The Food and Drug Administration doesn't allow companies to manufacture medical devices in vermin-infested facilities.Gareth Morgan, Associated Press
A researcher is framed by a dish containing maggots, which are approved by the FDA as "medical devices."
Click photo for larger image.
So how did Dr. Ronald Sherman, a California physician who has been providing maggots to doctors for years, get the FDA to bless his lab of legless grubs?
"We have a room in another building and we carry the eggs there from our maggot lab," he said. "We process them there and, by the time they hatch as maggots, they're medical devices."
The FDA ruled in January that Sherman can market his maggots to surgeons looking to remove dead tissue in a variety of ulcers, as well as for treating surgical wounds that aren't healing.
The insect larvae readily seek out dead tissue and eat it.
But the approval wasn't widely recognized prior to last month. FDA officials mentioned the maggots during interviews explaining the agency's June decision to allow the marketing of leeches as medical devices.
The approvals were two steps forward for an odd area of medicine that Sherman calls "biotherapeutics," a group of treatments that deploy living animals to advance the health of humans. In addition to working as a researcher at the University of California Irvine and for a public health department, Sherman runs a charity to promote these treatments called the BioTherapeutics Education & Research Foundation.
While the foundation's Web site describes seven such treatments, maggots and leeches apparently are the only ones that have ever been approved as medical devices by the FDA.
"We've approved plenty of animal products, but as far as other full-bodied, living organisms as treatments for something? No," said John Swan, historian at the FDA. "I don't know where I'd begin to look for it."
Early 20th century medicine provides one example, although it likely wasn't approved by the government.
As doctors struggled to help patients suffering from syphilis in the pre-antibiotic era, some patients were given the parasite that causes malaria in hopes that the resultant fever would burn off the bacterial disease, said Dr. Thomas Benedek, an emeritus professor of medicine at the University of Pittsburgh. Dr. Julius Wagner-Jauregg of Austria inoculated nine patients with the parasite, and six saw significant remissions.
Wagner-Jauregg won the Nobel Prize for the discovery in 1927, Benedek said. Doctors found that the best way to inoculate patients was to give them a shot of malarial blood.
But they tried other means.
"Initially, they just exposed patients to a bunch of mosquitoes and hoped that one carrying malaria would bite," Benedek said.
The malaria parasite isn't one of the biotherapeutic options described by Sherman's foundation. But the group is interested in whether the helminth, a parasitic tapeworm, can help calm bouts of inflammatory bowel disease.
Among other biotherapeutic options, ichthiotherapy involves letting fish nibble away at wounds to clean out dead tissue, not unlike what happens with maggot therapy. You won't find many ichthiotherapy practitioners at your neighborhood hospital, but it is practiced in Turkey, India and a few other countries, according to Sherman.
More people in the United States have paid attention to apitherapy, which tries to tap the healing powers of bee venom, but getting stung for a cure remains outside the mainstream.
Leeches and maggots, though, are practically golden.
Sherman knows of two U.S. companies that distribute leeches to surgeons, who use the critters to suck out blood that can accumulate in tissues following surgeries to re-attach fingertips, earlobes and the like.
Sherman says he's the only game in town when it comes to the U.S. maggot market -- he supplied 900 treatments last year. But Europeans go through about 30,000 treatments a year, he said, with four companies competing.
Socialized health care in Europe is one reason for the popularity, Sherman believes, since practitioners there don't have the same incentives to promote surgical or high-tech treatments.
Dr. Dan H. Gottwald, an orthopedic surgeon at Warren General Hospital, agreed that there's not much money in maggots.
"Every time I have used these, I have bought them myself and paid out of pocket," he said. "I've tried dealing with people in the insurance industry [to get reimbursement], but it's just a lot of head-banging."
Gottwald has used maggots in about 10 or 15 cases, including one just two weeks ago. Stephen Devore, 6, got a foot caught under a riding lawn mower.
Despite surgical cleaning efforts, the dying tissue combined with lawn debris in the wound created such an infection risk that Gottwald suggested maggots.
"It grossed me out, but it needed to be done," said Wendi Devore, the boy's mother. The family calls the treatment "special medicine" when talking to Stephen.
During a surgery July 2, Gottwald scooped about 400 maggots from a jar and placed them on the wound. The wound is bandaged afterward so they don't escape.
Gottwald usually removes the maggots within 48 hours. Some patients feel discomfort, and that was true for Stephen, who received morphine to deal with the pain, his mother said.
There's a lot of fluid produced while maggots work, and it can stink, Wendi Devore said. Gottwald applied more maggots Wednesday and said a third treatment might be necessary.
Despite the unpleasantness of the therapy, the alternatives of infections and possibly losing a limb are worse.
"The problem is, people get seduced by today's technology and they forget the basics of wound care," he said. "The bottom line is: You cannot have dead tissue in the wound and have things go well."
Sherman sold maggots without FDA approval for years because he'd been told FDA doesn't regulate the critters, he said. But two years ago, when he approached FDA again at the request of the University of California, the agency said he did, in fact, need FDA approval.
"The FDA approval for the maggots is based on a number of things including the strain that we use, but also the method of manufacturing, supplying and labeling the maggots," Sherman said.
Christopher Snowbeck can be reached at firstname.lastname@example.org or 412 263-2625.