Ampligen Co-Inventor / Head of Hemispherx Biopharma Fired: Implications for ME/CFS Drug Unclear

Cort

Founder of Health Rising and Phoenix Rising
Staff member
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[/fright]William Carter, the co-inventor of Ampligen and long-time CEO and Chief Science officer of Hemispherx Biopharma is gone. He was also removed from the Board of Directors (BOD). The move came just weeks after the Board reduced his salary and that of the President and Chief Financial Officer by fifty percent. The Board also announced a strict anti-nepotism policy; several relatives of Carter were on the companies payroll.

The company appears to be in difficult financial straits. The Board cited the need to reexamine its "fundamental priorities in terms of direction, corporate culture and its ability to fund operations.". It said it will begin a strong "financial austerity program" to bring its finances back into line.

"A Good Drug in the Wrong Hands"

The old adage "with friends like this who needs enemies?" was probably never more true for ME/CFS than with regards to recently fired CEO of Hemispherx Biopharma and co-inventor of Ampligen, William Carter. Carter deserves praise for co-inventing the only drug ever to make to the end of FDA trials for chronic fatigue syndrome (ME/CFS) and sticking with it for decades.

The company he's run for the past thirty years, however, has been embroiled in so many lawsuits as to become at times a laughingstock in the financial world. Carter twice sued (once successfully) to get his job back.

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[/fleft]Patients in the ME/CFS drug trials decades ago successfully sued after Hemispherx denied them the drug after the trial ended. (For a hilarious and often heartrending ‘fictional’ account of the early Ampligen trials read "Patient 002" by Floyd Skloot.)

By the early 1990's Kim McCleary, President of the CFIDS Association Kim Kenney (McCleary), now the President of the CFIDS Association of America opined that “Ampligen is a good drug in the wrong hands”. It's hard to imagine a company with more ups and downs than Hemispherx Biopharma which has survived as long as it has. Advocates repeatedly reminded themselves ignore the company and concentrate on the drug.

Recently investors sued the company asserting that it overstated its claims about the drug. It had and they won. The latest came only two months ago when Hemispherx announced Carter had been given more stock than IRS rules allow.

The headline for the Fierce Biotech piece on Carter's firing by the Hemispherx Biopharma board was "Bottom-dwelling biotech Hemispherx dumps its CEO and vows to stamp out nepotism". They called the company "a penny-stock firm with a penchant for hype". It noted that Hemispherx Biopharma's stock has not nudged above a dollar since 2009. Some commentators have been openly dismissive of the company for years.

A Difficult Road

To be sure, Carter's road - to bring a drug to market for a disease that few cared about or believed in - was a difficult one. Ampligen was moved from department to department as the FDA struggled to find the right place for it. Each time required a sometimes costly reset for the drug and the company.

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[/fright]The FDA and Carter were not friends. At the final hearing FDA officials raked Hemispherx over the coals for what the company and many advocates thought were side issues. Carter's decades long pursuit of FDA approval left him so bitter towards the FDA that advocates of the drug held their breath as he spoke hoping that he wouldn't ruin the drugs chances.

The company, though, may have shot itself in it's foot - not for the last time - when it chose over thirty years ago to end it's initial 48 week trial in 24 weeks - thus weakening its case. FDA approval was apparently assumed but three decades it still has not.

Carter and Hemispherx Biopharma seemed to chase every new virus (hepatitis B and C, smallpox, HIV, ebola, avian flu , swine flu- HINI, XNRV) that showed up in hopes they could gain traction for Ampligen. Shortly after the XMRV Science paper, in an ill-fated move, Hemipherx poured money into studies attempting to prove Ampligen's efficacy in treating XMRV infected patients.). (The company is now reportedly expanding its research into Ampligen's and Alferon's (it's other drug) effectiveness fighting MERS, Ebola virus, Equine Encephalitis and the mosquito-borne Zika virus.)

Numerous reports of Ampligen's effectiveness in ME/CFS have surfaced over time, however, and the doctors involved with the drug praise it. In the right patients the drug can produce miraculous effects.

[fright]View attachment 995 [/fright]Ampligen, which is available in Europe and Canada, remains an investigational drug in the U.S. I vividly remember one ME/CFS physician who provided strong testimony in support of Ampligen at the FDA hearings stating afterwards "Now Hemispherx is going to have to put some money into Ampligen".

