MetroWest Medical Center has won town health board approval for a drug trial to treat the most common sexually transmitted infection.
With the backing, MetroWest Medical can soon join a 58-site nationwide clinical trial for a drug from pharmaceutical giant the Roche Group for human papillomavirus, or HPV.
HPV is passed through genital-to-genital contact and oral sex, with at least 50 percent of sexually active Americans getting it at some point in their lives, according to the Centers for Disease Control.
in most cases, HPV infections are not serious, and they typically go away without treatment. But some types of the virus can lead to genital warts. And some strains are the main cause of cervical cancer, a disease that kills 12,000 American women yearly and does not have symptoms until it becomes advanced.
Both vaccines on the market – Merck's Gardasil and GlaxoSmithKline's Cervarix – are recommended for girls ages 11 and 12, although they can also be given up to age 26 for those who did not receive shots earlier in life or did not complete the series. Gardasil is also approved for boys and men ages 9 to 26.
But the existing vaccines provide prevention, rather than a cure. Roche's drug is meant to treat the abnormal appearance of cells on the cervix, a condition called dysplasia that is caused by HPV and can lead to cancer. Rather than attack the virus directly, the liquid injection delivers a protein similar to one found in HPV, priming the immune system to release antibodies.
the drug is a biologic, meaning it's created not through the old method of using chemistry equipment to create medications but rather through living organisms. like most other drugs in the growing biologics category, Roche's tweaks the DNA of the organism – not publicly identified by the hospital because it's a Roche trade secret – for production.
That was the initial rub with the health board, since Framingham has an unusual bylaw dating to the late 1970s or early '80s banning the use of humans in drug trials involving genetically modified organisms.
MetroWest Medical raised the possibility of changing the bylaw with the health board or receving a permanent exemption but received a variance just for the trial instead.
"We're very satisfied with this," said Gary Johnson, MetroWest Medical's research director. "what we need to do is demonstrate this can be done safely and effectively here."
the health board decided it would proceed on a case-by-case basis, with Genzyme Corp.'s biologics not at issue because it does not test them on humans in Framingham.
Health Board Chairman Mike Hugo, a former vaccine injury attorney, said his board doesn't plan to be unreasonable when assessing clinical trial requests and just wants to stay informed.
"This presents some great opportunities for the town," he said of the trial and others that may follow.
Town Health Director Ethan Mascoop and resident Carol de Groot-Bois will sit on a hospital biosafety advisory committee, which must still sign off on the HPV trial. Once it does so, the hospital will ask for referrals from doctors. it will look to enroll eight women who are over age 18 and diagnosed with an HPV infection and more serious dysplasia. some of the women will receive a placebo, although neither they nor the researchers will know whom so the study's integrity is maintained.
"They're not being shortchanged right now, because we don't know if it works," Johnson said of the control group, who will still receive surgery when needed to remove cells on the cervix.
even if vaccinated, women still need regular pap tests to screen for cervical cancer.
(Michael Morton can be reached at or 508-626-4338.)