Winnipeg doctor guilty of professional misconduct in controversial stem cell research
Dr. Susan Krause barred from practising medicine for a year: College of Physicians and Surgeons of Manitoba
A Winnipeg physician involved in a controversial stem cell research company has been barred from practising medicine for a year by the College of Physicians and Surgeons of Manitoba.
An inquiry panel of the college found of Dr. Susan Krause, formerly known as Dr. Susan Hauch, guilty on eight charges, including professional misconduct and demonstrating unfitness to practise medicine.
Conditions on her return to practice include strict supervision and mandatory participation in ongoing psychotherapy. She is also ordered to pay all of the college's costs of the investigation and hearing.
The costs are expected to be the highest of any in the college's history given that "Dr. Krause's lack of co-operation and deceit persisted for more than four years," registrar Dr. Anna Ziomek says in a statement that sums up the important findings of the panel.
That's not good enough, says the former partner of Patient L, a Winnipeg-based ALS patient who travelled to India for treatment in 2014 and died a year later. He provided key evidence in the case and says the disciplinary decision is not in line with the level of professional misconduct involved.
"It is outrageous that she [Krause] will be allowed to resume her medical practice in one year's time. In my opinion her licence should have been removed permanently," Patient L's partner wrote in an email to CBC News.
Dr. Krause's conduct was so gravely serious, her breaches of standards so concerning and diverse, and her disrespect of the college's processes so contemptuous ...- College of Physicians and Surgeons of Manitoba
The 83-page judgment follows investigations against Krause for her involvement in an international clinical trial that involved widening the veins of a test subject's neck, and then injecting the person's own stem cells.
MS (multiple sclerosis) and ALS (amyotropic lateral sclerosis) patients were recruited and processed by Winnipeg-based companies in which Krause had a financial interest, the college's judgment states.
Ethical standards in Canada and India preclude charging patients being part of a clinical trial.
In 2015, patients from around the world complained they had been scammed by Doug Broeska, a Winnipeg businessman with no formal medical training, who recruited them and others for experimental and expensive stem cell treatments.
Many patients said they felt better after the non-traditional, unapproved procedure, but others saw little or no improvement.
The procedure was based on so-called "liberation therapy," a controversial procedure that surgically widens neck veins as a treatment for MS. After years of concerns, a clinical trial in Canada debunked it in March 2017.
Several patients provided CBC News with letters Krause wrote to help them obtain medical visas to travel to India, as well as recordings in which she provided medical advice via Skype.
Five patients complained to the college. The judgment outlines the cases of several people who did not get any benefit from the procedure, and who subsequently died.
"The complainants felt that the CTP [combined treatment protocol] procedure and the CTP study constituted a fraudulent scheme and that Dr. Krause's professional judgment had been jeopardized by her business interests," the judgment says.
After investigating, an inquiry panel of the college found:
- Krause inappropriately and unethically participated in a "research" study that purported to investigate unproven therapy/interventions for multiple sclerosis, amyotrophic lateral sclerosis and other neurological illnesses. The procedure, called combined treatment protocol (CTP), was performed in Pure, India. Krause's misconduct was a conflict of interest arising from her personal and business relationship with Broeska and their related companies, Clinicard, Regenetek and Regenetek Research. Krause told the panel she lost more than $700,000 and her home because of her financial involvement in the companies.
- Krause had inappropriate personal interactions with 19 vulnerable patients who "were susceptible to being unduly influenced by the advice being provided by Dr. Krause by virtue of her being an experienced physician," including encouraging them to participate in the unproven, experimental therapy. Most patients paid $15,000 to $45,000 U.S. to a business in which Krause was a shareholder.
- Krause didn't co-operate with the college's investigation and provided false and misleading information from as early as 2013, when she "deceived" the college about her involvement with Broeska and the CPT study.
Krause pleaded guilty to all charges except the one that she had demonstrated an incapacity or unfitness to practise medicine. The inquiry panel concluded it had proof of her guilt on that charge.
It writes: "Dr. Krause's conduct was so gravely serious, her breaches of standards so concerning and diverse, and her disrespect of the college's processes so contemptuous," that she was unfit to practise medicine between February 2011 and April 2017.
