FORT WAYNE, Ind. - Stepping barefoot on a nail in April changed the path of Fred Bledsoe's life.
The puncture wound seemed innocuous, but because he's diabetic and wounds are hard to heal, Bledsoe cleaned it carefully.
The Fort Wayne man never imagined the antibiotic-resistant bacteria that infected his foot would land him in a local hospital for 10 weeks of unsuccessful treatment, then send him halfway around the world in search of a cure.
The treatment that worked, called bacteriophage, is available only in Russia and parts of Eastern Europe and the former Soviet Union. Tbilisi, in the Republic of Georgia, is the world's center for development and use of these naturally occurring viruses that destroy specific bacteria.
It is where Bledsoe found his miracle cure.
He and his family now are spearheading efforts to raise awareness about phage treatment and assist U.S. research to get U.S. Food and Drug Administration approval for its use in the United States.
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But the 46-year-old Bledsoe had to travel a difficult road before finding his cure.
He faced the bleakest of days in September, when, after 2 1/2 months of intravenous antibiotics, doctors told him only amputation would stop the spread of staphylococcus. The bacteria was creating oozing wounds on his toes, foot and leg. Dead tissue slowly crept upward.
"They actually had the amputation scheduled," he said. Then he called his sister, Saharra Bledsoe, who was out of town.
"I told him, 'Don't do anything until I get home.' I heard my mother's voice say, 'You didn't come this far to fail.' I knew God had another plan," Saharra Bledsoe said.
When she returned, she happened to see a CBS "48 Hours" show called "Silent Killers." Canadian musician Alfred Gertler told of his year-long battle with an antibiotic-resistant foot infection that was cleared using phage treatment given in Tbilisi.
From the show, Saharra Bledsoe learned of Betty Kutter, a U.S. professor who has done extensive phage research. The professor had connections to Eliava Institute, a world- renowned center for developing and manufacturing therapeutic phages.
Saharra Bledsoe contacted Kutter, who teaches at Evergreen State College in Olympia, Wash., and began making arrangements to take her brother to Tbilisi.
But Fred Bledsoe was skeptical when he heard where he was going and the method of treatment. His brother, Dr. Larry Bledsoe, a Fort Wayne internal medicine specialist, was doubtful, too.
"On the other hand, it was intriguing, the idea of viruses fighting bacteria. So, I went and researched it and found it had been used in the past in this country. There were very few side effects. I felt it was safe," said Dr. Larry Bledsoe.
The Bledsoe family chipped in and Fred Bledsoe and his sister were able to buy the $1,200-a-piece round-trip tickets to Tbilisi.
"We were treated like celebrities," she said. They were the first blacks ever to be treated at the Republic of Georgia Regional Hospital, which works closely with the Eliava Institute.
And," as far as I know, they are the first Americans to be treated there," Kutter said.
Cultures of the bacteria in Fred Bledsoe's foot were taken. Using a hypodermic needle, a phage solution, containing viruses that work against the three bacteria found in his foot, was squirted into the infected areas twice a day for two weeks. Then a phage powder was used for several days. In less than three weeks, tests showed the bacteria was gone. The wounds healed.
While in Tbilisi, Saharra Bledsoe also was treated successfully with phage for a lung infection.
"In Georgia, phages are the meat and potatoes of treatment," said Kutter, who has a Ph.D. in biophysics from the University of Rochester, N.Y. Kutter first traveled to Tbilisi in 1990 to examine bacteriophages of a specific E-coli bacterium. It was then that she learned bacteriophages were widely used there as antibiotics.
"I'm a serious, hard-core scientist. I was very skeptical. It took awhile of seeing things happen, talking to people before I started taking it seriously," she said.
Drug-resistant bacteria, such as methicillin-resistant staph aureus, or MRSA, has been a growing concern in medical circles in the United States. Staph is one of the three bacteria found in Fred Bledsoe's foot.
There has been a gradual rise in MRSA since 1980, said Dr. William Jarvis of the Health-care Quality Promotion division of the U.S. Centers for Disease Control and Prevention. Some blame over-use or misuse of antibiotics for the rise.
The "big gun" used against antibiotic-resistant bacteria has been vancomycin, but cases of vancomycin-resistant staph are cropping up too, according to the CDC.
People should understand phage treatment will not replace antibiotics, said Dr. Terry Brown, president of Intralytix, a Baltimore- based company researching agricultural and other uses for phage. The company is looking at how phages can keep meat-processing equipment and plants free of deadly bacteria such as listeria.
The company also holds the international license to make, market and distribute PhageBioDerm, a phage patch used to treat burns and other skin wounds.
Although PhageBioDerm is used in the Republic of Georgia, it is not yet available in the United States.
"As far as therapeutic products, we haven't started through the FDA process yet. We're presently working with the NIH (National Institutes of Health), who is interested in jointly going to the FDA for approval," Brown said.
Kutter said for U.S. citizens to access phage, "it will have to be manufactured here. It will not work to import it. Their standards would not meet FDA approval."
Working with phages "is a biological arms race," said Sandro Sulakvelidze, vice president of research and development for Intralytix and a Tbilisi native.
"Any alternative that can help us deal with infectious agents is good. Antibiotics are wonderful, but they will not solve all our problems. If you have vancomycin resistance emerging globally, you have a crisis in health care. You can have a tremendously successful organ transplantation, but the patient will die from secondary infection," Sulakvelidze said.
After seeing video of the hospital where his brother was treated, Dr. Larry Bledsoe said it was amazing what came from there.
"I would have probably turned around and walked away." he said, recalling broken windows, electrical wires hanging from former light fixtures and cracked flooring. There is no hot water.
Upon return to the United States in early December, Fred Bledsoe continued the inexpensive treatment - 10 ampules of phage cost $2.50 - at home for several weeks.
Now, he walks pain-free.
"The trip was expensive, but I think it was worth it. It did prevent an amputation," Larry Bledsoe said. "I'm a believer now."
So is the rest of the family.
Copyright © 2003 The News-Sentinel (Fort Wayne, Ind.). Distributed by Knight Ridder/Tribune Information Services. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
