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SKEPTOID BLOG:

The Stem Cell Business - Part 2

by Martine O'Callaghan

May 9, 2013

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Donate Part one of this short series looked at unregulated stem cell clinics fleecing patients of their savings and robbing them of their health and even their lives. I had intended to write about the changes to regulation of stem cell therapies being debated in Italy but Orac beat me to the punch and I am not going to attempt to out Orac Orac. In his post Deregulating stem cell quackery in Italy? A bad omen, he laments,
Italy's health minister, Renato Balduzzi, has been impressed by the blandishments and claims regarding adult stem cell therapy and on March 21 decreed that that a controversial (actually, let's be honest, a quack) stem cell therapy can continue in 32 terminally ill patients, mostly children, even though the stem cells were not isolated according to Italy's safety standards. This decision followed a prolonged campaign and media pressure to authorize the compassionate use of the therapy. As noted in this Nature report, hundreds of people protested in Rome on March 23, including a naked woman with pro-stem cell slogans painted on her body.
Instead, I am going to explore the case of the now defunct clinic that operated within the German regulatory system. The X-Cell centre in Dsseldorf offered patients from all over Europe highly experimental stem cell therapies for a wide range of conditions from Parkinson's disease to diabetes. For most patients who visited the clinic, all they got for their troubles was tens of thousands of pounds worth of debt.

Early in May 2011, the German clinic was forced to close. By August, its directors filed for insolvency stating, "German advisory authority has denied further authorization for stem cell transplantation." The very existence of the clinic relied on its exploiting a legal loophole that allowed patients to be charged for so-called therapies that had yet to be proven safe or effective. In the treatment of the seventeen conditions for which the clinic advertised therapies, the type of stem cell transplantation offered has no biological plausibility of working.

As described in the first part of this series, there are different types of stem cells. Some can become any cell of the body while others have more limited potential. At the X-Cell Centre, cells were harvested from patient's own bone marrow and injected into their brain, brain stem or cerebrospinal fluid. These multipotent bone marrow-derived stem cells could only ever differentiate to become one of a number of blood cell types, making their injection into nervous tissue not only pointless but totally without rationale.

Staff at the X-Cell Centre had been feeling pressurized as their work was being scrutinized ever more intensely following the death, in August 2010, of an eighteen-month-old Romanian boy. The fatality followed the serious injury of a ten-year-old child, in the preceding May, while undergoing the same therapy — stem cell transplantation into the brain stem — that resulted in him being more severely disabled than he had been before treatment was begun.

Dr. Michael Sabel, the consultant neurosugeon and his team at the University Hospital Dsseldorf saved that child's life when the ten-year-old was brought in to them with severe internal bleeding. Sabel, shocked that such dangerous and experimental procedures were taking place legally, wrote to the German authorities warning — as it turned out, predicting — that children would die if the clinic continued conducting this procedure. When the operation was botched once again, the eighteen-month-old victim was not taken to Sabel at the University Hospital just five minutes away from the clinic but, in what one can only assume was the centre's hope that its injury rate might go unnoticed, was driven to another hospital fifteen miles away.

The doctor responsible for injecting stem cells into the brains of these unfortunate children, neurosurgeon Uta-Kristein Tamaschke is now under criminal investigation for, as Dr Sabel sees it, "an unjustified surgical procedure...[injecting] stem cells into...the most delicate structure in the brain."

For a short time, I corresponded with a former member of staff from the centre whom I shall call T*. I asked T if the patients (s)he had contact with were aware of just how experimental the procedures on offer at the X-Cell Centre were. "Most English patients did...but because [the centre was in] Germany they think it's only cause the health service thinks it's too expensive they can't get it [in the UK]. People came from all over though." Asked if (s)he or anyone else explained to the patients that the therapies were of unproven safety and efficacy, (s)he retorts, "... lots of people are helped by stem cells and lots of them got helped at the centre...people are really devastated that it shut down it was their last hope." This statement alone begs the question of how informed was the consent to therapies given by patients. If the rest of the staff had the evangelical zeal of T, it is difficult to imagine that patients would anticipate outcomes other than success. Journalist Alisdair Palmer has multiple sclerosis and uses a wheelchair. In an undercover investigation of the X-Cell Centre for UK newspaper The Telegraph, he was told by Professor Haberland, "you have a win-win situation... 80 percent of our patients report improvements."

Experts in the field of stem cell technology were enormously relieved by the centre's closure. Professor of regenerative medicine at University College, London, Chris Mason, is delighted: "This is excellent news... X-Cell had failed to demonstrate its treatments were... safe and effective." His views echo words of a press release by German medicine regulator, the Paul-Ehrlich Institute, which "welcomes the news that the X-Cell Center is not accepting any more cases."

When pressed, T reveals that the data relating to clinical outcomes was based on nothing more robust patient questionnaires. I wonder to T whether people who had spent as much as 20,000 of their savings, donations raised from others or heavy bank loans, were be able to be objective. Did T, and other clinicians (T claims to have been a clinician but I have my doubts), believe that patients themselves are qualified to assess the outcomes of a procedure? T counters that the clinic offered a few follow up appointments in the cost of the treatment and that it was assumed that patients who failed to attend were doing well. Perhaps, I suggest, patients were not able to attend because they were too ill to do so or simply could not afford the travel expenses. T rejects this idea out of hand describing some patients as "too lazy to come back. If they can afford the treatment they can afford the travelling [expense]." If they could not, T suggests it would be "dumb to come."

Desperate families and patients who have paid often substantial deposits to X-Cell may get very little — if any — of their outlay back. The Company's insolvency administrator, Professor Sinz, asks for "understanding that, at the moment, it is not certain yet how much money I can refund to you." In the light of a child becoming more brain injured than he ever had been and another losing his life because of "therapies" administered at the X-Cell Centre, patients who, having paid for transplants that will now never take place, should count themselves fortunate that it is only money and false hope they have lost.

*T gave me permission to use quotes from our online conversations for a previous incarnation of this article. I no longer have contact with this person but am acting in good faith that having further obfuscated their identity and reducing the number of quotes used that usage of that material here is fair.

by Martine O'Callaghan

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