“I lied to patients,” testified a weeping, young woman in court related to a fraud allegation involving stem cells.
She had worked as an office assistant at a company that injected bogus and potentially dangerous cow-based “stem cell” treatments into human patients.
This company, which in different incarnations went by various names including Biomark in the U.S., was at the center of a dramatic global case of alleged stem cell fraud and criminal misconduct.
The Biomark case swept across the globe including the U.S., the Netherlands, and South Africa.
Importantly the two defendants in the Biomark case were Americans, Stephen van Rooyen and his “supermodel” wife, Laura Brown (pictured at left partying together).
The plaintiff was one Justine Asher. She sued van Rooyen and Brown, who ran the company called Biomark International in the U.S. until it was shut down in 2003 related to alleged criminal activity.
Prior to treating Asher in the Netherlands, van Rooyen and Brown had several years earlier reportedly fled the U.S. as fugitives to escape a federal criminal indictment (you can read it here) listing dozens of charges for their actions at Biomark. Brown at some point adopted the alias “Sean Castle” and Van Rooyen became “Sebastian Carlisle” according to court testimony. It’s unclear why they chose those names, but both had the same S.C. initials that could also stand for “Stem Cell”. The U.S. then reportedly was working to have Brown and van Rooyen extradited back to the U.S. as recently as last year.
Asher, who likely was unaware of Brown and van Rooyen’s earlier alleged criminal conduct in the U.S. related to stem cell treatments, was given a “stem cell” transplant in the Netherlands around 2006. van Rooyen and Brown allegedly told Asher that the treatment would make Asher miraculously walk again. Ms. Asher is a paraplegic due to injuries suffered in a car accident that broke her neck.
The treatment that Asher received sounds plenty scary. It was reportedly a “cocktail” that included bovine cells grown in fetal bovine serum that was injected into her neck and IV into her arm.
Muddying the waters, the new company in the Netherlands that van Rooyen and Brown opened up at which Asher apparently got treatment was called Advanced Cell Therapeutics (ACT), not to be confused with the current, legit stem cell company HQ’d in the U.S. going by the same acronym, Advanced Cell Technology (ACT), which is now conducting several early stage clinical trials based on hESC.
The woman who testified that she inadvertently lied to patients while working as a personal assistant for Brown and van Rooyen at Biomark was one Danielle Jibrail. She also testified that Biomark became the “new” company called ACT specifically for the purpose of avoiding negative reports about Biomark in the press.
Reportedly Brown and van Rooyen also gave many (more than 50 in the U.S. alone) patients “stem cell treatments” for MS and ALS.
According to her testimony, Jibrail came to discover later that van Rooyen and Brown gave patients potentially dangerous treatments and collected large sums of money from the patients, while they lived an “extravagant lifestyle”:
Jibrail told the court she later spoke to a doctor who worked for ACT, Catherine Orridge, who told her the stem cells came from California, and were meant for research purposes. They were not fit for humans. Jibrail said she logged on to the Internet and looked into the matter.
“Then I knew that Laura or Steve did not care about the patients they were treating,” she said, becoming emotional.
“They lived very extravagant lifestyles and spent the money patients paid them on entertainment.”
After that Jibrail contacted the FBI and emailed ACT patients the “truth”, before later resigning.
Getting back to the patient Asher who sued, reportedly she won her case last year.
As a result, van Rooyen and Brown had to sell their mansion in 2011 to pay the damages.
Adding further intrigue to the case, Brown reportedly died under mysterious circumstances shortly thereafter in Cape Town in 2011. The extradition lawyer website reporting the death said:
Brown, who had been separated from Van Rooyen, is said to have been suffering from depression since she lost their plush Llandudno mansion due to financial problems.
To my knowledge to date the cause of death for Brown remains unknown or at least not publicly available.
There are several lessons from this dramatic and tragic case.
