 |
  
|
  |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
AIDS Trestment News
|
Email
Print-Friendly
Glossary
Tenofovir (PMPA) Compassionate Access Study Opens |
|
Because of limited drug supply, priority is currently given to patients with a viral load of at least 10,000, and a CD4 count under 50 (those with a CD4 count of 50 to 200 and documented evidence of an AIDS-defining active opportunistic infection within the last 90 days may also be eligible). For enrollment information, physicians can call Gilead Sciences' Tenofovir Compassionate Access Study, 1-800-276-0231, 8:00 a.m. to 6:00 p.m. Eastern time, Monday through Friday. |
ddI: FDA Approves Once-Daily Dosingby John S. James |
|
Once a day use is important because this drug can be inconvenient to schedule, due to the need to reduce stomach acidity to protect the ddI, resulting in restrictions on food and certain other medicines near the time it is administered. The new dosing may improve adherence, and help patients stay on their therapy longer. |
Adefovir: FDA Committee Votes Against Approvalby John S. James |
|
It is still possible that adefovir could eventually be approved, with new clinical-trial data supporting usefulness in carefully defined situations. We do not know if Gilead Sciences will continue developing adefovir for HIV, or will focus instead on tenofovir (a prodrug of PMPA), which is related to adefovir but appears to be a much better antiretroviral; it is at an earlier stage of development. (Adefovir is also being tested for treating hepatitis B, where it appears to be far more active than against HIV.) Treatment activists have long had mixed feelings on whether adefovir should be approved for HIV treatment; it appears to have modest antiretroviral benefit with risk of serious kidney toxicity in long-term use, but appears to be useful for some patients in certain circumstances. On November 1, the Treatment Action Group (TAG) distributed a 4000-word analysis concluding that it "cannot endorse approval of adefovir at this time." TAG urged continued study for pretreated patients, especially those with the mutation conferring resistance to lamivudine (3TC). It also noted adefovir's "great promise in the treatment of hepatitis B." |
Activism Today: The Coalition for Salvage TherapyInterview with Linda Grinbergby John S. James |
|
One of the problems in HIV drug development is that companies most want to test their drugs on treatment-naive patients, where it is easy to show success -- and least want to test with advanced patients who have already failed multiple antiretroviral regimens, where it is harder to market one-size-fits-all medicine. Also, companies tend to avoid working together with competitors -- a particular problem for patients who have become resistant to many drugs, and need at least two experimental treatments in order to put together a regimen likely to be effective enough to prevent more resistance development. Heavily pre-treated patients are in many ways the most realistic test for a new drug, because any problems or deficiencies are likely to be found early, and drugs which work consistently in this population are likely to be outstanding for other patients as well. But companies typically think short term instead of years ahead. The Coalition for Salvage Therapy came to together in 1998 to advocate for persons with advanced HIV infection and multiple treatment failures; it is seeking better research (especially research with multiple experimental drugs), and also the earliest possible access for patients who most urgently need new treatments. AIDS Treatment News interviewed activist Linda Grinberg of FAIR (Foundation for AIDS and Immune Research) about the CST's current activities, history, and future. James: What is happening now with the Coalition for Salvage Therapy? Grinberg: Our initial focus was primarily directed at Abbott, simply because their new protease inhibitor, ABT-378, was the furthest along in development. After several contentious meetings and conference calls, through the CST's efforts, Abbott finally agreed to our proposal for a limited early access program in 1999, which is now underway. While access has received the most attention, the CST has also worked to convince Abbott and other pharmaceutical companies to do "true" salvage studies -- to conduct clinical research in MDR (multi-drug resistant) patients. Almost three years ago, Abbott had stated that they were not interested in developing another "me too" protease inhibitor, yet they were reluctant to test their drug in MDR patients. We had repeatedly brought up this issue at various meetings over a two year period, and finally this March got the company to agree to do some very small, "proof of concept" trials, in collaboration with Gilead on PMPA and with Trimeris on T-20. We had hoped these trials would begin earlier in order to have some preliminary data on combining these experimental agents, prior to the larger expanded access program, which will begin in January, 2000. Once Abbott agreed to the initial compassionate use program, we shifted our focus to Gilead's PMPA, and were able to secure a limited access program that essentially mirrors the Abbott one. It is also now enrolling. [Note: For more information, see "Tenofovir (PMPA) Compassionate Access Study Opens," above.] James: Who should be credited with leading this effort? Grinberg: Spencer Cox of TAG (Treatment Action Group) started the ball rolling. He initially wrote a letter to Abbott in November of 1998. Abbott's response triggered Dave Gilden and I to convert