NEW ORLEANS (WVUE) - When a doctor gives a test to determine if a patient has a potentially serious disease -- doctors and patients rely on that test to be accurate. But questions have surfaced on a test developed in a New Orleans lab and approved based on forged documents.
The test, named Stonewash, was a mouthwash-style test for sexually-transmitted infections created by New Orleans-based Stone Clinical Laboratories. Paperwork for the test was submitted in 2018 for approval. During that year, new research from the Centers for Disease Control and Prevention found 1 in 5 people in the United States had a sexually-transmitted infection (STI).
FOX 8 obtained what was known as a white paper for the test, a document that describes the test and signs off on its validity. But a mismatched signature on that document has one medical consultant questioning the test’s validity and a legal expert questioning whether laws were broken.
“It’s a pretty scary situation,” Dr. Elliot Cazes, a Tampa-based OB/GYN who participated in the project as a medical consultant. “I was led to believe this was a validated test.”
Cazes was hired to consult the project on marketing and use of the Stonewash test.
“What made the Stonewash [test] unique was that this was an oral test for sexually-transmitted infections -- something that nobody else had at the time,” Cazes said.
Tests like Stonewash need a signature from the lab’s medical director to authenticate it.
Dr. Cazes said he saw the white paper for the test.
“I was actually given what’s known in the field as a white paper, which is a paper which shows all of the data to validate a given test,” Cazes said. “You’d like to trust that data, you’d like to trust that paper. And based on what was in that white paper, I believed this was a good test for our patients.”
The Stonewash test’s white paper appeared to reveal Stone Lab’s Medical Director, Dr. Armando Moncada reviewed the report and signed off on the test. FOX 8 obtained other documents signed by Dr. Moncada that appeared to be strikingly different than the signature on the Stonewash white paper. We contacted Dr. Moncada, who is no longer at Stone Clinical Labs, and said the signature on the document legitimizing the test was not his and said it was forged.
Moncada declined to do an on-camera interview but told us he was calling his attorney and filing a complaint against Stone Clinical Laboratories.
Dr. Cazes was unaware of the signature, but after giving about fifty patients the Stonewash tests in 2019, he was told to stop.
“At one point I received a call from the CEO of the lab, Christopher Ridgeway, basically saying the testing we had been doing for several month at that point he no longer considered valid,” Cazes said. “He [Ridgeway] told me the chief medical officer fudged the data and fudged everything in white paper and so the data we are basing validity on was false.
Stone Laboratories and owner Christopher Ridgeway declined our requests for an interview. In a statement, spokesperson Jeff Eller said: “We are investigating the issues raised by FOX 8 and will take all appropriate action if we discover any improprieties.”
“It’s pretty hard to envision this was a mistake,” Cazes said. “A lot of work goes into putting together a white paper that you’re going to present to providers. My feeling is that a laboratory needs to be pretty comfortable and pretty sure with that data. So the idea that maybe this was a mistake -- although I can’t say beyond certainty -- I find it hard to believe this was a mistake.”
Cazes said he is worried about the patients who received the test.
“My concern when I received the phone call and was told this test was not a valid test was that we probably had patients who tested positive for an STD who didn’t actually have one, but now were led to believe they had an STD and we probably had patients who tested negative for an STD using the Stonewash who may very well have had an STD and that’s a major issue,” Cazes said.
Multiple sources have told us the federal government has opened up an investigation into Stone Labs. In October 2020, agents with the Federal Bureau of Investigations New Orleans Field Office conducted what they described as a “court-authorized search” of the Stone Labs offices on Baronne Street in New Orleans.
In a statement, Stone Clinical Laboratories told FOX 8 they are “actively talking with government officials about the information they collected. We will work with them to make sure they fully understand what we do and how we do it. We are confident in our company and the work we do.”
Stone Labs says the Stonewash test was valid, but the lab shut it down when they said supporting raw data was stolen by an employee. Stone Labs sued the former employee they believe was involved and said a determination will be made regarding the Stonewash test when the litigation is resolved.
Tulane Law Professor Joel Friedman said part of the federal investigation likely centers around the signature.
“Maybe they got it signed by unauthorized person because the information in the documentation about the effectiveness of the test is not accurate,” Friedman said. “It could be someone like you and me who has no capacity for assessing the validity of the study they conducted on efficacy and you need a professional.”
Stone Clinical Laboratories received money through private insurance companies and the federal government, through Medicare and Medicaid, for the test. The lab said all patients have been notified but said it had not reimbursed any of those providers for the test.
FOX 8 asked Stone Labs how many tests were administered before the call was made to stop use of the product. The lab responded that “HIPPA [sic] policy will not let us discuss this issue.”
HIPAA, the Health Insurance Portability and Accountability Act, is a federal law that prevents the release of sensitive patient health information. Friedman said the information FOX 8 requested would not be covered under HIPAA.
“That’s a false argument, HIPAA is designed to protect the privacy of individuals’ medical history,” Friedman said. “But if you say how many people came to you this week and took a test – it has nothing to do with that [HIPAA]. You’re not asking for the identity of any individual. You’re asking for the number of people who were tested.
“They are creating a fake defense that doesn’t exist and they’re hoping you’ll just walk away. But you shouldn’t walk away, because this is important. There’s a lot of people out there,” Friedman said.
Dr. Cazes said Stone Labs breached his contract for consulting on the project.
“There came a point when they basically stopped paying me,” he said. “They told me it was due to lack of funds, lack of capital and they were waiting on some investors to get involved. But there’s a significant sum of money that I never received for them for time I spent working for their lab.”
Cazes hopes the federal agencies figure out who is behind the mismatched signature because he fears that might have led to people receiving a false test for sexually-transmitted infections.
“I think that at some point whatever agencies involved need to get to the bottom of this and they need to figure out what happened and potentially there needs to be some punishment,” Cazes said. “I mean, you’re playing with patients’ lives.”
A Stone spokesperson responded to the accusations made by Cazes about Ridgeway calling him and saying the test is no longer valid, “Mr. Ridgeway denies making such claims. He stands by his previous statements about the validity of the test.”
Details on what was seized during the search by the FBI have not been released.
Stone Labs was one of a few labs chosen by the Louisiana Department of Health to perform COVID-19 testing at the beginning of the pandemic. As of December 2020, LDH said the company is not providing COVID-19 testing for the state. LDH did not say why the company is no longer providing those tests.
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