Ampligen study published in PLoS One 14mar2012

[mellster]

Hey careful, don't trash Viagra! Thinking back to the hey-days of work hard and play hard, I can tell you this is one drug that works

 

[heapsreal]

Hear, hear! It so burns my butt that drugs like Viagra get out of the chute with hardly a nod, and we are left to languish for decades. I still maintain that if CFS was a male-majority illness, this wouldn't be happening. In the midst of claims of equality, there are still a lot of ways in which women get marginalized. (end of soap box).

Dont bag males when there is more preventative medicine going on for females. I also dont think there is that big a majority of females to males with cfs/me. I know in australia large amounts of money are pumped into breast and cervical cancer and advertising on preventative screening for these, dont hear much about prostate cancer etc. I think in other medical conditions treatment of males and females in quite even. Treatment of cfs could be different storie but i think we all get treated like crap by most docs when it comes to cfs/me. It could be that males are generally a bit slow on the uptake when it comes to seeing doctors.

 

[Kati]

Dont bag males when there is more preventative medicine going on for females. I also dont think there is that big a majority of females to males with cfs/me. I know in australia large amounts of money are pumped into breast and cervical cancer and advertising on preventative screening for these, dont hear much about prostate cancer etc. I think in other medical conditions treatment of males and females in quite even. Treatment of cfs could be different storie but i think we all get treated like crap by most docs when it comes to cfs/me. It could be that males are generally a bit slow on the uptake when it comes to seeing doctors.

i have to disagree on equality of treatment on men vs women, especially when it applies to cardiology and "heart attacks": men are taken seriously when they complain of chest pain. Often for women, it is believed to be heartburn and indigestion. i believe women's symptoms are more likely to be blamed on stress or hormones. Men are taken much more seriously.

ETA: Of course if you have a diagnosis of "chronic fatigue" (roll eyes) or fibro, all of your symptoms, may them be cardiac or others are deemed non serious and blamed on these diseases.

ETA 2: http://www.nejm.org/doi/pdf/10.1056/NEJM197302082880605
From 1973...
Alleged Psychogenic Disorders in Women A Possible Manifestation of Sexual Prejudice
K. Jean Lennane, M.B., M.R.A.C.P., and R. John Lennane, M.B., M.R.A.C.P.
N Engl J Med 1973; 288:288-292February 8, 1973
Abstract
Dysmenorrhea, nausea of pregnancy, pain in labor and infantile behavioral disturbances are conditions commonly considered to be caused or aggravated by psychogenic factors. Although such scientific evidence as exists clearly implicates organic causes, acceptance of a psychogenic origin has led to an irrational and ineffective approach to their management.
Because these conditions affect only women the cloudy thinking that characterizes the relevant literature may be due to a form of sexual prejudice.
We are indebted to Mr. Graeme Duncan, F.R.C.S., M.R.C.O.G., for a review and criticism of the manuscript.

ETA#3 http://www.sciencedirect.com/science/article/pii/S0277953602005208
It is hard work behaving as a credible patient: encounters between women with chronic pain and their doctors

In various studies during the last decade, women with medically unexplained disorders have reported negative experiences during medical encounters. Accounts of being met with scepticism and lack of comprehension, feeling rejected, ignored, and being belittled, blamed for their condition and assigned psychological explanation models are common. Women patients exerted themselves to attract the doctor's medical attention and interest, and were anxious to be considered as whiners or complainers. Here, we explore the nature of work done by the patients in order to be believed, understood, and takenseriously when consulting the doctor. A qualitative study was conducted with in-depth interviews including a purposeful sampling of 10 women of varying ages and backgrounds with chronic muscular pain. The main outcome measures were descriptions reflecting the patients activities or efforts invested in being perceived as a credible patient. We focused on the gendered dimensions of the experiences. The women patients accounts indicated hard work to make the symptoms socially visible, real, and physical when consulting a doctor. Their efforts reflect a subtle balance not to appear too strong or too weak, too healthy or too sick, or too smart or too disarranged. Attempting to fit in with normative, biomedical expectations of correctness, they tested strategies such as appropriate assertiveness, surrendering, and appearance. The most important activities or efforts varied. However, the informants were not only struggling for their credibility. Their stories illustrated a struggle for the maintenance of self-esteem or dignity as patients and as women. The material was interpreted within a feminist frame of reference, emphasising the relationship between dignity and shame, power and disempowerment for women patients with medically unexplained disorders.

