Katherine Pistone, IL

Patients confront a lonely battle
Drug research lags on West Nile virus

By Josh Noel
Tribune staff reporter
Published October 2, 2005

When West Nile disease left her mother comatose and paralyzed in a hospital bed last fall, doctors could offer Patty Fritsch no sure remedy.

Her best option, they said, was a drug called Alferon N. Scientists are testing it as a treatment for West Nile, but so far, it has been approved only to treat the virus causing genital warts.

Fritsch felt she had no choice but to try it.

"When you're at life and death, you want the pill," she said. "The question isn't, `Will I get it?' It's, `How soon can you get it here?'"

More than 15,000 people have been infected by the West Nile virus since it reached the United States six years ago; almost 400 have died. Yet researchers say a vaccine won't be ready for at least two years. Work on treatments is lagging even farther behind, as scientists put a priority on prevention.

In the meantime, families are left to gamble on treatment and hope for recovery.

"The necessary work has been put in," said Vishnu Chundi, the infectious disease specialist who treated Fritsch's mother, Katherine Pistone, last year. "But it's moving at a snail's pace."

The mosquito-borne disease is nowhere near the threat it was in Illinois during the summer of 2002, when 884 people were infected and 67 died, according to the state Department of Public Health. But there has been a resurgence this summer, with new cases announced almost daily and four people dead, according to the state. Illinois has had the third-highest number of West Nile infections in the country this year (188), trailing California (801) and South Dakota (278).

Those most susceptible to West Nile are older than 50 and have suppressed immune systems.

Against the odds, Pistone, 64, appears to be beating the disease.

Days after getting 10 treatments of Alferon N, she opened her eyes. For months there was no movement, no speech and no recognition of anyone in her deep brown eyes.

Now, Pistone is conscious and gets around a North Shore rehabilitation facility in a wheelchair. She can lift her arms a few inches and do things that were unimaginable just a few months ago: brush her hair, feed herself, scratch an itch.

Fritsch, 38, doesn't know for sure if Alferon N caused Pistone's improvement, but she's on the Internet most days hunting for another new or experimental treatment. She'll consider anything that could help her mother continue to beat West Nile.

"If there's something that can speed up the process, we'll do it," Fritsch said.

Vaccine research began at the Centers for Disease Control and Prevention in 1999, shortly after the first U.S. cases were seen in New York, said Jeff Chang, an infectious disease research microbiologist at the CDC.

Within six months, a West Nile vaccine for animals was created based on an encephalitis vaccine, he said. There are vaccines for mice, monkeys and horses, among others.

But approving that vaccine for humans has been a slow process even though a modified version is in trials sponsored by the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health.

Chang said he is certain his vaccine will protect humans, but the trials are necessary.

"Proof the vaccine works is one side of the coin," he said. "The other side, more important, is safety."

At least two other trials for West Nile vaccines are ongoing, said Pat Repik, who leads studies on emerging viral diseases for NIAID. Some vaccines will wind up better suited for those most at risk. More robust vaccines will be better suited for younger people, she said.


However, even as interest surges from patients and health departments, industry fears simmer about whether there is actually a market for a West Nile vaccine, she said. Labs raced to find a Lyme disease vaccine when the disease dominated headlines but stopped making it when no one bought it, she said.

"Everyone is clamoring for the vaccine, but we have to see if people will actually be taking it," Repik said.

Lagging far behind and given less priority in scientific circles, is the search for West Nile treatment. The thought, said Walla Dempsey, who is leading an NIAID clinical trial, is that a West Nile vaccine will supplant the need for treatment. However, treatment still could be necessary for people with immune systems too fragile for a vaccine, she said.

At least three public and private trials are ongoing for West Nile treatments, but NIAID's trial is slow going.

The study targets 100 patients, but after three years, it is stuck at about 40 people nationwide, Dempsey said. The biggest problem has been finding patients within seven days of showing symptoms, she said.

While research continues, people such as Pistone and their families are left to fend for themselves.

Although the drug Pistone used is not approved as a West Nile treatment, Chundi said, he had no problem getting it from manufacturer, Hemispherx Biopharma, because it is FDA approved. He fed Pistone 10 doses over nine days, which is how it is being used in West Nile trials at New York Hospital Queens.

No one knows if it made a difference.

"We as doctors claim to know about a lot, but in this disease we don't really know where the outcomes are going to be," Chundi said.

Nevertheless, Pistone is getting better. She spends several hours per day in physical therapy, and her family visits daily.

She laments the horror of paralysis but maintains a bright outlook, and she even smiles as she wonders how a mosquito could so change her life.

"It upsets you that something that little can do so much damage," she said.

With no treatment or vaccine available, Chundi said, the most effective response to West Nile is simple.

"The best we can do right now is prevention," he said. "And prevention is not to be bitten by a mosquito."

----------

jbnoel@tribune.com