Date: 13 Aug 1999 10:12:25 From: aidsnews@igc.org Subject: AIDS Treatment News #324 AIDS TREATMENT NEWS #324, August 6, 1999 phone 800-TREAT-1-2, or 415-255-0588 CONTENTS: Diarrhea: New Treatment Option from Shaman International AIDS Treatment Momentum: Interview with Paul Boneberg, Global AIDS Action Network FDA Hearing Highlights Opposition to Dietary Supplement Practices; Written Comments Due August 20 AIDS TREATMENT NEWS Statement for Africa Hearing Statement on Needle Exchange ***** Diarrhea: New Treatment Option from Shaman by John S. James A symptomatic treatment for watery diarrhea, extracted from the sap of a tree in the Amazon rain forest which has been used for centuries for diarrhea, has been made available starting August 1 through the Web site of Shaman Botanicals in South San Francisco, California. Originally developed as Provir(TM), or SP-303, by Shaman Pharmaceuticals, it was tested in clinical studies involving about 1,200 people with AIDS or HIV (about 25% of whom received a placebo). However, the company did not have the money to complete the trials required for FDA approval--requirements which changed after the trials had begun, due to the FDA's experience with other drugs--so it formed Shaman Botanicals to market a similar formulation under nutritional-supplement regulations instead. This product, called "Shaman Botanicals--Normal Stool Formula," is believed to work by a different mechanism of action than other diarrhea treatments; and the clinical trials suggest that the effect is seen within four days for AIDS-related diarrhea (two days for travelers diarrhea). Extensive information from the clinical trials is available on the Web site, below. As of August 2, 1999, the cost is about $3.60 per day for the recommended adult dose (one tablet every six hours), depending on quantity ordered. At this time the minimum order costs $58.45, including shipping and handling. Because this product is not approved as a drug by the FDA, health plans may not reimburse it; but Shaman is starting to work with health plans, and says that they are increasingly willing to pay for supplements which are supported by clinical data. Shaman Pharmaceuticals has collected an extensive library of medicinal plants, and plans to develop treatments for diabetes and other conditions, based on traditional remedies. At this time, only the diarrhea product is being marketed-- and it is only being sold through the Shaman Botanicals Web site. For more information, or to place an order, see http://www.shamanbotanicals.com . Comment AIDS-related diarrhea remains a serious problem for many people--either from unknown causes (when no parasite or other obvious problem can be found), or from drugs like nelfinavir that patients may need to continue using despite this side effect. The significance of the Shaman treatment is: (1) The active ingredient has been clinically tested for AIDS-related diarrhea, and appears to be safe and effective (although the FDA would have required more evidence for approval as a drug); (2) While the mechanism of action is not entirely known, it appears to be different from that of other diarrhea remedies, reducing the abnormal flow of water into the gut--providing a new treatment option which might work when the other treatments have been unsatisfactory; and (3) Because it seems to work quickly, it easy and not too expensive to find out if this treatment is helpful. Note: We would like to hear from anyone who tries Shaman Botanicals--Normal Stool Formula, on how well it has worked, or not worked, for them. Contact us at jjames@aidsnews.org, or 415-861-2432. ***** International AIDS Treatment Momentum: Interview with Paul Boneberg, Global AIDS Action Network by John S. James Recently there have been extraordinary developments in laying the groundwork for making AIDS prevention and treatment more widely available throughout the world. Now it is up to everyone involved to help make sure that these possibilities become real. The July 14 announcement that a simple treatment with nevirapine could greatly reduce mother-infant transmission-- even if the woman first receives medical care only during labor--was widely reported (see AIDS TREATMENT NEWS #323). Also, the U.S. is significantly increasing funding and commitment to international AIDS programs, for the first time in many years--and for the first time, is planning to include access to treatment, especially for opportunistic infections and tuberculosis. In addition, the campaign to raise awareness of the problem of patented drugs being priced out of reach of developing countries continues to be extraordinarily successful (see "Congressional Hearing on U.S. Role in Global Epidemic," below). Here we ask Paul Boneberg of the Global AIDS Action Network (GAAN) to give us his perspective on current U.S. political changes. Paul started one of the earliest AIDS organizations, Mobilization Against AIDS, in 1984 in San Francisco; MAA fought successfully for greatly increased funding for AIDS research and prevention. In 1994 he left MAA to start GAAN, which moved to Washington in 1995, mainly to work with the Global Health Council, and the National Organizations Responding to AIDS (NORA), on international issues. GAAN has focused especially on the appropriations process, trying to increase U.S. funding for international AIDS programs and to make sure the funds are well spent. GAAN is especially interested in helping existing U.S. AIDS organizations become involved in global issues, in whatever way is most appropriate for each organization. [Note: This writer was a founding board member of GAAN.] The following interview took place on July 29, 1999. Interview