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AIDS, judges, and the right to medical care.

AIDS, Judges, and the Right to Medical Care

The AIDS epidemic continues to bring to public attention major problems in our medical care system. One central question is whether there is a "right to medical care," and if so, what it means for AIDS patients. This issue is at the core of a suit by the Dallas Gay Alliance (DGA) against Parkland Hospital in Dallas, Texas.

Parkland is one of the premier public hospitals in the U.S., and the only Dallas County hospital that treats indigent AIDS patients. It cares for about 55 percent (230) of the county's AIDS patients. The DGA had been negotiating with Parkland for months over issues relating to the care of indigent AIDS patients. The DGA had three major concerns:

* AZT availability: Primarily because of a shortage of physicians in the AIDS clinic to monitor patients on AZT, there was a long waiting list of AIDS patients who met the medical criteria for the drug and wanted it, but could not obtain it.

* Aerosol pentamidine availability: Parkland allegedly has a rule that no drug not approved by the Food and Drug Administration (FDA) for a specific use could be prescribed for that use for a Parkland patient, except as part of an IRB-approved clinical trial. Aerosolized pentamidine has not been approved by the FDA for use to prevent pneumocystis carini pneumonia.

* Rationing beds for AIDS patients: It was alleged that Parkland had set aside a limited number of beds for AIDS patients, and would not admit any more than this number of AIDS patients to the hospital.

The hospital was not totally unresponsive: It denied there was any formal bed rationing and said consistently that the medical staff would like to meet the other demands. The problems were manpower (sufficient physicians to staff the AIDS clinic) and money (particularly reimbursement for pentamidine, as AZT was fully paid for by the Texas Medicaid program). In a press release dated April 7, 1988, the hospital administrator promised to try to eliminate the AZT waiting list, then composed of some sixty patients, within thirty days; to increase the number of physicians serving the AIDS clinic; and to develop a clinical trial of pentamidine to begin July 1. The waiting list was almost immediately reduced to twenty patients (seven had died, and eleven no longer wanted the treatment or no longer met the medical criterial for it). Physician staffing was seen as a more intractable problem; the AIDS clinic allegedly remained the only one of more than 100 clinics at the hospital that medical students and residents did not routinely rotate through.

Nonetheless, on May 19, 1988, the DGA filed suit against Parkland Hospital asking for an immediate temporary restraining order to compel the hospital to: (1) dispense AZT to all patients who qualified for and needed it; (2) deliver aerosolized pentamidine inhalation treatment to all patients who qualified for and needed it; and (3) abolish all bed controls for HIV-positive patients, and allocate hospital beds to AIDS and ARC patients on the basis of need.

Judge John M. Marshall, of the Dallas County District Court, ruled on the request for a temporary restraining order after a brief hearing on the day it was filed. He essentially gave the DGA all they requested, ordering the immediate elimination of the AZT waiting list; the immediate dispensing of AZT "to qualified patients upon each patient's proper proof of indigence" and a physician's prescription; the immediate delivery of "aerosolized pentamidine inhalation treatment" to all qualified patients upon prescription; and the immediate abolition of all bed controls for HIV-positive patients. The judge read a brief statement explaining his decision:

This case presents the paradigm of AIDS cases that we will undoubtedly see in the future if a cure should not be found, that is, an AIDS victim, as the disease progresses, will descend the economic ladder into indigency so that, at the moment of greatest need, the victim has the fewest resources to meet it. To whom must the victim turn? Obviously, the public must intervene or else adopt a policy that says, "Let them die because we can't afford them." Such a result is not tolerable in a society that for over 200 years has prided itself on placing human values first.

On the other hand, there should be steps taken to insure that the effective treatment to be administered be administered by competent staff under the most efficacious conditions....Bed control as a means of excluding anyone from the treatment provided by a facility is not acceptable.

