AIDS Treatment News
September 5th, 1997

HMOs and Quality Care for HIV

Interview with Stephen Becker, M.D.
Part 1 of 2

Stephen Becker, M.D., is an HIV specialist in private practice in San Francisco, and also Director of the HIV Intervention Program at Brown & Toland Medical Group, the largest IPA (independent physician association) in San Francisco, with over 1200 physicians. Dr. Becker helped organize the HIV Intervention Program, which is developing standards for HIV care at Brown & Toland, standards required for HMOs (health maintenance organizations) doing business with that IPA.

This interview focuses on HMOs, not PPOs (preferred provider organizations), a different form of managed care which often allows greater choice of physicians and treatments.

Background: Managed Care, and Role of IPAs

AIDS Treatment News: What is happening today in managed care for HIV?

Dr. Becker: The two major trends in where HIV patients receive their treatment are Medicaid, and managed care. That is where the overwhelming majority of HIV patients are treated now. So it is important to understand those systems, and where the logical pressure points will be. If we can be nearly as successful in pressuring the insurance companies, as in pressuring the pharmaceutical industry or the Federal government, we can achieve quality care. The same level of advocacy and involvement will be necessary to bring about the needed changes. The community can learn how to do it successfully; it is just a different group of people to deal with.

ATN: As background for understanding your work on HIV treatment standards at Brown & Toland, can you explain what that organization is, and how it relates to HMOs?

Dr. Becker: Brown & Toland is the name of the recently merged California Pacific Medical Group and the University of California San Francisco Medical Group. Brown & Toland is not an HMO, although some people think that it is. Brown & Toland is an IPA, an Independent Physician Association, that contracts with numerous health plans providing HMO insurance. The major HMOs in the state -- for example, PacifiCare, HealthNet, Aetna, Cigna, Prudential -- have contracts with Brown & Toland, which provides healthcare services to persons covered by the HMOs.

If you are offered health insurance at work, and you signed up with an HMO, you would then select a doctor. The HMO then sends the monthly capitation money to the IPA that the doctor belongs to. If you signed up for me, the money would go to Brown & Toland; with some physicians it would go to a different IPA, for example, Catholic Healthcare West. When a patient selects an HMO they then select a doctor; they thereby select a medical group, and all of their medical services must be provided by that IPA.

ATN: Are some physicians not in IPAs?

Dr. Becker: Today you almost cannot avoid being in an IPA. You could not take care of HMO patients; the administration is too difficult, both for the patient and for the individual doctor. Almost all physicians in San Francisco who accept HMO coverage are in one of several large IPAs.

ATN: How does an IPA start?

Dr. Becker: Usually it has been a group of doctors, with colleagues from hospital administration, who get together and form this organization. The goal is to aggregate doctors in order to contract with the major insurance companies, to bring those patients to the doctors and secondarily to the hospitals.

Standards for HIV Treatment

ATN: And that contract would include standards for HIV care?

Dr. Becker: We are just getting those in place.

As HMOs grew, an organization called the National Committee for Quality Assurance (NCQA) created standard measurements for judging the quality of HMOs. This standard is called HEDIS (Health Plan Employer Data & Information Set). HEDIS defines a list of health-care related criteria, for example for childhood immunization, or Pap smears, or mammograms, that are standards of what must be done. If you do not do well with HEDIS criteria, you will not be successful either as an insurance company or as an IPA. The insurance companies will not contract with you as an IPA; and the government will not look favorably on insuring Medicare or Medicaid patients, if the HEDIS performance of the insurance company is not good.

At Brown & Toland, for the last couple years we have been working to develop HIV-specific HEDIS-like criteria. Examples include, as a minimum standard of care, TB skin test, hepatitis B serology or immunization; we have extended it at Brown & Toland to include viral load monitoring, T-cell monitoring, the frequency of ophthalmologic examinations, and a variety of other more detailed requirements.

ATN: Are these standards publicly available?

Dr. Becker: Yes, both the HEDIS standards and the Brown & Toland HIV guidelines are available.

ATN: What would be involved in getting additional guidelines into HEDIS?

