Patient 002 was a fictionalized version of the Ampligen trial
Numerous add-on effects from long COVID have been anticipated – insights into chronic fatigue syndrome (ME/CFS), new treatment possibilities, increased funding – but I don’t know if anyone really thought this one would pan out. Ampligen (rintatolimod) is a unique drug in ME/CFS history: it’s still the only drug that ever attempted to get FDA approval to treat ME/CFS. It popped up early in the ME/CFS saga, made a lot of waves – prompted the publication of two books including an at times hilarious fictionalized account of the trials, Patient 002, was even written about it – and then it faded.
Maybe it’s because Ampligen has hovered in the shadows for decades now that it seemed unlikely that even long COVID could bring it out into the sunlight – but it has: AIM ImmunoTech (formerly Hemispherx BioPharma) announced that it has received FDA approval to launch a phase II clinical trial in long COVID to start in early 2023.
The Hemispherx Years
One wonders if any drug anywhere has had a more twisted history than Ampligen. AIM ImmunoTech has been trying to get FDA approval for Ampligen in ME/CFS for over 30 years. Its predecessor, Hemispherx Biopharma, was – under the tutelage of Dr. Stephen Carter – wracked by lawsuits for years. It was only after the control of the company was wrenched from Carter’s hands that the lawsuits – except for the one that he filed – faded away.
It all began with a $30 million dollar infusion from DuPont in 1988. That was pretty big money back then ($107 million today), but trouble soon ensued, and in 1990 Dupont settled (what else) a lawsuit with Hemispherx and gave up all claims to the drug. Possibly hemorrhaging money after a major financier died, Hemispherx made a decision that came back to haunt them when it cut back a 48-week trial to 24 weeks and, according to one report, applied for fast-track limited drug approval at the FDA.
As the media spread accounts of a wonder drug that helped many patients, the FDA, citing toxicity concerns and calling the data before them ‘incomplete and inadequate’, nixed the fast-track status and told Hemispherx to stop making unproven claims. Hemispherx then turned its attention away from getting approval for the drug in the U.S. It would be almost 20 years before Hemispherx (HEM) would again seek approval for Ampligen.
There’s no doubt that Hemispherx was always up against it. It’s hard to envision a more difficult drug pathway than for a small drug company producing a drug for a controversial disease like ME/CFS.
Despite producing a drug that substantially helped some chronic fatigue syndrome (ME/CFS) patients though, Hemispherx gathered few friends. In the early 1990s, then President of the CFIDS Association of America (now the Solve ME Initiative), Kim Kenney (McCleary) said, “Ampligen is a good drug in the wrong hands”. Daniel Hoth, then head of the National Institutes of Health’s AIDS drug program, told the Wall Street Journal that “no professional drug company with any degree of professionalism would ever develop Ampligen the way it was developed by HEM.”
By 2009, Carter reported that all legal issues had been settled, leaving the company free to focus on the drug itself. After having missed the deadlines in 2005 and earlier in 2007, Hemispherx filed its ‘New Drug Application’ (NDA) with the FDA in October 2007. The FDA bounced back the application, with questions, in early 2008. Hemispherx replied and the FDA eventually passed the drug onto the final review.
The Fight for FDA Approval
Decades after its last trial Ampligen is slated to get another shot – with long COVID.
Thirty years after Hemispherx’s first failed attempt, the drug came up for approval again in 2012. This time, things were different. Citing what they called an ‘incredible’ response from the ME/CFS community (over 750 testimonials), the FDA rep said they got it…the ME/CFS community was in dire need of treatment options.
The FDA’s public statement that they considered ME/CFS to be a serious and life-threatening condition seemed to be setting the community up for a win. It bears noting, though, that the basis for Ampligen’s approval at the FDA rested on two studies, one of which was so old that it used the Holmes definition for ME/CFS.
The FDA committee, citing safety and efficacy concerns, voted Ampligen down. Surprisingly, two ME/CFS experts, Dr. Komaroff and Dr. Unger, who were expected to vote yes, voted no, while several members of the committee without ME/CFS experience voted for its approval.
