In a reversal of her previous stance, Elizabeth Holmes, the CEO of blood testing startup Theranos, last night announced she’d share the company’s data by opening it up to peer review.
Peer review is the analysis of a researcher’s work by other people in that particular field. It’s a way to add credibility to a study and verify that the results it came to are accurate.
The news came right before the FDA released investigator reports that showed the agency still has many concerns with Theranos’ operations.
Originally, Holmes had said she believed the best way to get her test’s data to the public was through the FDA, which publishes “decision summaries” that explain how they made their choice to either approve or deny a device.
“We chose right or wrong — I really believe in it — that the right way to get our data out in the public domain was through FDA decision summaries,” Holmes said at WSJDLive last week.
Why is peer review important for Theranos?
When it comes to evaluating new medical technologies, such as Theranos’ blood tests, there are a few ways to go about it: One way is by having government regulators, like FDA representatives, review the data themselves and decide whether it’s safe for its intended use. The other is having it validated by other experts in that particular field. Peer review makes the study’s methods transparent so whoever has access to the data can use it to replicate the work. If others can come to the same conclusions as the original researchers did, that adds credibility to the data.
Initial peer review goes through the National Institutes of Health, which selects a Scientific Review Group of people from outside of the federal government, each of whom has to disclose any potential conflicts of interest, such as a medical doctor with ties to a certain pharmaceutical company working on a competing pharmacetuical company’s study. While meeting, they critique the study at suggest changes that could improve it. The peer reviewers can look at a study’s methods, concepts, and results and give their opinion on the data that may or may not support the researcher’s conclusions.
The FDA has similarly strict oversight over trial data in the case of Theranos. There are guidelines, for example, over what is considered a laboratory-developed test. Instead of trying to market the test without FDA clearance (which would be possible, albeit risky), Theranos opted to run everything by the FDA first, gaining clearance for its first test in July.
Having data accessible for both forms of evaluation could help provide more insight into how the technology works on a larger scale.
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