Heartless Vol. 3: The greatest offender

This has been my most ‘dreaded’ post to write. I’ve been sitting on this for weeks, trying to figure out how to convey this the best way possible. The promise of a solution for cerebral palsy that tackles the problem at a cellular level—stem cells with an ability to proliferate that turn into neurons and replace the damaged, dead parts of the brain of the brain injured person with new cells—is just so powerful that resisting the temptation to try it feels like resisting a drink of water in the desert at the verge of dehydration. Seems unreasonable, seems foolish. But what if the water is poisoned?

The aim of this entry is to show the poison in the water—for anyone who is interested to find out about this. The information provided here is not my ‘opinion’. My opinion is that every parent, who considers stem cell therapy for their child with cerebral palsy, has the right to access this information. I have no opinion over what they should do with this information afterwards—that’s for each and every reader to decide for themselves.

It’s worth to watch ‘21st Century Snake Oil "60 Minutes" Cameras Expose Medical Con Men Who Prey on Dying Victims’—it was aired on CBS in April 2010. The show exposes two fake doctors who set up patients with ALS--which is an incurable, progressive neurological condition with a bad ending—selling offshore stem cell treatments to American patients suffering from this condition. The patient, who is secretly filming the discussion is told by the con man that the treatment will keep him out of his wheelchair and states “We've gotten people out of wheelchairs” which later in the show turns out to be a lie. What a cruel lie to tell to a dying patient!

The show interviews L. Goldstein, one of the country’s leading stem cell researchers. He is overall more optimistic than other researchers, but that won’t hurt anyone provided he gives a true account of where stem cell research is as of today—and he does: “web extra” contains online additions to the original show. It’s explained that “Goldstein believes that legitimate stem cell research will yield tremendous rewards”. However, it will be the legitimate stem cell research, and not the prematurely commercialized, untested, potentially dangerous “therapy” that will bring the rewards. In the other extra content “A warning about stem cell fraud” “researcher Doug Sipp is concerned about the explosion of ‘off-shore’ stem cell clinics promising unproven stem cell treatments that don't exist.”

There are currently over 200 of these clinics which offer some form of stem cell treatment for a huge range of conditions. You can get stem cell treatment for whatever ails you: ALS, MS, Parkinson’s, cerebral palsy, cancer, stroke, spinal cord injury, it matters little, as long as you pay. As one would expect it’s people who suffer from incurable conditions who are most likely to seek out these establishments and purchase very expensive false hope. The treatment for any condition is usually the same within the same clinic, but each stem cell clinic offers its own version of the treatment. They use embryonic, fetal or adult stem cells. Embryonic and fetal stem cells are sometimes derived from rabbits. The use of human embryos and fetuses is and will always be controversial (legitimate stem cell researchers in the USA use leftover embryos from IVF treatments which would otherwise be discarded), but without them there’s neither research nor future treatment. The problem is that aborted fetuses are currently being illegally used at quack clinics for anything one can imagine. The aborted fetuses are sold for thousands of dollars in Eastern Europe (a form of breadwinning for women) and are used as materials for fake wrinkle treatments at anti-aging clinics which cater for oligarchs and their wives. (Warning: do not read the article detailing this unless you have a strong stomach.) Needless to say, cells or organs coming from fetuses are not capable of rejuvenating anybody regardless how much they’re willing to pay, and such activity has more to do with witchcraft than science; it’s the 21st century equivalent of the belief that that bathing in young virgins’ blood will keep you forever young.

Other clinics use adult stem cells derived from various parts of the body (in some cases they use the patient’s own), bone marrow, fat tissue or cord blood. Adult stem cells have been used in scientific medicine for decades now for things that they actually can do (blood forming stem cells are good at turning into blood) and not for things they can’t do (turning into neurons), in procedures that have been proven to be effective and safe.

It also varies where the stem cells get injected to: spine or blood stream, but there are examples of injecting them into the brain to avoid the ‘minor’ and yet unsolved problem that the stem cells can’t really get through the blood brain barrier and will never end up in the brain unless they’re put straight there. (This unfortunately caused the worsening of the condition /Parkinson’s/, but they had to try it on a person without trying it on a mouse first, right?) Each clinic claims that it’s their version that’s effective; embryonic stem cell promoters claim that adult stem cells are ineffective in treating neurologic conditions because they can’t turn into neurons (true) while they stay quiet about the fact there’s a huge risk of cancer; adult stem cell advocates claim that embryonic stem cells are ineffective because they’re unethical and can cause tumors, but they don’t mention that nobody has ever turned a single adult stem cell into a neuron yet.