The FDA could have given the drug restricted approval and closely monitored its safety and efficacy but instead required a large clinical trial that Hemispherx clearly didn’t have the money to pay for. The ruling was believed to be a death blow for Ampligen and ME/CFS.
Upon losing the fight for FDA approval, Carter reportedly gave himself and other members of the company large bonuses.
Carter is Fired – AIM ImmunoTech Emerges
In 2016, just weeks after the Board had reduced his salary by fifty percent, Carter – the long-time CEO and Chief Science officer of Hemispherx Biopharma – was fired and removed from the Board of Directors. A strict anti-nepotism policy removed some of his relatives as well. Investors had just sued the company, asserting that it overstated its claims about the drug. It had and they won. Two months prior to his firing, Hemispherx announced Carter had been given more stock than IRS rules allow.
Ar the time of Carter’s firing, Fierce Biotech called the company “a penny-stock firm with a penchant for hype“, and noted that its stock has not nudged above a dollar since 2009.
The Equels Era
Thomas Equels won an award for his turnaround if Hemispherx Biopharma (now AIM Immunotech)
Thomas Equels was given a mandate to “strengthen internal controls, achieve enhanced governance, and create an environment for greater stockholder value.” He was brought in, in other words, to institute a new era of efficiency and productivity in order to appeal to investors.
Since he took over, AIM ImmunoTech’s and Ampligen’s fortunes have decidedly changed. Ampligen’s ability to affect the TLR3 receptors that play a role in viral control and cancer and reduce inflammation intrigued investors for years. Suddenly, the company that couldn’t shoot straight began raking in funding. A 2019 $6.4 million Dept. of Defense funded an Ampligen study in brain-metastatic breast cancer was quickly followed by another $8.3 million grant to do the same.
The Gist
- Ampligen, still the only drug to seek FDA approval to treat ME/CFS, has been hovering in the background for over 30 years. Originally produced to fight cancer, Ampligen is a dsRNA drug that has a unique ability to turn on the TLR3 pathway that boosts immune functioning without causing harmful side effects.
- One wonders if any drug anywhere has had such a twisted history. A small company that had a predilection for shooting itself in the foot while seeking drug approval for a controversial disease was never an optimal situation.
- After the company cut its initial study short, made unproven claims, and got its hand slapped by FDA, it didn’t seek FDA approval for another 20 years. Wracked by lawsuits, the company was frequently ridiculed by investing websites where it was characterized as a “penny-stock firm with a penchant for hype”.
- in 2013, with several ME/CFS experts unexpectedly voting against approval the company’s application for FDA approval was turned down. Despite the FDA’s acknowledgment that ME/CFS was a serious disease with many unmet needs, the FDA required that a large clinical trial to assess safety and efficacy be done – something that was clearly beyond the company’s ability.
- In 2016, William Carter – the long-time CEO, Chief Science Officer of Hemispherx Biopharma, and co-inventor of Ampligen- was fired and removed from the Board of Directors, and a strict anti-nepotism policy was enforced.
- The Thomas Equels era began. After Equels pledged to “strengthen internal controls, achieve enhanced governance, and create an environment for greater stockholder value” the company quickly began to turn around.
- Ampligen was approved to treat ME/CFS in Argentina in 2016, and from 2019 to 2022 tens of millions of dollars in funding to study Ampligen’s effects in various cancers rolled in, and Equels won an award for entrepreneur of the year. The company was also able to build a new “state of the art” facility.
- Under an FDA authorization, the drug had been licensed for use by Dr. Peterson and Dr. Lapp and the evidence of efficacy and safety continued to pile up. While the drug wasn’t necessarily a game-changer it did appear to confer substantial benefits for many.
- The Simmaron Research Foundation in collaboration with Maureen Hanson and the CDC is currently conducting several Ampligen studies including one to assess the molecular ramifications of going off and then back on the drug, as well as a study to determine which patients benefit from it.
- AIM ImmunoTech announced in October that it had been approved to conduct as a 14-week, multicenter, randomized, placebo-controlled, phase II trial in long COVID, which, if successful, could lead to an emergency use authorization. The company did not state if funding was secured but said the trial was expected to begin in early 2023, and that trial results could be announced next year.
