Date: Sun, 12 Feb 1995 20:35:56 -0800 (PST) Reply-To: Conference "aidstreatment" From: "John S. James" AIDS TREATMENT NEWS #216, February 12, 1995 phone 800/TREAT-1-2, or 415/255-0588 CONTENTS: Patent Office Expedites AIDS, Cancer Inventions AIDS, Cancer Patent Priority: Interview with Commissioner Bruce Lehman Human Retroviruses and Related Infections -- Major U.S. Scientific AIDS Conference of 1995, Part I San Francisco Area: Computerized Search for Local Clinical Trials San Francisco: Self-Empowerment in HIV Disease Symposium, March 4 Action Alert: Balanced Budget Amendment ***** Patent Office Expedites AIDS, Cancer Inventions by John S. James The U.S. Patent and Trademark Office (PTO) will now allow AIDS and cancer patent applications to receive top priority review, PTO Commissioner Bruce Lehman told AIDS TREATMENT NEWS on February 3. The new priority applies only if the patent applicant requests it, and the request is approved by the PTO. The new change is not yet well known, even by pharmaceutical companies applying for patents; we believe this article is the first public report. [See interview with Commissioner Lehman, page 4.] The new system allows the applicant for a patent on a treatment for AIDS or cancer to ask that the application be "made special," under rules outlined in the MANUAL OF PATENT EXAMINING PROCEDURE (section 708.02). This special status has previously been available only for patents related to environmental quality, energy, safety of recombinant DNA research, and superconductivity, and in certain unusual situations. Patent examiners are instructed to give these "special" applications top priority, not only initially, but also in all subsequent actions while the application is pending. Biotechnology patents now take an average of about 21 months from the time of filing until they are granted or rejected. The new rule will be important in cases where a drug developer or other inventor has a high-priority invention and wants to move it quickly. This will not only speed the development of the drug in question, but can also facilitate discovery of other treatments as well, since companies often keep their research secret until the patent is granted. But the public should realize that many medical patents are deliberately delayed by the companies that apply for them -- and the new rule will not help in this case. Why would anyone purposely slow their own patent application? The reason is that if the patent is granted years before the FDA approves the drug for marketing, the 17-year patent term will start running, and by the time the FDA approves the drug or medical device, part of the 17 years will have already expired. The company must APPLY for the patent early, to avoid a competitor applying first; but it may not want to RECEIVE the patent until later. As a result, information important for medical research and for patient care can be withheld for long periods. This problem should be reduced in the future, because of the new implementing legislation for the GATT treaty (the General Agreement on Tariffs and Trade), recently approved by Congress. Under the new law, the U.S. patent term will follow the international standard of 20 years from the date of filing, not 17 years from the date of issuance; this provision will take effect on June 8, 1995. There will be less incentive to deliberately delay pharmaceutical patents filed after that date. ***** AIDS, Cancer Patent Priority: Interview with Commissioner Bruce Lehman by John S. James On February 3 AIDS TREATMENT NEWS interviewed Bruce Lehman, Assistant Secretary of Commerce and Commissioner of Patents and Trademarks, in his office near Washington D.C. We had requested the interview to discuss proposals for giving priority to inventions for serious or life-threatening illnesses -- a recommendation most recently made by the National Task Force on AIDS Prevention, at its January 19 meeting. We did not know until the interview that the PTO had already gone ahead and implemented the rule, though only for AIDS and cancer. The patent system, while exceedingly important for medical research, has long been neglected by the AIDS community. But the PTO on its own has made important changes. It made AIDS patents available free through the Internet (see AIDS TREATMENT NEWS #210). On December 21, 1994, it issued new guidelines to prevent some patent examiners from requiring clinical trials before a new drug could be patented, after complaints from biotechnology companies (which usually need the patent in order to raise money to run the trials). And now it has made AIDS and cancer patent applications eligible for priority review. The following interview with Commissioner Lehman is important for companies, for AIDS and cancer researchers, and for treatment and policy activists alike. ATN: The National Task Force on AIDS Drug Development recently recommended that "drugs involved in the diagnosis and treatment of serious or life-threatening disease should undergo an expedited review process by the Patent and Trademark Office." Do you have any plans for priority review of these applications? Lehman: We have already established a policy inside the Patent and Trademark Office to allow applicants to apply for expedited handling of inventions related to therapies for AIDS-related illnesses, and for cancer. We have also made all of the AIDS-related patents available on the Internet. Eventually all of the patents will be available in the same manner, probably in about six or seven