Still, it also found Krause is genuinely remorseful, has "substantial rehabilitative potential" through ongoing psychiatric care for depression, anxiety disorder and narcissistic personality traits. Her psychiatrist says she's no danger to patient safety and can safely return to family medicine.
She has been providing surgical assists for the Winnipeg Regional Health Authority since March 2016, and started working as an attending physician at a Winnipeg hospital in December 2017.
Patient L's partner does not believe Krause is remorseful and sees this disciplinary action as a slap on the wrist.
"She has not apologized to me or my daughters, nor has returned the $45,000 US funds I paid to her and her conman partner," he wrote to CBC News.
"As a psychologist, if I was part of something this heinous I would fully expect to lose my licence permanently. This decision clearly calls into question whether the college can adequately police itself."
In her statement, Ziomek addressed that concern, saying the college's investigation committee wanted to revoke Krause's registration and licence to practise medicine. Krause argued she should only be suspended for six months.
The panel ultimately decided a 12-month suspension would "appropriately punish Krause for her misconduct and deter her and other physicians from similar behaviour, while protecting the interests of the public and maintaining the public's confidence in the medical profession's ability to regulate itself."
The inquiry panel gave Broeska's "malign influence" over Krause as one of three counter-balancing considerations.
It concluded she "was duped by Mr. Broeska," with whom she had an "intimate, personal and sexual relationship" between 2006 and 2014.
"Dr. Krause has stated that her misconduct is a result of an overriding emotional and financial conflict of interest," the judgment states, adding she has had no contact with Broeska since 2015 and now recognizes him as an "effective conman" who exploited his romantic and financial entanglements with Krause.
According to the judgment, Krause described him as "controlling," "dishonest," "manipulative" and occasionally verbally and physically abusive.
Broeska was also investigated by the RCMP and Health Canada after several patients filed complaints and raised questions about his qualifications as principal investigator for the clinical trials.
The college's inquiry panel found that "Dr. Krause has always been aware that Mr. Broeska had no formal education or experience in any field of medicine or clinical research and that his education was limited to incomplete undergraduate studies at a university and an online degree in "health administration," for a part of which she paid."
In 2017, Broeska sued CBC Manitoba and the Winnipeg Free Press for defamation. The suit against CBC was dropped several months later.
Neither Krause nor Broeska could be reached for comment.
However, in 2015, Broeska said he was "unfairly accused and victimized by inaccurate media reporting," providing what he said was proof of his educational credentials.
"We believed we had made an important potential discovery in 2015 by recognizing a vein-lesion relationship in MS and treating it," Broeska is quoted as saying in the news release.
"We were getting ready to publish our first paper. The data demonstrated that many study subjects were improving with measurable return of function and a reduction of the other symptoms of MS. It's a tragedy that the false allegations of fraud by the media put the research back a decade."
Expert opinion on the research
However, the Manitoba college's investigation committee got an expert opinion from a neurologist specializing in MS and related neuro-immunological conditions and with experience in clinical trials.
The expert consultant neurologist, who is given anonymity in the inquiry panel's written judgment, provided 12 reasons showing "that the design and implementation of the CTP Study … rendered it incapable of producing meaningful results."
- No control group was established without any apparent rationale
- No data collection occurred prior to patients receiving CTP.
- No reasonable or appropriate inclusion and exclusion criteria for patients was established.
- The disease under study was not adequately defined in the CTP Study Protocol or anywhere else
- The CTP Study Protocol contained inappropriate content — for example providing details as to the transport of sperm, which is completely unrelated to any aspect of the study.
- The CTP Study Protocol described inappropriate means for collecting data and interpreting results in the circumstances.
- Standardized procedures for carrying out the CTP were not established.
- The nature of the treatment under study was not adequately identified or described.
- Patients were charged a fee to participate in the CTP study.
- The informed consent documentation used in conjunction with the CTP Study Protocol did not meet the standard of the profession.
- The CTP Study Protocol changed one or more times during the CTP study.
- Several participants were removed from the study without regard to the impact these changes would have on the validity of the results of the CTP study.
The expert consultant concluded that the "the trial, as [inconsistently] described in the protocol, would not allow the collection of any meaningful data to advance care of MS and/or other neurological conditions it would be fundamentally unethical to proceed with such research," the judgment quotes the neurologist as saying.