RCMP, Health Canada investigate Winnipeg stem cell researcher

Regenetek head launches civil suit against a former employee

Image | Regenetek patient photo

Caption: Doug Broeska, centre, stands with Julia Browning, right. Seated are Sharon Nordstrom, left, and Kathleen Jaynes, far right. The patients travelled to Pune, India, in May 2014 to undergo combination stem cell therapy. (Supplied by Kathleen Jaynes)

The RCMP and Health Canada are looking into complaints from patients against Winnipeg stem cell researcher Doug Broeska and his company, Regenetek Research, CBC News has learned.
"To date, Health Canada has an open compliance verification file regarding the activities conducted by Regenetek," a Health Canada spokesperson confirmed in an email.
"The necessary follow-up steps have been initiated by Health Canada and are ongoing, although Health Canada cannot comment on the details of ongoing compliance and enforcement activities until such time as all the facts are available to us. Further to our commitment to openness and transparency, should a risk to Canadians be identified, Health Canada will notify Canadians accordingly."
The RCMP in Manitoba, too, confirms it's investigating "several complaints of fraud involving Regenetek."
Broeska couldn't be reached for a comment.
Details of the conspiracy to discredit me are now emerging. - Doug Broeska, Regenetek Research
However, in the last few weeks, he and his public relations firm have provided numerous invoices, financial documents and emails detailing what Broeska claims is an effort by his Indian partners to "push me out and subsequently vilify me as part of a larger scheme to steal my stem cell research protocol and run with it."
"Details of the conspiracy to discredit me are now emerging along with several inconsistencies and questions about the practices of Genesis Ltd and its newest directors and partners," Broeska writes in a five-page statement to CBC News.
Surjo Banerjee, the head of Genesis Ltd., rejects that.
"They are coming up with BS to counter the attacks on them," he responded via email.
"If they are so interested in providing information, please ask them to give you a list of ALL the patients that were treated, ALL the invoices that they received from Regentek Therapies India and ALL the invoices they received from Genesis Ltd. Total them up and tally the transactions."

Broeska sues former staffer

Meanwhile, Broeska is suing one of his former Winnipeg-based employees. Sherry Trudeau worked for Regenetek Research between August 2014 and Dec. 30, 2014.

Image | Doug Broeska

Caption: Doug Broeska is pictured with staff in India. (Courtesy of Surjo Banerjee)

In a statement of claim, Broeska claims Trudeau breached her conditions of employment by copying and keeping confidential patient information, and making unauthorized contact with participants of a clinical study "for the express purpose of causing damage to the plaintiffs, by making false, malicious and defamatory allegations."
The statement claims she distributed confidential information to reporters at the Winnipeg Free Press and the CBC, former Regenetek employees, the Manitoba College of Physicians and Surgeons, the Canada Revenue Agency and the RCMP.
None of these allegations have been proven in court, and Trudeau says she has no comment on advice from her lawyer. She has until Feb. 26 to respond.
One of Regenetek's former patients has launched a GoFundMe fundraising campaign(external link) to help pay for Trudeau's legal fees.
"As a former patient, hearing that Sherry had left her job and that she'd been sued, I thought she could use some financial support," Phoenix resident Kathleen Jaynes said in a Skype interview.
"I wanted Sherry to know there were lots of people that believed in her and supported her."
Jaynes is one of about 70 multiple sclerosis patients recruited by Regenetek to get combination stem cell therapy in Pune, India. It involves widening the veins of the neck, then injecting the person's own stem sells inside.
She has provided documentation showing she paid $20,000 US plus travel expenses to get the treatment in May 2014. Others have paid up to $45,000 US.
It's clearly medical tourism. - Kathleen Jaynes, MS patient
Jaynes says she felt stronger for about a week, but within three months, she had regressed to her original condition. Many patients say they felt better after the procedure, but others saw little or no improvement.
When Jaynes questioned the therapy and followup, she says Broeska and Dr. Susan Hauch suggested talking to her doctor about going off one of her blood-thinning medications, and also recommended a different supplement.
In a previous statement, Broeska has denied providing any medical advice to patients.
"I hope Doug Broeska will be out of business in any form and he will not be able to sell anything to anyone — in particular, a medical procedure to a sick person," Jaynes said.
"It's clearly medical tourism. I don't think there's anything more to say about it."
Concerns surfaced in December after an independent ethics board ruled Broeska's involvement didn't meet international standards.
The Indian research group replaced him as principal investigator for the study and later said it could no longer accept patients recruited by Regenetek.
However, Broeska says the new principal investigator, Dr. Bill Brashier, is the former head of the ethics board that had him replaced.
"I believe Dr. Brashier wrote the letter removing me as Principal Investigator, then he immediately resigned as head of the IECP, joined Genesis the same day and was appointed Principal Investigator of the Regenetek study, in my place," he writes in his statement.
"It is not possible for this timing to be anything but a deliberate conspiracy to seize control of the study both operationally and financially."

Questions raised about qualifications

Around the same time, patients began raising questions publicly about Broeska's qualifications.
In a LinkedIn profile, Broeska claimed to have a PhD from the University of Manitoba. The university says that is not true.
Broeska has produced a PhD certificate from Brightland University as proof of his qualifications. That university is unaccredited in the United States and United Kingdom, and the University of Manitoba confirms it would not recognize a degree obtained from there.
The University of Winnipeg's ethics board has also rejected a proposal to do followup rehabilitation with patients recruited through Regenetek.
Some patients are now questioning the amount they paid for their treatment. Banerjee says the costs for the procedure are $16,050 US.
Others are now trying to organize a class-action lawsuit against Broeska and Regenetek.
Still others asking for their deposit money back, although there is some dispute about which entity should repay them — Regenetek in Winnipeg or Genesis in India.
Australian Kate Millar says she hasn't received a $20,000 US refund for her daughter's treatment, even though she asked for one several weeks ago.
"It's like we're forgotten," she said.