Chronic fatigue syndrome (CFS or ME/CFS) is still without any FDA approved treatments -- Hemispherx Biopharma Inc. says the FDA has rejected its New Drug Application for Ampligen.
Ampligen is an immune-system modulator that has languished in the experimental stage for more than 30 years. Many people who've taken it for ME/CFS say it changed their lives, while others say they were disappointed in the drug. Ampligen currently is being investigated as a possible treatment for both avian and swine flus.
The FDA told Hemispherx that the 2 studies it submitted "did not provide credible evidence of efficacy of Ampligen." The company says it will consider the FDA's recommendation of at least one more study, involving at least 300 people for 6 months. Hemispherx also says it plans to work quickly to once again try to get Ampligen approved and on the market.
While no one expected this one drug to be a miracle treatment for everyone with ME/CFS, it's approval could have meant more public awareness, more credibility, and possibly more research dollars. For some, it could have meant access to a treatment that helps them regain functionality.
Are you surprised by the FDA's rejection? Do you think it was justified? Voice your opinion by leaving a comment below!
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Of course I am not surprised. I once had hope for Ampligen when I learned of the drug in the 1990’s. One need to only have followed the history of the company and the 58 proposed uses for Ampligen, including Carter’s pitch to use Ampligen in cigarettes, to realize that Hemispherx Biopharma was a scam.
I truly hope William Carter goes to jail. He knew what he was doing and gave a lot of CFS patients false hope while lining his pockets with investor money.
To be completely honest, not really surprised, and for what I know about the drug, it has done more harm than heal to CFS patients that have tried it out. It had a success rate of 20% of patients improving on it, which is not really high, and could very well be for many other reasons. Basically they need to do more homework, specially now that XMRV is on the plate…
But I agree on the credibility side, nonetheless I would not volunteer myself for trying ampligen.
What amazes me is that XMRV is not in all the media as the biggest discovery since HIV, because it could very well happen to be until opposite is proved… Media is not paying enough attention in my view, and that by itself would give us enough credibility if there was an officially approved blood diagnostic test.
From what I have seen one would need to take Ampligen within the first 6 months of getting CFS. This of course, is before one could be diagnosed as having CFS.
I agree with the earlier comment XMRV needs to be all over the news.
Is it just coincidence that this denial is fresh on the heals of the XMRV discovery? The timing seems very suspect. Strange how the FDA kept delaying a decision for months. Could they have been advised that this discovery was soon to be published?
Jeff,
That’s highly unlikely. The company has been working to get more data to the FDA and to bring a couple of facilities into compliance, and I think it truly is a coincidence that all these things came together a few weeks after the XMRV research was published.
By the way, Hemispherx has already said it wants to test Ampligen against XMRV (as do several drug companies right now.) Those results will definitely be interesting to see!
How anyone can believe anything Hemispherx says at this point baffles me.
First, how does not know that Carter was unaware of the FDA decision until recently. How could that possibly be? The company’s own filings said that animal toxicity data requested by the FDA would not be ready until next year. Second, of course HEB wants to text Ampligen against XMRV…..the company has no commercial products and without some kind of plan forward (stock pump) how can Carter and his partners keep making money.
Amazing really.
My take is that Carter found a mis-understood disease and found a way to hitch his 30-year old drug called Ampligen (Amplified Genetic Activity) to it in order to make millions of dollars per year.
Who was hurt…investors for one and second, poor desperate people with CFS hoping for some treatment.
Finally, HEB’s Ampligen trial data relied on treadmill test results. Anyone with CFS knows that for no good reason some days are a lot better than others. Just the fact that no other diagnostic to measure the effectiveness of the drug was available should have been a tip-off that Ampligen would not be approved….and BTW…the treatmill test improvements alleged by HEB were not very large….a matter of seconds…..
Thanks for the informed opinions. I have practically given up hoping for a cure. What a waste of human potential for all of us who could have served. We are casualty’s of a different kind of war.
What is wrong with those people at the FDA??
Chronic Fatigue Syndrome is awful to live with, it affects my life tremendously! I try to do volunteer work and errands but I am so tired afterward, that I usually take a nap every afternoon.