This Court is not a physician, nor is it a hospital administrator, but it must be to some extent a voice of the conscience of the community. That voice, even when confronted with the moral background of the AIDS phenomenon, must be, and is, raised in favor of life.... [1]

Judge Marshall seems unknowledgeable about the realities of financing and delivering medical care, and unaware of how radical his legal conclusions are. He asserts that the "conscience of the community" will not accept a policy that lets AIDS patients die "because we can't afford them." But his opinion makes no reference to either the law on medical care financing for the indigent or the role of the FDA. Marshall's core assumption that AZT and aerosolized pentamidine represent "effective treatments" whose denial leads to a policy in favor of death is not tenable. The current medical reality is better stated, "They will die because there is no effective treatment." I applaud Judge Marshall's politics on access, but when other judges review this decision and the issues it addresses, they will have to be guided by the law rather than politics.

The Right to Medical Care

The waiting list for AZT at Parkland Hospital was stated because the clinic's personnel simply could not meet the demand for proper care of all the indigent AIDS and ARC patients who applied to them. The Texas Medicaid program had previously decided to pay for AZT for qualified indigent patients, and thus payment for this drug was not a major issue in this case. But unless its own rules so provided, Texas Medicaid had no obligation to pay for AZT simply because it was an "approved drug."

Payment is a political decision, to be made by Congress and the individual state legislatures. There is no constitutional right to medical care, even to medical care that is lifesaving. The U.S. Supreme Court has determined that neither Congress nor the states have an obligation to fund even the one medical intervention that people have a constitutional right to choose--abortion--even if failure to do so could lead to the death of the pregnant woman. The court reasoned that Congress did not create "indigency," and Congress's refusal to pay for certain (or all) medical interventions does not create any obstacle that would not otherwise exist for poor people to obtain needed medical care. In the court's words:

"Whether freedom of choice that is constitutionally protected warrants federal subsidization is a question for Congress to answer, not a matter of constitutional entitlement." [2]

Nor is there anything inherently illegal or morally offensive about waiting lists for nonemergency treatments. Almost everyone in this country must wait at least some time for an appointment to see a physician about a particular complaint, and there is no right to instantaneous medical care. Problems with waiting lists can raise legal issues if, for example, they are arbitrarily administered, with preference based on who you know rather than medical need or a strict first-come, first-served basis. And as a matter of justice, it is reasonable to argue that the burden of AIDS should not fall disproportionately on the poorest patients, but should be shared among all AIDS patients. In organ transplantation, for example, we have reached basic societal consensus that organs should not be allocated on ability to pay, but rather on some nonfinancial criteria, with "objective medical criteria" regarding projected benefit from the transplant often considered the most appropriate. But this is a policy decision, not one that is constitutionally required.

If the real reason for the waiting list at Parkland was a shortage of medical staffing in the AIDS clinic because it is the only Parkland clinic that general medicine residents do not regularly rotate through, then AIDS patients are being directly discriminated against. Such a rotation scheme might be successfully challenged under section 504 of the Rehabilitation Act of 1973 if it served to deny treatment to AIDS patients, because patients cannot lawfully be discriminated against solely on th basis of handicap.

The bed limit on AIDS patients, however, is a much more difficult issue. AIDS patients do have a right not to be discriminated against--but so do all other patients. The real question is whether any such limit would be lawful. Limiting the beds available for AIDS patients would seem as constitutionally permissible as limiting the number of beds in an intensive care or any other specialty unit of the hospital. The course of the AIDS epidemic may mean that Parkland (and other public hospitals) could eventually fill themselves completely with AIDS patients. But there is nothing in the constitution that requires public hospitals to use all of thei resources to serve one group of patients or that prohibits Parkland (or any other public hospital) from making reasonable bed allocation decisions that take into account the needs of all the indigent patients who require hospitalization.

