Patients have been asking  where they can find Mary Dimmock’s CFSAC testimony from today and she has graciously agreed for me to publish it here.

I have a few things to say about this CFSAC meeting, but I need to decompress a bit for now. In the meantime, here is Mary’s testimony:

Mary Dimmock                           CFSAC Meeting Testimony                       May 2013

Good morning.

First, I wish to thank the FDA for creating an opportunity with the potential to change the future for ME. We look forward to seeing your action plans. Please share them in a follow-up teleconference modeled after your fall teleconference.

I especially want to thank all the patients who participated at a considerable cost to their well-being. Through you, people began to see how hellish this disease really is.

For me, the biggest lesson of the FDA meeting is that we are not going anywhere until we address the fundamentals – the definition and funding for needed research.

About the definition…

We have all heard the story of babel – people of the world divided because of different languages. Different words for the same thing. But there is a different kind of babel that is more insidious because it is harder to recognize. The babel when you use the same word but mean very different things. And that is exactly the situation we have with “CFS” – the same label applied to very diverse definitions and conditions.

CDC states that Oxford, Fukuda, Canadian and the ME-ICC “identify similar pools of patients”.  But Fukuda does not require PEM and Oxford only requires 6 months of fatigue and allows psychiatric illness. Numerous studies have shown that these definitions are not all the same patients. Yes, ME is heterogeneous but this heterogeneity is a manufactured artifact of inappropriately combining all these diverse definitions and conditions into one clinical entity called CFS.

Beyond that, there is a mixing and matching of  studies across definitions with the CDC using Oxford studies to support recommendations like CBT for all “CFS” patients. There are evidence based literature reviews that do the same. And then there are all those diverse theories of what CFS is – false illness beliefs, deconditioning, maladaptive personalities, bad nutrition, excessive rest, any unexplained chronic fatigue. You may say you reject these extreme views. But the reality is that patients live in a world that indiscriminately absorbs all these views, leaving their doctors, employers and families thinking that “CFS” is psychiatric, not real, not serious and perpetuated because patients are unwillingness to exercise. Even an FDA Advisory Committee member asked how the efficacy of Ampligen compared to CBT. Would he have asked that of a cancer drug?

I worked for a pharmaceutical company for 31 years and with all due respect to those present, this is sloppy science. It has impeded ME research, stalled ME drug development and negatively impacted clinical guidance for ME patients. Worse, patients have paid a terrible price in harmful treatments, stigma and disbelief. They continue to pay the price every single day.

Do any of us sitting here really believe that we need more study before we accept that PEM has been proven as real and measurable? Before we accept that PEM differentiates a group of very sick patients who need to be studied and treated separately from patients whose only symptom is 6 months of chronic fatigue or Fukuda without PEM? We must stop this confusion – this babel – immediately.

To that end, a group of patient organizations and advocates sent a letter to Secretary Sebelius and Drs. Frieden, Collins and Koh calling on DHHS to resolve this issue. Stop using the term “CFS” as a “one size fits all” umbrella for so many diverse definitions and conditions. Adopt the Canadian Consensus Criteria as a disease appropriate definition now and work to improve it. We look forward to a considered dialog and response on this. And if you are going to progress CFSAC recommendations with workgroups, then I’d recommend it would be wise to look at all DHHS definition efforts, not just CFSAC’s definition recommendation.

The second issue from the FDA meeting was the need for research to validate outcome measures, agree to biomarkers and perform the initial clinical trials in order to fuel pharmaceutical interest. And that is going to require money.

We have heard that the science isn’t ready, that researchers are not interested, that good proposals are not being submitted, that NIH doesn’t fund those kinds of studies, that money is tight. But with what we learned at the FDA, from our researchers and from other disease areas, we don’t believe these barriers cant be readily overcome with leadership.

About tight budgets and sequestration… At $3.7M, 2012 funding for this disease is 3% of the funding for multiple sclerosis, a disease with a similar level of disease burden. Funding for this disease is far, far below what would be expected based on burden of disease or economic impact. This is about a fair share of what funding is available.

The opportunities to change the future are palpable. But contrary to Mr. Munos’s suggestion at the FDA meeting, patients are too stigmatized, impoverished and terribly ill to come up with the funding to solve these challenges on their own. They already pay with their lives and with $18-23B a year in lost productivity and direct medical costs. If there ever was a time for the NIH to step up to the plate, it is now. Use the approaches used in other disease areas to foster the needed investments and collaborations. Use RFAs to encourage applications and get the needed studies done. Provide funding that is commensurate with the disease burden and economic impact. Use your power, influence and position to make it happen. Today. No more excuses.

Thank you for the opportunity to talk to you.

The NIH testimony above was shortened to read the following comments that came in from a patient expressing her frustration with the meeting:

The disconnect between my sense of urgency for treatments and a cure to get my life back after 23 years with this disease and their totally lackadaisical manner and approach to everything discussed makes me totally feel like giving up. This meeting is a stark reminder that I am alone. I’m stuck with this illness for the rest of my life, just staring at my ceiling from my bed.