Dear Patients, Patient’s Loved Ones and Friends,
Since I ended my hunger strike, I have learned that the FDA has sent invitations for the ME/CFS scientific stakeholder workshop scheduled for April 25-26th. The FDA hasn’t disclosed who it is inviting, and did not solicit input from patients. You, the patients, made this FDA stakeholder meeting happen, and we believe patients need to be involved in setting the agenda and ensuring that the most valuable clinical expertise is represented at the meeting.
Therefore, Ampligen patients and I are asking you to email the FDA and Secretary of Health to urge them to invite the most experienced ME/CFS clinicians who use the most sophisticated treatments available and to host an Ampligen Roundtable in conjunction with the FDA scientific and stakeholder workshop. The lessons that are being learned from the Ampligen trials will benefit every ME/CFS patient.
During my hunger strike, the FDA and Secretary Sebelius’s office were inundated with emails and phone calls, and congress people heard from their constituents. I humbly thank you for all your work during those days; our coming together raised the attention of our federal agencies on our health crisis. Once again we need to ACT together by emailing and phoning the FDA to have our voices heard. There is a template email/letter below. For those wishing to use it, just copy and paste for ease. The Cc is to me allowing me to calculate the number of emails sent.
For the health of Our ME/CFS community,
Robert Miller &The Ampligen Team
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Secretary of Health Kathleen Sebelius, FDA Commisioner Dr. Margaret Hamburg, CDER Deputy Director Sandra Kweder, David Banks in FDA Office of Special Health Issues
Phone contacts: Please call in to make a personal request if you can:
- FDA Commisioner, Dr. Margaret Hamburg (301) 796-5000
- Mr. David Banks, Office of Special Health Issues (301)-796-8459
See Email Template Below:
Email To: email@example.com, firstname.lastname@example.org, Sandra.Kweder@fda.hhs.gov, email@example.com, ME-CFS-Meeting@fda.hhs.gov, firstname.lastname@example.org
- Subject: ME/CFS FDA Scientific Stakeholder Workshop
Dear Secretary Sebelius, FDA Commissioner Hamburg, Dr. Kweder and Mr. Banks,
FDA states that the upcoming FDA scientific workshop and stakeholder meeting on ME/CFS is the right place to address the path forward for treatments, including but not limited to Ampligen. There is a serious unmet need in the patient community for medical treatment, and Ampligen is the only medicine that has been tested in clinical trials for ME/CFS in the last 20 years. However, we understand that the few clinicians with extensive experience using Ampligen have not been invited to the workshop to share their understanding of clinical endpoints related to this debilitating illness.
As a patient with ME/CFS, I am strongly urging FDA to do three things regarding the ME/CFS science and stakeholder workshop:
- 1. The FDA should invite Dr. Daniel Peterson, who has undeniably the most experience treating patients with Ampligen and has among the most sophisticated understandings of clinical endpoints, enabling him to identify likely responders by subgrouping patients for various treatments, not limited to Ampligen. In his role as Scientific Advisor to Simmaron Research Foundation, he is collaborating in scientific studies into the immunological abnormalities of ME/CFS, including the NIH and CFI multi-site studies. His clinic has the highest response rate to Ampligen. That, along with his 30-year clinical experience, necessitates his input into future treatment pathways.
- 2. FDA should hold an Ampligen roundtable with the most experienced Ampligen clinicians, patients, the sponsor and the FDA, CDC and NIH representatives, in conjunction with the FDA workshop. No other medication is, or is about to be, in advance studies for treating ME/CFS or has shown such promise. The experts need to collaborate on a path toward approval for Ampligen, so current Ampligen patients can continue to have access to the drug and many other patients and their doctors can decide if Ampligen might work for them. The benefit of clinical knowledge gained from identifying those who respond to Ampligen is imperative. After FDA denied the application for Ampligen’s approval in February, it posted a statement, saying “To assist companies with their development, FDA is sponsoring a workshop in spring 2013 focused specifically on ME/CFS drug development.” And Dr. Hamburg has stated, “We are committed to continuing our dialogue with companies, innovators, patients, and other stakeholders to identify barriers to progress and better define what steps need to be taken to overcome any obstacles to innovation.” This is the time to learn from Ampligen, as well as other experts.
