Will states follow Texas on HPV shot mandate?

In early February, 18 state legislatures were considering a mandate. Some doctors have raised concerns about the drugmaker's involvement in the push.

By Kevin B. O'Reilly amednews correspondent — Posted Feb. 26, 2007

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Pediatric and family physician leaders are taken aback by the speed with which Merck & Co. Inc. has lobbied states to mandate its new human papillomavirus vaccine. Academy officials say safety and cost concerns about the cervical cancer immunization need to be addressed before school girls are forced to get it.

Texas Gov. Rick Perry's February executive order made his state the first to mandate the HPV vaccine for girls entering the sixth grade. The order does allow parents to exempt their children for medical, religious or philosophical reasons.

Nationwide, 18 other states are considering bills to mandate the HPV vaccine for school entry, and 28 states have considered some kind of legislation related to the drug, such as education about the vaccine or insurance coverage mandates.

The Texas Medical Assn. came out against Perry's executive order, as did the American Academy of Family Physicians and the American Academy of Pediatrics.

In a statement, the AAFP said it is "premature" to consider HPV mandates because "the long-term safety with widespread use, stability of supply, and economic issues" need to be clarified.

AAFP President Rick Kellerman, MD, said problems can crop up with a vaccine after it goes to market. He cited as an example Rotashield, which was FDA-approved in 1998 to immunize against rotavirus but withdrawn from the market a year later after 76 cases of intussusception were reported.

Joseph A. Bocchini, MD, chair of the AAP's Committee on Infectious Diseases, agreed that "it's too early to consider mandates. There are other priorities that are more important right now."

Dr. Bocchini said priorities include figuring out how to ensure everyone can afford the $360, three-dose vaccine; and educating parents and young women about the prevalence of the sexually transmitted virus, the risks of cervical cancer and the effectiveness of the new vaccine.

Ripple effect feared

Other physicians were concerned that a rush to mandate the HPV vaccine could lead to a backlash that could hurt the childhood vaccination system as a whole.

"There are highly vocal individuals and groups who say we are abusing parent rights and children by one-size-fits-all mandating immunization. This gives them more ammunition to say that the vaccine makers and the government and the doctors, that all they want to do is push the vaccine and make money," said Louis Z. Cooper, MD, a member of the National Network for Immunization Information's steering committee.

Wall Street analysts estimate that state mandates could help Merck generate billions in revenue with the new vaccine, marketed as Gardasil. In November 2006, the drug manufacturer launched a national print, TV and online direct-to-consumer advertising campaign. The FDA in June 2006 approved the vaccine. It is 100% effective against four strains of HPV associated with 70% of all cervical cancer cases and 90% of all genital warts cases. The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices has recommended that females age 12 to 26 be immunized.

Hot on Merck's heels is GlaxoSmithKline PLC, which is developing a HPV vaccine to be marketed as Cervarix. GSK plans to file for FDA approval in April and hopes to get the agency's OK by the end of the year, giving Merck a short window to benefit as the sole manufacturer of an approved cervical cancer vaccine.

Financial conflict?

Some physicians and immunization experts have criticized Merck's aggressive lobbying on behalf of mandating Gardasil, arguing that the company's financial interest threatens to undermine public confidence in the vaccine system.

In the 18 states considering a mandate, Merck has donated $138,775 since 2006, according to a search of the Institute on Money in State Politics' database of political contributions.

Merck did not respond to AMNews questions by press time, but in other news accounts the drugmaker defended its lobbying push.

"States decide what works for them," Margaret McGlynn, the company's vaccine division president, told the Wall Street Journal. "Immunizing females against cervical cancer is absolutely the right thing to do."

Increasing availability

One focus of the lobbying effort is Women in Government, a bipartisan legislative group to which Merck donates and whose members are behind many of the mandate proposals. Women in Government officials would not share how much the group receives from Merck but said its members believe they are doing the right thing.

"Adding the HPV vaccine to the list of required immunizations for school entry is an effective way to ensure that as many girls as possible are given access to this lifesaving technology," the group said in a statement. "Experience has shown that school requirements increase the utilization of vaccines, reduce disease and lessen disparities in terms of who gets vaccines and who does not."

Colleen A. Kraft, MD, president of the Virginia chapter of the American Academy of Pediatrics, agreed.

"A mandate levels the playing field; you have access to this because you need it to go to school," said Dr. Kraft, speaking on behalf of the Virginia chapter.

"All the players have to get together to decide on how to pay for it and how to deliver on what we've decided is important," she said.

Dr. Kellerman, AAFP president, noted that health care mandates often go unfunded. In this case, physicians could be left holding the bag because insurance reimbursement often is not enough to cover overhead costs such as storage.

While a mandate might ensure a steady stream of patients asking for the vaccine, doctors say the finances are still risky, especially for smaller physician practices.

The American Medical Association had no comment on the mandate controversy. The Association has policy supporting insurance coverage of and adequate reimbursement for the HPV vaccine, as well as health education in schools about HPV, cervical cancer and immunization.

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It all started in Texas

[download pdf]

Other states are considering adding the human papillomavirus vaccine to school-required immunizations.

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External links

Kaiser Family Foundation fact sheet on HPV vaccine implementation and financing policy, in PDF (link)

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