Phoenix Rising - Cort Johnson's Column
...Presenting complex chronic fatigue syndrome (ME/CFS) research in a way we can all understand.
The First Federally Approved Drug For Chronic Fatigue Syndrome (ME/CFS)?
by Cort Johnson
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 Mary 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.
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. Carter 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. Carter, 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. Carter 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?)
A Safe Drug. Dr. Carter 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. Carter 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. Carter 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.
Read more about Ampligen at Phoenix Rising
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