A Winnipeg-based company says it stands behind its role in a study involving an experimental treatment for multiple sclerosis, while at least three patients in Canada have brought concerns about the company's CEO to the RCMP.
Regenetek Research issued a statement Thursday in response to media reports about Doug Broeska, who had recruited MS patients to take part in the experimental and expensive study involving stem cell injections combined with the widening of veins in the neck — a practice that advocates call liberation therapy. The treatments were being administered in India.
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"Regenetek Research stands behind its role in this clinical study — namely as researchers tracking participant progress following medical treatment, with such medical treatment having been provided by third-party medical practitioners located in India," the company's statement said.
An online biography of Broeska states he is "a PhD Medical Researcher and CEO of Regenetek Inc., a Canadian Biotech Research firm working with several hospitals and clinics world-wide to develop medical procedural protocols for neurodegenerative disease management."
Broeska was the principal researcher for the experimental therapy, which was being carried out in India, but his credentials as a researcher have been questioned by some of the patients he had recruited.
Patients said they spent tens of thousands of dollars and travelled to India for the treatment, but some claimed there was little medical followup.
One patient said his MS symptoms worsened after the treatment. However, others have reported improvement and said they believe in the therapy.
"Regenetek Research and its researchers do not provide medical treatment in connection with the clinical study. Further, the study was never intended to replace other medical treatment and individuals were directed to stay in contact with their treating physicians," the company's statement said.
"We are scientists simply tracking the progress of participants who have chosen to attempt innovative therapy options and to have their results noted by us for scientific study."
The company added that participants will have "varying results based on a number of factors — the tracking of which is a key component of the study.
Broeska has not responded to requests from CBC News for an interview. The company's statement was not signed by him, and it does not directly address specific questions about his credentials.
Ottawa woman suspicious of claims
Among those who have contacted the RCMP with concerns about Broeska is Florence D'Eon, a retired nurse in Ottawa who went to Europe for liberation therapy. She had no involvement with Broeska's study or the clinic in India.
D'Eon said she believes in the treatment itself, but she became suspicious of claims being published online about Broeska's work and conducted her own research on him.
'There was no date of birth, there was no way to trace him.' — Florence D'Eon
"The whole thing didn't make sense. The testimonials were so perfect," she told CBC News.
"They did due diligence to Dr. Doug and just in the right spots. It's almost like they were professionally written."
In an email obtained by CBC News, Broeska told another patient that his credentials are sound and he is "competent to perform research of this type."
'There was no way to trace him'
Broeska had stated on a LinkedIn profile that he has a PhD from the University of Manitoba, but the university says it could not find a record of him graduating from there. The profile has since been removed from the site.
"The registrar's office could not find a record of a Henry Douglas Broeska graduating from the University of Manitoba," John Danakas, a university spokesperson, said in a statement.
The university also said it could not find a record of a Doug Broeska having graduated from the institution.
The International Cellular Medicine Society, of which Broeska claimed to be a member, says it has no record of his past or present membership.
He is not a member of the College of Physicians and Surgeons of Manitoba, officials confirmed to CBC News on Thursday.
"You see these doctors at clinics and conferences. They write papers, they write peer-reviewed publications. They have their MDs, PhD," D'Eon said.
"Doug, there was no date of birth, there was no way to trace him."
D'Eon said she took her findings to the RCMP, but she does not believe the police force has acted on them.
The RCMP has not said if it is investigating the claims.
The ethics committee at the Inamdar Hospital in India, where the experimental treatment was being performed, ordered Broeska to step down as principal investigator last month because his lack of credentials and followup "violated international ethical standards."
Patient cancelling treatment plans
Oliver Sinclair, 39, who lives with MS in Durban, South Africa, says he had paid for the treatment and made plans to travel to India on April 1 after he contacted Broeska.
"He said, 'We haven't had one person that hasn't responded positively to our treatment,'" Sinclair recalled.
Sinclair's four-year-old son helped with a YouTube video urging people to help raise $35,000 US for the treatment.
- ON MOBILE? Watch Sinclair's YouTube video
However, Sinclair said he is cancelling those plans after reading of concerns from other patients, including Lee Chuckry of Airdrie, Alta., who told CBC News he believes his MS worsened after undergoing the therapy.
Sinclair said he got his money back, but only after dozens of emails were sent.
"I certainly don't want someone else to make the same mistake," he said.
Sinclair said he still hopes to try stem cell treatment someday, but just not through Regenetek.
University rejects joint proposal
Meanwhile, the University of Winnipeg says it has rejected a proposal for a joint research pilot involving Regenetek in which patients would go to the university for athletic therapy following their treatments in India.
The University of Winnipeg's ethics committee sent back the Regenetek proposal last week with some questions about "who Regenetek was, what type of work were they doing," said Jino Distasio, the university's associate vice-president of research and innovation.
Distasio said the committee rejected the proposal on Wednesday.
"We're quite satisfied that our internal processes were able to flag some issues," he said Thursday.
Distasio said no work had been done on the project, but the university had already accepted $10,000 from Regenetek to hire a researcher as part of the proposed pilot. She will be working on other projects at the university instead, he said.
Manitoba Health Minister Sharon Blady said she cannot comment on specific cases, but she urged people to contact the College of Physicians and Surgeons of Manitoba if they believe someone has misrepresented their medical credentials.
"It is heartbreaking and sickening to learn of individuals who are victims of fraud," she said in a statement.
"They should report this fraud to police who can investigate those who victimize people when they are most vulnerable, and lay charges if appropriate."
The following statement was emailed to CBC News at 6 p.m. CT on Thursday:
Regenetek Research is not available for media comment at this time as this matter has been referred to our lawyers for legal action. Regenetek Research stands behind its role in this clinical study – namely as researchers tracking participant progress following medical treatment, with such medical treatment having been provided by third party medical practitioners located in India. Regenetek Research and its researchers do not provide medical treatment in connection with the clinical study.
Further, the study was never intended to replace other medical treatment and individuals were directed to stay in contact with their treating physicians. We are scientists simply tracking the progress of participants who have chosen to attempt innovative therapy options and to have their results noted by us for scientific study.
Participants will have varying results based on a number of factors – the tracking of which is a key component of the study. This study is unlike, for example, standard double-blind randomized controlled drug trials, but rather is a case study series on a person by person basis. As such, the standards and protocols discussed in the media are poorly understood and have resulted in this clinical study being mischaracterized as inappropriate. In fact, much of what has been publicized is based on misinformation or misunderstanding.
As the matter is now with our legal counsel, we have been advised not to comment any further.