years. ATN: On the rapid review, the FDA has special procedures for "serious or life-threatening illnesses" -- including heart disease, diabetes, Alzheimer's disease, and others. Could the patent office allow special priority for all these illnesses, instead of limiting it to AIDS and cancer? Lehman: Keep in mind that there are many priorities in the patent system, which is an engine of economic growth for the country. So it is not easy to establish these priorities; it is a serious matter. Frankly it is not something we hear a huge clamor for, from the biotechnology and pharmaceutical industries. There is a reason for that; speeding patent applications is vastly different from speeding up regulatory review. By and large biotech companies are quite happy with a LONG pendency of the patent -- precisely because of its linkage to regulatory review. We can get the patent out as soon as six months after the application comes in, but then the companies may have to undergo years of clinical testing before they can sell the drug. Often companies do NOT want us to issue the patent -- because under the old law, you had 17 years from the issuance of patent for a patent term. So your term is running while you are going through regulatory review, and companies would rather delay the patent [and avoid losing time to sell their drug under patent protection]. We have just gone to a new system -- 20 years from filing, as opposed to 17 years from issuance. To some degree, that advantage of delay has been eliminated. And we still have patent term extension legislation, which permits you to extend the patent to compensate for regulatory delay at the FDA. The average patent is issued 19 months after it is filed; and the average biotech patent is less than 21 months. So without any expediting at all, the average patent is issued less than two years after it has come into the office, and it is the rare biotech or pharmaceutical invention which would be anywhere near through the regulatory process in that period of time. In that sense, the potential market, for purchasers of the therapy, is not really prejudiced at all [by delays in the patent office]. But often the patent applicant needs to have the patent in hand in order to obtain financing for the extended clinical testing that is necessary. Then they want to get the patent out quickly. It is this category of patent applicants who I think will use the expedited procedures that we now have, and be most benefited by them. Recently we made another change which also relates to treatment development. Last September we had a hearing in San Diego, a major center of the biotech industry, where we invited comment on problems of the industry. Overwhelmingly the number one criticism we heard was that patent examiners were demanding results from clinical testing, as a precondition to demonstrating that the patent had "utility," which is one of the requirements of the patent law. That clearly was a problem that was causing a great deal of dissatisfaction in industry; people thought we were being unreasonable, that it was getting out of hand. So in December I issued new rules where we vastly streamlined that procedure, and made it clear that one did not have to have the actual results of human testing in order to demonstrate utility; instead, evidence such as affidavits of scientists knowledgeable in the area, indicating that the treatment was likely to be useful in human beings, would be enough. That change has been favorably received in the biotech industry, and hopefully it will have a positive impact on research and development in this area, because it will enable people to obtain capital to support the development process. ATN: There is another problem in getting better AIDS treatments developed. Often the patent applicant keeps research findings secret while the application is pending. Apparently they fear that if the application has to be re- filed, somebody else could get in and have an earlier filing date. Lehman: We have addressed that problem. I'm very glad you raised it, because right now our solution is under attack, and people who see the value of our addressing the problem need to let their views be known. One of the differences between the U.S. patent system and all others in the world is that we keep all patents secret until they are issued, while others publish patent applications 18 months after they are filed. This, combined with the old 17- year term from issuance, enabled some applicants to game the system. They could file continuances, etc., to keep the patent bottled up in the patent office for quite a period of time before it issued -- and keep the whole thing secret. In fact, in some cases, they did not market anything; they waited until somebody else got into the marketplace with a product, then they sued them; they let their patent be granted, and then could show that they were in the patent office first -- and we have a first-to-invent system. That is totally counterproductive, because then the patent system has provided no incentive to get to the marketplace with the product, and it has provided a disincentive to the person who did, because they have to pay royalties to the "submarine patent" owner. [Note: The term "submarine patent" refers to a patent application deliberately delayed and kept secret, sometimes for many years, waiting to surface strategically at some later time, with the weapon of its early filing date. This abuse of the U.S. patent system has become a serious