The breakthrough of biotech startup Theranos–making it possible to get a blood test from the prick of a finger rather than a needle injected into a vein–increasingly appears to be too good to be true.
One of the most damaging allegations included in the Wall Street Journal‘s exposè of the company published on Sunday night was that two years ago Theranos deleted quality-control records to make the data from its proprietary machines appear to be more accurate. That type of alleged tampering is so serious because it represents a breach of scientific integrity and is almost unheard of in the biotech industry, legal experts tell Fast Company.
The WSJ report claims that a former lab worker filed a complaint including the allegation with the Centers for Medicare and Medicaid Services, or CMS, after being ignored by a superior.
From the Wall Street Journal:
Before doing the test, the employee put the device through three trial runs with a quality-control sample containing a known amount of the substance the test was supposed to measure.
The lab employee later told federal authorities that the results from the quality-control runs diverged from the known amount by more than two standard deviations, a red flag that suggested possible accuracy problems, according to a complaint filed by the employee.
The company told Fast Company that the incident “simply didn’t happen,” and that the former employee who spoke to the Wall Street Journal about the alleged data-tampering incident was fired for misconduct. The company declined to provide more detail about the misconduct.
Theranos said it has not been provided with a copy of the alleged complaint from CMS, and that it takes lab ethics “very seriously.”
Bradley Merrill Thompson, a lawyer with the firm Epstein Becker & Green specializing in health policy, said companies are legally required to preserve such records for two years after they are created. CMS enforces this rule under Clinical Laboratory Improvement Amendments, or CLIA, which are the set of standards applied to clinical lab testing companies like Theranos.
Thompson said it’s “interesting” that the former employee allegedly filed the complaint with CMS, rather than the U.S. Food and Drug Administration. It’s not clear in this case, he explained, whether the FDA or CMS would have jurisdiction to take legal action if the claims prove to be accurate.
“FDA takes data tampering very seriously, and there are a number of things that FDA might do if a company or researcher submitted false data to the agency,” said Patti Zettler, an associate professor of law at Georgia State University, who previously worked at the FDA.
Such cases are not particularly common. Thompson said he hasn’t come across many incidences where employees at biotech companies have disposed of required records.
“In my thirty years of practicing law, I’ve almost never seen this happen,” he explained. Thompson said he advises companies to ensure they introduce the “right incentives” and avoid unachievable deadlines to ensure that employees don’t take it upon themselves to tamper with results.
In the wake of the damaging reports, many industry insiders are calling for more transparency from Theranos rather than defensiveness. Theranos says it plans to open up its lab to reporters in the New Year.
“This is a public trust issue,” said Thompson. “There are a lot of unanswered allegations.”
This story has been updated.