AIDS Trestment News
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GATT and the Gap: How to Save Livesby John S. James |
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Before the speeches of World AIDS Day (December 1) again recount this grim reality, we want to suggest a new target for AIDS activism -- the rules of international trade -- where the work of a small number of people might save many lives. Until recently, pharmaceutical patents and other
intellectual- But today the system has changed. Not only are there major
international efforts to stamp out all pharmaceutical
"piracy" anywhere, regardless of the circumstances and the
human cost, but these efforts go far beyond unauthorized drug
manufacture to impose other restrictions as well. The U.S. in
particular has taken the lead in trying to force even the
poorest countries throughout the world to sacrifice their
public health and the welfare of their people, when necessary
to preserve the interests (even only symbolic interests) of
multinational corporations. U.S. government and industry even
try, with mixed success, to force other countries to obey
rules that the U.S. itself does not follow domestically.
These changes resulted mainly from GATT, the Global Agreement
on Tariffs and Trade. GATT originally began over 50 years
ago, and did not cover pharmaceutical patents. Today's GATT,
which does cover pharmaceutical patents and which established
the WTO, developed recently at a series of meetings called
the Uruguay Rounds. The WTO, headquartered in Geneva, began
in 1995 and now includes about 120 countries; some provisions
took effect before 1995.
GATT and the WTO, intended to improve the world economy by
rationalizing trade and other economic rules, require all
countries to change their laws when necessary to meet a list
of conditions, almost all of which are mandatory. The WTO
serves as an international forum to resolve trade disputes
and regulate retaliation. The result has been a regime such
that any country in the world which chooses to run its own
affairs differently can face ruinous economic warfare by
other nations.
GATT is not all bad. It was supposed to create trillions of
dollars of additional wealth in the world (and may have done
so, before the current world economic crisis). Many
developing countries have better rights under GATT than they
could get if forced to rely on bilateral negotiations with
much more powerful nations. GATT and the WTO can often be
used to support, as well as to oppose, measures which advance
human health in poor countries.
The problem is that the system is not evenhanded. As with
most such efforts, the rules are distorted to favor the
interests of the rich and powerful -- multinational
corporations, big investors, and large industrialized
countries. The poorest nations and peoples are the biggest
losers.
The result is a growth of what might be called 21st century
tribute. In traditional tribute, vassal states had to pay
extortion money to their conquerors. Today, tribute payment
is usually made not through lumps of gold, but through
submission to biased rules which poison the future of the
weak to unjustly enrich the strong.
Probably the worst single feature of GATT/WTO was the
decision to include pharmaceutical patents and apply them to
developing countries -- effectively locking in a system which
cuts off most of the world's population from almost all
access to new medicines, until 20 years later when the
patents expire. No one can fully tabulate the human costs,
because of the overall complexity; high pharmaceutical prices
are not the only major barrier to better medical care.
Perhaps the most pernicious consequence of the GATT/WTO
system is that many creative possibilities for better medical
care for poor countries cannot begin at all, because they
might cross the rights of too many parties, some of which
will require prohibitive royalty payments, or prohibitive
costs for legal research and negotiation.
Developing countries were given 10 years to change their
patent laws, but certain changes had to be made earlier. Some
of these deadlines have already been reached, setting off a
number of controversies.
It is likely that the GATT/WTO inclusion of pharmaceuticals
will kill millions of people, as companies increasingly price
their proprietary medicines for rich countries and tiny
elites exclusively, with many if not most forms of relief now
legally blocked throughout the world.
Even without changing the GATT treaty itself, it would be
surprisingly feasible for an activist movement to save lives.
The reason is that GATT is not only a fixed, static body of
rules, but is constantly being litigated and otherwise
applied in thousands of specific cases. In this ongoing
activity under the trade rules, the U.S. (the "world's only
remaining superpower") has been an extremist in trying to
force unworkable conditions on other countries -- resulting in
ongoing disputes with countries representing most of the
people of the world.