Dr. Becker: Getting new criteria into HEDIS is a very long process. About two years ago NCQA considered adding PCP prophylaxis as a criterion, but they dropped it from consideration. The mechanism needs to be loosened, so that new standards can be put on the list more readily.

Meanwhile, there is no reason that a series of HEDIS-like criteria for HIV disease could not be imposed upon either an IPA or upon an insurance company, if done from a position of strength -- either the patient advocacy community, or physicians, or a combination of the two groups, saying, "We must be assured that your doctors will be doing these minimal things" - including availability of expert physicians.

In San Francisco, the Mayor's AIDS Summit will take place Dec 2, the day after World AIDS Day. The insurance subcommittee for the Summit will be working with the Pacific Business Group on Health, a consortium of the major employers. PBGH has aggregated these big employers and said, we want the following standards; if you (an HMO) want to sell your product to us, all of you must meet the following requirements. Through the AIDS Summit, we hope to develop an equivalent list for HIV which we can get the PBGH to acknowledge and put into force. So besides requiring standards for such criteria as the number of pediatricians, and the mammogram rate, we will say there must AIDS expertise among the panel of physicians, that AIDS experts cannot be excluded simply because their patients will be more expensive. You must have certain standards of care. We will take the U.S. Public Health Service/IDSA 1997 guidelines on opportunistic infection prophylaxis, and the guidelines we have developed on immunization, and say that these are standards, that we want you to put these forward to the insurance companies, and make them do this, in the same way you have made them responsible for women's health or for childhood immunization. At a minimum we will educate this group on things they do not know; and we may be able to raise the minimal standard of quality in HMOs for HIV-infected individuals.

ATN: This would apply only in San Francisco?

Dr. Becker: Yes. But the experience here can be a model for other communities.

In California the pendulum has swung back a little from cost cutting, cost cutting, cost cutting, regardless of quality. Now some of the HMOs know that they have to deliver quality care in order to stay in business. HealthNet is a good example; it is one of the largest HMOs in the state, and had a decidedly anti-HIV posture for many years, until just a couple of years ago. It has had a change in medical directors, brought on an HIV-oriented chief pharmacist, set up an HIV Advisory Committee -- I'm on that, as are Paul Volberding, M.D., John Stansell, M.D., and some of the HIV physicians from Southern California. They are interested in doing it right. We said there will be dual protease treatment -- you have to let us do this, there are people who will need it. Since 3TC, every AIDS drug that has come to market has been on the HealthNet formulary on the day the FDA granted approval. The HMO did the work ahead of time, they read the literature and discussed with us what is the proper use of this drug.

So some of these HMOs have taken to heart the issue of quality. They know it makes more sense to treat people early on, that in the long run they save money.

ATN: This illustrates the importance of doctors getting together; otherwise there could be a race to the bottom.

Dr. Becker: Exactly.

Reimbursement and Incentives

Dr. Becker: Another issue is how reimbursement works. It is important to understand how these dollars flow from the health plan to the medical group and from there to the doctors.

There are basically three payment systems. One, "full risk," is payment at the straight commercial capitation rate. (HMOs divide their coverage into "commercial" and "senior" product; age 65, or Medicare eligibility, is the distinguishing point.) As a general rule, the medical group may get about $50 to $90 per member per month. That must include everything -- primary care, specialty care, laboratory, X-ray, hospitalization, rehabilitation, surgery; the primary care physician will get about $10 per member per month of that.

These amounts are adjusted by age and by sex, but not by severity of illness. This is fine for a healthy person who will seldom come to the doctor, who may come once a year. But if the person has HIV disease, clearly that payment will not be nearly adequate.

If you have HIV disease, clearly those figures are not enough -- unless you have so many enrolled lives, and a sufficiently large healthy population, that those payments can float the cost of care of HIV disease. In some cases that has worked -- there have been enough healthy people that the losses from care for HIV have been offset by the profits from the healthier people.

In the HMO world, the situation I have just described is called a full risk product. Brown & Toland's arrangement with HealthNet, for example, is full risk; it means we are at risk for everything. Starting September 1, we will also be at risk for pharmacy, the cost of drugs -- which previously were just passed through to the payer [the HMO].

