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Adrienne Dellwo

Petition Supporting Ampligen for Chronic Fatigue Syndrome

By January 4, 2013

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Do you want to let the FDA know that you support the approval of Ampligen (rintatolimod)? With the final decision now due in less than a month, and an advisory committee recommending against the drug, advocates have put together a petition to show the FDA how badly people with chronic fatigue syndrome want this drug on the market.

Currently, no drugs are FDA-approved for chronic fatigue syndrome. This is Ampligen's second attempt at approval, and while experts believe several factors make approval more likely this time, the advisory committee's decision is hanging ominously out there.

You can read and sign the petition here:

Are you in favor of approval? Why or why not? Have you tried Ampligen? Leave your comments below!

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Comments
January 4, 2013 at 9:06 am
(1) KAL says:

This petition may be effective in highlighting again how important this issue is to patients. Whether or not it will result in FDA approval of Ampligen remains to be seen obviously. Patients also need to be aware however that in general the FDA rarely overrides committee decisions.

January 4, 2013 at 9:35 am
(2) Brett says:

While I can certainly understand the desire to rally around something, I for one am not overly eager to promote this as someone unfamiliar with the effectiveness of the drug. If it is actually a dud, how is that supposed to help the cause? It would sure be great though if those with actual energy in our support networks could find a way to get some publicity on our behalf. Or finding some supportive prominent persons, like maybe getting Hugh Laurie or House M.D.’s creators to disavow the two instances, among the many otherwise very excellent episodes of the show, mocking chronic fatigue as an unreal condition.

January 4, 2013 at 5:41 pm
(3) Mary says:

I don’t thin it helps to push the government to approve drugs before their safety and efficacy have been proved. Why would anyone want to continue to be experimented on? Don’t we have enough symptoms we suffer from without new ones from unproven drugs? Let them do their clinical trials and make sure its safe before approving it.

January 4, 2013 at 7:04 pm
(4) Faith says:

You have no idea how bad the sickness is so why you are so negetive about Ampligen, this drug is the only hope for millions of poor people. Put politics on side and think about your self for a moment, how baddly I will need anything to help feel a just a little better for a moment. For over two decades this drug is in trial and you are telling that is not effective and not safe as it is so ask your self how those poor people have got better, those real poor people who got the Ampligen. Be very carefull what you are saying about a drug which is the only hope unapproved treatment as of now, millions of sick people need this one. I hope it will be approved this February I really do.

January 4, 2013 at 9:55 pm
(5) Peggy says:

Chronic Fatigue Syndrome is one of the very few diseases/conditions that has absolutely 0 effective treatment options OR medications that help this virus go into remission . I’ve had elevated Epstein Barr virus levels for 21 months , w/o any medications available to help me. Get or even feel better. This virus has turned into CFS b/c the EBV levels have tbeen elevated for long ! It’s the 3rd time this virus has become re activated within my body & this time I’ve had to live w/o any treatment for almost 2 YEARS. The virus is in my cells…not my blood therefore I’ve been told by every specialist that I’ve seen that anti viral RX will not help me. I’ve had fybro since 87as well as severe OA & RA. But the ongoing fatigue & pain from EBV has been the worst ! I want to be able to @ least have the opportunity to TRY this new RX. Thank you.

January 5, 2013 at 2:42 pm
(6) Blair says:

I think it should be approved, hopefully people on Medicaid will also be able to benefit from ampligen.

January 5, 2013 at 3:52 pm
(7) Karla says:

There were studies done with Ampligen years ago. It proved to be a good drug with helping CFS symptoms. The FDA did not approve it back then, and I’m not sure why or what their reasons were. I sure hope it gets approved this time! There a a lot of people that suffer with CFS, that could use this drug to resolve or make their symptoms more manageable. I sure hope they consider how many people they would help by approving Ampligen. We need something to treat the symptoms of CFS soon!

January 5, 2013 at 4:45 pm
(8) charley says:

If approved how will that affect costs to us as patients? It is very expensive, many of us are on SSDI with very low incomes & medicare / medcaid for health coverage. Will they cover the ENTIRE costs for this treatment , if FDA approves? (If they only cover their usual 80% of MEDICARE approved treatments. How much would Medicare Part D pay. (20% of $24,000 = $4800 out of pocket BUT if part of the $24,000 is drug cost that portion would fall under Part D , which if they will approve use, may only cover 65% of drug cost.) Kicks us again!!

January 5, 2013 at 6:48 pm
(9) Steve M says:

To “Mary”

No one is forcing you to take or even try this drug if approved. Also, the drug is not unproven. The panel didn’t vote to approve it because they don’t “believe in” CFIDS/ME, not because of any lack of efficacy or safety. The safety was proven in the early phase trials and the current trials are only there for efficacy. Does the drug work for every patient? Heck NO, but it should be an options for the many, many patients that it does work for. There is a subset of patients that achieved significant relief. Why should they suffer because the drug doesn’t work for ALL CFS patients?

They other problem is that they are using the definition of CFS that includes all kinds of chronic fatigue, not just CFS/ME. If they used the ME definition, instead of the one that the CDC is shoving down our throats (The 1994 case definition, I believe), the patients in the trials would only be the patients with CFISD/ME, and not as many misdiagnosis and the trial would have more positive and accurate results.

January 5, 2013 at 10:35 pm
(10) George says:

Oh My. Dr,. Carter wins…..Desperate patients supporting his sham drug so that he continues to make a nice living fleecing investors.

If Dr. Carter was serious about helping patients, he would have sold the rights of Ampligen to a real company that could have done real trials. Instead, he has used the CFS community to make himself rich.

It makes me sick, and yes, I understand how desperate some patients are for some sort of relief.

January 6, 2013 at 1:53 am
(11) Gabriela says:

I just wanted to remind Mary that this drug has been in testing for Two Decades…That is Twenty Years! How much Longer does it need to be tested? The people who have used it as test cases have benefited from it. It is Time that it was made available to All sufferers of ME/CFS. The FDA is Notorious for dragging their feet. Presssure is not uncalled for here.

January 7, 2013 at 2:03 pm
(12) Teri says:

The AAC voted 8 yes, 5 no, on safety of marketability, IT IS safe to market, therefore we should have access to it. PERIOD. Its not going to work for everyone, but we deserve the right to treatment! Its negligent not to at this point. In 2007 the AAC voted against Lyrica for Fibromyagia, yet, because there was no treatment available, the FDA passed it, now Cymbalta has also surfaced for them. It is the right thing to do. FDA it is time. Please approve Ampligen. The President has put laws into place so we could get treatments faster, please take his lead on this.
Thank you

January 22, 2013 at 9:24 pm
(13) George says:

Gabriela says the drug has been tested for 20 years. That is just plain false. The drug was tested in a few poorly run trials and the talk about those inadequate tests has gone on for 20 years…..and for each of those 20 years, Dr. Carter and his cronies have received nice pay checks for nothing.

Always remember, Dr. Carter once proposed using Ampligen in cigarettes…it is true.

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