Discussion in 'Phoenix Rising Articles' started by Mark, May 3, 2013.
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Wow, that must have been a lot of work! Thanks Joel and Gabby for a really interesting piece, and for time stamp links too.
There is going to be a parts 2 and 3? I can hardly wait. To be told by an FDA doctor to take anti-depressants, Lyrica, Cymbalta, anti-convulsives, anti-seizures meds. More horse dung. Stuff they were conned, forced into approving by greedy companies, supposedly for "pain." I really hope you didn't put that much time into all this, because medicine by government committee is a waste of time.
Excellent summary so far, thanks snowathlete and Nielk
I missed Day 2 due to being distracted by snooker and Anno 1404, so looking forward to more info about that
Thanks, Joel and Gabby - it was a real marathon to listen to Day One and I can't imagine what it must have been like to produce this summary of it! Really useful and I'm looking forward to the rest.
Was the morning presentation that Dr Peterson and the others 'sneaked in' recorded? I'd have loved to have seen that.
Thank you Joel and Gabby.
The transcripts were very useful as I have a slow internet speed and the videos would have been next to useless.
I actually found this quite encouraging.
No mention of fatigue per se - more of physical or mental overload leading to a complete shutdown of normal functioning - which is more like my experience of ME/CFS.
Also, when the discussion touched on sleep, it was good to see the response that a poor night's sleep can make things worse but is NOT the cause.
I actually feel that if the FDA are coming into this with no preconceptions they are getting a more accurate picture than that portrayed in the literature.
I'm also looking forward to the rest of the coverage.
Thanks Sasha. I think Gabby, in particular, did a great job and she is already working on the next part.
I don't think Dr Peterson's meeting was recorded - if it was then I haven't been able to find it anywhere. I've asked Dr Peterson for some comments but not heard back yet.
Thanks. Useful to have. For many of us, the full meeting, either live or recorded, is too much to try to follow completely.
All of this could have been put out by the Chronic Fatigue Association of America back in 1997. Do you really think any of this info adds anything valuable to the discussion? The fact that people get PEM? They get cognitive issues? There is absolutely no room for common sense in any of this. Not one new photon of light was shed on CFS. And anything that includes Kim McClearly is automatically going to be doctrinaire baloney.
Thank you Joel & Gabby. Clear, concise, excellent job!
Like the quote from Dr. Kaiser. Before he said that he
acknowledged housebound & bedridden patients who
are more disabled than he & unable to attend such
meetings. Be nice if speakers at future public meetings
did the same.
I am afraid I am going to have to agree with your cynicism.
I would not at all be surprised if Lyrica and Cymbalta are the two drugs pushed through for possible approval.
Seriously though, What drugs ARE they considering? What is out there that we are hoping to get approved? Not including Ampligen. How many years have we been waiting for Ampligen approval!?! Is it REALLY going to happen ever? Cynicism again.
. So many drugs, are already used off label by patients, in fact it seems like most medications end up being used for a lot of conditions different from the original condition it was approved to treat.
What difference will approval make? (not including Ampligen)I know people outside the US have trouble getting certain meds prescribed as they are off label but will FDA approval affect their ability to have them prescribed and covered through NHS for example? I really do not know.
Sorry for being such a downer.
I expect most of us understand the cynicism, and any pessimism!
There was nothing new, for us, in the conference, and it was a little bit regretful to see them asking the most basic of questions, such as "what symptoms do you get?"
And of course, there have been false starts in the past, and government agencies usually just mess up our lives.
However, watching the videos, I was very encouraged.
It's feels like a 'reset' button has been pressed by the FDA, and although they are asking the most basic of questions, this seemed to be a constructive process, as if they are actually hearing patients for the first time, starting with the fundamental nature of the illness. They appear to have an open mind, they appear to be sincere, and they appear to be listening carefully. And I mean actually 'listening' to patients, and hearing what we've got to say.
I really was encouraged, and I actually found it all quite heart warming. (Not something I'd often say about government agencies in action!)
Whether much comes of it, remains to be seen, of course.
The public were given an open mike, and many issues were touched upon, including: diagnostic criteria, biomarkers, research endpoints (how to measure improvements), and a variety of drug types were mentioned.
The FDA officials seemed to be saying that there are funds available, and that the researchers should approach them for help with designing and implementing clinical trials. Ampligen was mentioned a lot. Rituximab was mentioned. Immune modulators were mentioned. And more.
They discussed a range of biomarkers including VO2, genes, NK function, etc.
One biotech man even said that he wanted saliva from ME patients, so that he could test his medical saliva test, that he hopes can be developed into a quick biomarker test for fatigue! He said it wasn't yet specifically a CFS test, but it sounded interesting, and he's ready to do a trial with CFS patients.
I found it a very refreshing conference, in that, all the way through it, ME symptoms were being discussed in 'medical' (biomedical) terms, and never in psychiatric terms. This is a novel experience, for me, a UK patient, in terms of health authorities!
The patients present, were excellent advocates, and gave a very good account of the difficulties that we face. And these difficulties were always being interpreted in terms of biomedical problems that urgently need treatments.
The videos are well worth watching, for encouragement, IMO. I was very heartened, and encouraged by it all.
A number of our well known clinicians were there, and spoke, including Dan Paterson, and Nancy Klimas. Even Judy Mikovits spoke.
I agree with you Bob. I watched the webcasts live and now again and I was struck with the same feeling. I know that this is government and all...but, there seemed to be a genuine eagerness to find out as much as they can. The whole setting and the way they conduced themselves were very respectful. After giving my own testimony and watching many CFSAC workshops, this in comparison, was very refreshing to see.