Spencer's letter into a consensus statement, which we began circulating in November/December of '98, garnering wide endorsements, which ultimately gave birth to the Coalition for Salvage Therapy (CST). Spencer passed the baton to Lynda Dee (of AIDS Action Baltimore) and she has been acting as our ad hoc leader or "point person". There are perhaps 30 to 40 active members of the CST, but much of the "hands-on" work has been done by Dee, Carlton Hogan, Martin Delaney, Ben Cheng, Jules Levin, Mark Milano and others. Everyone's support at meetings and on conference calls has greatly helped this effort. James: What are the current issues in getting the trials we need? Grinberg: In addition to working with Abbott, we've been meeting and dialoguing with Gilead, Trimeris, Pharmacia & Upjohn and others, encouraging them to work together to address the problem of the growing number of "treatment failures" in the U.S. There are now several collaborative protocols on the drawing boards. Our ongoing work is to ensure that such studies start quickly, within the timelines promised, so that we have some real-world data before these drugs are launched in the marketplace. Initially, there was tremendous resistance to early access and salvage studies requiring collaborations, as these companies had no intention of working together. We've managed to push through some of these barriers and convinced several companies to agree to conduct small, "proof of concept" studies. Unfortunately, these studies will be very small, and we have not yet been able to get collaborations using three experimental, multi-class agents, which may offer a better chance at a durable response. We hope to establish a new paradigm, one which will be an important and critical component of all future clinical development plans for all new agents. James: What do you see for the future? Grinberg: In the past, to obtain early expanded access for those in need, we had to start from the ground up and keep reinventing the wheel, forming new coalitions for each new drug -- for example, protease inhibitors, 1592, Amprenavir. With the CST, we have been able to bring together a diverse group of community people, who years ago could not agree on much of anything, to work on protocol designs and criteria for early access to several drugs simultaneously. We have sought consensus on many issues, learning to work together cooperatively to develop a cohesive coalition with a strategy for the future. Most importantly, once a new agent has demonstrated some level of activity and safety, and the optimal dose has been identified, the CST wants the companies to expect, plan and be prepared (with enough drug supply) for early access programs for those unable to construct viable regimens without these new agents. The CST has established a structure, not without some growing pains, but one which will hopefully be ongoing. It is building unity and trust among activists who were formerly at odds, and from my perspective, that's a major accomplishment. James: How can others be involved? Grinberg: The Coalition is open to anyone who wants to participate. There is no formal structure or funding; people volunteer, and help us as they can. Note: If you are interested in participating, contact the Coalition for Salvage Therapy by email at baltoaids@aol.com. |
Durban Conference: February Deadlines, New Track, and Community Programby John S. James |
|
"The theme of the conference, 'Break the Silence,' is an acknowledgment of the many silences which surround and imprison HIV/AIDS -- from the silence of communities which obstruct acceptance and disclosure, to the silence which prevails across nations estranged by colossal inequities and divided by towering debts." DeadlinesThe conference itself is July 9-14, 2000 (with an important community meeting starting July 8); but February 1 is the deadline for abstract submissions, scholarship applications, NGO (non-government organization, i.e. nonprofit) exhibition booth application, and arranging for satellite meetings. (A few late-breaker abstracts will be accepted until June 1, if data was not available in time for the February 1 deadline -- but it is much harder to be accepted as a late breaker than through the regular process.) This year, for the first time, abstracts may be submitted through the Web (if they contain text only). Otherwise they must be sent by mail or courier (not by fax), in time to arrive before the deadline. Also, conference registration fees are reduced if paid before February 1. Five Tracks This TimePrevious international conferences have divided the main program into four tracks:
This year's conference is adding a fifth track:
This track "will explore how policies and programs are created, debated, applied and evaluated. The roles and responsibilities of governments, intergovernmental organizations and the private sector will be addressed." Community ProgramTo add an African flavor, each section of the community program has been named in one of South Africa's eleven languages:
For More InformationFor more information, see the conference Web site, http://www.aids2000.com. The conference can also be reached by email, aids2000@aids2000.com. You can also subscribe to an email discussion list on the conference. To join the list, send email to intaids@hivnet.ch with the word "join" in the subject line. |
Simultaneous Conferences Last Week: Lisbon, Paris, and Kuala Lumpurby John S. James |
|
LisbonThe Lisbon conference has the most immediately important clinical information. Excellent summaries are available on the Web -- see especially:
