Is a Health Industry Turf War Delaying the Next Medical Revolution?

[marmar]

via AlterNet:



Is a Health Industry Turf War Delaying the Next Medical Revolution?

By Rick Weiss, Science Progress. Posted June 26, 2008.

Genetic tests are one of the hottest new tools in medicine. They're also one of the most controversial.



Imagine a United States less united than today's, where each state has its own system for approving drugs and medical tests. Time for a prescription refill? Oops, you're on vacation in California, where the medicine you need is not approved. Hurt yourself and need a special kind of X-ray? Too bad, the state you live in does not allow that kind of test.

It sounds ridiculous, but this is the situation our nation is in for one of the hottest new tools in medicine, genetic tests. Gene tests conducted on a drop of blood can help predict what diseases a person is likely to get, fostering better preventive care and earlier diagnosis. For a growing number of diseases, gene tests can tell a patient which drug will work and which will not.

The moves by California and New York are the clearest evidence yet that a federal leadership gap now threatens to undermine the pending benefits of the genomics revolution.

But despite repeated calls by scientific and patient advocacy groups for the Bush administration to focus on this important emerging specialty, years have gone by without federal leadership. The Food and Drug Administration says it has the authority to regulate these tests -- to make sure they give accurate results and provide meaningful information -- but has largely steered clear of the complicated arena. The Federal Trade Commission, which has the responsibility for protecting Americans against false claims and consumer fraud, has effectively been AWOL on the gene test front, with the exception of a general "buyer beware" warning it put out in 2006. And despite repeated assurances that gene tests are a top priority, Health and Human Services Secretary Mike Leavitt has barely acknowledged receipt, back in April, of a long-awaited federal advisory report that called for HHS to take the reins on gene tests before this fast-moving specialty gets tainted by bad science and overzealous entrepreneurs.

Yesterday that lack of federal attention came sharply into focus with the revelation that California's public health department had sent "cease and desist" letters to more than a dozen gene test companies, including several direct-to-consumer companies that have recently begun to offer DNA tests through the mail. Health officials told the ventures they have two weeks to prove that they are in compliance with applicable state rules relating to such things as laboratory licensure and the status of the doctors or other professionals who are ordering and interpreting these pricey tests for clients. ......(more)

The complete piece is at: http://www.alternet.org/healthwellness/89327/