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This article was published 15/1/2015 (2564 days ago), so information in it may no longer be current.
The University of Winnipeg has axed a joint project with Regenetek Research, the local company selling stem-cell treatment to people with multiple sclerosis.
The move by the university’s ethics committee came Wednesday, hours after the Free Press published its investigation into Regenetek owner Doug Broeska’s credentials and his clinical trial.
The university’s move puts an end to Broeska’s repeated claim he was about to launch a study with U of W’s kinesiology faculty to track and test some of the 70 patients who paid Regenetek as much as $45,000 for experimental stem-cell transplants in India.
"The patient outcomes have been so significant that we will soon be announcing a companion study with the University of Winnipeg," Broeska told a prospective patient in an email obtained by the Free Press. "Dr. Glen Bergeron, assistant dean and one of Canada’s foremost physiotherapeutic specialists (head physiotherapist, Canadian Olympic Team) has confirmed our evidence based on patient observation... and would not have contemplated such a study if our patient/subjects had not demonstrated neural pathway restoration as a result of their therapies."
Winnipeg-based Regenetek and the U of W signed a preliminary letter of intent last spring. The company even gave the U of W $10,000 to hire a young researcher. She moved to Winnipeg from Waterloo, Ont., and began work in November in anticipation the joint research project would soon win ethics approval from the university’s review panel.
Last week, the U of W’s ethics committee sent the proposal back to Bergeron with questions and concerns. On Wednesday morning, the committee rejected the joint application outright.
Bergeron did not reply to requests for comment. Instead, Jino Distasio, the U of W’s associate vice-president of research and innovation, said the university takes the health of study participants extremely seriously and already harboured concerns about the project.
"The ethics review had some questions — about the project, the protocol and about Regenetek — and they were waiting for followup," he said. "At a certain point, the right questions were asked."
Distasio could not elaborate on what those questions were or whether they related to Broeska’s credentials, the ethics of asking patients to pay to participate in clinical trials, questionable claims of patient improvements or some other issue. He also could not say how Bergeron and the university vetted Regenetek when Broeska approached the school about the project.
Distasio said the research project would likely have included 10 to 15 people who’d already had the stem-cell treatment in India. The university would not have charged them for athletic therapy as part of the followup study.
Broeska, known as Dr. Doug to the 70-odd patients he’s sent to India since 2012, repeatedly said he had a PhD, first from the University of Manitoba, which is untrue, then from Brightland University, which does not appear to exist.
"I assure you that I paid tuition, studied with rigour under doctoral advisers and did the course work with the result of a doctoral dissertation," Broeska told the Free Press Monday. "I would appreciate that my hard work to attain my credentials not be treated as insignificant."
Broeska also claimed to be a member of the International Cellular Medicine Society. Staff members there say they can find no record of his ever having a membership.
Broeska also repeatedly told patients his clinical trial has ethical approval from "several" institutional review boards, including the one managed by the International Cellular Medicine Society, which is also untrue.
His treatments do appear to have ethical approval from the Inamdar Hospital in India, and several patients who spoke to the Free Press said they’d experienced significant improvement to their MS symptoms following the treatment in India.
But last month, the Inamdar Hospital’s ethics committee asked Broeska to step down as principal investigator of the stem-cell clinical trial, warning his lack of credentials and followup "violated international ethical standards." A letter obtained by the Free Press documents the committee’s concerns, including that Broeska is not a qualified health practitioner and doesn’t have sufficient experience in stem-cell research or neurology to oversee the studies. The committee said diagnosis of the diseases of some patients had been manipulated in the studies investigated.
Most worrisome, the ethics committee said it had been informed study patients were being "enforced/blackmailed to stop certain life-saving medicines" without scientific justification.
Broeska, who is in Trinidad this week, said by email his trial "is a legitimate and duly registered clinical study based out of India" and his removal as principal investigator was part of a misunderstanding.
Melissa Martin reports and opines for the Winnipeg Free Press.