ParisCent Gardes, a basic science meeting which occurs every two years, is by invitation only; this year it focused particularly on vaccines, and included reports of antiretrovirals as well. Daily summaries and interviews, as well as other information, are available at http://www.centgardes.org (click "Enter Here" for the English version). Kuala LumpurThe International Conference on AIDS in Asia and the Pacific is an Asian regional meeting which covers all aspects of AIDS. It takes place every two years; the previous one was in Manila, the next will be in Melbourne. This year there was relatively little new treatment information, because of the competing conferences in Portugal and France. Over 3,000 people attended; slightly over one third were from Malaysia, and almost all the others were from elsewhere in Asia. The issues we most noticed at Kuala Lumpur were:
The Web site for the Fifth International Congress on AIDS in Asia and the Pacific -- The Next Millennium: Taking Stock and Moving Forward, is at http://www.icaap99.org.my. Malaysian Prime Minister Mahathir on Drug Prices, Compulsory LicensingAccess to Care and TreatmentPrime Minister Mahathir of Malaysia gave the opening address of the conference, including the following section on drug pricing: "The high cost of HIV drugs means that most people in developing countries just cannot afford them. But this high cost need not be so if developing countries can get together and challenge the pharmaceutical companies to reduce the prices or allow compulsory licensing of lifesaving drugs. Compulsory licensing is allowed under the WTO but it is sad to see certain powerful countries aligning themselves with giant pharmaceutical companies to deny developing countries the right to produce cheaper drugs to save the lives of their people. Profit is taking precedent over peoples' lives. "Access to care means not just access to the most sophisticated antiretroviral drugs but also to drugs to treat opportunistic infections. This is possible for many countries. Even if they can't afford the protease inhibitors. "We accept that pharmaceutical companies expend a lot of money on research and need to recoup in order to continue their research. But they should not try to recoup from the sufferings of the poor. The governments of the rich should bear most of the cost of such research. We understand that some countries are never as prosperous as they are now. Surely they can spare some of their wealth to reduce the burden of the poor people in poor countries." |
Flyer for Progressivesby John S. James |
|
The issue of access to treatment in developing countries -- especially access being blocked by government power used on behalf of giant multinational pharmaceutical companies, regardless of the human cost -- seems almost ideal for building strategic alliances between these communities ("almost" ideal because it would help if more AIDS activists were familiar with global issues). In political as well as medical areas, AIDS casts a bright light on fundamental problems which would need attention anyway, even if there were no AIDS. We prepared the following flyer for talks to environmental, labor, and other organizations preparing protests against corporate globalization during the meeting of the world trade ministers in Seattle, November 29 - December 3. It is too late for AIDS to have a prominent place in the protests and public education which will occur later this month in Seattle. But AIDS activists have been remarkably successful in bringing the issue of drug patents, treatment access, and government trade policies into public awareness in the U.S., and progressive activists are interested in this issue, and in how it developed. |
Pharmaceutical Patents and Developing Countriesby John S. James
|
|
Until recently, U.S. policy was almost totally captive to the pharmaceutical industry -- which cares little about marketing drugs in developing countries, since there is little money there, but cares very much about avoiding any precedent, anywhere, which might weaken its intellectual-property protection in the U.S. or other lucrative markets. Many drugs could sell for a tenth or less their current prices if it were not for patent restrictions. The result is that U.S. policy stood firmly in the way of 20 million people with HIV in Africa alone who are facing death -- cutting them off from any hope of medical care which could extend or save their lives. Today, after high-profile protests directed mostly against presidential candidate Al Gore (the major custodian of this U.S. policy toward the Union of South Africa, which has taken the lead in resisting it), the U.S. has moderated its aggressiveness against that country's efforts to expand access to medicine to more of its citizens (when allowed within WTO rules). But this change applies to South Africa only, so protests are continuing -- for example, the October 6 demonstration in Washington D.C. against U.S. Trade Representative Charlene Barshefsky, with 14 arrests -- organized by ACT UP/Philadelphia and others. Capsule HistoryThe GATT treaty has existed for about 50 years, but only the recent incarnation (the Uruguay Rounds, which created WTO) demanded that all countries impose U.S./European style patents on pharmaceuticals. The result is that pharmaceutical executives no longer look the other way if anyone, anywhere, manufactures modern drugs without the permission of the patent holder. Industry pressures the U.S. government to use its great power to force unworkable arrangements on poor countries which cannot possibly afford U.S.