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CONTENTS:
Organ Transplants: Interview with Jeff Getty, on Ending the Exclusion of People with HIV
HIV/AIDS in Prison Project Threatened: Interview with Judy Greenspan, Director
5th Retroviruses Conference in Chicago
Adefovir Dipivoxil (PREVEON(TM)): Expanded Access Restrictions Being Eased
NTZ Submitted to FDA for Cryptosporidiosis
Organ Transplants: Interview with Jeff Getty, on Ending the Exclusion of People with HIV
By John S. James
Since about 1985 persons with HIV have been excluded from consideration for liver, kidney, heart, and other organ transplants--due to outdated information, inertia, and the idea that people with AIDS were about to die anyway so why waste a scarce organ.
In fact, even ten years ago organ transplants to HIV-positive patients worked fairly well--even without any drug therapy to control the virus.(1) Today the treatment and prognosis of HIV infection have changed greatly; but recent studies have not been done because persons with HIV are not allowed to receive transplants. As people are living longer, more deaths are occurring from organ failure, either HIV-related or otherwise. At the same time, perfectly usable organs from HIV-negative gay men are considered high risk and routinely thrown away.
Recently we spoke with Jeff Getty of ACT UP/Golden Gate, who is working to help patients overcome the automatic HIV exclusion and be considered for organ transplantation based on their overall medical situation, as is the case with others who need transplants.
AIDS TREATMENT NEWS: What progress has been made?
Jeff Getty: People with HIV in the United States usually cannot get organ transplants at this time. However there are sites that are doing them. One is the University of California San Francisco Medical Center, with Dr. Nancy Ascher; they are doing liver transplants, but are having problems finding the money, so they can only do a few. The other is the University of Pittsburgh, with Dr. John Fung; they have already done numerous kidney and liver transplants for patients with HIV. But it is hard to get insurance to pay if they know the recipient is HIV positive.
That is the landscape today for organ transplantation in the United States. If you are known to be HIV positive, it is almost impossible to be considered.
ATN: Where is the problem coming from?
Getty: In this country organ donations are coordinated by UNOS, United National Organ Sharing, which has guidelines saying that people with HIV should *not* be excluded from organ transplants. The problem is not with them, but with the 266 regional centers that do organ transplantation in the United States and its territories. They have the rules against people with HIV receiving an organ.
In a couple cases the transplant centers brought in HIV experts to talk to them, and they learned that the disease has changed; this is why two centers are now doing transplants. But in the rest of the country, we are still being excluded based on information about the disease which is five or ten years old. This is what needs to be reformed. We need to get to these committees at the regional centers, and educate them and pressure them to change the rules.
We now know who is making the decisions on whether people with HIV get organ transplantation or not. It comes down from the surgeons. The advisory boards of the various systems, including the Veterans Administration, are made up almost entirely of organ surgeons who know little about HIV.
I am now fighting for three people who have contacted me; two need livers and one needs a heart. It is sad when you lose; and so far progress has been slow. All three of these people have problems with payment. It is very difficult to get the operation, and if you have no way to get it paid for, you are out of luck.
ATN: Do the insurance companies have written policies, or do they exclude people case by case?
Getty: They go to the regional center and try to find the written policy that excludes recipients who are HIV positive.
ATN: So if those centers would change, we would be in good shape to fight the insurance?
Getty: Right. Now we are in a double losing situation. The rules are against you, and the insurance company will always be against you.
If you go to a regional transplant center and they do not know you have HIV, they will test you before you get an organ. And in the case of Gary Bent in New York City, they tested him while he was in a coma, and then left him to die. (For more on this case, see Getty's article, reference below.)
ATN: What does the law say?
Getty: The 1968 Organ Transplant Act, passed by Congress, says that people who need organ transplantation must be informed of their options. The biggest problem we are having is that many people who need organs do not know they do. They might suspect, but they cannot even be evaluated for transplantation because they have HIV; sometimes doctors will tell them that if they were HIV negative, they would be a strong candidate. According to the law, patients are supposed to know their options.
ATN: What else needs to be reformed?
