The Plot Thickens for HEMISPHERx Biopharma

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By M.E.Garza   
Friday, 29 May 2009 05:01

“What do we think CFS is?” Dr. William Reeves asked a worldwide audience watching his streaming video presentation from the meeting for the Chronic Fatigue Syndrome Advisory Committee (CFSAC) of the Department of Health and Human Services in Washington, DC. on Thursday. “It’s a complex illness, with alterations in complex homeostatic systems. It’s not the result of a single mutation or a single environmental factor. It comes from a combination of many factors: genetics, gender, stressors, immune stressors all interact.”

Reeves is chief of the U.S. Centers for Disease Control and Prevention's Chronic Viral Diseases Branch, the man in charge of the government’s top Chronic Fatigue Research program. A few years ago, during a press conference which was set-up in an attempt to sway public opinion and policy, Reeves revealed that CDC researchers had uncovered groundbreaking, scientific results which established that CFS had a "biological basis".  

It was during that day, in late April of 2006, that major television networks and hundreds of newspapers carried the message that many had been waiting to hear. In the eyes of advocates and patients, that day was to forever change the way chronic fatigue syndrome would be conceptualized - by scientists, physicians, and the public. At least, that’s what was supposed to happen. Since that time, Reeves has not minced words about his science or position on the matter. "CFS is quite common," Reeves told Forbes Magazine earlier this year. "It is a real illness. If you have the symptoms of CFS, see a provider. It's not all in your head -- it's not a crock."

Yesterday, Reeves was the ring master of what turned out to be an “Ampligen love-in” at the Health and Human Services event. Not an insignificant fact when you consider that this was the CFSAC's first meeting under the Obama Administration's and that the HHS is at the top of the food chain and rules the FDA, the CDC, The Social Security Administration, National Institute of Health, HRSA, Etc.

As some of you may already know, Ampligen, is an experimental immunomodulatory double stranded RNA drug developed by HEMISPHERx Biopharma (Amex: HEB). In addition, it is the only drug in any pipeline of any pharmaceutical company in the world which aims to become the standard treatment for CFS.

Reeves showed slide after slide with a diagrams and lists. Almost always near the top of those slides were references to HEB and Ampligen. “This is our current model. You see the brain in the middle. Around the brain, stress is involved, traumatic childhood stressors, allostatic load maladaptation to stressors, genes interact with one’s reaction to stress...”

Just then as countless CFS patients and HEMISPHERx Biopharma investors were watching, something went “Boom!”

It was yet another grenade lobbed at the publicly traded company whose stock price had continued inching upwards for yet another day in anticipation of the Food and Drug Administration’s pending decision to approve the drug for widespread use in America.

This time, the pin was pulled by Adam Feuerstein, a graduate from Emory University with a bachelor's degree in political science who serves as the Portfolio Manager, Biotech Select for TheStreet.com. Adam asserted his own opinion- which apparently many mistook for scientific fact. “Ampligen will not be approved.”

KABOOM! The moment TheStreet.com's Hemispherx's CFS Drug Is a Long Shot article hit the wires, the stock’s share price started to take a nose dive.

The thinly disguised opinion piece from a writer without a science or medical degree hit it’s mark with thousands of high-strung investors who began to dump shares en-masse. Many thought Feuerstein might just be right, so they began to sell as quickly as possible. Others thought the FDA had actually rendered a negative ruling against the company because the stock was suddenly dropping in value without any other apparent explanation. Panic had hit the world of Hemispherx share holders once again.

Did Feuerstein blister the company on purpose? Was it all part of a sinister plan orchestrated to sink prices lower so someone could swoop in and salvage their piece for a lower price? Whether it was planned that way or not, at least one big investor did just that to the tune of over 230,000 shares not long after HEB parcels had bottomed at $1.51- down from a day high of $1.76.

Still, it would be expensive, time consuming and difficult to prove a conspiracy like that beyond reasonable doubt and we are not here to crucify Mr. Feuerstein for exercising his constitutionally protected rights.

Certainly, he’s a bright man who is entitled to his own opinion-- even his conclusions didn’t come wrapped up as nicely as they could have to some investors who have since taken to slamming him repeatedly on social media sites and forums across the web.