-priced medicine, making health solutions impossible and assuring millions of deaths. But the WTO treaty does include some safeguards -- for example, "compulsory licensing," which recognizes the right of a sovereign government to license use of a patent within its borders on terms set by the government (subject to review by the WTO). Therefore most of the protest so far on this issue has not been against the WTO, but against U.S. policy which has gone well beyond the WTO treaty in supporting the pharmaceutical industry's claim that its intellectual property interests come first, before anyone's heath needs. Some are concerned that industry might try to take away safeguards during the next round of world trade negotiations, beginning at the November 29 - December 3 world trade ministers' meeting in Seattle. The Other SideThe pharmaceutical industry argues that what Africa needs most is not drugs but medical infrastructure. In fact, infrastructure varies greatly from place to place -- and intellectual property restrictions are particularly problematic, because they remove many promising public-health options from consideration. And the enormously inefficient U.S. medical infrastructure -- with vast sums spent for gold-plated "marketing," mostly influence buying with physicians, medical journals, influential professionals, and "thought leaders" -- is hardly a model for countries which cannot afford such extravagance. Industry argues that without strong patent protection, there will be no incentives to develop new drugs. In fact, industry does much less medical research than generally believed. But also, when a patient cannot obtain needed drugs at all, no royalty is generated and no research is supported, since no sale takes place. There must be a better way to support medical research than condemning 90% of people who need a drug to death, just to maintain high prices for the other 10%. On May 6 of the year, Bristol-Myers Squibb Company announced that it had committed $100,000,000 to a five-year program to improve AIDS research and treatment in five African countries. We commended them for initiating this program, when most companies do not care. But it's also worth noting that even if this program works perfectly, it will deliver treatment to no more than 20,000 people -- less than one in a thousand Africans living with HIV. The point is that while charitable projects are vital, charity alone cannot treat a whole continent. We also need rules and arrangements (including trade rules) that everyone can live with. What Organizers Can Learn from This IssueLess than a year ago, the issue of pharmaceutical patents and developing countries was nowhere on the radar screen in the U.S.; fewer than a handful of organizers in the whole country were working on it, and almost no one had ever heard about the issue or considered it at all. There was essentially no coverage in any mainstream, specialized, or alternative media. We expected a slow building of momentum through progressive organizations and churches, until eventually there could be mainstream attention. Instead, the issue has moved so fast into the mainstream that there was little time to even inform the progressive community about it. What worked was:
Washington insiders thought this issue had no chance. It has long been fundamental U.S. foreign and economic policy to protect the intellectual property rights of its companies -- with no institutional commitment to avoid killing people in the process. Few thought the public would care much about a complex trade dispute -- or about African lives. Recently when activists went to talk to Congressional aides on Capitol Hill, they found that regardless of ideology, the aides at least knew what this issue was -- a striking contrast to most AIDS and other issues for which far more legislative work has been done. What has been accomplished in the last six months is to put this issue on the table, when it was not on the table before. Thousands of journalists, activists, politicians, and trade or foreign policy experts in the U.S. and around the world now know the problem exists, and some are researching, writing, or otherwise working with it. The FutureWe believe the main focus should be on the central moral issue, rather than on a specific remedy. At the very least, government policy should not create impossible obstacles to saving lives and improving health care around the world. We are looking for workable ideas from any source, certainly including industry. For More Information
Copyright 1999 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. |
This article was provided by AIDS Treatment News. 
 |
 |
The Body: About The Body | Contact The Body | Content Policy | Content Providers | Advertise With Us | Site Map
Remedy Health Media: About Remedy Health Media | Contact Remedy Health Media | Terms of Use | Privacy Policy
The Body is a service of Remedy Health Media, LLC, 250 West 57th Street, New York, NY 10107. The Body and its logos are trademarks of Remedy Health Media, LLC, and its subsidiaries, which owns the copyright of The Body's homepage, topic pages, page designs and HTML code. General Disclaimer: The Body is designed for educational purposes only and is not engaged in rendering medical advice or professional services. The information provided through The Body should not be used for diagnosing or treating a health problem or a disease. It is not a substitute for professional care. If you have or suspect you may have a health problem, consult your health care provider.
