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This article was published 18/1/2015 (2723 days ago), so information in it may no longer be current.
The Winnipeg physician who worked closely with a now-discredited medical researcher says she was "duped" by Doug Broeska and is shocked by recent revelations.
"Scammed, yes. Duped, yes," said Susan Hauch, a physician and associate professor at the University of Manitoba medical school. "We’ve all been duped."
She said she’s shocked by news Broeska inflated his credentials, overstated the effects of the stem cell treatment and was asked recently by an Indian ethics committee to resign as the study’s principal investigator because he put patient safety at risk. "It’s very unfortunate things had to come out this way because it’s shattered a lot of lives," Hauch said by phone Sunday. "This has been a very shocking situation."
For the last three years, patients with multiple sclerosis and, more recently, Lou Gehrig’s disease, have paid Broeska’s Winnipeg company, Regenetek Research, as much as $45,000 to travel to Pune, India, for stem cell treatment. That’s despite ethics rules that bar doctors from charging patients to be part of clinical trials.
While many Regenetek patients saw their MS symptoms shrink, many others did not, and began raising questions about Broeska and his treatment.
Broeska was in Trinidad last week, meeting with medical researchers from India to open another clinic.
Hauch was in Trinidad last week with Broeska but said she has no involvement in plans to expand the stem cell clinic to the Caribbean country. She said she travelled to Trinidad to meet with representatives from Inamdar Hospital in Pune to discuss plans for a companion study on physiotherapies for stem cell patients. That study was to be done in conjunction with the University of Winnipeg, but the school cut ties with Regenetek last week following a Free Press investigation.
Industry Canada’s federal company records name Hauch as a director of Regenetek.And Manitoba company records list Hauch as a director, along with Broeska, of CliniCard Inc, a company related to Regenetek and located in the same office on Chevrier Boulevard. CliniCard calls itself "a pioneer in advanced card-based information and payment integration at the point of sale." Among the more than 10 patients who have spoken to the Free Press, most said "Dr. Susan" was a key contact in dealings with Regenetek. Many paid their fees to CliniCard, not Regenetek, which was listed as a non-profit corporation on the federal government’s website last fall.
Hauch wrote letters for some patients, saying the stem cell therapy is neither available nor sanctioned in Canada. That letter was needed to obtain medical visas to travel to India.
On Sunday, Hauch said she’s not Broeska’s business partner, but is a shareholder in his firm. She said her relationship with Broeska and Regenetek has been mischaracterized, but declined to elaborate, saying she first wanted to speak to her lawyer and the College of Physicians and Surgeons of Manitoba.
Questions about Broeska’s credentials and the veracity of his claims about the treatment and the clinical trials have been percolating for years, especially in online forums for MS patients.
"He kept an awful lot to himself," said Hauch. "There were an awful lot of questions along the way."
In emails to the Free Press, the CBC and patients in recent days, Broeska has vigorously denied the allegations about him and Regenetek.
He said he stands behind his company’s role in the clinical study, which he said was only to track patients upon their return from India.
"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," said Broeska in a statement. "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."
What we know about Regenetek
With offices on Chevrier Boulevard, Regenetek is a "private, not-for-profit medical research company" that recruits people who suffer from multiple sclerosis and, more recently, amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease, for a clinical trial based out of Pune, India.
Regenetek touts its combination therapy — a combination of the neck vein angioplasty pioneered by Paolo Zamboni in 2009 and a stem cell treatment in which bone marrow cells from the patient are extracted, expanded in a lab and re-injected into the patient.
Zamboni’s treatment has been widely challenged as ineffective in the long term, but stem cell treatments do hold some promise.
Though nearly all ethical rules, including those in India, say patients shouldn’t pay for clinical trials, Regenetek charged people as much as $45,000 for the combination treatment.
Since 2012, roughly 70 people have travelled to India for the treatment. Some are from Manitoba, but many live elsewhere in Canada or abroad.
Doug Broeska, known to patients as "Dr. Doug," claimed the treatment was "curative" and that every patient saw significant benefit from the treatment. Many did, but, a Free Press investigation found at least a half-dozen patients saw no effects from their treatments in India and received no follow-up, which is uncommon in a clinical trial. They are angry and believe they have been duped.
Until recently, Broeska was the principal investigator on the clinical trial. He claimed to have a BSc and a PhD, first from the University of Manitoba. Then he claimed to have a PhD from "Brightland University."
He does not hold any degree from the U of M, and Brightland University does not exist.
Brightland University has a barebones website that appears phony, misspells "Brightland" and includes no contact information, such as an address, for the school. An investigation into the website's architecture showed links to University Degrees Program, which was a well-known degree mill operating dozens of fraudulent institutions.
Broeska also claimed to be a member of the International Cellular Medicine Society and to have approval for his clinical trial from "several" ethical panels. Neither claim is true.
Last month, the ethics committee at the Pune hospital asked Broeska to step down as principal investigator.
The ethics committee raised several serious issues — that Broeska’s lack of credentials and follow-up "violated international ethical standards," that the diagnosis of the diseases of some patients had been manipulated and that some patients were being "enforced/blackmailed to stop certain life-saving medicines" without scientific justification.
Broeska and Regenetek have fallen through many regulatory cracks.
Health Canada has a complaint on file, though little has happened.
At least three people have complained about Regenetek to the RCMP. It’s not clear if officers are investigating.
The College of Physicians and Surgeons of Manitoba, which first became aware of Broeska and his MS therapies in 2011, has so far been hands-off.
But the Canada Revenue Agency has just launched an investigation.
The University of Winnipeg was about to begin a research partnership with Regenetek to study athletic therapies on patients who’d had the stem cell treatment.
The U of W cut ties with the company last week.
In emails to the Free Press, other media and to patients, Broeska has repeatedly said he received a PhD, never offered medical advice to patients and that the clinical trial is a legitimate, duly registered study that is based in India.
Melissa Martin reports and opines for the Winnipeg Free Press.