Chronic Fatigue Patients Fight to Get Drug Approved
`It Gave Me Back My Life'
Chronic fatigue syndrome seemed to first surface in the U.S. in the early '80s, but scientists believe it is the same illness that befell Florence Nightingale. That is why her birthday - May 12 - has been marked as CFS Awareness Day.
By Jenifer Joseph
ABCNEWS.com
Anita Patton dissolved her retirement account to get the $15,000 needed to pay for six months worth of the drug.
Karen Lang borrowed against her life insurance policy to come up with the money. And Linda Barossi sold her burgeoning flight school business and moved to Nevada to be closer to a source of the drug.
What could possibly get these women to take such drastic measures?
All three have Chronic Fatigue Syndrome, and they were among the lucky 20 CFS sufferers in the United States who were chosen for a six-month trial of a new drug called Ampligen.
"It's given me my life back," says Patton, who hasn't felt this good since she came down with the debilitating illness 12 years ago, at age 24.
A few months ago, she was unable to walk, think straight, and at times even hold her head up. Now, thanks to Ampligen, she lifts weights at the YMCA three days a week, shops, cooks dinner and plays with her three children.
Karen Lang's husband had to carry her to the bathroom and up and down stairs; now she can do it all herself.
Who can blame them for shelling out the bucks and rearranging their lives, says Dr. Marsha Wallace, a Washington internist and drug investigator. "These people are desperate for a drug that works. If three people did well on the drug, suddenly everybody wants it."
Tiny Company, Big Hurdles
Dr. William Carter, founder of Hemispherx, the company that makes Ampligen, is feeling feverish about the next few months. The drug is about to undergo its most rigorous test to date. Then, he hopes, he'll finally have the conclusive data he needs to make doctors sit up and take notice and to silence his critics.
In earlier studies of Ampligen, many of which were done outside the United States, more than 50 percent of patients showed significant improvements in physical and mental abilities.
The problem, however, was that the number of patients studied was too small, usually only in the double digits-too few for the studies to be published in peer-reviewed journals.
For the new round of trials, scientists in five states will study 200 people, half of whom will receive simple saline solutions in their IV bags rather than Ampligen. And this time, patients won't have to put up cash to participate.
The drug is expensive because Carter's 14-employee company can't afford the necessary mega-production like behemoth pharmaceutical companies such as Merck or Eli Lilly.
Brain Fogs and Wheelchairs
In an effort to get the drug on the FDA's fast-track approval list, a group of CFS patients rallied in Washington last Tuesday on CFS Awareness Day. But nobody seemed to be paying attention. Bob Patton, Anita's husband, has been chatting up U.S. representatives about Ampligen with little success.
"It's a bureacratic mess," he says. "And meanwhile, patients are severely ill. That's the government for you."
Because there's so little solid research on the drug, doctors can't even say for sure who it will help and what dosage should be given. Those answers should come out of the new trials.
"It may not help everyone," says Karen Lang, "but they at least deserve the chance to find out."
Mary Schweitzer is another CFS sufferer eager to know whether it will work. The Villanova history professor had a "brain fog" so thick last month that she poured an entire pot of coffee into the silverware drawer and couldn't figure out what she'd done wrong.
And 15-year-old Emilie Sutterlin wants to find out, too. She attends a special science and technology high school for gifted children yet often can't remember what 10 times 10 equals.
"I miss going out with friends, and I miss baseball," says the teen, who now needs a wheelchair to get around. "But I can't do these things even if I want to."
How Does Ampligen Work?
Patients with CFS seem to be missing certain antiviral material in their immune systems, and Ampligen ingeniously takes the place of the missing material. According to Dr. Marsha Wallace, here's how it works: Most, if not all, cells in the body contain an anti-viral defense system called the RNase-L pathway. By interfering with the cells' reproduction of viruses and destroying the viral RNA, it appears to prevent cellular damage. A few days after a person becomes ill with a virus, the level of RNase-L rises and then falls. Scientists believe that this activation of RNase-L allows a patient to develop immunity and produce antibodies to the virus.
But some viruses beat this defense mechanism by inactivating the RNase-L. Ampligen seems to reverse this process and stop an overly active defense system. Patients taking Ampligen receive twice-weekly infusions; the drug's molecular structure is too fragile to be put into pill form.
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