The truth is that all of them are doing mere guesswork, that the ‘doctors’ at these clinics at best know as much about stem cells as legitimate researchers (who admit they don’t know enough yet) and at worst they know a fraction of that. All types of this treatment are unethical, not only the versions that use embryos or fetuses because it’s unethical to sell unproven, untested, dangerous medical treatments in unmonitored clinics for thousands of dollars in countries with lax regulations or easy loopholes. Embryonic and adult stem cells of whatever origin can all cause tumors because nobody on earth at this moment knows how to control them. This is what legitimate researchers are trying to find out now using mice, but they haven’t quite figured it out yet and until they do, the stem cells will do as they please. In case of the man in his 60s with ALS—who doesn’t have much to loose (other than part of his little leftover time he could spend with his family and his family’s inheritance) because he has 2 more years to live and before the end comes he will become totally helpless—any treatment may sound worth to try regardless of side effects. However, the risk just seems way too high and may not be worth it to try in case of a typical child with cerebral palsy (cerebral palsy isn’t a death sentence like ALS) who would do much better with acceptance rather than a fixing attempt in the form of a dangerous snake oil therapy.

The stem cell clinics claim to have treated millions of people worldwide with a wide range of conditions. They claim that they overturned ALS, Alzheimer’s, Parkinson’s, they claim that between 70-90% of patients experience improvements, including children with cerebral palsy. If they really had any kind of results, documenting just a few by scientific standards would stop the wrath of ‘western doctors’ (as they call them). However, there isn’t one, not even one single properly documented and published case report, let alone placebo controlled trial—if there was, it would be enough to initiate the treatment under controlled circumstances in the USA or in any developed country where standards of medicine have already reached the heights of controlling, monitoring and documenting. Some of these websites claim between 1500-7500(!) ‘clinical trials’, but those are not published, they’re nowhere to be seen, therefore they can’t be reviewed—a very comfortable position to put themselves in! I can just as well claim that there are thousands of ‘studies’ hidden in my drawer so I and only I know the source of inexhaustible free energy and that all the scientists in the world are years behind me.

‘Western doctors’ are accused of the wildest things on websites that aim to defend these sham treatments, the most ridiculous of which is suggesting that they don’t know the difference between embryonic and adult stem cells, which is absurd; it’s like accusing mathematicians not to be able to count their fingers (yes, it’s that basic).

Any legitimate US scientist (or any scientist doing stem cell research in a developed country) knows way more about stem cells of any kind than any of the charlatans. Let’s see what they have to say so we can find out more about stem cells and gain a better understanding of the obstacles they’re fighting to overcome before successful treatment for any neurological condition becomes possible.

“As a scientist who works with stem cells, both in culture and in vivo I could have told you this therapy was a bad idea. (…)If you had described this therapy to us, we would have told you exactly what would happen based on scientific knowledge of how these cells act in vivo. The therapies offered to stem cell tourists are frank quackery. They are unproven, untested, unstudied, and unmonitored. And to you anti-FDA libertarians out there, this is what you get when you don't have regulatory oversight of human therapies. You get stupid quackery. The fact that this kid's cancer was detected is probably just luck - there are likely many more people who have tried these therapies of desperation who suffered side effects, and possibly even death, but we just haven't heard about it yet. Ethical human trials require many things. At the very least, the therapy should have been tested extensively for safety in animals and ideally for efficacy in animal models of the disease.”
“The major remaining obstacles towards implementation of some fairly crude stem cell therapies are going to be (1) differentiating the cells into the appropriate tissues, (2) purifying the cells so that undifferentiated cells aren't accidentally transplanted into humans, (3) preventing tumorous growth in the transplanted cells (possibly including a lethal gene to reverse the therapy if necessary), and (4) proper anatomic delivery of the cells so they perform a useful function and survive in the host. We know what the problems are. Careful study must include addressing each of these issues and ensuring they are resolved before shoving them into someone's spinal fluid.”
http://scienceblogs.com/denialism/2009/02/tumors_in_a_quack_human_stem_c.php


“First, there is not a shred of evidence to suggest that you can just inject stem cells, and they will become whatever the hell you want. Stem cells differentiate in a certain proscribed milieu based on the presence of certain growth factors and signals from neighboring cells. Specifically in the case of the girl with optic nerve hypoplasia, you want these stem cells to become neurons and the appropriate supporting cells. There is no research to suggest that stem cells derived from cord blood are capable of doing this. We have no idea what growth factors would be necessary to make them make this transition.”

“While we don't know enough about the side effects of injecting stem cells into a person, we can reasonably expect some -- a number of the serious. Not the least is that in animal studies injecting stem cells into the animal can cause cancer. Stem cells are undifferentiated cells not that different from the cells that cause cancer, and it is a highly risky proposition to just put them in someone's body.”

“An autologous transplant would not be recognized as foreign by the immune system. Thus, an autologous transplant would be much more likely to cause cancer because of more limited immune surveillance. (…) You either acknowledge that immune cells are killing your transplanted cells -- rendering your treatment a sham -- or you acknowledge that you transplant poses a reasonable risk of cancer.”

http://scienceblogs.com/purepedantry/2008/03/stem_cell_injections_in_china.php

“Fourth and most dangerous are the pronouncements by some people that adult stem cells can cure any disease. This has resulted in a proliferation of clinics across the border and around the world that will, for a price, offer unproven therapies. People go to them for help without enough information necessarily to know what they’re getting. These clinics are unregulated. There’s no accountability to make sure they tell the truth. The treatments are so hyped that people are putting their lives at risk. We’re seeing cases of people who have gone to these clinics and come back with real damage”.

http://www.signonsandiego.com/news/2010/mar/22/stem-cell-cellsman-science-quest/

“…there is a long lead up of scientific research before a new biomedical technology becomes a reality – if it ever does. This often means that there is a long period of media hype preceding scientific reality. This has been especially true for stem cells, likely resulting from the ethical controversy and partial Bush Administration ban on stem cell research.

