Sunday, 13 December 2015

EUROPEAN MEDICINES AGENCY - RESPONSE AND REPLY

Well I finally got a response to my questions of why sodium oxybate and milnacipran were turned down for use with Fibromyalgia.

Rather bizarrely they have responded and included Pregabalin with these two which, though I mentioned, is cleared for use with Fibromyalgia as far as I was aware!

Now if I missed something here and Pregabalin has not been cleared for use with Fibromyalgia I am a bit confused as to not only why I was told I would be prescribed it but that not a single GP or specialist I have mentioned the drug to has replied that it is snot cleared for Fibromyalgia.

Conclusion?

It is not cleared by the NHS for use with them and I was given a bullshit excuse for this too as they thought I had been told or informed it was not cleared for use.

Did they just let the proverbial cat out of the bag here?

Anyway I will now paste their full email response along with my reply ...


EUROPEAN MEDICINES AGENCY ..

Dear Mr Haswell

Thank you for your letter of 30 November.

The decision to apply for marketing authorisation of a medicine in a particular indication is not made by the European Medicines Agency (EMA), but the companies concerned. The Agency can only evaluate the evidence with which it is presented and can only approve a medicine for marketing if the benefits are clearly demonstrated and outweigh the risk of side effects. EMA’s assessments do not consider matters of cost and reimbursement, which are handled at a national level.

However, in the treatment of fibromyalgia, good evidence of effectiveness was not shown with sodium oxybate (Xyrem), pregabalin (Lyrica and its generic alternatives) or milnacipran when the companies marketing these medicines applied to the EMA to authorise such use.

In 2011, the company which markets Xyrem (UCB Pharma) applied to the Agency to extend the use of the medicine to patients with fibromyalgia. This involved results from two short-term studies involving 1,121 patients with moderate to severe symptoms and one longer term study involving 560 patients; the majority of the patients came from outside the European Union (EU). Results in the subgroup of patients from the EU in these studies did not demonstrate a clear benefit, either short- or long-term and there was a high incidence of side-effects on the brain and nervous system. As a result the EMA’s committee of experts responsible for the evaluation considered at that time that the benefits of the medicine did not outweigh its risks, and recommended against approving it to treat fibromyalgia. Details of this evaluation are given in the Agency’s assessment report at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/000593/WC500106940.pdf.

With respect to pregabalin, in 2009 Pfizer Ltd presented the results of five main studies involving over 3,000 adults with fibromyalgia. Again, most of the patients included in the studies came from outside the EU. After evaluation, the Agency was similarly concerned that the benefits of Lyrica in fibromyalgia had not been shown in either the short or the long term in patients from the EU. There were no consistent or relevant reductions in pain or other symptoms in the short-term studies. In addition, the change in symptoms did not seem to be related to the dose of Lyrica that the patients received, and the maintenance of Lyrica’s effect was not shown in the longer study. At that point in time, therefore, any benefits of Lyrica in the treatment of fibromyalgia did not outweigh the risks of its known side effects. Hence, the Agency recommended that the change to the marketing authorisation be refused. For further information, see http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/000546/WC500076177.pdf.

In the same year, an application was made to EMA by the company Pierre Fabre M├ędicament for the use of milnacipran to treat fibromyalgia. After evaluation of three main studies, involving 2,960 adult patients with fibromyalgia, the Agency’s scientific experts were of the opinion that the effect of the medicine was marginal. There was again a lack of data on the long-term effects in a European population. Therefore, at that point in time, EMA was once more of the opinion that the benefits of the medicine in the treatment of fibromyalgia did not outweigh the risks, and recommended against marketing authorisation. For more information on this, including details of the assessment, see under the various tabs on http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001122/human_med_001313.jsp&mid=WC0b01ac058001d124

Should a further appropriate application for use in fibromyalgia be made for any of these medicines, the Agency would thoroughly evaluate any new scientific evidence presented, in order to reach a decision on whether to recommend marketing authorisation.
The Agency’s remit covers the scientific assessment of medicines and the monitoring of their safety once they are marketed, and we are unable to comment on the other matters covered in your letter.

A copy of this reply has also been sent to you by post.

Kind regards


Paul Blake

Stakeholders and Communication Division




MY REPLY ...


European Medicines Agency

I have received your report on the situation regarding the application of the drugs sodium oxybate (Xyrem), pregabalin (Lyrica, though I never said it was refused to be used only refused over money and this has been told to me by at least two Doctors) and milnacipran.

