New AIDS drugs create gray area between patient rights and ethics
Protease inhibitors force hospice to reconsider role
"Greg," a film director in his early 30s, led a remarkably successful life as a writer and director of stage and screen until he developed AIDS. While still in his 20s he had won theatrical awards in both New York and Hollywood. But for the past three years Greg has battled one opportunistic infection after another and been in and out of the hospital.
Although he once earned a six-figure salary, his life savings has been depleted; his home, once a single-family dwelling in suburban Los Angeles, is now a third-floor walk up apartment. He has been in a residential hospice program for 25 days, his weight down to 96 pounds, and getting closer and more accepting of his death. Now, he has learned that a new group of anti-retroviral drugs protease inhibitors are giving friends with AIDS new life. Filled with hope, he calls his doctor and says he wants to start taking these new wonder drugs.
Men like Greg are becoming a common, and confusing, addition to many hospices and health care facilities across the country. As protease inhibitors have become more widely used, the portion of the health care community that deals with many AIDS patients has been grappling with the dichotomy of a new treatment that can reverse the course of the disease and yet raises a multitude of ethical questions.
Who should get these drugs? How sick is too sick to raise the hope of a cure? What happens if the drugs don’t work for your patient? If they do, how do you help him or her cope with "survivor’s guilt"? Do AIDS patients formerly considered terminal need to leave hospices?
All these questions are raising real ethical concerns among physicians treating AIDS patients. "Some doctors see this as a black-and-white issue when it is really quite gray," says Terri Ford, director of Linn House, a 25-bed residential hospice facility for AIDS patients in West Hollywood, CA.
Researchers reported the initial success of protease inhibitors last summer in Canada, pointing to their ability to decrease a patient’s viral load and increase CD4 counts. (CD4s are the antigenic marker on helper/inducer T cells.) To garner the results, AIDS patients must adhere to a strict regimen of prohibitively expensive drugs.
Even then, a positive response to the inhibitors is anything but assured. The treatment can rid the body of the HIV virus but has varying effects on the patient’s ability to ward off opportunistic infections. Therefore, the drug therapy is not as effective in some patients as others. In fact, in patients close to death it may damage the immune system.
The new treatment also gives rise to ethical questions about informed consent, truth telling, access, and allocation of resources.
When patients like Greg say they want to try protease inhibitors, it is important that they know and understand all the ramifications, says Claire Tehan, MPH, vice president for Hospice at Home Health Care Agency of California in Los Angeles. "Doctors may not realize the amount of time they have to spend with patients to help them fully understand what they are getting into," she warns.
"If a patient decides to go for the gold, I have to do my best to inform him or her of the potential for both harm and good in their particular medical situation," says Gary Reiter, MD, associate medical director of Hospice Life Care of the Holyoke (MA) Visiting Nurses Association. "I see this as sort of an enhanced patient autonomy model," says the chairman of the ethics committee and director of palliative medicine at Holyoke Hospital.
Many sicker or demented patients may be unable to keep the drugs refrigerated or tolerate the side effects every six hours, warns Tehan. Patients who suffer dementia will require more skilled home care or access to an inpatient facility.
If patients do not comply with the drug regimen, the body can quickly develop mutant genes and the patient’s immune system will be resistant to multiple drugs. Patients who have not tolerated other anti-retroviral medications are highly unlikely to see improvements with these drugs, says Reiter.
"Try to size up each patient’s situation individually," he suggests. "Do reality counseling. Tell the patient that the drugs may work or may not, and may make you quite sick," he says.
He cautions that the real ethical dilemma for AIDS patients and their caregivers may be down the road. "We have to look beyond this situation to the bigger picture. What happens to the patient population that is left? The patients with strong resistance to these therapies will be entering hospitals and hospices a lot later in the disease process, and they will be dying faster," he warns. "How will we assure these patients are treated appropriately?"
"These drugs are giving patients incredible expectations," says Michael Wohlfeiler, MD, JD, assistant medical director of VITAS Healthcare Corp. in Miami. "This is really anxiety-producing for people, and health care professionals must be particularly attuned to addressing psychosocial problems that were never anticipated," he stresses.
Wohlfeiler explains that if the treatment works for a patient like Greg, he will be faced with a number of issues, for example, "What will I do with my life now? Should I change my life? How will I survive financially?" On the other hand, if the treatment fails, Greg and/or his friends may suffer severe guilt and depression. "You must have some really good support to help patients deal with these issues."
Where will they live?
Of concern to those watching the effect protease inhibitors have on AIDS patients is the question of housing.
In many cases, AIDS patients have either already given up or lost their homes as they become less physically and financially able to care for themselves. "Is it ethical to tell a dying patient who has no place to go that he or she has to give up their home [Linn House] if they want to try a drug that may save their life?" Ford asks.
What about a patient like Greg, who has an apartment but could not live there alone without a caregiver? What about a homeless patient who would have no place to go or to refrigerate the drugs?
Hospice programs are particularly concerned that many of the patients taking protease inhibitors may initially still require the comfort and support that hospice offers. But should they limit access to hospice or are they obligated to help patients transition to other health care providers?
"It is getting harder and harder to expect [AIDS] patients to come into the door with an acceptance of the hospice philosophy," says Ford. "But if we say, You’ve reached the end of your 30 day benefit period’ [for Medicaid/Medicare coverage] or may not fit the terminal diagnosis, this means the patient may be forced to choose between hope and home."
"A more global question is how we promote palliative care outside of hospice," says Reiter. He suggests that hospice programs concerned about limiting access review all AIDS cases and analyze whether patients are reasonably and equitably granted access and readmission if necessary. "So often, we see patients dying without appropriate care. Physicians in hospitals are inadequately trained in palliative medicine and uncomfortable talking to patients about death. Maybe this situation will provide an opening for discussion of a whole range of care," says Reiter.
What price do the living pay?
Yet another looming problem is the cost of protease inhibitor therapy, estimated between $10,000 and $12,500 per patient annually. This cost is for the medication only and does not include associated costs such as two antiviral load tests per month to assess the drug’s effectiveness.
Currently, federal and state funding under the Ryan White CARE Act, and separate fundraising by AIDS support groups, has been able to cover the costs of treatment for patients taking protease inhibitors. But as the number of patients taking the drugs increases, funding is bound to run out, says Dean Kauffer, LCSW, MSW, a social worker at Horizon House, a residential AIDS hospice in Chicago.
"This will certainly raise the question of access," he warns. "Ethically, it will be a challenge to take care of people for less money and to make sure that the therapy is not denied to patients who are homeless or legal immigrants."
"We must take on the responsibility of making sure that all patients, wherever they are in the disease process or in life, have appropriate medical care," says Kauffer.
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