Forbes’ science and medical reporter, Matthew Herper, has written an interesting and somewhat discouraging article on “the Gardasil problem” — why U.S. consumers have so far failed to embrace this six-year-old vaccine against the human papilloma virus (HPV).
HPV viruses, which are spread during sexual activity, can cause cervical, vulvar, vaginal, penile, anal and certain types of head and neck cancers. They are also responsible for genital warts. Because the HPV vaccine works best when given long before sexual activity begins, health officials recommend that both girls and boys be vaccinated when they are 11 or 12 years old.
Currently only about 30 percent of eligible girls and about 1 percent of boys have been vaccinated with either Gardasil (marketed by the pharmaceutical giant Merck) or its rival, Cervarix (marketed by GlaxoSmithKline).
Yet, as Herper notes, these vaccines have an “exceptional safety record and effectiveness rate.”
Herper places much of the blame for the failure of HPV vaccines to win the public’s confidence on “poisonous politics” and on Merck’s initially over-aggressive marketing tactics. (Gardasil was the first of the two HPV vaccines to come on the market.)
First, the politics. Writes Herper:
Drug safety, vaccines, antibiotics and reproductive medicine — all have become proxies for the culture war, often tripping up public health in the process. …
For many on the right the issue is promiscuity. Because HPV is usually transmitted through sex, it is viewed as a permission slip for lasciviousness.
For many on the left the issue is the big, bad drug companies. Merck lost credibility through its aggressive tactics marketing Vioxx, an arthritis pill that turned out to cause heart attacks. But now that taint hinders the prospects for all their products, notably Gardasil.
And both sides increasingly embrace the narrative that vaccines, one of the great success stories of modern innovation, are somehow unsafe. In many ways they’re just channeling their voters: A Thomson Reuters/NPR Health Poll last year found one in four Americans believes there are safety problems with vaccines, which experts say are among the safest medical products ever created.
Minnesota’s own Michele Bachmann didn’t help matters. Writes Herper:
[Last] September, as the Republican presidential candidates jostled for position, Representative Michele Bachmann attacked Texas Governor Rick Perry for being the first major politician to mandate Gardasil use. Rather than simply point out his ties to Merck or question his authority to do it, Bachmann asserted that Gardasil was dangerous and, on TV the next day, claimed she’d met a mother whose daughter had become “mentally retarded” because of the vaccine.
Otis Brawley, chief medical officer of the American Cancer Society, calls the episode “disastrous.” “It’s an insult that people are not looking at the evidence,” says Brawley. “It’s a tragedy that we could prevent people from dying from cervical and head and neck cancer but our society just can’t bring itself to have an open, rational, scientific discussion about the facts.”
Backlash to aggressive marketing
But, as Herper also explains, Merck must bear “more than a little responsibility for the negative response to Gardasil”:
When it was introduced in 2006, Merck was still reeling from the 2004 withdrawal of Vioxx and the resulting flood of lawsuits. Instead of going slow, as many of its own advisors recommended, Merck began an advertising push to raise awareness of the risks of HPV and began lobbying state governments to make Gardasil shots mandatory. Perry was the first to sign on. Virginia, which originally voted to make HPV vaccines mandatory, recently reversed the vote. Merck would have done better to take a stance like that of the American College of Obstetricians & Gynecologists, which strongly recommends HPV vaccines for 11- and 12-year-old girls but says they should not be mandatory.
“It would not have been the way the old Merck would have done business,” says David Kessler, who ran the Food & Drug Administration from 1990 to 1997. “It was a science-based company, not a marketing company. They would have been able to educate the medical community about the benefits, and the medical community would have adopted the product over time.”
Although the HPV vaccine could save thousands of lives annually in the United States, including many of the 4,000 American women who die of cervical cancer each year, the greatest harm from “America’s Gardasil war,” writes Herper, is occurring in the developing world:
In the U.S. the number of cases of cervical cancer is controlled by the fact that women get regular Pap smears. Among the most effective cancer screening tests ever invented, they catch precancerous growths before they turn into tumors. As a result, the main benefit of Gardasil in women who are getting regularly screened is that it prevents the painful procedure to remove the precancer.
Women in the developing world, and in poorer parts of the U.S., lack this safety net. The GAVI Alliance, the vaccination effort started by Bill Gates, is working with Merck and GlaxoSmith-Kline to try to lower the prices of the vaccines and separately to raise money to get them to these women. But it’s tougher to raise money in a political firestorm, and there’s also worry that the women whom GAVI seeks to help will be scared by the bad press in the U.S. “It certainly hasn’t helped that we have political candidates who stand up with irresponsible comments,” says Seth Berkley, chief executive of GAVI.
You can read Herper’s article on the Forbes website. It’s also in the April 23 print issue of the magazine.