Getty: Despite the organ shortage--600 people a year die in the United States while waiting for livers--when gay or HIV- positive people donate, their organs are thrown away. A paramedic told me that they are trained to look for signs of gayness in a traffic accident or other situations where an organ will be harvested--such as rainbow bumper stickers or gay publications. Even if the donor is clearly HIV negative, the organ will not be used. The regional centers have these policies; and also UNOS will not take gay peoples' organs.
Over a year ago, UNOS promised us in a letter that we can have HIV-positive organs to use for HIV-positive patients. But so far no surgeon has been willing to do that operation-- probably because of the payment issue. What insurance company will pay?
But the other reason we are not getting organs is that transplant surgeons do not know much about HIV and tend to be very conservative.
ATN: What is being done?
Getty: ACT UP/Golden Gate has formed a working group, which I am leading, to try to change the rules in various locations around the country. At this time we are focusing on the larger centers on the West and East Coasts. We are looking for people in other areas to join and help work on this.
In California now the battle is to get MediCal, the state Medicaid system, to consider paying for organ transplantation for people with HIV. If they do, then many of the insurance companies and other payer systems will follow. So we have asked them to reconvene their organ transplant advisory board, the Medical Committee for Anatomical Transplantation. We are insisting that experts on HIV disease and its prognosis be heard on these boards.
We are asking individuals who need organs to get in touch with us, because we are using media on this issue, and need people willing to be interviewed and tell their stories.
For More Information:
For more background see Jeff Getty's 5000-word article, "The Politics of Organ Transplantation: People with HIV Are Left to Die," on the ACT UP/Golden Gate Web site, http://www.actupgg.org.
You can reach Jeff Getty by leaving a message for him at ACT UP/Golden Gate, 415-252-9200, fax 415-252-9277.
References
1. Tzakis AG, Cooper MH, Drummer JS, Ragni M, Ward JW, and Starzl TE. Transplantation in HIV+ patients. TRANSPLANTATION. February 1990; volume 49, number 2, pages 354-358.
HIV/AIDS in Prison Project Threatened:
Interview with Judy Greenspan, Director
By John S. James
Judy Greenspan, director of the HIV/AIDS in Prison Project of Catholic Charities of the East Bay, is widely recognized as a leading authority on HIV/AIDS and correctional policy, and testifies before state, national, and international scientific and government bodies on this topic. She is one of the founders of the California Coalition for Women Prisoners; previously she was AIDS Information Coordinator of the ACLU National Prison Project.
Lifesaving advocacy work for thousands of persons with HIV or AIDS in California prisons will end this year unless the HIV/AIDS in Prison Project in Oakland can find new funding. Although housed in Catholic Charities, the project had been supported primarily by foundation grants, which ended when the foundation changed its direction and stopped funding AIDS policy work.
Judy Greenspan and the HIV/AIDS in Prison Project have been critically important in improving the medical care of the ever-increasing number of California prisoners with HIV:
* Before the current organization was formed in January 1995, Ms. Greenspan worked through the Prison Issues Committee of ACT UP in San Francisco and helped obtain the groundbreaking investigation by the Assembly Public Safety Committee of the California legislature, which exposed appalling medical care at the California Medical Facility at Vacaville (CMF- Vacaville)--improving that institution to the point where it has become a model for prison HIV/AIDS care. This facility now has infectious disease specialists, uses protease inhibitors, has an in-prison hospice, peer education on HIV prevention and care, and pastoral counseling services. The Vacaville medical prison cares for over 500 of the 1,500 known HIV-positive men in California prisons--but none of the 200 known HIV-positive women. It is believed that there are actually several times more prisoners with HIV in California than are reflected in the official statistics.
* Mistreatment of the women with HIV--mostly at the Central California Women's Facility (CCWF) at Chowchilla, the largest women's prison in the country with over 3,600 prisoners--led to a class-action lawsuit with the assistance of the HIV/AIDS in Prison Project, to improve medical care for these women. The lawsuit was settled on August 11, 1997, a few days before it would have gone to trial. But constant monitoring is needed to make sure that improvements agreed to are in fact implemented.
