View the Post on the BlogReversing a 2009 decision some commentators felt was potentially crippling to Hemispherx BioPharma, Ampligen's producer, the FDA today stated they would not, after all, require a expensive 300 person study to assess Ampligen's effectiveness in chronic fatigue syndrome (ME/CFS). (Safety concerns appear to have been taken care of.) Instead they would allow Hemispherx to use new analyses of data it's already collected. Hemispherx must be breathing a huge sigh of relief.
A 300 person, double-blinded, placebo controlled drug trial was far beyond Hemispherx financial capacity, whose assets, Reuter's reported, fell from 58.1 million dollars in late 2009 to just 3.6 million dollars in March of this year.
The FDA imposed some major conditions on Hemispherx in 2009 but it could have rejected the application outright. Instead it chose to give the company more and more and more time; essentially keeping the door open. With this decision, which occurred after a recent meeting between the company and the FDA, the FDA opened the door a bit wider. Reuter's reported that Hemipherx's stock price soared 50% on the news.
It's not clear what circumstances prompted the FDA to change its mind but its been under fire for low rates of drug approvals over the past five years; in particular for drugs to treat chronic illnesses. With about a million people with ME/CFS in the US and government-funded studies suggesting as much as 20 billion dollars a year in economic losses, ME/CFS may be the only 'major' disorder without an FDA approved drug. In its report MarketWatch called ME/CFS a 'chronic, serious debilitating disorder". (The FDA recently agreed to a Stakeholder's Meeting to discuss its approach to chronic fatigue syndrome.)
In March an analyst noted that although the economics of ME/CFS treatment are unclear Hemispherx could be sitting on a multi-billion dollar chronic fatigue syndrome market worldwide. Even if just a portion of ME/CFS sufferers were treated with Ampligen the potential upside for the company and its shareholders is large indeed.
Marketwatch reported that upon news of the FDA's decision Hemispherx immediately began hiring more staff, consultants and independent contractors to prepare for the work ahead.
A 2010 study suggested Ampligen could take the place of drugs that expose some ME/CFS patients to cardiac toxicity. Other studies have shown Ampligen can significantly increase exercise tolerance.
The best drug never to get approved for ME/CFS suddenly appears to have a real chance. Hemispherx reported it will file its response in the fall of this year. The FDA typically takes up to six months to produce a decision.ar
Nothing is assured but with Hemispherx finally getting its day 'in court' and Rituximab trials ramping up the treatment possibilities for ME/CFS appear quite a bit brighter.
Tomorrow a blog reporting on Dr. Peterson's take on the drug with three of his Ampligen treated patient will appear (See Dr. Peterson Talks!)
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Major Move From FDA Puts Ampligen Back on Track
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The FDA ought to have fast-tracked Ampligen for approval based on the phase II results back in 1998. They didn't. This was partly due to the perception that CFS was not a serious disease.
Fifteen years later, CFS remains a crushing burden on the economy and no other drug companies have even gotten through a phase II study. There are no prospects for a treatment being approved for CFS in the next five years other than Ampligen.
Other treatments being considered are much more dangerous than Ampligen.
The agency said no in 2009 but they have a lot of discretion in how strictly they scrutinize drugs. They should consider the burden of CFS on society and the failure of any other drug company to make progress and give Ampligen the benefit of the doubt.
how to avoid being debbie downer in our position? a difficult assignment, at which i am largely failing. my main roadblock is knowing that many people who have our damnable illness do not have the kind of medical coverage required to pay for Ampligen, so what's the difference anyway? after all, almost nobody has the kind of money that the Whittemores spent on their daughter. after 30 years of fighting, i am very tired indeed... and it is a big job to remain positive after seeing all the BS that comes with our trying so valiantly to get some help.
best wishes to the younger ones. that's about as positive as i can muster up for now.
It's all about building momentum. Approving a drug specific to ME/CFS is a big hurdle that will be very positive if achieved.
This is definitely good news. I won't be able to afford it, but it'll definitely be judged in the court of patient opinion.
I'm hoping Dr. Peterson's subjects were long-term, intractably ill patients. Because the CFIDS Assoc stated on their web page (http://www.cfids.org/resources/newly-diagnosed-faq.asp) that a third of all persons who become ill recover completely: "...About one-third of persons with CFS recover almost fully, but no one knows why. Some people recover in small to moderate degrees, while others recover minimally, if at all...."
I'm hoping Dr. Peterson's subjects were long-term, intractably ill patients. Because the CFIDS Assoc stated on their web page (http://www.cfids.org/resources/newly-diagnosed-faq.asp) that a third of all persons who become ill recover completely: "...About one-third of persons with CFS recover almost fully, but no one knows why. Some people recover in small to moderate degrees, while others recover minimally, if at all...."
Most drug companies will have a patient assistance program to give the drug free to uninsured, poor patients after the drug is approved. If Ampligen is approved, it will be very profitable and it is likely that Hemispherx would create such an assistance program.
Second, if Obamacare is not repealed, you will be able to buy health insurance that will cover Ampligen in 2014. Please don't give up hope!
The main barrier is the FDA's approval process. If it can pass that hurdle, you'll almost certainly be able to get it one way or another.
Not to mention that most approved drugs for serious conditions have a patient assistance program to help people who cannot afford the medicine.
This is how some patients are getting access to drugs like Valcyte now.
Hemispherx would be able to create a patient assistance program if their drug was approved and profitable.
Dr. Peterson talks on Ampligen and we have stories from three Ampligen patients on the latest article here.
i guess its still three years from being available in the UK on the NHS, if everything pans out...
Still, better than nothing.
Still, better than nothing.
Almost no drug for chronic diseases has permanent effects. Immune-modulating drugs are almost always reversible (which is a very good thing for people who have bad side effects). Ampligen changes the functioning of the rnase-l system and improves natural killer cell function. If the virus theory is correct, this allows the patient's immune system to reduce herpesvirus levels over time. When treatment is stopped, the immune system is no longer being modified by Ampligen and the viruses can begin reproducing again. If the autoimmune theory is correct, ampligen shifts the immune system into a mode where it produces fewer autoantibodies. They are gradually depleted during treatment. When treatment is stopped, the body starts gradually producing the bad stuff again until the patient gets sick.
There is a long delay both in responding to Ampligen and in relapsing after you stop it.