Make Room on Your Calendar 20 Dec for the Live Webcast of the FDA Ampligen Hearing

December 18, 2012

Try to leave your calendar open from 8am-5pm EST on the 20th for the FDA’s hearing in Ampligen!

Information about the meeting is available at December 20, 2012 Meeting of the Arthritis Drugs Advisory Committee (not mistitled!).

The webcast will take place at https://collaboration.fda.gov/aac122012/ and Phoenix Rising will attempt to embed the video locally to make it easier to simultaneously watch and comment.

We’d appreciate it if pre-meeting discussion can be kept to the forum thread from this post, just to make life easier for the moderators (and to keep from having to merge a zillion discussion threads)

We’ll make another post the day of the meeting for discussion about the meeting as occurs…so take some time on the 20th to join in the discussion here/in the forums or in chat!

See you on the 20th!

28 comments

{ 28 comments… read them below or add one }

Sasha December 18, 2012 at 3:28 pm

Typo in the first line there – that should be 8am to 5pm.

In the UK, that's 1pm to 10pm.

wdb December 18, 2012 at 3:46 pm


Sasha

Typo in the first line there – that should be 8am to 5pm.

In the UK, that's 1pm to 10pm.

Thanks Sasha

urbantravels December 18, 2012 at 3:56 pm

On the West Coast, that's 5 AM to 2 PM (sigh). This time difference thing is quite annoying.

Purple December 18, 2012 at 4:13 pm

You can use Time Zone Converter to find out the time of this where you live: http://www.timeanddate.com/worldclock/converter.html

Other places:
Japan (Tokyo) – start 10pm (end 21st at 7am)
New Zealand (Auckland) – start 21st at 2am (end 21st 11am)
Australia – Sydney, Melbourne – start midnight 20/21st (end 21st 9am)
Europe – start 2pm (end 11pm)

Cort December 18, 2012 at 6:11 pm
SirArthur December 18, 2012 at 11:26 pm

Excellent overview Cort, will be following this closely come Thursday.
I know Dr. Kogelnik (as a patient, seen him a few times) and hope his 50% guesstimation of Ampligen FDA approval is on the low side.

Cort December 19, 2012 at 7:24 am

I'm afraid the FDA background report for the committee released yesterday was very critical and does not bode well for Ampligen's approval.. Ampligens stock dropped almost 50% when it was released…Its going to be rough.

Sasha December 19, 2012 at 7:48 am


Cort

I'm afraid the FDA background report for the committee released yesterday was very critical and does not bode well for Ampligen's approval.. Ampligens stock dropped almost 50% when it was released…Its going to be rough.

Oh… well, good to know the situation.

JustJack December 19, 2012 at 10:09 am

CONCLUSION from FDA prelim review
"In summary, CFS is a serious, life threatening and unmet medical need. There are currently no FDA approved products specifically for the treatment of CFS. Ampligen has the potential to be a positive therapeutic option for patients with CFS who do not have an alternative to directly treat the condition. Given the overwhelming physical and cognitive health issues; the decrease in activities of daily living and overall lack of quality of life associated with CFS, Ampligen clearly represents a clinically meaningful advance for a significant unmet medical need, and the weight of evidence supports FDA goals to advance treatment for chronically ill patients with severe debilitating, life threatening, conditions such as severe CFS.
It can be stated that the burden of the symptoms associated with CFS is greater than any risks associated with Ampligen, since a CFS sufferer’s life may be at risk for years of debilitation often followed by premature death."

mezombie December 19, 2012 at 5:30 pm

Here's a good article that puts the FDA report in context. As the writer states,

"The problems facing Ampligen-or any putative therapy for CFS for that matter, is that the underlying cause(s) are unknown. As a result, there are quite possibly distinct sub-groups within any potential CFS study population with markedly distinct pathophysiologies, and hence efficacy measures would need to be tailored to the sub-group.

