After more than a decade of evasion, Theranos is finally stepping into the scientific spotlight.
And that’s creating quite a stir.
Elizabeth Holmes, the turtleneck-clad CEO of the once dazzling diagnostics startup, is slated to deliver the first comprehensive rundown of the science behind Theranos’s blood tests on Monday, in front of industry professionals at the American Association for Clinical Chemistry conference in Philadelphia.
But she does not yet have any peer-reviewed data to present.
And it’s not clear how much information Holmes will be able to divulge, given that the company is the subject of both a federal criminal probe and a congressional investigation. Holmes has also been banned for two years from the industry she set out to revolutionize, after federal regulators found deficiencies that posed “immediate jeopardy to patient health and safety” in a Theranos lab.
Given all that, Holmes’ very presence at the prestigious scientific conference — which draws nearly 20,000 members a year — is proving divisive.
“Would you have Al Capone come and talk about his novel accounting practices?” asked Geoff Baird, a clinical pathologist at the University of Washington. “Is it acceptable to allow someone to talk about science if they’ve used that science so horribly inappropriately?”
But others are willing to listen, in part because Theranos has made notable efforts to improve its image in recent months.
The company’s been working to strengthen its scientific backbone: Four former AACC presidents joined Theranos’s board in April. And last week, the company brought on two new executives: a vice president for regulatory and quality issues and a chief compliance officer. (None of Theranos’s board members — or leadership team — were available for comment.)
“The people on her board are people I respect — and if they say [Holmes] has real science, then I am willing to listen and hear her science,” said Patricia Jones, president of the AACC.
Jones calls herself an “eternal optimist,” hopeful that Holmes may, indeed, have substantive data to share. “We’re not endorsing her,” Jones said. “We’re just giving her an opportunity to show us what we’ve been asking her for years — to show us the science.”
Among the key questions Holmes faces: Are Theranos’s woes simply due to poor lab practices? Or is the underlying technology a bust?
In March, a study published in the Journal of Clinical Investigation found that Theranos’s cholesterol tests reported abnormal results more often than rivals Quest Diagnostics and LabCorp. Theranos contested the accuracy of the study — but in May, the company voided results for blood tests run on its signature Edison device in 2014 and 2015. Theranos is now the target of at least nine class-action lawsuits from angry patients.
Launched in 2005, Theranos shot to prominence — and a $9 billion valuation — based on Holmes’s claims that its Edison machines could run an array of diagnostic tests with just a few drops of blood.
The startup attracted support from big-name investors and politicians. But Holmes never disclosed the scientific underpinnings of the technology. A series of Wall Street Journal stories cast doubt on the accuracy of the lab tests. Then federal regulators from the Centers for Medicare and Medicaid Services found flaws.
Today, the company’s worth effectively is zero.
Among AACC members, the company is “uniformly viewed as a fraud,” Baird said, and giving Holmes the plenary stage is “tremendously embarrassing.” He said the group’s private online message board has played host to a heated discussion over whether AACC should have anything to do with Theranos.
“If they presented something that was absolutely fabulous, would I change my mind?” Baird said. “I’m not actually sure that even if they came up with something like a Star Trek Tricorder device that I would care.”
He also takes exception with some of the guidelines in place for Holmes’s presentation: Audience questions are permitted, but only as they pertain to Theranos’s science. AACC has explicitly told attendees that questions about the company’s finances or regulatory concerns won’t be entertained.
Monday’s presentation is so controversial that the AACC put an unusual disclaimer on its official announcement: “Holmes’s appearance does not reflect an endorsement of Theranos or its technology by AACC, and Theranos has not provided any financial contribution to AACC in exchange for the invitation to speak, nor has it provided any sponsorship monies or other forms of grants to AACC.”
An image offensive
Theranos has been trying to present a more open image in recent weeks.
Much of that job has fallen to William Foege, a former director of the Centers for Disease Control and Prevention — and a long time advisor and board member at Theranos.
In an op-ed earlier this month, Foege noted that many scientists were cynical when invited to tour Theranos’s California headquarters and lab. “Initially skeptical, that group of scientists came to realize the tremendous promise of Theranos’s technologies,” he wrote. They later agreed to sign on as scientific and medical advisors.
The company has been “vilified,” Foege told Becker’s Hospital Review this week, for problems with its lab operations, and the lack of peer-reviewed publications. But “changes are being made,” he said.
A Theranos spokeswoman said the company is “in the process of preparing material to submit to publication for peer review.”
But the scientific community isn’t just waiting on publications. It’s also looking for third-party validation — and on that front, Theranos is still coming up short.
Theranos struck up an alliance with the Cleveland Clinic to validate its technology back in October of 2014. Nearly two years later, the parties still have not agreed on protocols to allow the work to proceed. “We are trying to reach an agreement to conduct a study, but that has not occurred yet,” said a clinic spokeswoman, Eileen Sheil.
The Theranos spokeswoman said the company would still like to go ahead with the study.
She also said Theranos is still hiring.
— Damian Garde and Casey Ross contributed to this report.