The most awful thing for Brian Meshkin was the Federal Bureau of Investigation raiding Proove Biosciences Inc.’s Irvine headquarters and making “political theater about it” with media on-site.
The former chief executive of the genetic testing company said the agency didn’t find any evidence of wrongdoing after more than a year of going through company records and materials, and no charges have been filed. He told the Business Journal his attorney informed him that the grand jury that was looking into allegations against Proove expired.
“The company never filed for bankruptcy but ultimately shut down because it was impossible to do business after that,” he said.
It went into court-ordered receivership a year ago.
He currently serves as a managing partner of Newport Beach-based Profound Ventures LLC, a healthcare investment firm that he started this year targeting early-stage opportunities.
Proove’s tests were designed to help doctors make more informed decisions, taking DNA samples gathered through patient cheek swabs to analyze their pain thresholds and predisposition for addiction to prescription opioid pain killers.
Meshkin said similar laboratories or diagnostics companies don’t recommend specific medical care but provide insights. He told the Business Journal in an earlier interview that pain is the most prevalent and most expensive healthcare condition in the U.S. and that he started Proove because he believes there must be a better way to understand and manage pain than, “on a scale one to 10, how intense is your pain.”
The opioid risk tests took off along with the opioid abuse epidemic.
Opioid overdose-related emergency room visits increased 30% last year, according to reports by the Centers for Disease Control and Prevention. The OC Health Care Agency said the rate of opioid-related emergency department visits increased more than 141% from 2005 to 2015, and that seven out of every 10 overdose deaths from 2011 to 2015 involved opioids, according to a 2017 report.
Proove was founded in December 2009, and by 2015, it had 170 employees and was generating $17 million in revenue. It reached 278 employees and $28 million in revenue the year after. It was ranked among the nation’s fastest-growing firms by Deloitte Consulting and Inc. Magazine. Meshkin won a Business Journal Excellence in Entrepreneurship Award in 2016.
Meshkin had plans to recruit more doctors and monetize Proove’s databank, citing great value in accessing genetic information combined with pain medication outcome data. Then Charles Piller wrote his first story. Meshkin blamed the investigative reporter, writing for the health-news website STAT, for starting a series of “erroneous and damaging” stories that tanked the company.
He said Piller based his stories on false allegations from disgruntled employees he’d fired and that the reporter ignored the documents Proove provided. “He had the story he wanted to write,” Meshkin said.
In an email response, Piller told the Business Journal that he wrote four articles about Proove while he was at STAT and that he “stands by all of my articles as factually accurate and exceptionally fair.”
Piller is now an investigative reporter for Science Magazine.
He quoted scientific experts, including researcher Dr. Mary Kreek of Rockfeller
University who said Proove’s test was “hogwash.”
“Proove is one of an expanding number of players in the multibillion-dollar genetic testing market that promote tests unsupported by hard data to doctors and consumers—and because of a regulatory loophole, it’s all legal,” he wrote in a December 2016 article.
Meshkin said the company spent $20 million on research and development.
“Proove’s technology involved laboratory tests that used algorithms, which combined genetic, environmental, lifestyle and demographic information to better understand patient sensitivity to pain and predict risk for opioid abuse,” Meshkin said. He told the Business Journal that Piller gave false information to his scientific experts to get them to react the way he had wanted, “By asking the misleading question, ‘Can you have a purely genetic test to predict addiction?’”
Meshkin agrees that it was not possible to have a purely genetic test to predict opioid addicts.
He said Piller was told that Proove’s test “was not purely genetic but basically a 50-50 split between genetic and nongenetic factors.”
The articles also said Proove promised doctors research fees in exchange for participating in the company’s clinical studies.
Meshkin said the studies were all approved by an institutional review board and independent research ethics committee, followed good clinical practices guidelines and were listed on ClinicalTrials.gov. He said doctors don’t need to be associate clinical investigator to order tests. The average researcher at Proove was paid about $500 per month for performing about 3 1/2 hours of research services, in-line with the national average of about $150 per hour, he said.
As to Piller’s claim that Proove tried to “test every patient,” whether there was a need or not, Meshkin said nothing could be further from the truth. He said that on average in a pain management clinic “doctors would see an average of 20 to 30 patients on a given day, and out of those patients the doctors would order Proove tests on one to two patients.
Piller said STAT received a letter from a crisis-PR agency representing Proove after his second article appeared.
The letter “alleged inaccuracies in my first two stories … my editors and I evaluated the claims carefully. We found that none of the allegations about my stories made by Proove’s representatives was accurate, so no corrections were made,” he wrote in an email. He added that he spoke with the executive of that PR agency and that the executive said that his firm is no longer representing Proove and that “STAT and I should consider the letter to be formally withdrawn.”
Meshkin said he chose to keep quiet so that there would be no suggestion that he was interfering with a government inquiry—the Business Journal had reached out to Meshkin over the course of last year, but he declined to comment on the investigation—and he will be filing “defamation lawsuits against all those who created these false allegations and those who spread them” at the end of this month.
Meshkin’s venture fund is a “social entrepreneurship accelerator that is helping profound social problems.” Profound Ventures plans to make seed investments in the five- to low six-digits, starting with healthcare opportunities. The current portfolio includes technologies to help people age at home.
He’s not giving up on pain. He said Profund will launch new analytics technology that focuses on pain and opioid overdose.