 

[heapsreal]

i have to disagree on equality of treatment on men vs women, especially when it applies to cardiology and "heart attacks": men are taken seriously when they complain of chest pain. Often for women, it is believed to be heartburn and indigestion. i believe women's symptoms are more likely to be blamed on stress or hormones. Men are taken much more seriously.

ETA: Of course if you have a diagnosis of "chronic fatigue" (roll eyes) or fibro, all of your symptoms, may them be cardiac or others are deemed non serious and blamed on these diseases.

ETA 2: http://www.nejm.org/doi/pdf/10.1056/NEJM197302082880605
From 1973...
Alleged Psychogenic Disorders in Women A Possible Manifestation of Sexual Prejudice
K. Jean Lennane, M.B., M.R.A.C.P., and R. John Lennane, M.B., M.R.A.C.P.
N Engl J Med 1973; 288:288-292February 8, 1973
Abstract
Dysmenorrhea, nausea of pregnancy, pain in labor and infantile behavioral disturbances are conditions commonly considered to be caused or aggravated by psychogenic factors. Although such scientific evidence as exists clearly implicates organic causes, acceptance of a psychogenic origin has led to an irrational and ineffective approach to their management.
Because these conditions affect only women the cloudy thinking that characterizes the relevant literature may be due to a form of sexual prejudice.
We are indebted to Mr. Graeme Duncan, F.R.C.S., M.R.C.O.G., for a review and criticism of the manuscript.

ETA#3 http://www.sciencedirect.com/science/article/pii/S0277953602005208
It is hard work behaving as a credible patient: encounters between women with chronic pain and their doctors

In various studies during the last decade, women with medically unexplained disorders have reported negative experiences during medical encounters. Accounts of being met with scepticism and lack of comprehension, feeling rejected, ignored, and being belittled, blamed for their condition and assigned psychological explanation models are common. Women patients exerted themselves to attract the doctor's medical attention and interest, and were anxious to be considered as whiners or complainers. Here, we explore the nature of work done by the patients in order to be believed, understood, and takenseriously when consulting the doctor. A qualitative study was conducted with in-depth interviews including a purposeful sampling of 10 women of varying ages and backgrounds with chronic muscular pain. The main outcome measures were descriptions reflecting the patients activities or efforts invested in being perceived as a credible patient. We focused on the gendered dimensions of the experiences. The women patients accounts indicated hard work to make the symptoms socially visible, real, and physical when consulting a doctor. Their efforts reflect a subtle balance not to appear too strong or too weak, too healthy or too sick, or too smart or too disarranged. Attempting to fit in with normative, biomedical expectations of correctness, they tested strategies such as appropriate assertiveness, surrendering, and appearance. The most important activities or efforts varied. However, the informants were not only struggling for their credibility. Their stories illustrated a struggle for the maintenance of self-esteem or dignity as patients and as women. The material was interpreted within a feminist frame of reference, emphasising the relationship between dignity and shame, power and disempowerment for women patients with medically unexplained disorders.

Working in the health care industry, if someone presents to a hospital with chest pain they are or should be given an ecg and a blood test to rule out cardiac condition no matter if male or female and is the case in my experience. Men are known to have a higher risk of heart attacks then women until menopause kicks in then the risks are about equal. Maybe it depends in what country you live in. Women seem to have higher risks of other causes of chest pain as well like pulmonary embolisms, which birth control pills greatly increase this risk. I dont know what country you are from but maybe it also depends on the health system of your country. here in australia the health care system is mostly free, so maybe this plays a role compared to other countries where health insurance is needed. Its a very brave doctor who doesnt atleast do an ecg for someone with chest pain or diagnoses heart burn from symptoms.

I dont think its all one sided when it comes to health care, as i have seen nurses laugh at men who have a viral infection/symptoms and told they have man flu, now thats sexist and im sure it go's both ways. Being on the mens side of the fence i have seen them treated badly as well. Plus if a man presented to a doctor with fibro, he would get laughed at because its a 'womens' illness, how many men would keep persisting with getting help from doctors when facing that sort of stigma, and maybe why alot of men dont see doctors.

