Ethical Issues: 

 

Pharmacogenomics is undeniably a positive development for drug safety and effectiveness, but will it benefit everyone? In the United States, the typical large drug manufacturer will endeavor to produce a drug that will sell well enough to recoup the costs of the expensive development process and generate a profit. 

Where the audience for a drug is relatively small, market forces dictate a higher price for the drug. The smaller may be defined by a particular genotype that occurs in a smaller number of persons whose need for a drug to treat asthma or arthritis, for example, is no less real. Where a smaller market is defined not only as persons who share a genetic characteristic but also happen to share race as well, the chances are greater that a higher price will act as a barrier to access and treatment. Nevertheless, the cost to produce a drug for a smaller number of people will be no less than the cost to produce a drug for either a larger population or a population more likely to afford the drug. How will pharmacogenomics affect the criteria for deciding which drugs to develop and for whom? In a country with such strong traditions of racial and ethnic discrimination, what forces, if any, will ensure that all segments of the population are included in the drug development strategies of drug manufacturers? (6)

Assume that pharmacogenomic research produces a drug to treat diabetes, which occurs across racial lines. The new drug is particularly effective in Hispanics, who are at risk for severe side effects from the drug used by the mainstream population. The new drug, while safest for Hispanics, costs more than the more widely used drug. Will HMOs and other managed care organizations and third-party payers be more or less likely to support the prescription of the drug best suited for each patient when the best drug may well cost more? Absent insurance coverage for prescription drugs, an Hispanic person will pay more to be treated for the same condition. The result is consistent with science and economics, but how well will it sit with consumers? From a broader perspective, how will the health insurance industry respond to a scenario in which different ethnic minorities require more expensive care than their white counterparts? (6)

The trends in drug development have not escaped the notice of federal regulators. The Food and Drug Administration (FDA) requires drug manufacturers to disclose effectiveness and safety data for gender, racial, and age subgroups, but does not require drug sponsors to conduct studies, much less include persons from specific subgroups in such studies. Through the Orphan Drug Act, the government offers tax credits, research grants, exclusive marketing rights, and other valuable incentives to companies to encourage research on rare diseases. Biotechnology companies that labor under the Act are able to set their own prices; the FDA does not regulate the pricing of the final products. The law has made orphan drugs a popular area of research and a moneymaker for the industry. Similar incentives may become necessary to encourage the production and distribution of drugs that benefit larger but neglected sub-populations. (6)

In a free market, the prospect of economic gain should be sufficient motivation for producers to distribute goods and services to all consumers. Many private institutions in the United States still have to be forced by law to drop policies that discriminate against persons based on their race and ethnicity, even when the illicit policy is contrary to sound business practice and the pursuit of profit. Will racial politics sustain a system in which drug companies market higher-priced drugs to specific minority communities? How do we balance the higher economic costs associated with targeting a group with genetic similarities against commitments to equitable social treatment of all persons without regard to race? (6)

With the growth of pharmacogenomics, race could play a legitimate role in the clinical treatment of illnesses. Whereas attempts toward equality have emphasized the absence of meaningful differences between races, society must confront the reality that immutable genetic differences among individuals of various racial and ethnic backgrounds may require separate treatment for the same conditions. Moreover, society must decide how best to promote equality in this context. The creation of a pharmaceutical apartheid, in which the price and availability of a needed drug are a function of genetics and race, must be avoided. (6)

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