By Henry Douglas Broeska, Special to California Business Journal.
For those worried that drug companies have deep influence over the medical establishment, this article should ring an alarm. A decorated and respected career professor, Dr. Susan Krause, formerly teaching medicine at the University of Manitoba in Canada with no history of misconduct, has been suspended by her governing body, the College of Physicians and Surgeons of Manitoba (CPSM). Her “crime” was her ‘side’ involvement in a non-profit research organization that was following study participants in an experimental Phase 1 study of a novel treatment for Multiple Sclerosis (MS).
The interventional protocol under study utilizes the patient’s own stem cells, thereby minimizing chances for immunological rejection. The patients’ cells are then cleaned and delivered intravenously into specific areas of the patient’s brain employing a minimally invasive novel interventional radiological procedure. The underlying basis of this therapeutic approach is that, MS is initially and primarily a vascular disease.
The theory ascribed is that with the placement of stem cells at the level of blood vessel leakage across the blood brain barrier, the therapeutically augmented number of repair cells can effect endothelial tissue regeneration within the vessels. This has the knock-on effect of halting neurotoxins in the blood from crossing the blood brain barrier. These are toxins that are known to cause brain inflammation and subsequent nerve cell damage that leads to the symptoms of MS. Evidence, having been peer-reviewed for publication in a scientific journal shows that many of the study participants benefitted with improved function including walking ability.
The significance of this experimental therapy is that it is the first known clinical trial of selective stem cell placement as a therapeutic modality for treating vascular dysfunction in MS. The purpose of the research was to determine the safety and efficacy of the treatment. Planned Phase 2 clinical trials may demonstrate the protocol’s potentiality as a superior alternative for the treatment and management of specific sub-populations of MS patients.
In its scathing rebuke of this research, the College of Physicians and Surgeons of Manitoba disgraces itself with an outrageous and self-serving decision to suspend Dr. Krause for her role in this novel, experimental and hopeful therapeutic paradigm in the treatment of MS. Their “theory of the case” against Dr. Krause was intentionally built upon disinformation, false testimony and a wildly speculative fictional narrative. The clinical study formerly followed by Regenetek Research (Regenetek Research was a Canadian “not-for-profit” entity and by law, it cannot make profits) has to date developed a research method, produced data, as well as a pending patent for the novel protocol and, a manuscript that has been peer-reviewed.
The hypothesis of MS being primarily a vascular disorder is a solid theory with a rational basis for investigation that has developed a life of its own in the United States and globally. It is not only Regenetek that believes there is a vascular association in MS. Since Regenetek began its investigational work in 2010, many more researchers from across the world have begun to go down that avenue of investigation. And with or without the originators of this hypothesis, it’s research that will continue.
But rather than recognize the innovative clinical research that Regenetek was following as an accredited and highly monitored protocol conducted by world class interventionalists, the CPSM has instead chosen to categorize it as “invasive and painful surgical interventions, accompanied by risk of harm.”
No attention at all has been paid to the scientific basis upon which the therapeutic hypothesis was founded. During the course of this clinical study, no participants experienced any harm as there were no adverse events, significant or otherwise. Furthermore, as is mandatory in all clinical trials, all participants signed informed consent after being informed of the risks and were aware that they may have no response to the experimental treatment.
The research was being conducted by world-class clinicians and interventionalists in a modern Indian research hospital. It had all of the national and local ethics accreditations required, and was being monitored by representatives of the local Ethics Committee who were in the hospital daily over the two-week period required to perform the multi-part protocol on each participant. Dr. Krause had little or nothing to do with the research. But there are others who did — others who are not on trial and whose motives are not in question.
Dr. Uta-Sboto Frankenstein, one of Canada’s foremost pre-clinical researchers in the field of diffusion tensor imaging in neurodegenerative disease study was Regenetek’s Director of Research in Canada. Her opinion of the research she was following was that it was highly advanced and “ahead of its time.” She sent numerous emails to others stating that fact. Before the media attacks in 2015 she was about to perform MRI follow-up on the first group of participants. Dr. Glen Bergeron, professor and Director of the Heads Up Concussion Research Institute in the Gupta Faculty of Kinesiology and Applied Health at the University of Winnipeg was quoted in a public forum attended by scores of people as saying that, “I have had to change the way I think about MS with the evidence I’ve seen in the recovery of the participants as a result of this novel therapy.”
