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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.....
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.
[fleft]
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.
[fright]
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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