprofit organization founded by
Nelson Vergel.  The cover price is $24.95, but copies can be
ordered from the Houston Buyers' Club, 1-800-350-2392, for
$18.95 +3.95 shipping; the book is also available through
http://www.amazon.com , which can ship internationally.

Comment

     BUILT TO SURVIVE provides an accessible overview of
certain important therapies, by advocates who have made
themselves experts in this area.  Some of the
recommendations may be controversial, and we are not
qualified to judge their medical appropriateness.  We
suggest this book as a source of ideas that you may later
want to discuss with your physician -- a discussion which 
the authors repeatedly urge their readers to have.

*****

Vaccine News, March 2, 2000

     Several major vaccine announcements were made on March
2, at a conference on the President's Millennium Vaccine
Initiative in the White House:

     * The International AIDS Vaccine Initiative (IAVI) will
invest $10 million this year to help fund the development of
six HIV vaccine candidates for developing countries.  IAVI,
funded by foundations and governments, establishes
partnerships with industry using a "social venture capital"
approach:  in return for investment, IAVI secures rights to
ensure that a successful vaccine will be available to
developing countries at a reasonable price.

     * Pharmaceutical corporations announced donations of
millions of doses of existing vaccines to developing
countries; four major companies promised to speed research
and development of vaccines for AIDS and malaria, which
currently have no vaccines.  Also, Clinton has proposed a
billion-dollar tax credit over ten years to speed
development of vaccines for HIV, tuberculosis, and malaria,
and a $50 million contribution for a global vaccine bank.

     * The U.S. National Institute of Allergy and Infectious
Diseases released THE JORDAN REPORT 2000, on the state of
development of vaccines for many diseases; 8 pages of the
173-page report summarize the current status of several
current approaches to an AIDS vaccine, but other sections
are also relevant.  THE JORDAN REPORT 2000 is available at
www.niaid.nih.gov; more information on NIAID's role in AIDS
vaccines is at http://www.niaid.nih.gov/aidsvaccine

     * The Global Alliance for Vaccines and Immunization
(GAVI) is a major government/industry/foundation alliance to
get existing and new vaccines to poor countries.  According
to GAVI, vaccines save about three million children's' lives
every year -- but almost three million other children die
each year because they were not vaccinated.  For more
information, see http://www.vaccinealliance.org

     * New vaccine bills introduced in Congress:  On March 1
Senator John Kerry (D., Massachusetts) and two others
introduced the Vaccines for the New Millennium Act of 2000
in the Senate, and Representative Nancy Pelosi (D., San
Francisco) and nine others introduced it in the House.
[Rep. Pelosi had previously introduced the Lifesaving
Vaccine Technology Act of 1999 to provide a tax credit for
research and development of vaccines for HIV, tuberculosis,
and malaria; President Clinton had instead proposed a fund
to purchase these vaccines after they were developed, which
incidentally would not cost the government money now.  The
new Kerry/Pelosi bill combines several ideas and includes
both approaches.]

*****

Fluconazole:  Pfizer Asked to Lower Africa Price

by John S. James

     On March 13 the Nobel prize winning medical
organization Doctors Without Borders/Medicins Sans Frontiers
(MSF) demanded that Pfizer, Inc. greatly reduce the price of
fluconazole in poor countries, in a communication delivered
to the company in 18 countries (Pfizer is headquartered in
New York).  Doctors Without Borders supported South Africa's
AIDS-activist Treatment Action Campaign (TAC), which on the
same day organized a delegation of union leaders, church
leaders, and others representing millions of South Africans
asking that Pfizer either lower the price, or grant a
voluntary license allowing TAC to import the drug or
manufacture it locally, with a 5% royalty to Pfizer.

     According to MSF, fluconazole costs almost 15 times as
much in South Africa, where it is patent protected, than in
Thailand, where it is not (in U.S. currency, $17.84 in
Africa for an adult's daily maintenance dose, which must be
taken indefinitely, vs. only $1.20 at the generic price in
Thailand).  The African price is more than twice the average
daily wage of employed South Africans.

     The consequence is that few Africans are treated for
cryptococcal meningitis, and as a result their life
expectancy is less than one month.  Patients who are treated
can live for years with a greatly improved quality of life.
Many Africans could be treated if they could obtain the drug
at the generic price.

