Lets talk together

Reblogged from ALS/MND Research and Care Community Blog:

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.

Read more… 442 more words

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:

Warning of spam email offering an ‘electro medicine’

We are aware that a number of MND organisations, forums and people living with MND have received spam messages regarding a gentleman who claims that he can stop the deterioration for MND through an ‘electro medicine’ treatment. He urges readers of the message to reply to his email so that he can provide his proof.  We are concerned about this as the mailer, a Mr Oholiav, is selling an unproven treatment for MND that could either be harmful, or non-existent – either a ‘snake-oil’ salesman or a complete hoax.

Trust in evidence not hearsay

We are aware of countless internet sites and scams that offer unproven treatment regimes that ‘prove’ the effectiveness of treatments through anecdotal evidence: through quotes from people who have taken the treatment; through articles in the media and other publications that have not been peer reviewed; case study reports; and documents written by ‘Drs’ that look credible at a glance. However, these treatments have not been through clinical trials, and so there is little proof whether a treatment is safe or beneficial.

A treatment is proven to be effective through carefully controlled clinical trials that test both safety and effectiveness. Trials have to be very carefully designed and carried out to ensure that the treatment is tested in the most unbiased circumstances possible, while giving the treatment the best chance of showing that it is safe and effective. If a treatment successfully shows this through trials, then treatments can be licensed for use. Clinical trial results can then be published in reputable scientific journals – the cornerstone of knowledge sharing in terms of research.

Without researchers publishing their results, and their studies being reviewed by their peers for integrity, we simply wouldn’t know what to believe. Allowing your work and your claims to be subjected to peer review is the internationally recognised way of evaluating research work and medical treatments. And by researchers sharing their knowledge and experience in a controlled setting – through publishing peer reviewed scientific journal articles- we can trust in evidence, not hearsay.

We recently created a new page of our website which discusses what a good ‘gold standard’ clinical trial is if you’re interested in finding out about this.

Sharing evidence: A chalk and cheese affair

As I’m writing this, we’re in the process of proof reading study overviews (abstracts) ready for the International Symposium on ALS/MND to be held in Sydney, Australia from 30 November to 2 December this year. It’s a real opportunity for researchers, clinicians and health and social care professionals to come together to share their recent study results – their evidence.

Flitting between reading the abstracts (which I must add have been peer reviewed), Mr Oholiav’s unproven treatment email, and our news that we’re now part of UK PubMed Central (read Belinda’s Blog entry published this morning for more information on this great news) is a real chalk and cheese affair. It’s a definite case of comparing how research should, and should not, be shared.

There are hundreds of researchers, clinicians, and health and social care professionals around the world dedicated to ending MND. These are the people who methodically set up their research projects; who place great care and attention in publishing their research papers in reputable journals; who attend the International Symposium on ALS/MND to learn about current avenues of MND research; and who share their knowledge with other researchers from around the globe through the appropriate channels. These are the people who have the right tools to unlock the secrets of MND.

We believe that exceptional claims require exceptional evidence. We believe too, that allowing treatments to be made available which have not been through the established clinical trial processes can encourage unscrupulous individuals to market ineffective treatments for financial gain and provide false hope to patients and their families.

We have already received feedback from a number of people affected by MND who have been emailed by Mr Oholiav who have informed us of their anger and upset over his correspondence. They have told us that they have deleted the email as they know it’s content is full of mis-information.

But we know that some people will want to explore unproven treatments as they see it, understandably, as a beacon of hope. This is why we urge anyone contemplating an unproven treatment to contact the research team here at the Association so that we can give them the latest information on unproven treatments to help them make an informed decision.

If you’ve received an email from Mr Oholiav, please let us know your thoughts by commenting below.

New unproven stem cell treatment via IV and mannitol causes concern

We have been made aware that there’s a new kid on the block in terms of unproven treatments, which is a new route of administration of stem cells at the X-Cell stem cell clinic based in Germany.

