Here's yet another article on Regenetek. I am posting it because member Claire tried to contact Paul Knoepfler alerting him to this situation and yet was not afforded a reply from him. Her comments are at the bottom. It is surely disappointing when patients try to reach out to someone who continually blogs about "dubious" stem cell clinics, trials, and doctors and they are dismissed or ignored or lost in the shuffle somehow. I have had the same thing happen with the FDA so I know how frustrated Claire feels. Also, I would think Paul (and others) would want to call out the University of Winnipeg and Dr. Glen Bergeron for their "dubious" behavior in all this.
As for Broeska's previous experience being in lumber, so what? Doug Sipp, who is often considered a spokesman for the stem cell industry is an ex-trucking administrator. He majored in English and has no advanced degree that anyone has been able to verify to my knowledge. He also has no science education, no degree or training in bioethics and yet is considered an expert by some. He is employed at Riken in Japan. Doug is frequently vague when asked about his background. Many reporters have claimed that he’s a “researcher” with the implication that he holds a Ph.D. or that he conducts stem cell research. Others merely point to the fact that he works for an academic entrepreneurial research center as proof that he must be an academic himself. Broeska should produce his credentials, but there are many who refuse to do so, including the President of the United States who has not produced college records. So is this a major big deal or not?
http://www.ipscell.com/2015/01/regenetek/
Stem cell clinic faces fraud allegations over dubious stem cell trial for MS
Posted on January 15, 2015
The Winnipeg Free Press is reporting that Regenetek, a Canadian stem cell company, faces serious charges related to for-profit stem cell therapies. (Update: a followup story in the Free Press has been published).
Doug BroeskaA very thorough article in the newspaper by Melissa Martin and Mary Agnes Welch reports that a “researcher” at the company named Doug Broeska who ran a stem cell trial for Multiple Sclerosis (MS), had faked credentials and overstated results of the trial.
Broeska, who apparently patients referred to as “Dr. Doug”, not only did not have an MD, but also lacked a Ph.D. In fact, Broeska’s previous experience was in lumber, which is long way from stem cells or MS or really anything medical or scientific.
Regenetek and Broeska ran a clinical trial based on stem cells for MS in Pune, India. The Free Press has investigated the trial and found numerous concerns:
“A Free Press investigation has found Broeska fabricated his credentials, including his PhD, and overstated the effects of the stem-cell treatment, for which he often charged desperately ill people $45,000. Four patients spoke to the Free Press on the record, saying they got no benefit from the treatment, got none of the followup common in clinical trials — such as MRIs or physical acuity tests — and believe they are victims of fraud.”
And patients who later complained or raised concerns were then reportedly the subject of verbal attacks:
“Patients who were once ardent supporters were attacked as saboteurs or shills for “Big Pharma” and threatened with removal from the study after they asked questions.”
Unfortunately this sounds a lot like what happens at some stem cell clinics right here in the US as well including some offering “treatments” for MS. Further, I myself have been called a friend of Big Pharma numerous times by fans of dubious stem cell clinics in the US. The marketing of the Regenetek clinical trial (a practice banned in Canada) also sure sounds similar to the approach used by many US stem cell clinics:
“Marketing or promoting clinical trials is banned in Canada. But, Broeska repeatedly asked patients to post positive experiences on an active “patient-run” Facebook page and later hired a marketing expert to create professional-quality videos showing patients who experienced significant recoveries. Those videos are available on his website, on YouTube and on Facebook. Of the nine patients who spoke to the Free Press about their treatment, nearly all said the videos helped convince them Regenetek’s stem-cell treatment was credible.”
The Royal Canadian Mounted Police (RCMP) has reportedly received patient complaints about Regenetek and their stem cell therapies:
“At least two of Regenetek’s former patients have complained to the RCMP, and sources say the Canada Revenue Agency is investigating, though CRA officials would not confirm that. Last week, Regenetek’s website, Broeska’s LinkedIn page and a “patient-run” Facebook group were taken down.”
The newspaper also published a letter from an ethics oversight committee in Pune that ordered Broeska to stop the clinical trial because he had “significant potential to jeopardize patient safety and patient rights”.
