Genetics Lab Pays Doctors to Push Dubious Tests

FBI probes alleged wrongdoing

A STAT investigation has found that employees of Proove Biosciences, a California medical laboratory, paid doctors $30 for every person enrolled in a study of genetic tests meant to help select the best pain medication for each patient. A typical physician could make $144,000 a year in “research fees.” In reality, Proove employees stationed in physicians’ offices pushed unnecessary tests on patients and sometimes completed research evaluation forms on behalf of the doctors, rating the tests as “highly effective” when they weren’t, according to an article posted on the STAT website.

STAT began its examination of Proove late last year after being contacted by current and former employees who had read an article about the dearth of evidence supporting the company’s flagship opioid-risk test.

Separately, the FBI and the Office of Inspector General of the Department of Health and Human Services are investigating possible criminal wrongdoing by Proove. Agents are focusing on possible kickbacks involving payments to doctors.

Proove’s first clinical study subjected to peer review, based on data from 134 patients, was published in late January in the Journal of Psychiatric Research. In it, doctors said that most patients improved after treatment decisions guided by a pain-perception test marketed by Proove.

However, Dr. Eric Fung, a biotech executive who briefly served as the firm’s chief scientific officer in 2015, said Proove’s database of tens of thousands of patient records was mined for any evidence of a testing benefit. He acknowledged that the lack of a comparison group, made up of patients who did not get the test, also weakened the findings. Fung added that he left the company over doubts about the utility of its tests.

“I could not find a good statistical or clinical benefit for these tests,” he said. “I didn’t feel comfortable with the science being done at Proove.”

According to STAT, Proove’s formula is simple: recruit doctors as paid “researchers,” providing them with a financial stake in ordering tests for their patients. Here’s how it works: The firm conducts large trials—two currently aim to test 150,000 patients—that ask clinicians to rate how much various Proove tests helped patients. Company sales representatives pitch “research contracts” to doctors, often targeting financially troubled practices that need a new revenue stream. The reps promise a steady income for light work.

Proove then places some of its 300 employees inside doctor’s offices, and instructs them to try to collect cheek-swab DNA samples from each patient and recruit them for clinical trials. Patients are informed that trial participants will not be billed for test fees. The Proove employees also are supposed to tell patients that their doctor has insisted on the tests, according to the STAT report. Even patients without pain, seen at family-medicine and OB-GYN practices, were enlisted for pain- and addiction-related tests.

Many doctors “would test every single soul who walked in,” a former Proove employee told STAT. “But they didn’t do research. The doctor is steadily getting paid, and did nothing to deserve it except ‘rent’ space [to Proove].”

Proove urges all doctors—whether participating in a study or not—to sign a “standing order” for all of their patients to get any Proove genetic tests, such as those for the risk of opioid abuse, pain sensitivity, and response to opioids and other drugs. Many doctors have been reluctant to sign, but by 2015 about 70% had done so. Examples of orders obtained by STAT authorize Proove “research assistants” to collect DNA from any patient under the doctor’s care.

Previously, Proove’s CEO, Brian Meshkin, had legal problems related to another genetic testing venture. His “nutrigenomics” company, Salugen, sold genetically customized dietary supplements through Las Vegas spas and directly to consumers. Meshkin said he sold the company in 2009, soon after California authorities sent a cease-and-desist letter for improper marketing.

Source: STAT; February 28, 2017.