Indian MS researchers disassociate from Winnipeg company

An Indian medical group doing experimental stem cell therapy with multiple sclerosis patients is cutting ties with a Winnipeg man and his company, Regenetek Research, saying it's concerned about questions of his credibility and research methodology.

"I am in the favour of this disassociation with Regenetek Research in Canada immediately, until or unless the allegations against Dr. Doug Broeska and/or Regenetek are proven false," Surjo Banerjee, director of Genesis Ltd., said in an email to CBC News.

"We won't be able to accept any more patients through Regenetek," he later said in an interview.

"It's shocking for me. Surprising and dangerous to our credibility. If it keeps going on, we may lose credible people from our side.

"The worst thing is that patients are stressing out and that's not good for MS."

Broeska has been recruiting MS patients in Canada and around the world for the experimental stem cell therapy and study being done in Pune, India.

The treatment involves widening the veins of the neck and injecting the patient's own stem cells.

The cost of the procedure in India is $16,050 US, Banerjee confirms, but Broeska has been charging patients up to $45,000, saying the extra cost is for travel, research followup and physiotherapy.

Up to 70 people have reportedly already had the treatment, although some say they never received any followup care or assessments. Several patients are in India right now, and others have paid deposits and are waiting to go.

But some patients recently started raising questions about the research and Broeska's educational credentials.

On a LinkedIn profile, which has now been removed, and on a CV Broeska has circulated, he claims to have received a PhD from the University of Manitoba. The university says that's not true.

Broeska claims to be a member of the International Cellular Medicine Society and the International Society for Cellular Therapy. Both groups tell CBC News they have no record of that.

Even the prestigious private high school Broeska says he graduated from denies that. An administrator says he only attended Grade 10 at St. Paul's High School.

Last month, the chair of the ethics commission at the Inamdar Hospital in Pune ordered Broeska to step down as the research study's principal investigator, saying his lack of credentials and patient followup "violated international ethical standards."

A new study head has been appointed and is now responsible for recruiting and following up with patients. Dr. Bill Brashier is also drafting a new study protocol that will involve patients who say Broeska disqualified them from the original study.

"The data (in the original study) may not be accurate. We may need to create a new study sponsored by Genesis," Banerjee said.

Some patients demanding deposits back

Meanwhile, the University of Winnipeg has backed out of a research proposal involving Broeska and Regenetek. If the project had been approved, physical therapists would have done rehabilitation with patients after their treatment in India.

Several people have made complaints to the RCMP, the Canada Revenue Agency and Manitoba's College of Physicians and Surgeons.

Some patients are also demanding their deposits back. Mark Taplin, of Adelaide, Australia, is threatening to sue Broeska if he doesn't receive his $20,000 US by Friday.

"I paid my first $20,000 payment of $35,000 the day or two before this all blew up in Canada," Taplin said, adding that he had been planning to go to India for a procedure on April 15.

"If someone tries to rip me off, I will go straight after them. Unless I get my money back by the end of the week, I'll get everybody to take a class action against Regenetek and the directors to ensure all our interests and financial side was respected."

Taplin and other patients have documents showing they had sent money to The CliniCard Inc., a company listing Broeska as president and CEO.

Court documents connect Winnipeg family physician Dr. Susan Hauch to The CliniCard.

Hauch is also a director of Regenetek and has sent letters on behalf of patients as part of their application process for treatment.

- Read a letter from Dr. Susan Hauch to patient Lee Chuckry (PDF)

- View a receipt from The CliniCard Inc. to a Saskatoon MS patient (PDF)

She and Broeska were meeting with Banerjee and other members of the Indian research team in Trinidad last week when the controversy broke publicly.

Hauch has declined comment with this email response: "I've just spoken with a lawyer and have been advised that I am not able to speak with the press/reporters until such time that legal counsel has reviewed all of the necessary documents/files."

Like many patients CBC News has interviewed, Taplin said he believes in the potential of stem cell therapy and still wants to get the treatment in India, just not through Regenetek.

"I hope the authorities step in and continue this trial and ensure all the people involved that have paid money or want the process done can be continued and proper medical trials be conducted with follow-up so we can all learn from this," he said.

"I would like to be optimistic, but it doesn't sound too good."

Damage control

Genesis is now scrambling to do damage control.

"There are patients currently undergoing treatment in India and we are trying to recover their payment from Regenetek," said Banerjee.

"We don't want them to panic in India (by hearing the two companies are no longer associated) while we get Regenetek to clear the dues."

The outstanding bill owed by Regenetek to Genesis is about $70,000 US, Banerjee said.

Patients are not required to use Regenetek as a middle man and can apply to join the study and get the treatment directly through Genesis, Banerjee said, adding that his group is starting a satellite clinic in Trinidad so patients from North America don't have to travel as far.

"We will be taking over followup for them and start fresh, collecting data which shows us light to further improve the treatment protocols," he said.

Last week, Regenetek issued a statement stating, in part: "Regenetek Research stands behind its role in this clinical study — namely as researchers tracking participant progress following medical treatment, with such medical treatment having been provided by third-party medical practitioners located in India."

Broeska has also hired a Winnipeg public relations firm to represent him. Resultz PR Canada provided the following statement to CBC News late Wednesday:

- Doug Broeska has not been notified of any interruption of the Regenetek Research stem cell case study in India. Despite what the media reports, he verifies that the study remains ongoing. Broeska is in the process of assembling a full authentication of his credentials.

- Broeska states participants who have paid their fees can be assured that their therapies will be completed. All participant intake schedules will be honoured. Regenetek will continue to subsidize each participant's therapy through its research budget. Participants desiring an enrolment refund will be fully accommodated.