Critics question cervical cancer vaccine

In two years, cervical cancer has gone from obscure killer confined mostly to poor nations to the West's disease of the moment.

Tens of millions of girls and young women have been vaccinated against the disease in the United States and Europe in the two years since two vaccines were given government approval in many countries and, often, recommended for universal use among females ages 11 to 26.

One of the vaccines, Gardasil, from Merck, is made available to the poorest girls in the country, up to age 18, at a potential cost to the U.S. government of more than $1 billion. Even the normally stingy British National Health Service will start giving the other vaccine — Cervarix, from GlaxoSmithKline — to all 12-year-old girls at school in September.

The lightning-fast transition from newly minted vaccine to must-have injection in the United States and Europe represents a triumph of what the manufacturers call education and their critics call marketing.

The vaccines, which offer some protection against infection from sexually transmitted viruses, are more expensive than earlier vaccines against other diseases. Gardasil's list price is $360 for the three-dose series, and the total cost is typically $400 to nearly $1,000 with markup and office visits, and is often only partially covered by health insurance.

"One less statistic"

Advertising has promoted the vaccines. In ads on shows such as "Law & Order," a multiethnic cast urges girls to become "one less statistic" by getting vaccinated.

The vaccine makers also brought attention to cervical cancer by providing money for activities by patients and women's groups, doctors and medical experts, lobbyists and political organizations interested in the disease.

Even critics of the marketing recognize the benefits of the vaccines. Girls who get the shots are less likely to have Pap tests with worrisome results that would lead to further treatment, saving themselves anxiety and discomfort and, in those cases, saving money. When it occurs, cervical cancer is a dreadful disease; genital warts, partly prevented by the Merck vaccine, can be a painful nuisance.
But some experts worry about the consequences of the rapid rollout of the new vaccines without more medical evidence about how best to deploy them.
In the United States, hundreds of doctors have been recruited and trained to give talks about Gardasil — $4,500 for a lecture — and some have made hundreds of thousands of dollars. Politicians have been lobbied and invited to receptions urging them to legislate against a global killer.
"There was incredible pressure from industry and politics," said Dr. Jon Abramson, a professor of pediatrics at Wake Forest University who was chairman of the committee of the Centers for Disease Control and Prevention (CDC) that recommended the vaccine for all girls once they reached 11 or 12.

"This big push is making people crazy, thinking they're bad moms if they don't get their kids vaccinated," said Dr. Abby Lippman, a professor at McGill University in Montreal and policy director of the Canadian Women's Health Network. Canada will spend $300 million on a cervical-cancer-vaccine program.

Merck's vaccine was studied in clinical trials for five years, and Glaxo's for nearly 6 1/2, so it is not clear how long the protection will last. Some data from the clinical trials indicate immune molecules may wane after three to five years. If a 12-year-old is vaccinated, will she be protected in college, when her risk of infection is higher? Or will a booster vaccine be necessary?

Some experts are concerned about possible side effects that become apparent only after a vaccine has been more widely tested over longer periods.

And why the sudden alarm in developed countries about cervical cancer, some experts ask. A major killer in the developing world, particularly Africa, where the vaccines are too expensive to use, cervical cancer is classified as rare in the West because it is almost always preventable through regular Pap smears, which detect precancerous cells early enough for effective treatment.

Because the vaccines prevent only 70 percent of cervical cancers, Pap-smear screening must continue.

"Merck lobbied every opinion leader, women's group, medical society, politicians, and went directly to the people; it created a sense of panic that says you have to have this vaccine now," said Dr. Diane Harper, a professor of medicine at Dartmouth Medical School. Harper was a principal investigator on the clinical trials of Gardasil and Cervarix, and she spent 2006-7 on sabbatical at the World Health Organization developing plans for cervical-cancer-vaccine programs around the world.

"Because Merck was so aggressive, it went too fast," Harper said. "I would have liked to see it go much slower."

In receiving expedited consideration from the Food and Drug Administration (FDA), Gardasil took six months from application to approval and was recommended by the CDC weeks later for universal use among girls. Most vaccines take three years to get that sort of endorsement, Harper said, and then five to 10 more for universal acceptance.

Dr. Richard Haupt, medical director at Merck, said five years in clinical trails was normal before applying for licensing. He said Merck educated people about the new vaccine to "accelerate and facilitate access."

Spokesmen for Merck and Glaxo said all indications are that their vaccines are safe and effective, and there is no evidence a booster shot will be needed.

Need greater elsewhere?

Health economists estimated that depending on how they are used, the two cervical-cancer vaccines will cost society $30,000 to $70,000, or higher, for each year of life they save in developed countries.

Looked at another way, countries that pay for the vaccines will have less money for other health needs. "This kind of money could be better used to solve so many other problems in women's health," said Lippman at McGill. "I'm not against vaccines, but in Canada and the U.S., women are not dying in the streets of cervical cancer."

By contrast, if the vaccine were to become cheap enough to be used in the developing world, it would revolutionize women's health. Charities such as the Global Alliance for Vaccine and Immunizations, backed by the Bill & Melinda Gates Foundation, are trying to devise a solution.

The vaccines offer partial protection against infection from human papillomavirus, or HPV. The Merck vaccine also prevents some genital warts that are caused by other strains of the virus.
Cervical cancer is the second-leading cause of cancer death in women, with 500,000 new cases worldwide each year. More than 90 percent are in developing countries, according to the World Health Organization; 274,000 women died of this cancer in 2006.