problem.] This is the fundamental reason for our shift to the international standard of a 20-year term from filing and an 18-month publication. Also, conforming to the standard will give us advantages in dealing with other countries. The 20- year term is already passed, as part of the GATT legislation. The 18-month publication was introduced but not passed in the last Congress; we hope it will be passed in this one. These changes can have a number of salutary effects. One of them is to speed things up, not slow things down. You want people to get into and out of the patent office with a good, solid patent as quickly as possible, then use that to get to the marketplace to finance the research and development, and get out there with a product. That is the whole function of the patent system. The function is not served when somebody deliberately delays; it is not served when they keep their patent secret indefinitely. The whole reason for the patent system is that in return for getting exclusivity, the right solely to make, use, and sell your invention, you have to fully disclose everything about it, including how to make it, to other people, so that they can go to work on something else and get their own patent that will compete with it. By that you get a leapfrogging effect, presumably accelerating the pace of innovation. It not only stimulates economic activity, in this case it stimulates the creation of new therapies. I think that the patent system, in combination with the best and biggest basic research enterprise in the world, NIH and related government-funded enterprises, are the reasons we have the world's most dynamic and far-reaching medical research industry. But clearly the patent system has had some flaws in it, and this in one that would be addressed. Now Congressman Dana Rohrabacher (Republican, Orange County) is out there doing everything humanly possible to turn this back. He is opposed to 18-month publication, he is opposed to the 20-year term. He has legislation pending in Congress which has 90 cosponsors to reverse our progress, and is trying to work against us in many ways. Members of Congress might be interested to know that there are people who would like their patent to be published in 18 months, who would like people to be incented (given incentive) to get in and out of this patent office, and there are people perhaps whose life may depend on it. ATN: We have found that the procedure to "make special" certain applications is not well known, even among people who are knowledgeable about patents. No one I talked to has known that AIDS and cancer were included. Lehman: We just did it recently, a couple of months ago. One of the things we are trying to do is to beef up our whole public-affairs operation, because I think the whole patent office has been a bit of a secret for quite a few years, and I think we need to change that around. Probably that is not widely known in the industry. There is a whole suite of things we are working on, to make the system work better. There are two sides to this. There are people, like Congressman Rohrabacher, who want to permit people to game the system to make money, as opposed to incenting innovation. And other people are interested in having the most dynamic patent system, where the sole objective is to enable people to get in and out of this office as quickly as possible with a dynamite patent that they can take to the bank, and not to the courthouse, and turn into a product or process that is going to help the consuming public. And then, by disclosure of the invention, encourage somebody else, a competitor, to get out there and have full access to the technology so they can develop their own patent, or at least, the moment that patent term expires, be in there with a competing generic product. ATN: What is Congressman Rohrabacher's argument for keeping the current system? Lehman: His argument is that a long patent term is good, and we should not do anything to shorten patent term, and that there is a possibility that someone will not get the patent out of the patent office in three years, and therefore people will lose patent term. The question of how much patent term is appropriate to incent research and development is a serious question. I think that by and large the 17-year term from issuance in the United States has generally been considered to equate to the international norm of 20 years from filing, as it gives you three years to get into and out of the patent office. Over the years patent pendency in this office has depended on its efficiency and resources available to it. We have just about always been able to get most of the patents out within three years. That is also true of many patent offices in the world. I do not think any case has been made that we need to lengthen patent term beyond what we have right now. Rohrabacher favors the ability to get the longest patent term possible. There are serious consumer and public-interest considerations in that. I am a total, 100 percent believer in the patent system and in intellectual property; I am one of the strongest advocates for the owners of intellectual property rights in the world. But the genius of the constitutional system that we have is that those rights are limited. There comes a point at which the knowledge goes into the public domain to be used by all, and that is the essence of the generic industry, for example, and other industries. Once you have provided the incentive -- and our system provides that -- for