- Going international won’t protect you if you are giving dubious stem cell treatments. As is illustrated by this Biomark case and also from the more recent RNL case in which a Korean company treated non-U.S. citizens in Mexico, dubious stem cell clinics conducting business outside the U.S. are not safe from litigation simply by being outside the U.S. Patients can sue such clinics. Note, the Biomark case was not directly related to the stem cell fraud case filed against RNL Bio, the company that is (or at least was) running Celltex’s stem cell clinic in Texas (see recent post on the RNL case).
- Dubious clinic operators can lose their own personal savings due to patient lawsuits. Patients can sue the individual people who are the clinics operators personally for allegedly misconduct related to stem cells. As a result, clinic operators can literally “lose the ranch” from stem cell misconduct. They can lose their homes to pay for court judgments.
- Stem cell companies often go by various names for dubious reasons that have nothing to do with the well being of patients. If I were a patient considering a stem cell treatment I’d do extensive research on the Internet first to see if the company offering the treatment has dirty laundry hidden away under some previous company name.
- As a potential patient considering a stem cell transplant use extreme caution! Read my websites patient’s guide to stem cell treatments. Talk to your own personal physician. If something sounds too good to be true, it probably isn’t true. When in doubt, err on the side of not getting a dubious treatment.
I predict that within the next year we’ll see several more civil lawsuits filed by patients against stem cell clinics and doctors such as dermatologists and surgeons who are conducting dubious stem cell treatments.
As I’ve said before, there’s also a wicked paradox for stem cell clinics. The more patients they treat (which should be a good thing for them, right?) the more potential people there will be who can and in many cases likely will sue them at some future time.
A huge hat tip to Dr. Leigh Turner for his help researching this case!
I found this comment on another site. Very interesting.
“Laura Brown was someone I knew in Cape Town South Africa. This is what I know of her recently-
The impression of the New Age online that she was depressed about the loss of her house and that she was fearing extradition is actually incorrect.
On the contrary, she seemed very happy and was holed up in a Clifton mansion with her new fiance, Tyrell Singh. He is a young Mobile Telecommunications millionaire. When I last spoke with Laura, she was excited to marry him and seemed genuinely happy. Her “new life” with him was all she spoke about, and he seemed to truly love her!!!??
My friends and I often saw them in his convertible Mercedes (and other exotic cars) or Range Rover and they were at every high profile society Cape Town event together. Her death was a shock to us as well, but it certainly appeared that she was not afraid of any legal procedings in the future.
I often see her fiance walking their dogs on the beach but he remains noticeably absent from any Cape Town event since her death.
No matter what she did in the past, it seems she died the happiest and fearless anyone had ever seen her!! Take that for what it’s worth.
ps. Great blog”
Barbara you give a great argument for the practice of medicine approach, in fact it is the best I have heard to date. This is still not enough to help with widespread safety issues though. FDA and other similar agencies are looking at ways to make changes such as conditional provisionary market approval with patients monitored by devices that input data needed and safety to a databank. http://www.medscape.com/viewarticle/761951?src=ptalk&goback=.gmp_4416703.gde_4416703_member_137686834 This could propel genomics, neuroscience, cell biology etc. and make efficacy tracking standard and much less costly with the advantage that the ntervention gets to the patient faster and with reliable data behind this. Even with all the industry regulation we are seeing including 1.5 and 3 billion dollar fines for improprieties in regards to data transparency.
There are interesting cases where organ bank licensing has been issued without the same oversight and hospitals have used organs that come from questionable sources (took one felon 3 days to get a license!) and now even hospitals advertise on facebook for kidney donors. We also have companies, Pharma, med device and biologics that take their products out of the country and do not regard Helsinki, Belmont or FDA and do harm to recipients for which they remain unaccountable and yet they can use this unethically derived data to prop up their case for USA markets.
These inconsistencies suggest that change is needed that will be fair for all markets and puts patients first.
There is little successful recourse for a sick patient who suffers adverse events in a clinical trial in the USA, or even a malpractice suit, but you are right with malpractice at least there is a chance. Patients mostly lose or spend years fighting and they end up spending the money they need to pay for their care and also use the mental and emotional energy they need to heal, maintain their immune systems and rebuild their futures and the bulk goes to lawyers, experts, court costs and the like.