with Paul Boneberg John S. James: What are the most important recent changes in the U.S. response to global AIDS issues? New Funding and Commitment Paul Boneberg: There have been several. One is the issue of funding, which is basic because it is so real; if you win on a funding battle, it can drive everything else. U.S. funding for international AIDS programs has not increased significantly since 1993, when President Clinton took office- -although HIV infections cumulatively have increased 300% in that same period. This year we had the first major breakthrough, where both the House and the Senate appropriating committees for foreign operations increased funding for U.S. global AIDS programs by $25 million to $30 million, depending on how you look--a 15% to 20% increase. That is an extraordinary breakthrough, the most significant increase in U.S. recent history, and it will be a model for other nations to increase their assistance as well. It is now virtually certain that this U.S. increase will occur. Also, because of the efforts of Sandra Thurman (Director of the Office of National AIDS Policy, in the White House), the White House has proposed a global AIDS initiative, now at $100 million (this figure includes the $25 to $30 million, above, that is already being appropriated). U.S. international AIDS funding could nearly double next year-- from about $125 million to about $225 million. USAID (U.S. Agency for International Development) programs alone would go from $127 million to about $180 million, and the U.S. Department of Health and Human Services (HHS) would launch programs they are not now doing, about $30 million. This will be for next year; it is not a done deal, and will rely on reprogramming money from Justice, within Defense, and funds that have been obligated but not spent in USAID. There is a very serious commitment in the people I talk to in USAID, the White House, and elsewhere, that there will be a profound increase in funding, above the $25 to $30 million. Some have suspected that the increases in funding are not real, but done for the November 2000 election. While the election is clearly helpful, the fact is that people have worked on this for many years--and that Congress is controlled by the Republicans, and the increases in the House and the Senate certainly are not being driven primarily by the election. And the commitment coming out of the White House is a recognition that it failed to increase funding sooner, and needed to do so. Also, we pushed very hard to make sure that this funding will not come from other health programs, either in foreign assistance or in HHS. There is no way to be sure, until the funds are actually there and nothing has been cut, but certainly we obtained every commitment we could that funds will not be taken from other development programs in USAID, or from other health programs within HHS. People need to see this as real, and as something we need to make as effective as possible--not something that is just fraudulent and therefore does not deserve our attention. James: Where can our readers learn more about this initiative? Boneberg: It is described in a 29-page document, REPORT ON THE PRESIDENTIAL MISSION ON CHILDREN ORPHANED BY AIDS IN SUB- SAHARAN AFRICA: FINDINGS AND PLAN OF ACTION. This report was published by the Office of National AIDS Policy and is available at: http://www.whitehouse.gov/ONAP/ Medical Care in U.S. Foreign Assistance Another huge change is a new commitment to care. For the first time, the United States is saying we are going to spend tens of millions of dollars to get access to drugs for opportunistic infections and other kinds of care, to most of the people in the world with HIV. This is extraordinary; we have never done it before. Until two years ago, the U.S. strategy formally said that basically everything would be prevention, meaning almost entirely condoms. In the last couple years, official policy has allowed support of medical care also, as part of a prevention-care continuum. But recently, GAAN has learned that there are no care programs, except for research into how to do such programs. If you ask officials at USAID about it, they basically say that they are doing care; but when you push them, what they mean is they are testing people for HIV- -but not giving them access to medicines, not providing them nutrients--and when they have such plans, these are for a research setting, not a care delivery setting. The new money, and the new commitment to care, are two huge changes. And they will drive changes within USAID, within HHS, within the White House, Treasury, Commerce, and other departments, as these agencies move forward to work on a broad initiative that will now have lots of money behind it. We are seeing major movement on building infrastrucure, and expanding infrastructure to also include getting drugs into bodies, meaning drugs for opportunistic infections and tuberculosis, and for prevention of HIV infection during childbirth. So far no donor nation has done much on care; the French have mentioned it, but we do not see much money moving forward. For the United States to say that we are going to commit tens of millions of dollars to make drugs available to people with HIV, and to help pregnant women have access to treatment to stop mother-to-infant transmission, is a revolutionary change. U.S. AIDS activists need to help make sure (1) that this happens, and (2) that the money is well spent. Human Rights We also need to understand how HIV care relates to human rights. Medical care for people will usually include testing for HIV. And if you test people, you are putting them at risk, as we know from the murder