With government authorities warning an anxious public about scams related to the coronavirus, a California company is facing scrutiny by members of Congress and the city attorney of Los Angeles for selling COVID-19 test kits that it claimed can be used “in the home or at the bedside.”

The Food and Drug Administration has stated unequivocally that it has not authorized “any test that is available to purchase for testing yourself at home for COVID-19.” Yet at the end of March, Wellness Matrix Group, a company based in Huntington Beach, Calif., offered such a test at a cost of $49.95. “These tests,” the company promised customers, “are legitimate and have been vetted and approved by the U.S. Food & Drug Association [sic].”

Several customers who ordered the tests now say they never received them and have tried to cancel their payments.

The company has since come to the attention of authorities. On March 30, after NPR reached out for comment about Wellness Matrix Group’s products, investigators for the House Committee on Oversight and Reform sent the company a letter seeking information about its purported in-home test. Investigators also had questions about a $500 sanitizer that the company claims “kills corona on contact.”

Separately, LA’s city attorney, Mike Feuer, says his office has sent a cease-and-desist notice to the company regarding its test sales.

The queries from investigators coincided with several changes to websites where the tests were being sold by the company. A graphic stating that the product was FDA “approved” became FDA “registered.” A reference to testing “in the privacy of your own home” was removed, as was a line stating “At-Home Kit.” NPR documented these changes on the platform archive.is.

One site abruptly stopped working on March 27, only to return on March 30 at a different address. Finally, on March 31, the company appeared to stop offering products for sale and claimed in a statement that it was “always our sole intention” to sell the test “as a point-of-care system,” meaning for use by health care providers.

The company also offered to “provide telemedicine services” to customers who still wanted to receive the tests, “so that they may appropriately use the test as directed.” For those who didn’t, the site offered an “immediate refund” for any customer who wanted one.

In an interview, David Saltrelli, Wellness Matrix Group’s vice president of marketing, insisted that the company’s tests are indeed real and FDA approved.

In a statement, an FDA spokesperson reiterated that the agency “has not approved an at-home test, whether a health care provider walks them through the process or not.”

Frightened customers

Charles and Chelsey Goodan, a Los Angeles couple, say they learned about the Wellness Matrix Group test through a friend.

At the time, Chelsey Goodan says, she had started feeling sick and worried she might have contracted COVID-19.

“My chest felt like I had smoked a pack of cigarettes,” she says. “I was just freaked out.”

Charles Goodan says he has parents in their mid-70s nearby, who are at higher risk in the pandemic.

Given the nationwide shortage of tests, Chelsey Goodan says, “we were scared of not having access to tests.”

So when the two got an email about the test, they decided to buy six, just in case. With shipping and taxes, they spent a total of $333.70.

Other friends also put up money.

Max Sloves bought a kit because he wanted to visit his mother on her 84th birthday. She is bedridden and in hospice care with Alzheimer’s disease.

“She’s not in a condition where I can FaceTime with her and have her even be responsive at all,” says Sloves. “The ability to put your hand on someone’s shoulder right now in her condition is really meaningful.”

But Sloves says he didn’t think it was safe to visit his mother unless he was certain he did not have the virus.

“I just felt like it wouldn’t be responsible, ethical [or] safe to be around her without having some level of certainty that I’m not contagious,” says Sloves.

Anna Galle and her husband, PJ Sodaski, spent $246 on four tests. They were especially concerned about the shortage of testing nationwide, because Galle is pregnant.

Sodaski, Galle, Sloves and the Goodans all say they received receipts for their purchases but never received messages with shipping information. Now, more than 10 days after ordering, they say they still have not received any actual tests.

Explanations from the company

In filings with the Securities and Exchange Commission, Wellness Matrix Group describes itself as a start-up, with “plans to combine the latest innovations in Artificial Intelligence (AI), Virtual Reality (VR), Augmented Reality (AR), Medical Technology (MedTech) and clinical research.”

After unsuccessful attempts to contact representatives of the company and its CEO, Barry Migliorini, NPR was able to reach Brian J. Esposito, a New Jersey man who describes himself as an outside adviser for Wellness Matrix Group.

“It is with great pleasure to announce the rollout of #coronavirus at home testing kits,” Esposito wrote on March 23 in a since-deleted tweet.

Esposito agreed to set up an on the record phone interview with himself and Saltrelli, the company’s vice president of marketing.

When asked whether he had any experience in the health care industry, Saltrelli said, “No, other than that I’ve used it.” Saltrelli said his primary experience was in marketing. Esposito said his experience in health care came primarily from his work in the “beauty and personal care space.”

With the growing coronavirus pandemic, Saltrelli said, the company had been working for “several months” on finding and distributing a suitable at-home test. “It made sense,” Saltrelli said, “to offer it as a test that people could buy from us and take the test at home.”

“The biggest thing was getting FDA — you’ve got to send it in there,” Saltrelli said. “Obviously, you’ve got to make sure of the accuracy of the test. You just can’t pull a test out of nowhere.”

Saltrelli said that the company had indeed won approval from the FDA but said “you’d have to ask the attorneys” for details about the testing and approval process. He was unable to answer questions about why the FDA explicitly states that it has not approved any at-home tests.

