In exchange for that money, Jaynes and roughly 70 other patients received what one of Canada's top MS researchers calls an "impossible" promise.
In December, Dr. Mark Freedman looked over Regenetek's study protocols, after a reporter drew his attention to the company's claims. Freedman, who is the director of Ottawa Hospital's MS research unit, has plenty of experience with stem cell treatments for the disease: In 2000, he and bone marrow transplant physician Dr. Harold Atkins launched a study to examine whether transplanting stem cells from a patient's own bone marrow could halt the disease.
The study was closely watched, the results tremendously encouraging. The 24 patients in the study -- all of whom had a rapidly advancing form of MS -- showed improvement. Freedman and Atkins also treated about a dozen more patients outside of the study, who have shown the same positive results. The researchers have submitted the study's results for publication in a scientific journal, and are preparing to announce new research sites later this month.
It didn't take long for this story to start snowballing. Freedman now is stating that there should be legislation to go after those who recruit patients for medical tourism. I am not understanding why that would be illegal. Falsifying credentials, yes, but marketing to patients for offshore treatment, no. If patients were given a choice between traveling thousands of miles vs staying in their own country for treatment, I think most would choose not to travel. If Freedman's study showed so much promise, then why has it taken from 2000 to now to publish and prepare to announce new research sites? The study should be open to all that want to participate, just as former FDA commissioner Dr. von Eshenbach proposed. Treating 24 patients in 15 years in the study and a handful outside the study is hardly giving much hope to those who are suffering.
Freedman also states that patients who believe they got good results from the treatment they got in India are most likely experiencing the placebo effect. I've been told that myself about my own treatment. Since Freedman doesn't actually have first hand knowledge of what the treatment consisted of and was not there when the cells were processed, I am not sure how he could make such a definitive statement. This is not to say I defend the apparent shoddy practice of misrepresenting himself that Broeska appears to have done, in fact it's quite despicable and I hope that there will be some recourse for patients, but this type of thing is hardly confined to offshore medical treatment. It happens in research and academia too.
By: Melissa Martin and Mary Agnes Welch
http://www.winnipegfreepress.com/local/the-impossible-dream-288911741.html?cx_navSource=d-top-story
The numbness entered Kathleen Jaynes' body 19 years ago, and during the intervening years the multiple sclerosis symptom has spread from her toes to her chest. Nothing really changes the numbness, or helps. Which is why, despite her sister's misgivings and her own lingering questions, Jaynes paid $20,000 to receive an experimental stem cell procedure in India through Regenetek, a company led by a now-discredited Winnipeg researcher who fudged his credentials and misled patients.
It's not like there are many other sources of hope out there for patients such as Jaynes, 59, who lives in southeast Arizona.
"You're a no-option patient," Jaynes said. "You have no other options. I justified it in every way that I could, despite my family saying this guy is not for real. Unless you're in my numb body, you can't know how desperate you feel to not feel that way."
In exchange for that money, Jaynes and roughly 70 other patients received what one of Canada's top MS researchers calls an "impossible" promise.
In December, Dr. Mark Freedman looked over Regenetek's study protocols, after a reporter drew his attention to the company's claims. Freedman, who is the director of Ottawa Hospital's MS research unit, has plenty of experience with stem cell treatments for the disease: In 2000, he and bone marrow transplant physician Dr. Harold Atkins launched a study to examine whether transplanting stem cells from a patient's own bone marrow could halt the disease.
The study was closely watched, the results tremendously encouraging. The 24 patients in the study -- all of whom had a rapidly advancing form of MS -- showed improvement. Freedman and Atkins also treated about a dozen more patients outside of the study, who have shown the same positive results. The researchers have submitted the study's results for publication in a scientific journal, and are preparing to announce new research sites later this month.
But the procedure Regenetek owner Doug Broeska was touting wasn't anything like the technique that showed such promise in Freedman and Atkins' study.
For instance, Jaynes and other Regenetek patients the Free Press spoke to described having stem cells extracted, expanded and implanted within days of their arrival in Pune, India.
But the premise that patients could receive benefits from stem cells taken from bone marrow extracted just four days earlier -- and which had to make a 300-kilometre round-trip journey between Pune and a lab in Mumbai at that time -- is "impossible," Freedman said.
Culturing and expanding enough of those kind of stem cells is a process that takes "weeks," Freedman said, adding bluntly: "They're not getting anything."