ATN: Isn't that an improvement for patient care [since it lets Brown & Toland physicians make prescription decisions, without need for approval of the HMO]?

Dr. Becker: In some ways, yes. But what HealthNet and others have done is passed on the risk. Total drug costs increase about 15% per year. Health plans have not been able to pass on that 15% to the employers. So they make the doctors take more risk -- they give doctors a payment per patient, and we have to manage within that.

ATN: Is that 15% just for HIV drugs?

Dr. Becker: That is the increase for all drugs. It is a lot, each year. Drug cost is the fastest growing segment of healthcare costs.

ATN: The pharmaceutical industry has said that only around 7% of total healthcare costs go for drugs.

Dr. Becker: In our HIV Intervention Program at Brown & Toland, our drug costs are more than 50% of the total costs of care. That is just oral drugs. If you add injections and infusions to oral drugs, about 68% or 69% of the total cost of care for HIV is drug, infusion, or injection costs.

Since the commercial capitation rate will not cover the cost of care for HIV or other major illnesses, HMOs sometimes pay for treatment of these patients through a disease-specific carve-out -- either capitated or not. Very few places have developed an HIV-specific capitation rate. We are trying to develop a fair rate.

Meanwhile, many of the HMO health plans will pay a discounted fee for service for HIV care. For example, you might get $25 or $35 for a routine office visit.

[Part 2 of this interview will look at using an HIV carve-out, and at the economics of treatment by HIV-experienced physicians.]

Retroviruses Conference Deadlines

Community Press, Scholarships, Nov. 3;
Abstracts October 3;
Late-Breakers January 5

The 5th Conference on Retroviruses and Opportunistic Infections will be held February 1-5, 1998 at the Sheraton Chicago Hotel in Chicago. About 3,500 people will be able to register -- 50% more than last year, when many who wanted to go could not attend. The meeting is likely to be full again this year -- and registration will close at the deadlines below -- so anyone who wants to go should mark the important dates on their calendars.

"Registration will be limited to investigators actively involved in the field of HIV. In addition, a limited number of slots have been reserved for: (1) press, (2) community advocates, and (3) senior marketing personnel who provide liaison functions within their companies." This meeting is not open to anyone who wants to attend and pay the registration fee (about $500); therefore, those who want to go must do so through one of the categories allowed.

Community Categories/Deadlines

1. Full community scholarships -- 30 persons (if funding available).

2. Partial scholarships (free registration) -- 30 persons (if funding available).

3. Community press -- about 90 slots reserved. "Community press will be limited to two writers per established AIDS treatment newsletter. A writer may also obtain a letter from an organization (with a newsletter) stating the description of his or her conference writing assignment." Note: "mainstream press" is being handled separately. All press must register in advance, as no one will be admitted at the door. For more information, contact the conference secretariat.

The time line for all three community categories is:

• September 26: Full and partial scholarship applications, and community press applications, will be mailed to more than 100 community organizations, and posted at www.retroconference.org.

• November 3: Deadline for community press and scholarship applications. On November 21, applicants will be notified of the status of their application by the conference secretariat.

Note: This year's Community Liaison Subcommittee has been expanded to five members: Dawn Averitt, Henry E. Chang, Michael Marco, Kiyoshi Kuromiya, and Billy Pick. This Subcommittee is committed to raising funds for the scholarships. You can submit comments, suggestions, or questions to the Community Liaison Subcommittee by email to kiyoshi@critpath.org.

Researcher Categories/Deadlines:

• October 3: Deadline for abstract submission (except late breakers). Abstract dispositions will be mailed November 1.

• November 7: Registration opens for authors with accepted abstracts.

• November 28: Deadline for preferential registration/housing for authors with accepted abstracts.

• December 1: Registration/housing opens for other investigators.

• December 31: Final registration/housing deadline (or when registration reaches capacity at 3,500).

• January 5: Late breaker abstract deadline.

This year's conference is sponsored by the Foundation for Retrovirology and Human Health, in scientific collaboration with the National Institute of Allergy and Infectious Diseases and the Centers for Disease Control and Prevention. The conference secretariat is the Westover Management Group, Inc., 211 N. Union St., Suite 100, Alexandria, VA 22314, phone 703/684-4876, fax 703/684-4841, email info@retroconference.org, home page www.retroconference.org.

