Experts Reflect on the FDA Stakeholder Meeting

Another great article, this definitely belongs on our 'front page'. The unofficial meetings are where the action is, and not just in ME/CFS; it is encouraging to read of them.

I am dismayed that after decades of misery our government leaders are just now bothering to find out how severe our illness really is. They didn't need a two-day meeting to find this out, just an hour or two of reading the literature or even a phone call to one of our esteemed clinicians should've been enough.


I think that there is a lot of powerful impact by hearing individual stories as opposed to hard statistics. When one hears for example about a tragedy like the Oklahoma tornado of yesterday, it is heartbreaking but, when one sees a picture of a woman carrying a child out of the debris, one cannot help but cry.
 
Thanks Joel (and contributors), that was interesting.

I think Mary Dimmock highlighted well the problems we have:

"But alone it's not enough and that's the not so good news. Drug development is downstream from research and there are perennial issues here that must be addressed to make drug development work more effectively and to attract investment by pharma - issues like the bad definition, inadequate characterization of subtypes of patients, lack of funding from the NIH and inability of researchers to access funds, lack of studies to validate the biomarkers and outcome measures, lack of preliminary clinical trials.



"I came away with a much deeper appreciation of the challenges in designing a clinical trial because of the complexity of the disease. Even with the best case definition in place, there are so many factors to consider - the profile of viral and cytokine markers, types of co-morbid conditions, the medications that the patient is on, whether they have been overly exerting themselves, whether the disease is waxing or waning, how to assess drug side effects when the symptoms that patients experience every day are similar to side effects of drugs - and to control or manage so that the results can be compared across patients. Not impossible, and some good ideas were discussed on what is required.

I think a basic understanding of the pathophysiology of the illness will be important. And the lack of it may slow things down much longer than I'd like. It won't be long till I'll have been housebound two decades and progress has been quite slow in that period.

I think the ME/CFS community needs to focus on raising money for research. I have seen a lot of people spend a lot of money on very speculative therapies of all sorts over the years. That is their prerogative but it does show to me that quite a lot of money could be raised if people invested even a small quantity (e.g. 1%) on what they spend on therapies, on research. Fundraising also doesn't need to cost people money and even these days people can raise money by voting in competitions.

There are large numbers of people affected around the world but the amounts being raised privately remain relatively small. The MEandYou campaign is perhaps a good example of what is possible with enough effort.

 
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