I understand and share everyone's frustrations and I have no idea if anything will eventually come out of this. I do know that at least, they will be better informed in the future.
Right on Bob! Excellent and accurate post. I lost faith many years ago in Gov sincerity in anything having to do with this disease......yet this conference appears to open a new chapter with lots in our favor.
Huge thanks to all those physicians involved, especially to Dr Peterson who gave of his time to fight yet another fight for us.....this in spite of lacking an invitation to participate. Thanks to all the PwME who gave of their precious and limited time who likely paid a price later. Thanks to the authors of this article who gave much of themselves as well.
A brand new immune modulating drug was just approved for MS. It's called BG-12. It is being prescribed now to patients (literally starting this month). The stock of the company of Biogen shot through the roof because the trial results were so convincing. It really WORKS, in other words, unlike the crap that we hoping to get to take. Plus, it is entirely free of serious side effects. Lucky for you MS patients!!
Not one of our devoted, paleolithic doctors has mentioned this as a possible dual-use medication for CFS. They should NOT be invited to speak simply because they "believe" in CFS; because they have no new ideas;. They are utter intellectual wastelands of new ideas. He and she are stuck back in the 90s, or 80s. If they treated you kindly, fine!! Invite them to your next backyard BBQ. But don't kept pushing them up as heroes of our illness. They are proven failures.
Giving CFS patients antibiotics, anti-virals is a proven failure. There is nothing there. Start over. Reboot the machine. Jettison the dead weight doctors (Klimas, Peterson, et al) and start over with new imaginative treatment modalities. And DON'T expect the federal government, at a time when it is ACTUALLY SHRINKING, to put together an effective treatment for this illness.
MishMash - I can't see that what you're proposing makes any logical sense. We all want to see flesh blood in the field, bringing new ideas and approaches with them, but the way to achieve that isn't to "jettison" the few people who are already working in the field. Quite the opposite in fact. We need our experienced doctors to help get young researchers interested and to support them in taking their first steps in the ME/CFS arena which is so full of stigma and ridicule. Enlander, for instance, has a fellowship programme at Mt. Sinai which is introducting new young researchers to the field.
I'd be intererested to hear how you would go about rebooting the machine and getting fresh blood involved in ME/CFS having removed all our current doctors.
Not so as far as side effects....I was just on an MS forum while researching BG-12. Interesting because some MS patients realized that make huge money for drug companies and the not all MS patients trust the drugs being approved. From one site, I learned that the one year cost for one patient to be treated with BG-12 is $54,000.
Turns out BG-12 (dimethyl fumarate) has been in other treatments like Fumaderm for psoriasis and Panoplin. The forums are talking about the fumarates and PML.
Here is a link to direct recent info about problems associated with this drug: http://www.nlm.nih.gov/medlineplus/news/fullstory_136220.html
WEDNESDAY, April 24 (HealthDay News) -- The active ingredient in a drug that's expected to become a popular treatment for multiple sclerosis has been linked to four European cases of a rare but sometimes fatal brain disease called progressive multifocal leukoencephalopathy (PML).
The ingredient, dimethyl fumarate, is used in a drug called Fumaderm that was approved in Germany in 1994 to treat the skin condition psoriasis. It is also in a different but closely related medication called Tecfidera, which was just approved by the U.S. Food and Drug Administration in March for the treatment of multiple sclerosis (MS). It is known as a fumaric acid ester, which is commonly used as a food additive and has been used to treat psoriasis in Germany for 30 years.
According to reports published in the April 25 issue of the New England Journal of Medicine, however, four patients who were taking Fumaderm to treat their psoriasis developed PML.
"A brand new immune modulating drug was just approved for MS. It’s called BG-12. It is being prescribed now to patients (literally starting this month). The stock of the company of Biogen shot through the roof because the trial results were so convincing. It really WORKS, in other words, unlike the crap that we hoping to get to take. Plus, it is entirely free of serious side effects. Lucky for you MS patients!!
Not one of our devoted, paleolithic doctors has mentioned this as a possible dual-use medication for CFS."
Multiple sclerosis has several intriguing associations with ME/CFS including an infectious mononucleosis trigger, a relapsing/remitting nature, possible herpesvirus activation and high rates of fatigue (that are not associated with demyelination). The neuroprotective effects of a novel oral treatment, BG12 (dimethyl fumarate) has been recently shown to slow disease progression in relapsing/remitting MS in phase III trials. Neural degeneration in MS is believed to be mediated by oxidative stress and an analysis of the neuroprotective effects of dimethyl fumarate suggests that these effects are due to enhancing the recycling of glutathione, a key antioxidant. (Lee et al, 2012).
This is intriguing because the experimental model used to simulate neurodegeneration in MS involves both glutamate toxicity and glutathione depletion. It suggests that extracellular glutamate leads to deprivation of cystine and its reduced form cysteine, which is the rate-limiting substrate for the synthesis of glutathione. The subsequent glutathione depletion gives rise to the accumulation of reactive oxygen species and cell death by oxidative stress (Albrecht et al, 2012).
The one lady mentions we feel fear not anxiety I understand what shes saying I agree that it's not anxiety. But I worry and feel that the FDA (Government) won't understand the context shes talking about. Or equates 'Fear' of a crash to being the act of Fear Avoidance. And/Or think our symptoms (the crash) are psychosomatic and brought on by our fear. That if we addressed our fear via therapy we wont crash.
I think that this was a response to the moderator's previous comment saying "you probably feel anxiety regarding crashing". I think (imo) that she was trying to banish the word "anxiety" as it has psychiatric connotations. What we feel is really "fear" of what we know is going to follow.
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