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City man who ran stem-cell trial for MS patients fabricated credentials, overstated results

Hey there, time traveller!
This article was published 13/1/2015 (1769 days ago), so information in it may no longer be current.

Hey there, time traveller!
This article was published 13/1/2015 (1769 days ago), so information in it may no longer be current.

The hope of dancing at her son’s summertime wedding led Sharon Nordstrom to pay $38,000 for a treatment she hoped would keep her multiple-sclerosis symptoms at bay.

That money paid for what she hoped would be a life-changing stem-cell procedure at a hospital in Pune, India. It was part of what she, and nearly 70 other patients from Manitoba and from as far away as Australia, believed was a clinical study helmed by a brilliant Winnipeg medical researcher with a PhD, who said the procedure could stop MS in its tracks.

Winnipeg researcher Doug Broeska previously ran a lumber business.

REGENETEK.COM

Winnipeg researcher Doug Broeska previously ran a lumber business.

Soon after her return in May, Nordstrom began to uncover troubling facts. Doug Broeska, whom patients reverently call "Dr. Doug," has no recognized medical credentials. Regenetek Research, his company based out of a spartan office on Chevrier Boulevard, boasted credentials and positive medical results that didn’t add up. 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.

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.

Patients, doctors in India and now Canadian officials are questioning the claims of Winnipeg researcher Doug Broeska and his $45,000 stem-cell therapy for MS sufferers.

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 most disturbing evidence is a letter, dated Dec. 10 and obtained by the Free Press, in which the chairman of the medical ethics committee at the Inamdar Hospital in Pune ordered Broeska to step down as principal investigator of the stem-cell study, warning his lack of credentials and followup "violated international ethical standards."

The committee said its conclusions were based on information from an investigation done by the Indian Council of Medical Research, along with numerous study-related complaints.

The letter documents the committee’s concerns, including that Broeska, who previously ran a lumber business, 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.

"Your appointment as Principal Investigator has significant potential to jeopardize patient safety and patient rights," the letter to Broeska stated.

Letter result of a 'mix-up,' says Broeska

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.

"(A)s I understand it, there was a mix-up of institutions as well as a distortion of material facts after which the Indian side explained the situation," said Broeska by email. "I did not know about this enquiry, about these unauthorized therapies at other hospitals, and I was not there to answer allegations."

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."

'This smells fishy': patient

The Free Press investigation into Broeska and Regenetek Research uncovered misrepresentations, evasions and belligerent behaviour toward patients that support the concerns raised by the hospital’s ethics board and by patients who believe Broeska’s business is medical tourism masquerading as research.

Robert Freelove’s wife, Lynn, had the stem-cell treatment last year and saw no change at all to her MS. Their Regenetek paperwork said to expect regular followups roughly every three months, so they waited for word about MRIs, medical exams, patient questionnaires or any kind of scientific measurement that Lynn had made progress.

"It’s been over seven months, and they’ve not contacted us at all," said Freelove, who lives in the Vancouver area. "This smells fishy. I just can’t get to the bottom of it."

Since the couple returned from India, they have followed some of the questions raised by other patients online, and Freelove said he was even more concerned when it appeared Broeska disqualified vocal patients.

"They have been kicking people out of the trial for voicing an opinion," said Freelove. "To me, that doesn’t sound like a proper trial."

70 have already sought treatment

Though Broeska was careful to avoid using the word "cure," he repeatedly touted the "curative" effects of stem-cell treatment, saying every patient in his studies was making a "return to health."

Regenetek is located on Chevrier Boulevard, but its stem-cell study is being conducted at a hospital in India. The study is not listed on any clinical-trial registry.

PHIL HOSSACK / WINNIPEG FREE PRESS

Regenetek is located on Chevrier Boulevard, but its stem-cell study is being conducted at a hospital in India. The study is not listed on any clinical-trial registry.

Some prospective patients, in a race against time and the degenerative effects of their disease, began calling Broeska’s program a "miracle treatment."

By this month, more than 70 patients had sought treatment through Regenetek, and Broeska said the company hoped to qualify as many as 300. Plans to open a satellite clinic in Trinidad are underway.

