Markkula Center of Applied Ethics

Personalized Medicine: The Ethics of Access

by Karen Peterson-Iyer

The Medicare prescription drug plan, which went into effect this summer, will cost an estimated $724 billion over 10 years. But that figure may be a gross underestimate if American health care follows the trend of designer drug development made possible by pharmacogenomics.

This relatively new field looks at the connection between a person's genes and his or her response to pharmaceuticals. The idea behind pharmacogenomics is simple. Rather than accepting the "one-size-fits-all" approach of ordinary drug therapy-where dosage is the only primary variant from patient to patient-researchers envision that medications would be tailored to fit the genetic profile of each individual patient. In this way, medicines could be made more effective and provoke fewer adverse reactions in any given case.

To some degree this is already being done. A newly diagnosed breast cancer patient can now find out whether her tumor is "HER2-positive" or not, leading to a determination of whether or not she would benefit from the drug Herceptin. In women whose tumors have a HER2 positive genetic profile, Herceptin can significantly lower the rate of recurrence and raise the chances of five-year survival.

But Herceptin is a good example of the cost-control problem. A year-long course costs $36,000 to $47,000 per patient. Experts agree that the cost of genetically-tailored drugs like Herceptin will probably remain high. By virtue of being targeted to particular populations, they will not likely become blockbusters with huge markets, so pharmaceutical companies will price them accordingly.

In these circumstances, only the rich or the insured may be able to afford them. From the standpoint of justice, one of the most disturbing possibilities raised by pharmacogenomics is that it will further entrench the already-deep socioeconomic divisions that characterize modern U.S. society.

And even the insured may be vulnerable. Will private insurers be willing to pay for expensive drug therapies or the tests needed to prescribe them? Several patients recently had to take South Africa's largest medical insurer, Discovery Health, to court to gain access to Herceptin.

Although the issue was resolved, Maurice Goodman, Discovery Health's head of clinical communication and marketing, defended the company's reluctance: "The issue that comes to the fore here is the weighing up of the rights of the many versus the rights of the few. New medical breakthroughs could save countless lives, but what if the costs are prohibitive and medical [insurance plans] buckle under the costs?" he asked.

Even in societies that have comprehensive, public health insurance, the question remains as to how expensive drug therapies will fit into overall health care budgets. Patients in Britain and Australia have had to fight to get their respective health services to cover Herceptin treatment. In April, a British appeals court ruled that a local health service had acted illegally in withholding Herceptin from a woman with breast cancer.

Herceptin is just the leading edge of the cost-containment problem. Both conservatives and liberals must face up to the reality of rising health care costs and the corresponding potential breakdown of the U.S. health care system. One way or another, limits will need to be set. We can rely on the market to set those limits (potentially excluding those who cannot pay) or we can extend benefits to everyone (raising costs even more). But only a thorough overhaul of our health care system-including uncomfortable choices about where we will spend our health care dollars-can help avert such a breakdown. Moreover, justice demands that the limits that we set do not shortchange those who already struggle at the economic and health margins of society.

Program Specialist in Health Care Ethics Karen Peterson-Iyer has been conducting research on pharmacogenomics and ethics through a grant from the Honzel Family Foundation.

July 2006


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