"Ampligen's trials had no way to account for this meta-population problem beyond looking for interesting trends within the data set. And that is what they did. In the briefing documents, the FDA referred to these statistical tests as a means for "hypothesis generating", not efficacy testing. As you can see this is a circular argument. No one seems to know what an appropriate biomarker for the general CFS population is, but the FDA is holding Ampligen up to an unrealistic standard nonetheless. In the end, HEB did find statistical support that Ampligen provides a biologically meaningful impact on the lives of at least some patients with CFS."

and

"Hemispherx is thus being penalized for the scientific community's willful ignorance on CFS for decades, and not being rewarded for taking a major risk of pushing Ampligen through clinical trials."

http://seekingalpha.com/article/1072481-hemispherx-faces-fda-day

dannybex December 19, 2012 at 5:58 pm


mezombie

"Hemispherx is thus being penalized for the scientific community's willful ignorance on CFS for decades, and not being rewarded for taking a major risk of pushing Ampligen through clinical trials."

Actually, if you'll read the FDA document that was released yesterday, it's clear that the exact opposite it true.

Hemispherx refused to comply to the FDA's 2009 request for a new, larger and longer trial, and instead manipulated the results from two earlier trials. They're pissed at the way the Hemispherx may have withheld information about adverse effects, removed like 20 or so patients from the original analysis to make the outcomes look better, etc..

If it isn't approved, I wouldn't blame the FDA, but instead ask Hemispherx why they didn't comply with the FDA's 2009 requests? Hopefully they'll be asked these questions tomorrow.

Here's a link to the FDA's analysis — it doesn't look good at all — and although this document is like 600 pages, just reading and skimming from about page 15 to page 30 will make it clear that they're not pleased with Hemispherx at all.

http://www.fda.gov/downloads/Adviso…rugs/ArthritisAdvisoryCommittee/UCM332514.pdf

satoshikasumi December 19, 2012 at 7:35 pm


dannybex
mezombie

"Hemispherx is thus being penalized for the scientific community's willful ignorance on CFS for decades, and not being rewarded for taking a major risk of pushing Ampligen through clinical trials."

Actually, if you'll read the FDA document that was released yesterday, it's clear that the exact opposite it true.

Hemispherx refused to comply to the FDA's 2009 request for a new, larger and longer trial, and instead manipulated the results from two earlier trials. They're pissed at the way the Hemispherx may have withheld information about adverse effects, removed like 20 or so patients from the original analysis to make the outcomes look better, etc..

If it isn't approved, I wouldn't blame the FDA, but instead ask Hemispherx why they didn't comply with the FDA's 2009 requests? Hopefully they'll be asked these questions tomorrow.

Here's a link to the FDA's analysis — it doesn't look good at all — and although this document is like 600 pages, just reading and skimming from about page 15 to page 30 will make it clear that they're not pleased with Hemispherx at all.

http://www.fda.gov/downloads/Adviso…rugs/ArthritisAdvisoryCommittee/UCM332514.pdf

Here's the problem. They ran out of money.

The first Ampligen trials were in 1988. Ampligen should have been fast-tracked approved in 1998 for this devastating orphan disease.

Hemispherx was the only company that took a gamble on us. Like a lawsuit that drags on for years until one of the litigants is finally bankrupt, the FDA has slowly waged a war of attrition against Ampligen over nearly 25 years, in concert with agencies like the CDC led by Bill Reeves who aggressively promoted CBT/GET despite ANY lack of evidence they objectively improve function or help anyone.

satoshikasumi December 19, 2012 at 7:41 pm

Also, the definition of "statistically significant" in science is arbitrary, defined as a p<0.05

The initial Ampligen results are called "insignificant" by the FDA because they had a p=0.10.

What this actually means is that there is a 10% chance the results are explained by chance, and a 90% chance Ampligen is effective.