I’m interested in the research being done by Robert J. Thomas MD at the Harbard & Beth Israel Deconess Medical Center… In the recent “American Fibromyalgia Syndrome Association, Inc. Update” newsletter it mentions:
“The standard approach to measure sleep uses the electroencephalogram (EEG) to depice brain wave activity. In general, this approach has not been useful in identifying characteristics specific to people with FMS, nor can it help explain why patients are so unrefreshed following a night of apparently ‘good” sleep’ {according to the sleep study results!}.” Dr. Thomas plans to use new technology that “evaluates the interactions of the cardiac rhythm and respiratory pattern during sleep using information taken from the ECG. This technique can easily differentiate stable or effective sleep, which allows normal nighttime functions, and unstable or ineffective sleep, which may not allow normal sleep functions to occur,” says Dr. Thomas.
His results will be very interesting! I have always been disappointed with sleep studies results saying ‘everything was normal.’
Diane
Diane makes my point. There are so many beaten down people with CFS who have been sick for a long time. 23 years for me.
Diane blames the FDA. There is nothing wrong with the FDA. There is a lot wrong with Hemispherx Biopharma.
Instead of using company money to pay bonuses, the company should have been spending money on additional studies and trials to show that Ampligen works against CFS. The company should have partnered with a larger firm.
The company did not and I can only sumise this is because Carter did not want to expose his fraud and cash cow.
As a sufferer from CFS and FMS, I’d love to see a cure for one or the other, or, if they are one disease with slightly different symptoms, for both.
As to the FDA, the staff is doing its job keeping a drug that hasn’t passed scientific muster off the market.
From the sound of it, this drug is more of a ripoff than a valueable treatment.
As a patient treated by Ampligen and having some inside information,I am convinced that this is a first rate scandal
involving FDA with a corrupt company with a good product .
Rather childishly -and highly unprofessionally- FDA has
started a veritable vendetta with a small and underfunded
company whose leadership tried a long time ago , when the
Ampligen testing started , to fool FDA by not reporting any
negative side effects -no matter how minor they were that must occur when any medicine is tested -which angered FDA so much that they started looking for revenge.Clearly FDA has
not the best interest of the suffering patients in mind but
their own hurt professional pride . Among specialists it well
known that there exists enough positive evidence to approve
Ampligen now , but FDA wants to continue its private vendetta against Carter and associates till they after an excessively long and drawn out testing will finally approve it .
By that time they probably hope that Carter has been forced
to sell Hemispherx to a well funded corporation that can really
afford to launch Ampligen internationally in contrast to the
seriously underfunded Hemispherx. From some negative
comments above concerning Ampligen and its effectiveness I
understand that those commentators know far to little about
the drug ,its effects and limitations .Obviously , Carter is a crook, but Ampligen works .However , FDA is not much better
than Carter , and neither of them cares much about the
suffering patients.
Slightly off topic but isn’t amantadine a drug already on the market that can do what this ampligen is claiming it can? Amantadine is used to help MS and for those in rehabilitation, as well as in avian flu and influenza A. I have virally mediated CFS/FM after West Nile Virus infection. Amantadine has been my ONLY relief from fatigue, pain, and ‘brain fog’. The side effect risk is very low. Maybe it could help more people with CFS/FM? Ohhhh how I wish I was well enough to use my degrees to construct the studies!!
Here I am, the dissenting loner again. Yes, Ampligen helped some people, but it also hurt many…a google search will back that up. But more importantly, like most drugs these days, it was an expensive and TEMPORARY bandaid that did nothing to treat the underlying causes of CFS/ME. And yes, there are multiple causes…the XMRV findings while interesting, may not be “the” answer, because there are so many other triggers involved. That’s why it’s so difficult to treat and why so few patients get well…because everyone has different causes, different genetics, different chemical exposures and on and on.
I don’t think Ampligen is the end all answer to this disease, but it seems to helped many people. Carter is just a scientist who believes and he has done everything he could to get the drug to this point. I think for the right patients Ampligen is an answer, but nor for everyone. The key is to identify the bio-markers where it can help.
