Friday, January 23, 2015
A Stem Cell Scam Unravels…
Sadly, where there are significant populations of desperate people, there are almost always human sharks ready, willing, and able to take advantage of them. Thus, it seems, we have the story of Regenetek, a Canadian company that arranged for patients to travel to India for an experimental stem cell treatment under the guise of a certified medical clinical trial. Over the last several weeks, the Canadian press has revealed that the man behind Regenetek, Mr. Doug Broeska, allegedly misrepresented his credentials, the qualifications and abilities of his company to conduct a valid medical clinical study, and cajoled, bullied, and berated patients who dared question his authority or the veracity of his claims (click here). It must be said that while some of the patients who underwent the Regenetek’s stem cell therapy in India received no benefit, others have reported good results, and that’s where this story gets tricky. Though Regenetek and Doug Broeska may turn out to be complete shams, the stem cell therapy the company was hawking may have value, at least according to patients who claim to have seen benefit from it (click here).
I first became aware of Regenetek when Mr. Broeska invited me via email to join Regenetek’s private Facebook group, where patients discussed various aspects of the company’s stem cell treatment and their experiences with it. At that time, Broeska was known as Dr. Doug Broeska, or “Dr. Doug”, claiming that he was a “PhD medical researcher”. That rather generic designation set off a few red flags in my mind, especially after a quick Google search revealed little other than the fact that Mr. Broeska had been involved in some sort of electronic medical records company before taking an apparently rather sudden interest in stem cells.
Further red flags sprung up when, after spending a little time on his Facebook page, I saw that Broeska was posting articles he had written on various stem cell related subjects that contained errors and misinformation. These articles were also posted on Regenetek’s website and blog. One article in particular raised my cackles, a piece about HSCT – a type of stem cell therapy in which a patient’s immune system is ablated using chemotherapy drugs and then rebooted through the use of bone marrow derived stem cells, which clinical trials are proving to be quite effective in properly selected patients – that was so ill-conceived that I felt compelled to call out the myriad inaccuracies in the piece. After a bit of back-and-forth, Broeska removed the article, but his seeming intentional misrepresentations of fact set off alarm bells of doubt in me about his credibility.
As I’ve mentioned in the past, I’m not a huge fan of Facebook, and after the above incident I didn’t spend much time visiting the Regenetek page. I was left with questions about the clinical trial the company was supposedly conducting, since it seemed that the only follow-up being done after patients returned from India were e-mailed anecdotal patient self-reports of how they were doing post treatment (no MRIs, neurologic testing, or other objective measures required), as well as doubts about many of the statements and claims made by “Dr. Doug”, but I’d seen how anybody raising such concerns on the site were met with hostility and frankly wanted no part of it. I remained in email contact with one of the members of the group, who occasionally asked for my opinion on stem cell related topics and told me about several disgruntled patients, but other than that I didn’t give Regenetek or Mr. Broeska much thought at all.
A few weeks ago I was alerted to the fact that the Regenetek Facebook site and related webpages had been taken down, along with Doug Broeska’s business profiles on the LinkedIn website. Soon after, an article appeared in the Winnipeg Free Press detailing Mr. Broeska’s alleged web of deceit (click here). Among the article’s findings were that “Dr. Doug’s” claims of earning a PhD at the University of Manitoba could not be confirmed (the University had no record of his graduating), and that another of his claimed degrees came from an institution called Brightland University, which apparently doesn’t actually exist, and is only part of the University Degree Program, an online degree mill that operates dozens of sham institutions. Furthermore, Broeska had claimed that he was a member of the International Cellular Medicine Society (click here), an international stem cell research oversight organization, but the executive director of the ICMS could find no evidence of Broeska’s membership. It had also been claimed that Regenetek’s clinical trial was being run under the direction of several Institutional Review Boards (IRB’s), which are governing bodies that ensure the validity of medical research efforts. No record of any legitimate IRB approvals could be found, and one of the organizations cited by Broeska as overseeing the Regenetek clinical trial was found to be headed up by one of his business partners.
Additionally, Broeska often boasted that Regenetek was a not-for-profit corporation, and that the company actually helped subsidize the cost of patients' treatments, for which the patients themselves paid up to $45,000 US. While Regenetek is indeed registered with Canada as a not-for-profit entity, most of the patients sent for stem cell treatment in India paid their fees to another Broeska owned company, CliniCard, which is a for-profit corporation (click here). Allegations have also been made that Regenetek paid patients that had gone through their stem cell protocol to recruit other patients, and to post testimonials and videos on Facebook and YouTube.
