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| GATT: A New Target for AIDS Activism |
| From AIDS Treatment News
Contents: GATT and the Gap: How to Save Lives Testosterone Cream and Gel Available; Prices Vary Greatly Health Insurance: New NAPWA Guide Flu Season Protection: Information on Web Retroviruses Conference: Press Must Register by December 31 or Earlier Medical Marijuana Wins 7 of 7 U.S. Elections Northern California: HIV Advocacy Conference, December 12-13 Free Newsletter Subscriptions Through Medical Practices, Clinics
GATT and the Gap: How to Save Lives By John S. James
This year's World AIDS Conference (June 28 - July 3 in
Geneva) chose the theme "Bridging the Gap"--the gap between
the lifesaving treatment advances for about 10% of people
with AIDS or HIV in rich countries, and the other 90% in
developing countries who have no access to modern HIV care.
Despite the hard work of a few, it was clear at the
conference and afterwards that the world as a whole is doing
little about this lack of medical care (see "'Bridge the
Gap?' Or, 'Cut the Crap!'," Project Inform Perspective #25,
September 1998, available at
www.projinf.org/pub/25/gap.html).
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-property restrictions on life-saving and other medications were widely recognized among major industrialized countries, but the system did not care very much if poor countries quietly manufactured patented medicines like AZT without permission when necessary. The patent holders' losses were negligible, since otherwise there would have been almost no sales anyway, as the people and governments who needed the medicines could not afford them and would only have been forced to do without. And these low-cost products took little if any market share in rich countries, since few people pay for expensive drugs out of pocket, and the government health plans, pharmacies, distributors, private insurance, and managed-care companies which do pay cannot use illegally imported medications. (In over 10 years of publishing AIDS Treatment News, we have not heard of any U.S. resident obtaining AZT or any other antiretroviral which was manufactured without authorization of the patent holder--with the possible exception of AZT from a Canadian firm, which was stopped long ago by legal action.) 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. Intellectual-Property Abuses 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. What Can Be Done? 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-class moral issue, like the international campaign against apartheid. But meanwhile, even a far smaller movement could restrain some of the worst excesses, by exposing abuses and forcing debate on the merits. If Federal agencies heard not only from industry, but from churches, doctors and other medical professionals, activists, and others--and from the press as well--much would be different. Below we include some authoritative information sources which activists can use in educating themselves and others. For More Information In our experience, the hardest part of engaging this issue was knowing where to begin. The following can help others get started.
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Search Terms on Pharmaceutical Intellectual Property and World Trade: WTO (or World Trade Organization, www.wto.org) GATT (or Global Agreement of Tariffs and Trade) TRIPS (or Trade Related Aspects of Intellectual Property Rights, which is a section of GATT) U.S. Trade Representative (or USTR; see explanation above) Special 301 (a provision in U.S. law which requires the U.S. Trade Representative to create an annual watch list of countries for possible retaliation for not adequately protecting U.S. intellectual property rights; this year about 40 countries are on the list.) PhRMA (or Pharmaceutical Research and Manufacturers of America, representing about 100 U.S. pharmaceutical corporations, is a major opponent of liberalization on pharmaceutical patent issues; see http://www.phrma.org) Data exclusivity (forbidding the use of data submitted to regulatory authorities--even if publicly available--for approval of other companies' drugs) Compulsory licensing (requiring patent holders to license their rights in an emergency, or certain other circumstances, meaning that others can use the rights and pay a set royalty. The U.S. pressures other countries to end compulsory licensing of vital pharmaceuticals for their citizens--but meanwhile within the U.S. it provides compulsory licensing of musical entertainment, and of patent rights in other business contexts. In both cases, the government is responding to pressure from corporations, which insist on workable arrangements within the country, but are unmoved by the sacrifice of people abroad.) Turmeric; Neem; and other medicinal plants (on the issue of multinational companies patenting plants which have been used in traditional medicine for centuries. Fortunately these patents are starting to be overturned in the U.S. and Europe, and in the WTO, as Western institutions are finally beginning to acknowledge that the traditional uses claimed in the patents are not original.) Parallel importing (importing authorized patented drugs, originally sold by the patent holder at discount to distributors in large markets who have more negotiating power than many small countries, then resold by the distributors without the patent holder's permission. Parallel importing is related to the doctrine of "exhaustion of rights" of the patent holder by the first sale--which is neither supported nor opposed by GATT). Bolar provision (a provision in U.S. law which allows the use of patented drugs (purchased on the open market) for medical research, without the approval of the patent holder. Generic drug companies can use this law to develop bioequivalent products while the proprietary drug is still covered by the patent, so that they will have low-cost generics ready to go as soon as the patent expires. Some U.S./multinational pharmaceutical companies want to stop other countries from using this strategy to reduce drug costs.) Trade dress (color and appearance of pills or other medicine. By trademarking the appearance, companies can create disincentives to the substitution of generics, because of the risk that public confusion could cause dangerous medication errors.) Medicines and Related Substances Control Amendment (South African law strongly opposed by PhRMA) Nkosazana Zuma (South African health minister, advocate of wider use of generic drugs and other public-health reforms) Other search terms: intellectual property; patent; pharmaceutical; names of specific countries; 1998 (to help select recent articles and Web pages); etc. Conclusion 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-property professional. I asked him what could be done about the effect of GATT on treatment access in poor countries. He seemed concerned, but said that he had never thought of that problem before. Apparently the effect on access to medical care was not a significant part of the discussions establishing today's GATT and the WTO. (GATT seldom mentions pharmaceuticals, and when it does, it lumps them with agricultural chemicals--suggesting that the human consequences for medical care were not carefully considered.) 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. Testosterone Cream and Gel Available; Prices Vary Greatly By Tadd Tobias and John S. James
In issue #306 we reported a nationwide shortage of all
generic injectable testosterone products. Both cypionate and
enanthate forms are now out of stock at many but not all
pharmacies and distributors, and it could take as long as a
year for supplies to be re-established. Brand-name injectable
testosterone products, as well as testosterone patches,
should remain available, but they are much more expensive
than the generic versions, and supplies may be tight at times
because of increased demand due to the unexpected lack of the
generics.
