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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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12 thoughts on “Be Wary of Stem Cell Pseudoscience

  1. overshoot says:

    In memoriam

    Appropriately, this post reflects Clarke’s Law: “any sufficiently advanced science is indistinguishable from magic.” Alas, for many it doesn’t take much to be “sufficiently advanced” to qualify.

    The popular thinking thus goes: “I don’t understand foo mechanics. Thus foo mechanics is magic. Magic can do anything imaginable, thus foo mechanics can do anything imaginable.”

    Bon voyage, Arthur.

  2. daedalus2u says:

    It seems that for many of these stem cell treatments the only important patient characteristic is the ability and willingness to pay large sums of money. Even when there is no credible theoretical expectation that stem cells will have any benefit. For example in autism, where the underlying problem is known to not be neurodegeneration.

    http://www.autismvox.com/stem-cell-therapy-in-costa-rica/

    Apparently the “theory” of these stem cells (which apparently are injected into the peripheral blood) is that of increased angiogenesis. If insufficient angiogenesis were the problem in autism, a one-time treatment with stem cell could not fix it. Angiogenesis is an ongoing process, without it any type of healing of even trivially minor wounds would be impossible.

  3. apteryx says:

    You write:

    “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.”

    Under DSHEA, structure-function claims are supposed to be made only if they can be supported with scientific data, although often in practice the supporting data actually supports not the structure-function claim, but a related disease claim that cannot legally be made no matter how true. Every manufacturer is not required to individually pay for generation of similar research data; they can rely on data generated by others for similar products. But some relevant information had better exist before the claim is made.

    Unfortunately, there is a lot of stuff sold on the internet with claims that have no support whatsoever. It would be nice if the FDA came in and squashed a few of these scammers. Too bad that the Bush administration thinks enforcement of regulations is a Commie plot.

  4. apteryx,

    I think you are mistaken. Under DSHEA there is no requirement for manufacturers to provide any data or evidence to back up their claims. They can go to market with structure-function claims without a lick of data. The FDA has, in fact, no oversight over such claims.

    The FDA can get involved only if their is evidence that products are not safe – and then the burden of proof is on the FDA.

    The regulation of marketing claims for supplements is now in the hands of the Federal Trade Commission (FTC) – and they can go after supplement manufacturers and marketers for fraud in the same way that they can go after any company for fraudulent advertising or making misleading claims. So structure-function claims for supplements are now in the same boat as vacuum cleaners. The FTC does go after fraudulent claims for supplements – but they do not have anywhere near the man power to do this effectively. At present an occasional slap on the wrist by the FTC is just the cost of doing (multi-billion dollar) business.

    It is also misleading to say …”but a related disease claim that cannot legally be made no matter how true.” If a disease claim is true and a supplement manufacturer wants to make it, they can. But disease claims are under FDA regulation and a company would first have to prove the claim to the FDA.

    Regulation depends on the type of claims being made – disease claims are regulated like drugs by the FDA; structure function claims are regulated like supplements – outside the jurisdiction of the FDA (except when they can prove harm) and regulated only post marketing like any other product by the FTC.

  5. David Gorski says:

    There was a long story about Chinese stem cell quackery tourism on NPR yesterday. Basically, for optic nerve hypoplasia (ONH), a cause of blindness in children. This morning, an ophthalmologist was interviewed who pointed out that up to 50% of children with ONH regain considerable function without any intervention, even to the point reported by the Chinese clinic. Without controlled trials, it’s impossible to tell whether the improvement was just regression to the mean. Similarly, as Steve pointed out, so too did this ophthalmologist that the “recovery” happened far too quickly to be attributable to stem cells growing new neurons. Moreover, there’s no logical reason on a scientific basis to assume that simply infusing stem cells into the blood stream would lead them to hone in on the optic nerve and repair it.

    Yes, stem cells are a very popular area for quackery these days. It has all the elements, particularly the claim that stem cells can cure virtually any disease. They’re even using stem cells in China to treat autism, fer cryin’ out loud!