     According to TAC, Pfizer in South Africa agreed to
respond within one week as to how TAC's letter was being
handled -- although it could not act on the issue itself
within a week, as the decision would have to be made in the
United States.

Letter from Archbishop

     The Most Reverend Njongonkulu Winston Hugh Ndungane,
Anglican Archbishop of Cape Town, wrote the following to the
chairman and CEO of Pfizer, Inc.:

     "Dear Mr. Steere,

     "In the face of evidence to the effect that it is
     possible to manufacture and sell Fluconazole at a price
     affordable to a significant number of South Africans,
     we urge you, in the interest of justice, to make this a
     reality.

     "We do understand that Pfizer is neither a charitable
     nor a humanitarian organization and that you have a
     responsibility to your shareholders.  We assume,
     however, that Pfizer's market share in our country
     warrants an interest in our economic and social
     stability -- both of which are acutely threatened by 
     our AIDS pandemic.

     "Many so called "First World" institutions and
     corporations are busy taking out patents on every new
     intellectual idea and discovery in every field.  The
     poor are continually being excluded from benefits of
     these discoveries and will continue to be so until some
     sense of global responsibility is introduced.
     Creativity is needed to bridge the huge gap between
     human need, scientific effort and market returns.

     "Both rich and poor need to direct their attention
     towards a common plan of action regarding mobilization
     of science and technology for poor country problems.
     One recent suggestion is the creation of a vaccine fund
     which would guarantee future markets for epidemic
     vaccines.

     "Besides the bottom line issues, we strongly urge you
     to consider these humanitarian and moral aspects.

     "Grace and Peace,"

*****

Dietary Supplement Regulation:  FDA Public Hearing April 4,
Written Comments Due May 4

by John S. James

     On April 4 the FDA will hold a public hearing on
regulation of claims for dietary supplements.  While the
technical issues involved do not directly affect AIDS
treatment access, they are part of a larger issue which
does.  Anyone wishing to speak at this hearing must register
in writing by March 28.  But written comments can be
submitted until May 4.

     The hearing is to get public input on how the FDA
should change its regulations in response to a court case
which it lost.  An appeals court held that "the First
Amendment [of the U.S. Constitution] does not permit FDA to
reject health claims that we [FDA] determine to be
potentially misleading unless we also reasonably determine
that no disclaimer would eliminate the potential deception"
[FDA's summary in the FEDERAL REGISTER, March 16].

     For background and more information, see "Food
Labeling; Dietary Supplement Health Claims; Public Meeting
Concerning Implementation of Pearson Court Decision and
Whether Claims of Effects on Existing Diseases May Be Made
as Health Claims," FEDERAL REGISTER, March 16, 2000 [page
numbers not available as this article goes to press].

Comment

     The larger issue is the regulation of "dietary
supplements," such as the herbal products which are widely
sold in the U.S.  in health-food stores, and now in
mainstream drugstores as well.  There is widespread
agreement that more regulation is needed than exists today.
The appropriate kind of regulation is unclear.

     The danger is that we will get the wrong kinds of
regulation, just because the models are most readily
available.  If natural products become regulated like
pharmaceutical drugs, most will be effectively banned since
no company will pay for the large clinical trials which
would be necessary for approval.

     Even worse is the war-on-drugs model, which for decades
has had a major impact on medicine in denying appropriate
pain relief, because doctors reasonably fear trouble even
when their prescribing is entirely legitimate and legal.
The drug war has also greatly hindered the appropriate use
of anabolic steroids in treating wasting, which causes many
AIDS deaths -- and greatly impeded the use of needle
exchange, although it has been clearly shown to prevent HIV
infection without increasing drug use.

     Fortunately there are more positive regulatory models
from some European countries -- which have long allowed the
sale of a large variety of natural products at reasonable
prices, under effective but not prohibitive controls.

     The U.S. is prone to destructive "moral" crusades --
which is why we have both the drug war, and the new mass
imprisonment of the last 20 years.  Because of the
difficulty of making anything happen, this destructive
spirit may be used as an ally by persons and institutions
seeking legitimate safety measures for natural health
products.  Anyone interested in access to inexpensive or
natural treatments should be paying attention at this time.

