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September 21, 2011

Should the fight against bogus stem cell therapies be turned back to the lab?

by Lisa Willemse

This morning's news scan turned up yet another sad tale about the dangers of unproven stem cell therapies and a warning to consumers to once again be skeptical of the claims made by the many unscrupulous clinics operating abroad. For the most part, the article echoes repeated calls made on this blog and numerous other sources, including the ISSCR's Closer Look at Stem Cells, to draw more attention to the issue of "stem cell tourism" in hopes of reducing the numbers of patients paying for such potentially harmful treatments.

Interestingly, I also had an email in my inbox today that contained a recently published paper in EMBO reports that addresses the same topic, albeit in a very different fashion. The authors of the paper, Zubin Master and David Resnik, argue that stem cell scientists could do more to curb stem cell tourism in the face of the questionable success gained from such public education initiatives such as Closer Look at Stem Cells. In fact, the authors suggest that in the case of stem cell tourism, a successful strategy requires the active involvement of scientists.

This strategy was neatly summed up by the authors in The Scientist:

 Scientists are uniquely positioned to help quell stem cell tourism because of their knowledge and control over stem cell materials. We propose that scientists could use existing contracts called MTAs (material transfer agreements) to share materials and reagents only with responsible scientists. This would require researchers to evaluate the requestor’s CV, supplementary documentation, a clinical protocol, and website before providing reagents such as stem cell lines, nucleic acid sequences, growth factor enriched cocktails, or purified proteins to others. Those requesting materials would have to sign an MTA, which would outline the intended purposes of the materials. For example, MTAs for sharing stem cells that are not clinical grade or are not being used to develop clinical grade cells should stipulate that the cells are to be used for non-clinical research purposes only.

Although our proposal places limits on scientific openness and sharing, we believe it is necessary to have such restrictions in this situation in order to prevent greater harms—potentially worsening the condition of patients who receive fake treatments and the possibility of reducing public trust and undermining legitimate stem cell research. Our proposal also adds additional time and resource burdens to stem cell researchers, but again, this is a necessary inconvenience to stop the growing illegitimate stem cell industry. There is also concern that MTAs themselves will be ineffective, says Robin Lovell-Badge, a renowned stem cell scientist at the MRC National Institute for Medical Research in London. His contention is that rogue clinics can themselves derive embryonic stem cells from embryos, create induced pluripotent stem cells from patients, or simply not transfer anything into a patient, providing nothing more than a placebo (Robin Lovell-Badge, EuroStemCell, 2011). These are definitely valid concerns and we agree that MTAs, by themselves, will not stop stem cell tourism. But if they can deter some irresponsible stem cell therapy and research, why not use them? As with education and international policies, control of materials is simply one strategy in the scientist’s arsenal that can help mitigate the use of bogus stem cell remedies.

The problem of stem cell tourism raises a host of questions, not the least of which is who should take up the fight? Is it the scientists? Advocacy groups? Governments? Up till now, a simple, single source solution has not emerged. Master and Resnik may not earn any popularity points among over-stretched scientists for their suggestion, but if a more coordinated effort is required, then scientists have an important role to play.

 

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Selling Hope. October 2011

Hello,

I am writing this letter to in the attempt to caution or inform anyone considering traveling abroad for medical procedures, in particular stem cell treatments. With all of the hype surrounding stem cells, it is no surprise that millions of people suffering from incurable disease or disability are hoping these magical cells may hold the answer to many of medical sciences toughest questions.

Stem cell tourism is a booming business with clinics popping up all over the globe and the demand growing. If you simply Google “Stem Cells”, the side bar lights up with Ads. Google and Yahoo do not care that these ads are promoting dangerous or unethical treatments–they are simply moneymaking machines. In a way, I don’t totally blame them because once Yahoo and Google start censoring their ads, where do they stop? But it is still worrisome. Frequently the ads show pictures of patients and stories about their successful treatments. As part of medical tourism it should be a good thing, but the problem here is that most of the so-called “stem cell treatments” abroad are illegal or unproven and will cost you something around $20 000-40 000 USD.