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-pocket expense. 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-life in the body, so it is usually applied twice a day. 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/gram (some pharmacies indicate concentration in percent; 100 mg/gm is 10% testosterone). A one-month supply (60 grams of cream or gel) costs $17.21 regardless of the concentration--a price that Women's International Pharmacy has not raised in 13 years. It comes with a measuring device and instructions on applying one gram twice per day. The source of this company's testosterone is the soybean plant (but it can be used by people with soybean allergies). 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-oil based. In all cases, the usual amount of the cream or gel applied is 1 gram twice per day. Men often apply it to the scrotum, because absorption may be better there since the skin is thin. 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 atwww.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. Comment--Biodiversity 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. Health Insurance: New NAPWA Guide By Tadd Tobias The National Association of People with AIDS has published a guide to your health-insurance rights under Federal law. Protecting Your Private Health Insurance, How the Health Insurance and Accountability Act Of 1996 (HIPAA) Could Help You!, by Jeffrey S. Crowley, M.P.H., and Robin L. Massengale, is a consumer's guide to this federal legislation, which passed after the defeat of the Clinton administration's attempt at comprehensive healthcare reform. The authors note the three main goals of HIPAA are to give people with group coverage new protections from discriminatory treatment, to make it easier for small businesses to obtain and keep health insurance, and to give persons losing group coverage new options for obtaining individual coverage. 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-existing conditions and how they can affect your coverage, enrollment periods and limitations of coverage, and options for persons losing group coverage. It also discusses the tax-free status of accelerated benefits and viatical settlements. It includes a glossary, and listings of state and federal agencies that may be able to answer questions about HIPAA compliance or obtaining health insurance. 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 www.napwa.org. Flu Season Protection: Information on Web
A brochure, "Protecting Your Family from Influenza," is
available at www.apic.org, the Web site of the
Association for Professionals in Infection Control and
Epidemiology, Inc. It is written for the general public, not
specifically for persons with HIV.
It outlines approaches including vaccination, handwashing, avoiding exposure, and drugs which can be used to lessen the severity of the illness. Retroviruses Conference: Press Must Register by December 31 or Earlier
All press covering the important 6th Conference on
Retroviruses and Opportunistic Infections (January 31 to
February 4 at the Sheraton Chicago) must register by December
31 (and before press registration fills, which may be
earlier). Any physicians or researchers who want to go but
have not already registered should do so immediately. Even
though the conference was expanded last year, there will not
be enough room for everyone who should go.
For more information about deadlines and how to register, see http://www.retroconference.org, or call Westover Management Group, 703-684-4876. Medical Marijuana Wins 7 of 7 U.S. Elections By John S. James
Medical marijuana measures were on the ballot in six states
and the District of Columbia, and won in all of them by
substantial majorities. In two cases, legal maneuvers
prevented the election results from taking effect. There were
two other statewide votes to liberalize laws against non-
medical use, and both of them won also.
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. Northern California: HIV Advocacy Conference, December 12-13 A two-day conference on "HIV/AIDS policy and what you can do as a grassroots advocate for people with HIV/AIDS" will be sponsored by the HIV Advocacy Network, San Francisco AIDS Foundation, in San Francisco. The first day will address issues for the 106th Congress, HIV/AIDS and the new California governor, HIV surveillance, partner notification and testing, and responding to the emergency in the African- American community. Day 2 will focus in depth on access to care/treatment, housing, prevention, and community organizing skills. For more information, call Lisa Schneider, 415-487-3034, or email lschneid@sfaf.org. Free Newsletter Subscriptions Through Medical Practices, Clinics By John S. James AIDS Treatment News is starting a program to help physicians and clinics provide free subscriptions to treatment newsletters (ours and others) for patients who want them. 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
Because of our policy of not accepting grants from companies whose products we might cover, AIDS TREATMENT NEWS cannot be involved in negotiating funding from the companies; and we must be paid by the clinic or medical practice, not by the companies. If the clinic can find the funding, we can handle the paperwork to set up the subscriptions. The funding can also pay for the clinic's administrative expenses if necessary.
Comment The 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-pocket expenses from their readers. 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- leave-it choice. 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 E-mail: aidsnews@aidsnews.org
Editor and Publisher: John S. James Associate Editor: Tadd T. Tobias Reader Services: Tom Fontaine and Denny Smith Operations Manager: Danalan Richard Copeland 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: $270/year. Includes early delivery of an extra copy by email. Nonprofit organizations: $135/year. Includes early delivery of an extra copy by email. Individuals: $120/year, or $70 for six months. Special discount for persons with financial difficulties: $54/year, or $30 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. Fax subscriptions, bulk rates, and multiple subscriptions are available; contact our office for details. Please send U.S. funds: personal check or bank draft, international postal money order, or travelers checks. ISSN # 1052-4207 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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