Like it or not, this subject has become the talk of the biomedical financial sector as many feel his article was not substantiated by enough positive knowledge or proof. Others argue that his research was actually filled with misconceptions, and misplaced scientific information. They’re not alone.

“Adam Feuerstein wouldn’t know good science if it bit him in the ass!”

In a world where CEOs of publicly traded companies make it a point not to get into shouting matches with misled members of the media, I was actually given explicit permission, told I could “record and report everything I’m going to say."

"I’m not going to say too much in direct response, actually. The record can be set straight on this matter by the government themselves. The same people who have already told us this is a serious gene malfunction that costs us north of $90 billion a year in lost wages and productivity not to mention social security benefits.”

Yes, Dr. William A. Carter, CEO and Chairman of the Board of HEMISPHERx Biopharma was making it abundantly clear to me that an exposed nerve had just been pricked – again. This is the same man who has been accused of everything from not caring about his own company’s investors to selling snake oil. He’s also the brilliant mind who has never given up on Ampligen and who genuinely seems driven to help those who have to live with CFS and the stigmas associated with it.

“It sounds like those guys are living twenty years behind in time,” continued Dr. Carter, as he referred to Feuerstein’s assertion that “CFS, a poorly understood disease with no known cause...”

Had Feuerstein really not gotten the memo about the scientific community’s findings in 2006 or did he simply choose to ignore them?

“This is a disease that destroys lives,” said an impassioned Dr. Carter. “It costs people their jobs, their marriages- as their frustrated spouses walk out on them. In some cases it even costs them their very lives due to suicide and catastrophic heart failure. Our drug helps so many of these very sick, suffering people. There is ample peer reviewed data and proof of that, yet they choose to ignore it.

“Perhaps the writers at TheStreet.com are unaware that for several years now, the FDA has given people suffering with CFS the right to use Ampligen for emergency (compassionate) use. “

Indeed, the company is authorized by the FDA and has a "promising'' designation by the Agency on Health Research Quality (AHRQ) emergency treatment, which means HEMISPHERx can charge patients up to $20K a year for treatments. “That’s a price most health insurance companies actually prefer to pay when compared to the high costs of misdiagnosis, MRIs, CAT scans and even surgeries that occur from time to time when patients suffering from the illness show up at hospital emergency rooms seeking help,” explained Dr. Carter. “In order for us to get that designation, the government had to establish that CFS was, indeed, a very serious disease. Second, the FDA had to be shown that there was not any other adequate treatment and perhaps most importantly, Ampligen had to be safe to administer. That is one thing that has never been withdrawn or questioned by them. “

In fact, one insider tells us that in the early days of it’s use under the program, the FDA required the company to submit safety reports every month. They did so every month for 150 months. In fact, the reports were delivered with such positive data and accuracy that eventually a top administrator at federal agency grew tired of reading them. He told them to stop.

The CDC, as represented during Thursday’s presentation, has made important commitments to HEMISPHERx when I comes to CFS. “We’re talking to them two to three times a week as we compare protocols and treatments,” explains Dr. Carter. “Because they have vast resources, they have been prolific in the publication of research about the disease. They’ve published about the severity of the gene malfunction. This is a major medical research organization in the world and they recognize that we are leaders in the field of CFS.

“You can’t tell me they’re not aware of that... I don’t know what the agenda is at TheStreet.Com, but those guys may as well start selling off their 401K’s because they apparently know very little about investing. Not only do they manipulate the facts- they conspicuously don't talk about our collaborations and data. “

The same drug used for CFS has now taken center stage in the fight against so called swine flu (H1N1). The company has made headlines in recent days as it has moved full force into collaboration with health ministries and scientists in Japan. In fact, BiomedReports has learned that the company is officially on the fast track to making some substantial sales of its products to Japan. Purchases that will initially treat as many as 30 million Japanese military and paramedic personnel may be announced soon. When the orders come, research indicates that first year sales figures for Ampligen as a vaccine booster may actually dwarf sales for Ampligen as a treatment for CFS. That trend, as currently projected, would continue for at least the first two years.