They still haven't. Upon losing the fight for FDA approval Carter reportedly gave himself and other members of the company large bonuses. It bears noting that the basis for Ampligen's approval at the FDA rested on two studies, one of which is so old that it used the Holmes definition. It was widely assumed that the company did not have the resources to meet the FDA's demands for new ME/CFS trials.

Effects on Ampligen Unclear

What all this means for Ampligen is unclear. Short of the company dumping the drug, it's hard to imagine that it could be worse off than before but the company clearly has financial issues. That's no surprise; how deep they are is another question.

Carter's long, turbulent road with Ampligen and Hemispherx appears to be over - unless he sues.....
 
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IrisRV

Well-Known Member
This drug is not exactly new. Shouldn't it be off patent by now? Can't someone just do a generic knock off and put Hemispherx out of it's misery.
My guess is that they hold the patent until X years after they put it on the market. Companies need time to finish research, jump through all the legal hoops, and sell if for a few years before their product goes off patent. Since they never put in on the market, they can sit on the patent so no one else can make it. It's rather spiteful, but companies have done it to prevent anyone else from making money off their idea, even if they can't.

Also, if it's not FDA-approved, we couldn't get it anyway, could we? It's not in pill form, it's still an infusion product (right?) so it's not like we could easily buy it from an overseas generic manufacturer and administer it ourselves at home.

My best hope at the moment is that with Carter gone, the company will finally break down and sell the "recipe" to a pharma company who has the big bucks, legal horsepower, and research capability necessary to properly jump through the FDA hoops. Hemspherix didn't have what it takes to get all the approvals in place and Carter simply refused to sell to someone who could. He just wanted the most money he could get out if it and patients be d****ed.
 

Strike me lucky

Well-Known Member
If ampligen eas approved years ago it probably would have been improved upon where it can be infused subcut like they now do with ivig.

The companies other drug, a type of interferon could possibly be useful for cfsme also.
 

Cort

Founder of Health Rising and Phoenix Rising
Staff member
Ampligen is not approved in Canada.
Wikipedia says it is "Although Ampligen was cleared for use in Canada in 1997,[3] and obtained orphan drug status for treatment of CFS in the European Union in 2000,[4]" Are they off on this one?
 

Cort

Founder of Health Rising and Phoenix Rising
Staff member
My guess is that they hold the patent until X years after they put it on the market. Companies need time to finish research, jump through all the legal hoops, and sell if for a few years before their product goes off patent. Since they never put in on the market, they can sit on the patent so no one else can make it. It's rather spiteful, but companies have done it to prevent anyone else from making money off their idea, even if they can't.

Also, if it's not FDA-approved, we couldn't get it anyway, could we? It's not in pill form, it's still an infusion product (right?) so it's not like we could easily buy it from an overseas generic manufacturer and administer it ourselves at home.

My best hope at the moment is that with Carter gone, the company will finally break down and sell the "recipe" to a pharma company who has the big bucks, legal horsepower, and research capability necessary to properly jump through the FDA hoops. Hemspherix didn't have what it takes to get all the approvals in place and Carter simply refused to sell to someone who could. He just wanted the most money he could get out if it and patients be d****ed.
Yes it's infused.

My hope is yours. I hope to get an interview with the new President and find out more though.
 

Cort

Founder of Health Rising and Phoenix Rising
Staff member
This drug is not exactly new. Shouldn't it be off patent by now? Can't someone just do a generic knock off and put Hemispherx out of it's misery.
That's an interesting question...I wonder if it has to be FDA approved or? Its gotta be off patent by now. It's over 30 years old.
 

Merida

Well-Known Member
Thank you Cort. This reminds me a bit of the Elmiron/ interstitial cystitis story. I first became aware of that controversy in 1986, as it was thought my son had IC - following Epstein Barr infection - age 5. Elmiron had been approved in Europe for years - clearly safe and helpful for many. There were no other drugs for IC - only DMSO bladder infusions.

A few patients actually flew to Germany to get the drug. Patients could not understand why the drug was not approved here. Patients wrote congressmen, etc. etc. etc. Finally it was approved here in 1996. Patients were so grateful to IVAX pharmaceuticals who finally made this 'orphan' drug available.

I see that IVAX was purchased by TEVA in 2005 for 7.4 billion.

Maybe there are 2 major forces at play in the Ampligen story :
1. Money - is there a major drug company who is putting pressure on keeping Ampligen in a cave? Trying to put this company out of business?
2. If there was a drug approved for CFS/ME then the validity of the disorder would sky rocket.