That said, some patients who have travelled abroad for stem cell treatments have reported positive results. In this case, Freedman thinks, "there's a tremendous placebo effect associated with it. You're going to be looking for every positive little itch. It's just human nature. These are the patients for whom we've come up with no effective therapy, and they're desperate... They don't want to hear there's absolutely no reason to believe that it's working."
Hope is a powerful thing. It's what led Jaynes to set her initial skepticism aside, and give Regenetek a second look. She was leery when she first heard of the company and its owner, Broeska, whom patients often called "Dr. Doug." But she saw other patients' glowing reports of the procedure he was selling, and one Saturday in 2013 she sent Regenetek an application. The next day, Broeska called her at home.
At first, Jaynes thought he seemed "knowledgeable and articulate." Over the ensuing weeks, she and her sister noticed parts of his background that didn't add up -- they couldn't find any research he'd published, or details about his credentials. Still, Jaynes pressed forward. "I have a brain," said Jaynes, a former paralegal. "I can be very skeptical. The skepticism was being outweighed by how I felt in my body, and my wanting to get better. That trumped my common sense."
While Jaynes waited to travel to India, she chatted with other patients, including one avid stem cell advocate. In January 2014, Broeska sent Jaynes an email demanding to know why she had asked the advocate about Broeska's background. As a result, he told her that her application for the study had been destroyed, and that her "negative opinion and preconceived notions" may prevent her from obtaining the procedure in the future.
"It seems to me at this point, that despite my sincerity and patience in answering all of your questions and providing you with all of the evidence as requested regarding our research, you have for some reason... attempted to discredit or disparage the work we are doing," Broeska wrote. "I am wondering about your motivations and why you are distrustful of the research when I have given you everything you've asked for..."
Jaynes was stunned, but fear at being frozen out of the procedure trumped her reaction. She responded to Broeska clarifying that she never disparaged his work and wanted to continue with the procedure, and Broeska quickly said he was "perhaps hasty" and that they were "all good."
Four months later, Jaynes travelled to India to receive the "combination therapy" that Broeska touted, a mixture of stem cell implantation and a vein-opening procedure that made headlines in 2010 as a possible MS treatment. Subsequent studies haven't held up well compared with early hopes or anecdotal reports; Freedman has been a staunch opponent of the narrowed-vein theory, and called that part of the Regenetek procedure "nonsense."
When Jaynes had asked Broeska whether the "combination therapy" would help with her creeping numbness, he told her it would. And for a week or two she felt a little bit better, a little stronger on her feet. It didn't last. By August, the numbness was worse than ever, and Jaynes turned to Broeska and his business partner, Winnipeg physician Dr. Susan Hauch, for advice.
They suggested one of her medications might be interfering with the stem cells; then Broeska issued a long list of supplements or foods that might also prevent the stem cells from working. Finally, they suggested she obtain a new MRI. After reviewing the result in November, Broeska told Jaynes the reason she wasn't getting better is that she had cervical stenosis, which puts pressure on spinal nerves. He suggested she have surgery.
When Jaynes reviewed her past MRIs, she learned that stenosis had been visible in the MRI she had sent to Regenetek before her procedure, as well as others dating back to 1996.
"Now you're telling me the stem cells I got don't solve the problem, and you'd have known about the problem before I went, if you'd looked at the report," Jaynes said. "He tried to make it sound like I was ungrateful, because he'd made this great discovery that this is my real problem."
Like other patients, Jaynes is frustrated. "We did not get what was promised," she said.
Jaynes still has hope for stem cell research into MS -- and there is reason to have hope, as the research Freedman and others have done has shown.
"I think (stem cell treatment) is the only viable treatment option," Jaynes said. "The MS drugs... they treat symptoms. But it's like with anything, if you're just putting a Band-Aid on the problem, you're not getting to what's underneath. I want to solve the problem, I don't want to put the Band-Aid on it."
Freedman, who watched the Regenetek story unfold from his office in Ottawa, worries regulations to protect patients haven't caught up with the times.
"We probably need legislation to go after individuals who are recruiting individuals for medical tourism," he said.
"This guy is obviously a fake. He has no credentials. He's never published anything. But he can just set up a website, and everybody goes for it... Patients obviously need some sort of protection. Just like the (Better Business Bureau)."
melissa.martin@freepress.mb.ca, maryagnes.welch@freepress.mb.ca