DMP 266 Trials Recruiting, Many Cities

Protease Inhibitor Naive

DMP 266, an important antiretroviral now in clinical trials, is an NNRTI (non-nucleoside reverse transcriptase inhibitor, in the same general class as the approved drugs nevirapine or delavirdine). But it is a new kind of NNRTI, and unlike the others in that HIV drug resistance seems to develop much more slowly (although it does occur). So far we have heard good anecdotal reports about this drug.

Other potential advantages of DMP 266, which is being developed by DuPont Merck Pharmaceutical Company of Wilmington, Delaware, are (1) this drug is taken once a day, which should make adherence easier, and (2) so far there do not seem to be the serious supply problems which have occurred with Glaxo Wellcome's 1592 and some other antiretrovirals.

Two phase III trials of DMP 266 are now recruiting. Unfortunately both are open only to persons who have never used protease inhibitors. Both studies last 24 weeks, but the company is providing the drug to volunteers who complete either trial and want to continue.

DMP 266-020

The problem is the entry criteria. Volunteers must have taken some nucleoside analog treatment for at least eight weeks (within 12 weeks before being screened for this trial), but must never have taken any protease inhibitor, nor nevirapine nor delavirdine. They must be asymptomatic, with a CD4 count of at least 50, and a viral load of at least 10,000. Other entry restrictions include: no other experimental drugs for at least 30 days; no abnormal levels of serum creatinine, liver function tests, alkaline phosphatase, bilirubin, or serum amylase; and no below-normal levels of hemoglobin, platelets, or absolute neutrophil count.

Also, this trial does not pay for the nucleoside analog drugs which the volunteer was already on, which need to be continued for the 24 weeks of this study.

DMP 266-020 is now running in: Augusta, GA; Bradenton, FL; Buffalo; Calgary; Chicago (2 sites); Columbus, OH; Fall River, MA; Guaynabo, PR.; Hampton, VA; Lexington, KY; Los Angeles (2 sites); Manhassett, NY; Nashville; New Orleans; New York City (2 sites); Ottawa; Palm Springs, CA; Pittsburgh; Portland, OR; Rochester; Salt Lake City; San Antonio; San Francisco (2 sites); San Juan (3 sites); Seattle; Somerville, NJ; St. Louis; Tampa; and Washington, DC (2 sites).

DMP 266-006

1. DMP 266 plus indinavir;
2. DMP 266 plus AZT plus 3TC; or
3. Indinavir plus AZT plus 3TC.

Volunteers must never have taken any protease inhibitor, nor nevirapine or delavirdine, nor 3TC. They must be asymptomatic or mildly symptomatic, with CD4 count at least 50 and viral load at least 10,000. They must not have taken any antiretroviral within 14 days. Other entry restrictions include: no other experimental drugs for at least 30 days; no abnormal levels of serum creatinine, liver function tests, bilirubin, or serum amylase; and no below-normal levels of hemoglobin, platelets, or absolute neutrophil count.

This study is running at sites in: Augusta, GA; Beverly Hills; Boulder; Charlotte; Chicago; Dallas; Frankfurt, Germany; Houston; Hove, Brighton, UK; Indianapolis; Irvine, CA; Kansas City; Lexington, KY; London, UK (2 sites); Los Angeles; Metairie, LA; Miami; New York City; Newark; Philadelphia; Providence, RI; San Antonio; San Diego; San Juan (2 sites); Seattle; Tampa; Toronto; Tucson; Washington, DC; and West Palm Beach, FL.

For more information, call the AIDS Clinical Trials Information Service, 800/TRIALS-A (TTY for the hearing impaired, 800/243-7012), 9 a.m. to 7 p.m. Eastern time, Monday through Friday; ask about DMP 266-020 or DMP 266-006. Or call the DuPont Merck HIV Clinical Trials Information System, 800/870-8899.