* Another major accomplishment of the HIV/AIDS in Prison Project has been its help in securing a new law to improve the procedures for compassionate release of dying prisoners. There was a law before which sometimes worked, but usually the delays were so long that the prisoner died before the release went through. The new law attempts to expand the number of prisoners who can apply for compassionate release; it has time limits for the Department of Corrections, and allows the prisoner's family to be more involved in the process.
* A critical issue today is the grossly inadequate medical care at Corcoran prison, the newest HIV/AIDS unit maintained by the California Department of Corrections. We interviewed Judy Greenspan about Corcoran and other unfinished work of the HIV/AIDS in Prison Project.
AIDS TREATMENT NEWS: What are some of the problems at Corcoran State Prison today?
Judy Greenspan: The major problem is that Corcoran was set up as a maximum security punishment prison; it was not originally set up as a medical facility. This is the prison that was spotlighted on 60 Minutes, and there has been much information in the local papers about an FBI investigation several years ago. Prisoner fights in the security housing unit yard were set up by guards, gladiator fights where the guards could place bets on opposing gang members, and shoot them. Two years ago there were more shootings at Corcoran than in all the prisons in the country combined. Corcoran is where prisoners are sent when they disobey the rules, or the prison system doesn't like them.
About a year and a half ago the Department of Corrections decided to set up an HIV unit there. But they did not put medical services in place before they brought in men from all over the state.
Then last April, there was an escape at the California Medical Facility at Vacaville; a man climbed down a wall and escaped. He was eventually picked up. But it caused a reaction which has impacted HIV-positive and other prisoners in the state system. The department moved almost all of the "lifers" or men considered escape risks to Corcoran. Now there is an HIV unit of over 200 men there.
Many of them were moved from CMF-Vacaville, where they were receiving very good treatment; most were on triple combination therapy, they were being monitored, and getting their drugs on time; at Vacaville they are watched as they take their pills. At Corcoran their triple combination therapy was not on the formulary, and there were months of delays for them to get on any HIV therapy. At Corcoran they just received a bag of pills, some of which were damaged; many of the men stopped taking them. At least several dozen started going rapidly downhill.
Over Labor Day an HIV-positive man died of a heart attack; he had spent three weeks trying to go to sick hall, and he kept being turned away. There have been more deaths. One man lost 40 pounds. For them to go overnight from good care into a life-threatening situation is outrageous.
Corcoran has a multimillion dollar hospital attached to it. But what the men found was that no matter how sick they got, they could not access the hospital.
One example shows how security is considered more important than care. One of the men who was shipped from Vacaville walked into the institution, but began rapidly deteriorating and losing weight and was in a wheelchair. But as a security measure, no wheelchairs were allowed in the dining hall. It took five days for the prison to figure out how to bring him into the dining hall; three of those days he received no food whatsoever. Corcoran has many problems like that. And there is sewage backup on the tiers, the showers are not equipped for disabled prisoners and many men have fallen, they are not even given enough soap and detergents to clean their toilets. And their special unit does not have a yard, so they are sent into the same yard where there are the fights.
The HIV units tend to house a more responsible, less violent group of men. And yet they are being treated the same as everybody else. Not all of the men in this unit at Corcoran are even maximum security.
ATN: Are you trying to get these men sent back to Vacaville?
Greenspan: Ideally yes. We met with the Director of Operations for California prisons back in December, and basically were told they were not going to move anybody, and certainly they were not going to close the unit. I also met the new director of the Department of Corrections and explained the situation to him.
I have been part of a legal investigative team that has made three visits to Corcoran so far, both to the HIV security housing unit and to the so-called HIV general population. We wrote to the new warden who is supposed to be cleaning things up there, and let him know which prisoners absolutely needed immediate medical care or scrutiny or attention. He ignored the letter, and two weeks later the first prisoner on our list died.
There is no peer education program there, and no pastoral care services to speak of. Two of the nurses the men really liked were just fired, probably because they were too sympathetic to the men.
We presented information about the unit to the California Legislature, specifically to Senator John Vasconcellos' Public Safety Committee, and also to Senator Richard Polanco's Prison Oversight Subcommittee. I testified at a joint hearing, so the legislature sent people to Corcoran. The warden felt he needed to let the prisoners have a grievance committee. But about two months ago he dissolved this committee. Things are back almost to where they were when we started.