I don’t think Carter is a scammer as so many suggest. He is just resource constrained and forced into many strange methods of funding his company. I think he truly believes in what he is doing. I don’t think it is about the money. It’s about the science.
Here’s the way I feel. I belong to an organization of scientists and others interested in furthering science, the Committee for Skeptical Inquiry, and they have taught me that science is a process. In the medical field, a finding is reported in a peer-reviewed journal. It is then followed by further studies (by the finder & others), and these dissenting scientists can be very clever in finding ways to disprove the finding. If it can be disproved, then the finding is dismissed as another sidetrack in the journey to the truth. We can hope that no matter the results of other findings, some nuggets of truth can be gleaned. When the preponderance of evidence is in favor of the finding, it is accepted as fact. The FDA is there to oversee the studies and agree that the benefits outweigh the risks. However, like all things done by people, there will be mistakes, misrepresentation, and out-and-out fabrications or ommissions. Politics play a part as well. Of course, with medical problem as serious as ours, we want a cure today! But the FDA is our “watchdog”. It’s easy to be swayed to attempt alternative therapies (I myself had prolotherapy and I’m the skeptic, but I understand the need to “try anything”!). CSI has proven over and over that some of these are only effective in a placebo-type of way. In other words, if you believe it hard enough, it may help you feel better for a while. But eventually the fact that there is a physical cause for ME/CFS will cause you to feel as bad as you previously did. I take Lyrica & Cymbalta and, for now, they hold my pain level to bearable.
In looking over my last comment, I see that I have made a mistake. Funny, with my fibro, that almost never happens
Anyway, I meant to say that when the preponderance of evidence points to a finding it becomes a “provisional fact”, not a fact. Also, medical science is continually evolving and an open mind is needed when new research & evidence may point to a rejection or confirmation of the proposed finding. Not understanding this willingness to follow the evidence, even tho it might set accepted knowledge on it’s ear, is why the public (and particularly us) becomes so frustrated when doctors change their advice. You need look no farther than the revised breast cancer advice (no self-exam and fewer mammograms) and the outrage it has caused in cancer organizations to see what I mean.
Drugs and cures are always created to make money primarily. The population is secondary to the income. If it were the opposite way, we would not have Pharmaceutical Companies, we would have individuals who are creating a cure for close ones. But we do have these companies and these companies do have employees and the major function of any company is income. Companies make this income by appealing to the consumer, NOT by serving them. Overall, Carter is in it for the money and fame.
I have to ask, isn’t it possible for someone to be interested in BOTH good science and making money? I’m not going to speculate about anyone’s motivation in particular, but I think it is likely that most people who go into medicine do so for a combination of reasons. While the possible money is a big motivator, getting through medical school is grueling and I can’t imagine that cash is enough to keep people going through all of that.
I also want to add that I know someone who’s a researcher at a pharmaceutical company. Yes, she makes good money — as she should, as someone with an advanced degree in molecular biology and who knows what kind of student loan debt — but she’s also a highly ethical, compassionate person who truly wants to have a positive impact on the world. Are some of her bosses corrupt business people who care a lot more about money than helping people? Probably. However, if we didn’t have large corporations doing this work, it wouldn’t get done. They’ve got the money, the facilities and the scientists all gathered together so that these expensive experiments and trials can happen.
The financial gain behind pharmaceuticals is a double-edged sword — it provides companies with the incentive to find effective drugs that a lot of people want to pay for, but it also gives them incentive to overstate results, quash dissenting research, etc.
I was one of the original people who tried Ampligen. I did a clinical trial in San Diego Ca. I have had CFS for the past 15 years now. When I did the Ampligen trial I was very hopeful that it was going to be my ‘miracle’ cure. Let me tell you this….. I did Ampligen ONE time. It gave me a very high fever and I had to go to the emergency room because I literally was so sick I thought I was going to die. I was sick for a week and I quit the study. There were a few people in the group that tolerated it okay. But I didn’t know anyone in my group that it helped. One guy who brought his daughter to his appointments ended up killing himself. That is when I told everyone who had Hemispherx stock to sell it. This company is a total scam. I hope they never get this stuff approved. I would never want anyone else with CFS to go through the hell I went through from just 1 dose!