That is not good enough for most clinical trials, but FDA should make an exception and grant PROVISIONAL APPROVAL because ME/CFS patients have no other prospects and Hemispherx had to go into this blind with no idea how to measure outcomes. The company should be rewarded because they took a risk and found something that very likely helps some people. :)

Cort December 19, 2012 at 8:09 pm

Its a complex situation..the FDA report was harsh but the committee looks good….I just met with a Hemispherx rep who appears confident they can respond well to the FDA's challenges…Check out the latest on the Ampligen situation in

Harsh Report…Good Committee: Which Way Ampligen?

Cort December 20, 2012 at 8:11 am

find tweets from meeting at CortJohnson https://twitter.com/CortJohnson

Sasha December 20, 2012 at 8:21 am


Cort

find tweets from meeting at CortJohnson https://twitter.com/CortJohnson

Cort is doing some great tweeting!

Cort December 20, 2012 at 8:22 am

Thanks Sasha…Carter and Strayer presenting a strong case…

waiting December 20, 2012 at 9:36 am

Hi Cort — thank you so much for your tweeting — can you see if PFL members are there — will they be speaking about the primary endpoint exercise test?

Thanks!

Cort December 20, 2012 at 9:53 am

Dr. Snell is here! I thought he was going to speak in the first section but he didn't. The Hemispherx team did run long; it may be that he lost his slot but we'll see…he's their ace on exercise testing -which the committee does not know much about.

One of the discussion questions specifically refers to ETT I believe -so I think he will get his chance…

Cort December 20, 2012 at 9:54 am

One question…Did Carter come on too strong? Or did he effectively state his case?

waiting December 20, 2012 at 10:00 am


Cort

Dr. Snell is here! I thought he was going to speak in the first section but he didn't. The Hemispherx team did run long; it may be that he lost his slot but we'll see…he's their ace on exercise testing -which the committee does not know much about.

One of the discussion questions specifically refers to ETT I believe -so I think he will get his chance…

Yes, the ETT is such an essential and strong, objective aspect of this study that I hope Dr. Snell has a chance to make the necessary points to the committee.

From the trial paper (March 2012):

"Cardiopulmonary exercise tolerance (ET) testing is an objective

measurement of treatment efficacy for fatigue and is accepted as a

regulatory standard for drugs ameliorating exertional fatigue by

exhibiting an average improvement of at least a 6.5% in intragroup,

placebo-adjusted ET [16–19]. The Phase III multi-center,

double-blind, placebo controlled trial reported here uses ET as its

primary endpoint and the reduction in drug usage for symptom

relief as one of several secondary endpoints in the evaluation of

rintatolimod in the treatment of CFS/ME."

dannybex December 20, 2012 at 11:56 am


satoshikasumi

That is not good enough for most clinical trials, but FDA should make an exception and grant PROVISIONAL APPROVAL because ME/CFS patients have no other prospects and Hemispherx had to go into this blind with no idea how to measure outcomes. The company should be rewarded because they took a risk and found something that very likely helps some people. :)

I don't know what you mean by "ME/CFS patients have no other prospects", unless you mean drugs. ???

dannybex December 20, 2012 at 11:58 am


satoshikasumi

Here's the problem. They ran out of money.

At one point I suppose they did. But they made a ton of money in June 2009 when they released false reports that the FDA was about to approve Ampligen, sending the stock from something like 50 cents to over $4.00. Someone made a lot of money during that period…

waiting December 20, 2012 at 12:38 pm

Cort, you gave poignant, clear testimony. Thank you.

Sasha December 20, 2012 at 12:42 pm


waiting

Cort, you gave poignant, clear testimony. Thank you.

I wondered why he'd stopped tweeting – phew!

Cort December 20, 2012 at 2:10 pm

Thanks…for some reason my legs were shaking like leaves in the first one…I couldn't believe it…I dropped out to study the next testimony I had to give…

Next up the all important question period…and then the Vote:aghhh::aghhh: o_O

waiting December 20, 2012 at 2:15 pm

There was no sign of any shaking legs that came across on video anyway. You're a great speaker, just like you are a great writer. :)

Marg December 20, 2012 at 9:00 pm

Thanks Cort fot the tweets, as usual you are telling the story as it should be told…blow by blow.

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