Given all that, it was not surprising to see Thomas Equels receive an “Entrepreneur of the Year” award for his ability to turn around the company. The drug apparently had promise all along. As Kim McCleary had stated 20 years earlier, the company was the problem.
Things just got better in 2021. Following the approval of a 100-person Ampligen/ME/CFS trial run by Dr. Peterson and Dr. Lapp, the first long hauler with ME/CFS was given Ampligen in early 2021. A successful Phase I intranasal Ampligen safety study to treat respiratory viruses was concluded and a Phase II study began; an intranasal and IV patent to treat brain fog in long COVID was filed, and the late-stage pancreatic cancer study received positive results.
In 2022, AIM reported positive results from a colorectal cancer study and a Phase I metastatic triple-negative breast cancer study, moved to a new “state of the art” facility, reported early positive results from its pilot long-COVID study, and began a melanoma trial.
Long-COVID Trial
Just this week, AIM ImmunoTech announced it had received FDA approval to begin a Phase II two-arm, randomized, double-blind, placebo-controlled, multicenter study in long COVID that it expects will begin in early 2023. Solve M.E., which hosted a webinar on Ampligen, long COVID, and ME/CFS (see below) in June, reported:
In July, Equels said funding needed to be secured. In October, the company said it “expected” to enroll up to 80 patients in up to ten centers across the U.S. in a 14-week trial.
“Should the trial yield promising results, it would open the possibility for an accelerated development and approval process, including potentially an Emergency Use Authorization (EUA) from the FDA, as was the case for treatments of the acute phase of COVID-19. The results from this study may emerge as soon as next year.”
Chronic Fatigue Syndrome (ME/CFS)
In a 2016 interview, Equels stated that Hemispherx BioPharma’s number one goal was getting FDA approval for Ampligen for ME/CFS. Instead of an antagonistic relationship that had prevailed, Equels pledged that Hemispherx (now AIM ImmunoTech) would be there, “arms locked with FDA officials”, to do what was necessary to move the drug forward.
A 2016 overview reported that:
“Taken together, the entire database provides a consistent picture of durable activity in this population of severely disabled subjects and the accumulation of over 90,000 doses. More than 1200 patients have been enrolled in various rintatolimod studies in which over 830 unique CFS/ME patients received active drug.”
Over 200 patients have received the drug for over a year, with no evidence of serious side effects emerging, Dr. Peterson’s data indicates that Ampligen has provided significant relief to many patients over many years. Besides increasing VO2 max, it’s been able to increase natural killer cell activity – a common problem in ME/CFS.
Gunnar Gottschalk Ph.D. and Dr. Peterson of the Simmaron Research Foundation and Dr. Unger of the CDC are currently attempting a determine which ME/CFS patients benefit – an important need regarding drug development for ME/CFS. Simmaron and Dr. Maureen Hanson also took advantage of a lapse in the drug’s availability to assess what happened molecularly to people who went out off the drug. Gottshalk reported in July at Solve ME’s webinar that a paper would be published shortly.
With several million people with ME/CFS in the U.S., if the long-COVID trial is successful, it would be surprising if investors wouldn’t turn to the disease the drug, almost forty years ago, was originally intended for – ME/CFS.
The last major Ampligen trial in ME/CFS began in 1998. Twenty-five years later, Ampligen with a renewed company behind it, appears to be getting another shot at, if not ME/CFS, its close cousin – let’s hope it makes good this time.
Does the study I was in from 2003-2004 not count because it wasn’t large enough?
Thanks for a great article, Cort. This is all good news.
I believe it was actually the largest Ampligen study done. I believe it was started in 1998 and ended at about that time. If I have it right it wasn’t published until 2012 – which seems to have kind of been par for the course.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3303772/
That would make the commitment to publish the results of the next study – if they can get it going by the beginning of the next year – by the end of next year – a big jump indeed.
The trial I was in started in 2003 and ended in December 2004. I went to DC to testify at the FDA hearing in December 2012. From what I recall, they didn’t approve the drug because of the poor design study, that they didn’t have enough of the right kind of data. Hemispherx was pretty poorly managed at that point. I just hope that whatever iteration it’s in now, they do a better job of it, because Ampligen really helped me.
