LOS ANGELES — The head of Talent Testing Service (TTS), Sixto Pacheco, offered a lengthy interview to adult industry trade publications this morning regarding his withdrawal from the PASS testing system overseen by the Free Speech Coalition (FSC).
In the 45-minute interview, Pacheco said he had made that decision after what he described as a long history of frustration with TTS offering the FSC “expertise and knowledge” about testing protocols, and the FSC not being responsive to the advice.
Pacheco also questioned the comments made to XBIZ last week by a competitor, CET’s Dr. Miao, who said that “the government also mandated that the laboratories that are doing the proper, FDA-approved tests [for COVID-19] can charge no more than $100 and not less than $100. You cannot charge more or less, except $100, to avoid price gouging.”
Pacheco said that he was not aware of such a price-fixing and asked to see federal documents mandating the $100 price.
The TTS COVID-19 test, said Pacheco, has a cost of $75; it’s also priced by the lab to talent at $75, although it can be offered for as low as $35 if the tester takes advantage of offered discounts.
As for the FSC’s reluctance to bundle COVID-19 testing with the previous STI tests into the same “green vs. red” system showing availability for work, Pacheco indicated that a debate he had with FSC leadership two weeks ago was the immediate reason for his withdrawal.
“They decided to separate the COVID test from the panel,” Pacheco told the journalists participating in the group call this morning. “We have an issue with that because when you separate the COVID test from the panel, first you have an issue with HIPAA.”
Pacheco also added that in case one of their tests detects an STI transmission or an HIV positive going forward, TTS itself would be in charge of informing individuals and the community through people or "the media,” including calling for a production halt.
A History of Disagreements
“At this time,” Pacheco began his remarks, “we feel that throughout the years Talent Testing has been providing expertise and has been providing to PASS certain knowledge in terms of testing and medical advice for testing performers and our expertise as to what we understand needs to be done for advancing. And it gets to a point where we understand that the advice we are giving and the things we understand that need to be in place to safeguard and protect the talent safety are maybe not put into place, they are not implemented, they are not followed and it gets to a point where we can’t be a part of that anymore.”
“It put us at risk and we cannot be part of that anymore,” Pacheco added.
Asked to mention instances of suggestions TTS had made to the FSC that had been disregarded, Pacheco gave as one example the electronic transmission of results, which he said he has “been trying to push from the beginning.”
“When we transmit clearances over to FSC we do it electronically, there is no human involvement when we do a clearance, these are based on algorithms. When you have negative or non-reactive a transmission was done electronically. Other laboratories punch it in manually, and that’s prone to error, when you have human involvement. We have pushed for other laboratories [that are part] of PASS that they should have a system where clearances are pushed electronically.”
Pacheco says this was but one example of a history of disagreements regarding PASS implementation between himself and TTS, and the FSC.
“It’s a progression,” Pacheco added. “When you provide help and expertise and that expertise and that help, in order to move forward a system or a process to protect the industry to the best of your ability, to implement things so that talent’s health and well-being is protected to the best of your ability, and that [ability] is hindered because certain resources are not available... then why would TTS be subjected to that?”
Another issue was a standardized auditing system for bringing new labs into PASS.
“There has to be a way that when you bring in other labs, you have to have a system where you need to audit laboratories,” Pacheco said. “How are you gonna add other labs into the PASS system when you don’t know who these labs are? Do they comply with clear requirements? Do they have [the proper] accreditation? Are they FDA compliant? Who is their medical director?”
Pacheco claims “an accumulation of things” have been provided to PASS and FSC by his company “in order to make the PASS program excel and be a great program, and those things keep being ‘Yes, those are great ideas,’ ‘Yes, we’ll look into it’ and nothing gets done.”
The TTS COVID-19 Test Disclaimer
XBIZ asked Pacheco about the recent interview with CET’s Dr. Miao, who had questions about the FDA status of the COVID-19 test being currently offered by TTS.
Miao told XBIZ that “the government-set cost for an FDA-approved test is $100, so pricing should be somewhere around $100, or a little less or more if the drawing center is taking a loss or adding a small profit.”
Earlier during the pandemic, Miao said, “because of the urgent need to get tested to try to control the pandemic, the FDA allowed a whole bunch of laboratories to do the testing. And now they are realizing, some of the tests are good and some of them are worthless, which is not a good thing.”
During last week’s interview, Miao stated that “our competitor, TTS (also known as Biocollections Worldwide), is offering COVID-19 testing for $35 and I’ve seen a copy of their results that has a disclaimer saying ‘this is not FDA approved.’ So I’m very concerned because I know the cost to run a proper, FDA-approved good test has to be at least $100 or a little more or a little less depending on your pricing strategy.”
