ALSUntangled – untangling the mysteries of alternative and off-label treatments

There are literally thousands of websites on the internet that make claims about amazing alternative or off-label treatments (AOTs) and even cures for MND but with little or no scientific evidence to back these claims up. This presents a real problem for people living with the disease who may want to try them. Are they safe? Will they help? Or are they going to cause more problems than they solve?

Bedlack, Dr Rick

 

In 2009 Dr Richard Bedlack, Professor of Neurology at Duke University in the USA, founded ALSUntangled to develop a system of review for some of these treatments using the available evidence, to make it easier for people with MND and their families to make more informed decisions about them.Read More »

ALSUntangled: Lessons Learned after 5 Years

Dr Richard Bedlack is based at the Duke ALS Clinic in America. Back in 2009 he founded ALSUntangled and to start off MND Awareness week he writes about the group and what they’ve achieved in the past five years.

ALSUntangled started in 2009 as a method for helping people living with MND (commonly known as ALS in America) make more informed decisions about alternative and off-label treatments (AOTs) they were interested in.   I wasn’t sure how it would be received by people living with MND or by other clinicians.

ALSUntangled207x130Read More »

Twitter and MND

With over 140 million active users Twitter has grown up a lot since it arrived in 2006. This means that Twitter can be an extremely powerful tool for engaging, influencing and reaching out to a wide range of audiences across the world.twitter-bird-blue-on-white

Twitter is a social network (like Facebook and Google+) which allows you to network and engage with other users.

Anyone who knows me is well aware that I am a very keen advocate of Twitter. I believe Twitter is an excellent tool for engaging with, and getting people excited about science.

As a researcher Twitter can be used to promote and publicise your research (without having to travel to international conferences) and it also enables the public to raise awareness of important issues (like MND awareness month) and engage with the scientific and research community (@ALSuntangled)

As a researcher, Twitter can be used to promote and publicise your research (without having to
travel to international conferences) and find out what’s going on in your field – ‘listening rather than talking’ to your peers.
For more examples of why researchers should be using Twitter please see the post on our Research and Care Community Blog (ReCCoB) ‘Why you should be using Twitter’

Get involved

Our ‘Get Started on Twitter today!’ blog post also on ReCCoB explains how to join Twitter in five easy to follow steps. It covers everything from picking a name, deciding who to follow and sending your first tweet!

To get you started here’s some good examples of Twitter accounts to follow:

Lets talk together

Dr Rick Bedlack, founder of ALSUntangled speaks at the International Symposium about assisting patient choices. Dr Belinda Cupid, from our Research Development Team explains more:

Neurologist and natty dresser Dr Rick Bedlack, from Duke ALS Clinic in North Carolina USA, took on a challenging topic of patient decision making at this afternoon’s session of the 23rd In ternational Symposium on ALS/MND from the perspective of different decision making models.

In quite a philosophical talk, he framed the discussion of the different models of doctor – patient relationships from a discussion that he’d had with one of his patients. An educated patient accepted Dr Bedlack’s offer of riluzole and management of their care through a multidisciplinary team care approach, but declined to participate in a research study. The patient explained that they were going to pursue an unproven treatment that they’d heard about. Dr Bedlack commented that “their decisions bothered me and I started to think about why they bothered me”.

Starting with their refusal to participate in clinical trials, from one perspective, slower enrolment…

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Blue-green algae called Spirulina investigated by ALSUntangled

An unproven treatment called ‘Spirulina’, which is a type of blue-green algae, has recently been investigated by ALSUntangled*. They concluded that there is no evidence that Spirulina is effective for treating MND. Their findings also suggest that it could be toxic to people with MND.

In their investigative paper, which is free to download and easy to read (link at the bottom of this article), ALSUntangled discuss the research behind this unproven treatment.

The study that was critiqued examined the effect of feeding mice that model MND with Spirulina against those that were not fed the supplement. From their findings, the research group concluded that “a Spirulina supplemented diet may have future clinical benefit in treating ALS as an alternative or adjunctive therapy”. By reviewing the original research paper, ALSUntangled did not come to these same conclusions and identified significant flaws in the study.