- 3. I also urge FDA to invite Robert Miller as a patient representative. Mr. Miller has taken the lead among patients in urging federal health agencies to pursue smart science and effective treatments for more than 10 years. He played a large part in getting the FDA stakeholder meeting scheduled. His longtime experience in the Ampligen clinical trial gives him a perspective that is necessary to represent patients who participate in the only clinical trial available, as distinct from any of the patients who have been invited thus far. He is a leader among ME/CFS patients generally.
Our understanding is that this stakeholder meeting is designed to identify endpoints for measuring efficacy, so that more clinical trials can be set up and a path to approved treatments and drugs will be established and clarified.
As an ME/CFS patient my voice should be represented at this critically important meeting.
Your Name Here___________
Years ill ______________ City and State ______________
Dr Peterson has not been invited? Besides Ampligen he has more experience with antivirals than anyone (except for Dr. Lerner) and he treats a more distinct population which has NK cell dysfunction…That’s unbelievable….
Support you a 100%, but I do think it is a strategic mistake to focus solely on Ampligen, as it is highly unlikely that the FDA will reverse its ruling. The hope lies in applying pressure for new federally funded RCT´s of promising drugs
It is not about Ampligen only, but the truth of the matter is that Ampligen is a good starting place for A DRUG OF ANY KIND to be approved for ME/CFS. There are no other drugs in the pipeline for any of us. The year that AZT was approved, there were NINE other drugs approved that same years BECAUSE of the fact that having even one drug approved for a disease makes other pharmaceutical companies take notice and start TRYING to find other therapies. Sure there are only a few people on Ampligen right now, but that subset can be used to teach the FDA why and how it works. This is an *opportunity* to stand up and fight for treatments as patients with this horrible disease. it’s time!
I have similar feelings. No question a progress with Ampligen is crucial. But at the same time there are other drugs like e.g. Rituxan which look very promising but lack funding for clinical trials. The OMI for example is still trying to raise funds for a Rituxan trial, this could be supported by the government / FDA and be promoted at the workshop as well.
Despite of that I appreciate the advocacy of you, Bob, very, very much – thank you for doing all this for the community!! Will send an e-mail, thanks for the template.
Nothing approved for ME/CFS yet – why not – it’s been going on long enough. Best wishes Bob in your hard fight.
While I will write emails and attempt to make phone calls I think it would be equally important to try to get our respective representatives to put pressure on those involved in the “workshop” to actually make progress in the production of drug development for our disease.
I think it would be important to first find out what/who are their criteria for inclusion in the workshop. If they feel they have already dealt with the Ampligen issue beyond their necessary scientific evaluation (and I believe that’s the case) then why waste precious time beating a dead horse? They have put the ball back in Biospherx’s court to do due diligence- it’s now their job!
I think it’s important to have some but not too much patient representation and maybe Robert and one other would be great!
I could debate using Dr. Petersen as again we’re getting involved with the whole Ampligen issue which I think may not be anything but a spring board and not a main issue of this meeting. An argument could very easily be made for Dr. Klimas as she is much more Academic and surely knows how to work the system and get NIH grants etc.,. She would be my first pick and I have no experience with either.
I think this whole Workshop could be a tremendous opportunity but needs to be pressured heavily!
I used Bob’s letter with such valuable information. Changed it around a bit so if they only read the first sentence of each paragraph it will say something different. I have posted it in my FB notes, and sent it of course.
The response from the HHS was the usual, nothing like the one Senator Reid got, but I think Bob is sure proof that persistence counts. It only takes a minute. I hope everyone will follow through.
TY again for all you do to spread the word. In healing and hope, Celeste
So who has been invited to the workshop? Maybe we need to find that out.
FDA is not telling anyone who they are inviting or even what the agenda is. They claimed this would be a transparent process and that patients would have input. We have heard of patients already being invited to be representatives, over a week ago, so much for transparency and the same with clinicians.