Laurel, Did Ampligen help you?
Yes, it helped me a lot. Not everyone in my cohort were, but most improved at least a little.
AMP has historically been my greatest joy and saddest experience in that other patients have not had access to this what-can-be-if-your-labs-indicate a wonder drug.
Thanks – I added your story to the blog:)
The ongoing ME/CFS trials require participants to pay for the drug, which (including infusion costs) could be up to $80k. Who the hell are they going to find who can afford to drop that on a drug that may not even work for them??
Americans that are not customed to public health care and are already paying like 500k if they get cancer.
They won’t but a major purpose – probably the overriding purpose – of these trials is to get FDA approval so that it will be covered by insurance.
Hasn’t this been trailed and failed repeatedly? I know Dr. Enlander ran a trial about 8 to 10 years ago and it was unsuccessful.
I don’t know about Enlander but if he did a trial he never published the results. Actually, all the trials have had positive results and Dr. Peterson and Lapp have data on hundreds of patients who’ve tried it over the years. They’ve both analyzed their own personal data and concluded that the drug is indeed helpful and both have strongly pushed for its approval as has Nancy Klimas.
One problem with the data is that the company ended the first trial early and – which meant they didn’t have all the data they needed to make a strong case. Plus it took them over a decade to launch another trial. Then it took them years to try to get FDA approval. By the time that rolled around I was told the FDA had to hire outside statisticians to analyze nd help them understand the outdated statistical analyses that were done.
All in all it was a mess – but if not for the 2 ME/CFS experts that voted against it. the drug would have had a chance.
Why did Kamaroff and the other ME expert vote against?
See the response to Mirella.
So why did those two ME-experts vote against it?
As I remember there wasn’t that there was anything wrong with the drug – there were no indications that the it was unsafe – it was just that they wanted more data. Again, if I remember correctly, the application relied on three main things – the great need the community clearly had for a treatment, reports from doctors like Dr. Peterson and Dr. Lapp. that the drug was safe and worked, and the one truncated study and a larger study. To be honest, I believe the study data was less than what was usually provided for FDA approval but we hoped that the community need would trump the need for more data – which does happen in some cases. Oddly enough, the community need and the presentations were enough for some people on the panel not affiliated with the ME/CFS community but not with some that were.
What are the theories, suggestions, or guesses so far – professional or not so much – as to which ME/CFS patients would benefit from Ampligen?
The only thing that I think we do know is that Ampligen works better in earlier-duration patients. As to which other patients it works best on – no one has said a word yet that I know. Figuring that out would be huge.
thank you Cort! i even remember, was it from your blog long time ago, drug searchs patients….
may i be a bit of topic for another drug for ME/cfs? I do not ask anyone to pay but if possible to sign.
it is BC 007. in Erlangen they have i thought 1.8 million for research on ME/cfs with it.
I am to ill to search the follow up article but here is a link where they describe the first patient with ME/cfs cured with it.
https://www.fau.eu/2022/08/05/news/research/diagnosis-and-therapy-of-me-cfs-what-can-we-learn-from-long-covid/
but 1.8 million is not much (that stood in the second article).
so there are people running a petition for BC 007 for ME/cfs, long covid and post vaccin syndrome.
I just want to ask for signatures if i may, no money for petition. it is about 100 million. if you scroll down you can read it in english.
i hope i may place it here, otherwise remove it please. i signed, payed several times but “we” need more signatures. and spreading the link to others for signatures.
I hope, hope, hope anything comes soon out, equally what it is… for all of us!!!
https://www.change.org/p/bc007-now-chance-auf-heilung-f%C3%BCr-millionen-erkrankte-menschen-longcovid-nichtgenesen?cs_tk=AuDM_9Qej3YpAK-mQGMAAXicyyvNyQEABF8BvG3Beei84AKQ8lIhWOU58ls%3D&utm_campaign=1c6d695ab8b84e36a40817773e66fb9c&utm_content=initial_v0_1_2&utm_medium=email&utm_source=promoted_petition_receipt&utm_term=cs
thank you !!!!