There are different opinions from experts and patients about this controversial tourism. The seekers basically say “if traditional medicine can not help us and we can not get experimental stem cell treatment here, why shouldn’t we go? We have nothing to lose and we are willing to pay for our last hope!” Experts (aka “stem cell community”) say “It’s unproven, it could be the waste of money and even harmful.” Seems like both sides sound reasonable. What do millions of desperate patients searching for information daily see on the Internet? Advertisements of clinics, selling hope. What can the community (stem cell researchers and physicians) offer them? Almost nothing!

I am one of those patients…told by my Canadian doctors nothing could be done to improve my chronic condition, so against my better judgment and doctor’s recommendation, I underwent a stem cell implant in Mexico.

In 1998 I suffered a spinal injury, from a devastating snowboard accident that left me to deal with permanent neurological dysfunction, but through the miracle of medical science and a remarkable support system, I was able to return to an active and productive life. For 10 years I embraced my second chance, and shared my enthusiasm for life with all those around me, especially those faced with health challenges.

In 2008 I suddenly started experiencing increased back pain and neuropathic pain down both legs. These symptoms continued to worsen and elude all the medical experts. After exploring every reasonable explanation for these symptoms and exhausting all traditional and alternative treatments, I traveled to the Mayo clinic to try to get a solid diagnosis. So after three years of searching for answers, I was finally diagnosed with a rare spinal degenerative disease called Arachnoiditis. It is a debilitating condition characterized by severe stinging and burning pain and neurologic problems. It is caused by an inflammation of the arachnoid lining—one of the 3 linings that surround the brain and spinal cord. This inflammation causes constant irritation on the nerves triggering merciless nerve pain. There is currently no treatment for Arachnoiditis, and most patient’s only option is a life of high dose narcotic painkillers.

So after being told there was no treatment for this disease, I started searching for alternatives or anything that could offer me hope. Pain and desperation can certainly cloud ones rational thinking and it was not long before found a clinic that claimed to help many people with chronic conditions, located in Scottsdale AZ. The cost of the treatments was extremely expensive, but it seemed as though they had some great testimonials and a good reputation online. So I started an aggressive 4 week treatment program at cost of 5K per week. After a couple weeks of treatment without any change in my pain levels, I was told the clinic also offered stem cell transplants that could benefit patients with neurological problems. These treatments were performed at their sister clinic just across the border in Mexico, outside FDA jurisdiction. I got so caught up in the stories of hope and the slick presentation that I lost site of the warning signs all around me. First of all, much of the details of the procedure and cost seemed very vague. I had already spent 30K on treatments that where not showing results, and now I was going to throw down another 30k for a risky unproven treatment in Mexico. So without much thought, paid 30 k upfront and got shuttled 4 hours to Rocky Point Mexico, where I was to be given 50 million umbilical cord stem cells via lumbar puncture.

I was a little nervous when I met the doctor and toured the clinic. It was clean and modern, but lacking the experience and sophistication one would expect from a clinic offering $30,000 cutting edge treatments. I was feeling some reservation about going ahead with the procedure, and the idea of getting 4 lumbar punctures was making me a little nervous. The Doctor reassured me, and went on to tell me about several patients that had amazing results from the stem cell implants. Again, with the constant nerve pain driving me insane, I felt I had nothing to lose and everything to gain.

Man! Was I wrong…the first infusion of stem cells seemed to go smoothly with only minor discomfort, but that night things took a turn for the worse. It started with an aching low back, then my entire spine felt like it was going into spasm. The pain spread up my spine and neck until my entire head was pounding with the worst headache of my life. As the night progressed, fever and chills took over my body as I shuttered with fear at the situation I suddenly found myself in. Early in the AM I called clinic, which rushed me to clinic in ambulance after a few hours of monitoring, the fever and headache started to subside. It was a concerning idea to keep going with treatment if this was going to be the reaction each time. We decided to wait a day and see how I feel before proceeding…the doctors felt, that if they reduced amount of fluid injected, it would reduce the chance of repeating reaction. So after a day to recover, I repeated the procedure, this time my reaction was less severe, but the back pain and headache still persisted. So after 5 days of hell, I was back in the shuttle headed for Phoenix with 50 million stem cells, and hopes that this expensive and painful exercise would pay off.