that occurred last December in South Africa. We need to focus strongly in the next several months on how to make sure that U.S. funding for care reaches people in developing nations in such a way that they can use it safely. We cannot just go into a country and parachute doctors and drugs, and say here are medicines. One of the principal reasons that many women in developing countries do not seek prevention is because of the enormous stigma that is attached to them, their child, and their entire family, if they do. In many countries it is difficult to get pregnant women to seek counseling and testing. And a huge percentage of women who are tested do not come back for the results. The stigma issue is real, and we are hearing from people in developing countries that in many situations it is not safe to be tested. So a human rights component, and reducing the stigma, is key. U.S. activists understand that to make care succeed, to provide drugs and medical care for people, we have to make it safe for them to access care. So far human rights has not been on the official agenda. For example, there was the horrible murder of Gugu Diamini in South Africa in December 1998, after she revealed publicly on World AIDS Day, December 1, that she had HIV. Our conversations with the Department of State indicate that the U.S. ambassador in South Africa said nothing, that the Department of State said nothing, that the White House said nothing, and in fact the highest levels of the Department of State did not even know that the murder had occurred--despite the fact that 20 U.S. AIDS groups wrote, specifically calling attention. So there is a huge problem around human rights and safety of people with HIV seeking care, a problem that those of us who are concerned about getting drugs into bodies need to address. Intellectual Property James: How do you see the new attention to the effect of drug patents on access to treatment in developing countries? Boneberg: It's completely complementary. The less expensively medicines can be obtained, the better. Building infrastructure, training physicians, and making it safe for people with HIV to seek care, is only part of the equation; it does no good if there are no medicines there for people, just as it does no good to have medicines if people will be threatened if they seek care. The two go hand in hand, and build on each other. Those who follow trade issues and are now looking at medical care bring one set of issues and one constituency--and those who work with care from a medical and classical development viewpoint bring another, complementary perspective. It is an extraordinary success that the Health GAP Coalition [http://www.healthgap.org] and others have been able to raise parallel imports and compulsory licensing, the whole intellectual property debate; this is extraordinarily helpful to the efforts to try to get care to people in developing countries. James: How do you see the July 22 hearing in the House on the U.S. role in combating the global HIV/AIDS epidemic? Boneberg: It brought to the highest possible forum, the United States Congress, the issue of access to drugs and intellectual property in AIDS. I wasn't at the hearing, but the presentations I saw in writing were exceptional. My impression is that the bipartisan members of the Committee who stayed for the six-hour hearing thought so as well. I am also told that there was bipartisan praise for Sandra Thurman and her initiative. Again, we see reinforcing agendas, reinforcing support on issues driving toward the same goal, which is getting drugs into bodies in developing countries. I defer to James Love of the Consumer Project on Technology, and to Eric Sawyer, with the Health GAP Coalition, as to what the next step is. We are seeing continuing efforts to clarify the position of the U.S. Trade Representative. I think that office has not gone far enough; that given the wrong position of the United States government on this issue, somebody needs to say clearly that the position was wrong, and that we are going to change it. I think that James Love's analysis, which is that we are seeing good movement but it is not enough, is where GAAN would come down as well. There are two issues. There are the intellectual property issues, what is the policy and what should it be; and then there is the electoral issue of what should the Vice President of the United States say. I think the Administration, the Vice President, has not gone far enough to clarify that the policy has been wrong, and that U.S. intellectual property is not an obstacle, above and beyond the requirements of the World Trade Organization, to getting drugs into bodies in developing countries. And right now, the United States is perceived to be an obstacle, by many people here and in other parts of the world. It needs to be absolutely clear that this is not our country's agenda. There are intellectual-property purists, trade purists, in the U.S. Trade Representative's office and elsewhere, who cannot grasp that there is an extraordinary situation that vetoes their purity. It's similar to the Administration on many levels being unable to recognize that this epidemic is an emergency, like a war. The key to changing is for someone in authority to say that we recognize this as an emergency. Once they say that, their position until now becomes indefensible. If we were at war, and were allied with South Africa, and someone there were making bullets, would the U.S. Trade Representative say to South Africa, "You're stealing our patents for bullets?" In a war situation that would be absurd; of course we wouldn't sue South Africa over patents on bullets, during a war. But