As a brief background of the story to date, last year, a group of international researchers collectively known as ALSUntangled investigated the claims of X-Cell.

ALSUntangled wrote, and published an article (in the journal ALS) on the X-Cell clinic which concluded that until they demonstrate the safety and effectiveness of their stem cell treatment through a rigorous clinical trial that they would not condone X-Cell centre’s protocol for people living with MND. We wrote about this in our ‘X-Cell Stem Cell Centre has been investigated by ALSUntangled’ blog article.

X-Cell has now adapted their strategy to use intravenous (IV) administration for stem cells, meaning that the cells are delivered into a vein in the arm rather than via surgery on the brain or spine. X-Cell claim that they are able to use this new, far less invasive route of administration because they also give patients IV mannitol to help the stem cells gain access to the central nervous system. Mannitol is a drug used to draw water out of the brain in cases of cerebral oedema (swelling of the brain). There has been research into mannitol use to ‘open’ the blood brain barrier for chemotherapy to improve delivery of drugs to tumors in the brain. However, there is a big difference in trying to get a reasonably small chemical through the blood brain barrier – which in real life terms is like a sieve from the blood through to the brain, and trying to get comparatively huge stem cells through the blood-brain barrier. Unless research is published to demonstrate that this is possible, then it is an unproven method.

We are aware that unproven treatments can seem attractive to people affected by MND given the lack of a treatment. However, they often come at a large cost and have not demonstrated their effectiveness in rigorous clinical trials. To find out more about what makes a good clinical trial, visit our website: ‘what makes a good clinical trial’, or ‘unproven treatments’.

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. We provide 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.

*Updated – the X-Cell centre has now been closed due to the German Government tightening the loophole that allowed the centre to offer unproven stem cell treatments.

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.

Information means informed choice

Alternative treatments can be tempting if you have a disease like MND, for which conventional medicine can only offer one moderately effective drug.  Unfortunately this temptation is easily preyed upon by clinics around the world that claim to be able to provide effective treatments or even a cure (at great expense of course), despite having no supporting evidence.

We often take enquiries from people with MND who are considering undertaking one of these ‘unproven’ treatments and want to know if we have more information about them. Often, all we can talk about is the lack of sound evidence that they work, so it can be helpful when a bit of hard evidence does come along – even if it’s suggesting that the treatment doesn’t work. This is the case with an article from the journal ‘Brian Pathology’, which crossed my desk recently.

Many people with MND have travelled to a clinic in Beijing to receive a type of stem cell treatment  known as ‘olfactory ensheathing cell (OEC) transplantation’. This treatment is effectively experimental, having not undergone clinical trials, yet the Chinese clinic demands large sums of money from its patients and does not appear to follow their progress after treatment.

Independent neurologists who have tracked the progress of people with MND before and after treatment in China have failed to see any real improvement in their condition. Now, Italian scientists have presented in Brain Pathology some clues as to why this treatment isn’t working.

Two Italians with MND who had undergone the Chinese treatment generously donated their brains for use in research after they had passed away. This gave the scientists an opportunity to look at what had happened to the transplanted stem cells. They were able to see the tracks left by the needles used during the procedure and found that all of the tracks ended in different places, with none of them actually reaching the main motor neurone pathway from the brain to the spinal cord. The researchers did find some OECs, but they had been trapped within the needle tracks by the brain’s own defence mechanism – so the stem cells never got to where they were really needed.  In addition there was no sign that the transplanted cells had produced any neurone-nourishing substances or turned into neurones or support cells – all mechanisms by which stem cells could potentially have some effect in MND. In light of all of this, it is not surprising that the researchers also found that brains showed all the typical hallmarks of MND degeneration and that their donors had experienced a typical progression of their disease.

This research may only have looked at the brains of two people with MND, but it all adds to the information we can give people who ask us about this treatment – and information means informed choice.

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.