School of Advanced Nutritional and Medical Research

By Ken Alltucker
February 27, 2007

Genes can be powerful predictors of a person's future health problems, but testing a patient's genes to tailor treatment strategies remains at the cutting edge of health care and legal professions.

The promise behind personalized medicine is that genetic tests can be used to craft ways to detect, treat or delay disease. Yet using genetic tests to tailor health care strategies is rarely done. These tests are too expensive for the typical patient, and many doctors aren't trained properly to administer, assess or use the tests for patient care.

"It is clearly the wave of the future. It's where people are going," said Terry Roman, a partner at Snell & Wilmer law firm in downtown Phoenix. "The challenge often is that the legal and ethical worlds have not caught up with genetic testing."

Doctors, lawyers and labs that offer genetic testing envision a day when genetic tests will become a routine part of clinical care, much like cholesterol screens that are regularly used to help prevent heart disease.

Many things need to happen before personalized medicine becomes routine care, though. Not all doctors are convinced that DNA triggers a disease as much as environmental or lifestyle factors. Ethical concerns persist about how data from genetic tests will be used.

Perhaps the biggest hurdle is the expense to administer the tests and whether insurers will pick up some costs as part of standard care.

Gary Marchant, executive director of the Center for the Study of Law, Science & Technology at Arizona State University, said lawsuits will force doctors to take a closer look at using genetic tests.

Marchant and other lawyers predict that, as more people become savvy about their health care options, patients will increasingly initiate lawsuits against doctors who fail to order DNA tests to predict genetic disorders and potential side effects from prescription medication.

"This is a huge issue. Doctors need to be educated," Marchant said. "I see (liability) as speeding up personalized medicine. There is a real risk out there. It will push people off the status quo."

The topic of genetic tests when prescribing medication is one of several that will be discussed Friday at ASU's personalized-medicine law seminar.

Liability concerns

Marchant said many doctors already have been sued for not ordering tests related to disorders such as cystic fibrosis, Down syndrome or even deafness.

He expects patients will increasingly sue doctors who fail to order genetic tests when prescribing drugs.

Data published in the Journal of the American Medical Association showed that side effects from prescription drugs kill more than 100,000 patients a year. Some of those could be prevented if doctors understood more about a patient's genetic makeup.

Doctors aren't the only group that faces the prospect of lawsuits.

Drugmakers, insurers and pharmacists all are at risk of being sued for failing to order genetic tests before ordering drugs that may harm some patients based on their genetic makeup.

But Marchant said doctors are "sitting ducks" in this emerging class of litigation because they typically don't have the legal muscle of the pharmaceutical industry and often don't have proper training related to genetics.

"This potentially is a big liability issue," Marchant said. "Many doctors don't have an understanding of genetics. Many doctors say, 'I am not ready to deal with this.' "

First Steps

The federal government now is crafting regulations to govern labs that process genetic tests. The Food and Drug Administration regulation plans have drawn criticism from some health care groups. They worry that the FDA will create another unnecessary layer of bureaucracy and affect doctors, drug manufacturers and others that seek to pursue tests as part of personalized medicine.

Another major hurdle before such tests become part of standard patient care is ensuring that patients can easily afford them.

The costs of genetic testing have come down dramatically because of lower costs of equipment and computers. Still, these tests can cost $3,000 or more, for example, to detect whether a breast cancer patient is likely to experience a recurrence.

The Molecular Profiling Institute, a spin-off of the Phoenix-based Translational Genomics Research Institute and International Genomics Consortium, offers tests to monitor prostate and other types of cancer.

Lawyers and health care interests worry that personalized medicine will create a caste system of sorts.

"Are we going to create a society with two tiers of patients? Those who can afford these tests and those who cannot?" Roman said.