  • effectiveness was not shown with sodium oxybate (Xyrem), pregabalin (Lyrica and its generic alternatives) or milnacipran
  • 1) This conflicts greatly with everything I have ever researched and even solicitors I worked for stated that I am extremely good at research
  • 2) This also conflicts with the patients accounts of the use of these drugs
  • In 2011, the company which markets Xyrem (UCB Pharma) applied to the Agency to extend the use of the medicine to patients with fibromyalgia. This involved results from two short-term studies involving 1,121 patients with moderate to severe symptoms and one longer term study involving 560 patients; the majority of the patients came from outside the European Union (EU). Results in the subgroup of patients from the EU in these studies did not demonstrate a clear benefit, either short- or long-term and there was a high incidence of side-effects on the brain and nervous system.
  • This is a … frankly bizarre statement also ... WHAT side-effects?
  • 1) Are you stating that thins are not done this way in Europe in which case why would they ever bother approaching Europe over these drugs
  • 2) I very much doubt that drug companies would approach the EU, despite my understanding of their underhanded nature and dislike of them, with drugs that do not clearly work or cause such terrible side effects
  • 3) All drugs have side effects and do you not think it I down to the patient when it comes to weighing up the risks to the benefits? Anyone can so no or do you not think that patients are capable of rational thought?
  • 4) Further to the first point … where are your own trials?
  • 5) Your statement of weighing up the benefits and risks contradicts your statement that there was little or no effectiveness

Do you know what I constantly think of several time each week and have done for the last 7 years at least?

What it would be like to actually take sodium oxybate even for just a week to ee what it feels like to be normal once again.

I also ponder that as the Fibromyalgia Syndrome issue is lack of restorative sleep and that symptoms collect over many years that taking sodium oxybate for just one week may reset everything back to the start prior to being affected by my first ever symptom.

In other words having none at all or only one of the 120 odd symptoms I currently experience.

Another conclusion I have come to regarding just the case with Fibromyalgia Syndrome is that the people that make up the committees and organisations that make thee absurd decisions are idiots made up of friends of people in government, central or local, that have not the first clue about just how bad some conditions can be on the human body as well as the mind.

Your answer has had zero effect in changing that view.

Incompetence, corruption and general skulduggery can manifest absolutely anywhere and in my years of endeavours I have generally found it to be everywhere I look 100% of the time.

In which case and in every instance there is a general protocol that exists for making challenges, legally or otherwise, to said organisations.

I would like to ask of you what exist for you?

Can you provide me with a ombudsman for you or governing body or even a watchdog? I imagine any challenge would be quite tricky for any professional body especially when they have other professional bodies that conflict with their reasons that are based on something as flimsy as …

Side effects of drugs.

This made even said drugs are cleared for ailments that re not even in the same league as Fibromyalgia Syndrome.

Now I will mention my blogs once again.

I blog about corruption and I have covered organisations in the dozens. As big as you like. I have never been challenged bot that is because of who I am and how I do things.

No bullshit. I am honest in everything I do, sincere and to the point no matter how sharp this may be. Except that when I do this I am not doing this purely through my blogs on corruption.

You might have noted the letters after my name? BSc Applied Computing.

I do a blog on computer hardware and software with some gadgets thrown in. But this is not my only subject of expertise and I provide blogs on …

  • Batrachology
  • Herpetology
  • Ichthyology
  • Astronomy and Astrophysics
  • Orchidaceae
  • British Wildlife
  • others including Kung Fu, Photography, Music, Movies and more

My corruption blogs alone number around 3,000 posts and some read like Tolstoy's War & Peace.

I have a dozen blogs and the amount of writing involved is astronomical and with each and every one what people see is someone level headed, factual, professional and honest. Someone that does not like what he sees, dislikes the lack of professionalism, abuses of positions of power and what the UK has become.

Someone that has not just gone out and done something about it but has spent years secretly recording, collecting and compiling letters that go back 20 years and publishing everything for to help other victims, people suffering physically, mentally or both.

What surprises people most of all is that I have done this alone and there is one very outstanding endeavour that over-shadows everything I have done previously.

Despite many of my endeavours being worthy of front page national tabloid news this one last one is capable of a front page serial all on its own.

If they are surprised at what I have done and achieved so far with my excess of 100GB of data it is nothing compared to what is coming over the next couple of months. Something that will amass so much attention that it will make the 300,000 visitors I have had thus far look like a drop in the ocean.

While I twiddle my thumbs waiting for this to happen I had some requests to my GP go unanswered and I know all the reasons why. As I have proved them in the past over and over again to show my visitors this is not a localised incident, not a one off but that many Doctors and GP's are lying and are doing so under command.

Indeed many of the stories that have arisen on everyone, not just the NHS, have originated as one my stories.

Indeed if I inform you that the late backbench Labour MP, Michael Meacher, approached me via email in January 2013 requesting if he could use my blog data to atack Iain Duncan-Smith in the House of Commons while end others to the news media I am sure you will realise that even two years ago I had a hell of a lot of data?

I have not even published half of what I have!

So getting back on track …

I found myself being fobbed off again, I looked up the link between high blood pressure, which I have and my father died of a burst aneurysm at 56, I am 47 nearly, and read about milnacipran and it being refused along with sodium oxybate. I then decided to look into who make these decisions and mount another challenge against another organisation.

It kind of kills the time while my secret four year long court battle waits to hit the headlines and gives me something to do while peaking my interest.

So that procedure/ombudsman/governing body I asked for?

I look forward to hearing from you with great interest.

Yours sincerely


Martin Haswell BSc

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