Company packaged nasal spray in laundry room


People who think they're seriously sick from mold exposure in their home or office often complained they aren't treated seriously by traditional doctors.
 
That's why some turned to alternative medicine. But alternative can also mean unproven.

Gainesville-based Biotrek Laboratories sold mold tests over the phone to concerned people who found the company on the internet. Some of those desperate and suffering patients may not like what the FOX 5 I-Team uncovered: videos shot by one worker showing testing materials not in a sterile location... but loaded into a pickup truck.

"What I'm transporting... which is medical testing from my administrative house so the company I'm working for doesn't get in trouble," Biotrek worker Cole Chambers said into his phone as he moved the supplies in November 2015.

Why did he think it was important to record what he was doing?

"To prove a point," he told the FOX 5 I-Team. "These are peoples' lives that we're messing with and it's unacceptable."
 
Chambers said he took direction from Michael Pugliese of Gainesville, a self-proclaimed international expert on mold exposure connected to companies like the one he advertised on YouTube, which is now closed.
 
"Or pick up the phone and speak to an expert," Pugliese said on the video. "The NMRC. The National Mold Resource Center. People helping people with their mold problems."

Patients around the country tell the FOX 5 I-Team they traveled to the National Treatment Centers for Environmental Disease in Alpharetta, where Pugliese offers his advice. An office visit requires $3300 up front. Special nasal spray and vitamins cost hundreds more. But the spending doesn't stop there.

 "We'd go through your symptoms and I would sell you a test," remembered Khal Hamin, another former Biotrek employee.

The company sold urine mold testing kits -- called mycotoxin tests --  to people worried about mold exposure. Cost: $599. But twice the Centers for Disease Control publicly criticized those tests, calling them "inappropriate and unvalidated" and said they needlessly scared government workers in Chicago and Oklahoma into thinking they had deadly mold in their office space.

"I think we all felt something was wrong," Hamin recalled. "We just didn't understand what was wrong."

According to the FDA, those Biotrek urine tests for mold are not approved for use on humans. Why? Because most of us eat food with tiny amounts of mold, like raisins or cheese. The government says that would guarantee a positive test even in healthy people… because what shows up is likely what you've ingested… not what you've inhaled.
 
Kahl Hamin says he sold as much as $10,000 worth of lab tests for Biotrek each month.
 
"Did you ever see a negative?"

"No."

"How many tests did you see?"

"I sold maybe over 500 tests. And I never saw a negative."

"Does that concern you?"

"Yes."
 
Sherri Higgins was in a group of seven family members and friends from various cities who all traveled to Atlanta for treatment.
According to her complaint to the Georgia Medical Board, all got the same result, positive for mold.
 
"In the exact same concentrations," she told during a Skype interview. "So that means none of us were any different which would seem almost impossible."

Biotrek's attorney would not comment about those results, but did confirm that Biotrek was forced to stop processing testing samples last year after government inspections raised questions about their accuracy.

Even though the Gainesville testing company and the Alpharetta mold clinic share office space and family connections, federal law forbids them from referring business to each other. And that brings us back to that November errand which had Cole Chambers so concerned.

Here's what Cole said into his phone that day.

"My bosses don't want to get in trouble with having all this medical testing that they order from labs they put together in the house because CLIA's inspecting them and they're going to get in trouble."
 
According to Chambers, the company was worried when state health inspectors representing a lab certification agency called CLIA showed up... the company worried because he said Biotrek was secretly packaging the testing kits in this old building in Gainesville.
 
"They asked me personally to remove all the test kits from that house and take them over to a warehouse," Chambers stated. "The test kits and the testing and the specimens should have never have been in that house."
 
All those testing supplies to be sent to sick people around the country --  loaded into a pickup truck. When we played the video for Sherri Higgins, she was stunned.

"Oh my God," she said as she put her head into her hands. "Looking at the video you just showed us, I'm sick. More sick than when I started. This is not even funny. This is horrific and I can't believe that he's gotten away with it."

We tried talking to Michael Pugliese outside his Gainesville office, but he didn't like our questions. Any of them.

"There's three sides to every story," he told us. "His, hers and the truth. Come back."

 "Yeah, I'm here to get the truth," I said. "And I'm wondering, are you trying to hide information from CLIA when they came to investigate who was here?"

 "You know what?" Pugliese asked. "Just get out of here."
 
Finally, one more video Cole Chambers recorded. Remember those special Pugliese minerals and nasal spray sold to sick patients around the country? Chambers said this he was taught to package them without gloves or a mask, sitting in the laundry room of that century-old Gainesville building frequented by Pugliese and his longtime companion Deborah Muchwart, the CEO of yet another mold testing company, Biotrek Direct.
 
"And I'd get a blow dryer, a pink blow dryer and I would turn it on and it would heat the plastic seal which would close the bottle to where it would seem like it was coming from an actual like pharmacist when really they were being made in a laundry room," Chambers told us.

Pugliese's attorney said if those minerals were packaged in the laundry room it happened only once. Two other former employees confirmed it was a routine practice.
 
Patients already worried about germs now have new worries.

"They could be completely contaminated with anything," warned Sherri Higgins.

She asked government regulators to take action, but so far neither state nor federal authorities have commented.