In many outpatient HIV clinics the medical staff is so poorly funded that over 95% of the cost of patient care goes to drugs and laboratory tests--and less than 5% to physicians, nurses, other staff, clinic overhead, medical records, patient education, adherence monitoring, and other costs of care.

This misdirection of resources results in patients not receiving the professional time and attention they need, and drugs being taken incorrectly, leading to unnecessary drug failure and other medical problems.

Keith Henry, M.D., who recently called for more cautious use of antiretroviral therapy, describes the realities of inadequate funding for medical care, and some needed steps for improvement. Also, we asked him to explain how his clinic has consistently performed leading-edge research without the major funding usually available at research institutions.

One of his major concerns was that in many clinic settings, HAART treatments are not being used properly because of lack of funding for the medical staff. One of several reasons for more judicious use of intensive antiretroviral treatment is to better focus the scarce staff time and make sure that these treatments are managed properly when they are used.

In this interview, we asked Dr. Henry about the problems in medical management at many clinics, and what could be done to make the system work better. We also asked about his impressive record in relevant, published research--which has been accomplished with surprisingly little funding (see "Clinical Research without Major Funding," below).

Dr. Henry is medical director of the HIV Clinic at Regions Hospital in St. Paul, Minnesota, and supervises care for over 400 HIV patients--most of whom are either indigent, or referred to Dr. Henry because of antiretroviral drug failure or side effects.

AIDS Treatment News: What are you learning about management of patients in a large public clinic, issues such as paying for drugs, and paying for care?

Dr. Henry: A study of prisoners(1), presented as a poster by Dr. Margaret Fischl at the recent Retroviruses conference, illustrates the results of a system which is not set up properly.

This study compared virologic outcomes at one year for patients starting antiretroviral therapy in a Florida prison, vs. those starting comparable therapy at a university research clinic, which would presumably select for adherent patients with often better follow-up than seen in a regular clinic.

The prisoners started with a higher viral load and lower CD4 count, which would normally result in worse outcome. But at one year, the prisoners had a markedly better rate of HIV suppression below the detection limit, and also fewer reports of adverse drug effects.

The difference is that the prisoners were on directly observed therapy, so they had close to 100% adherence and used the drugs as they were supposed to be used. In the U.S., it is ironic that prisoners may have more access to supervised use of antiretroviral therapy than people in regular clinics. In our clinic, we try to duplicate the high adherence as best we can. But last time I checked, only 3% to 5% of the total cost per year in our clinic was the support of the staff; the rest of the money was drugs and laboratory tests.

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And little or none of the money spent for drugs goes into the education and monitoring which is essential to assure that these drugs are used properly.

The system needs to be re-designed for overall management, with HIV specialist physicians, nurses, adherence educators, and pharmacists being part of the team, and having the revenue to support their very important efforts.

That's not the way it is happening, except in a few lucky clinics, or institutions that have grants which allow them to do this.

ATN: What are the practical consequences of what's happening now?

Dr. Henry: I am having to see patient after patient who is having side effects from drugs, or other important primary- care issues; these visits are time-consuming.

Yet we also see the patient with more serious problems--who is not doing well from the HIV perspective, sinking if you will, and really needs to have hours of time and lots of resources put into sorting things out before their situation gets out of hand.

They need pharmacists, educators, and even home-care nurses who visit them to make sure that the regimen is taken properly, who stay on top of it. In our clinic, and in many others as well, it is very difficult to get resources to do this.

One of my points about why we should have fewer patients on complex regimens is that you should be able to focus better on the people who need the drugs, and not be basically diverted by concerns of people who maybe do not need to be on the drugs at this time. Then we could use the limited resources and time in a more efficient manner.

The time it takes me to see a patient adequately is increasing. Ten years ago you had an AZT discussion, you discussed treatment of complications, but it was fairly straightforward.

Now there is so much uncertainty, so many options, that I like to give patients many options across a range of treatment philosophies--anywhere from being cautious to being much more aggressive than what current guidelines call for.

We look at what the patient wants to do, what their condition calls for, what the benefits and risks are--that's a long discussion, not 15 or 20 minutes, which is often the amount of time each person "has" with the physician. This discussion usually requires a nurse HIV specialist, if not the medical doctor.

Otherwise, it's hard to do a good job, and have the patient really buy in that they are ready to do the best they can with whatever therapy they choose to use.

