It's in the Genes - Pharmaceutical Technology

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It's in the Genes
In an age of "pre-existing conditions," can a new bill help patients get the treatment they need?


Pharmaceutical Technology


Michelle Hoffman
Several years ago, I asked my doctor to give me a genetic test to see whether I carried a mutation predisposing me to develop a particular disease. My concern stemmed from the fact that I belong to a demographic with a higher incidence of predisposing genes than the general population. Because I had no other risk factors for the disease, he advised me not to take the test. The reason? He was concerned that if I tested positive for the mutation and then later developed the disease, I could be refused health insurance because I had a "pre-existing condition."

I thought he was joking at first. Yes, yes, I replied, very funny. Obviously the mutation pre-existed the condition. But the same could be said of diabetes, certain heart conditions, cancers, Parkinson's, and so on. Were the insurance companies really going to deny insurance to everyone whose illness arose from some genetic mistake? Ultimately, science was going to decipher the gene or genes that predisposed all of us to some condition or another. And in that case, who could get insurance?

It turns out my doctor was not the only one concerned about preventing genetic discrimination by insurers and employers. For the past five years, Congress has been trying to pass some form of a genetic information nondiscrimination act. Most recently, the 2007 version passed in the House this April by a vote of 420 to 3. But the need for such legislation is not apparent to everybody, it seems.

On March 8, in a hearing before the US House Energy and Commerce Committee's Subcommittee on Health, Burton J. Fishman of Fortney & Scott, LLC, speaking on behalf of the Genetic Information Nondiscrimination in Employment Coalition, an employer group, called the bill a "remedy in search of a problem," according to a press release issued by the Genetics & Public Policy Center (GPPC). Burton went on to argue against a law "that imposes real burdens and actual costs based on distant, contingent eventualities...."

Not so hypothetical, countered Karen Pollitz, who conducted a study as a research professor at the Georgetown University Health Policy Institute. In her study, Pollitz asked insurance providers to evaluate the insurability and premiums for hypothetical applicants. Of the 23 companies surveyed, said the GPPC release, 5 indicated they would take an adverse action (denying coverage, charging more for premiums, or excluding certain conditions from coverage) on the basis of genetic test results.

The bill is now in the Senate, where it is expected to pass—if it ever comes up for a vote. Senator Tom Coburn (R–OK) has put a "hold" on the bill, which can delay the vote indefinitely. According to a report published on Aug. 8, 2007, at
the Senator wrote in an Aug. 1 letter to his constituents that he believes the bill, as drafted, "contains unintended consequences." The Senator's letter went on to say that it was lack of precision and not the overall purpose of the bill that he found objectionable. We emailed the Senator asking him to enumerate his specific concerns, but at press time, we had not yet received an answer.

Without further elaboration, we can't know what unintended consequences the Senator fears. But we can imagine the grave consequences that a failure to pass the bill might have for the pharmaceutical industry. The industry is now moving toward targeted therapies; therapies aimed to treat specific subsets of individuals in a disease population. And more often than not, the likelihood of an individual benefiting from a particular therapy, where others afflicted with the disease will not, will be determined by a genetic test. How ironic then, that the very genetic test that suggests an individual would respond favorably to a certain course of therapy might also preclude that individual from taking the drug, because it shows that the individual has a pre-existing condition.

I took my doctor's advice, by the way, and declined to take the test. But if the Genetic Information Nondiscrimination Act is passed, I certainly will.




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