For doctors, the brochure from a California medical laboratory sounded like easy money: $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.”
But the clinical trial was largely a ploy to boost Proove Biosciences’s revenues, and many of the doctors who signed up did no actual work, say current and former employees.
Proove has grown rapidly by tapping into the public angst over surging opioid addiction.
It is one of many companies touting personalized DNA-based tests backed by little or no credible scientific data showing their reliability.
That’s because a regulatory loophole has left huge swaths of the multibillion-dollar genetic testing industry largely free of government oversight.
A STAT investigation found that Proove employees stationed in physicians’ offices pushed unnecessary tests on patients — a practice called “coercion” by one former manager — and they sometimes completed research evaluation forms on behalf of doctors, rating the tests as highly effective when they weren’t.
In fact, Proove tests of DNA captured by swabbing inside a patient’s cheek were so unreliable that many physicians disregarded the results.
There was scant evidence, said the company’s former chief scientist, that the tests improved patient outcomes.
The company, located in two modern buildings in a burgeoning life sciences corridor in Irvine, Calif., also billed insurers in misleading ways to bump up payments, according to current and former employees and copies of insurance forms.
Promoting itself as the “leader in personalized pain medicine,” Proove claims its tests predict how patients will react to pain medicines and who might become dependent on opioids.
The company has enjoyed glowing television news coverage suggesting it can help combat the opioid crisis.
Current and former employees and doctors who worked with Proove called such portrayals the product of hype generated by CEO Brian Meshkin, who lacks a background in science and is known for his consummate sales abilities and talent for self-promotion.
The government has been concerned about companies marketing tests under the guise of research for several years.
In 2014, HHS issued a fraud alert warning laboratories that some ways of paying doctors for “research” might violate laws against kickbacks for lab test referrals. The alert followed a spate of cases involving allegedly improper payments to doctors by laboratory companies
In response to the HHS alert, Proove’s legal counsel drafted a memo6 for executives and sales staff stipulating that company practices complied with the law.
Among other arguments, it said Proove compensates doctors only for research they personally perform. But current and former employees and doctors who worked with Proove have since disputed that claim.
The Food and Drug Administration warned in 2015 that some laboratory developed tests harm patients by leading to erroneous diagnoses and treatments.
But the agency withdrew proposed regulatory guidelines for these tests late last year, deferring to President Trump’s yet-to-be named FDA commissioner and Congress to decide what, if any, rules to put in place.
For now at least, Proove and similar companies can sell tests without having to show that results are valid and meaningful. STAT obtained Proove laboratory reports9 with gene-test results for six patients that included numerous incompatible clinical recommendations.
A push to swab every patient
The questionable science hasn’t stopped Meshkin from building the privately held Proove into what Deloitte Consulting and Inc. magazine call one of the nation’s fastest-growing businesses.
His formula is simple: recruit doctors as paid “researchers,” providing them with a financial stake in ordering tests for their patients.