May 05 2009

More China Stem Cell Quackery

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Comments: 11

One of my earliest blog posts in NeuroLogica was exposing clinics in China that are offering stem-cell therapy for a range of neurological disorders. The post focused on Dr. Hongyun Huang and his clinic, but there are, unfortunately, many others. A new Chinese stem cell clinic, Beike Biotechnologies, has been in the news recently, showing that the practice, if anything, is growing in China.

The use of stem cells to treat neurological injury or degenerative disease is certainly a promising idea. In 10-20 years such treatments may not only be a reality, they may revolutionize our approach to some diseases. But 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. At least that is a reasonable default assumption until the evidence is presented.

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? They have no legitimate excuse. In fact, if their treatments worked as claimed they would be doing the world a huge disservice by failing to document it in a way that would convince the scientific and medical world. They are depriving millions of patients effective treatment.

Dr, Sean Hu from Beike Biotechnology was recently interviewed by Karolyn Y. Zeng for H+ magazine. The interview, in my opinion, is absolutely terrible from a journalistic point of view. Her questions are obvious and she never asks the hard questions – where is the scientific evidence, and why are your claims not generally accepted. The result was little more than an advertisement for Hu’s clinic. In the interview Dr. Hu claims:

As of February 2009, Beike has treated over 5,087 patients with cord blood stem cell injections for diseases like ataxia, autism, ALS, brain trauma, cerebral infarction, cerebral hemorrhage, cerebral palsy, diabetics, Guillain-Barre, encephalatropy, and spinal cord injury – many of these are considered incurable diseases.

(I think “encephalatropy” is supposed to be encephalopathy.)  Here we see another red flag for quackery – the claim that a host of different conditions can be treated with a single therapy. These conditions involve the brain, the spinal cord, and the peripheral nerves – all with distinct cell types and characteristics that would likely not be treated by the same type of stem cells. Autism is also a very different kind of disorder from the other entities as there is no cell damage that we know of. Although the exact nature of autism remains unknown, it appears to be the result of differences in brain organization and communication – not cell damage.

What Dr. Hu offers instead of scientific evience is yet another red flag for quackery – anecdotes. He even encourages his patients to keep a blog of their experience at the clinic. As I have discussed numerous times before, anecdotes are highly misleading and are not a way to discern whether or not a treatment works. Here is one story being reported on a spinal cord injury blog, regarding one patient with ataxia:

“Immediately, I was about 20 per cent better,” he says.

Since returning to Canada in February, he’s had a relapse of symptoms. But he says that was probable considering the degenerative nature of ataxia. He’s now looking at other stem-cell treatments.

Stem cells do not work “immediately” even if they do work.  So any report of immediate recovery is suspect, and is likely either due to the placebo effect or to a temporary response to anesthesia or some other aspect of the treatment. Of course, this temporary effect quickly faded leading to the “relapse”, which the patient rationalized as a result of the degenerative nature of his condition. However, it is easier explained as a simple treatment failure.

The placebo effect is likely to be particularly large in this situation as well. Patients spend 20+ thousand dollars for the treatment, more if you include travel expenses. Twenty percent, according to Hu, get follow up treatments at the same price.  This is often against the advice of their doctors back home who are appropriately skeptical. This creates a huge psychological need to justify the decision and the expense. I have personally seen this in my own patients who have gone for controversial treatments. Even with no objective improvement in exam or function, they will find something to justify their decision. It is often a sad display of the human potential for self-deception.

Hu claims that his company, and China in general, is just way ahead of the western medical establishment.  This is simply not credible. No one is that far ahead – there simply has not been enough time. It is true that research was slowed in the US by the Bush ban, but not by that much. And research continued in Korea, Japan and Europe as well.

The simple fact is that the technology is not yet at the point where there are proven effective treatments – let alone for a long list of the hardest neurological disorders to treat. Researchers are still working out the basic science and technology – making stem cells from various sources, investigating their properties, learning how to use them, to get them to do what we want without causing cancer or other unwanted side effects.

At best we are at the point where early clinical trials are possible for a limited number of the easiest conditions to treat. So Hu and these other Chinese clinics are claiming they are not just ahead of the rest of the world, but by one to two decades.  And they have nothing to show for it in the way of scientific evidence. They may or may not be sincere in their claims, but that does not matter. This is unacceptable behavior.

It is also a financial boon for these clinics – they can charge 20 thousand dollars per treatment, and rich desperate westerners are glad to give it to them. Desperate patients are also in no position to do anything about it if the treatments fail. They are given no guarantees. The treatments are experimental, and they know they are taking a chance. If they are harmed they have no recourse. The situation is ripe for exploitation.

It is also very difficult to dissuade patients from seeking such treatments.  The possibility of hope, no matter how tenuous, is simply too much of a lure. When journalists or bloggers try to do a “balanced” treatment of the topic they typically include scientific skepticism and anecdotes of sucess. Of course most patients will find the anecdotes more compelling. And much of the journalism, like the Zeng interview, is not balanced and ends up being gushing and promotional.

At present all we can do is educate patients about the situation and give our advice and hope they make the right decision.  We could also put pressure on the Chinese government to better regulate these clinics, but that seems unlikely. Also, there are similar clinics in many countries, not just China. This is one of those unintended consequences of globalization – fraudulent clinics can be set up outside of regulatory jurisdiction, and then clients can be lured there through advertising and gullible journalism on the internet.

While hopes for stem cell therapy remain legitimately large, we are not there yet. Any treatment currently being offered should be in the context of a properly designed clinical trial, with informed consent and ethical oversight. Any clinic selling stem cell therapies for thousands of dollars is therefore likely to be a cruel fraud.

