This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by David Dooling of the Genome Center at Washington University in St. Louis School of Medicine.
We are currently in the throes of a heated debate on the future of health care in the United States. Despite endless hours of discussion amongst politicians, health care experts, and pundits, very little time has been spent discussing the implications of the current and any proposed health care system on medical research. The passage of the Genetic Information Nondiscrimination Act (GINA) last year makes it illegal for insurance companies or employers to discriminate on the basis of genetic information, e.g., the results of genetic tests for breast cancer susceptibility. The passage of this law promised to usher in an era of genetic testing and personalized medicine, but that era has not begun. There have been announcements of studies involving large cohorts of patients being genotyped as part of their normal course of treatment, but what percentage of patients will consent to these studies knowing that insurance companies can deny life-saving care because of clerical errors? While there have been some success stories applying genome sequencing to cancer treatment (ironically the above linked Nature News article cites an example from Canada), other more complex genetic diseases will need very large cohorts of patients to establish genotype/phenotype relationships.
These cohorts will not (and indeed should not) materialize until insurance companies cannot deny coverage for pre-existing conditions and cannot drop or limit coverage for the seriously ill. After all, genetic testing performed during treatment for one disease could turn up susceptibility to a whole host of other diseases; susceptibility to diseases that may induce insurance companies to look back through your forms for clerical errors. Fortunately, most members of Congress agree that the above are worthwhile reforms. Unfortunately, neither of these reforms do anything to control the cost of health insurance, and may even cause it to increase, leading to fewer insured and therefore fewer potential study participants unless there are other reforms to address skyrocketing health care costs (e.g., a strong public health insurance option). In short, without health care reform that guarantees coverage and controls costs, medical researchers in the United States will be at a significant disadvantage because the large-scale genetic studies required to understand complex diseases will not be available to them.
Without these studies our knowledge of the link between genetics and disease will remain vague probabilities that provide cocktail party fodder for those wealthy enough to afford health insurance and consumer genetic testing.