The Pros (and Not Many Cons) of Merck’s HPV Vaccine, According to UW’s Laura Koutsky
Everyone has human papillomavirus (HPV) crawling all over our skin. This usually doesn’t cause us any harm, but in about 11,000 cases a year in the U.S., sexual activity leads to an infection that causes cervical cancer, which kills about 3,800 women a year.
This basic fact is at the root of a revolution in the world of vaccines. New understanding of various strains of HPV has unleashed a multi-billion dollar vaccine from Merck marketed as Gardasil, paved the way for a new generation of vaccines in development, and sparked controversy about the ethics of mass vaccination among young girls before they become sexually active.
Vaccines have been on my mind lately because I’m preparing for Xconomy’s Vaccines 2.0 event coming up next week. So I decided to get a dose of the subject by going to a talk by University of Washington epidemiologist Laura Koutsky last night. She spoke at T.S. McHugh’s at a meeting of Science on Tap, a group that aims to make science accessible to the public with informal talks over a beer.
Koutsky’s talk was titled “The Pros and Cons of HPV Vaccines.” although she didn’t really spend much time on the cons. She has reason to be an enthusiast—she’s credited with playing a key role in the development of the Merck vaccine, through UW trials that date back to the late 1980s. The fruit of the labor is a vaccine that’s been found 100 percent effective at building immunity against infection with four strains of HPV that cause 70 percent of cervical cancers, and about 90 percent of genital warts, she says. This has prompted the American College of Obstetricians and Gynecologists to recommend that all 11 and 12-year-old girls get the vaccine before becoming sexually active, a recommendation that has sparked a bit of outrage among evangelicals who claim this is promoting promiscuity. This is clearly not Koutsky’s favorite group of folks.
“You can go online and find out all about why this is a horrible vaccine, it’s a horrible company, and why you should be worried,” Koutsky said. “In reality, it’s not true.”
Much of the bad publicity has been generated by 27 deaths reported among girls on the vaccine. What many people fail to appreciate is that 20 million injections have been given worldwide, and none of the deaths have been attributed to the vaccine, Koutsky said.
The other controversy—one that Koutsky doesn’t dismiss as easily—is the debate over pricing. Gardasil sells for $375 for a three-shot regimen spread over six months. That’s a big reason why the vaccine generated a whopping $1.5 billion in sales in 2007, its first full year on the market.
My question to Koutsky was whether this high price creates too big of a barrier to usage in the developing world, where about 80 percent of the world’s cervical cancer occurs. She deferred on that question to Vivien Davis Tsu, a senior program adviser for reproductive health at Seattle-based PATH, who was in attendance. Tsu’s answer was that it’s a big challenge getting people vaccinated around the world because of price, and because public health authorities are most accustomed to vaccinating babies, not young girls, and so systems need to be set up in schools or community centers. The Global Alliance for Vaccines and Immunization considered whether to put a lot of its money into purchasing HPV vaccine for people in the world’s poorest 72 countries, with per capita annual incomes of less than $1,000, but a vote was postponed at the end of October while the alliance figures out how to best allocate its money during the financial crisis, Tsu said.
Koutsky, who said she doesn’t own Merck stock or receive any payment from the company, said she’s hopeful that competition will bring down the price over time. GlaxoSmithKline’s vaccine Cervarix, which isn’t yet approved by the FDA, could offer a competitive threat that brings down the price over time, she says.
Since this talk is called Science on Tap, I should probably relate some of the science Koutsky covered. One reason HPV is such a good candidate for a vaccine is that its viral genome is stable, and not constantly mutating and creating a moving target for a vaccine, like HIV does. The outer shell of the virus is also highly immunogenic, which means that it provokes antibodies to fight it right away. The vaccine is also made by using yeast cells as miniature drug factories, which means that Merck pays a royalty to the Washington Research Foundation on the latter’s intellectual property for making proteins in yeast. That could be a boon to the UW for years to come, since that vital intellectual property doesn’t expire until 2014.
Even though she didn’t point to many cons to the vaccine in her prepared talk, Koutsky had a pretty balanced view of the pharmaceutical industry when pressed. She encouraged some of the young scientists in the audience to consider jobs at Merck, but to go in with their eyes wide open. “The scientists at Merck are top-flight,” she said. “I’d encourage you to look at it, because they have tremendous resources and a tremendous agenda to get something done. Sometimes in the public sector we wonder what the heck we’re working on, and what we’re trying to accomplish.”
But all that focused energy sometimes means that science takes a backseat. Afterward, Koutsky related a story that Tsu told her, that HPV vaccine is being marketed to older women in Argentina who have the money to pay for it, even though it’s most effective for young women before they become sexually active. “Once you have a product in the pharmaceutical industry, then marketing becomes involved,” Koutsky said.