For example, the study in question had no data on whether it slowed progression of motor symptoms. The treatment was also given before the onset of the disease, which is not clinically possible for people with MND.

ALSUntangled also used PatientsLikeMe.com as a resource to find out how many people had taken Spirulina. All six members with ALS (the most common form of MND) who had stated they were taking blue-green algae had decided to stop taking the treatment due to lack of effectiveness or cost –which had been reported as being between $50-$200 a month.
 

Importantly, the possible toxic effects of Spirulina are also discussed in the ALSUntangled paper, stating that it could theoretically accelerate the progression of the disease.
 

 Read the ALSUntangled article published on in the journal ALS:  http://informahealthcare.com/doi/pdf/10.3109/17482968.2011.553796 
 *ALSUntangled is a group of international clinicians/researchers in MND who investigate the claims of unproven treatments.
 
 ALSUntangled also have a twitter page where people can suggest unproven treatments that they should investigate.

ALSUntangled are not alone in their endeavour, as within the research development team a number of us are able to make sense of the claims of unproven treatments for MND. We provide people with the facts so that people affected by MND can make up their own minds about whether it’s an option they would like to consider.

If you are considering an unproven treatment and would like to know the facts about the information they provide, please contact us at research@mndassociation.org.

Stem cell conference part six: unregulated treatments

The room was crowded at 8am for the first presentation of day two, from Dr Doug Sipp (RIKEN Institute, Japan) on ‘Unregulated ALS/MND treatments and public education’.  Dr Sipp provided an insightful and entertaining overview of the plethora of self-styled stem cell ‘clinics’ and the tactics they employ to attract business. During the talk, the song Snake Oil, by the country singer Steve Earle, kept going round my head…. 

“Ladies and gentlemen, attention please
Come in close so everyone can see
I got a tale to tell
A listen don’t cost a dime
And if you believe that, we’re gonna get along just fine….”

Time was given over for a discussion on the issue of unregulated treatments, moderated by Dr Rick Bedlack (Duke University) and involving myself and Steven Byer of the US charity ALS Worldwide. Dr Bedlack is one of the founders of ALSUntangled, a consortium of ALS clinicians that used the Internet and social media to investigate alternative and off-label ALS treatments. Although in its early stages of development, ALSUntangled is fast becoming a very important resource to people with MND, providing the sort of objective information that helps people to come to an informed choice on whether or not to pursue alternative approaches to treating their disease.

There was clear consensus among those in the room that clinicians, scientists and patient associations need to find mechanisms for working more closely together – in separating ‘hope from hype’ and providing a more accurate explanation of the potential uses of stem cells in both basic science and disease treatment. Stephen Byer talked about the two C’s: the need for closer Collaboration and sharing of information; and better methods of Communication. I added a third – Consistency – to the discussion. We don’t necessarily all need to be providing exactly the same message, as different individuals and organisations we may well have differing opinions, but we should be basing those opinions on the same level of information and understanding.

Stowe/ Morales treatments are investigated by ALSUntangled

ALSUntangled have debunked yet another unproven treatment advertised on the internet. Publishing these results in a reputable journal is of the utmost importance as it means that their findings can be read and be trusted as a reliable source of information.

The unproven treatment that the group of clinician-researchers investigated was the Stowe/Morales treatment protocol for MND. The idea that the Stowe/Morales protocol proposes is that most diseases are caused by ‘infections and toxins’ – including MND. However, there is no scientific evidence to suggest that this statement is true. The treatment regime that they offer to combat the ‘infections and toxins’ includes stem cell treatment and a number of other unproven treatments that are fraught with pseudoscientific terms and unjustified claims. The treatment regime comes at a jaw-dropping sum of about $150,000. As a spoiler: ALSUntangled did not find any evidence to suggest that the treatment regime would be beneficial to people living with MND.

