Jeannette Burmeister lives in Incline Village, Nev., where, twice a week, she gets a three-hour infusion of a drug to treat chronic fatigue syndrome that she says has very nearly saved her life.
But it comes at a steep price: Burmeister's husband and her 2-year-old daughter live more than 200 miles away in Menlo Park, and she's able to see them only once a week. Because the drug she says she needs - an experimental medication called Ampligen - isn't approved by the Food and Drug Administration, the only way she can get it is through a clinical trial run by a doctor in Nevada.
And as of this month, when the FDA officially refused to approve Ampligen for treatment of chronic fatigue, she's not sure how much longer she'll be able to get the drug.
"The hope was that the FDA would approve it, and once it was approved other doctors could give it to me - doctors in the Bay Area. But that didn't happen," Burmeister, 41, said. "I'm hoping the drug will remain available, but who knows."
If it had won approval, Ampligen would have been the first drug available specifically to treat chronic fatigue syndrome. The drug bolsters the immune system and works as an antiviral against a variety of pathogens, according to the manufacturer, Hemispherx Biopharma in Philadelphia. Ampligen also is being studied as a possible treatment for drug-resistant HIV infections.
Ampligen was rejected because FDA officials weren't convinced of its efficacy or its safety, according to a letter sent to the drug manufacturer. There have been concerns about the drug's effects on the kidneys and liver.
Chronic fatigue syndrome can be a debilitating disease marked by oppressive fatigue that lasts for days, weeks or even months and doesn't go away with rest or proper sleep. Burmeister describes it as constantly living with the worst jet-lag combined with the worst hangover of her life.
Other common symptoms include mental fuzziness and poor memory, sore throat and headaches, pain in the joints and muscles, and gastrointestinal problems.
The disease was identified in the early 1980s, and more than a million people in the United States are believed to suffer from it. But it's only in the past decade that chronic fatigue syndrome has received serious recognition by federal agencies like the U.S. Centers for Disease Control and Prevention and the National Institutes of Health.
Research into it is still minimal. Scientists believe it's likely caused by a virus, but they've never found it. Because there is no drug to treat chronic fatigue syndrome, patients often are advised to seek behavioral therapy to learn to live with their condition.
That's why the rejection of Ampligen was especially upsetting to so many chronic fatigue sufferers, said Dr. Jose Montoya, an infectious disease specialist who helped establish a chronic fatigue syndrome team at Stanford. Montoya said he isn't convinced of Ampligen's effectiveness, but he fully appreciates the frustration that patients, and their doctors, feel at having nothing to ease their symptoms.
"I have been very hesitant to use it, and I have never indicated it or prescribed it," Montoya said. "But it appears there is a group of patients that do benefit from Ampligen. And with that FDA decision, you are taking away access. It's a huge blow to the patients.
"On the other hand," he added, "we're another step toward bringing the disease to a center stage of government agencies. We're making them see that this is an unmet medical need and something needs to be done."
One man in Reno, who gets the drug from the same doctor who treats Burmeister, went on a hunger strike for 11 days over the FDA rejection. Robert Miller started eating again earlier this month, after the U.S. secretary of health's office promised to participate in a meeting between the FDA and patients, doctors and drug manufacturers this spring to discuss research into chronic fatigue.
Many patients said they understand why the FDA rejected the drug, which may be effective in only a subset of chronic fatigue sufferers. Ideally, said Miller, federal agencies would work with the drug manufacturer to conduct more clinical trials and figure out who would benefit from Ampligen. Such research might also help scientists understand what causes chronic fatigue syndrome and find new drugs for treatment.
Hemispherx may continue research on the drug and reapply for approval - a process the company has gone through once before - but patients worry that because Hemispherx is a small company, it may not have the resources to conduct more trials that will meet the FDA's approval requirements. Already, patients are required to pay roughly $20,000 a year, almost none of which is covered by insurance, for the Ampligen they take in clinical trials.
If Hemispherx abandons its research, Burmeister said, she probably won't be able to get the drug at all, and she is convinced that her chronic fatigue symptoms will return.
Before she started taking Ampligen nine months ago, she wasn't able to walk three blocks to take her daughter to the park, and just changing a diaper was taxing enough to send her back to bed.
"But five months into being on the drug, I could go shopping and do laundry and empty the dishwasher, all in one day. I could have coffee or lunch with friends. I hadn't socialized in years.
"If I can't get the drug anymore, I will relapse fairly quickly and go back to needing a wheelchair for more than a block, and spending most of my time in bed or on the couch," she said. "There's literally nothing else for me."
Erin Allday is a San Francisco Chronicle staff writer. E-mail: firstname.lastname@example.org