getting a fair reward on your investment, then we ought to open it up. Then you have two things going at once: you encourage the development of the generic industry with cheap, older therapies, but you are constantly incenting the production of new innovative therapies, which may cost more for the period that they are under exclusivity, because you have to amortize the investment -- that's the tradeoff. In many cases these new therapies may cost more than a generic older therapy on a per-pill basis, but many times they are much more cost effective, because they are cheaper than hospitalization, the use of medical devices, whatever -- not to mention cases where there are no other therapies, and the alternative is catastrophic for the patient. I think we have a good basic fundamental approach, and I think Congressman Rohrabacher is playing with it, and people do not understand that. Rohrabacher is no more generous to the AIDS community on other matters. He is now going around on Capitol Hill collaring many members of Congress who do not know anything about this issue. In the new environment, there is some mob mentality that if it's a Clinton Administration idea it must be bad. He is taking advantage of that. ATN: On another issue, we are concerned about intellectual property denying access to AIDS care in many parts of the world. When a really effective treatment is found, what about Africa, India, Thailand, Brazil, and other countries, where few can pay U.S. drug prices? What can be done about this -- or is there nothing that can be done? Lehman: Until the signing of the GATT treaty, there has been no patent law in Brazil for example, and in much of the developing world. Any drug invented here can be replicated there for the cost of manufacture. The GATT treaty brought that situation to an end. I think there is a very good rationale for doing so -- lack of patent protection ultimately helps nobody. First of all, it creates higher pharmaceutical costs in the few markets where you do have protection; it means that the cost of development of drugs is borne entirely by the citizens of the advanced industrial countries, particularly the United States. Their drugs cost more so others pay less. Also, lack of patent protection virtually rules out the creation of indigenous, research-oriented pharmaceutical industries in those countries. Some countries are not ready for a research-intensive industry, but certainly Brazil is -- yet they have no research-intensive pharmaceutical industry. They have many diseases that are unique to those kinds of climates, which there is no particular incentive for companies to research. I think it is short-sighted to assume that no patent protection in these countries is even to their benefit. And it disproportionately penalizes consumers in countries like the United States, and reduces the resources available to pharmaceutical innovators to spend money on developing new treatments. The GATT treaty has changed all of that; over a ten-year phase-in, all signatory countries to the GATT treaty will have to start providing full protection to pharmaceuticals the same way we do here in the United States. Incidentally, the U.S. biotech industry thinks the 10-year phase-in is overgenerous; I think it will allow the countries to adjust. Ultimately there are always going to be poor countries in the world that cannot afford anything. Many countries in Africa cannot even afford generic drugs, much less research- intensive ones. That is why we have the World Health Organization, and various aid programs, because ultimately the answer to universal access to any product or service is not necessarily to make it free, so that you have no market, and therefore no incentive. Instead, address the specific problem; identify the group of people who need and should have access, as a matter of public policy. Then provide the funding, usually from a public funding source, to subsidize them and see that they have access. ATN: Often people do not think of the patent system when they think of medical research. Lehman: Some people's eyes glaze over when you start talking about patents and intellectual property; they want to just forget about it. Yet patent protection is fundamentally important to the growth of technology and innovation. It is absolutely at the core of commercialized medical research. Pharmaceutical companies do not make pharmaceuticals, they make patents. That is what they own (except for generic-drug companies). Obviously there is a value to generic drugs, because they are cheap. But if we just had a generic drug system, we would not have a single new therapy; there would not be anything other than what we have out there right now, unless we had some socialized system. We obviously have much government input in basic research, but government does not get the pill into the customer's medicine cabinet without the patent system, which is the critical link. So if the patent system is not working right, we have a problem every bit as fundamental as problems at the FDA or anywhere else. ***** Human Retroviruses and Related Infections -- Major U.S. Scientific AIDS Conference of 1995. Part I. by John S. James With no International Conference on AIDS this year (in the future, that meeting will occur only in even-numbered years), the Second National Conference on Human Retroviruses and Related Infections, January 29 - February 2 in Washington, D.C., with about 2300 people attending, was probably the largest conference on AIDS basic