The reason for the U.S. extremism in this area is that
Congress, the White House, the U.S. Trade Representative, and
others usually hear from only one side -- multinational
corporations, their industry associations, and organizations
which have been created, paid, or pressured to echo their
line. Usually no one even addresses any other side -- effectively turning the U.S. government into a tool of corporate interests. When abuses occur -- for example, when a major pharmaceutical company got Senator Jesse Helms to obstruct an unrelated treaty, in order to punish South Africa for passing a domestic law which could be interpreted to give the public health and welfare of South Africans priority over the intellectual property interests of multinationals -- or when policy makers abroad are given misleading information,
such as copies of a U.S. law with a key section omitted -- the U.S. public seldom hears anything about it.
Access to health care when life and death are at stake could
become a world- In our experience, the hardest part of engaging this issue
was knowing where to begin. The following can help others get
started.
You can find many other relevant Web sites by using the
search engine of your choice (for example, http://www.metacrawler.com). Some of the following search terms may be helpful; and often the Web pages returned will suggest other terms for additional searches reflecting your interests. The same list may also help reporters, librarians, and others using searchable archives of news stories -- or help locate USENET electronic discussions (another forum for
activism) in http://www.dejanews.com.
Other search terms: intellectual property; patent;
pharmaceutical; names of specific countries; 1998 (to help
select recent articles and Web pages); etc.
The current problems of intellectual property and treatment
access may have resulted partly from oversight. A few years
ago this writer attended an AIDS meeting where another
participant happened to be an intellectual- This issue is winnable because the powerful pharmaceutical
industry need not be the enemy. When someone dies from lack
of money for treatment, there is no sale and no profit. If
they were saved with a lower-cost equivalent drug -- available
through compulsory licensing or parallel importing, for
example -- there would be no loss to anyone's profit,
investment, incentive, or research. Many lives could be saved
with little financial impact anywhere.
Corporations seem to fear losing precedents for strong
intellectual property protection -- a legitimate concern
perhaps, but not one to kill for. We can support market
incentives, while opposing market extremism which disregards
the health and welfare of the majority of people. Better
arrangements are possible, and we should insist on them.
Industry gains nothing and only loses from condemning most of
the world's people to lack of access to modern medical
treatment, even when they need it to save their lives. Surely
the human race, and the companies as well, can do better than
that. The problem is that corporations often act on
autopilot, with managers fighting for advantage and oblivious
to long-term consequences, including effects on the company's
reputation. Much can be gained without pressuring companies
to go against their interests. They need only stop and think
about what they are doing and what their interests are.
A first step is for potential activists to acquaint
themselves with this issue, and begin discussions on specific
alliances and strategies.
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Testosterone Cream and Gel Available; Prices Vary Greatlyby Tadd Tobias and John S. James |
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Since that article went to press, we have learned that cream
and gel topical forms of testosterone, which work well for
many people, remain available with no supply problems. And
the total cost of treatment, which can be less than $20 per
month regardless of dose, may be less than with any other
form of testosterone available. But we have found that prices
for top-quality products can vary greatly -- as much as ten
times between different pharmacies -- and that not all of the
cream and gel formulations are of good quality.
These products are available today only from compounding
pharmacies -- that is, pharmacies willing to mix medications
according to physicians' instructions, as opposed to only
dispensing medications in prepared forms. Relatively few
pharmacies will do this, but some of them can ship mail
order, so the products are available anywhere in the U.S.
Traditionally, few insurance or health plans have covered
compounded medications, but more are beginning to cover
topical testosterone as more patients are demanding it. And
the cost of the cream or gel can be so much less than the
brand-name injectable or patch medications that the co-pay
with the latter may be a comparable out-of- Topical testosterone avoids the need for injections or
patches, and may reduce the large variation in blood level of
the injected medication, which is commonly given once every
two weeks. However, the drug supplied by the cream or gel has
a much shorter half- We talked to Kathy Lammer, Pharm. D., of Women's
International Pharmacy, which has been in business for 13
years and specializes in compounding hormones which are
applied topically in a cream or gel; we were referred to her
by AIDS treatment expert Lark Lands, Ph.D. She told us that
there is no shortage of their product, which can be prepared
in either cream or gel form, in any concentration from 1 to
100 milligrams/ In Dr. Lammer's experience, older men who are being treated
for hypogonadism usually use the 25 mg/gm strength twice
daily, while men with HIV often use 50 mg/gm twice daily.
