Discussion in 'Phoenix Rising Articles' started by Phoenix Rising Team, Feb 9, 2013.
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Thank you Bob for your amazing determination and effort to bring a wake-up call to our federal agencies.
Job well done!
Pleased to hear for Bobs sake. nevertheless, I have been very inspired by what Bob and those supporting him have achieved.
Bob has done a tremendous job. Thank you very much.
Before the FDA Stakeholders Meeting are 2 other very important events and these are from the Hemispherx press release on the Ampligen non-approval: “end-of-review conference with the FDA as a precursor to submitting a formal appeal … regarding the Agency's decision.”
I believe the FDA Stakeholders Meeting is just to calm us down and we will still not have an approved drug for many years. From the many CFS Advisory Committee meetings, the FDA stakeholder teleconference on Sep 13, the many emails and testimonies the FDA should have had a good understanding that we need approval of Ampligen now. But they have decided not to adopt their approval requirements to the unmet medical needs of this serious and life-threatening disease as the FDA made me believe in the FDA stakeholder teleconference on Sep 13.
So I think we still need to act that Hemispherx is successful with their formal appeal, that Ampligen is approved now and the trials with the NIH will follow post-approval. Otherwise there will be no approved drug for many years.
You make a good point. The FDA has so far paid lip service to CFS being a serious and life threatening disease, now they need to produce an action that, at the very least, moves ampligen and other drug development to a near term possibility. However, IMO, I don't think they are going to approve ampligen on an appeal, - I think they will want one more trial. There must be a better fit for Hemispherx, other than a large, expensive, long drawn out phase III. Here are some questions I'd like to know the answer to before the spring stakeholders meeting.
The FDA has a new policy named: Enrichment Strategies for Clinical Trials to Support Approval
How can Enrichment Strategies help Hemispherx?
The FDA met last week to discuss a New Pathway To Approval for Serious and Life Threatening diseases. The idea is to focus smaller and quicker trials for quikcer approval on the most serious afflicted and then expand to the labeling later to include the not as serious afficted.
If passed, how can the New Pathway to Approval, if passed, help Hemispherx?
In the September 13 Stakeholders meeting, the FDA touted the new FDASIA statute as a possible fit for Ampligen and Hemispherx. Is FDASIA still a possibility for Hemispherx and if not, why not?
In the September 13 Stakeholders meeting, the FDA stated that they had some other drugs under consideration but when pressed, these turned out only to be Supplements. Why is the FDA considering supplements for a serious and life threatening disease, when real and effective therapeutics are needed? And why, in the 20 years that Hemispherx has been developing Ampligen, there are no other drug makers developing real and effective therapeutics for this disease?
There should probably be some separate thread to start building a case for the Spring Stakeholders meeting. And I mean build a strong case.
You might like to repost your comment there, Johnny - it's a very good one.
Done. Thanks Sasha, I missed the thread.
I'd have posted it on this thread earlier if I'd been faster off the mark! So much to do...
there are two viable options still open to get Ampligen legalised and designated for CFIDS / ME.
1. Hemispherx is unlikely to win its appeal to the FDA, though it is still worth a try. There is a high probability of them losing the appeal. To counteract this injustice, many CFIDS / ME organisations throughout America and Europe and Australasia could make an agreement to jointly fund a legal case to the US Federal court or the US Supreme court demanding that Ampligen be legalised and designated for subgroups of CFIDS patients, as efficacy has been proven in a certain percentage of patients (the subgroups), on the legal grounds of medical necessity including life and death issues, and on the grounds of human rights. Some law firms may take this case on at a reduced or lowered fee and if someone has family or friends who are partners in law firms then one could get the case for free. There are some conscientious lawyers still around. If we could set a legal precedent for this in the US Supreme court we could over-turn and over-ride the corruption in the FDA now and in the future, which would work for the benefit of CFIDS and other neglected disabilities. We must remember that the government and its agencies are there to serve the people, including respecting their Constitutional rights and human rights.
2. Hemispherx may not be able to afford more detailed clinical trials with large populations. So in addition to the above legal case, get the NIH involved in a full scale Ampligen trial. Get them to run very detailed tests of Ampligen on those CFIDS subgroups which are benefitting or have benefitted from Ampligen. This would include full recoveries and those people who improved 70 - 100% of normal function. This trial would include deciphering the biological pathways and mechanisms involved and gene changes and expressions involved in the Ampligen responders. Some of these biomarkers are catalogued on www.cfs-ireland.com
And differentiating these CFIDS subgroups from other subgroups which don't respond to Ampligen. This precision analysis by the NIH would then enable the Ampligen responders to be identified from CFIDS populations and subgroups before Ampligen is even administered. Thus treatment with Ampligen would be 100% effective in the identified subgroups, and both efficacy and safety proved beyond reasonable doubt. This NIH trial could be concluded within 6 months. The NIH findings would force the FDA to legalise and designate Ampligen for CFIDS. A similar NIH trial could be undertaken for Rituximab and similar type drugs. And again if successful the FDA could be forced to comply and legalise and designate these drugs also.
Another good article from Bioworld. to read the entire article:
A late-stage change in clinical direction and the use of a trial placebo that turned out also to be a treatment in chronic fatigue syndrome (CFS) may have hobbled Hemispherx Bioscience Inc.'s regulatory efforts with Ampligen (rintatolimod), the Toll-like receptor 3 modulator that was hit with a complete response letter (CRL) earlier this month.
But Ampligen may still have a chance, said Kimberly McCleary, president and CEO of the Chronic Fatigue and Immune Dysfunction Syndrome (CFIDS) Association of America.
The scenario "cries out for [Hemispherx] to take on a capable partner, whether that's the National Institutes of Health [NIH] or a company with more experience and some ability to provide the kind of financing that would be required," McCleary said.
"It's a shame that Hemispherx didn't undertake the Phase III [trial] they had planned, and is evident in their [quarterly statements] after the 2009 CRL," she said. "They outlined the cost per patient, and how they would trim down the costs from the last study they did, and then the strategy shifted to submitting a new analysis of the data" from the earlier, AMP516 trial.
Saline was used as the placebo control in the 516 study. "They made that decision back in the early 1990s, before anybody had connected the orthostatic and blood-volume problems in CFS," and before physicians had begun to use saline as a therapy for those problems, McCleary said. "This may have made it more difficult to show efficacy. What is the appropriate placebo, if saline has some active properties?"
Others trying to come up with therapies for CSF will face the same question. But there aren't any others, at least not in advanced stages, doing so, which means patients have all their chips on Ampligen, which already has helped many in trials. These include Robert Miller, 54, whose hunger strike to draw attention to the issue has entered its second week. (See BioWorld Today, Feb. 6, 2013.)
This is another article by Randy Osborne - the third in a series. We're really lucky to have him writing about this - let's follow that link so that he gets the well-deserved traffic to show his editor so that he can keep covering the story.
As Johnny says, that's only part of the article - there's good stuff in the other two thirds!
Bob pushes things forward again. I applaud his commitment and his effectiveness. (As a fellow blogger I love the title of the blog as well )
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