we are willing to pressure them in the war against AIDS around patents on medicines. The fundamental fallacy of the Administration's arguments on trade is very similar to its fallacy on why it has not provided funding, why it does not react on human rights, and so on--the Administration has not seen the AIDS epidemic as a crisis equivalent to war. If they saw that, all the other arguments would fall away. The recent hearing was a major success; one cannot get a better forum than the U.S. Congress. The larger points are that the discussion occurred at all, and that it was not driven just by trade purists, it was driven mainly by people who care about Africa, and those who care about AIDS, as well as those who care about trade. James: What can people do now to help on international AIDS issues? Boneberg: Given that large amounts of funding are starting to flow, and given the strong concern among many activists, GAAN urges U.S. AIDS groups to involve themselves in global AIDS issues and projects. The way to do so is to take an area or constituency in which your group is expert, and to try to work on that, either by connecting with people in developing countries, by looking at the policy issues in what the United States is doing, by attending conferences--there are many ways to engage, and now is the time to do so. U.S. government funding alone is likely to almost double in one year, and probably increase dramatically after that. And we are also seeing major funding from pharmaceutical companies and others. In addition, new connections are developing between Southern groups and Northern groups. The time is now for U.S. AIDS groups to engage themselves in reshaping the U.S. global AIDS response. For More Information * You can contact GAAN at globalaids@aol.com; our phone number is 202-667-6300, but email is preferred. * For other information and contacts, see the Health Gap Coalition, http://www.healthgap.org , or the Consumer Project on Technology's page on medicines and intellectual property, http://www.cptech.org/ip/health/sa/ . * A transcript of the Congressional hearing is available at: http://www.house.gov/reform/cj/hearings/7.22.99/index.htm * On August 3, 1999, an excellent 10-page background paper on compulsory licensing and parallel importing was published by ICASO (the International Council of AIDS Service Organizations). Written by Margaret Duckett, "this document aims to provide people with sufficient information to participate fully in the debate, and to help people better understand the potential for advocacy work on these matters in their own countries and with their own governments." Spanish and French translations will soon be available. The English version is at: http://www.icaso.org/compulsory_english.htm ***** FDA Hearing Highlights Opposition to Dietary Supplement Practices; Written Comments Due August 20 by John S. James We attended part of the all-day FDA hearing on dietary supplements (July 20, Oakland, California--see AIDS TREATMENT NEWS #321, June 18, 1999), and were most struck by the vehemence of opposition by many speakers against the relatively free rein given to dietary supplement manufacturers under current laws and regulations. Clear abuses were highlighted (such as labeling a dangerous bodybuilding drug as a "cleaning fluid" to evade the law, selling a testosterone precursor to children seeking athletic performance, and panacea-like claims to mass-market herbal and other supplement products). We could not stay for the handful of industry speakers, but clearly no response would have satisfied many of the panelists. There is a growing movement to impose drug or drug-like safety and efficacy requirements on dietary supplements before they could be sold--appealing in theory, but in practice it could be an effective ban, since our economic system provides little or no incentive or track for development of non-proprietary natural products. Such a change would require an act of Congress, but it could happen unless a more intelligent way can be found to control current abuses--abuses which increase the risk of a drug disaster, with many people hurt or killed by an unsafe product. At an earlier meeting in Washington D.C., industry representatives criticized the FDA for not using its existing authority to crack down on fraudulent or otherwise improper health-food products. Another suggestion at that meeting was to have the National Institutes of Health research the safety and efficacy of these products, perhaps with fees assessed from industry--which might overcome the incentive problem of how to get research done on unpatentable natural products. The FDA is asking for public input on how it should proceed on regulating dietary supplements. The current law, called DSHEA (Dietary Supplement Health Education Act), was largely written by the dietary supplement industry, and passed by Congress after massive public pressure from people who wanted their freedom to buy the supplements they want to use. Our system tends to swing between extremes of liberty vs. control, since people often have mindspace for only one of these sides at a time--so the pendulum could move back to Big Brother, with many supplements unavailable in the U.S. at any price. That would hurt people with serious illnesses, who often try various approaches to find those which seem to give them relief--an intelligent strategy, but one regarded skeptically by many academics and officials. The key issue is how to stop unethical marketing while maintaining public access to supplements that are properly labeled and not unreasonably dangerous. Written comments can be submitted until August 20. If any supplements have