The fight for Ampligen is on.

UPDATE: sadly, yet again the FDA have refused to approve Ampligen for ME patients. They are asking/demanding for Phase III trials to be done. This is massively expensive and I am unsure how Hemiphrex are going to do this; especially as there are some complications in the Hemiphrex finances apparently.

Can’t help wondering why approval can’t go ahead with “yellow slips” for this drug now it’s passed Phase II. I think there are plenty of ME patients who would be willing to risk it considering how horribly sick many people are.

The fight continues.

 

Over the next two days the FDA (Food n Drugs Admin in the USA) are going to hold a webinar on  Creating and Alternative Approval Pathway For Certain Drugs  Intended to Address Unmet Medical Need.

There is some understandable concern that this is more smoke and mirrors and more stalling from the FDA over approving Ampligen for patients with severe ME/cfs. I don’t think I have stumbled upon a disease this serious that has so much bizarre politics surrounding it.

There is no doubt that ME is a very nasty complicated disease and there are plenty of co-morbidities to add layers of complication. Very few people with ME only have ME. Most of us have other stuff like FMS, PoTS, other dysautonomic problems. We have compromised immunity and endocrine abnormalities. I don’t really blame doctors blanching when faced with someone who has such a shambolic and system wide disease set. (I can’t see this as one disease it’s a multitudenous mass)

Of course one of the major obstacles even in America where at least there is the International consensus diagnostic criteria – which outstrips the ridiculous Oxford Criteria here in the UK – there is still no definitive narrowed judgement as to what ME/cfs actually is.

The daft name Chronic Fatigue Syndrome came from the CDC in America back in the ’80s when, for reasons that have never been clear, they were hell bent on not helping the patients affected in those cluster outbreaks (See Hillary Johnson’s tome for the full story; but even she couldn’t work out why the CDC staff behaved that way)

There are a number of biomarkers being put forward for the disease. The primary one would be the Post Exertional Malaise (PEM) which can be measured in muscle biopsy and VOX2 Max tests (that is oxygen consumption)

Other biomarkers are mitochondrial dysfunction and Mast Cell reactivation.

Then there’s EBV reactivation antibodies, Coxsackie virus, CMV and a whole lot more.

421435_447018611982695_518522216_nThe rates of heart failure, kidney failure and bizarre forms of cancer are much higher in ME patients (and life expectancy is 58 as opposed to 82 in the general population and this is a massive improvement from a few years ago when heart failure and ME gave a life expectancy of 46/7.

Coupled with a quality of life that has been measured as worse than those with COPD you can see why so many patients are begging for a chance to have this drug (or any drug that might work!)

A doctor once said to me that people don’t die of ME, they die of something else. It’s a bit like saying the 1918 flu epidemic was fine really because no one died of the flu. No, they didn’t, they died of pneumonia or other opportunistic infections. The fact is, however, that none of those people would have died if they didn’t have flu.

People don’t die of HIV, they die of the opportunistic infections.

There is a strongly supported hypothesis that CFS should be renamed CIDS or CFIDS; Chronic (Fatigue) Immune deficiency Syndrome.

Pray for those who are fighting for Ampligen to be approved. There are people so ill they were bedbound until they received Ampligen in trials. It might not be a cure-all for ME/cfs/cfids/whatever-the-hell-this-is but it certainly helps some people.

About these ads

6 responses to “The fight for Ampligen is on.

  1. Wow. I have heard once before that me/cfs sufferers can die up to 20 years earlier than the expected lifespan, but reading this has shocked me all over again. I’m 45 in July, and have been left with me/cfs since contracting viral meningitis in 2007. I’m not bed-bound, but I cannot work at present, I’m pacing and seeing some improvement. Can I really only look forward to possibly another 13 years of life?

    • Hi Jackie, it is a worry isn’t it? But then there are times when I am glad the life expectency is lower because the thought of going another 20 even 30 years this sick scares me more than death.
      I’m not bedbound either thankfully but these days I am often sofa-stuck. The prospect of being bedbound does scare me – but I’m trying to trust and just live each day as it comes.
      So long as I can look after and educate my kids I am content

      • That is so true – we have to stay positive but sometimes it’s so hard, at the mo I’m feeling a bit run down and fed up with it. Keep smiling though :)

  2. Reblogged this on jackiewriting and commented:
    The rates of heart failure, kidney failure and bizarre forms of cancer are much higher in ME patients (and life expectancy is 58 as opposed to 82 in the general population and this is a massive improvement from a few years ago when heart failure and ME gave a life expectancy of 46/7.

    • Thanks for reblogging. I hope you continue to see improvements and I pray you will go into complete remission and stay there :)

      • Thankyou and you too :) Think I may have been a bit ambitious though but I’m sure I’ll get back on track, it seems to be getting easier to do that x

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s