Some patients emptied their retirement funds, mortgaged their homes or launched community fundraisers to help raise the cash to get their veins opened and stem cells implanted. Nordstrom and her husband used cash set aside to buy a specialized van.

At 55, MS had ravaged Nordstrom’s body, attacked her bladder and bowel control and forced her to use a wheelchair outside her house and a walker inside. When she started reading what Broeska wrote about the treatment’s success — it would "halt the disease process," he said — she began to dream of dancing again.

"The thought of getting better overrode the common sense," said Nordstrom, who lives south of Saskatoon. "I didn’t just fall for it. I talked a lot with Doug. We looked into it, but not as in-depth as I should have."

Half of the 10 patients the Free Press contacted said they experienced some improvements following the stem-cell treatment, and even the four who didn’t said they still believe stem cells hold real hope for MS and ALS sufferers.

Punted from trial

In May 2014, Nordstrom flew to India to receive the treatment at Inamdar Hospital in Pune. Broeska told her the first thing that would improve after the procedure would be her bladder and bowel control. She felt so confident after their discussions, she didn’t take incontinence supplies for the trip home.

"There was nothing he didn’t think this could cure," she said. "He targeted everyone’s weaknesses and appealed to that."

After their two-week stay in India, she saw no change to her MS. Nordstrom and her husband had to make a pit stop in Germany to stock up on adult diapers. The promised followup contact with researchers also evaporated.

In June, Nordstrom sent an email to the Regenetek founder expressing her frustration with his silence.

In reply, Broeska sent an angry email, suggesting she was now punted from the clinical trial because of her "uncompromisingly hard feelings" that "may have already created a significant recall bias."

That email was the last contact Nordstrom had with Broeska or anyone from the clinical trial.

Study’s validity can’t be verified

Regenetek, located on Chevrier Boulevard, calls itself a private, not-for-profit medical research company that is conducting stem-cell clinical trials on MS and ALS patients at a partner hospital in Pune, India. The treatment costs between $30,000 and $45,000. Roughly 70 people have already paid for and had the treatment.

Doug Broeska’s credentials

In his LinkedIn profile, now removed, Broeska says he has a B.Sc. and a PhD from the University of Manitoba. He has signed emails with those designations. The U of M’s registrar’s office said although Broeska attended the Faculty of Arts for one year and the Faculty of Agriculture for two, he was not awarded any degrees.

In reply to repeated questions from the Free Press, Broeska said Monday he received his PhD in 2012 from "Brightland University," which may not exist. There is a website for Brightland University that lists its administrator as David Miller with UDP International.

That company, University Degrees Program, was a well-known degree mill operating dozens of fraudulent institutions. The U.S. Federal Trade Commission shut down many of its sites in 2003, though it remained active on a smaller scale.

The International Cellular Medicine Society

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.

Institutional review boards

Those are independent ethical review panels, often associated with hospitals or medical societies, that review clinical trials to make sure they are on the up and up. The credibility of any IRB must be assessed, because doctors or researchers can create their own "independent" IRB and use it to give their research an aura of legitimacy.

In emails, on Facebook and on the Regenetek website, Broeska frequently makes reference to his IRB approvals. It’s difficult to track the maze of acronyms and verify these.

In a Facebook post last fall, Broeska said, "We have several Institutional Research Board (IRB) accreditations. The therapeutic protocol adheres to all rules and guidelines for such therapeutic research as laid down by the International Cellular Medicine Society (ICMS) and the World Medical Association."

In an email to patient Kathleen Jaynes, Broeska claimed he had approval from the ICMS’s ethics committee. Reed Davis, head of the ICMS, searched his files and consulted with his board and could find no record of Regenetek or Broeska having applied for or received ethics approval for the clinical trial.

More recently, Regenetek’s website said "as of March 16, 2014, Institutional Review Board approval has been granted by the US-based International Cell Surgical Society (ICSS)." The ICSS is a very new organization, founded by David Audley, now Regenetek’s spokesman and partner. Last week, the ICSS’s address, listed online, matched that of David Audley. Documents suggest Regenetek’s study does have approval from the ethics committee at the Indian hospital in Pune.

In an email to the Free Press Friday, Broeska said his treatment "is a legitimate and duly registered clinical study based out of India."

