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Ampligen Patient Hunger Strike; Hemispherx Takes CRL Tailspin

By Randy Osborne
Staff Writer

Hemispherx Biopharma Inc.'s complete response letter from the FDA in the wake of a negative advisory panel review of Ampligen for chronic fatigue syndrome (CFS) left the company weighing its chances of success in appealing the decision, and left patients without options.

More than a week ago, to highlight the promise of the Toll-like receptor 3 modulator Ampligen (rintatolimod), 54-year-old Robert Miller, began a hunger strike. Miller, who has had access to the drug since 1999, hopes that an outcry will push the National Institutes of Health (NIH) to become involved and save Ampligen, as happened long ago with azidothymidine (AZT), from Burroughs-Wellcome Co. (now GlaxoSmithKline plc). AZT went on to become the first approved HIV therapy.

"This denial will crush [Hemispherx]," and will take a therapy that has been proven viable from more than a million Americans with CFS, Miller said.

The Philadelphia-based firm's stock (AMEX:HEB), already trading well under a dollar, dipped another 14.7 percent, or 4 cents, Tuesday on word from the FDA. Shares closed at 22 cents.

The FDA wants Hemispherx to conduct at least one more trial, along with various nonclinical studies and further data analysis. Hemispherx said it will ask for an end-of-review conference with the FDA, and then submit a formal appeal. Meanwhile, CFS patients wait.

On Jan. 29, Miller – who said Ampligen allowed him to improve from being bedridden with CFS to functional – stopped ingesting anything but water, although he was given saline for kidney problems that developed.

"I don't know how long I can last," he told BioWorld Today, in a sometimes-halting voice. The father of 12-year-old twin boys, Miller said his wife "understood" his decision. "Is she thrilled about it? No," he said.

Hemispherx, in a press release about the latest action by the FDA, did not mention Miller by name but asked that "any hunger strikes be discontinued." The agency has made acknowledgements of its own, not of Miller's hunger strike but, in a formal press release, of the importance of CFS.

"They don't do these things on their own," Miller said. "They are doing this because someone is telling them to do it. They're getting political pressure put on them, and that's what we want."

Miller was a coal miner, 24, when he came down with flu-like symptoms that steadily worsened. "It took me 17 years before I saw a doctor who said, 'This is what you have,'" he said. A year later, he entered Hemispherx's clinical trial in Reno, Nev. "All of my lab work was in the toilet," he said, and his immune system operating "at the level of an AIDS patient."

After six months in a regular trial, Miller had the option to keep getting Ampligen through Hemispherx's "cost-recovery" trial, which had only 100 slots and collected $25,000 to $30,000 per year from each patient, Miller said. The cost depleted his family's savings, but a year or so later, his health was nearly normal.

Vows to 'Hold the FDA Accountable'

By 2004, Miller's condition had reached a satisfactory plateau. His wife was offered a good job in Washington, and they decided to relocate. His doctor told him that about a third of Ampligen patients stay healthy after they stop using the drug, another third seem to improve even more and the final third go back to their previous status.

"We thought the percentages were good," he said.

But, after two years, his energy started to decline. "I was in denial about it, and refused to admit that I was getting sick again," he said. By the fourth year, Miller was bedridden. The housing market crashed, but "we – and I say we, but it wasn't me – my wife chose to sell everything we had and move back to Reno so I could get back on Ampligen," he said.

"I have regained my health," he said. "I can interact with my sons."

The FDA's Arthritis Advisory Committee in December heard similar testimony, but voted 8-5 against recommending approval. Miller said the panel meeting "was not about the patients. It was more of a battle between the FDA and the sponsor." (See BioWorld Today, Dec. 21, 2012.)

Hemispherx, Miller said, "is losing money, and they've been losing money since 1993 when the cost-recovery trial started. They're not going to be able to do it. Go [try to] find an investor after you've had your drug denied by the FDA."

He's not asking that the FDA put Ampligen on the market immediately, Miller said.

"I don't expect an exact plan that they're going to follow and in a few weeks' time, approve [the drug]," he said. Sufficient would be a decision to involve the NIH's many inter-agencies in an effort to help get Ampligen to patients, as took place with AZT.

"[The FDA] told us that the reason AZT happened, the reason it moved forward, was because of the patients doing the activist stuff that they did," he said. "That's what we have to do, in order for us to get treatment, and in order for them to do their job."

A glimmer of progress was made in 1999, when the Trans-NIH Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Research Working Group formed, Miller said. "Within weeks, people from almost every agency in the NIH were sitting at the table, talking about this illness, and working on what each department could be doing," he said. A year or so ago, the leader of the group, Dennis Mangan, retired. "Since then, nothing," Miller said.

With Ampligen and CFS, the government could take a similar approach, he said – could "sit down and somehow bridge the gap between the data that the FDA is looking at, and the data that the company is looking at, because it's the same data. They're looking at [the data] from different points of view."

His hunger strike has begun to gain ground online, and has knit the CFS patient population more tightly together, said Miller, who spoke with an FDA rep as late as this week.

"I made it clear that, just because they denied this, they are not going to be able to wipe their hands clean and say they are out of the picture, and somebody else has to deal with it now," Miller said. "I, and the other patients, will hold them accountable."