We’re pleased that ALSUntangled have published their findings as a few months ago we received an enquiry on the ‘Stowe Foundation’, which is one of the companies that offer this unproven treatment regime. Here’s a snippet of the response that we gave at the time: 

“Fundamentally, it is unrealistic for the Stowe Foundation to say that their methods can help any patient with any chronic illness. All diseases and disorders are so different from one another that it would be unrealistic to suggest that they can all be treated by the same means…

“If such a regime of treatments is to be used as a treatment for any disease (as they suggest) then it is important that the evidence they state is peer-reviewed and published. This way the rigor and validity of the research can be tested to assure the public that the information given is accurate. Unfortunately, I could not find any evidence to suggest that the statements made by the Stowe Foundation can be backed up by peer-reviewed articles and therefore its validity is questionable.”

In the article written by ALSUntangled on the Stowe/Morales protocol, they conclude that “ALSUntangled strongly recommends that patients with ALS (MND) avoid the Stowe/Morales ALS Protocol. The rationale for this exorbitantly expensive protocol is unsound. The specific treatments being used range from mysterious, to already disproven, to potentially harmful. No valid outcome measures are being followed and the discussion of safety and efficacy taking place between sellers and potential patients considering this is impossibly optimistic.”

The full article is free to access in the journal ALS and is written in an easy-to-read way. If you’re interested in reading more about their findings and what brought ALSUntangled to their conclusions then please read their article ‘ALSUntangled No. 5: Investigating the Stowe/Morales ALS Protocol’.

If you are considering an unproven treatment and would like to know the facts about the information they provide, please contact us at research@mndassociation.org.

X-cell stem cell centre has been investigated by ALS Untangled

With the internet providing an expanse of ‘quackery’ jumbled up with facts, it’s becoming increasingly difficult for anybody to know what source of information can be trusted. This issue is especially apparent to us when we add unproven treatments into the mix. An unproven treatment is, quite literally, a treatment that has no reliable proof for its benefit as a treatment.

As a bit of background, the only way that a treatment can be moved from being ‘unproven’ to ‘proven’ is by conducting a series of controlled clinical trials that can confirm that it is more effective at treating something than a ‘dummy drug’ – called a placebo. This may seem a bit bureaucratic and time consuming but it is a necessary step in finding a truly beneficial treatment for any disease or ailment. Until a treatment has proven itself to be effective, it remains unproven.

So, to shine some light on the clouded situation of where the facts lie within unproven treatments advertised over the internet, a group of international researchers, collectively known as ALSUntangled (ALSU) was set up. ALSU’s most recent investigation was into a stem cell treatment that is provided by a German clinic called ‘X-Cell Stem Cell Centre’.

The X-cell centre is a clinic based in Germany that injects a person’s own stem cells – extracted from their bone marrow, back into them and claims that it can treat MND (as well as a large number of other conditions). To-date, no such stem cell treatment has undergone any clinical trials that have demonstrated their safety and effectiveness. The use of stem cells as a treatment is therefore regarded as an unproven.

ALSU therefore set out to find out if there was any truth behind the X-Cell Centre by investigating:

  •  The procedure that they adopt is scientifically sound
  • The progression and opinions of three people who went to the X-Cell Centre.

From this, ALSU concluded that the data provided on the X-cell website is flawed and suggest either its removal, or for them to add a disclaimer to alert readers to its flaws. From the small number of people they followed, none showed signs of improvement. ALSU therefore concluded that until they demonstrate the safety and effectiveness through a rigorous clinical trial that they would not condone X-Cell centre’s protocol for people living with MND.

ALSU have published these results in a free to read article in the Journal ‘ALS’, which is written in an accessible way. ALSU also have a twitter page where people can suggest unproven treatments that they should investigate. More information on stem cells as a treatment for MND can be found on the stem cell pages of our website.

ALSU are not alone in their endeavour, as within the research development team a number of us (Brian, Belinda, Kate and I) are able to make sense of the claims of unproven treatments for MND. We provide people with the facts so that people affected by MND can make up their own minds about whether it’s an option they would like to consider.

If you are considering an unproven treatment and would like to know the facts about the information they provide, please contact us at research@mndassociation.org.

*update – The X-Cell centre has now been closed down by the German Government due to a loophole in law being tightened.