I was told it might be months before I would see any benefit, so I returned home with a new found hope that I might see at least minor benefits in coming months. Unfortunately, things have not improved, and ever since that first stem cell injection, my health has quickly deteriorated. The pain has spread up my back and throughout my legs; suddenly I have numbness in my feet and hands. Two months after the procedure, I am now unable to stand, walk or sit for than a few minutes. No amount of pain medication can control the nerve or back pain, and with paralysis taking over my legs, my medical condition went from bad to horrible.

I know that I must now live with this decision, and beating myself up will only make coping with these health challenges even more difficult. What I can do is warn anyone who might be feel they are out of options, and considering going down a similar path. I certainly do not want to discourage anyone from seeking legitimate treatment, or keeping hopeful in the face of overwhelming health challenges, but the realistic facts remain; \ we are years away from any viable stem cell treatments, so until that day comes, there will be scum bags selling hope to the most desperate among us.

It is hard to accept the devastating results of spinal injuries or degenerative diseases, and it is only natural to try anything in an attempt to regain a quality of life. That is why it is so important to listen to your doctors, because placing hope and spending thousand of dollars on experimental therapies are a gamble not worth taking. From the beginning of time there have been purveyors of hope, the Internet has created the perfect environment for these vultures to exploit the most vulnerable without any accountability for their actions. Now more than ever, it is important to filter all the information we get via the web, so that we can make sound decisions based on facts, rather than being fooled by sophisticated marketing traps.

If you would like more information or would like to use me, or my story to warn others of the dangers of medical tourism, I am willing to assist anyway I can.

Hi Brian,
It is challenging for any researcher or group of researchers to monitor the practices of the many hundreds of clinics operating across the globe. This, of course, is why the peer-review system is in place, so that such experimental work can provided to others in the field to be measured against the highest standards of research. When clinics choose not to publish or share their practices and data, then there is no real way of knowing what they are doing, except from their own claims. Unfortunately, there is no global standard in place to regulate them and when a clinic is closed in one jurisdiction (such as what we saw with the X-Cell Center) there is little to prevent them from opening a new clinic in a country with less oversight in place. In a way, the International Society for Stem Cell Research (ISSCR) does attempt to provide some regulation by providing a set of guidelines for patients, but, as you and the authors cited in this blog post point out, it may not be enough.

That said, there are some researchers who are particularly outspoken about clinics in general - Timothy Caulfield at the University of Alberta speaks and publishes on this frequently (see http://www.walrusmagazine.com/articles/2011.09-essay-blinded-by-science/) and Jeanne Loring at the Scripps Research Institute in California has even offered to analyze samples from such clinics to verify the cells used in the treatment: http://www.youtube.com/watch?v=SgHBi1y1KG8 . Doug Sipp is another who operates an independent blog on unproven therapies: http://sctmonitor.blogspot.com/ .

Might I suggest that if researchers believe a particular stem cell clinic to be bogus then they should explain why they think that specific treatments are either ineffective or unsafe, or both... I invested a little time reading the scientific literature and came to my own conclusion that X-Cell was a no-go zone for me.

I take it that you are not simply dismissing all clinics as being bogus? I know of one that isn't... And the innovative medical doctors at that clinic do publish their results.

Fortunately, researchers do not control all stem cells. Patients come equipped with their own Mesenchymal Stem Cells (of various types). Used intelligently, with growth factors from ones blood, these repair cells can aid the healing process, at least for some conditions...

On the other hand, embryonic stem cells are really not evolved for repair. They're evolved for a totally different task. My bet is they will always be promising but never deliver the goods, like nuclear fusion. As for induced pluripotent cells, that's not even part of our evolutionary history, like drugs, inherently dangerous.

Regards,
Brian Sanderson

I keep on reading this attractive blog.

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