science and clinical trials to occur in 1995. Many felt that this was a better conference than most, with a higher quality of work presented and a more consistent focus on important research issues, reflecting improvements in the research today. There was more sense of optimism, based on a growing understanding of HIV, and growing agreement on some of the important research directions. Lack of access by persons with HIV was a serious problem, however. The conference was expensive -- $425 on-site registration. The absence of corporate advertising booths may have been a welcome contribution to the focused scientific atmosphere, but also meant that the considerable expenses of the meeting had to be paid largely by those who attended. And there were no HIV scholarships, which meant that few people with AIDS could go unless they could register as press. Because many people were not there, AIDS TREATMENT NEWS is expanding its coverage of the information presented. We urge organizers of future AIDS conferences to re-think the entire project in view of the development of computer communication. As much as possible of the information to be presented -- in writing, slides, and eventually video -- should be released on the Internet BEFORE the conference, and made freely copyable so that it will be immediately available to AIDS physicians and other service providers throughout the world. Future conferences will focus less on formal, mass lectures, and more on working groups of people who need to meet face to face to discuss and extend the information already released. Highlights These are some of the areas we found most memorable and important: * Protease inhibitors. This new class of HIV treatments -- not yet widely available to patients -- is getting the most research and public attention today. It is fairly clear that protease inhibitors will be an important advance in AIDS treatment, but will not be the answer. They will need to be used in combination -- with each other, and with other drugs. Their development is one of a number of incremental steps toward better treatment. The new information presented at the conference was about as expected -- neither more nor less optimistic. More information should become available next week at the protease meeting of the National Task Force on AIDS Drug Development. * 3TC plus AZT. This treatment is more widely available, at least to U.S. patients who are failing other treatments. Data from U.S. trials presented at the Human Retroviruses meeting basically confirmed the data from European trials presented in Glasgow last November (see AIDS TREATMENT NEWS #212, December 2, 1994). But as at the Glasgow meeting, most of the data now available is only for the first 24 weeks of the trial, and is only from blood tests; also, there was a fairly high dropout rate from both the European and U.S. trials. And, as expected, the results are less dramatic for people who have already used AZT extensively. The apparent benefit of this combination is not enough to keep skeptics from arguing that it may be no better than other combinations already available; for example, both 3TC plus AZT and ddC plus AZT caused comparable reductions in viral load (almost 10 fold) sustained at least for 24 weeks and perhaps beyond 48 weeks, when they were compared head to head in the same trial. But the general sense is that the AZT plus 3TC combination appears to give better and especially more sustained blood-work improvement than more standard combinations, and probably to be safer as well. * Long-term non-progressors. It is now generally believed that not everyone with HIV disease will eventually become ill. About five percent are "long-term non-progressors" -- defined in one study as persons who have had HIV for at least seven years, have stable CD4 counts over 600, and no HIV- related illnesses. (Although the definition specified seven years, most of the people studied have been HIV-positive and stable for over ten years.) While this information is not new, an important report appeared in the NEW ENGLAND JOURNAL OF MEDICINE on January 26, just before the Human Retroviruses conference -- and the conference seems to have marked a change in the "conventional wisdom" about HIV, the general assumptions that pass unthinkingly into newspaper stories, etc. In the past, the conventional wisdom had been that everyone would probably progress to AIDS eventually. Now the conventional wisdom is that, as far as we know today, about five percent of people with HIV will never become ill as a result. Another study presented at the Human Retroviruses conference used statistical methods to project AIDS-free survival, based on data from the MACS project, which includes a large cohort of men with HIV who have been followed for many years. This study predicted that about 13 percent of people with HIV would be AIDS-free 20 years after they became HIV positive. There is no contradiction between the five percent estimated by one study, and the 13 percent estimated by the other. This is because there are many kinds of long-term survivors, not all of whom fit the above definition of "long-term non- progressor." The 13 percent probably includes the five percent who may never get sick as a result of HIV infection, and others who will develop AIDS but very slowly, after 20 years or more -- unless better treatments are found by then. Neither figure includes another group, who are HIV negative but whose immune systems show that they have been exposed to HIV in