*****

FDA Drug-Approval Background:  New Web Pages

by John S. James

     The FDA recently launched an excellent Web site with
detailed release:

     The information includes:

-Drug Approval Application Process.  An overview from test
tube to marketing
-Investigational New Drugs.  Includes emergency INDs, FAQs,
etc.
-New Drug Applications
-Generic Drug Applications
-Electronic Submissions
-Small Business Assistance Program.  Includes funding sources
and orphan drugs.
-Post Drug Approval Activities.  Includes advertising,
medication errors, drug shortages and surveillance
activities.

     Treatment activist Brenda Lein of Project Inform said,
"The information is absolutely wonderful and I'd encourage
any treatment activist who isn't clear about the FDA and
their process to read through the materials and become
familiar with the drug discovery and development process...
[including] why companies conduct certain tests based on
what the FDA requires of them, and why other tests may not
be conducted."

     The FDA site is at
http://www.fda.gov/cder/regulatory/applications/default.htm

*****

African Americans and AIDS:  Highlights of 2nd Annual
Washington Conference

by Al Cunningham

     African Americans have access to modern HIV treatment,
but far too many have not been tested and are not receiving
medical care, according to speakers at the 2000 National
Conference on African-Americans and AIDS, February 24 and 25
in Washington, D. C.; racism, sexism, homophobia, stigma
associated with HIV and AIDS, lack of trust in the
healthcare system, and lack of access to healthcare, remain
major barriers.  The two-day conference, sponsored by Johns
Hopkins University School of Medicine and Bristol-Myers
Squibb, was the second annual meeting on African Americans
and AIDS, with talks by leading researchers, public health
officials, and non-government activists.

Some highlights:

     * Long-term survivor Phill Wilson, who opened the
meeting, later noted that 50% of the new AIDS cases among
men who have sex with men are now men of color.  "The
tragedy is that this did not have to happen.  Men of color
were disproportionately impacted in 1989 when they were 30%
of AIDS cases among men who have sex with men.  The question
now is what are we going to do at this time?"  Wilson is a
gay African American activist and founder of the African
American AIDS Policy and Training Institute,
http://www.AAAinstitute.org

     * U.S. Health and Human Services Secretary Donna
Shalala described the Clinton Administration strategy as
3-fold:  to put needed money into communities; to prevent
the spread of HIV, and to eliminate barriers to care.  "Too
few African Americans are getting tested or getting access
to care.  The cost of treatment is high.  The regimen of
pills is difficult to follow.  And prevention messages have
not been targeted enough -- or become accepted enough -- in
the African American community."

     * Human-rights leader Jesse L. Jackson Sr. called for
visible African Americans to model the importance of testing
-- followed by his own public test at a local HIV clinic for
African Americans.

     * John G. Bartlett, M. D., from Johns Hopkins,
discussed the government guidelines for HIV treatment, most
recently updated January 29 (see "New Guidelines for HIV
Treatment; Resistance Testing Now Recommended,"  AIDS
TREATMENT NEWS #337, February 18, 2000).  Dr. Bartlett also
cited some of the long-term consequences of the HAART
combinations, including elevated triglycerides and
cholesterol levels, fat accumulation and fat wasting
(lipodystrophy), insulin resistance or diabetes, and other
disorders.  He suggested that it is too soon to generalize
about the benefits and risks of early HAART therapy.

     * Anthony S. Fauci, M. D., Director of the National
Institute of Allergy and Infectious Diseases (NIAID) of the
National Institutes of Health, emphasized that while the
guidelines are important, they do not mean that everyone
must be treated -- and patients' rights to choose not to be
treated should be respected.  Dr. Fauci also noted that
globally, 90% to 95% of people who need antiretroviral
treatment will never get it.  He referred the audience to
http://www.hivatis.org for the latest updated version of the
treatment guidelines.

     * Robert C. Gallo, M. D., discussed the search for
biological treatments for HIV infection, which could be
nontoxic and inexpensive.  His talk included beta
chemokines, and also the role of tat in HIV infection and
immune suppression.  His group is developing a tat toxoid
which might be useful in both treatment and/or vaccination
against HIV.

     Full audio and slide presentations should be available
by April at the Johns Hopkins Web site, http://www.hopkins-
aids.edu

*****

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