Dr. Bergeron was the Principle Investigator of a pilot study associated with Regenetek’s follow-up of selected participants. He, not Regenetek, was responsible for choosing which participants to enroll in an adjunctive follow-up study on spinal deterioration in MS, a new, significant finding that will need to wait for others to discover. An office had been secured at the University of Winnipeg and clinical staff had been hired and equipment purchased to conduct the research. A host of other outstanding clinicians performed and assisted with therapies in India. None of these facts were brought forward in the CPSM’s “theory of the case.” Instead, the CPSM really got down into the mud and traded in the most salacious rumors.
None of the governing bodies of those other researchers ever thought that there was anything to investigate because in their direct monitoring of the research, it was all being performed ethically and in accordance with all of the appropriate rules and guidelines. It was only the CPSM, the governing body that was least involved and used second-hand information to concoct a theory that it isn’t true.
The CPSM did not reach out to the staff neurologist in the Indian hospital monitoring the procedures, nor did they speak with the Drugs Controller General India (DCGI), the Independent Ethics Committee Pune (IECP) nor the Indian Council of Medical Research (ICMR) to inquire whether the study subjects in the program were being treated ethically and in accordance with all guidelines. If they had, they would have been told that the approved study was meeting, and had met all of the appropriate rules and guidelines. In fact, each one of those governing bodies monitored the clinical procedures as they were ongoing. If none of those oversight bodies found anything wrong, then who is the CPSM to judge the matter after the fact? In the fouryears duration of this inquiry, if CPSM truly believed that medical malfeasance had occurred, then why did it not report its findings to those governing bodies, and to the U.S. Food and Drug Agency (FDA) and the World Health Organization (WHO) as practices that are an endangerment to the public?
For their “Inquiry,” the CPSM actively sought out study participants who had not experienced harm and who had no intention of filing a complaint. The organization was actually helped in its coercive efforts by some members of the Winnipeg media who, through a devastating series of articles in the Winnipeg Free Press, induced some study subjects to believe that they had somehow been deceived into participating in a medical fraud. The CPSM reached out by casting a wide net to entrap other study participants in order to elicit negative comments or viewpoints based on prejudicial statements that they attempted to seed into their opinions with leading questions.
One of the study participants was summarily rejected as a witness for the CPSM inquiry because she would not provide false testimony against Dr. Krause. A letter of complaint from that study participant against the improper behaviur of the CPSM suggesting that she do so was sent to legal counsel contemporaneously and this prejudicial conduct by the CPSM is a matter of record. It is also a matter of record that Dr. Krause’s first legal representative appointed by the CMPA to represent her in the inquiry had to recuse himself for a serious conflict of interest but only after Dr. Krause discovered his conflict accidentally, and not before he had done much damage to her case.
Neither the Winnipeg Free Press, the CBC, nor the CPSM in their collective and conjoined intent to discredit the research and the researchers, ever reached out to anybody at Regenetek to discover the underlying scientific basis for the novel protocol. One would like to believe that the news media has the best intentions in presenting a balanced view to the public. Had they been serious about balance, we could have presented abundant evidence in the literature to demonstrate that every element of the novel protocol has a valid, scientific basis for investigation.
No part of the protocol was either conceived or performed without evidence of rigorous testing and prior evaluation in other clinical investigations. The paradigm for the novel protocol is now in the form of an extensive pending patent filed with the United States Patent and Trademark Office (USPTO), complete with citations from the literature to support all claims. There is no prior art in this area that we know of indicating the originality of the scientific process. Furthermore, it can be demonstrated through data as a result of using standardized measures that the protocol is effective as a treatment for a large sub-group of patients with Multiple Sclerosis. That evidence has now been peer-reviewed for publication in a scientific journal.