Clinic Funding

ATN: How does funding work, or not work, at your clinic?

Dr. Henry: Every year we lose money seeing patients. And last year, ominously, we lost money doing research as well. Generally research has supported our clinical care. But even though we enrolled several hundred volunteers in studies at our clinic, we had a financial loss because the research reimbursements have been ratcheted down.

So the only place we make money is by handouts, or by giving drug-company sponsored talks. That's the only place the money is coming in. The more talks I give, the less time in the clinic. We have a small staff--and when you are away giving talks, it is easy to become disconnected from what is really happening in the clinic.

I'm in a bind because I have to get revenue to cover salaries for nurses and social workers, so I give talks that otherwise I would prefer not to do because they won't accomplish much, just to generate revenue. But I don't have many options now, the way health care is financed today.

ATN: Why does your clinic lose money in patient care?

Dr. Henry: As I mentioned earlier, at least 95% of the cost of HIV care for our patients goes into drugs and laboratory tests. And we get none of the revenue stream for drugs, because the vast majority of our patients get their prescriptions filled at the national chains, or by mail order out of state.

Some places are lucky because they either have a high capitated rate, or the state gives a bonus for HIV with a certain diagnosis. That's not true here in Minnesota; we just get paid low with the managed-care history we have.

I recover less than 50 cents for a dollar we bill for a clinic visit. It's often $30 or $40 dollars reimbursement for a half hour visit with me; and from that we must pay the overhead for the clinic, the receptionist, the dictation system because you're creating a legal document, the heating, air conditioning, secretaries, nurses, and social workers. By contrast, I just had a plumber at my house--$75 for 15 minutes in and out.

Medical centers that see more indigent patients used to get a bonus payment but that is decreasing under the Balanced Budget Act.

Furthermore, our hospital was swallowed up, went from a public hospital to being owned by a managed-care company, without any fanfare. Then the rules become even more complex in how one survives--and there are no advocates looking out for our interests. It's not just HIV care that has these problems.

Adherence Issues

ATN: How is adherence affected?

Dr. Henry: It is very rare that I get a call from a pharmacy that a patient did not pick up their prescription on time--a basic example of how we lose control when decisions are based on cost, and outsourcing the pharmacy. The consequence is that serious medical problems happen all the time.

Yesterday our clinic saw a patient who was not taking the proper dose of their protease inhibitor, after we switched from the liquid Norvir back to the capsules. At first we couldn't understand why their viral load went up with an otherwise good regimen.

Finally, after spending much time with the patient, we learned they were not taking the right dose. A national chain pharmacy did not make the transition right when the patient converted to the capsules.

These kinds of things happen all the time. We get detailed to death, have too many places to call, and don't have enough time in the day to fill out forms and make phone calls and double check on everything.

Somehow the revenue stream, which is heavily lab and pharmaceutical influenced, needs to support the medical care- -at least to assure proper use of the drugs.

A lot of the money flows through the pharmacy--a thousand dollars a month per patient for many of the regimens. There should be a guaranteed education and adherence system with that, absolutely guaranteed.

As it is, we try to provide the drug education and adherence on top of everything else, and then only find out through the back door when it's not working, either because we just happen to discover a problem, or because the patient's response isn't what we expect. And of course we deal with the drug side effects constantly. But none of the money spent on the drugs supports these efforts.

Clinics need to have pharmacy and key laboratory tests linked with the provision of services, part of a whole package. As it is, nobody's paying attention, and very many people are on these difficult drugs. Lots of money is being spent, but education around the drug use is not nearly optimal.

U.S. Treatment Guidelines

ATN: Are the official treatment guidelines helpful?

Dr. Henry: The guidelines do say that care should be managed by an HIV specialist. But people look mostly at the tables in the boxes--that's what gets reproduced endlessly.

The first and most important box in big print should be that the care needs to be managed by a good care system--with an HIV specialist, linked to research, linked to the key specialties including psychiatry, chemical dependency, dermatology, and to good nurses, and pharmacists, and adherence programs.

Resources should go into patient care--not only to pay for drugs from column A and column B. If you don't have your medical management in order, you don't get good results. That's what people are running into now.

Today we deal more with drug side effects than with AIDS complications. It's very time consuming; and you need more specialist support--endocrine, cardiology, dermatology, and others.