It is a time bomb waiting to happen. The HIV unit at Corcoran should not exist.
ATN: What problems have you had due to the political climate?
Greenspan: I have been doing this work for ten years. Prisoners have never been the most popular members of our society. But over the last ten years I have seen the increased legislative and political reaction; many politicians have built their campaigns on the punishment of prisoners. The drug war has tended to demonize poor people of color who use drugs or are addicted, and that is most of the people you have in prison. It is certainly harder to get the attention of the policy makers, who are busy building more prisons. And there is a lucrative prison industry.
We now have a compassionate release law in place, but it is harder to get people out on compassionate release, because nobody wants to look soft on crime.
On many of these issues there would be public sympathy, if we could get the information out to the media. To demonize people, you have to keep them from the public eye, so that the public doesn't know who these prisoners are. One of the first things Governor Wilson did last year was to impose a media ban; it was ratified by the Department of Corrections and is in place. State Senator Quentin Kopp sponsored a bill to end the media ban; it was popular with the legislators, but was vetoed by Governor Wilson.
Wilson's policy takes away prisoners' rights to have face to face media interviews. If I told you there was a prisoner with AIDS who was an activist, leading the struggle at Corcoran, you could not go in and interview him. And he could not write to you confidentially; before, prisoners could write confidential mail to the press. If the prisoner calls you collect, and if somebody from the prison was listening in on the phone, they could stop the call.
The medical care budget for the Department of Corrections has skyrocketed, but most of it funds the bureaucracy, and does not translate into better medical care for the prisoners themselves. The number of prisoners is skyrocketing; women prisoners in California and around the country are the fastest growing population. In California we have a prison population of 156,000; it is still the largest state prison population in the country, although Texas is catching up fast.
ATN: For women prisoners, what was good about the legal settlement on medical care, and what needs to be done to make sure it works?
Greenspan: There were problems with the settlement for the HIV-positive women prisoners. Part of the agreement involved hiring a part-time infectious disease specialist. They have had a part-time specialist who made no difference; he was prescribing two-drug combinations after it was contraindicated by the federal treatment guidelines. He is no longer there, and who knows whom they are going to hire.
A major problem in any prison, but especially at CCWF-Chowchilla, is that everybody's test result seems to be public information. Sometimes women's cellmates knew before they did that they were HIV positive. Once someone who worked in the warden's office went into the computer and printed the list and circulated it. There are few safeguards for confidentiality. Unfortunately the way the settlement was worded made it sound as if the confidentiality breach was coming from the prisoners, rather than from the staff. Confidentiality has to do with policy; it is the staff and the prison administration's responsibility. Women who are peer educators are worried that the implication was that they were not observing confidentiality; they fear that the settlement could make it impossible for their program to continue.
If the settlement is followed, medical care would improve. The problem is the accountability of the Department of Corrections. If you don't continue the public scrutiny, the activism, the support of the women inside, then nothing will change.
There will be a 16-month legal monitoring period. At that time, if things have not improved, the women will see their day in court. Meantime it is up to us, the AIDS activists and prisoners' rights activists, groups like the California Coalition for Women Prisoners, to get the word out about conditions inside the women's prisons.
One of the problems at all of the California prisons except CMF-Vacaville is that when you run out of your protease inhibitor, it takes them two weeks to refill it. But now I have heard from the women inside that they are finally getting these medicines on time; doctors are making sure they do not run out. But there is still a problem with getting medical care when you are sick; there have been a couple of deaths which seem to be due to dehydration related to food poisoning.
ATN: You mentioned "segregation"; does this mean keeping all the HIV-positive prisoners together?
Greenspan: It means keeping the *identified* HIV-positive prisoners together. Every prison does it differently. At Corcoran all the men who are identified are in a certain unit. At CCWF-Chowchilla, the HIV-positive women are basically told that if they do not go to C Yard, they will not get medical care. But there are HIV-negative women in C Yard as well, and because of lack of education, there can be problems. Women want to know if you are HIV-positive or not before you move into their room. You need a statewide departmental policy when you begin to desegregate, you need education.
