Private clinics providing palliative IV therapies – what are the ethical issues?
A caseA 55-year-old woman with metastatic colon cancer has been receiving irinotecan-based chemotherapy for more than two years, but her disease is now progressing. The Cancer Care Ontario GI Disease Site Group treatment guidelines state that the standard therapy for a patient like this is second line chemotherapy and the monoclonal antibody bevacizumab.
Although this antibody was approved for the treatment of metastatic colorectal cancer by Health Canada in November, one of the few ways a patient can receive it in Ontario is at a private infusion clinic in downtown Toronto. Patients must pay for the medication through private insurance or out of their own pockets. The bill for the first month of therapy? About $7,000.
The problemEffective new systemic therapies are constantly being introduced into medical oncology practice as randomized trials demonstrate clinically important benefits. Most of these new therapies are very expensive. The Cancer Care Ontario (CCO) New Drug Funding Program (NDFP) funds many of these therapies, but there is often a significant time gap between availability of evidence and funding by NDFP.
So, for new agents like bevacizumab where evidence and guidelines are available to support its use, but have not been funded by the NDFP, an oncologist is faced with a challenging array of choices. One choice - considering whether to refer a patient to a private clinic for this medication - raises some important ethical issues.
What are the ethical issues associated with private clinics getting involved in the provision of palliative IV therapies?Before considering some of the ethical issues involved, it is worth considering some of the legal and constitutional issues. The Canada Health Act (CHA) sets out the primary objective of Canadian health care policy, which is "to protect, promote and restore the physical and mental well-being of residents of Canada and to facilitate reasonable access to health services without financial or other barriers."
However, the CHA only states that drugs be paid for by the government when medically necessary medicines are given in the hospital. So if patients pay (or have their insurance companies pay) for these expensive therapies at a private clinic - the letter of the CHA is not being violated.
What are the important ethical issues? Fundamentally, this is an issue of justice - is access to the medications at these clinics fair? However, in addition to justice, consideration also must be given to personal liberty and the physicianpatient relationship. As these issues are considered, many important questions are raised that will need to be considered by physicians, their patients and our society.
There are several theories of distributive justice including egalitarian, communitarian and libertarian. An egalitarian theory of justice states that those in equal need will have equal access regardless of ability to pay.
The CHA has a strong egalitarian vein, but there are many grey areas that are subject to important value judgments. The CHA promises "reasonable" access to "medically necessary" services. But what is reasonable? Are the current delays between availability of evidence and potential funding by the NDFP reasonable?
Are all of these expensive new therapies for what might be seen as modest benefits medically necessary? These are important questions that need full and open discussion by patients, health care providers and policymakers.
Communitarian theories of justice focus not on individual, but community concepts of the good and traditions nurtured in different communities. In Canada, the concept of health care as a common good that should be available to all citizens regardless of ability to pay has become part of the Canadian "tradition" and provides some of the normative support for the CHA.
Do private clinics, although they adhere to the letter of the CHA, contravene our community's concept of the spirit of the CHA? Could our provincial government, as a voice of our community values, consider restrictions on private clinics as a matter of social policy?
Libertarian theories of justice advocate distribution of goods (including medicines and medical care) on the basis of ability to compete for those goods in an open market. A libertarian theory of justice would permit access to private clinics to anyone who has the resources to pay for them.
But personal liberties can be limited or restricted by a democratic government for the good of its citizens. One very important question worthy of consideration is: Does the existence of the private clinic so disrupt our community understanding of the CHA that the province should interfere with the liberty of its citizens?
Individual physicians must consider their relationship and duties to their patients. Could an individual physician who personally opposed the private clinic justify restricting a patient's opportunity to access legal venues of treatment? Do physicians have a duty to assist their patients to obtain treatments that they are recommending and that are legally available?
Answering the questionsConsidering the ethical issues involved in the provision of palliative therapies at private clinics raises many questions that can be considered within a framework that considers different theories of justice, concepts of personal liberties, societal values and the responsibilities of the physicians to their patients. The answer to these questions is not easy, but they deserve careful thought and debate.
Scott Berry, BSc, MD, MHSc, FRCPC, is a medical oncologist and assistant professor and director of the medical oncology training program at the University of Toronto and the Toronto Sunnybrook Regional Cancer Centre, the comprehensive cancer program at Sunnybrook.
