Ampligen for XMRV-Positive Chronic Fatigue Syndrome

This information is a little misleading I tested positive for XMRV and the drug made me a lot sicker . I was on for 6 months.

The good news is that instead of self-report this trial is using biological outcome measures specific to ME/CFS – not just something for “depressed” people. When a characteristic is not unique to a disease it is easy to introduce bias.

@Sadie, sorry to hear about your personal experiences.

Drug trials are not really set up to measure individual results – they express the results in aggregate. Nor has there every been a drug that not one person ever had a bad experience with. That’s why your doctor tells patients about possible side effects.

These are the adverse reactions that people like yourself experience during a clinical trial and they are expressed in percentages usually. There is no other way to find out really other than animal models.

And CFS patients are notorious for not responding well to drugs – HHV-6A may be the culprit at least for some of those patients – it is possible to have multiple pathogens in the body. HHV-6 is well known for causing such problems in other types of diseases and immunocompromised patients.

Perhaps for yourself, a different immune modulator might be better tolerated.

There are so many variables.

I too know someone who is XMRV positive and was on Ampligen — it didn’t help him. But I guess time (and more trials) will tell.

Prozac and amitryptine 8 years erious vomiting pain sleep disturbance and massive weight gain. Still dr insisted I continue “if you want to get well” they lied. Presented it as definite cure. Massive big pharma con.
Very little evidence tthat these drugs help. Rest pacing, chuck out your tv, gluten free diet and gentle hydrotherapy.

I’m XMRV positive on trial for 1 and 6 months and this drug Ampligen helped me dramatically. I was able to do my normal activites and in my heart. I hope Ampligen will get approved for any CFS patient

Sad really…the company keeps using our illness to try angle after angle to insist their “drug” is still relevant so that the company can keep paying its executives.

And it keeps getting reported. At what point…….

The crummy thing about these comments is that there is no way to tell if Siaz,Sadie, Or Katie Tam are even telling the truth. They could all just be employees of a big pharma company or Hemispherx Biopharma. That is exactly why we need meaningful studies that measure real, quantitative, and meaningful measurements of disease improvement. Otherwise, any of these people that posted could be fake and they would be influencing people’s view of Ampligen on false premises. Hopefully, when more meaningful measures of XMRV activity and viral count are available, Hemispherx Biopharma’s claims can be tested.

Yes. I’m sure Big Pharma hangs out online a lot drumming up support on About.com. @@

I know people who have been helped tremendously, and I know people who get sicker or just not helped at all by Ampligen. For those it helps, there is not reason to deny them access to this drug. I personally know two people who have moved across the country, one with their entire family and another leaving husband and home, to go to the only doctor in the country allowed to deliver this drug right now. There is no reasonable rationale for one doctor to have control over Ampligen. And there is no other reason for those people to uproot their lives if that drug didn’t work for some. What they need to do is get to the root of why it works for some CFS patients and not others. In this instance, it’s the FDA’s fault and not Big Pharma (who stands to make plenty of money off of Ampligen) for letting patients lives dwindle down the drain. For the FDA to approve Ampligen would have suggested that CFS is biological and not psychologically driven. Before XMRV, they were getting away with it to. XMRV definitely changes the game.

To correct Heidi, there are only two doctors in the country using the drug on a cost-recovery open-label basis. I am seeing one of those doctors and based on my immunological markers I am a good candidate for the drug. However, I am waiting for more data from the company regarding XMRV before I proceed given the high cost (~20k/ year)

Regarding the notion that some of these people are fake, only people that are not actively-networking ME/CFS patients would suggest that. Ampligen has NOTHING to gain by posting comments on here or anywhere else masquerading as patients. Patients are not going to propel their drug to FDA approval; the FDA is all over that decision and please practice some common sense when asking yourself if FDA officials are looking for input from patients on whether the drugs work or not. They care only about hard data, not self-reports.