Perhaps worse than all of Broeska’s alleged falsehoods and financial sleight-of-hand were his practices involving many of the patients with whom he dealt (click here and here). According to reports, patients were threatened with being kicked out of the Regenetek clinical trial if they questioned any of the claims or methodologies used by Broeska after they returned from India. Broeska repeatedly stated that virtually all patients undergoing the treatment protocol in India saw “curative effects”, and that many had “returned to complete health without symptoms” (click here). Patients who reported little or no benefit from the treatment were accused of working for competitors, or otherwise having ulterior motives, and were booted out of the Regenetek study. Upon returning home, most patients received little if any follow-up, despite their supposedly enrollment in an ongoing clinical trial. Broeska was known to spend hours emailing and even Skypeing with prospective clients, befriending them in an effort to convince them of the validity of his claims and of his expertise in stem cell research, and ultimately to sign them up for treatment in India, to the tune of tens of thousands of dollars.
Regenetek partnered with an Indian firm called Genesis, whose Chief Operating Officer is an IT professional named Surjo Banerjee, that oversaw the medical procedures performed at a hospital in Pune, India. As previously stated, patients were charged up to $45,000 US for treatment (not including travel expenses), which consisted of CCSVI angioplasty combined with an infusion of stem cells derived from the patient’s bone marrow, in addition to intravenous and intrathecal (spinal) infusions of these same autologous mesenchymal stem cells. While in India, patients also underwent roughly 2 hours of physical therapy each day, purportedly to help the stem cells circulate to where they were needed. Perhaps not coincidentally, studies have shown that periods of intense physical therapy alone can markedly improved the functionality of many MS patienes, although the benefits fade after physical therapy is stopped (click here). Many of the claims and methodology used in what Regenetek dubbed the CTP (Combination Treatment Protocol) have been challenged by doctors familiar with stem cell technology (click here).
Due to the fact that so little actual follow-up was done on the approximately 70 patients who traveled to India for treatment, it’s impossible to quantify the actual effects of the treatment; suffice it to say that of the relatively few patients who have been heard from there are some who say they have seen sometimes dramatic improvement, and others who claim the CTP treatment to be a total failure. It’s impossible to objectively judge the veracity of subjective anecdotal patient reports, as any number of factors could contribute to the self-reported success or failure of any experimental medical procedure.
I will say by all accounts it does appear that Regenetek patients did receive some sort of stem cell therapy from licensed doctors while in India, effective or not; the scam that occurred lies mostly in the manner by which patients were recruited and then handled after they returned home, and in the financial shenanigans allegedly undertaken by Mr. Broeska and his colleagues. Unfortunately, because of the lack of any rigorous follow-up whatsoever, the actual effects of the treatment on the 70 or so patients who underwent the stem cell therapy will never be known, at least in any scientifically valid fashion. This is a real shame, for who knows what valuable lessons might have been learned if these patients had been properly assessed post treatment by qualified medical professionals?
As of this writing, the Indian company Genesis, which worked hand-in-hand with Regenetek until news of this scandal broke, is planning to continue offering stem cell treatments in India (at a cost of $16,050 US, as compared to the $45,000 charged by Regenetek), and even has plans to open a clinic in Trinidad despite the questions surrounding its offerings (click here). Patients who paid deposits to Regenetek but have not yet gone to India are demanding refunds, but thus far have had very little success getting any response. Posts have appeared on Facebook pages on which this matter has been discussed stating that representatives from Genesis or Regenetek will not be answering any inquiries posed on those sites. A Canadian doctor who worked closely with Regenetek has claimed she was “scammed” (click here). It seems that most of the players involved are now in serious “cover your ass” mode, and investigations into Regenetek by the Royal Canadian Mounted Police and other Canadian government agencies are now underway.
If any or all of the allegations made about Regenetek hold true, I hope all who read this will see this story as a cautionary tale about the dangers lurking in some corners of the world of alternative medicine. Distressingly, there are living, breathing human beings out there who somehow feel no guilt in taking advantage of desperate people with horrible illnesses. Back in high school I took an art appreciation class, most of whose content I don’t remember. I do remember, though, something that my art teacher, Mr. Rosen, once said: “Be careful, there’s human garbage out there…” Don't ask me what that quote had to do with art appreciation, but it sure was memorable, and quite apropos of charlatans who seek to profit from the desperation of sick people.