XBIZ repeatedly attempted to contact TTS and BioCollections Worldwide principal Pacheco before it ran the interview with Miao. Today, Pacheco apologized about his lack of response at the time and offered his answers to Miao's questions.
“FDA does not ‘approve’ tests,” the TTS director explained today. “FDA provides clearances for tests. FDA approval of tests is an incorrect terminology. There’s no FDA-cleared test for COVID. That does not exist.”
“Every COVID test that is being performed at TTS is under an ‘EUA’ or Emergency Use Authorization. Biocollections has secured an EUA from the FDA, so when Dr. Miao indicates that we are performing a non-FDA approved test for COVID, this is a false statement.”
As for the disclaimer included with TTS results, which Pacheco said he did not have handy during the interview, and would not read to or share with the journalists, he alleged it’s “mandated by the FDA” as part of the EUA.
The TTS results sheet that XBIZ has seen for their SARA-CoV-2 RNA Real-Time RT-PCR test states that it was developed by Biocollections Worldwide in compliance with a “Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency” issued by the FDA on February 29.
TTS' own disclaimer states, “this test has not been FDA cleared or approved.”
Bundling COVID-19 Testing Into PASS
In the most emotionally charged part of the interview, Pacheco was then asked about his decision to withdraw from PASS in the context of his insistence to bundle COVID-19 testing with STI testing.
Pacheco sees his crusade to include the TTS COVID-19 test into the PASS protocol in very personal terms, repeatedly insisting that he could not sleep at night thinking about the health and safety of the adult performer community.
“This is an infectious disease!” an impassioned Pacheco repeated several times. “People are dying!”
Pacheco explained that TTS “included COVID in the panel back in early May and we did this because we saw that there were still individuals that were testing. We were under the impression that people were still shooting and we understood and saw the curve of infection under the testing that we are doing.”
Pacheco insisted his perspective was shaped by non-adult-industry testing he oversees in the Fort Lauderdale, Florida, area as the director of Biocollections Worldwide, and mentioned prominent government and corporate clients in South Florida, including Broward County, the Broward Sheriff Office, and the city of Key Biscayne.
“We were seeing a spike coming, and because of that we decided that it was important that we would not exclude talent, to not be protected, of not knowing of a COVID status,” Pacheco explained. “It was important that they knew their COVID status.”
“COVID is a novel, infectious disease. We are learning of it, we are in the infancy of trying to figure out how it moves, how it transmits, how it propagates,” he added.
“We needed to protect the talent as much as you could. If people were shooting, we needed to do that. We were telling the FSC, ‘You need to make a decision now — you need to protect the talent.'"
“I was not sleeping well at night knowing that people were getting the Gold Star panel and not being tested for COVID. If we have the ability to test for COVID, then you include it in the panel.”
“And that’s why we implemented that,” Pacheco stated.
Two weeks ago, FSC informed Pacheco that they had decided to separate the COVID test from the panel.
“We have an issue with that because when you separate the COVID test in itself from the panel, first you have an issue with HIPAA. Now you’re looking at a particular test, and you know what test it is.”
After several of his objections to separating COVID-19 testing from PASS were dismissed, Pacheco decided he'd had enough.
“You know what?” he told XBIZ during the press call this morning, “no más — I’m not gonna be taking part of this anymore. I’m sorry. I’m out.”
“In order for me to sleep at night, things have to make sense, and this didn’t make sense,” Pacheco said.
TTS, he added, “will have our own procedure” in case of an STI situation. “We contact the talent, our doctors do their thing, that’s second nature.”
Pacheco added that in case of an HIV positive result, “we shut the industry down” through “the community and the media.”
The Bearer of That Weight
Questioned by XBIZ about the FSC’s argument that the difference between testing for STIs and COVID makes it difficult to bundle all the tests into the pre-COVID PASS system, Pacheco denied that was an issue.
“It’s an infectious disease!” he insisted. "A transmissible disease. An infection that can make you sick. People are getting sick, people are dying.”
“It doesn’t matter if it is an STI or not an STI. The only thing that is gonna get us away from this is when the vaccine comes out. But if it’s an STI or not an STI, it doesn’t make a difference. People need to know their status.”
Pacheco finished by stressing that his laboratory operates under “an EUA issued by the FDA that provides the use of these assets for protecting the population against SARS, COVID-19. It’s the best we can do right now, and it’s gonna get better.”
“I am giving you the best-in-class testing for a pandemic that’s out there right now to protect the talent.”
“Otherwise, don’t test. And that won’t make me sleep well at night. If you prefer not to test, don’t test, but I’m not gonna be the bearer of that weight.”