WEDNESDAY, June 23, 2004 (HealthDayNews) -- A topical treatment derived from human breast milk showed great effectiveness in treating common skin warts, a new study says.
Despite its promise, experts say that, for several reasons, the salve is more than a few steps away from practical application.
"The fact that this therapy specifically killed infected cells and left others alone was really impressive, and the fact that patients experienced no side effects was also impressive, and the remission was long-lasting," said Dr. Sumayah Jamal, an assistant professor of dermatology and microbiology at New York University School of Medicine. "Having said all of that, I have no idea how this therapy would ever get cleared by the U.S. [Food and Drug Administration] because they used human breast milk."
Warts caused by the human papillomavirus (HPV) are one of the most common reasons for visits to a dermatologist. Certain strains of this virus can cause cervical cancer, but this study, appearing in the June 24 issue of the New England Journal of Medicine, was concerned only with strains that cause cutaneous warts, mostly on the hands and feet. There are about 130 different strains of the virus in all. In general, the warts aren't that dangerous, but they can be disfiguring and they can spread, Jamal said
Current therapies are inadequate for several reasons. "We don't have any truly elegant treatments for warts," Jamal said. "The treatments are destructive. We freeze them, burn them, sometimes administer chemotherapeutic drugs or laser treatments, so you wind up killing the infected cells as well as the normal skin cells. Most of these treatments are associated with considerable patient discomfort such as blistering, swelling, and pain."
The authors of this study, who worked out of Sweden, looked at 40 patients with warts -- known medically as cutaneous papillomas -- who were resistant to conventional treatment. The participants were randomized to receive α-lactalbumin-oleic acid (also known as human α-lactalbumin made lethal to tumor cells, or HAMLET) or a placebo every day for three weeks.
Thirty-one patients had functioning immune systems and had no other illnesses, while the rest were receiving immunosuppressive drugs either after organ transplantation or for an illness. (Warts tend to be more of a problem in patients with inadequate immune systems.)
The medication was purified from human milk whey obtained from the hospital milk bank.
After the first phase of the study was completed, 34 individuals participated in a second phase, an open-label trial also consisting of a three-week course of the medication. Two years after this phase ended, 38 of the original 40 participants were examined.
In the first phase, wart lesion volume was reduced by 75 percent or more in all 20 patients in the group receiving HAMLET. This effect was seen in only three of 20 patients in the placebo group.
The patients in the second phase, all of whom were treated with HAMLET, experienced a median reduction of 82 percent in lesion volume. At the end of two years, all lesions had resolved in 83 percent of those receiving the medication. There was no difference in outcomes between individuals with immune problems and those without.
Whether this treatment will ever make it into U.S. pharmacies is another matter. "The first obstacle to getting this in the States is to meet FDA requirements for using a bodily fluid on another human being," Jamal said. "The second thing is getting an ample supply of human breast milk. We have a lot of warts, and I'm not sure if milk banks here would be willing to give supplies for this purpose."
Dr. Karl Beutner, a clinical associate professor of dermatology at the University of California San Francisco, agreed. "I can't imagine getting it approved in the U.S. unless that protein has been cloned," he said. "Do you have a bunch of wet nurses donating milk? How do you get enough of it, and how do you prove it's free of all pathogens?"
FDA officials declined to comment on the the salve's chances for approval, saying that no one has yet sought it.
The purification process might also add to the cost of the treatment, Jamal added.
"Even if you wind up clearing the FDA, somehow getting tons and tons of breast milk and paring down the costs of manufacturing, then there's the aesthetic thing to be considered," Jamal said. "Are people going to want to use this? The only way I can see this really working in the U.S. is if they figure out a way to produce a recombinant version of this protein."
More information
For more on warts, visit the American Academy of Dermatology.