There are a number of clinics and companies around the world, but especially in China, taking advantage of this premature media hype, and the desperation of people with serious injury. They are offering stem cell treatments now, and claiming stunning rates of cures. At the same time they are offering zero scientific evidence to back up their claims. That is a formula well known to those of use who pay attention to health fraud – stunning claims combined with a lack of rigorous scientific evidence = fraud.” (…) “In fact, the greater the treatment effect being claimed the easier it would be to document scientifically. Large treatment effects and high rates of success can be documented relatively easily with relatively few subjects. So why haven’t they done so?”

http://www.theness.com/neurologicablog/?p=530

“…stem cell technology is simply not at the point yet where we can use them to cure such diseases. There are many technical hurdles to be overcome first – knowing how to control the stem cells, to get them to survive and become the types of cells necessary to have the desired therapeutic effect, and also figuring out how to keep them from growing into tumors. Basic issues of safety have not yet been sorted out.”

“…we don’t even know what the clinic doctors are injecting into patients and what happens to the cells, if any are even present. There are risks to the procedure without any evidence of benefit. And the clinic is not following standard ethical procedures for experimental treatments.”

http://www.sciencebasedmedicine.org/?p=614

“In the more far-out scenarios, if the totipotential nature of embryonic stem cells can be mastered, they could even be used to generate replacement organs for use in organ failure without the need for transplant and the attendant risk of rejection and need for lifelong immunosuppressive therapy. (…) But very little of this potential has been realized yet, and it will take years, perhaps decades, to determine what stem cells can and cannot do.”

“Because there's no way to control where the stem cells go once they're injected, they may end up causing more problems than they cure. Mice bred to have stomach ulcers, for instance, were shown to have a higher incidence of cancer formation at the site of the sores, because stem cells aggregate at those lesions. Adding more stem cells might increase that risk. (…) "Even when I do direct injections to the heart, the majority of the cells don't stay there," Patel [Dr. A. Patel, of the University of Pittsburgh Medical Center] says. "Once the cells are in your bloodstream, who knows where they're going to land."


“The bottom line is that stem cell research, although potentially holding great promise for many diseases, is nowhere near ready for prime time yet. The data presently available regarding its potential uses and efficacy come primarily from preclinical cell culture and animal studies, with the occasional human case report. Worse, we do not yet know the potential complications of their use, the worst of which may be cancer.”

http://oracknows.blogspot.com/2005/10/stem-cell-quackery.html

At this stage one might ask: if stem cells really don’t work, why do so many people come back from the offshore stem cell clinics validating the results, talking about all kinds of improvements?

Look at India on this photo. She was a bit sick last week and was sent home from school. The next day she was a bit better and she wanted to go for a drive and we went to Starbucks and bought her pink milk. As she was sitting there in her stroller, her daddy was holding her pink milk with a straw so that his poor sick baby could have a few sips. The ‘poor sick baby’ grabbed the glass out of daddy’s hand and she slurped it up faster than we could blink, jamming out to the music playing while she was holding the drink by herself. First of all, India NEVER, EVER drank a whole glass of anything unless it was literally poured into her by her caregivers to avoid dehydration; second, she absolutely never drank a whole glass of anything by herself, holding the glass by herself, and third, there definitely wasn’t any drinking while jamming to music! :-). None of these ever happened before. So, what caused this sudden, miraculous change in India’s willingness and ability to consume a whole glass of drink by herself? I have no idea, most probably a combination of several factors, but if I were one of the parents who took her to stem cell therapy last month, I’d have every reason to think that the ‘stem cells are working’ and they are responsible for this sudden, unexplainable positive change. Parents returning from stem cell clinics simply attribute the sudden, unexplainable, positive changes (which would happen anyway) to the stem cells.

Children with cerebral palsy, and in fact every kind of brain injured and non brain injured child has the ability to learn.

All kids sometimes demonstrate knowledge or abilities that we have no idea where they came from; and while in case of our typical kid we assume they just picked it up somewhere and we don’t put much thought into it, we somehow feel the need to find a medical, neurological, therapeutical, etc reason why our brain injured child picked up skills. The reason brain injured children learn is exactly the same why non-brain injured children learn: they play, they do things, they observe things, they participate in things, and sometimes things just fall into place all at once—learning is universal and it’s part of life. If we want our children to learn more, we should just allow them (and help them) to play more, allow them (and help them) to do more things, allow them (and help them) to observe things, allow them (and help them) to participate in things, and as a result, we’ll observe how things will fall into place—without any trips to stem cell clinics.