Im not saying women arent treated like the nagging old depressed house wife but men can get treated just as badly, told they are soft or have man flu etc. At the end of the day its hard to find compassionate medical help, i think thats the bottom line, not being male or female.

cheers!!!

 

[heapsreal]

In various studies during the last decade, women with medically unexplained disorders have reported negative experiences during medical encounters. Accounts of being met with scepticism and lack of comprehension, feeling rejected, ignored, and being belittled, blamed for their condition and assigned psychological explanation models are common.
I think in the above study if they did a study with men and women they would find the same results. I know myself as well as many men who started their cfs journey who have been told by countless doctors they have depression, even though they didnt feel depressed, maybe frustrated but not depressed. unexplained disorders cause skeptism amongst doctors know matter what sex you are??

cheers!!!

 

[Kati]

At the end of the day its hard to find compassionate medical help, i think thats the bottom line, not being male or female.

cheers!!!

Yes Heaps. In the end, we are all at the mercy of the physician and health care professional who is assessing you.

i still maintain that patients with Lyme Fibro and ME have a bigger hurdle to jump and face more stigma and discrimination than others. It certainly doesn't help that ME doesn't belong to any medical specialty, that most medical school barely touch the subject and that most governments do not fund biomedical research for us. you know, the usual.

My challenge is, as a patient, how can you change that, other than waiting until things change by themselves?

(sorry if I am going off-topic)

 

[Dolphin]

If this men/male vs women/female discussion is going to continue, it'd probably be best if it got its own thread.

 

[Kati]

Dolphin I agree, it should be taken elsewhere.

But as I think of my posts on this thread, I now understand that my bigger question is, is advocating under the premises that we are stigmatized and discriminated against working? I will start a post under "advocacy".

 

[heapsreal]

Its all sorted, we just want a cure???

 

[LaurelW]

Amen to that, Heaps!

 

[dannybex]

"By week 40, the rintatolimod cohort (n = 100) had a mean change increase in ET of 96 seconds to 672..."

This is precisely why I think the drug has never and will never be approved. There was improvement, but 96 seconds? And at $1,200 a month, that minute and a half cost approximately $12,000?

???

 

[Dolphin]

"By week 40, the rintatolimod cohort (n = 100) had a mean change increase in ET of 96 seconds to 672..."

This is precisely why I think the drug has never and will never be approved. There was improvement, but 96 seconds? And at $1,200 a month, that minute and a half cost approximately $12,000?

???

Don't forget that the exercise test gets more demanding with time (e.g. change in elevation %). And isn't self-paced but paced at the speed of the treadmill:
http://www.plosone.org/article/fetc...ri=info:doi/10.1371/journal.pone.0031334.s006

 

[satoshikasumi]

The drug is wonderful- the study design was extremely flawed. First, clinicians using the drug in open label studies know that it barely works after 6 months, and takes 1-2 years for full effect. So it was too short. Second, the dose regimen used in the phase-III study was too inflexible- everyone got 400mgs. Third, the measure was treadmill duration- the phase II study had used a more expensive but clinically significant measure, VO2 max, and found that Ampligen improved VO2 max 10 times as much as the improvement seen in the placebo group. Finally, clinicians believe that the greatest effect of Ampligen is on cognitive performance. Early reports of the drug suggested that it improves performance IQ scores and utterly reverses CFS dementia in severely affected cases. But Hemispherx/the FDA decided not to study cognition at all in Phase III.

 

[dannybex]

Well...

If the drug is so "wonderful", then why did the FDA conclude in 2009 that Ampligen "did not provide credible evidence of efficacy." ? If the company has tried for 25 years to get it approved, why would it participate in a poorly designed study that you suggest almost guaranteed it would fail? Why did Dupont invest $30 million in the company back in the early 1990's then pull out a year or so later? Don't you think they would've stayed with it, perhaps even bought out Hemispherx if it was so promising to their bottom line?

I'm seriously not trying to be a Danny-downer, and mean no disrespect at all to anyone, as I know some patients have indeed been helped by it (in particular, the understandably outspoken Mary Schweitzer), but I just think it's important to look at the pros and the cons, and this one seems to have a history of more cons.

