Gatekeepers of life

Lucentis, a drug used to treat age-related macular degeneration, the leading cause of blindness in people over 50, costs hundreds or even thousands of dollars per injection (the price seems to vary greatly depending on the location). Avastin, which was designed to treat colon cancer, is also being used to treat AMD “off-label” (it is not approved for this purpose, which raises ethical questions) and costs C$12 to C$15 a dose.

The government of the province of British Columbia is going to pay physicians a fee of $530 every time they do the five-minute intraocular injection procedure, regardless of which drug they use. Lucentis might be the better drug, but it has been reported that its use will result in little profit for the physician. In contrast, using Avantis will mean $500 or more profit for each injection.

This situation has been described in the media as a “potential conflict of interest for physicians.” That's wrong: It is a conflict of interest, no matter which drug the doctor decides to use. A conflict of interest already exists before any decision is made, when, as here, the physician's interests are in conflict with the patient's “best interests” and with the physician's primary obligation of personal care to each patient, that is, the obligation always to put the patient's interests first.

This situation is an example of the rapidly increasing number of difficult ethical situations arising in relation to the allocation of health-care resources and access to them, especially very expensive ones.

Avoiding conflict of interest and ensuring ethics in the use of health-care resources requires, first, an understanding of the roles physicians can play as “gatekeepers” in allocating these resources.

In “positive” gate-keeping, the physician is rewarded for using resources: For instance, the physician or a close family member owns a pathology laboratory, so the more tests that are done, the more profit the physician or his family makes; or the physician receives a payment for sending patients for tests, so, likewise, the more tests he orders, the more money he receives. This gate-keeping is unethical and not allowed.

In “negative” gate-keeping, the physician is rewarded for reducing the amount of treatment patients receive. Some American health-care insurers (HMOs) had such a scheme at one time. This also is unethical.

“De facto” gate-keeping, as its name indicates, is an unavoidable everyday reality in health care - physicians allocate about 80 per cent of health-care resources. While, unlike with the other two kinds of gate-keeping, this is not unethical conduct, the allocation must be carried out ethically.

Among the requirements for that is obtaining patients' informed consent to treatment or their informed refusal. Informed consent mandates that patients be given “all the information that would be material to a reasonable patient in the same circumstances.” That includes being told of all reasonably indicated treatments for their condition, the benefits, potential benefits, harms and risks of each, including of forgoing all treatment. As well, patients' consent must be voluntary: They must not be coerced or unduly influenced in making their choice.

So, leaving aside for the moment the ethics of the BC scheme, does it mean that in order to obtain patients' informed consent, a physician must explain to them the different costs of the AMD treatments and the different benefits to the physician that result? And must they explain that Avantis is an “off-label” use? If so, a failure to make these disclosures means that the patient has not given informed consent to any treatment administered, no matter what it is.

And might the differential benefit to physicians cause them to put pressure, subtle or not and intentionally or not, on patients to choose the cheaper treatment, so affecting the voluntariness of any consent?

And, to obtain informed consent, must physicians disclose treatments that are indicated for a patient's disease but which are unavailable because a hospital or government refuses to pay for them? I believe that they must, although physicians “freak out” when I tell them this, as it places them in a difficult situation.

Such disclosure is required because it puts patients on notice that these other treatment possibilities exist and they might decide to seek them elsewhere. Moreover, physicians have an obligation to be patients' advocates for treatments that could help them, even if that is an uphill battle and the basic presumption is the treatment will not be provided. Some health-care schemes might be recognizing this ethical requirement and allowing for it.

Although we don't always recognize it, all our decision-making starts from a basic presumption and we need to consider what the ethical choice of the basic presumption is regarding access to any given treatment.

There are four basic presumptions:

♦ “No” - the drug will not be made available;
♦ “No, unless ...” - the drug will not be made available unless ... (this presumption makes the frugal choice the default position);
♦ “Yes, but ...” - the drug will be made available, but not if ... (the generous choice is the default position);
♦ “Yes” - the drug will be made available.
If the basic presumption used at the general level is “no,” it can be argued that, at the individual level, ethically, we must provide for an “unless,” that is, an exception in individual cases.

Britain seems to have recognized this in its latest approach to payment for very expensive life-prolonging drugs: “The National Institute for Health and Clinical Excellence (NICE) has asked its appraisal committees to consider ‘survival benefits' when evaluating end-of-life medicines that fail to successfully pass the institute's cost-effectiveness evaluation [and, therefore, do not qualify for funding], that is, to look further than the basic health-economics model and give greater consideration to survival benefits when evaluating end-of-life medicines.” In short, compassionate provision on a case-by-case basis of drugs not made available generally is contemplated.

In conclusion, ethics requires that physicians act without conflict of interest, and their primary obligations of personal care to each patient mean that it is not ethical to bring the resource question to bear at the individual level of the bedside in making treatment decisions.

That said, physicians do have secondary obligations to other patients and society to conserve health-care resources.

Likewise, decision-making about the provision and allocation of health-care resources at the collective level must be free of conflict of interest. But, in contrast to the individual level, it is unethical not to bring the resource question to bear at this level; ethics requires it in order to do justice.

Margaret Somerville is founding director of the Centre for Medicine, Ethics and Law at McGill University.


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