Regarding those self-reports, I have spoken with several patients personally that have been helped dramatically by this drug. I have also spoken with a few that were not helped at all. It may very well be that it helps a subset with a specific immunological profile, and that is what Hemispherx must determine if it is going to have any market for this drug. Some of the patients I spoke with that were not helped at all were XMRV+, so that alone is not going to be the “it” factor.

I am on Ampligen. I have been on Ampligen since 1999. Twice I went off it (once deliberately; once because the head of my practice died and FDA made us reapply, and then we were denied).

I went from a Karnovsky disability score of 30 to a 70 – not well enough to return to my position as a professor, but well enough to be coherent, to drive a car, to understand what people say to me, to write again. Well enough that I was no longer in constant pain 24/7. Well enough to walk on a beach, and well enough to dance with my son at his wedding.

Both times I went off Ampligen I relapsed terribly – I had a year the first time, only seven months the other.

I am positive for XMRV, which perhaps explains why I cannot go off this immune modulator.

But long before XMRV, we knew of other biomarkers that predicted success with Ampligen. One is HHV-6, Variant A (and I am sorry it did not help the patient above). The others are a low natural killer cell count or function, and the 37kDa Rnase-L defect. I had them all.

Quite frankly, I think HHV-6, Variant A, is a viscious disease. It’s in my spinal fluid now. Ampligen was shown to beat it back in vitro, and I am glad it works for me – again, sorry it did not work for you.

There is no AIDS drug that helps every patient with AIDS. Everything can’t help everyone. We have to be more like the AIDS community, though, and support what helps some of us. It is evidence that this is not a psychogenic disease.

Our real enemies are at CDC, telling people that we are sick because of childhood trauma, and that Cognitive Behavior Therapy and Graded Exercise will cure us.

If Ampligen can pass Phase III, universities can design new studies. We can try antivirals and antiretrovirals. And patients with AIDS can take the drug off label.

Ampligen needs to be passed for those of us who need it. And more drugs need to be brought forward for our disease.

PS – Ampligen is not produced by Big Pharma. Hemispherx is a small, venture-capital firm (and I suspect is just barely above water because of the income they get from those of us paying for Ampigen). The FDA system was set up when the pharmaceutical industry was oligopolistic, consisting of a very few firms – FDA allowed them to behave as a cartel, and since they were repeating monopoly profits off patented drugs, they could afford multiple retrials. Of course, once upon a time those monopoly profits used to pay for research and development. Now it pays for fancy ads on tv and glossy ads in magazines.

Research and development (R & D) today is conducted by small, venture-capital firms, that have sprung up since the 1980s. Hemispherx is one of those. Theoretically, they do the developing and Big Pharma buys the drugs that work. In practice, however, Big Pharma roots for them to fail so they can pick up the drug patent in a fire sale. Unfortunately, if Hemispherx fails, so does Ampligen, because the inventor, not the company, owns the drug.

Big Pharma has also been known to fight approval of a possible competitor, if the competitor wasn’t big enough to fight back. Because of this institutional mess, the U.S. is no longer on the forefront of experimenal medicine – Germany is. Good research on our disease comes out of Germany, Italy, Spain, Brazil, and Japan. Pity, isn’t it?

So fighting Ampligen is just what Big Pharma wants you to do. Not to mention the insurance lobby.

Again, I say – our real enemies are those who would portray our disease as psychogenic. Anything that demonstrates it is biomedical in causation is good for everyone, even if that particular drug does not help every single person with The Disease.

i have heard from some people who say they were not helped by ampligen but it is my understanding, after communicating with some european patients, that some people, for unknown reasons, take a very long time to respond to the drug. someone once told me about a woman who had to take it for 4 years to recover, and went back to work for 13 yrs, full-time, before she needed the drug again.

One thing that needs to be specified here is regarding the definition of “XMRV positive.” Any reports I’ve seen by Hemispherx are talking about XMRV serology positive. Meaning you create an antibody to XMRV. That kind of makes sense then, if Ampligen is supposed to boost your immune system it will boost your antibodies to get to work. However what about those of us who are “XMRV positive” by culture only? If anyone has any ideas on this, please let me know: lannieinthelymelight@gmail.com