Hi Konijn,
I signed, hope others do. I feel there is hope with this, we need answers quickly.
thank you so much!!!! please if i may ask, spread it to others. in the 25% ME group we may not post anything like this, petitions and i, we have no other way…
even if it only works in a subgroup, it would allready be great.
and a compagny, once noticing it works, would go fast worldwide for the money…
thanks so much!!!
Of course – thanks so much, Konjin for posting it. I was told that the company is a small company and its taking them time to get up to speed on doing a trial.
thank you so much for letting me post this here. In the 25% ME group it is not allowed for petitions and i had no idea where else.
I do not know how big berlin cures is, but the first link, the article is from a university where they got 1.8 million for further research. the first “case” looks hopefull. but if they, or berlin cures get 100 million, they can do so much more, so much faster. 1;8 million is nothing in research if you look for excample in cancer.
previous i have been following berlin cures and first they had ME/cfs also mentioned. but now (or i do not see good) no more. but maybe with the money, they are interested or the money go’s to the first link erlangen hospital/research what is also fine for me. most importent is lots of money and good and fast research and if it go’s first to erlangen and works, berlin cures will follow soon…then the work is in fact allready done ….they just need to sell it.
I signed it Konijn. I wonder if they’ll take signatures from the US. The drug sounds promising. I am not clear on how they discovered it. Did they create it for the antibodies they discuss, or is it something already in use.
thank you so much for signing Tracey!!! I do not know for shure if they accept signatures from the US but normally they are not so strict with that here. otherwise it would be mentioned i guess, just like decodeME study only UK, solve only US, etc I think, the more signatures, even worldwide, the better so that they ee there is really interest in it. And the suffering is globally. I hope you can share it with other sufferers or people you know to. Sandly enough i am so severe, that i forget in 1 second and can not read, search much. the first link i put there was a “case” study. it is indeed verry hopefull but only a case study and more research needs to be done. as with all meds and our heterogenus group (even long covid seems to be heterogenous) there needs to be done much more research who will profit, how long it works, side effects, etc as with all meds. but in erlangen, the hospital/researcher with the 1.8 million it is in good hands. I must honestly say that i also do not know how they discovered it. I read a longer time ago a blog from cort with mentioning berlin cures (the manufacturer) and looked there, followed it. As i wrote, in the beginning berlin cures had ME/cfs on its site and now, unless i can not find it/read well no more now. but in between i saw by coincidence the the news from erlangen. and the petition. So why ME/cfs with berlin cures disapeared, i will have to mail them and hope for an answer. Maybe just long covid was easyer and heartfailure. I do not know the history from berlin cures so i can not answer on your questionif they created it for the antiboddys. maybe Cort knows. I know it is yet not available. a copy of a piece on there site: “The goal of Berlin Cures is to make BC 007 available on the market as fast as possible for Long Covid Syndrome patients and, in parallel, to successfully complete its ongoing clinical studies in relation to heart failure.”. but i know from carmen scheibenbogen, also from germany with other anti boddys for ME/cfs and from what i have/could read that there is a subgroup, or maybe all, I do not know, with auto anti boddys. Please make a difference between berlin cures (a compagny who removed ME/cfs fot i do not know wich reason) and erlangen/hospital/research with the same drug. I also even do not know if with this petition the money will go to berlin cures (also for ME/cfs then and post vaccin syndrome) or erlangen. sorry i can not answer all your questions well. I am just to bedridden and ill.
You know I’m always quite critical, but given the results I feel that ampligen can provide a significant improvement for a subset of ME/CFS patients. Also in an objective way: Vo2max and NK cell. I would like to see a measurement of the blood flow to the brain before and after using this drug according to the method of Dr. Visser (echodopler).
Why is it taking so long before this drug can be further investigated? Is it because it is an expensive drug? Or are there side effects that we don’t know about?
I think its a matter of funding really. There’s funding for a post-infectious disease caused by a specific pathogen and it’s still hands off for a mostly post-infectious disease causing by a bunch of different pathogens – hence the need to figure out which patients this drug works in.
I think the SImmaron study to analyze people when they’re on the drug, when they go off the drug and then when they go back on, is so clever and should provide clues as exactly what the drug is doing in ME/CFS. Then, maybe they can look at patients the drug fails in to see which things are not kicking and finding a way to pluck out those first.