When the public reads about regulatory inconsistencies they lose respect and they are left with the choice to trust an FDA they do not know or an MD they meet face to face who hints at the possibility of a solution. We are all socially conditioned to trust and not to question an MD’s judgement. If we are vulnerable and in pain or have no other options it is no contest.
Most will assume the doctor has ethics, is honest, he/she is compliant, the lab is clean and the treatment is good even when it is not. If the doctor says it is safe and they have a chance and are fortunate to have the funding to broker the deal they will go for it regardless of FDA. Even if the MD is legally barred from performing a procedure within the USA, the medic or the staff or a designate can still see patients in a USA office, recommend treatment offshore and then go and perform it or have others they hire do this for them. How safe is? There are concerns when there are complications plus there is the additional bodily insult of extended travel.
Most will continue to support the medic even when treatment harms them or is unsuccessful as they invested in the process and gave their trust and to consider otherwise is questioning their own judgement which is yet another loss. By the time they figure out they have been taken advantage of it is too late. If a family member has helped pay for the treatment it is even more serious as none of us wants to tell a family member that their help was harmful or did not good. If any seek legal redress they will be outspent and intimidated plus since this intervention is so new tying the adverse events to the cell therapy in a court of law will not be easy.
If they are fortunate and treatment succeeds they will not look back, most of us would give everything we have for the health of someone we love. For those that care about science, patients and ethics the system needs innovation and the exercising of integrity compassion and wisdom from all stakeholders. History does not show a good track record for self regulation in the health industry. Their needs to be a cooperative effort for change with the needs and concerns of all stakeholders understood and validated without unfair power advantages or hostility
Doctors in the U.S. and elsewhere can be sued for malpractice. If our own stem cells are used in a treatment as the practice of medicine, patients can sue if something goes wrong. States license physicians so there is strict oversight. Unfortunately, using our own stem cells does not fall under the practice of medicine. As it is now, sleazy clinic operators can simply open a company under one name, shut it down when a problem arises, open another one, etc. These con artists flee the country when needed or hide their assets. In a perfect world, the patient would be able to sue for malpractice and get compensation if the doctor has done something wrong. In my opinion, a patient would fare far better suing a doctor for malpractice than trying to pursue con artists all over the world. This would help eliminate doctors who have no expertise in stem cell therapy. There are many examples of those that have taken advantage of the desperately ill who continue to operate simply by moving around or as I mentioned changing the name of their company. It’s not just a monetary issue for patients either. Some patients have lost their lives. There are others out there that the FBI and the FDA have been informed about. Unfortunately, the system moves glacially slow and in the meantime, they continue to put patients at risk while adding to their own bank accounts.
This employee is not the only person to find they had inadvertently been put in a position where information they gave to potential patients or otherwise vulnerable persons was overstated or a lie.
MDs and health professionals are in a trust position in society and they are believed because of their training and expertise. It takes a long time to come to terms with the fact that what you were required to report does not reflect truth, ethics or undermines regulatory authority. If you do not know what the truth is and you trust your employers until something goes wrong there is no reason to suspect you are being used as a propaganda machine.
First there is denial, then justification, negotiation and then anger and despair. It is like a living death. She will feel used. It happens often. These people are not scientists, they need a job, often they are drawn to medicine because they want to help people, they are sold on the product and they want to believe the best.
My compassion goes out to her, sadly she will be judged by most and will carry this burden of guilt for being complicit in the potential harm of another for the rest of her life.
These kinds of scenarios drove me to evidence based health care where I learned to tell research from marketing and good science from bad science and how to search for anything and understand what I find. We are setting this kind of learning up for the public so they won’t be as vulnerable and can learn how to exercise the power of informed choice.
Wow- What an Amazing story of greed, betrayal & intrigue. I hope you will keep us up to date on any future developments, especially on Browns death.
Someone needs to option this for a movie!
I had the same idea–this is movie material. Truth is stranger than fiction sometimes. I wonder if the FBI is still working to get van Rooyen back to the U.S. for trial. I also wonder how Brown died. I hope van Rooyen has not opened up yet another stem cell clinic somewhere else in the world putting more people at risk.