Adefovir Dipivoxil Trials

CD4 100-500, Protease Inhibitor Naive

Two trials of adefovir dipivoxil in combination with other antiretroviral treatments are recruiting in cities throughout the U.S. This drug, taken once a day, has shown modest activity against HIV, and also is known to be active against CMV, hepatitis B, HHV6, and Epstein-Barr virus. Adefovir is believed to be active in macrophages as well as lymphocytes, and to be active against viruses which have become resistant to other drugs. It is important to complete these trials so that if this drug proves helpful in combination treatment of HIV, it can be approved and used.

Both studies last 48 weeks. Since the viral load tests will be analyzed in batches, patients will receive their viral load results after weeks 8, 20, 32, and 48. All of the drugs and tests are free.

Study GS-96/411 -- Antiretroviral Naive

1. adefovir + indinavir + AZT + 3TC
2. adefovir + indinavir + AZT
3. adefovir + indinavir + 3TC
4. adefovir + indinavir + d4T
5. indinavir + AZT + 3TC

Study GS-97/417 -- Protease Inhibitor Naive

1. adefovir + nelfinavir + saquinavir soft gel
2. adefovir + nelfinavir + nucleoside analog treatment
3. adefovir + saquinavir soft gel + nucleoside analog treatment

This trial is running in: Atlanta; Baltimore; Boston; Chicago; Dallas; Greenwich, CT; Long Island, NY; Los Angeles (3 sites); Miami; New York City; Philadelphia; Phoenix; Ponce, PR; Providence, RI; San Francisco; Santurce, PR; Seattle; Tulsa; Washington, DC; and Worchester, MA.

For More Information

Or call the AIDS Clinical Trials Information Service, 800/TRIALS-A (TTY for the hearing impaired, 800/243-7012) 9 a.m. to 7 p.m. Eastern time, Monday through Friday; but note that 800/TRIALS-A lists these trials as FDA 232D and FDA 232E, respectively.

Activism

Virologic Failure;
Managed Care;
Treatment Rejectionists;
Medical Research:
GLMA Achievement Award

On August 23 this writer received an Achievement Award from the Gay and Lesbian Medical Association, at its 15th Annual Symposium in San Francisco. The GLMA, with 1,900 members in all 50 states and twelve countries, provides counseling to HIV-positive medical professionals, publishes the quarterly JOURNAL OF THE GAY AND LESBIAN MEDICAL ASSOCIATION, is active in public policy, and has awarded more than $150,000 to 21 research projects through its Lesbian Health Fund. GLMA, founded in 1981 as the American Association of Physicians for Human Rights, has quadrupled its membership and budget in the last four years. GLMA can be contacted in San Francisco at 415/255-4547, fax 415/255-4784, email gaylesmed@aol.com.

We were asked to speak for ten to 15 minutes, and used the opportunity to address four treatment issues we see as among the most important.

I am honored to receive this Achievement Award. The Gay and Lesbian Medical Association is to be commended for an excellent and important symposium.

AIDS Treatment News depends on you -- medical professionals working in this epidemic. The best information we can publish is what you have learned, what you believe important to get out to those involved with AIDS -- patients, professionals, and others who are friends and supporters.

What are we working on now? Here are four areas that we at AIDS Treatment News are focusing on -- two of them obvious, and the other two often overlooked. We want to hear from you on these four subjects, but also on others as well.

1. What to do in cases where viral load returns after treatment? One part of this question is what are the clinical consequences of virologic failure? We are hearing of many patients who seem to be doing well on Crixivan and perhaps other protease inhibitors, even after viral load returned almost to baseline. Although the viral load is back up, their CD4 count stays high and they are not getting sick. Is this real, or just temporary, or an illusion? Is it possible to devise regimens of available drugs, which still work partially even after multi-drug resistance develops to those agents, because even though the virus is there, the drugs are keeping it weaker in some way, or less harmful? We will find out first from clinical observation and experience, long before getting certified answers from clinical trials.

   In any case, many patients will need new treatments, both antiviral and other. We cannot let up our vigilance on whether research, development, and access are being managed effectively.

2. A second major area is managed care. Can people with expensive illnesses receive quality care in an age of capitation and pervasive pressures to hold down costs? We need much more advocacy in this area, through coalitions including medical professionals, patients, advocates for other illnesses, and seniors, among many others.