Experimental Drugs

Providing aerosolized pentamidine upon request for nonapproved uses is also much more complex than Judge Marshall suggests. The issue is whether AIDS patients have more rights to nonapproved medical care than others, and ultimately whether the FDS should prohibit the marketing of drugs that have not been proven "safe and effective." The question of whether the FDA should make an exception for drugs given to individuals who are terminally ill was, of course, widely debated in the 1970s during the laetrile craze. At that time many argued that since traditional medicine could not cure most forms of cancer, and since laetrile was widely demanded and did not seem to harm people, there should be a "right" to obtain and take laetrile. As one commentator put it, Americans have the right to "life, liberty, and the pursuit of quackery." [3]

The FDA strongly opposed laetrile and was ultimately vindicated by a unanimous U.S. Supreme Court opinion, which held that there was no statutory exemption from the FDA requirements for "terminally ill cancer patients." Commenting on the FDA's obligation to protect these patients from exploitation and harm, the court said:

For the terminally ill, as for anyone else, a drug is unsafe if its potential for inflicting death or physical injury is not offset by the possibility of therapeutic benefit....To accept the proposition that the safety and efficacy standards of the Act have no relevance for terminal patients is to deny the Commissioner's authority over all drugs, however toxic or ineffectual, for such individuals. If history is any guide, this new market would not be long overlooked. [4]

The AIDS epidemic, and the lack of an effective treatment, has made the FDA's job extremely difficult. In 1987, the agency issued new regulations that permit the use of a non-approved investigational new drug "for a serious or immediately life-threatening disease condition in patients for whom no comparable or satisfactory alternative drug or other therapy is available." Drugs that have not been proven safe and effective can be sold to patients under these circumstances. The FDA has also decided not to try to restrict the sales and distribution of "AL-721," an egg and soybean substance sold for its alleged anti-viral properties. [5] The rationale appears to combine a fear of the gay community's ability to arouse political opposition to agency decisions, and an acknowledgment that traditional medicine has nothing to offer most AIDS patients.

Reopening the Debate

All this may be reason to reopen the question of whether AIDS patients should be an exception to the general rule that only "safe and effective" drugs should be offered to patients, but we ought not draw such a conclusion on the basis of a brief hearing followed by less than an hour of reflection. To do so assumes that AIDS patients cannot be injured by unproven drugs. But this assumption is patently false--AZT has had devastating effects on a large percentage of its users. It also assumes that AIDS patients cannot be viciously exploited by quacks, and demeaned by being taken advantage of by individuals and companies interested only in reaping financial gain from the suffering and desperation of dying patients.

Judge Marshall is correct in wanting to see indigent patients treated fairly; but he is wrong to think that the law requires Parkland to make available (or even to permit its physicians to prescribe) a drug that has not been proven safe and effective. Physicians can legally prescribe any approved drug for a nonapproved use as long as it is done with the informed consent of the patient and the unapproved use is a medically reasonable one. Thus physicians can (and do) prescribe aerosolized pentamidine to AIDS patients. But this fact alone does not mean that the drug will do anyone any good; the only way we will ever know if it is a useful drug is to conduct randomized clinical trials. Parkland's proposal to run such a trial is reasonable and medically sound. Patient demand alone cannot legitimate a drug. If it could, the FDA should be abolished.

The treatment of a universally fatal disease is frustrating and frightening. But judicial fiat will neither cure the disease nor make the management of public hospitals more efficient. Judge Marshall seems to see making exceptions to the general rules when people are dying as compassionate and morally compelling. It should be understood that such exceptions are not legally required, but are political and policy decisions. Exceptions would be more justificable and useful if they involve treatments that are effective and affordable. AIDS highlights the dominant weakness in our health care system: lack of universal access. The solution will have to come from Congress and the individual state legislatures, not from well-meaning but uninformed judges.

References

[1] Dallas Gay Alliance v. Parkland Memorial Hospital, No. 88-6346-A (14th Dist. Dallas Co., May 20, 1988).

[2] Harris v. McRae, 448 U.S. 297 (1980).

[3] B.D. Colen, "Laetrile Dispute Focuses Attention on Patient Rights," Washington Post, May 29, 1988, 1.

[4] U.S. v. Rutherford, 442 U.S. 544 (1979).

[5] 52 Federal Register 19465-77 (May 22, 1987).

[6] Gina Kolata, "F.D.A. Action in AIDS Issue Provokes Anger," New Y ork Times, June 26, 1988, 1.

George J. Annas is Utley Professor of Health Law, Boston University School of Public Health, and Chief, Health Law Section, Boston University School of Public Health.
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Author:Annas, George J.
Publication:The Hastings Center Report
Date:Aug 1, 1988
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