The newspaper article got in touch with Broeska for comment and he claimed it was all a “mix up”:
“Broeska, who is in the Caribbean on business for several days, said in an email he was terminated only because it was decided to have a local principal investigator stationed in India. He also said the concerns about the clinical trial related to research at another Indian hospital entirely.”
That’s hard to imagine that such a mixup could occur, but let’s see how this plays out.
The Free Press continued to find evidence of problems with this trial as it investigated: “In several emails to patients and in the company’s promotional material, Broeska claims he is a member of the society. The ICMS’s executive director, Reed Davis, said he could find no evidence Broeska was or is a member.”
Apparently there were claims of an IRB approval from ICMS as well and then later from the US-based International Cell Surgical Society (ICSS), a company that can issue IRBs (e.g. it seems to have issued IRBs to one of the largest stem cell clinic chains in the US, Cell Surgical Network).
The Free Press talked to Audley as well:
“In a phone interview Monday, Regenetek spokesman David Audley said the stem-cell treatments are legal and ethical in India, and the company is now seeking similar ethics approval in North America.
“What’s going on with these treatments right now is perfectly legal in the jurisdiction where it’s happening,” said Audley, noting the clinical trial has approval from the Pune hospital’s ethics board.
Audley refused to provide the inclusion and exclusion criteria for the clinical trial or what followup is mandated.
“I’m not going to go into the specifics of the clinical study, because it’s an ongoing clinical study,” said Audley. “We’re not going to go into the details about the structure of our clinical trials, nor are we going to go into detail about how the clinical study is being managed or the outcomes are being collected. That’s all part of Regenetek’s protocol.”
In the end this Regenetek trial sure sounds like it mostly about making money at patient’s expense (quite literally). Unfortunately this story is all too familiar in many respects for how the for-profit, dubious stem cell industry operates globally including in the US.
Comments:
I called your office and tried to tell you about this; you chose NOT to return my call. Now you post this AFTER I’ve already posted MULTIPLE links in multiple LI groups? Interesting. I’m SURE my comment will not be approved for posting.
Reply ↓
Claire Hooper on January 15, 2015 at 3:24 pm said:
If you really cared about patients, you would have returned my call weeks ago when I left messages for you regarding this situation. (Another comment I’m sure you will not post.)
As for Broeska's previous experience being in lumber, so what? Doug Sipp, who is often considered a spokesman for the stem cell industry is an ex-trucking administrator. He majored in English and has no advanced degree that anyone has been able to verify to my knowledge. He also has no science education, no degree or training in bioethics and yet is considered an expert by some. He is employed at Riken in Japan. Doug is frequently vague when asked about his background. Many reporters have claimed that he’s a “researcher” with the implication that he holds a Ph.D. or that he conducts stem cell research. Others merely point to the fact that he works for an academic entrepreneurial research center as proof that he must be an academic himself. Broeska should produce his credentials, but there are many who refuse to do so, including the President of the United States who has not produced college records. So is this a major big deal or not?
http://www.ipscell.com/2015/01/regenetek/
Stem cell clinic faces fraud allegations over dubious stem cell trial for MS
Posted on January 15, 2015
The Winnipeg Free Press is reporting that Regenetek, a Canadian stem cell company, faces serious charges related to for-profit stem cell therapies. (Update: a followup story in the Free Press has been published).
Doug BroeskaA very thorough article in the newspaper by Melissa Martin and Mary Agnes Welch reports that a “researcher” at the company named Doug Broeska who ran a stem cell trial for Multiple Sclerosis (MS), had faked credentials and overstated results of the trial.
Broeska, who apparently patients referred to as “Dr. Doug”, not only did not have an MD, but also lacked a Ph.D. In fact, Broeska’s previous experience was in lumber, which is long way from stem cells or MS or really anything medical or scientific.