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11 responses so far

11 Responses to “More China Stem Cell Quackery”

  1. Saorsaon 05 May 2009 at 9:20 am

    Sadly, these fraudulent clinics also waste money and resources that can be better utilized by those attempting legitimate stem cell research. I believe Dr. Young, of Rutgers, is seeking to set up a stem cell therapy clinical trial network in China that will adhere to established research standards. I’m not familiar with the details, but some of his writing is available, here: http://wiseyoung.wordpress.com/

  2. Deanon 05 May 2009 at 10:02 am

    Thanks so much for exposing these quacks, Steve. Despite my very skeptical nature, I was actually tempted by some of these places spouting miracle tales. My son was slowly dying from Spinal Muscular Atrophy, so I was desperate to do anything that might give him more time. Instead, I ended up listening to the neurologist, trusting the real science, and spending that precious time enjoying my beautiful little boy and giving him as much of life as I could. I’m so glad I didn’t get sucked in by these bastards when I was so vulnerable. I feel for those who do. It’s the cruelest kind of quackery.

    On a lighter note, I hope to meet you in Australia if/when you make it over here!

  3. Enzoon 05 May 2009 at 11:45 am

    Wow. As far as I can tell from reading the Beike group’s website, the treatment is nothing short of injecting these “stem cells” intravenously or straight up into the CSF…Presumably via injection into the spine. They are also pumping their patients with NGF. Seems to me that this is way beyond simple sugar pill medicine. This may have a risk.

    I can’t imagine foreign stem cells are tolerated by the immune system and am actually shocked that they are shooting these things into CSF. Is the rejection of the cells harmless or is it actually a big risk? This seems nuts.

    Quote:

    Important: the stem cells can be injected in two ways.
    - Direct injection into the spinal fluid
    - IV (intravenous) in your hand.

    End quote.

    Also, I’m not sure what kind of protocols are in place to maintain the “stemness” of the cells prior to transplant/injection. Odds are they are injecting cells that have lost their ability to become other cell types, let alone with the specificity required for his claims to be validated.

    This is why science can be so stigmatized. I can’t stand things like this. Some people believe the cure for cancer is being suppressed by big pharma and other people believe that people like Dr. Huang can work medical miracles years ahead of their time. Sigh. We need to do a better job informing people.

  4. Steven Novellaon 05 May 2009 at 12:37 pm

    Yes – I did not cover risk in this post but did in the first one. It seems that Dr. Huang’s protocol is even worse – opening up the spinal cord to place the stem cells, resulting at times in infection and other complications. But even Dr. Hu’s protocol is not risk free – rejection and tumors being just two concerns.

    These treatments may not only be worthless, they may be harmful. And even if you think they work, it is a crime not to study it properly to find out.

  5. daedalus2uon 05 May 2009 at 6:22 pm

    One of the side effects that is talked about, a mild fever, is typical of an immune system activation, exactly what would be expected if a foreign material were injected and attacked by the immune system.

    ”The most common and frequent issue is a slight histamine response within the body which can elevate the patient’s temperature.”

    If the stem cells were migrating to where they are supposed to, and taking up residence and differentiating into the precise type of cell they are supposed to be replacing, why would there be a histamine reaction and a fever? Those are signs of an immune system reaction, not normal differentiation and growth.

    Nerve cells can’t grow back in a few days. It is simply not possible. Particularly for something like motor neurons which are very long. They only grow out from the cell body, and then only very slowly. Any prompt positive effect can only be due to the placebo effect, or due to non-specific effects from the immune system stimulation.

  6. asonginthisworldon 05 May 2009 at 7:34 pm

    I have been extremely skeptical about the stem cell trials in China because of the lack of data and transparency. I use many therapies on my daughter that while not empirically proven and in some cases without strong clinical evidence there is still strong anecdotal evidence as well as lots of information past from parents. China is the wild west when it comes to doing business. Caveat Emptor certainly applies when dealing with China and we have witnessed how unsafe their food and toys have been to our population. Thanks for creating this blog!

  7. nalon 05 May 2009 at 9:20 pm

    Saw something about a blind girl on the Austin news who has Septo Optic Dysplasia. She’s going to use Beike Biotech if the family can get the money. It’s an expensive way for parents to feel like they’re doing something to help their child.

    The Procedure

  8. sarahon 06 May 2009 at 12:46 pm

    Thanks for sharing this blog post.

    I help manage an online support community for people affected with Ataxia. If you have come across this site in search of support and kind words from others like you, stop by and say hello: http://www.livingwithataxia.org

  9. David Weismanon 06 May 2009 at 1:45 pm

    1. Sadly one doesn’t expect anyone to be so immoral as to take advantage of truly sick people with quackery and sexed up degrees. Yet there they are.
    2. What are your thoughts about poorly studied but often offered endovascular therapies for acute stroke and intracraial stenosis? Interventionalists are not waiting for data, but seem to be highly aggressive. One can view this with a similar economic framework as well.
    3. For pure horror, go to the site patientslikeme. They have an ALS site in which many take questionable therapies like stem cells. Doubly tragic.

  10. KPMonroe100on 08 Jun 2009 at 6:55 pm

    All these comments sound reasonable. But what about the stories? Has anyone followed up on the stories, to see if any improvements were permanent?

  11. Science-Based Medicine » Quack Clinicson 05 Aug 2009 at 8:37 am

    [...] is also the recently reported case of the mother who was convinced that her blind child could see after getting stem cell therapy in [...]

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