MS BLOG: Sort Anecdotal Claims, Real Science Before Research Treatments

Well said Laura,

I for one immediately saw the mortality rate in the Canada study and went "oh my". It was also stated that two of the other patients died within 3 years as I recall though it was not stated as to cause.

If the cause was medically related in any way such as a MS comorbidity that may well be relevant as well.

People who live with MS such as myself and you also need realize that MS is rather different in demographics that most other neurological disorders or for that matter other most other chronic conditions.

In MS more progress has been made towards both disease management and symptoms management than many other diseases. Scant years back few DMT's even existed. Its only with the last 10 years really since Tysabri came along that things changed in as far as progression for many people.

MS has a very broad demographic, women, men, teens, pediatric, young adults, middle aged and even geriatric. We all need consider that fact. I know many people with MS diagnosed in the past 2-10 years who's progression, symptoms are quite minimal.

The DMT's at least in the statistical/clinical short term for those who have not incurred severe disability makes for a completely different demographic than say, myself. For years I judged "MS" by my disease and that of friends.

My eyes are way way more open now. Its quite possible that the 18 - 28 someodd's disease aspects will be so completely different than mine or yours it may well appear disability (symptoms) wise as statistics come in to be enormously different. Not a different disease but VERY different prospect outcomes or symptom onsets / progression.

I know of 7 patients local to me that are young (aged 22-28) who received Lemtrada and stopped the disease and progression in its tracks.

Not only have they no where near the disability (symptoms) common but the majority of them have had onset symptoms near disappear and several completely disappear.

The research and indeed writing and patient community need realize we are really looking at a demographical split. Those of us around before all these significantly effective DMT's who already have incurred disability of significance towards quality of life and those getting these new treatments before incurring disability of significance.

This essentially changes the face in a way of MS unlike almost any other chronic disorder.

My experience since diagnosis of Primary Progressive Multiple Sclerosis (PPMS)6 years ago has convinced me that our regulatory system for approval of medical treatments is in serious need of reform. It was originally conceived as a protection for the public against snake oil salesmen but the industry was quick to realize that this could be a restriction on profits and they have been very successful in debasing it. It has become a system that can be used by industry and governments to corruptly increase profits and prevent access to drugs that are banned because of 1960’s attitudes to drugs that have been abused recreationally.

This applies to stem cell treatments too. There have been experimental treatments done with stem cells 15 years ago and some remarkable results ensued and are documented. The fact that there are only now trials being conducted is criminal and some of these are still excluding PPMS. The fact that people are driven to try these treatments before trials are completed is completely understandable. Many people do not have 20 years to wait. Criticisms like "...the Canadian Trial had one death in a study group of 24 is unacceptable." are irrelevant and unhelpful. There was no mention of the cause of death. It could have been unrelated to the treatment, a heart attack for example, but because it happened during the trial and the absolute cause and all contributing factors were not identified it must be reported in the results. If the death was not caused by the treatment then the results were very good, one third improved and one third stabilised is a positive result for two thirds with the remaining third no worse off.

I have participated in a phase 3 trial of Fingolimod (Gilenya) for 3 years and it has become obvious that this was a strategy to manipulate the system to extend Novartis’s patent for, at least, 7 years. You may be aware that this drug was approved for other types of MS in 2008. Had PPMS been included in the trials at that time it would have been available, or been shown to be ineffective then. Given that they conducted a phase 3 trial now, and that this trial was been extended twice for a year each time, I’m sure that an effect was demonstrated. By excluding 10% of their ‘market’ they have been able to sell it to 90% of their ‘market’ at $3000/28 days worth for 7 years and will now be able to claim a new application and so start the clock again on their patent for 100% of their market and taxpayers will pay for this.

This example highlights 3 issues which, although they are not criminal because they are not illegal, are unethical and immoral. These are :

- the manipulation of the patent system to extend the profits to the company. This is a serious rort and costs taxpayers through subsidies such as the PBS.

- the price is derived from knowledge of how much can be screwed out of the system. The company would not be able to sell the drug at all at this price otherwise so this is a serious swindle of government funded systems.

- the 10% of the ‘market’,people with PPMS, have been denied access to the drug for 7 years. This drug has been shown to to slow the progression of the disease and there are no other treatments approved for PPMS. You are probably aware that the average progression of PPMS from diagnosis to death is 17 years and for many it is much less so this is extremely serious for anyone waiting for this drug.

We have had numerous examples of ridiculous restriction on the availability of drugs to people who need them such as opiates for pain in terminal cancer because they are addictive and cannabis for for pain and nausea in terminal lung cancer because smoking can cause lung cancer.

I get very angry when ill-informed people say that now we have DMTs we should be happy with these. There are none for PPMS.

I am supportive of research and trials, I have been involved in 3 to date, as I understand that this, and my illness, is a learning opportunity for all concerned and necessary for the development of treatments. I do understand though that there are aspects of the system that range from out dated and ridiculous to the sort of thing that would normally be associated with organized crime. I think that the MS Advisory Council should be considering strategies to achieve a comprehensive review and reform of the aspects of the drug regulatory system that are shown to be unethical.

I'm wondering if you are really investigating on CCSVI or not.
There was 1 death erroneously lined to CCSVI treathment since it was used a stent that was not valid for vains.
Does it means the theory and that the treathment are invalid?
Are you looking at the latest studies on CCSVI treathment?
See this one:
http://www.minervamedica.it/it/riviste/acta-phlebologica/articolo.php?cod=R43Y2016N01A0027
and ask yourself "why an angioplasty should be dangerous"...would you consider dangerous it if you had to do for you legs? so why should it be dangerous for the neck veins? why allowing dirthy blood getting out of your brain should be bad?

Thoughtful blog post with insightful information. I appreciate your time. Thank you.

I 'enjoyed' reading your post which echoes very closely my own feelings/views. I have had PPMS for a little over 10 years and fortunately the progression is quite slow and is largely restricted to my legs (and the common bladder/bowel issues) but can now only walk with a cane and for relatively short distances. Initially I followed up everything I read and tried all sorts of ill-researched and 'anecdotal' cures and was disparaging of the medical community's seeming lack of interest/vision to consider 'alternative' cures. Over the years I have developed a much greater respect for their caution and skepticism in the absence of scientific evidence. I am sure it is human nature for MS sufferers to continue to hope for a 'miracle cure' where just one treatment or tablet will stop this condition in its tracks and even reverse the damage - but realistically I think this is now almost inconceivable, certainly in my lifetime. My view (and I accept that it is only that) is that this condition is a complicated malfunction of our own bodies' complex chemical processes and that treatments will be equally complex and probably only partially effective for many years to come. I do agree that stem cell therapy and maybe gene manipulation may be powerful elements in the growing armoury of treatments but they are still many years away from being proven. In the meantime I find a lot of personal benefit from improving my lifestyle - giving up smoking, drinking much less alcohol, eating less processed and high saturated fat food, exercising and meditating. It may be that none of this actually makes any difference (although I firmly believe that it does) but mentally it has hugely improved my mood - plus I have lost about 2 stone of unwanted weight - and it will certainly not be doing me any harm.