the past. This group may have recovered from HIV infection, or may have had a small exposure which did not result in infection. It is clearly important to study all kinds of long-term survivors, to find out what is different about them and/or about their virus. This information might lead to new ways to treat HIV disease, whether or not it has already progressed to AIDS. * Clinical trial design. There were signs of movement toward consensus on this controversial issue -- perhaps more in the hallway conversations and overall atmosphere of the meetings than in the formal sessions on this topic. And it was encouraging to see that seemingly obscure meetings on clinical trials could pack large lecture halls. The general professional opinion is clearly accepting viral load as a useful measure, and wants to see it used in small, rapid trials (the position we have long advocated in AIDS TREATMENT NEWS), while also acknowledging that there is much to be learned about how well viral load reduction translates into clinical benefit to patients. A minority does not argue that viral load is useless, but rather that it is unproven. These people are concerned that we could be making a mistake -- that "treating the marker" (blood test value) may not mean that we are "treating the patient" -- in other words, that the strategy of lowering viral load might not prove helpful. They point to the Concorde trial, which showed that early use of AZT raised the T-helper count but did not lead to longer survival, as an example of the need for caution in judging drugs by blood-test results. They want to see a large trial to test the strategy of changing drugs to lower viral load, compared with changing drugs by other criteria without using viral load, to prove that viral load is superior for this purpose. The practical controversy is between those who emphasize small, rapid, data-intensive trials generally using blood tests, and those who emphasize large, long-lasting trials with "clinical endpoints" -- statistics on how many people progress to more serious illness or death. But a working compromise seems to be developing. Those who want the large trials know that there can be very few of them (because of the limited number of qualified patients, as well as limited money, trained personnel, and other resources); therefore, rapid small trials will be needed to find the best treatments to put into the large trials. And those who emphasize small trials know that large trials will also be necessary, and that these large trials will help to define the appropriate use of viral load and other blood tests for studying new drugs in the future, and for managing patient care. * New immune-function tests. Even with viral load tests in addition to T-cell counts, doctors are missing something important -- measures of how well the T-cells are working. Specialized research tests can measure immune function, but they have been labor intensive, expensive, and inherently imprecise. They are not suitable for widespread use, and even research use can be problematic. Now there is a new kind of immune-function test, based on an "early activation" marker called CD69; this test is becoming commercially available for research use (but not for routine patient care) this month. The new test has many advantages. It uses whole blood at body temperature, greatly simplifying the procedure and leaving the cells in their natural environment, so that the test result will better reflect how the cells behave in the body. The entire procedure takes a few hours, compared to two weeks for earlier methods; only a few minutes of labor is required, and no radioactivity is used. Also, the cells are typed and measured individually, while previous methods gave bulk answers; variations of the technique can even show the production of certain substances, such as IL-2, within each cell. And the new test is inexpensive -- probably well under $100 for reagents and labor. An expensive flow cytometer is required, but many laboratories have one already; they can begin running these tests at little start-up cost, only a few thousand dollars for reagents. The major barrier to widespread use is conceptual; this new technology makes possible many different immune tests, and doctors do not know what tests to order or how to interpret the results. Different patients can have the same disease status by all conventional measures, but have different results on immune function tests, predicting different disease outcomes. As more becomes known, these tests will be used not only to study the pathogenesis of HIV disease, but also to see if treatment or lifestyle changes are correcting the immune defects they find. Much research will be necessary before this technology can become part of routine care; but existing AIDS research organizations, including specialized medical practices, can begin this research now. The Human Retroviruses conference had only one poster involving this technology, which has been developed by Beckton-Dickinson Immunocytometry Systems and is being marketed under the name FastImmune (TM) (see poster #174, "Diminished V-Beta T Cell Subset Responses to Superantigen in HIV+ Individuals as Determined by Multiparameter Flow Cytometry," VC Maino, JJ Ruitenberg, MA Suni, L Mole, and M Holodniy; also see abstract #504A from the Yokohama conference, "Rapid Flow Cytometry Detection of T Cell Subset Activation in AIDS," by the same research group). We will continue to report on these and other immune-function