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EDITOR'S PAGE

In previous editorials, I have discussed personalized medicine and the important role that IVDs, in particular genetic tests, will play in assessing patients for targeted therapies. I have explored in these editorials the business and political challenges of personalized medicine that IVD manufacturers would encounter. In addition to these challenges, the IVD industry will have to address another critical matter: ethical issues related to genetic testing.

An article published in February in the New York Times (“Insurance Fears Lead Many to Shun DNA Tests”) raised some of the ethical issues regarding the use of genetic tests for personalized medicine. This article examined the apprehensions of patients in getting genetic tests, primarily their fear of genetic discrimination by employers or insurance companies if a test showed a predisposition to a disease.

The New York Times article reported that various insurers and employers assured that genetic information would not be used to deny someone either health insurance or employment. However, the article also pointed out situations in which the exact opposite occurred. Either way, since any anxiety over genetic tests by patients would be detrimental to the prospects of personalized medicine, legislative action must be taken to prevent such discrimination.

One beacon of hope that would protect patients from genetic discrimination is the Genetic Information Nondiscrimination Act, known as GINA. Last month, the U.S. House of Representatives passed this legislation as part of the Paul Wellstone Mental Health and Addiction Equity Act (HR 1424).

Under GINA, it is illegal for health insurers to deny coverage to an individual or charge higher premiums based on a genetic predisposition to a specific disease. The legislation also bars employers from using genetic information when making hiring, firing, job placement, or promotion decisions.

However, despite this legislation’s passage, other members of Congress are opposed to GINA becoming the law of the land. Last April, when the House first passed GINA, Senator Tom Coburn (R–OK) placed a procedural hold on the bill because he believed it lacked proper legal protections for employers and health insurance companies. This time, a group of 11 senators, including Coburn, sent congressional leaders a letter that reiterated their continued objections to GINA.

“We believe the final draft of GINA should provide clarity to the health insurance industry, maintain the integrity of the underwriting process, and ensure accurate premium assessment,” stated the senators in the letter.

The ethical and political issues surrounding personalized medicine are another significant hurdle for the IVD industry and its partners in personalized medicine. I urge IVD manufacturers to express their strong support for GINA. This bill would provide patients protection from genetic discrimination, which would result in encouraging them to get DNA tests that could be used for determining targeted therapies. If such ethical issues are not resolved, personalized medicine will not come to fruition as hoped.

Richard Park