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Reno man on hunger strike after FDA rejects drug

Fri, 02/08/2013 - 2:02pm
JEFF DeLONG - Reno Gazette-Journal - Associated Press

A Reno man suffering from a debilitating disease is on a hunger strike as he tries to raise public attention about the condition and the government's decision not to allow use of a drug he said can dramatically improve the lives of those afflicted.

Feb. 5 was the eighth day Robert Miller, who suffers from Chronic Fatigue Syndrome, abstained from food in an effort to shine a spotlight on a still little-understood disease he said affects one million Americans.

He was feeling pretty poorly, but then that's something to which he's grown fairly accustomed.

"This feeling is not new to me, but it's not a feeling I want to have," Miller, 54, told the Reno Gazette-Journal (http://on.rgj.com/WI44CD). "I'll take this as far as I have to. The point is to get (the government) to move forward."

Miller started his hunger strike Jan. 29 in anticipation of a decision by the U.S. Food and Drug Administration not to approve use of the drug Ampligen to treat victims of Chronic Fatigue Syndrome, or CFS. That decision was announced Feb. 4.

In a letter posted on the FDA's website, the agency said it had completed review of an application by the drug's manufacturer, Hemispherx Biopharma Inc., and that the administration "cannot approve the application in its present form."

The decision not to approve the drug took into account factors like "safety and efficacy data" and advice from an FDA committee that held a hearing Dec. 20 on the drug, according to the FDA letter.

"The majority of (committee) members were concerned about the lack of consistency within the clinical trial results, as well as the limited size of the database available to evaluate Ampligen," the letter said. "The members shared FDA's concerns, as well, about how the studies had been conducted, including multiple discrepancies and gaps in the safety data."

The FDA letter acknowledged patients' feelings.

"We are acutely aware of the seriousness of this disease, that no FDA approved treatments are available, and of the community's strong desire to see (the drug) approved," the FDA said. "... We understand the frustration and pain of ... patients and their caregivers, and how important it is that we continue to work toward development of treatments."

To Miller, the decision likely means a descent into misery.

"It means I'll slide back," Miller said. "And it's not just me. Where we're going is back to our beds and being chained to our houses."

Miller traces his illness back to 1982 when he developed what he thought was a flu that simply wouldn't disappear. Symptoms came and went over the years, sometimes improving enough to allow him to work, then worsening to the point he lost whatever job he was trying to hang onto. He slept constantly.

Like many suffering from CFS, Miller sometimes had difficulty convincing even family members he suffered from a serious physical disease and not a psychological condition. It's a stigma he said still hasn't completely disappeared despite significant research advances.

At times, Miller said, "you're so sick you can't lift your head and you're in constant pain."

Miller moved to Reno from Las Vegas in 1998, largely to seek treatment from Incline Village-based physician Daniel Peterson, a pioneer CFS researcher. The following year, Miller was a participant in one of the first trials of Ampligen for treatment of the disease.

Miller has been on and off the drug ever since and, to him, there's little doubt as to its value.

"It was huge," Miller said. "It was like a little light started shining again. You could feel the life creeping back."

Miller is at something of a loss to explain why federal health agencies have rejected Ampligen as a treatment for his condition. He expects Monday's decision will put Hemispherx out of business and that the drug will soon be unavailable to anyone.

"The only thing I can think is none of them want to be the first to show they truly believe this to be a biological illness that affects a million people in this country," Miller said.

The FDA called CFS "a serious disease" and said "treatments for it represent an important area of unmet need."

Miller said he plans to continue fasting — taking only water and a saline solution to help address kidney problems that have already arisen — until he gets a commitment from the U.S. Secretary of Health that steps will be taken to make Ampligen available to those afflicted with CFS and that expanded research into the disease will be conducted.

He cites widespread support from other CFS sufferers. He's saved a recorded telephone message from one thanking him for his "bravery and courage" for doing what he's doing.

"I'm not doing this alone," Miller said. "This is not a one-man band."

His wife, Courtney, backs him up. So do his 12-year-old twins, Alex and Dan, who were conceived through in vitro fertilization using sperm frozen before Miller started using Ampligen as a precaution against any potential birth defects.

Courtney Miller acknowledges concern over the hunger strike but also understands what her husband is trying to accomplish.

"Something has to change," she said.

To Miller, the decision likely means a descent into misery.

"It means I'll slide back," Miller said. "And it's not just me. Where we're going is back to our beds and being chained to our houses."

Miller traces his illness back to 1982 when he developed what he thought was a flu that simply wouldn't disappear. Symptoms came and went over the years, sometimes improving enough to allow him to work, then worsening to the point he lost whatever job he was trying to hang onto. He slept constantly.

Like many suffering from CFS, Miller sometimes had difficulty convincing even family members he suffered from a serious physical disease and not a psychological condition. It's a stigma he said still hasn't completely disappeared despite significant research advances.

At times, Miller said, "you're so sick you can't lift your head and you're in constant pain."

Miller moved to Reno from Las Vegas in 1998, largely to seek treatment from Incline Village-based physician Daniel Peterson, a pioneer CFS researcher. The following year, Miller was a participant in one of the first trials of Ampligen for treatment of the disease.

Miller has been on and off the drug ever since and, to him, there's little doubt as to its value.

"It was huge," Miller said. "It was like a little light started shining again. You could feel the life creeping back."

Miller is at something of a loss to explain why federal health agencies have rejected Ampligen as a treatment for his condition. He expects Monday's decision will put Hemispherx out of business and that the drug will soon be unavailable to anyone.

"The only thing I can think is none of them want to be the first to show they truly believe this to be a biological illness that affects a million people in this country," Miller said.

The FDA called CFS "a serious disease" and said "treatments for it represent an important area of unmet need."

Miller said he plans to continue fasting — taking only water and a saline solution to help address kidney problems that have already arisen — until he gets a commitment from the U.S. Secretary of Health that steps will be taken to make Ampligen available to those afflicted with CFS and that expanded research into the disease will be conducted.

He cites widespread support from other CFS sufferers. He's saved a recorded telephone message from one thanking him for his "bravery and courage" for doing what he's doing.

"I'm not doing this alone," Miller said. "This is not a one-man band."

His wife, Courtney, backs him up. So do his 12-year-old twins, Alex and Dan, who were conceived through in vitro fertilization using sperm frozen before Miller started using Ampligen as a precaution against any potential birth defects.

Courtney Miller acknowledges concern over the hunger strike but also understands what her husband is trying to accomplish.

"Something has to change," she said.

___

Information from: Reno Gazette-Journal, http://www.rgj.com

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