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Be Wary of Stem Cell Pseudoscience

At the end of the 18th and beginning of the 19th century electricity and magnetism were cutting edge science, full of excitement and unknown potential. Capitalizing on this excitement, Franz Anton Mesmer captured the imagination of the European intelligentsia with his bogus claims of animal magnetism. At the turning of the next century radioactivity was the new and fascinating scientific discovery, and this lead to a market for radioactive tonics good for a multitude of complaints, or just for extra energy. A few decades later radio waves were the latest healing craze.

Cutting edge science is cool and exciting, it evokes the promise of the future and the public has learned to expect that the latest gee whiz science appears like magic. Its newness also virtually guarantees that the public at large will mostly not understand the science or its true implications. This is a situation ripe for exploitation.

Today one medical technology that does possess great promise but is not yet ready for prime time is stem cell therapy. Legitimate scientists involved in stem cell research are almost giddy about the possibilities. Early applications are possibly just around the corner, and only time will tell what the full potential of this technology is. But right now there are no legitimate stem cell therapies outside of research protocols. It is therefore not surprising that the con artists of today are exploiting the tremendous hype of stem cells.

The most direct exploitation are clinics that claim to have stem cell therapies today for terminal or debilitating diseases. For example there is in China one Dr. Hongyun Huang (not to be confused with disgraced Korean stem-cell researcher Hwang Woo Suk) who runs a clinic where he injects (or claims to inject) stem cells derived from olfactory sheath cells taken from aborted fetuses into the spines of those suffering from spinal cord injury or motor neuron disease. Dr. Huang claims (while simultaneous saying he promises nothing) that his treatment has resulted in miraculous cures of his patients. His clinic has lured the desperate from around the world, at a fee of $20,000 plus all associated expenses. He is abetted by a gushing and disgraceful press (such as in this Guardian article) who sensationalize his vision and courage, while cynically disparaging those skeptics in “western medicine.”

Dr. Huang’s clinic has all the red flags associated with quack clinics – optimized for money extraction from the desperate rather than actually helping people or extending medical knowledge. First, Dr. Huang has not disclosed to the scientific community what is in the cocktail he uses to culture the cells he extracts from fetuses. He has performed no tests on the cultures themselves to determine what cells are present, their viability, or their biological activity. There is no way to confirm that what he is injecting, therefore, is what he claims.

Dr. Huang has also failed to conduct even the most basic observational controls in assessing his treatments. There are no blinded before and after examinations, no objective tests of function, no imaging or other anatomical or physiological tests to see what is happening. Rather, he relies entirely on the uncontrolled subjective experience of his patients.

When confronted with this apparent lapse on his part, his response is absolutely typical – he states that he is simply too busy treating people and doesn’t have the time to do research. He also states that such research would be unethical because of the need to do sham surgery (expose patient’s spinal cords and then not inject his cocktail).

Of course, this is the opposite of the truth, in that it is unethical not to do appropriate research. His treatment might be worthless, or in fact harmful, and it is unethical to subject patients to a highly invasive procedure without adequate assurance of safety and effectiveness. He can also use controls that do not involve sham surgery, or at least make objective measurements of function to compare to historical controls. If, on the other hand, his treatment works, then he is robbing the world of its benefits by refusing to conduct proper observations. He is in an ethical lose-lose situation.

There are good reasons to suspect that his treatment is worthless. First, most patients who report improvement say that they had an improvement immediately after the surgery. Of course, this does not allow enough time for any kind of neurological regeneration to have occurred – but is perfect timing for a good old-fashioned placebo effect. When confronted with this “inconvenient truth” Dr. Huang simply responds (again, true to form), “I don’t know how it works.”

Also, reports of improvement are typical of placebo responses. One touted case of a young girl with a spinal cord injury indicates that she continues to need a respirator and a wheelchair, but she has a new tiny sensation in her right forearm, which gives her hope that the treatment will work.

Frustrated by the tide of patients Dr. Huang is turning into victims, some skeptical western physicians decided to at least do some basic before and after observations of patients who chose to receive the treatment. Dr. Dobkin and others found that in the 7 patients they observed, not one had any objective improvement with up to a year of follow up. Five patients had serious ill effects from the surgery, including three who developed meningitis.

The one bright spot in this dismal picture is that responsible patient advocacy groups (like the ALS Association and the Motor Neurone Disease Association) are generally warning patients away from Dr. Huang’s clinic. But such warnings tend to be drowned out by the din of credulous reporting and glowing anecdotes on the internet – with one common theme: that Dr. Huang is offering the one thing his patient’s most keenly desire – hope.

But patients do not need to travel to China to be victimized – they can be injected with stem cells from cord blood through various companies online. Regenecell claims their treatment is useful for “Autism, Cerebral Palsy, Type II Diabetes, Heart Disease, Multiple Sclerosis, Parkinson’s Disease, Rheumatoid Arthritis, Stroke, Inflammatory Bowel Disease, Anti-ageing.” None of these claims have been established by clinical research. It should also be noted that stem cell technology has not even progressed to the point that is can be deemed safe. In early trials, for example, stem cells have revealed a tendency to form tumors. One of the big challenges for stem cell therapy will be controlling the stem cells so that they form the desired type of tissue without causing cancer.

Other companies have exploited the “stem cell” hype without injecting or claiming to inject stem cells. Stem Tech advertises  “breakthrough stem cell research” but a closer look reveals they are not selling stem cells but rather just another nutritional supplement cocktail. They claim their supplements will “help to support the release of stem cells from the bone marrow into the bloodstream.” This is the type of ambiguous “structure function” claim that the law (in the US) currently allows manufacturers to make for supplements without any requirement for research or data to back up the claims.

Conclusion

The lesson for the public is to be very skeptical of claims that seem to be echoing the latest research or cutting edge science, but that seem too good to be true or to be ahead of schedule.  New therapies tend to take at least several years (usually at least 5-10) from the time they first appear in popular science magazines or make the evening news, to the time that they are actually available to the public. By the time a therapy becomes available it may seem to already be old news.

Also be wary of amazing treatment claims that are peppered with the latest scientific buzz words but, but are either vague or seem out of place. Take the time to research such claims by checking to see what legitimate organizations have to say about it – before you invest time, hope, money, and your health in what could very well be a scam.

Posted in: Health Fraud

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