"Manitoba Health Minister Sharon Blady offered the same advice.
"The college and the police would be the best places to start," she said, adding her department knew nothing of Regenetek or Broeska until media reports emerged this week. She said she found the reports distressing. "I cannot imagine what these families have been going through."
Really? The college isn't about to want to investigate this in my opinion considering their apparent approval and the police would most likely consider it not something in their jurisdiction. I don't think this in anyway compares to protecting citizens from heinous criminals and terrorists, so their time should be put to better use. So that brings us to the Health Minister herself who should not be speculating on this based on media reports, but instead should be going directly to those involved. Talk about passing the buck!
This really isn't the story of the year in my opinion, but it is an opportunity to highlight the need for more clinical studies in Canada and the U.S.
The Health Minister says she can't imagine what these families are going through. How about what patients go through every single day? How about opening up clinical trials for everyone like former FDA commissioner Dr. von Eschenbach proposed? Then maybe patients wouldn't be going offshore. This woman learned of all this from the media? She should resign.
Agencies mum on Regenetek
Won't reveal if city firm being investigated
By: Mary Agnes Welch and Melissa Martin
http://www.winnipegfreepress.com/local/agencies-mum-on-regenetek-288791301.html?cx_navSource=d-tiles-2
WHAT WE KNOW ABOUT THE COMPANY
With offices on Chevrier Boulevard, Regenetek is a "private, not-for-profit medical research company" that recruits people suffering 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 reinjected. 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 ought not pay for clinical trials, Regenetek charged people between $35,000 and $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 who saw no effects from their treatments in India. 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.
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 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 followup "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.
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 this week.
Fallout from fake credentials Alberta MS patient says Regenetek researcher was seen as 'some sort of god' U of W cancels proposal for joint research study City man who ran stem-cell trial for MS patients fabricated credentials, overstated results
News that a Winnipeg man falsified his credentials and charged chronically ill people thousands of dollars to participate in a questionable clinical trial has prompted health officials, regulators and police to pass the buck.
Meanwhile, Doug Broeska and his associates, including a Winnipeg physician, are in Trinidad this week preparing to open a new stem-cell clinic.
So far, at least three people have filed complaints with the RCMP about Broeska and his Winnipeg firm, Regenetek Research. The earliest complaints were filed in the summer of 2013 in Alberta and Manitoba. Another complaint was lodged in Saskatchewan last month.
RCMP would not say whether they are actively investigating Broeska and Regenetek. The three people who lodged the complaints told the Free Press they have not been contacted since their initial contact with RCMP.
In the last three years, Regenetek charged about 70 people as much as $45,000 for stem-cell treatment in India that Broeska claimed would halt the progress of multiple sclerosis and, more recently, Lou Gehrig's disease.
"Each and every one of over 60 patients in the trial has demonstrated significant functional improvement with enduring effect," Broeska wrote on his website. "Many have returned to complete health without symptoms, and some have been declared 'disease-free' by their neurologist."
But, a Free Press investigation found at least half a dozen patients experienced no improvement after travelling to India. And Broeska overstated the ethical approvals awarded to his clinical trial and falsified his credentials, claiming to have a PhD when he does not. In December, the Indian hospital where the stem-cell treatments are performed asked Broeska to step down as principal investigator, claiming he was putting patient safety at risk.
Despite these revelations, the only agency that appears to be investigating is the Canada Revenue Agency. The CRA would not confirm it is looking into Regenetek's finances, but sources say an active investigation has begun.
Alberta patient Lee Chuckry, whose MS has confined him to a scooter and who is a critic of Regenetek, also complained to Health Canada in 2013.
Health Canada confirmed the complaint. "The necessary follow-up steps have been initiated and are ongoing," Health Canada wrote in an email.
Health Canada could not elaborate, but added any complaints about physicians should be reported to the College of Physicians and Surgeons of Manitoba.
Manitoba Health Minister Sharon Blady offered the same advice.
"The college and the police would be the best places to start," she said, adding her department knew nothing of Regenetek or Broeska until media reports emerged this week. She said she found the reports distressing. "I cannot imagine what these families have been going through."
Broeska is not a physician, so the College of Physicians and Surgeons of Manitoba said its ability to investigate him is limited.
Broeska works closely with Susan Hauch, a Winnipeg physician who is listed as the co-owner 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.
The college would not say if it had received any complaints about Hauch, whether it has launched its own investigation or whether it is taking action on the matter. Nor would it say whether it has launched an investigation under Section 5 of the Medical Act that bars people from giving medical advice if they are not registered health-care practitioners.
"The college cannot comment on an individual investigation regarding a physician unless there is a public discipline finding," registrar Anna Ziomek wrote in an email.
Hauch, who is in Trinidad with Broeska, did not respond to messages, emails or texts.
