IT'S BUSY AT MERCK THESE DAYS— and not just in the Vioxx legal department. Instead, the entire office buzzes with activity: Executives work late hours, finalizing the regulatory submission; conference calls echo throughout the Whitehouse Station compound, dialed in to local affiliates around the world. In other offices, scientists write up scientific papers, while communications execs buzz in on intercoms, patching the flood of media calls to top scientists.
One could witness the rattle and hum of this sort from almost any company awaiting regulatory approval for a drug. But, in fact, Merck's human papillomavirus (HPV) vaccine Gardasil is unique. Rather then a cancer treatment, Merck has taken the monumental step forward in science and developed a vaccine that prevents HPV, the virus that causes cervical cancer. FDA is now expected to review the application in June.
There are more than 100 different strains of HPV. However, only a few types are linked to cancer: HPV-16, HPV-18, HPV-31, and HPV-45. Of those, types 16 and 18 are responsible for 70 percent of cervical cancer cases, while types 31 and 45 cause about 10 percent. Women develop cervical cancer when infections from these high-risk HPV types persist. Although it could take a decade, those persistent infections cause pre-cancerous—and finally, cancerous—cells in the cervix.
HPV is the top sexually transmitted disease in the world. And it affects nearly everyone—men and women—with an estimated 80 percent of the population expected to contract the virus by age 50, according to the American Social Health Association. It used to be a big problem in the United States, before the introduction and widespread use of PAP smears, which test for cervical cancer. (Since the introduction of the PAP smear in the 1950s, the numbers of US cases of cervical cancer have dropped by almost 75 percent.) Still, many women fall through the cracks, explains Pam Rasmussen, vice president of corporate communications at Digene. Many women don't receive PAP smears, and in other cases, the tests don't catch pre-cancerous cells until it's too late. As a result, 15,000 US women are diagnosed with cervical cancer each year and 4,100 die, according to the National Cancer Institute. But the prevalence of the disease in the US pales in comparison to that in developing countries with weak medical infrastructure. Each year, worldwide, 500,000 cases of cervical cancer are diagnosed and 250,000 women die from the disease.
To turn the hope of a cancer vaccine into reality will take substantial investment. Certainly, companies must foster a national, and even supernational, understanding of the disease and the vaccine if they are to successfully carry out the steps needed to begin to eliminate cervical cancer. On order: mass vaccinations of pre-teen girls, and that's just to start.
Eliav Barr, MD, Merck's head of clinical development for Gardasil, and Gary Dubin, GSK's head clinical developer of Ceravix, have both been involved with the development of the HPV vaccines from the earliest research.
"I see this as a once-in-a-lifetime opportunity," says Dubin. "To actually be able to help in the development of a vaccine from the beginning to widescale use is not an opportunity that many of us have. I think this is going to be a vaccine that hundreds of millions of women around the world will ultimately get, that will change the way women's healthcare will be administered in many countries."