The day my article came out I was in clinic, and getting media calls; I had to turn most of them down as I was seeing patients. And my patients were ripping me for side effects. One was unloading on me for 15 minutes because he lost his hair when he started a HAART regimen. He was mad at me for not spending time on hair loss as a possible problem.

Hair loss from HAART is a rare event. He had good points, but I don't have enough time to go through each possible side effect. The patients are starting to expect that.

They deserve hours of our time, if we had it--or a fairly long session with a pharmacist going over each drug in great detail--so there are no surprises. Often this is not possible, because clinics do not have the funding. Usually the pharmacist on clinic is one of the first people to go when the budget gets tight.

When people are spending a lot of money on a condition, they need to realize that the most important part of it is how the care system is set up. The outcomes need to be measured long term.

Recently we were awarded a Ryan White Title III grant for indigent care at our site; they are discussing audits on whether you are in compliance with the DHHS (U.S. Department of Health and Human Services) guidelines as the quality marker.

I think the quality marker should be that the care is supervised by an HIV specialist--who can decide what's in the patient's best long-term interest, which may or may not be the best way to suppress the virus for the next few months.

Sometimes it is better to hold back to wait for better regimens, or hold back to avoid toxicity, or hold back because the risk to get sick from AIDS just seems too low-- and therefore be judicious with the resources, and focus them on people who are in more trouble.

It becomes a self- fulfilling prophesy if you define quality of care as having the highest percentage of patients on certified HAART regimens.

Possible Reforms

ATN: How could the funding stream from public sources be changed so that it might include the HIV care and the drugs in one source, so if you spend less on drugs you could spend more on staff?

Dr. Henry: People tried to cut out the drug part, separated that--so then the capitation has been for the services and staff support. That doesn't motivate people to be cost effective in using the drugs.

The surveys of the percent of people on HAART regimens have been quite high in the U.S. AIDS death and complication rates look good. But I would argue that we might do better by applying really good therapy to people at the highest risk.

An excellent paper by Frank Palella and others is often used to support the value of aggressive therapy(2). But all the patients in that study had a CD4 count under 100. So maybe this study supports cautious use of antiretroviral therapy, starting in late-stage disease, when you get your maximum benefit because you are protecting people against death and disease.

I certainly would not advocate waiting until T-cells were 100. But if we were aggressive not in everybody, but just at the low end, we would end up having fewer people on therapy who perhaps could then be better managed.

Some places benefit from having lots of people on drugs, even when I would think it is somewhat unnecessary. There needs to be a reward system for overall management. This is a challenging topic; I don't have an easy solution.

ATN: Any reforms short-term that would be particularly valuable for your situation now?

Dr. Henry: If sites get Federal or state money for HIV care, their pharmacies should be required to have certain quality features. They should link to the clinic and the care provider. There should be an adherence program built in, and feedback to the people writing the prescriptions, if they are not being picked up on time. It's ridiculous not to have this information. This change would lessen the burden back at the clinic, because we are doing their work now--we know it's so important, so we have to do it, by default.

Requiring an adherence system with a pharmacist/educator is not negotiable, it has to be done. If a site gets Ryan White funding, a system for monitoring adherence should have to be in place. Ryan White would be a good place to start.

ATN: Any suggestions on public advocacy, maybe a focus for activism on the economics of care?

Dr. Henry: With the debate opening up about the best way to use HIV drugs, for each individual this involves dialog with an open-minded HIV specialist, which is time consuming. Access to a good care system is as valuable as protease inhibitors, or having RNA levels available; it is at the top of the list.

In the U.S., it's so easy to get fooled into relying just on technology--new drugs will come along, and new tests, and they will get sorted out. But maybe if we use what we have the best way possible for each person, we can do even better.

I believe we already have excellent opportunities to help each individual patient--but it has to be done very carefully. And careful requires time, time requires money, and today the money is going to pay for the drugs and the lab tests, and not to pay for the time of the team involved with the decisions and the monitoring.

It's hard to ask for more money these days. So you try to ask for the same, but divided up more rationally.

Regions Hospital HIV Clinic

ATN: Could you give our readers a sense of your clinic? How many HIV physicians does it have? What other staff?

Dr. Henry: Our clinic provides primary care to 430 HIV- infected persons and follows many more within research protocols or on a consultative basis. There is another ID physician who does the inpatient care and follows a small number of patients, as well as a family practice physician who provides primary care back up one day per week. There are no other M.D.s.

