Ex-worker: Thanedar wouldn’t report spiked drug to feds

Lansing — A former employee of Shri Thanedar, a Democratic candidate for governor, says he quit Avomeen Analytical Services in 2014 after Thanedar refused to alert federal regulators to a customer suspected of illegally spiking a male “herbal supplement” with prescription Viagra.

Joel Crookston, who began as a quality assurance manager at the Ann Arbor chemical analytical company in 2013, made the claims in June 2017 during a sworn deposition as part of an unrelated lawsuit over polling place photography.

In the deposition, Crookston told a state assistant attorney general he went around Thanedar and personally reported his concerns to the U.S. Food and Drug Administration after Avomeen analysts discovered a customer’s product marketed as an herbal supplement for men contained Viagra.

Crookston said he later chose to quit the job because he “was having difficulty” with Thanedar, who he claimed eventually learned about his report to the federal agency.

“We didn't see eye to eye on quality,” Crookston said in his sworn testimony. “There were a couple of instances of things that were very questionable to me that I, I ended up reporting something to the FDA unbeknownst to him because he didn’t want me to.”

Thanedar said Thursday he remembers Crookston but denied any memory of the herbal supplement or customer in question. Working as CEO of the firm at the time, Thanedar said he was not directly involved in day-to-day projects.

“We ran our business very ethically and transparently,” he said. “I don’t have any understanding of this particular situation, but we did work for clients who asked us to do analysis, and we would report that back to the client.”

Crookston first told The Detroit News a similar account late last year, but a reporter couldn’t independently verify his allegations at the time. The News on Thursday obtained a transcript of his sworn deposition.

A former analytical chemist at Avomeen, who asked his name be withheld because he still works in the field, told The News he recalled Crookston saying multiple times he was going into Thanedar’s office to discuss the herbal supplement and seeing him do so. But Crookston said afterward he was not able to convince Thanedar to take action or drop the client, the co-worker said.

The product was called S.W.A.G., short for “sex with a grudge,” Crookston told The News in multiple interviews. He suggested his report may have prompted FDA action, including an April 2014 alert warning consumers that S.W.A.G. contained sildenafil, the active drug in Viagra.

The federal agency could not immediately provide information about any complaint that may have triggered its review of the product. The News is seeking documents through a Freedom of Information Act request.

The undeclared sildenafil could interact with other prescription drugs and “lower blood pressure to dangerous levels,” the FDA said in the alert, issued after its own laboratory analysis. The agency urged consumers to throw away any remaining product and consult a medical professional as soon as possible.

The FDA also sent an August 2014 warning letter to S.W.A.G. parent company owner Baronne Fleming, demanding he remove inaccurate statements from a website claiming the “misbranded drug” was safe for users with high blood pressure.

Crookston said he thought Avomeen had a moral and legal obligation to report S.W.A.G. and drop Fleming as a customer.

“We need to report this and sever ties with this company because we’re registered with the FDA,” Crookston said in the deposition, recalling an alleged conversation with Thanedar. “Morally it’s the right thing to do. And he was not okay with that so I ended up reporting it to the FDA on my own.”

A phone number associated with Fleming’s Maryland-based company was disconnected as of Thursday, and he could not be reached for comment. The Baltimore City Paper reported in 2015 that a suite address listed in company paperwork no longer existed.

Local critics told the newspaper they thought the product name and packaging, which featured stick figure images of an erect male standing over women with smoking and burning genitals, promoted and normalized rape.

Thanedar said he has no recollection of S.W.A.G. or Fleming. In general, he said, Avomeen officials often “don’t know what the client is sending us.”

Asked if he recalled working with Fleming or S.W.A.G., Avomeen senior technical director of product development Evan Boyst said Thursday he could not respond.

“Unfortunately, I can’t talk about any clients past or present without their permission to disclose whether I have or have not worked with any of them,” Boyst said.

Thanedar, who sold a controlling stake in Avomeen in late 2016, said he had not heard about Crookston’s claims until Thursday.

“If that’s what he felt and that’s what he did, then fine,” Thanedar said, noting Crookston voluntarily quit the company. If Crookston did report a client’s product to the FDA, “we wouldn’t take any kind of action on him,” Thanedar said.

The scientist entrepreneur describes Avomeen as a “problem-solving” company. Customers ask the chemical testing firm to analyze products, and the company reports its findings back to the customers, he said. Thanedar retains a minority interest in Avomeen but no longer runs it and is fighting a separate lawsuit filed by its new owners.

“We worked with thousands and thousands of products,” Thanedar said. After conducting a chemical analysis, “we give a truthful answer” to any questions the customer had about a product.

In one case, he said, a mother asked Avomeen to analyze medicine from a compounding pharmacy that was making her child sick. They found it was 10 times more potent than it was supposed to be, Thanedar recalled.

“We reported it to her, and then she reported it to the pharmacy. But we don’t take it upon ourselves to go and sue the pharmacy, because we don’t have the resources,” he said. “Our role is to do the analysis and provide good quality data to the person who is coming to us. And we will make no compromise there.”

Crookston described his experience at Avomeen under oath as part of a separate lawsuit he filed against the state over its longstanding ban against so-called “ballot selfies.” Secretary of State Ruth Johnson is fighting the case and seeking dismissal.

During the deposition, Crookston was asked about his personal history and whether a new job he had at Pfizer was a step up professionally. “Not necessarily,” he said, going on to describe his previous work at Avomeen and frustrations with Thanedar.

Assistant Attorney General Ann Sherman, representing Johnson from the office of Attorney General Bill Schuette, a Republican candidate for governor, asked Crookston whether he had gotten along with Thanedar prior to the alleged dispute over the FDA report.

“Absolutely,” Crookston said. “Yeah, he really appreciated what I did for his organization in term of putting him into compliance.”

Thanedar, is competing for the nomination against former state Senate Minority Leader Gretchen Whitmer of East Lansing, former Detroit health director Abdul El-Sayed of Shelby Township and former Xerox executive Bill Cobbs of Farmington Hills.