Usually the prisoners do not want to be segregated. It probably should be voluntary, and based on medical condition, not just being HIV-positive.
The journey to being segregated is a very painful and difficult one. For example, San Quentin is a reception center; it's where you go after trial, if you have been convicted in Northern California. On your trip in, if they find out you are HIV positive, you will be taken out of general population and put in a dorm called H Unit. Sometimes you might be kept by yourself in an infirmary for a few weeks, waiting for a place to open up in this dorm.
At any prison, if you decide to get tested, and are HIV positive, you could be sitting for six to eight weeks alone in the infirmary, with no counseling, no support, waiting to be transferred to an HIV unit. During that time you lose good-time credits, because you are not working. You might have had a great prison job; you probably had visiting privileges. The change can mess up your life. And then you get to an HIV unit, which may not be what you need. Especially if you are asymptomatic, you will not be getting any care.
And this segregation sends a message to the other prisoners that they are OK, they are not in the HIV unit--when many of them have HIV but do not know it.
ATN: What do you need to continue your work?
Greenspan: The HIV/AIDS in Prison Project started with a $50,000 grant, which provided much of our funding for two years. We need to pay salary for a director, and at least a part-time assistant. Also we want to accept collect calls, and send out material.
We would like to do a comprehensive program with advocacy, providing assistance for peer-education programs in the prisons (including education for prisoners ready to be released), and contracting with an attorney for certain legal services which a non-lawyer cannot provide. But our grant applications have not been funded, and now we are out of money.
We could run a minimal program for about $75,000 per year. Smaller amounts would allow us to keep going for the next few months.
During the last six years, fewer and fewer people have been willing to take on prison advocacy, even aside from issues of funding. The danger now is that prisoners will be left with nowhere to turn. We must prevent that from happening.
* Judy Greenspan can be reached at the AIDS in Prison Project, 510-834-5656x3150, or by email to judyg@igc.org. Tax-deductible donations can be sent to Catholic Charities/HIV In Prison, 433 Jefferson St., Oakland CA 94607.
5th Retroviruses Conference in Chicago
The 5th Conference on Retroviruses and Opportunistic Infections, the largest AIDS research meeting in the United States, will take place February 1-5 in Chicago. Since we could not adequately cover the meeting and also produce a newsletter in the same week, we decided to publish this issue early and take more time for our coverage of the meeting. Some Web sites may have daily reports; see below.
At the conference we will be looking for information on:
* New drugs in early human trials, for example PMPA and FTC. (T-20 will not be presented at this meeting.)
* More information about the antiretrovirals now in expanded access and most likely to be approved in 1998: efavirenz (DMP-266), abacavir (1592), and adefovir dipivoxil (bis-POM PMEA).
* Longer followup from ongoing trials of combinations of currently approved antiretrovirals (efficacy and side effects).
* Current medical thinking on what to do after virological failure of initial treatments.
* Any news on the observation that patients have done better than expected clinically, while on certain treatments which no longer fully suppress the virus.
* Drug resistance (not only the viral mutation mechanism which is most talked about, but also entirely different ways that drugs can lose antiretroviral effectiveness).
* Hydroxyurea (there is a whole section on it at this meeting).
* Immune recovery which occurs (or does not occur) after long-term viral suppression.
* Immune markers, immune-based therapies, and vaccines.
* Changing patterns of opportunistic infections when effective antiretroviral treatments are in use.
* Results of treating primary HIV infection.
* Potential mechanisms of action for new drugs (zinc fingers, chemokine/receptor interactions, various gene therapies, etc.)
* HIV-related malignancies.
* Vitamins and nutrition (but there is little of this at the Retroviruses conferences).
After the conference there will be public updates in some cities to explain the most important presentations. Check with AIDS service or medical organizations in your area.
For in-depth information during the conference or later, check the World Wide Web, including:
Note that the official site usually has the published abstracts of all the presentations (including the late breakers); it will also have audio lectures (which you listen to through the Internet, sometimes viewing the slides as well) of keynote talks, review-type lectures, and symposia--but usually *not* of the "slide" sessions or poster sessions, where new data are presented. The unofficial sites have summaries by AIDS experts and medical writers of any presentations the authors consider most important.