We have a part-time nurse practitioner who helps with primary care, two nurses who help with the clinic, three to four research nurses, three social workers/case managers, and a data entry person.

Even with a fair amount of grant support, we are losing money; we cannot afford another doctor. We never turn patients away, so our clinic, located in downtown St. Paul, serves a very indigent patient population. We have to spend considerable time addressing housing needs, food, transportation issues, and chemical dependency. These issues dominate many agendas for patient visits.

The other typical patient is a referral, someone who has failed protease inhibitors, or who has metabolic problems. My bias to be cautious is based on the real work I deal with, which involves patients with many psychosocial issues, or referred patients with challenging problems. This is representative of the situation at many HIV clinics.

Major Clinical Research Without Major Funding

A recent AIDSLINE search showed Dr. Keith Henry listed as author or co-author of 143 publications and presentations, many of which have advanced the national understanding of AIDS and its treatments.

We asked Dr. Henry to briefly highlight some of the research to which his clinic has contributed, and indicate how such important work could be done with relatively little funding.

Dr. Henry: I have been lucky to work with many good people and labs at the University of Minnesota and elsewhere that are sometimes in search for projects. We do what I would call translational research, where we see problems or issues develop in our patients and then talk to people in the labs and see if we can teach each other something. Also I have been fortunate to work with the AIDS Clinical Trials Group and with many very talented and hard-working people willing to share their time and energy with me.

In the beginning we were involved with the development of use of intravitreal ganciclovir for CMV retinitis; I was the first person to administer that treatment. This research happened because people were going blind and they were not eligible for IV therapy, so we had to do something. We were involved with the first published case of sexual transmission of AZT-resistant virus.

I worked with Ashley Haase's group on developing the technology to look at virus in tissues, which taught me several years ago that a cure was not forthcoming. I have also worked closely with Courtney Fletcher's group in the College of Pharmacy where I have learned the importance of better understanding the relationship between plasma levels of drugs and their efficacy.

More recently we have also been working with Pablo Tebas at Washington University of problems relating to salvage therapy. With Pablo we did one of the earliest salvage trials seeing how patients who had failed nelfinavir responded to a subsequent dual protease inhibitor regimen.

We also have conducted one of the first U.S.-based switch studies looking at what happens when nevirapine was substituted for a protease inhibitor. We also are looking at novel ways to use population modeling to get a better handle on how to approach therapy over the long term.

We are working with Andrew Zolopa at Stanford on a number of practical clinical studies as a part of the clinic-based investigators group (C-BIG) that he is spearheading.

Finally, over the last two years we have focused on issues relating to the metabolic problems seen in the setting of HIV and its treatment, including early efforts at using lipid-lowering agents for management.

We see what's happening in the clinic, but our hospital does not have the resources to fund research to take it to the next level. So I try to find good people in good labs to address the issues we see in clinic all the time.

But no one should think that clinical research is not affected by funding problems. My impression from the Retroviruses meeting is that many of the more interesting and relevant clinical studies presented were from Europe and Australia.

It was my impression that recent U.S. research efforts have been too inflexible looking more or less exclusively at aggressive early use of HAART, or that the major clinics and clinicians have been so swamped by the healthcare financing problems that they have not had the time to think outside the box and do creative research.

There are problems in Europe, too. But if they want to do a DEXA scan to look at body-fat issues, they just add it, it's already paid for in research. Here everything has a cost, and everybody's time is badly diverted. Even though U.S. medical research is held up as a world model, it is now being impeded by funding problems.

I was disturbed to hear from so many clinicians at the Retroviruses meeting about their financial difficulties and concern for burnout.

The bottom line is that we must learn how to better use our available drugs and resources for the best long-term outcomes. The best place to start that process is by providing better financial support for what should be the most important box in the guidelines--oversight of care by qualified HIV specialists and their staff.

References

1. Fischl M, Rodriguez A, Scerpella E, Monroig R, Thompson L, and Rechtine D. Impact of directly observed therapy on outcomes in HIV clinical trials. 7th Conference on Retroviruses and Opportunistic Infections, San Francisco, Jan. 30 - Feb. 2 [abstract 71].

2. Palella FJ Jr., Delaney KM, Moorman AC, and others. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. New England Journal of Medicine March 26, 1999; volume 338, number 13, pages 853-860.