Comment *Firmado
I think this is very interesting! I would have liked to know more about how the drug is being used in Argentina where it has approval for ME/CFS. Whether the use is widespread and what the impression is of its efficacy. Do you know more about that, Cort? Or anyone from Argentina, maybe?
Yes, I have been searching for years to find any serious report on how the patients that have traveled to Argentina for treatment have responded. Zippo?
I was in the Ampligen study for many years and found benefit , especially in the early years. After a while,, it was not as effective but am glad I was able to get access to the drug. Yes, improved VO 2 max and really lifted NK cells. It should have been approved the second time in front of the FDA. It may not help all ME patients and it only helps while you are taking it, but sick ME patients need approved treatment options and Ampligen should be one of them.
thanks for the hope!!! although i am allready decades ill but there are many not so long ill. I hope it comes to Europe to!
it is allways insane what in different parts of the world is possible and what not. here in belgium stil get and cbt… even no low dose abilify, no LDN, no pots treatments, etc
Carol, which Ampligen study were you in and how did it affect your fatigue if any?
Ampligen® was based on a double-stranded RNA (dsRNA) compound developed by the pharmaceutical company, Merck, in the 1960s, as a potential cancer drug. Why has it taken 60 years to figure out what it is effective for and why is it so expensive?
Dr. Cheney told me that some of his patients participated in one of the first Ampligen studies, but he abandoned it because of adverse effects.
Dr. Peterson and Dr. Lapp obviously have had very different experiences since then. I have no idea about the expense. As to the other, I would hazard a guess that a poorly run small pharmaceutical firm had something to do with it – look at what happened with Equels took over.
In the last few months, I contacted Dr Lapp’s office (Hunter Hopkins Clinic in Charlotte, NC) to ask about this. Patients pay 100% of costs for IV infusion, twice per week at over $1000/ea for “18 to 24 months, depending….”
When I asked “Depending on what?” there was no answer.
I asked if anyone was ever cured. The answer was “Oh, yes, we’ve had several people improve.” To me, this is a “no.” In twenty or so years of trials, “several people improved?” at a clinic that also does not take any insurance for its own services… hasn’t applied for and received funding for treatment, etc… despite “treating” exclusively “Chronic Fatigue Syndrome” patients.
In twenty or more years of running “trials” and collecting data, if even ONE person had been cured of Myalgic Encephalomyelitis, they would have been screaming it from the rooftops. If I had spent about $100,000 out-of-pocket (how? most are disabled… wealthy spouses, I guess) to take this medication twice a week for a couple of years and it cured me, you COULDN’T STOP ME FROM TELLING EVERYONE!!!! We haven’t heard a peep from anyone who is cured. Just vague mentions of people allegedly ‘helped’ by it.
As to the comment above about a desperate need in the community, that’s no reason to approve snake oil, cheap or expensive. It’s a reason to use careful scrutiny. On the other hand, IF warranted, we need major funding bump to investigate. But how is it possible that 30 or 40 or more years in, we don’t have a clue? No solid foundation good enough to convince anyone to pay for robust trials?
Read Anita Patton’s story – https://www.healthrising.org/forums/resources/ampligen-does-the-trick-for-anita.380/
Not that many people have actually tried Ampligen. Plus consider what you need to do to get your story out – you need to have a way to do that – you need a website, a popular Facebook page, whatever. Plus you have to have the desire to do so. Plenty of people have contacted Health Rising over time about their recovery stories. Even they – when the offered the opportunity to put it on our Recovery stories page – often do not.
Dr. Lapp did a statistical assessment of his Ampligen patients and concluded that the treatment was on the whole quite helpful. I would go with that – whether you want to shell out that kind of money for something that might or might not be really helpful is of course another matter. 🙂
I’m not sure how to reply to your reply below: so I’m doing so here. You said:
“Not that many people have actually tried Ampligen. Plus consider what you need to do to get your story out – you need to have a way to do that – you need a website, a popular Facebook page, whatever. Plus you have to have the desire to do so. Plenty of people have contacted Health Rising over time about their recovery stories”
Cort, any and everybody has access to facebook, twitter, instagram, comments on reddit, your page, Science4ME, numerous other places and that’s before you get to medical sites and obvoiusly journalistic outlets. I don’t understand this comment. Who would be so selfish to have found a cure to this torture and keep it to themselves?
