States Step Back From Vaccine's Promise: Cervical Cancer Shots Victim Of Wariness

May 20, 09:20 AM

Current Headlines: By Hilary Waldman, The Hartford Courant, Conn.

May 20--For a brief moment this past winter, a new vaccine that can prevent most new cases of cervical cancer seemed like one of those motherhood-and-apple-pie issues for state governments.

Lawmakers jumped on the bandwagon quickly, with 25 states -- including Connecticut -- proposing laws that would require the shots for girls as young as 11 or 12.

But as legislative sessions wind down this spring, only Virginia has passed such a mandate. Here, and in most other places, the efforts to make it a requirement for middle school enrollment appear to be dead -- at least for now.

The lack of support has very little to do with the vaccine's efficacy. Studies show that a three-shot series of the Gardasil vaccine can prevent infection from strains of the HPV, or human papillomavirus, that cause 70 percent of cervical cancers in women who have not yet become sexually active.

Instead, a confluence of factors -- all influential in so many aspects of the national health care debate -- weighed in to help quash efforts to make the vaccine a legal requirement.

First, suspicion was touched off in January when the pharmaceutical company Merck & Co. launched an expensive and aggressive advertising campaign and bankrolled lobbying efforts pushing state legislatures to require its HPV vaccine, Gardasil, for young girls entering middle school.

The vaccine had been approved by the U.S. Food and Drug Administration only six months earlier. Many saw the drugmaker's hard sell as too much, too soon -- particularly in a country already stung by deaths associated with drugs such as Vioxx, which were FDA-approved and then yanked from the market.

Combine national wariness with a vaccine that costs more than any other in U.S. history; skimpy or non-existent insurance payments to doctors; and concern from social conservatives that a vaccine to prevent a sexually transmitted disease might promote promiscuity, and efforts to mandate the HPV vaccine ended up on the legislative back burner.

On top of all that, while cervical cancer remains a serious disease, it is not a public health crisis in the United States.

Regular pap tests can detect pre-cancerous cell changes that can be treated before they become deadly. About 3,700 women die of cervical cancer in the United States each year -- compared with more than 40,000 deaths from breast cancer -- although the number is much higher in the developing world.

"I think a lot of it was a lot of issues and a lot of factors happening at the same time," said Alina Salganicoff, vice president and director of Women's Health Policy for the non-partisan Kaiser Family Foundation. "Everybody ran out of the gate really fast and everybody said, 'Whoa, let's slow down here.'"

At a public hearing in Hartford this winter that set the groundwork for the ultimate legislative defeat, a broad cross-section of physicians, public health officials and women's advocates agreed that a vaccine to fight the deadly cancer is a laudable goal.

But it was the cautionary words of experts such as James Hadler, head of the Connecticut Department of Public Health's infectious disease section, that sealed the mandate's fate.

"Some vaccines have been shown to have unanticipated side effects when they go into wide use during the first year," Hadler told members of the Connecticut legislature's public health committee in February. He suggested that lawmakers wait at least two years to ensure that the vaccine is safe and that there is enough to go around before they consider requiring it.

That was among the arguments that convinced state Sen. Mary Ann Handley, D-Manchester, co-chairman of the public health committee, to back off a vaccine mandate this year.

"Conversations with constituents and public health people suggested that maybe that euphoria should be restrained," Handley said.

The editor of the Journal of the American Medical Association concurs.

"Years from now, when additional data and experience better inform clinicians and policy makers about the risks and benefits, states might consider requiring the HPV vaccination as a condition of school entry," wrote Catherine D. DeAngelis, editor of JAMA and co-author of an editorial published in the journal this month.

By then it is also possible that at least one other drugmaker, GlaxoSmithKline, will have won approval for a competing vaccine, which might drive down the cost.

For now, the vaccination is approved for young women from 9 to 26 years old and is available at most physicians' offices, although there have been insurance-coverage problems.

"People are excited and feeling very positive about the possibility of preventing cervical cancer," said Salganicoff of the Kaiser Family Foundation. "But we're not ready to move so quickly on this."

The death of most cervical cancer vaccine legislation -- including Connecticut's, which was never voted out of the public health committee -- does not mean that HPV will not someday join measles, mumps and rubella on the list of vaccines required for schoolchildren.

It is likely that the discussion of a school requirement will come back.

In fact, about the same time bills that would require the vaccine for girls were dying on most state capital vines, evidence was mounting that the vaccine may benefit boys as well.

Last week, a newly published study linked the HPV virus to certain types of throat cancer among people infected through oral sex. The incidence of oral cancer has not dropped in the United States, despite a decline in the major risk factor, smoking, leading researchers to suspect that HPV might be a culprit.

"It makes it absolutely clear that oral HPV infection is a risk factor," said Maura L. Gillison, an assistant professor of oncology and epidemiology at Johns Hopkins in Baltimore, who led the study published May 10 in the New England Journal of Medicine.

Contact Hilary Waldman at hwaldman@courant.com.

-----

Copyright (c) 2007, The Hartford Courant, Conn.

Distributed by McClatchy-Tribune Information Services.

For reprints, email tmsreprints@permissionsgroup.com, call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.

NYSE:MRK, NYSE:GSK,