By Phyllis Griffin Epps
Recent advances in genetic research offer a glimpse into the future of pharmaceuticals. The relatively new fields of pharmacogenomics and pharmacogenetics leave no doubt that drug manufacturers will develop tomorrow’s medicines with individuals and specific groups of people in mind. Given finite resources available for research and development, the questions for drug manufacturers are "who will they have in mind" and "who will be left behind" in new drug development. Whether the answers are palatable to health care consumers is another question entirely.
Increasingly, researchers can identify specific genes and polymorphic markers of an individual’s ability to metabolize a drug. Pharmacogenomics refers to the entire spectrum of genes that determine drug behavior and sensitivity. Pharmacogenetics, a subset of pharmacogenomics, is the study of differences in drug response between individuals based on inherited variations in genes, and the enzymes and proteins produced by such genes. Persons with a particular genotype, or genetic characteristic, may suffer adverse responses to a drug and such responses may be traced through families, ethnic groups, and geographic clusters. Pharmacogenetics also promises to identify the most efficacious drugs for individuals.
Advances in pharmacogenomics will reduce the number of people who die from adverse drug reactions each year. Drugs that prevent diseases to which a person is genetically predisposed may become common. Several pharmaceutical companies have formed alliances with genomic research firms to facilitate the translation of data on the sequencing of genes into the development of new drugs. For drug manufacturers, the focus will shift from the development of drugs that are safe and effective for the greatest number of people to the development of drugs for specific, genetically identifiable subgroups of the population.
To date, all pharmacogenetic polymorphisms, or relatively stable variations of the genes involved in drug metabolism, differ in frequency among ethnic and racial groups. For this reason, race must be considered in studies intended to discover whether specific characteristics are associated with disease risk or drug toxicity. For any given malady, drug manufacturers may find themselves dedicated to the task of developing a drug for use by a specific racial or ethnic group. Alternatively, individuals could find themselves precluded from using a drug that has been proven effective for one or several racial or ethnic groups, but ineffective and even dangerous for another. Such exclusion, while medically justified, may cause negative social repercussions unless addressed in a timely and sensitive manner.
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 market 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. Absent incentives to the contrary, a drug manufacturer in the United States will pass the costs onto the consumer in the form of higher prices. That is, if the drug manufacturer decides to develop the drug at all. 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?
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?
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, see Food/980213FDARequires.html, 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 subpopulations.
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?
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.