Please anonymize the information you have received and post it.
Please ask Dr. Lapp to do the same. Again, in over 20 years, there should be a significant number of cured patients and that should have supported PAYING for treatment (NOT patient-funded research that has been fruitless).
I hope it’s a matter of scale and funding but if that’s the case, let’s get on with it. The information available does not lead to that conclusion.
The fact that there are many longterm patients on this drug also speaks to its effectiveness. Even if someone posted on twitter, Facebook, any of the Forums – how would you know? It’s not like the news automatically spreads. Health Rising
Mary Schweitzer is another person who benefited dramatically. Check out our Ampligen section for more. One guywrote a whole blog series on his Ampligen experience on Health Rising – a popular website – that you’ve never seen! If you missed that as well as Anita Pattons and Mary Schweitzers and others stories why would you think you know what’s out there? (Check out our Ampligen Resource page.) The fact that Dr. Peterson is not only still using Ampligen but has made researching it a priority for the Simmaron Research Foundation should tell you something. Likewise Dr. Lapps endorsement of it during the FDA hearings.
Replying to your comment at 7:43 below here (I can’t figure out how to do it otherwise… there’s no “reply” button next to any of your comments other than this top one):
You said “The fact that there are many longterm patients on this drug also speaks to its effectiveness” then went on to say if people posted on Twitter or forums, how would I know? Well, how do you know? Do you know how many? You say “there are many.” I’m literally asking if you know how many? And since when? And what are the results? Not a couple of anecdotal positives (good for them), but DATA… Not doctors getting paid to use it recommending doing more of that, but their DATA VETTED. If it’s so great, I will be THRILLED. But IF it’s so great, WHY aren’t they presenting data, going after funding, and aggressively pursuing studies leading to approval? Why aren’t they presenting mechanisms of improvement? You just keep saying essentially ‘people are saying good things’ or that you’ve heard good things. I hope they are true, but even if true they aren’t necessarily informative about the efficacy of the drug or its safety. DATA DATA DATA. It’s been DECADES. Give the objective, vetted data. Let’s get on with it, doctors… ME patients should be ahead of Covid patients on trials IF it’s safe.
Andrea Whittemore had to stop Ampligen after she developed toxic reactions to it.
$40,000 a year.
Wow – this is the first I’ve learned of Ampligen – a very frustrating history! What year(s) was the first trials? I was diagnosed with CFS in 1985, and sometime between then and 1989, my doc gave me a series of infusions for an experimental drug. I always felt significantly better for 4-7 days after the infusion. But then he no longer was able to give me the treatment, and then he retired and I moved to a different city, and I’ve been trying to find treatments, supplements, etc since then. My CFA was triggered by a severe CMV infection, and I’ve also tested positive for EBV and all the other herpes viruses. I’ve had some improvement from taking monolaurin, and now also ubiquinol and NADH. Tried LDN but that was a disaster – set me back 2-3 months.
Judith, please say more about your experience with monolaurin? Starting dose, frequency, current dose, anything else? I’ll look it up asap but I don’t recall ever reading/ heating of monolaurin.
I learned of monolaurin from my naturopath MD – she suggested it because apparently it has shown antiviral activity against CMV and HSV-1 in vitro. It’s a derivative of coconut oil. I wasn’t able to find any research articles on it. Here’s a somewhat informative website:
https://www.healthline.com/health/monolaurin#forms-and-doses
I started with a single 600 mg capsule once per day, and gradually (over about 4 weeks) increased it to 4 capsules per day, for 6 weeks. Then slowly ramped back down to a single capsule daily for long-term maintenance. It significantly decreased all my symptoms except the recurrent fatigue, which has been quite persistent. The ubiquinol and NADH seem to be helping that. The monolaurin I’m using is from Ecological Formulas, purchased on Amazon.
Thank you, Judith – much appreciated! I like ubiquinol too.