The CPSM and some members of the Winnipeg news media have rejected multiple attempts by those helped by this therapy to be able to “tell their story.” There are some remarkable participant outcomes that have been intentionally suppressed. Over the course of the inquiry and in past media campaigns waged against Broeska and Regenetek, both the Winnipeg news media and the CPSM have rejected attempts by other clinicians who are involved in the current research, in their attempts to explain the basis for the research. Those who have tried have been continually turned away.
Further, the media has dishonestly misrepresented participants’ statements in previous interviews, even to the point of editing “soundbites” of participants in order to produce the opposite meaning of what they actually said. The CPSM has relied heavily upon the dishonest reporting of some members of the media in their Inquiry to build their “theory of the case.” The clear bias of the CPSM therefore was to reject any and all evidence in favour of Dr. Krause but to admit unsubstantiated and unbalanced testimony, thereby completely mischaracterizing all matters to do with the research and her conduct. In its scathing judgement of Dr. Krause, it could not allow the possibility that she did anything for reasons that were other than grotesque and selfish. And it must all now be made public to demonstrate that the governing body is acting in the public’s best interest.
The CPSM conducts disciplinary proceedings unlike any other professional body in exercising its quasi-judicial responsibilities. In total secrecy, it admits the testimony or the material that the prosecutor chooses, even if it’s based upon rumors, innuendo and speculation. If it supports the prosecutor’s “theory of the case,” it is unquestioned and entered into the record as fact. The prosecutor gets to reject other material and the subjects of inquiry have little defense except to accept their fate. It is highly unlikely that Dr. Krause had any choice other than to accept what she knew to be untrue; after all, she hopes to practice medicine again.
But so ruthless was the prosecutorial onslaught with its multitudinous charges and accusations, that it would only be natural if the casual or unknowing observer ended up believing that something of what prosecutors say must be true. Here’s where all Manitoba physicians should take pause. With this CPSM decision against a respected educator with 35 years of immaculate professional practice and celebrated mentoring of medical students, residents, and colleagues, some questions must be asked. For example, why would she do it? After all, she contributed so heavily financially to the research that she put herself into bankruptcy. Who does that? Unless there’s a reason that perhaps this respected healer had a motive that is other than the one of greed portrayed by the CPSM.
What do we know of the protocol itself and the evidentiary basis on which it was founded? Does anyone care to cover that? And maybe it’s time we asked some of the others who have not been heard in this matter to raise their voice in defense of gross injustice. Let’s speak with some of the clinicians and researchers. Let’s speak with some of those participants who have had unusually positive, healthful and, in some cases, life changing results — outcomes that the medical establishment tell us are not medically possible.
A January 2019 clinical study report out of the U.S. stated “A single stem cell transplant could stop or delay MS symptoms better than some medications,” as published in the Journal of the American Medical Association, which contradicts CPSM’s contention that “a single stem cell treatment could not be effective” and thus Regenetek’s research protocol was “a scam.” Maybe there’s actually a better therapy at hand than to just treat MS symptoms for $100,000 a year, each patient. With a MS patient population of nearly one million in the U.S. alone, that’s a lot of money — trillions of dollars over a relatively short number of years.
As consumers who are constantly in the sights of those who are attempting to monetize our diseases, we should finally ask, in whose interest is it to keep these outcomes from ever being seen by the public? How is it that such a concentration of effort was spent on convicting a benign and by all accounts, competent educator who “got out of line” by questioning the prevailing therapeutic modalities for MS, which all happen to be drugs? Who is the conflicted party here?
Henry Douglas Broeska is an Orange County, California researcher and author. He is the co-author of “The Effectiveness of Selective Stem Cell Placement on Gait Performance in Patients with Multiple Sclerosis: A Phase I Clinical Trial,” as well as recent book on the adoption of a single payer healthcare system in the United States.
Comments from some of Dr. Susan Hauch’s patients: https://www.ratemds.com/doctor-ratings/43321/Dr-Susan-Hauch-Winnipeg-MB.html