Women use much lower doses, usually the 2 to 5 mg/gm
concentrations twice daily. Men have usually preferred the
gel, which is alcohol based, and women have usually chosen
the cream, which is safflower- The prescriber must be a licensed M.D., D.O., P.A., or N.P.
with a DEA number, since testosterone is a Schedule III
controlled substance; some states require a triplicate
prescription -- an inconvenience for doctors -- but others do
not. There can be up to five refills, but no more since a
prescription for a controlled substance is only valid for six
months; then a new prescription is needed. Most physicians
are not familiar with prescribing topical testosterone; the
prescription can say "testosterone ? mg/gm, apply one gram
twice per day," where the concentration is usually 50 mg/gm
or 25 mg/gm for men, much less for women.
When purchasing testosterone cream or gel, it is important to
choose a pharmacy which has experience compounding this
product. We know of one case where a major pharmacy tried
preparing it, but the drug did not remain properly in the
suspension.
Women's International Pharmacy can be reached at 800-279-5708
(9 a.m. to 5:30 p.m. Arizona time). For additional
information, see its Web site at http://www.wipws.com.
We know of other compounding pharmacies which are also
reputed to have good products. But they are much more
expensive, and we have no reason to believe that they are
better.
Note: UNIMED Pharmaceuticals is developing a form of topical testosterone for FDA approval as a packaged product (not
compounded by the pharmacy). It is unlikely to be available
until at least mid 1999. Probably it will be expensive, but
covered by most health plans.
We believe that environmental and biodiversity organizations
should be aware of topical testosterone, because it might
have a role in saving some endangered animal species. Certain
species are hunted because some elderly men use animal
products to revive lost sex drive. It is likely that they are
suffering from hypogonadism, and that testosterone
replacement would work at least as well as the animal parts,
reducing the killing of endangered species. The cream or gel
formulations may be more readily accepted than testosterone
injections or patches. If this treatment works in these
cases, people would use it if they knew about the
possibility.
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Urgent: Medicaid Rule Changes, Comments Due November 30 |
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What happened is that a Federal law for balancing the budget required Medicaid to rewrite its rules; 500 pages of new rules on Medicaid managed care were produced. Many of the changes are good, but nowhere do they acknowledge the existing Federal documents which establish a standard of HIV/AIDS care. AIDS advocates believe that the best approach now is to get the new rules to acknowledge the Federal standard, instead of going through the 500 pages to try getting changes piecemeal. While these rules will only apply to Medicaid managed care, they will be persuasive for other programs. Public comments are due by 5:00 p.m. Monday November 30 in Baltimore. An original and three copies must be delivered, not emailed or faxed, so usually they would need to be shipped by November 27. More information, including how to submit comments, is being sent to Project Inform's Treatment Action Network, and will be posted on the Project Inform Web site, http://www.projinf.org. If it is not on the site when you need it, or if you do not have Web access, you can call Anne Donnelly at Project Inform, 415-558-8669 ext. 208. |
Health Insurance: New NAPWA Guideby Tadd Tobias |
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The book includes understandable explanations and practical examples of the various provisions of this legislation. It also describes the law's major limitations. HIPAA does nothing to provide access to health insurance for people who have none, nor to insure that coverage is affordable. The good news is that HIPAA does mandate uniform and equitable treatment of all plan members regardless of health status, medical condition, claims experience, receipt of health care, medical history, genetic information, evidence of insurability, or disability. The guide includes information on pre- HIPAA is federal legislation but states have flexibility in
how it is implemented. This means that states will vary in
their approach to health insurance. The Institute for Health
Care Research and Policy at Georgetown University Medical
Center has researched these variations for all 50 states, and
has now posted guides for 45 states on their web site,
http://www.georgetown.edu/research/ihcrp/hipaa. If you do not
have Internet access, the Information and Referral Service at
NAPWA will mail or fax your state's guide to you.
