Saturday, October 10, 2015

Sunday Globe Special: Providing Some GeneSight

I will be away from the blog tomorrow.

"Genetic tests for psychiatric drugs spur hope, doubts; Business unregulated and science often thin, critics say" by Beth Daley New England Center for Investigative Reporting  October 03, 2015

RUTLAND, Vt. — For the first time in John R. Brown’s two-decade quest for the right medication to make his brain behave, his psychiatrist offered him hope in the form of what seemed like rock-solid science.

By collecting the former editor’s DNA with a quick cheek swab, a new genetic test retailing at $3,800 would reveal which depression medications Brown would likely respond well to and those he would not.

The GeneSight test result helped prompt Brown’s psychiatrist to switch him to a new drug in June, making Brown, 40, optimistic that there might be a path back to a job, an apartment, and even a new girlfriend. But three weeks later he was suicidal, checking into a mental hospital at his therapist’s urging.

“I can’t help but wonder if I should have stuck with the devil I know,’’ Brown now says.

Genetic tests to identify the most effective psychiatric drugs are the hot new technology in the race to create personalized treatments based on people’s DNA.

Yeah, it's all in the genes.

More than 600,000 of these tests have likely been administered in the last three years, based on company websites and research data, to better treat conditions ranging from depression to attention deficit disorder to anxiety. In a nod to the tests’ growing acceptance, the federal Medicare program last year agreed for the first time to pay for the GeneSight test for some depressed patients.

But a review by the New England Center for Investigative Reporting has found that virtually all the evidence that these psychiatric tests work is based on limited studies funded by the companies themselves or researchers they fund, including all five studies used to promote GeneSight on the company’s website.

The federal government doesn’t require companies to prove that this and thousands of other tests are accurate before marketing and selling them. Unlike drugs, the Food and Drug Administration does not regulate them, though that may soon change.

Some of the testing firms’ research practices also raise questions about potential conflicts of interest. For example, California-based Proove Biosciences provides a full-time employee to administer and run a study on the company’s test at a Littleton, Mass., mental health clinic. It pays clinicians for time spent related to the study, a relationship that could give clinicians an incentive to steer patients to the test — and give the company access to insurance reimbursement for those patients.

Patients also cannot find out for themselves if their doctor stands to gain financially by recommending a personalized medicine test. A public federal database created in 2014 to disclose financial relationships between the health care industry and physicians excludes most genetic tests.

“It is the Wild West,’’ said Mildred Cho, associate director at the Stanford Center for Biomedical Ethics, who says there is little published evidence on the effectiveness of drug response tests.

Eric Lander, a leader of the Human Genome Project and founding director of the Broad Institute in Cambridge, goes further, saying in a New England Journal of Medicine article earlier this year that the mental health testing company claims are “not harmless and may be quite dangerous.”

In psychiatry, a field hampered by a lack of definitive tests for conditions and treatments alike, the idea of a genetic test to identify the drugs most likely to be effective is particularly appealing as a way to cut down on the trial-and-error approach to medications that many patients face.

And the tests do hold promise. The basic science behind them is built on years of solid research — analyzing an individual’s genetic make-up to determine how they may respond to drugs. GeneSight’s test was developed using technology from the respected Mayo Clinic and Cincinnati Children’s Hospital Medical Center.

Officials at Assurex Health, the Ohio-based company that makes GeneSight, stand behind their product. They make no guarantee that GeneSight will lead doctors to pick the right medicine for patients, but they point to company studies that show it more than doubles the odds they will. Plus, the officials note, the test underwent close review by a Medicare contractor before the agency agreed to pay for the tests.

“Patients do better,’’ said Bryan M. Dechairo, senior vice president of medical affairs and clinical development for Assurex. “We continue to do more studies” to show the test’s value.

The amount of money at stake is enormous, but psychiatric genetics remains in its infancy. Aggressive marketing and a lack of regulation of tests that have a thin scientific foundation have raised concerns for some bioethicists.

“The claims of these companies are weak,’’ said Robert Klitzman, a psychiatrist and bioethicist at Columbia University in New York who had a commentary published last week in a mental health journal calling for vigilance in the marketing of genetic mental health tests.

Conflicts of interest in the field are major problems,” he said....


Anyone can see where this is going

DNA samples will need to be collected from everyone -- for your own health, of course.