The MS Society of Canada's vice-president of research would also not comment directly on Regenetek or its clinical trials.
maryagnes.welch@freepress.mb.ca melissa.martin@freepress.mb.ca
"The college and the police would be the best places to start," she said, adding her department knew nothing of Regenetek or Broeska until media reports emerged this week. She said she found the reports distressing. "I cannot imagine what these families have been going through."
Really? The college isn't about to want to investigate this in my opinion considering their apparent approval and the police would most likely consider it not something in their jurisdiction. I don't think this in anyway compares to protecting citizens from heinous criminals and terrorists, so their time should be put to better use. So that brings us to the Health Minister herself who should not be speculating on this based on media reports, but instead should be going directly to those involved. Talk about passing the buck!
This really isn't the story of the year in my opinion, but it is an opportunity to highlight the need for more clinical studies in Canada and the U.S.
The Health Minister says she can't imagine what these families are going through. How about what patients go through every single day? How about opening up clinical trials for everyone like former FDA commissioner Dr. von Eschenbach proposed? Then maybe patients wouldn't be going offshore. This woman learned of all this from the media? She should resign.
Agencies mum on Regenetek
Won't reveal if city firm being investigated
By: Mary Agnes Welch and Melissa Martin
http://www.winnipegfreepress.com/local/agencies-mum-on-regenetek-288791301.html?cx_navSource=d-tiles-2
WHAT WE KNOW ABOUT THE COMPANY
With offices on Chevrier Boulevard, Regenetek is a "private, not-for-profit medical research company" that recruits people suffering 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 reinjected. 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 ought not pay for clinical trials, Regenetek charged people between $35,000 and $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 who saw no effects from their treatments in India. 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.
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 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 followup "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.
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 this week.
Fallout from fake credentials Alberta MS patient says Regenetek researcher was seen as 'some sort of god' U of W cancels proposal for joint research study City man who ran stem-cell trial for MS patients fabricated credentials, overstated results
News that a Winnipeg man falsified his credentials and charged chronically ill people thousands of dollars to participate in a questionable clinical trial has prompted health officials, regulators and police to pass the buck.
Meanwhile, Doug Broeska and his associates, including a Winnipeg physician, are in Trinidad this week preparing to open a new stem-cell clinic.
So far, at least three people have filed complaints with the RCMP about Broeska and his Winnipeg firm, Regenetek Research. The earliest complaints were filed in the summer of 2013 in Alberta and Manitoba. Another complaint was lodged in Saskatchewan last month.
RCMP would not say whether they are actively investigating Broeska and Regenetek. The three people who lodged the complaints told the Free Press they have not been contacted since their initial contact with RCMP.
In the last three years, Regenetek charged about 70 people as much as $45,000 for stem-cell treatment in India that Broeska claimed would halt the progress of multiple sclerosis and, more recently, Lou Gehrig's disease.
"Each and every one of over 60 patients in the trial has demonstrated significant functional improvement with enduring effect," Broeska wrote on his website. "Many have returned to complete health without symptoms, and some have been declared 'disease-free' by their neurologist."
But, a Free Press investigation found at least half a dozen patients experienced no improvement after travelling to India. And Broeska overstated the ethical approvals awarded to his clinical trial and falsified his credentials, claiming to have a PhD when he does not. In December, the Indian hospital where the stem-cell treatments are performed asked Broeska to step down as principal investigator, claiming he was putting patient safety at risk.
Despite these revelations, the only agency that appears to be investigating is the Canada Revenue Agency. The CRA would not confirm it is looking into Regenetek's finances, but sources say an active investigation has begun.
Alberta patient Lee Chuckry, whose MS has confined him to a scooter and who is a critic of Regenetek, also complained to Health Canada in 2013.
Health Canada confirmed the complaint. "The necessary follow-up steps have been initiated and are ongoing," Health Canada wrote in an email.
Health Canada could not elaborate, but added any complaints about physicians should be reported to the College of Physicians and Surgeons of Manitoba.
Manitoba Health Minister Sharon Blady offered the same advice.
"The college and the police would be the best places to start," she said, adding her department knew nothing of Regenetek or Broeska until media reports emerged this week. She said she found the reports distressing. "I cannot imagine what these families have been going through."
Broeska is not a physician, so the College of Physicians and Surgeons of Manitoba said its ability to investigate him is limited.
Broeska works closely with Susan Hauch, a Winnipeg physician who is listed as the co-owner 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.
The college would not say if it had received any complaints about Hauch, whether it has launched its own investigation or whether it is taking action on the matter. Nor would it say whether it has launched an investigation under Section 5 of the Medical Act that bars people from giving medical advice if they are not registered health-care practitioners.
"The college cannot comment on an individual investigation regarding a physician unless there is a public discipline finding," registrar Anna Ziomek wrote in an email.
Hauch, who is in Trinidad with Broeska, did not respond to messages, emails or texts.
The MS Society of Canada's vice-president of research would also not comment directly on Regenetek or its clinical trials.
maryagnes.welch@freepress.mb.ca melissa.martin@freepress.mb.ca