While Mary and others (Laurel, etc.) have found amazing benefits, as with any drug or therapy there are also some who were in the original trial, who have spoken out against it:

http://www.ncf-net.org/forum/ampligeninPink.htm

Meanwhile, many patients are reporting in other sections on these forums that they are improving using other protocols and forms of medicine. (And yes, some of them are getting worse too.) But there are many other options out there perhaps worth considering while one waits for it to be approved. I just wouldn't hold my breath, don't think it's gonna happen.

Just my two measly cents.

Wishing everyone well,

d.

 

[JAH]

The drug is wonderful- .

Not for me. Ampligen made me permanently worse. Glad it worked for you and many others,

JAH

 

[Snow Leopard]

"By week 40, the rintatolimod cohort (n = 100) had a mean change increase in ET of 96 seconds to 672..."

I suspect this is because it only seems to work for a proportion of patients. But I suspect Hemispherex has no way of predicting which patients will respond (plus it is probably more financially beneficial for them if they just give it to everybody and find out who responds).

 

[Kati]

I think it's in our best interest to have a pharmaceutical company interested in "our market" and develop their product for us. No big pharma, no health care.

Getting a drug approved for our disease provides options for the patients but also recognition that this disease does really really exist.

Rheumatologists that I have contacted via mail are not too keen to see "CFS" as an auto-immune disease, like Fluge and Mella suggest on their Rituximab paper. See it puts them in a bad position because they don't want to get involved in a complicated and stigmatized disease. Besides, they don't have to. They can stay with their RA, Lupus, Sjogren's and company and not having to look for work, they have plenty of it.

So getting Ampligen approved is an acceptance that this disease is real and that we need physicians to care for us, perhaps medical school curriculums and textbooks need serious revision.

It may not be everybody's drug. For me, it's not, can't afford a move and drug infusions for a year. But if it means that it puts us in a map, and that investors feel confident that buying stocks in the company, that's a good thing all around.

 

[satoshikasumi]

The FDA is not willing to approve anything for CFS because they don't think it is a serious disease. I can't believe they expect the manufacturer to prove a negative- that Ampligen does not carry any risks of autoimmune disease or prolonged QT intervals.

Drugs for other diseases as severely disabling as CFS (i.e. RA, MS, COPD) are MUCH riskier than taking Ampligen. We are talking about a risk of death with some of the drugs used to treat these other immune-based diseases.

When the condition is CFS, the FDA is asking the impossible- an immunomodulating or antiviral drug with no risk of serious side effects. But ALL IMMUNOMODULATORS CURRENTLY APPROVED BY FDA MAY CAUSE SERIOUS SIDE EFFECTS.

The only reason the FDA won't approve Ampligen is because they think CFS is not serious enough to warrant a risky and expensive drug.

Regarding efficacy, the trial could have been designed better but it met the FDA's own criteria! What more do they want? Also, the fact that patients like me would GLADLY pay $12,000 in cash to go on it for a year should be a good clue. And, why don't we give them the benefit of the doubt when there is NOTHING ELSE approved or in the pipeline to be approved anytime in the next five years!? Whatever happened to priority review for orphan diseases!? It's shocking the cruelty and indifference to people with CFS by the regulators. You have a right to take this if you want to! They are stealing your lives away! If you have this now you don't get to be for the future. We have known this stuff helps since 1991 for Christ's sake.

(Disclaimer: I took Ampligen 2007-2008 for 12 months. It really worked.)

 

[satoshikasumi]

By the way DannyBex. I will never trust NCF and to the extent their lobbying against the approval of Ampligen has been effective, I will never forgive them. They will never be relevant in the CFS advocacy movement.

 

[snowathlete]

I have to agree about the indifference to the illness from regulators and healthcare organisations. I find it very difficult to take. Our illness is treated like its some kind of minor ailment that we should just get on with, and we are odd because we try whatever treatments we can access privately.
My GP couldn't understand why I am self treating at home (methylation) I said, what's the alternative you ate offering me? Anything at all? I'd love to try something like ampligen and can't believe it's much worse than treating myself at home the best I can, how can that be better and safer than taking a drug that works at least for some people under proper supervision?