“The highest level of the Japanese government and public medical community is now focused exclusively on our product,” says Carter. “They stopped working on all other adjuvants (boosters) and are only working with this one because they’ve found that it enhances the vaccines by 100 fold.”

In so called animal (monkey) models, all of the sickest animals' lives have been saved after researchers added a little Ampligen to the administered novel influenza vaccines. This has all been reviewed by the Japanese National Institutes of Health with great attention since the H1N1 virus has been spreading in that part of the world swiftly and threatens to breakout even further into Asia.

“Drug safety is the number one priority in Japan,” explains Dr. Carter. “Research there is excellent and their scientists have an outstanding historical safety record.Our research and results are independently verifiable, and internationally recognized.”

Another tremendous platform in the influenza space is Hemispherx’s flagship product, Alferon which is already approved by the FDA.

“That’s already passed FDA muster,” says Dr. Carter. “Furthermore, It’s a fully natural interferon- all others are manipulated. That makes it the most effective interferon available. It can stop the SARS coronavirus, Avian Influenza (H5N1) and we have a treatment program with plenty of this drug already stockpiled.”

No report on today’s events would be complete without shedding light on some of the conspiracy theories surrounding the FDA decision on Ampligen.

The company already knows something and they’re just not telling us.

Actually, they don’t. They know as much as you do.

The new FDA commissioner’s husband is insider trading with shares of HEB and other biomedical stocks.

Where can one go to start to prove something like that- even if true?

The wording on the press release about the delay was carefully crafted by lawyers at HEB.
No, actually it was communicated to them pretty much verbatim by officials at the FDA.

Yes, as those conspiracy theories go, perhaps the most deeply rooted ones can be found around the disclosure made earlier in the week by HEB. In it, the company informed the market that the FDA had advised the company of a possible delay that might require up to 1-2 additional weeks to take action beyond the scheduled action date on the New Drug Application for Ampligen.

“Hemispherx's statement makes no sense because the FDA's Ampligen review is either delayed or it isn't.” wrote Feurerstein in his controversial article. “With the clock now ticking past the scheduled May 25 approval-decision date, the review is clearly delayed, so perhaps it's incumbent upon Hemispherx to provide a better explanation.”

Actually, it’s probably incumbent on the FDA to do so. They were the ones who picked up the phone and gave that very same explanation to Hemispherx officials. There is a game of musical chairs going on at the administration these days. Not only is there a new commissioner, there is also a new senior associate commissioner and some of the people working in the molecular division have been affected as well.

As one insider told me, “PDUFA (Prescription Drug User Fee Act) dates are like the date the doctor gives you when you’re pregnant. They’re a pretty good guess, but the baby could decide to come sooner or later. You have no real control.”

In this case, anyone can speculate and look for signs one way or the other, but the truth is that companies who are trying to get drugs approved spend a great deal of time, energy and millions of dollars meeting the strictest of requirements- and that's simply to submit an application. This time, at least, Hemispherix has done the best job they feel they could. All of their paperwork, studies and data were handed over and they even went as far as to voluntarily submit additional data which pushed their original PDUFA date in February back three months.

“Sure, we’ve probably been slow,” says Dr. Carter when asked about Ampligen’s long, multi-decade, journey to this point. “Sometimes we didn’t have enough money, we were also shooting in the dark for the most part and you’ve got to remember that when it comes to CFS, even the CDC is a ‘Johnny come lately.” The real progress in this disease has been recent.”

There are some things we do know as we await the fateful decision from the FDA- and still some things we don’t. I’m told that at least one very well respected medical publication will be publishing an article submitted by the company less than 48 hours ago. We’re told that when the yet to be publicly disclosed (“it’s a household name”) medical review journal releases the data shortly, it will be impressive.

In addition, the publishers of The Pink Sheet- a comprehensive publication for and about the pharmaceutical industry- have informed the company that all of their extensive research and findings has led them to one conclusion: “Ampligen is poised to become the first drug approved for Chronic Fatigue Syndrome.”

Adam Feurerstein, as he'll be happy to tell you, disagrees.

We’ll soon see who was right.

 

Disclosure: No positions





BiomedReports is not paid or compensated to report news and developments about publicly traded companies. Full disclosure can be read in the About Us Section

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