Allergic to Ampligen - Not the Drug For Me

[BEG]

I was accepted into one of the double-blind Ampligen trials back in 2003. I'm aware this drug has greatly helped many people, and they are outraged at the FDA because they can't get it except at cost. I understand.

My experience, however, is quite different and maybe more common than we think. Approximately 2-3 weeks into the trial, my feet started burning. The two nurses were very excited and they whispered to me, "You're getting the real thing!" I had several more infusions and the pain in my feet became intolerable. "You have what are called the hives," they said. I thought it was a misnomer. I had red, quite painful, burning feet, too tender to tolerate socks, and which made walking excruciating. The nurses knew right away how to control these "hives." I was prescribed Atarax (sp?). Unfortunately, I had a very bad reaction to it. The nurses asked me, too late, if I tolerated decongestants, to which I replied, no. Even though I was urged to stay with the program, I knew I couldn't go on like this.

I consulted with my primary care doctor who confirmed that the atarax was the culprit in my present circumstances. Her advice to me was the obvious, continue in the drug program or quit. But she quietly added that she didn't think Ampligen was the drug for me. I dropped out to the dismay of many people.

I couldn't tolerate any of my meds except klonopin which I took frequently in very, very small doses. It seemed to quiet down my body. As each medication metabolized, I could recognize it. No kidding. It was so bizzare. Eventually I was able to add back my meds and return to my normal sick self.

I wonder now if Ampligen contains sulfa. I'm allergic to that. If not sulfa, what ingredient caused the allergic reaction? I probably will never know.

 

[cfs since 1998]

I am sorry you had that experience. However if you were in a double blind trial how could you know for sure you even had the real drug? If you had the placebo, which is saline, which has salt in it, that could make your feet swell, no?

 

[caledonia]

The nurses told her:

The two nurses were very excited and they whispered to me, "You're getting the real thing!"

Although if it was really a double blind, wouldn't the nurses be in the dark too? Or is that not required?

 

[cfs since 1998]

The nurses told her:

The two nurses were very excited and they whispered to me, "You're getting the real thing!"

Although if it was really a double blind, wouldn't the nurses be in the dark too? Or is that not required?

Double blind means neither the patient nor the doctors and nurses who administer the drug know; basically no one. The nurses were outright guessing.

By the way I swear I remember reading that several side effects in the Ampligen trials were *worse* in people getting the placebo (saline) than those getting the actual drug.

 

[mezombie]

I know of three people who were or are on Ampligen.

Out of these, one got better, one got worse (I believe for quite a long time if not permanently), and one did not notice any difference.

Sobering, huh?

 

[BEG]

In the past, I've had saline infusions for P.O.T.S. without ANY reaction. I've also had them twice before surgeries. No problem. I'm considering them again.

Double-blind means that neither the givers nor receivers of the medication knew who was getting the real thing. Apparently, the nurses have seen this type of Ampligen reaction before. My friend, also in the trial and other Ampligen trials, used the word hives when I told her about my painful feet. She was familiar with the reaction. By the way, my feet never swelled. They became red and extremely painful.

I doubt I would have been so strongly encouraged to continue had the medical personnel felt I was getting just the saline. They lost a study subject getting Ampligen.

Thank you for your comments! Hope I've answered some questions, and I'm sorry I communicated so poorly the first time around.

 

[BEG]

I know of three people who were or are on Ampligen.

Out of these, one got better, one got worse (I believe for quite a long time if not permanently), and one did not notice any difference.

Sobering, huh?

Hi Marie,

Yes it is very sobering. I've heard many mixed reviews about ampligen because I looked into it before beginning the trial. I know it made my friend slightly better. She took it for a long time in the trials. It would be great to get the statistics. I still very much hope it is approved. I just wanted to caution others that it might not be the drug for them either. Thanks for commenting.

 

[August59]

My geuss is that if it is ever approved that it will end up being a very individualized dosing regime. I have never bought into the one size fits all scheme. Peoples metabolism are just too different.

 

[dannybex]

I hate to be the Ampligen-basher, but IMHO, the problem with the drug (besides some nasty side effects that you experienced) is that even though it has helped some people temporarily, it does nothing to address or treat the many, many potentially different causes of CFS -- so that as soon as one stops the drug, they relapse back to their pre-Ampligen state.

Plus, it's incredibly expensive.

And on top of all that, Hemispherx, the company that makes Ampligen, has been trying for 26 years to get it approved for something...for anything...with no success so far. And just two weeks ago several class action lawsuits were filed, claiming the company lied about specific issues last spring relating to the 'pending' approval of the drug by the FDA.

I seriously doubt it will ever be approved.

 

[Advocate]

I hate to be the Ampligen-basher, but IMHO, the problem with the drug (besides some nasty side effects that you experienced) is that even though it has helped some people temporarily...

I know three people who were helped by Ampligen, and relapsed into agony when they couldn't get it anymore. They were in a better position than you or I to be aware of the side effects, and they still wanted Ampligen.

Until it is known why some people are helped and others are not, wouldn't the compassionate approach be to allow those who know they are helped to at least buy the drug?

 

[dannybex]

I know three people who were helped by Ampligen, and relapsed into agony when they couldn't get it anymore. They were in a better position than you or I to be aware of the side effects, and they still wanted Ampligen.

Until it is known why some people are helped and others are not, wouldn't the compassionate approach be to allow those who know they are helped to at least buy the drug?

That would certainly be ideal, but I'm guessing they'd have to pay for it out of pocket. But, maybe it would be covered under some insurance plans...if it gets approved...?

d.

 

[oerganix]

Dr Judy Smith?

One of the patient/public testimonies given at the last CFSAC meeting was by a doctor, a urologist, who said she has ME/CFS. She lives in North (or maybe it was South?) Dakota and FLIES twice a week to wherever it is she gets Ampligen. (Nevada?) She says Ampligen is the reason she is able to continue working full time as a doctor. She didn't mention any side effects. So, I doubt she is looking forward to hearing the "obituary" for Ampligen; and if or when it is approved and produced in large quantities, the price could go down and eventually be covered by insurance, for those lucky enought to have it.