miércoles, 8 de junio de 2016

When Is It Ethical to Withhold Prevention? — NEJM

When Is It Ethical to Withhold Prevention? — NEJM


When Is It Ethical to Withhold Prevention?

Thomas A. Farley, M.D., M.P.H.
N Engl J Med 2016; 374:1303-1306April 7, 2016DOI: 10.1056/NEJMp1516534
An impoverished 63-year-old woman is diagnosed with squamous-cell carcinoma of the lung with extensive metastases. There is no hope for cure, but radiation and chemotherapy, which could cost more than $100,000, may extend her life for a few months. If this patient unambiguously requests treatment, her doctors may struggle with the decision but will probably provide the treatment, ignoring the cost as a matter of principle.
On the other hand, a health department — or a hospital — proposes an action that would prevent many cases of lung cancer by helping smokers quit. It could be offering free nicotine-replacement therapy to every smoker or running smoking counter-advertisements on television. The organization will immediately face resistance: Can we afford that?
In both instances, health experts must make tough decisions that entail weighing the costs of an action against its benefits in extending human life. Why is the value of extending human life the determining factor in the first example and the cost of the intervention the determining factor in the second? These two scenarios expose tangled issues of ethics, cost, and cost-effectiveness and highlight a troubling structural bias against prevention.
Many people reject any attempt to put a dollar value on human life. From such a perspective, any withholding of potentially life-extending interventions on the basis of their costs is unethical. But within every organization and throughout society, limits on funding make it impossible to pay for every conceivable intervention. That reality forces health leaders to make painful decisions about what to pay for.
Some observers argue that the most ethical strategy under funding limits is to base payment decisions on the principle of doing the most good per dollar spent. The measure most commonly used in applying this principle is the incremental cost per quality-adjusted life-year (QALY) saved, as compared with a base-case scenario. Various experts have proposed various thresholds, generally in the range of $25,000 to $100,000 per QALY, below which an intervention should be considered cost-effective and thus worth paying for and above which it should be considered too expensive for the benefit conferred.1
Congress has used cost-effectiveness analyses in deciding that Medicare should cover selected secondary prevention services, such as screening for breast cancer and colon cancer.2 But the measure of cost per QALY is routinely ignored in decisions both about treatment for demonstrated disease and about primary prevention of disease. It is ignored, though, in entirely different ways. Medical treatments are paid for even if they are cost-ineffective; in fact, the Medicare program has been blocked from even considering cost-effectiveness in determining whether to cover the costs of treatment.2 For example, treatment of metastatic lung cancer may cost $800,000 per QALY, but it is typically provided.3
In sharp contrast, primary preventive services are often withheld even if they are highly cost-effective. For example, the Diabetes Prevention Program, a lifestyle-training program focused on exercise and nutrition that costs only $14,000 per QALY, is covered by only some health insurance plans; Medicare is not among them. Even more extreme, provision of free nicotine-replacement therapy costs less than $5,000 per QALY gained4 and televised mass-media campaigns for smoking cessation cost less than $300 per QALY gained,5 but such programs are rarely undertaken.
The starkly different standards for treatment and primary prevention stem from the nature of empathy and the financial structures of our health care system. First, the woman with lung cancer receives treatment regardless of cost because she is a specific human being, with a name and a face, with whom we can empathize and whose suffering from lack of treatment we can see. The mass-media campaign, on the other hand, prevents suffering in people who are unnamed and unseen — and thus easier to ignore. Second, the woman receives treatment because as a society we reimburse hospitals and doctors for the costs of her care, with government funding of uncompensated care and allowances for shifting the costs to insured patients. In contrast, we finance most primary preventive services through budgets for public health agencies, which are subject to fixed annual appropriations and must compete with budgets for schools, police, and every other public need. Our frames for weighing costs in the two scenarios are entirely different.
Whereas medicine has ethical standards supporting withholding of treatment that is futile — meaning that it offers no benefit — it has no such standard supporting withholding treatment that is extremely expensive for its benefit. In fact, the American Medical Association Code of Ethics is fairly explicit that the cost of treatment should not be a consideration. But shouldn’t that principle make us distinctly uncomfortable with the ethics of withholding actions that are preventive? If cost is not a legitimate reason to withhold treatment to extend the life of a woman with lung cancer, how could it be an acceptable reason to withhold free distribution of nicotine-replacement therapy, which would extend many more lives?
Ethicists have indeed considered public health interventions, just as they have medical treatments. But they have focused primarily on whether it is ethical for society to mandate certain actions, such as immunization or treatment of active tuberculosis. There has been little written about the ethics of offering beneficial primary preventive services. It is difficult to develop an ethical justification for withholding these services; the fact that we don’t know the names or recognize the faces of the people who would be helped is clearly not a good reason.
In recent years, public health experts have increasingly turned to cost-effectiveness analysis, in part with the hope that in proving that primary prevention is effective at low cost, they will build support for it. Perhaps surprisingly, preventive interventions taken as a group do not appear more cost-effective than treatment interventions (see graphDistribution of Cost-Effectiveness Ratios for Primary Prevention and Treatment Interventions.). But even when specific preventive actions — such as free distribution of nicotine-replacement therapy and mass-media campaigns for smoking cessation — have been proven to be cost-effective, these analyses have not overcome the structural barriers to support of those actions. I believe it is time, then, to argue on ethical grounds: it simply isn’t right for our $3 trillion health system to withhold interventions that can save hundreds or thousands of lives.
Integrating or combining the different pools of funding for health care and public health to support primary prevention would not be easy. However, the Affordable Care Act has opened up new opportunities for collaboration between health care systems and public health agencies, including requiring hospitals to take some amount of responsibility for the health of populations. Now is the right time, then, to rethink the funding structures of our health system, reconsidering not just cost-effectiveness, but also ethics.
Realistically, no framework that we could develop will eliminate what appear to be ethical inconsistencies between these different situations. But we can acknowledge that we currently have a systemic bias against prevention and that decisions about whether to provide or withhold proven preventive actions are not just tough budgetary choices, but are also ethical ones. Because withholding primary prevention leads to unnecessary suffering and death, I believe that as a society we should be just as creative in finding ways to pay for it as we have been in finding ways to pay for the penniless woman’s lung-cancer treatment.
Disclosure forms provided by the author are available with the full text of this article at NEJM.org.


From the Philadelphia Department of Public Health, Philadelphia.

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