"However, we are also in the process of having the clinical study registered in the U.S., through the IRB (registration pending)."

The World Medical Association

In several emails to patients, Broeska makes reference to the World Medical Association and its rules, particularly its rules allowing patients to pay for clinical trials.

"Patient funding of medical research is permitted as an ethical practice by convention in accordance with the World Medical Association...," Broeska wrote to a patient in 2013. That is "absolutely not true" said the WMA’s London-based spokesman, Nigel Duncan.

The ethical guidelines for stem-cell research in India, as laid out by the Indian Council of Medical Research, prohibit patients paying for clinical-trial treatment.

Clinical-trials registry

Regenetek’s study is not listed on any registries, in North America or in India. On active Facebook sites, patients have frequently asked why Regenetek’s trial is not listed on the National Institutes of Health’s registry or on the Indian Council of Medical Research’s clinical-trials registry.

Late last month, a "patient-run" Facebook site dedicated to Regenetek’s research was abruptly shut down following a heated discussion on this topic.

Paul O’Connor, a neurologist and the national scientific and clinical adviser for the MS Society of Canada, said patients should be wary of clinical trials not listed on registries, ideally the NIH’s. "I wouldn’t be comfortable," he said.

In a post last Wednesday on Regenetek’s official Facebook site, spokesman David Audley said he is "conducting a full audit and review to assure regulatory compliance" so Regenetek can apply to the NIH’s registry.

Efficacy of outcomes

Broeska frequently represents the success of his stem-cell treatment, stopping short of calling it a cure. "As a result of our translational research, we are currently the ONLY therapeutic research project world-wide where patients under study are demonstrating consistent and significant long-term improvements in both mitigation of the disease itself and the recovery of neurological deficits," he wrote in an email to a patient.

More recently, on Regenetek’s website, Broeska wrote: "Patient outcomes over the past 30 months have been compelling. Each and every one of over 60 patients in the trial has demonstrated significant functional improvement with enduring effect. Many have returned to complete health without symptoms, and some have been declared ‘disease-free’ by their neurologist."

There are at least six patients who say they have had no lasting effects from the stem-cell treatments. The Free Press has spoken to four on the record. At least one, Alberta’s Lee Chuckry, believes the stress of travelling to India and his frustration with Regenetek’s aftercare made his MS worse.

Marketing

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.

Broeska told the Free Press participation in the study is "voluntary, highly confidential and by word of mouth. Regenetek did not advertise or solicit for participants in the clinical study."

Disqualifying patients

Three of the four patients who spoke on the record, including Sharon Nordstrom, say they were "disqualified" from the study for raising questions about Regenetek’s methods, Broeska’s credentials and especially the lack of followup care and assessment. Broeska denied any patients were disqualified because they criticized him or Regenetek.

In Nordstrom’s case, her final contact with Broeska was an email on June 16, 2014, about a month after she had returned from India and began asking questions about the lack of followup care or monitoring.

"I really don’t appreciate the tone you’ve taken in this email considering the fact that I work from 12-16 hours per day for all of the patients including you, and for the purpose of extending the research into physiotherapy," Broeska wrote.

"If you take personal effrontery at the fact that I can’t simply schedule myself to sit in front of the telephone and dial in the hope of getting through to you, then there’s nothing more I can do for you. From your email it doesn’t seem that you care to continue in the research program. Furthermore, your uncompromisingly hard feelings over a perceived slight may have already created a significant recall bias that won’t permit your continued participation. I am now required to send this email off to the other physicians in our group for review and I must report it to the Ethics Committee for comment and advice."

The MS Society’s senior neurologist, Paul O’Connor, said disqualifying patients from a clinical trial after treatment is simply not done.

"You follow the patients for the entire duration of the study, no matter how they’re doing," said O’Connor. "Otherwise, you bias the results."

melissa.martin@freepress.mb.ca, maryagnes.welch@freepress.mb.ca

Melissa Martin

Melissa Martin
Reporter-at-large

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History

Updated on Wednesday, January 14, 2015 at 6:37 AM CST: Changes headline

11:24 AM: Tweaks formatting

7:27 PM: Adds document from U of M.

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