Analysis: Gene tests put docs at risk

By OLGA PIERCE, UPI Health Business Correspondent   |   Jan. 5, 2007 at 11:33 PM   |   0 comments

WASHINGTON, Jan. 5 (UPI) -- The growth of personalized medicine -- treatment designed specifically for the genetic makeup of an individual -- could lead to a flood of new medical malpractice lawsuits, says a new report.

More than 100,000 Americans are killed by prescription drugs each year, and many more are sickened. Advances in genetic testing mean that an increasing number of those cases could be prevented.

However, it also means that doctors that fail to test patients could be exposing themselves to liability, according to a new study by researchers at Arizona State University appearing in the journal Personalized Medicine.

"If you have the wrong genotype, you either metabolize a drug too fast, too slow or not at all," said Gary Marchant, executive director of the Center for the Study of Law, Science, & Technology at Arizona State University.

"That means the drug either won't work or is toxic," he told United Press International. "When you have a lot of people dying from a preventable cause it's going to lead to litigation."

Doctors already have the ability to test for genes that make medications ineffective or dangerous -- and new genes affecting the way medication is metabolized are being discovered all the time.

Thus far, incorporating scientific advances into personalized medicine has moved at a fairly glacial pace. Much of the delay is due to social concerns about the morality of genetic testing, and economic concerns about its cost-effectiveness, according to the article.

There is also some debate within the scientific community about the validity of testing results and their correct interpretation.

The threat of litigation, however, could speed the widespread use of such tests, which are already commercially available.

A number of lawsuits have already been filed alleging doctors failed to administer appropriate genetic tests or failed to communicate the results of those tests effectively to patients.

Thus far, lawsuits based on a failure to offer genetic testing before prescribing a drug have mainly targeted drug manufacturers' deep pockets. But drug companies have circumvented legal problems by including information on genetics and the potential danger of the drugs in package inserts given to consumers with their medication.

That means doctors have become the new targets, Marchant said. "It's a short matter of time before we see a new wave of these cases. Juries are going to say 'you should've done something different.'"

But doctors are faced with a "catch-22," he said. Most health insurance plans do not cover such genetic tests. If patients cannot afford them, the doctor must decide whether to risk malpractice allegations or simply not prescribe a potentially helpful medication.

"Doctors are in a very difficult position," Marchant said.

Doctors' general lack of training in genetics makes matters worse, he added. "Anybody practicing medicine in the country in the next ten years has to understand genetics -- or go out of practice."

Institutions and professional organizations can help by establishing clear guidelines for when genetic testing is required, he said, and medical schools should offer new doctors more genetics training.

Nonetheless, there will be a dangerous period for doctors, he said. "It's doctors that are going to bear a lot of the risk during the transition period."

© 2007 United Press International, Inc. All Rights Reserved. Any reproduction, republication, redistribution and/or modification of any UPI content is expressly prohibited without UPI's prior written consent.
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