If we could follow the Money, I bet the picture would get clearer. When there is money to be made, you can bet someone will make the drug available. Cost to patient - well, that is another story.
 

IrisRV

Well-Known Member
Money - is there a major drug company who is putting pressure on keeping Ampligen in a cave? Trying to put this company out of business?
If we could follow the Money, I bet the picture would get clearer.
I think the currently available evidence shows that it is all about the money, but not because some outside agency is influencing Hemispherix. Carter, the CEO, is no friend of patients. He was clear that he had no interest in selling the rights to Ampligen to a company with the capability to bring it to market. Since Hemispherix clearly doesn't have the capability, the drug has been lying round doing nothing for patients for 30 years. Carter would rather keep the drug out of the hands of patients for 30 years than get less than the maximum possible profit from it. Think Shkreli.
 

Cort

Founder of Health Rising and Phoenix Rising
Staff member
I think the general consensus is
  • Carter always had a tough row to hoe getting a drug for this disease approved by the FDA and getting it to market; this drug had a lot working against it
  • Hemispherx Biopharma has been poorly managed from Day 1

Put a tough market and poor management together and you have what you have. ...

I wish they had completed that initial study. That plus the second study could have been enough for approval. In the end they had a half-hearted first study and a moderately effective second study - which was published 18 years later.....

Hows that for support!
 

Thom

Member
Wikipedia says it is "Although Ampligen was cleared for use in Canada in 1997,[3] and obtained orphan drug status for treatment of CFS in the European Union in 2000,[4]" Are they off on this one?
Way off. This drug is not approved and does not even have a drug identification number. In order to get it one would have to go through Health Canada's tedious Special Access Program. No doctor here as even heard of Ampligen.

At least that is what the government has told me.
 
I am a patient that has benefited from using Ampligen for years. I have paid for the drug, labs and all associated costs only to be disappointed and angered by the blatant greed and mismanagement of Dr Carter. Again and again, Carter has submitted incomplete and out of date material knowing he would not meet the FDA's requirements. Why? stock price manipulation aka greed.
Running up a penny stock based on misleading and false information so that insiders can profit is fraud This practice ( also knows as pump and dump) is common on thinly traded stock like Hemispherx. Carter and other insiders profit while patients and other shareholders get screwed.
Dr Carter has , through salary and profit from his stock holdings, managed to make Ampligen a paycheck, not a drug to be taken serious. This long drawn out circus may make Ampligen difficult if not impossible to market to other pharma's.
I am glad to see Dr Carter go, good riddance, but Ampligen's looming price increases to loyal existing patients will most likely force the majority of those left in the 511 trail to abandon their course of treatment. How then is Hemispherx going to be able to submit new data to the FDA when there are only a few people left in the trial?
 

Cort

Founder of Health Rising and Phoenix Rising
Staff member
I am a patient that has benefited from using Ampligen for years. I have paid for the drug, labs and all associated costs only to be disappointed and angered by the blatant greed and mismanagement of Dr Carter. Again and again, Carter has submitted incomplete and out of date material knowing he would not meet the FDA's requirements. Why? stock price manipulation aka greed.
Running up a penny stock based on misleading and false information so that insiders can profit is fraud This practice ( also knows as pump and dump) is common on thinly traded stock like Hemispherx. Carter and other insiders profit while patients and other shareholders get screwed.
Dr Carter has , through salary and profit from his stock holdings, managed to make Ampligen a paycheck, not a drug to be taken serious. This long drawn out circus may make Ampligen difficult if not impossible to market to other pharma's.
I am glad to see Dr Carter go, good riddance, but Ampligen's looming price increases to loyal existing patients will most likely force the majority of those left in the 511 trail to abandon their course of treatment. How then is Hemispherx going to be able to submit new data to the FDA when there are only a few people left in the trial?
:mad:

I hope to get an interview with the new President of Hemispherx this week or the next. If I can I will ask him about the price increases, where Hemispherx stands with the FDA, how Carter's firing changes Hemispherx and other questions...
 

Strike me lucky

Well-Known Member
:mad:

I hope to get an interview with the new President of Hemispherx this week or the next. If I can I will ask him about the price increases, where Hemispherx stands with the FDA, how Carter's firing changes Hemispherx and other questions...

Ask questions about their biomarker i recall them mentioning a while back?

Also be interesting if they are looking into subcut infusions similar to gamma globulin as they can be done at home??
 

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