So help me understand this…
I heard the long Covid Ampligen study is going to be for long Covid patients and not ME patients and current ME patients getting Ampligen are going to be dumped so the same doctors can work on the long Covid patients.
How the fork is that going to help ME patients? And why are there not opportunities for ME patients to try Ampligen?
“This week AIM Immunotech announced that it had been given FDA approval to launch a multicenter, placebo-controlled long COVID study and expected the study to begin next year. Meanwhile, the Simmaron Research Foundation is in the midst of efforts to understand Ampligen’s effects on ME/CFS.”
There are opportunities for ME/CFS patients to try Ampligen – unfortunately, you have to pay the full price of the drug. The long COVID study could help the way other studies help – by showing Ampligen works in long COVID – that will hopefully open the door for it being trialed in ME/CFS. I think we’re about one large Ampligen study away from getting approved. Long COVID is much further away unless it gets some sort of emergency authorization.
Also, on the recent Mass ME/CFS webinar “Emerging Similarities of ME and Long-COVID and Why It Matters” with Anthony Komaroff, M.D.” this past Saturday….
Komaroff seemed surprised but very glad to learn that Ampligen was going to be used in a clinical trial for long Covid, even though he said he did not approve it for ME because the he said data behind the ME trials was unreliable, at times even false and concerns about side effects.
So why is it good enough for him for long Covid but not ME patients if the data wasn’t great? Why not fight for a be better ME trial? Why are the ME doctors not fighting for us?
Seems like all to often doctors are willingly to basically dump helping ME patients or stop taking ME patients for the newer more popular illnesses with hotter funding options. This happened with Aids, Lyme, and now long Covid. And they rarely come back to ME patients or ME research. How is that even ethical?
Why are the doctors not saying ok I’ll help with long Covid etc. but not without funding for my ME patients too. If the doctors of ME patients stood together as a strong united group we would be much further along.
Komaroff doesn’t believe in or talk about Myalgic Encephalomyelitis. He pushes a model and thinking that reflect a vague “Chronic Fatigue” Model, just as the people trialing Ampligen for over 20 years do. That’s the problem. Komaroff has been instrumental in ‘leading’ the discussions that quash proper scientific research into ME and correct treatment of ME patients.
Myalgic not tired, Ampligen is supposed to correct the 2,5 RNASEL antiviral pathway which is supposed to be abnormal in ME/CFS. I had an RNASEL test in the late 90s with Dr De Meirleir in Brussels and it was NORMAL yet I had bad ME/CFS symptoms. Now what ever happened to this thesis that De Meirleir was pushing in the 90s, ie that the 2,5 RNASEL pathway is abnormal in ME/CFS? You don’t hear anything about it anymore. I wonder if any of the American people who did the Ampligen trial had an abnormal RNASEL. De Meirleir does not practise anymore in Brussels, he has moved to the USA I believe to the Peterson Institute or whatever it’s called. Don’t know why he did that although probably he makes a lot more money in the USA I don’t know.
Hi Martin. I’m sorry I’m not familiar with Dr. De Meirleir’s work or with who had Ampligen trialing here. I have no idea how many patients have actually had it or what their results were. I think that’s a problem. We should all have that information–as well as what the status was going in (with thorough screening, testing–not just ‘fatigue’ stated).
Hope you’re doing okay.
Hi Cort,
It seems likely now that CFS is actually SEVERAL DISEASES, or, at least derives from various different causalities.
“Dr. Peterson of the Simmaron Research Foundation and Dr. Unger of the CDC are currently attempting a determine which ME/CFS patients benefit.”
And that different lineages of our disease will respond, or not respond, to different drugs – AMPLIGEN and others.
Now that it’s 2024 (oy veh, I’m 81) can you tell us how much progress has been made in differentiating between the different types and origins of our malady, and in how and why they respond to different treatments.
…. Thanks, Laurence of Berkeley
Is there any way to try Ampligen? LIke right now? I’ll go anywhere. Who can I ask?
I understand it’s in a clinical trial, I understand it’s not doing great right now, I understand it costs a fortune, I understand it’s IV. I just want to try it. Can I?
My dumb doctor says, nope it’ll be years before it’s available. I will take any possible leads.