first federally approved drug for MF/CFS

[Guest guest]

just got this of of Cort s web page enjoy and hopefully it

might be able to help some of you. Heidi

The First Federally Approved Drug For Chronic Fatigue Syndrome

(ME/CFS)?

Ampligen: There can't be many more frustrating subjects than

Ampligen. Chronic fatigue syndrome (ME/CFS) advocates hoped that the

FDA` would fast-track' Ampligen twenty years ago and yet its fate is

still in limbo. At the 2007 IACFS/ME conference Ampligen

representatives seemed excited over their chances at the upcoming FDA

review. Ampligen did not, however, pass muster and the FDA, citing

numerous problems, kicked the application back to the company.

What is it with Ampligen? We know Ampligen works very well and has

even been something of a lifesaver for some patients. Federal

advisory committee (CFSAC) members were recently treated to

impassioned testimony from a father with CFS and his wife regarding

his decline after he had to stop Ampligen. Annette Whittemore's

daughter and Schweitzer are two prominent figures who've

benefited greatly from Ampligen. Yet here we are 20 years later and

this drug is still available only to study participants. What's going

on here? Is it the FDA? Is it the company? Is it the drug?

It's probably everything but in this case we are indeed unlucky in

our friends. Hemispherx has been embroiled in financial intrigues and

lawsuits for much of its existence. The founder of the company is a

hard working but at times very contentious eighty-something figure

who some believe might have done the drug better by remaining more in

the background. The drug may be good but you hear little good about

its maker.

Dig Deeper: Twisted History: Ampligen and Chronic Fatigue Syndrome

(ME/CFS ) Part II

Why was Ampligen's latest (last?) bid rejected? The FDA said it was

missing information. Apparently the information was there but it was

in an unusual format that the FDA had trouble understanding; Ampligen

has been in the works long enough that Hemispherx has been stuck

using an old statistical package the FDA was not familiar with. Due

to the long time frame, Hemispherx is also reportedly stuck using the

old Holmes definition chronic fatigue syndrome (ME/CFS). Questions

have also been raised whether they're measuring the right endpoints

and why different study sites reportedly had very different success

rates….Despite all these questions Hemispherx appears to remain quite

optimistic about Ampligen's future.

Good News – Dr. almost oozed confidence in a recent conference

call on Ampligen's prospects. The FDA accepted Hemispherx's revision

and will make a determination on the drug's suitableness for chronic

fatigue syndrome (ME/CFS) probably in the first half of 2009.

According to Dr. , just getting past the first round with FDA

was a huge step. The FDA is now taking a very hard look at drug

applications early in the process – if a drug survives that scrutiny,

Dr. reported, it has an 80 percent chance of approval.

Filling a Hole. Ampligen also gains points with the FDA because it is

categorized as filling an `unmet need'. (Yes `need' does seem to

register with at least one government agency – would that it would

with others.) The FDA does care enough about underserved diseases to

give drug companies something of a break when they build a drug for

one. That `unmet need' reportedly gives Ampligen another 10-15%

boost. (Could we really be talking a 90-95% chance of approval?)

Dig Deeper! Ampligen and Chronic Fatigue Syndrome (ME/CFS) Treatment

A Safe Drug. Dr. believes Ampligen has some other aces up its

sleeves. The FDA is very interested in immune stimulation but is

scared to death of approving an immune enhancing drug that pushes

immune performance to the point where a monster – an autoimmune

disease – is created.

The Fading Question of Legitimacy – Another point in Ampligen's favor

is the increasing legitimization of the disease. Having the head of

the Centers For Disease Control (CDC) stand up at a national press

conference and publicly state that this is a real, serious disease

apparently really did open many people's eyes. The CAA's media

campaign also provided a substantial boost. (Indeed it's difficult

now to find a mainstream website that does not treat this disease

respectfully).

The federal advisory committee on CFS (CFSAC) gives Ampligen another

arrow in its quiver. It's been stated before but it's true (and

rather startling) that while the NIH has over a hundred advisory

committees only a handful are focused specifically on one disease and

CFS is one of them. (How did that happen??). An FDA representative

sits on the CFSAC panel and he interacts with ME/CFS physicians on

the panel, some of whom have been involved in the Ampligen trials. He

also hears the patients' stories - some of which have concerned their

relapses after being deprived on Ampligen. His presence on the panel

can only help.

Insurance. Ampligen is expensive, expensive enough that one wonders

if insurance companies would be willing to pay for it. But even here

Dr. had good news. He reported that Hemispherx has studies

showing that because chronic fatigue syndrome (ME/CFS) patients on

the drug require fewer doctor's visits, hospitalizations, etc. that

if insurance companies commit to this drug their costs should go

down, not up; i.e. ME/CFS patients on Ampligen will cost their

insurance companies less.

Length of treatment.Dr. said they were working very closely

with the FDA about `labeling'. Despite having done studies of all

sorts of different lengths (6, 20, 40, 75 weeks) he couldn't give a

hard and fast time about how long a patient would have to be on the

drug. Patients with a more severe illness or who've had the disease

longer might need to take it for longer periods. He said the length

of treatment would be a `doctor-patient' decision.

Approval? Only 16 drugs were approved in all of 2007. Will Ampligen

join that select club? Will the first FDA approved drug for ME/CFS be

an immune modulator? FDA approval of an immune enhancing drug would

cause many in the medical establishment to reassess their ideas about

the disease and, of course, help ME/CFS's legitimacy. Have the stars

aligned for both Ampligen and chronic fatigue syndrome (ME/CFS)?

We'll know within the next six months.

Dig Deeper! Ampligen and chronic fatigue syndrome (ME/CFS)

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