been important to you, it would help to let the FDA know of your experience. Then your needs can be taken into account when new regulations or policies are designed. How to Submit Written Comments (Due August 20) Before submitting comments, you might want to check the transcript of a similar meeting in Washington D.C., http://vm.cfsan.fda.gov/~dms/ds-0699b.html . The transcript of the Oakland meeting may be available later, but was not on the FDA Web site when this issue went to press. From the FDA's notice of the meetings: Interested persons may, on or before August 20, 1999, submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may also send comments to the Dockets Management Branch via email to: "FDADockets@bangate.fda.gov" or via the FDA Web site, "http://www.fda.gov". You should annotate and organize your comments to identify the specific issues to which they refer. You must submit two copies of comments, identified with the docket number found in brackets in the heading of this document [Docket No. 99N-1174], except that you may submit one copy if you are an individual. You may review received comments in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday. ***** AIDS TREATMENT NEWS Statement for Africa Hearing by John S. James We did not attend the July 22 hearing of the Subcommittee on Criminal Justice, Drug Policy & Human Resources, on "What is the United States Role in Combating the Global HIV/AIDS Epidemic?" but sent the following statement for the record: In Africa, over 20 million people have HIV and face almost certain death without treatment. All proven HIV treatments are patented, and all are priced far beyond the reach of the great majority of people with HIV. Intellectual-property and trade restrictions are far from the only obstacles to providing treatment, but they are often intractable obstacles, preventing potentially valuable projects from being successful, or even being considered. For the United States to tell so many people around the world that it will continue to use its immense economic power to block them from any chance of saving their lives would be a disaster, in foreign policy as well as in health. There must be a better way. Earlier this year Bristol-Myers Squibb announced a $100,000,000 program for research and for treatment of women in five African countries. We strongly encourage and commend such initiatives. But this program includes no price reform, and if it works as planned, it will deliver treatment to 20,000 people--about one person in a thousand in Africa who have HIV. Ultimately, charity-type programs can go only so far; we also need to develop rules (including trade and intellectual-property rules) that everyone can live with. ***** Statement on Needle Exchange AIDS TREATMENT NEWS sent the following letter to California Governor Gray Davis, on July 30, 1999. We do not usually publish articles on needle exchange, but this letter includes two unusual arguments we want to bring to wider attention. One is that needle exchange programs protect the public by reducing the number of infected needles in circulation. While the reduction of risk from needles which are disposed of improperly may be small, this argument addresses an anxiety which comes from a non-quantitative part of the mind--by providing reassurance that the interests of the public at large are being addressed by needle exchange, not only the interests of intravenous drug users, whom many people dislike. Also note the political-trophy analysis showing why this issue will be viewed differently by history than it is viewed today (in case Governor Davis is concerned about his legacy, as many leaders are). Needle exchange, like medical marijuana, is controversial in the U.S. because it has become a trophy of drug warriors, who need a victory to show that they are potent and winning. In the longer view of history, this trophy dynamic will be largely absent, while the public- health and human-compassion cases for needle exchange and medical marijuana will remain. * * * AIDS TREATMENT NEWS strongly supports AB 518 (allowing needle exchange programs in jurisdictions which choose to use them), and we urge you to sign it when it reaches your desk. The evidence is overwhelming that needle exchange reduces HIV infection, and does not increase drug abuse. The main value of needle exchange is to get people who are using injection drugs into social services and medical care. Also, these programs remove infected needles from circulation, helping to protect the public as well as drug users from risk of HIV infection. Needle exchange programs, when and where they are necessary, can save thousands of lives and many millions of dollars in expenses. They have been controversial mainly because of their sound-bite representation (of government giving needles to addicts). Needle exchange has also become a political football, a trophy of victory or defeat for people who made up their minds long ago, before current evidence was available. When history is written, the sound bites and trophies will be gone, and everyone will see that this indiscriminate prohibition has sacrificed thousands of lives for no purpose. Sincerely yours, John S. James, Editor and publisher, AIDS TREATMENT NEWS. ***** 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 email: aidsnews@aidsnews.org useful links: http://www.aidsnews.org Editor and Publisher: John S. James Associate Editor: Tadd T. Tobias Reader Services: Tom Fontaine Operations Manager: Phillip T. Alden Statement of Purpose: AIDS TREATMENT NEWS reports on experimental and standard treatments, especially those available now. 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