“I don’t know how to answer your question, OK,” Saltrelli said. “Other than, it was normal.”

Nor could he address why one of the company’s websites included an FDA registration form for a product called “CoronaCide.” Not only does that product lack FDA approval for at-home use, but a representative for the Utah-based company that makes it said it had no affiliation with Wellness Matrix Group.

Asked about the information on the website linking to the FDA registration for CoronaCide, Saltrelli said, “I’m not familiar.”

As for the manufacturer of the kits, Saltrelli said, “we’re not going to give you the exact source,” adding, “Right now, we’re sourcing them from Hong Kong.”

He said he was unfamiliar with another claim on the website that said the tests were actually made by a biotech company in mainland China, the Hangzhou Biotest Biotech Co.

Saltrelli also declined to answer questions about sales through the website.

“Obviously, there’s a huge demand,” Saltrelli said. “We’ve just got to make sure we’ve got enough coming in to cover it.”

Addressing his own role in the company, Esposito said, “My job is to bring awareness to the products and get them into as many people’s hands as possible and hopefully help people.”

Because the interview left questions about the company’s testing and activities, NPR again called the main phone number at Wellness Matrix Group to obtain additional comment. The person who answered declined to provide a name, complained about a “dirty reporter” and hung up.

Questions about past work

Past legal actions against Saltrelli and another figure involved with Wellness Matrix Group, George Todt, raise additional questions about the company.

In the 1990s, the Federal Trade Commission sued Saltrelli and others in federal court, alleging that they “deceptively marketed travel packages to consumers through a network of telephone salesrooms and allegedly aided and abetted the telemarketers in deceiving consumers.”

According to filings with the Securities and Exchange Commission for another one of Saltrelli’s business ventures, the FTC obtained a permanent injunction against Saltrelli, barring him for life from certain business practices around telemarketing and the travel industry.

Saltrelli — then and now — has denied any wrongdoing. He said that the FTC case should not reflect on his work on coronavirus testing.

“The two have nothing to do with each other,” Saltrelli said. “Everybody, including every single congressman, every politician, has done certainly the exact same thing at some point.”

NPR reached Todt on Twitter, where he describes himself as a “Father, meditating visionary, creating internet III.” On March 19, he tweeted, “Home test kits now! Fda approved.”

Todt also registered the domain name www.cs-28.com, one of the sites selling the test kits, according to the Web domain registrar GoDaddy.

He posted a video promoting a coronavirus-killing “virucide” from Wellness Matrix Group with which you could supposedly “build a force field around your event or even spray your entire city.” Both the city attorney of Los Angeles and members of Congress have requested information about these disinfectant products.

In an email to NPR, Todt wrote that he performs “business development” for Wellness Matrix Group.

When emailed a series of questions about the test kits, Todt replied that he was willing to address them only in a live TV or radio interview.

“I’m not interested in you twisting & taking me out of context,” he wrote. He declined to answer questions posed by NPR. He did, however, send an email stating, “Every person has the right to test themselves [and] you are stopping that.”

In 2005, Todt was sued by the SEC. The commission alleged that Todt “orchestrated two fraudulent schemes” in which he disseminated “false and misleading information” to artificially inflate a company’s stock price — a practice commonly known as a “pump and dump” — and also issued “unregistered securities” for penny stock companies. A federal court ordered that Todt be “permanently barred from participating in any offering of penny stock.”

In a letter to NPR regarding this story, Hardy L. Thomas, an attorney representing Todt, wrote that his client “has not and does not intend to promote penny stocks or any other security in the public markets and no evidence exists to the contrary.”

“It feels really so morally corrupt”

In any public health crisis, experts say scams are common.

“Whenever we have diseases or conditions that lack good treatments, we tend to see companies come out of the woodwork marketing products and preying on people’s hopes to treat those conditions,” says Patricia Zettler, a law professor at The Ohio State University and a former associate chief counsel at the FDA.

When the FDA finds a problem with a more established company’s claims, the agency will generally start by sending a warning letter.

“If a company is not a repeat player with FDA and is a fly-by-night, snake oil sales company, warning letters may be less effective,” says Zettler.

The Trump administration has promised to “aggressively” prosecute fraudulent schemes related to the pandemic.

The FDA does have the ability to bring both civil and even criminal actions against companies that flout the law, Zettler says. As of now, the FDA has not publicly announced any action against Wellness Matrix Group.

Feuer, the LA city attorney, says his office set a deadline of April 2 to receive more information from Wellness Matrix Group. The company’s answers, he says, will help determine whether his office will pursue action in court.

Several customers of Wellness Matrix Group say they feel embarrassed and duped by the company.

“I definitely feel taken advantage of,” Chelsey Goodan says. “It feels really so morally corrupt that anybody would take advantage of people at this time.”

Because he didn’t receive a test, Sloves was not able to visit his mother on her 84th birthday.

“To think that someone would prey upon people’s known anxieties and fears in a moment just so fraught with uncertainty and panic,” says Sloves, “it’s so repulsive.”

NPR’s Barbara Van Woerkom and Huo Jingnan contributed reporting to this story.

Copyright 2020 NPR. To see more, visit https://www.npr.org.



Source link