tests as we learn more about them. [Part II of this article will continue our report from the Human Retroviruses conference.] ***** San Francisco Area: Computerized Search for Local Clinical Trials by Denny Smith The Community Consortium, an organization of HIV care providers in the San Francisco Bay Area, is now offering the use of a computerized data base by which people with HIV can quickly and easily find out about local clinical trials. The project is called "Trials Search," and is a free service to any Bay Area resident. The information offered by Trials Search is the same as that contained in a published directory of trials that the Consortium also produces. But the computer search has the most current information, since new trials are available as soon as they are entered, while the printed directory is only published several times a year and will not have the latest listings. In addition, the results of the search are completely specific to the needs of the inquirer. Information about health history and current lab work, especially the CD4 count, is entered into the computer. That data is then compared to the sometimes complicated entry criteria of all local clinical trials, and the resulting printout matches the patient with those trials for which he or she eligible. Our own experience has shown that the search can winnow out interesting trials that a visual scan of the hard-copy directory might miss. To obtain copies of the questionnaire for Trials Search, or the DIRECTORY OF HIV CLINICAL TRIALS IN THE BAY AREA, interested persons should call the Consortium office at 415/476-9554. ***** San Francisco: Self-Empowerment in HIV Disease Symposium, Mar. 4 This Saturday afternoon symposium includes talks on viral load tests, and on fatigue. Tarek Elbeik, Ph.D., Supervisor, Virology Research Laboratory, San Francisco General Hospital, will speak on New Concepts in Lab Testing: The New Viral Load Assays, PCR vs. bDNA. And Jon D. Kaiser, M.D., will talk on New Directions in the Evaluation & Management of Fatigue: A Practical Approach. This free public program, Saturday, March 4, from 2:00 to 5:00, is sponsored by Ortho Biotech. It will take place in the Pacific Conference Center, California Pacific Medical Center, 2333 Buchannan St. (at Clay), San Francisco; persons are advised to call 415/922-8971 to reserve a space. Take the 1, 22, or 24 bus lines, or parking is available in the Clay/Webster garage. ***** Action Alert: Balanced Budget Amendment by John S. James The future of AIDS research, prevention, human rights, and care will depend on how well we explain the need to the larger public, and also on how well we establish a grassroots culture in which tens of thousands of people regularly speak out to their elected representatives, the media, and others, as a part of everyday life. Today, if you live in California or one of other 15 states listed below, your calls to one or both of your Senators are especially important; also get friends living in those states to call. The U.S. Senate may vote next week on a "balanced budget" amendment to the U.S. Constitution; the House has already passed it. The bottom line is that a balanced-budget amendment will hurt people who need help, including people with AIDS. Also, the Constitution should not be changed without good reason; the deficit has already been reduced by almost half since 1992, without changing the Constitution; and many economists believe that the Federal government needs the flexibility of deficit spending to help people during recessions, stabilizing the economy in the process. This attempt to change the Constitution is being rammed through before people have a chance to understand the consequences. Call or write your Senators and ask them to OPPOSE the balanced budget amendment. On February 11 the AIDS Action Council listed the following Senators as especially important, because they are undecided or not firm about how they will vote. The vote will be close; if you live in any of these states, call the Capitol at 202/224-3121, ask for your Senator's office, and ask them to vote NO on the balanced budget amendment. [Note: The busy office staff will seldom ask why you are opposed; they just need to get the count of those who call for and against. If the receptionist does ask, you could say that you are concerned about AIDS funding -- or about changing the Constitution unnecessarily.] Alaska: Ted Stevens (R-AK) California: Diane Feinstein (D-CA) Delaware: Joe Biden (D-DE) Georgia: Sam Nunn (D-GA) Iowa: Tom Harkin (D-IA) Kentucky: Wendell Ford (D-KY) Louisiana: John Breaux (D-LA) Maryland: Barbara Mikulski (D-MD) Massachusetts: John Kerry (D-MA) Montana: Max Baucus (D-MT) Nevada: Harry Reid (D-NV) New Mexico: Jeff Bingaman (D-NM) North Dakota: Kent Conrad and Byron Dorgan Rhode Island: Clairborne Pell (D-RI) South Dakota: Tom Daschle (D-SD) Vermont: Jim Jeffords (R-VT) ***** 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 Internet: aidsnews@igc.apc.org Editor and Publisher: John S. James Reader Services and Business: Richard Copeland Thom Fontaine Tadd Tobias 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: $230/year. Nonprofit organizations: $115/year. Individuals: $100/year, or $60 for six months. Special discount for persons with financial difficulties: $45/year, or $24 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. VISA, Mastercard, and purchase orders also accepted. ISSN # 1052-4207 Copyright 1995 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.