As for this meeting, it was to be on treatments and drug development. So does it not make sense to have the top ME/CFS treating experts in the same room at the same time??? FDA will say as NIH has, we want new blood, well the new blood leaves when their funding dries up…And our experts remain…They are truly committed…
We shall see what FDA offers up come April.But for now they should hear from the patients…
Thanks to All,
Thanks for the reply Bob. I’m just wondering here….. as I understand both Hemispherx and the FDA said that they would be open to meeting together and working towards getting Ampligen through the approval process. And that meeting should absolutely happen.
Would the time at the FDA Stakeholder meeting be better spent then on other more general topics that will of course include Ampligen but also other drugs, the approval process in general, setting up new subcommittees to meet more regularly and so on?
Always appreciate what you do for the patient population!
What if there is not and never will be a “drug” to treat ME / CFS with? That is, what if what is required is a stress free environment, a massive dietary change, a tailored nutritional therapy and substantial lifestyle changes? If the ANS (autonomic nervous system) is at the root of this, it would seem that such an approach would seem more likely to have comprehensive long term benefit than just dealing with separate pieces of the puzzle…immune, gut, POTS…etc. Treating the genesis of all of our symptoms will be the only reasonable approach, as opposed to masking the individual symptoms.
That the FDA is not inviting Bob and Dr. Peterson clearly shows that up to highest levels the FDA is not willing to listen to and work with the patients. And this despite all the emails, phone calls, petition, testimonies, hunger strike and intervention by senator Reid.
Of course we need to do another email action and it will probably force them to invite Bob and Dr. Peterson but it will not change their attitude and without a change in attitude there will be no willingness to approve Ampligen and to do other important steps. The stakeholder meeting in April, the stakeholder conference call in September 2012 and all the CFSACs are just there to pretend as if they would care – but they do not care.
So one question is what is their motivation for not wanting to help us? Approving Ampligen would make heroes out of the FDA, they could proudly say that they are doing all to help patients. But now they are rightfully accused that they do not want the patients to get better.
And the next question is how can we achieve that the highest levels are changing their policy with real actions and not just with planning another meeting. How can we achieve real big public and political pressure on the FDA. A few articles on local TV and newspapers, emails or a meeting of senator Reid with Sebelius is obviously not enough.
The opinion was posted that Ampligen should not be a major topic of the meeting because the FDA will not reverse their decision. But all possible drugs will face the same difficulties as Ampligen is facing. No drug will meet FDA’s current expectation on safety and efficacy because CFS is such a complex disease and because of the difficulties in enrollment criteria and endpoints. Therefore the Ampligen data has to be used to discuss this. For example Hemispherx stated that FDA’s analysis resulted in a p-value of 0,1. One outcome of the meeting must be whether this p-value is acceptable for the only drug for CFS.
I cannot get email to Seblius anymore. >>>>>
“Sorry, we were unable to deliver your message to the following address.
Remote host said: 550 #5.1.0 Address rejected. [RCPT_TO] ”
( what does this mean?) I keep trying to email her and I get the above response.
Other email recipients designated in the header…are they meeting their intended designation?
Ampligen team? You getting my daily emails?
Anyone else feeling ‘rejected’?
Here is the address and it just worked fine: Kathleen.Sebelius@hhs.gov
Deborah Ann, checking this now, I have not had trouble, nor has anyone else told me this.
Ok, after 3 DAYS OF DAEMONS, I now have a ty from her in my inbox. Must be that Sebelius fans are ..swamping the servers.
That is a Good Thing!!! Thanks to all sending the Emails, as of this afternoon, No invitation had been sent.
ty Bob; might be just my problem ~ hopefully resolved
If we do get envited, Please suggest having in a hotel with conference room to cutdown on the walking distance and the chaos of bus pick- up, waiting for, be dropped off at the wrong. Ect. The timing of patient attendance must be planned with our patient disabilities in mind. I attended the last NIH meeting beginning at 0800 and ending at 430p. X 3 days. I was in remission when I arrived and in total collapse by the end. I could probably attend every afternoon, but not three days in a row. I volunteer my time to work with the program planner by phone to plan a conference PWCFS can gain the most from without causing a crash an relapse for the patients. NIH is not a good place forMe/CFS patients to tackle.