Wednesday, June 30, 2004

Giving a sucker an even break

FDA clears marketing of leeches

By Peggy O'Farrell
Enquirer staff writer

The Food and Drug Administration's decision to allow leeches to be commercially marketed as medical devices gives an official stamp of approval to a practice that's been used for decades.

As gruesome as it sounds, leeches are widely used to help patients heal after skin grafts or surgeries to re-attach fingers, toes, lips or other extremities damaged by trauma.

The FDA's decision Monday gives the agency the right to review information on how leeches are fed and handled by firms that supply the bloodsuckers. A French firm was the first to get approval from the FDA. The new rule applies only to suppliers that are new to the market.

Dentist Marc Silverman credits the bloodsuckers - a segmented worm related to night crawlers - with saving his ear in 2002 after it was nearly sliced off in a bad fall. His surgeon applied leeches near the suture area, which helped regulate blood flow in and out of the injured ear.

Silverman, of Symmes Township, admits it was "kind of freaky" to see the leeches feeding on his ear.

But it was worth it, Silverman said.

"Right when they put them on, you can hear them sucking a little bit," he said. "I don't know if it saved my life, but it sure saved my ear. It kept the circulation flowing."

Dr. John Kitzmiller, a plastic surgeon at the University of Cincinnati, estimates he uses leeches "a couple of times a year."

They're most commonly used for replantation, or re-attachment, procedures when no functional vein is available in the injured area, Kitzmiller said.

Without a functional vein, blood can't flow out of the injury site, so it pools and prevents the tissue from healing, he said.

"The leeches have an enzyme in their saliva that allows a little bit of oozing at the bite site, and that allows just enough decompression to let the blood out while the capillaries are re-forming in the affected region."

The enzyme, hirudin, is a blood-thinning chemical similar to heparin and other anti-clotting drugs. But leeches can be applied only to the injury site, while drugs are systemic and can be harmful to patients already weakened by trauma and surgery, Kitzmiller said.

Dr. Christopher Gordon, a plastic surgeon at Cincinnati Children's Hospital Medical Center and UC, once used leeches to help a child whose lip had been bitten off in a dog attack.

"Because of the gross aspect of the leeches, we had to keep her under sedation while she was in the ICU, and the family was kind of weirded out," he said. But the procedure worked, and the child's lips healed.

Leeches were used for centuries by healers and physicians in the belief that bleeding the patient would release harmful "humors" and heal disease. That practice stopped in the mid-19th century - when doctors realized the blood loss was harming and, in some cases, killing the patient.

Rudy Rosenberg, vice president of Leeches USA Ltd., the largest medical supplier of leeches in the United States, said the FDA's decision won't have much effect on the industry.

Rosenberg wouldn't say how many leeches his company, based in Westbury, N.Y., sells annually, but adds, "it's not a huge business."

Now, leeches can be delivered by air round-the-clock, Kitzmiller said. "You call a 1-800 number, and they Fed-Ex them in."

When he was a resident, one of his duties was to help maintain the hospital's leech colony - something most major hospitals had at the time.

"They're pretty low-maintenance," Kitzmiller said. "You have to keep them hungry."


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