Regenetek and Broeska ran a clinical trial based on stem cells for MS in Pune, India. The Free Press has investigated the trial and found numerous concerns:
“A Free Press investigation has found Broeska fabricated his credentials, including his PhD, and overstated the effects of the stem-cell treatment, for which he often charged desperately ill people $45,000. Four patients spoke to the Free Press on the record, saying they got no benefit from the treatment, got none of the followup common in clinical trials — such as MRIs or physical acuity tests — and believe they are victims of fraud.”
And patients who later complained or raised concerns were then reportedly the subject of verbal attacks:
“Patients who were once ardent supporters were attacked as saboteurs or shills for “Big Pharma” and threatened with removal from the study after they asked questions.”
Unfortunately this sounds a lot like what happens at some stem cell clinics right here in the US as well including some offering “treatments” for MS. Further, I myself have been called a friend of Big Pharma numerous times by fans of dubious stem cell clinics in the US. The marketing of the Regenetek clinical trial (a practice banned in Canada) also sure sounds similar to the approach used by many US stem cell clinics:
“Marketing or promoting clinical trials is banned in Canada. But, Broeska repeatedly asked patients to post positive experiences on an active “patient-run” Facebook page and later hired a marketing expert to create professional-quality videos showing patients who experienced significant recoveries. Those videos are available on his website, on YouTube and on Facebook. Of the nine patients who spoke to the Free Press about their treatment, nearly all said the videos helped convince them Regenetek’s stem-cell treatment was credible.”
The Royal Canadian Mounted Police (RCMP) has reportedly received patient complaints about Regenetek and their stem cell therapies:
“At least two of Regenetek’s former patients have complained to the RCMP, and sources say the Canada Revenue Agency is investigating, though CRA officials would not confirm that. Last week, Regenetek’s website, Broeska’s LinkedIn page and a “patient-run” Facebook group were taken down.”
The newspaper also published a letter from an ethics oversight committee in Pune that ordered Broeska to stop the clinical trial because he had “significant potential to jeopardize patient safety and patient rights”.
The newspaper article got in touch with Broeska for comment and he claimed it was all a “mix up”:
“Broeska, who is in the Caribbean on business for several days, said in an email he was terminated only because it was decided to have a local principal investigator stationed in India. He also said the concerns about the clinical trial related to research at another Indian hospital entirely.”
That’s hard to imagine that such a mixup could occur, but let’s see how this plays out.
The Free Press continued to find evidence of problems with this trial as it investigated: “In several emails to patients and in the company’s promotional material, Broeska claims he is a member of the society. The ICMS’s executive director, Reed Davis, said he could find no evidence Broeska was or is a member.”
Apparently there were claims of an IRB approval from ICMS as well and then later from the US-based International Cell Surgical Society (ICSS), a company that can issue IRBs (e.g. it seems to have issued IRBs to one of the largest stem cell clinic chains in the US, Cell Surgical Network).
The Free Press talked to Audley as well:
“In a phone interview Monday, Regenetek spokesman David Audley said the stem-cell treatments are legal and ethical in India, and the company is now seeking similar ethics approval in North America.
“What’s going on with these treatments right now is perfectly legal in the jurisdiction where it’s happening,” said Audley, noting the clinical trial has approval from the Pune hospital’s ethics board.
Audley refused to provide the inclusion and exclusion criteria for the clinical trial or what followup is mandated.
“I’m not going to go into the specifics of the clinical study, because it’s an ongoing clinical study,” said Audley. “We’re not going to go into the details about the structure of our clinical trials, nor are we going to go into detail about how the clinical study is being managed or the outcomes are being collected. That’s all part of Regenetek’s protocol.”
In the end this Regenetek trial sure sounds like it mostly about making money at patient’s expense (quite literally). Unfortunately this story is all too familiar in many respects for how the for-profit, dubious stem cell industry operates globally including in the US.
Comments:
I called your office and tried to tell you about this; you chose NOT to return my call. Now you post this AFTER I’ve already posted MULTIPLE links in multiple LI groups? Interesting. I’m SURE my comment will not be approved for posting.
Reply ↓
Claire Hooper on January 15, 2015 at 3:24 pm said:
If you really cared about patients, you would have returned my call weeks ago when I left messages for you regarding this situation. (Another comment I’m sure you will not post.)