For a free copy of Protecting Your Private Health Insurance, How the Health Insurance Portability & Accountability Act of 1996 (HIPAA) Could Help You! contact the Information and
Referral Service at the National Association of People With
AIDS (NAPWA), 1413 K Street NW, Washington, D.C. 20005-3442,
202-898-0414, fax 202-898-0435, or http://www.napwa.org.
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Flu Season Protection: Information on Web |
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It outlines approaches including vaccination, handwashing, avoiding exposure, and drugs which can be used to lessen the severity of the illness.
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Retroviruses Conference: Press Must Register by December 31 or Earlier |
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For more information about deadlines and how to register, see http://www.retroconference.org, or call Westover Management Group, 703-684-4876.
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Medical Marijuana Wins 7 of 7 U.S. Electionsby John S. James |
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Varying medical marijuana measures were on the ballot in
Alaska, Arizona, Colorado, Nevada, Oregon, and Washington.
Five won with majorities between 57% and 59% of the votes
cast on the issue; in Oregon the majority was 55%. In
Colorado, a state court invalidated the election.
In Washington D.C., Congress ordered the local government not
to count the votes -- possibly the first time in U.S. history
that an election result has been kept secret. The votes were
tabulated by machine, but the totals have not been released.
The result is hardly in doubt; an exit poll estimated that
69% of the voters supported the measure, vs. 19% opposed and
12% not voting.
In California, medical marijuana was not on the ballot this
year. But its archenemy, Republican Attorney General Dan
Lungren, was defeated by a large margin in his race for
governor. His deputy, running to replace him as attorney
general, was also defeated.
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Northern California: HIV Advocacy Conference, December 12-13 |
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For more information, call Lisa Schneider, 415-487-3034, or
email lschneid@sfaf.org.
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Free Newsletter Subscriptions Through Medical Practices, Clinicsby John S. James |
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One model for this program is the experience at Marin County Specialty Clinic, which serves many low-income clients and for over a year has provided free subscriptions to AIDS Treatment News to about 200 patients. We ship the issues to the clinic, which mails them to the individuals, so that their names are not given to anyone (the clinic already has them). [We could also mail the issues directly from AIDS Treatment News -- in which case, to maintain confidentiality, the physician's office could give its patients a form which they could send us for a free subscription for themselves or someone they choose, and the medical practice would not need to mail the issues itself.] The group subscription at Marin County Specialty Clinic was funded by grants from pharmaceutical companies -- whose representatives are often looking for ways to help doctors. AIDS Treatment News was not involved in arranging the funding. Medical Director Craig Lindquist, M.D., Ph.D., noted, "We have used AIDS Treatment News to complement our other patient education, and have found it an extraordinarily helpful source of information that can be disseminated on a regular basis. The quality of reporting and the breadth of topics may be unmatched in general HIV publications. We have received many compliments from patients about the program; we have received questions from patients that have arisen from their reading articles in AIDS Treatment News. We have extended subscriptions to community agencies, and to some private practices who do not have the resources for patient education, and the responses have been very supportive. The pharmaceutical companies have also been enthusiastic; they can see that objective information is reaching all patients equally." Any practitioner who wants to know more about how the program was set up at the Marin Specialty Clinic can call Dr. Lindquist at 415-499-7377.
How the Program Works
CommentThe changing demographics of the epidemic have raised
questions about how independent AIDS treatment information
can be supported. Treatment newsletters are never covered by
health insurance, and are finding it harder to rely on out-of- Industry, government, and charitable donations each have
advantages and disadvantages in supporting treatment
information. The best approach may be to fund medical
practices and let physicians choose, instead of funding
specific materials and giving the physicians a take-it-or- Copyright 1998 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. |
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