  6. apteryx says:

    Steven-

    I don’t want to create a distraction from the important topic of this post, but here’s what FDA has to say on structure-function claims:

    “The manufacturer is responsible for ensuring the accuracy and truthfulness of these claims; they are not pre-approved by FDA but must be truthful and not misleading…. The disclaimer must also state that the dietary supplement product is not intended to “diagnose, treat, cure or prevent any disease,” because only a drug can legally make such a claim…. Manufacturers of dietary supplements that make structure/function claims on labels or in labeling must submit a notification to FDA no later than 30 days after marketing the dietary supplement that includes the text of the structure/function claim.”

    You cannot make a truthful and well-supported disease claim on a dietary supplement; that would turn it into an “unapproved, misbranded drug.” FDA does have jurisdiction over both disease claims and structure-function claims on the packaging of the product itself; FTC regulates claims made in advertising elsewhere. Manufacturers must inform FDA of the label claims they are making so that FDA can spot obviously false claims and – if the spirit so moved them – issue cease-and-desist letters.

    To return to these quack products that promise to increase your stem cells: AFAIK, there is no evidence at all to support those claims. If this Stem Tech product has a label claim, then FDA has the authority to tell the manufacturer to show some evidence or stop making that claim. Either the manufacturer broke the law by not informing FDA of it, and has so far gotten away with that as well, or FDA was informed but chose not to intervene. FDA and FTC can’t do anything about Chinese scammers, but perhaps we should be asking why they don’t do anything about scammers operating right here in the U.S.

  7. apteryx,

    We are kind-of saying the same thing, but I think there are some distinctions worth making.

    Label claims need to be filed with the FDA – to ensure that 1) they don’t make disease claims, and 2) that they have the required disclaimer on them.

    The phrase ““The manufacturer is responsible for ensuring the accuracy and truthfulness of these claims; they are not pre-approved by FDA but must be truthful and not misleading….”

    Specifically means that the FDA is not responsible for regulating the truthfulness of these claims, the manufacturers (not the FDA) are responsible. To be clear – this does not mean that the FDA regulates the claims placed on labels – beyond the two criteria I listed above. The FDA does not review evidence nor are manufacturers required to present any. The FDA is NOT empowered to take any action based upon the lack of scientific support for supplement claims. That was, in fact, the very purpose of DSHEA.

    The point I am making about supplements and disease claims is that the claims made for a product are what determine if it is a supplement or drug. A company can make disease claims for echinacea, for example, but then it would be classed as a drug and have to meet FDA regulations for drugs. But some people mistakingly interpret this as – no company can ever make disease claims for herbs. Trudeau even said on one of his infomercials that the FDA says that supplements cannot treat disease, that only drugs can treat disease – and he made it clear that he meant that the FDA says that categorically supplements are unable to treat diseases.

  8. Joe says:

    The story on NPR is available here
    http://www.npr.org/templates/story/story.php?storyId=88552267

    The text is not quite the same as the audio, also linked there.

  9. Wicked Lad says:

    Steven Novella: “But right now there are no legitimate stem cell therapies outside of research protocols.”

    I object. My brother is alive today thanks to a stem cell transplant to treat his MDS. As I understand it, that’s a well-established, evidence-based treatment. A minor point in this discussion, but not to my brother. :o)

  10. Calli Arcale says:

    There is also a very specific type of stem cell therapy which is not only legitimate but has been around for years. Because it’s so old (younger than most stem cell science) people tend to forget that it really is a form of stem cell therapy. That would be the bone marrow transplant, first performed in 1968. It’s not as sexy or magical as what a lot of the general public thinks of when they hear the words “stem cell therapy”, though.

    I agree completely with the premise that “stem cell therapy” is just the latest buzzword. It’s right up there with “nanoparticles”. 150 years ago it was electricity and magnetism. 75 years ago it was radiation. This is just the “magic treatment” du jour.

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