Adefovir Dipivoxil (PREVEON(TM)): Expanded Access Restrictions Being Eased
By John S. James
After meeting with advocates for people with AIDS, Gilead Sciences has agreed to remove the CD-4 and viral load requirements for entry into the expanded access program for adefovir dipivoxil (brand name PREVEON, formerly called bis-POM PMEA). This and other program changes must be approved by the FDA; but Gilead is already making exceptions under the current program for persons who are able to obtain either DuPont Merck's efavirenz (SUSTIVA(TM)) or Glaxo Wellcome's abacavir (1592U89), so that they will be able to start two or three new drugs at once, in case of failure of their current treatment.
Adefovir is an antiviral which has shown about a half log median decrease in viral load when used as monotherapy; this is comparable to approved nucleoside analogs, but adefovir may have less viral resistance problem than the other anti-HIV drugs. In laboratory studies, adefovir is also active against many herpes viruses which can be important in HIV disease, including herpes simplex types 1 and 2, CMV, and hepatitis B. It is taken as one tablet once a day. A phase II/III clinical trial is currently underway to determine the best way to use adefovir in combination with other antiretrovirals.
Gilead's proposed modified expanded access program will still require that patients "have failed or be intolerant to combination therapy with at least two commercially available nucleosides and at least one commercially available protease inhibitor. In addition, the treating physician must be unable to construct a viable regimen based on current treatment guidelines and the patient's previous antiretroviral use."
The proposed program may also assign patients at random to either a low dose (60 mg. once a day) or a high dose (120 mg. once a day), in order to collect safety data which may help in the approval of the drug. However this randomization will be voluntary; a doctor who wants the 120 mg. dose for a particular patient can request assignment to that dose.
Gilead has notified physicians who have registered for the adefovir dipivoxil expanded access program about these proposed changes--and that exceptions to the current CD-4 and viral load requirements will be favorably considered for patients starting abacavir or efavirenz.
Note: For more information on either the ongoing clinical trials or the expanded access program, call 800-GILEAD-5.
NTZ Submitted to FDA for Cryptosporidiosis
By John S. James
On January 15 UNIMED Pharmaceuticals announced that it had applied to the FDA for permission to market NTZ(TM) (nitazoxanide) for treating cryptosporidial diarrhea in people with AIDS. The company, which submitted the NDA (new drug application) on December 30, asked for a rapid review, and expects that an FDA advisory committee will consider the drug around May of this year. NTZ is already approved in Mexico.
UNIMED submitted data on over 200 patients in three open-label trials it has conducted, and claims that about 60% of the volunteers improved, with 35 to 45% of them having a greater than 50% reduction in stool volume; these results have not yet been published. A placebo-controlled trial in the ACTG (AIDS Clinical Trials Group of the U.S. National Institute of Allergy and Infectious Diseases) is still recruiting; this trial assigns placebo to half the patients for three weeks, then gives everyone the drug. UNIMED will continue to support this study after drug approval.
Comment
AIDS TREATMENT NEWS has covered NTZ since January 1996 (see issues #239, #250, #258, and #260). To us it has long been clear that, barring any major unexpected safety problem, it should be available. But difficulties in trial recruitment, and technical problems such as diagnosing the parasite in some cases, make it hard to get the kind of clean data that appeals to academics and regulators.
NTZ is a very broad spectrum drug, active against many parasites and bacteria. This is important because it is often hard to identify the specific cause for AIDS diarrhea. Exact diagnosis becomes less critical if the drug is active against more than one microbial cause.
UNIMED has found only a few complete cures of cryptosporidiosis after NTZ treatment. But the first person we knew who used the drug has been cured. He is a physician and had complete flexibility to adjust his dose when necessary, as he was not following a research protocol.
Cryptosporidiosis occurs mostly in the summer, often after heavy rains wash cow manure into municipal water supplies, or from swimming in contaminated pools or lakes. Person to person spread is also very important.
The PWA Health Group, the oldest AIDS buyers' club in New York, is still carrying NTZ.
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