3. A third area is what we have called the treatment rejectionist movement -- aggressive organizations, sometimes but not always following the Duesberg ideas that HIV does not cause AIDS, which are now succeeding in getting more and more people to reject all medical care for HIV. People are being told that safer sex doesn't matter because HIV is harmless -- that their doctors are prescribing poisons because they have been corrupted by the pharmaceutical industry -- and that scientists are promoting the belief that HIV causes AIDS, in order to fraudulently obtain money from Congress for AIDS research.

   This ideology has been spread farther and faster than people realize. It is well financed. It is all over the Internet, and so far almost no one has gone to the trouble to answer it there. It has groups in 20 or more U.S. cities, and groups are now starting in other countries. This problem does not get the attention it deserves, because those affected stay away from the medical system, so there is no interaction, and the damage is silent.

   I have talked to believers; many are legitimately seeking a forum for alternative views. But also what is happening here is a religious enthusiasm attached to medical decisions, like that of parents who let their children die of a readily treatable condition because medical care is against their religion. Why would anyone do such a thing? They do it to keep the faith, to remain true to their beliefs. Their faith is so important because it is what holds together a community, a society which is central in its members' lives. In the AIDS example, this in-group includes university professors, at least one lecturer with grace and humor, apparently two Nobel prize winners, effective debaters, and Web sites well designed to look credible. Now it wants very much to get medical doctors involved.

   Why is this problem becoming critical now, at a time when treatments have so clearly improved over what they used to be? Part of the reason is that long ago, when AZT monotherapy was the standard treatment, it did not matter much if people rejected it. But also, those who are believing the treatment rejectionists -- often young people who are newly diagnosed -- are hearing only the most bizarre ideas and theories, since no one is going into their world to support or defend any other.

   One reason why not, is that no one wants to take these people on. A few days ago, a message distributed on the Internet suggested that both I, and Martin Delaney of Project Inform, deserved a firing squad for our work. This message, likely to reach thousands of people, was provoked by our opposition to Duesberg, who spoke in San Francisco recently. We were accused of being among the murderers of a generation of gay men, because we had encouraged use of HIV treatments, leading to the increase in unsafe sex which was recently reported in the news, therefore spreading the epidemic. Notice how the writer so emotionally defended Duesberg, while apparently believing that HIV DOES cause AIDS. What counts is not the ideas themselves, let alone consistency, but the ideas as symbols, evoking the memories of friends who have died, holding together the relationships and cult-like communities which are, for some people, their only important human connection.

   In a free country people can say what they want, and adults must make their own medical decisions. We should not try to stop the treatment rejectionists' free speech. But we must answer them with speech of our own -- point by point, forum by forum, not just in a one-sentence dismissal. If persons who are newly diagnosed hear only the bizarre theories which urge them to ignore modern medicine, and never hear from any other side, then we as a community have let them down. And many will die as a result.

4. Another issue needing attention is how to make medical research and drug development more productive. Here is a project which can bring together advocates for AIDS and other diseases, and many other potential allies.

   An article in NATURE MEDICINE almost two years ago -- "The Slowing of Treatment Discovery, 1965-1995," by Richard Wurtman and Robert Bettiker, both of M.I.T. -- analyzed the huge decrease in major new treatments in the last 30 years, compared with the 30 years before, despite the vast increase in biological knowledge. The authors ask what went wrong. They suggest that today's fundamental approach to government funding of science, which emerged from the atomic bomb development of World War II, does not work as well in medicine as it does in physics, which has a smaller gap between the methods of basic and applied researchers.

   They see the interaction between basic, clinical, and applied scientists as crucial -- but today in drug discovery, the relationship is usually "a disordered one that invariably runs over extended distances and times." They call for a national conversation over the next several years on how to make medical research and drug development more effective.

   The AIDS community, allied with others, could bring critical insights to this conversation, because of its experiences in dealing with some of the real obstacles to effective drug development, everyday practical problems which have been ignored by others. And this project could build needed relationships and coalitions with other disease advocates, countering efforts to divide us.

   Again I thank the Gay and Lesbian Medical Association for the opportunity to speak with you tonight.

   
   
   

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