Merck suspends mandatory HPV vaccine campaign

Read story on page 2: Merck suspends campaign to make Gardasil vaccination mandatory, Wall Street Journal, 4:52 p.m. EST

[Hat tip: Dave Diersen]

Read story on page 2: Merck stops campaign to mandate gardasil vaccine use (update 3), Bloomberg, 5:27 EST

[Hat tip: Illinois Review]

Merck suspends campaign to make Gardasil vaccination mandatory, Wall Street Journal, 4:52 p.m. EST

Merck & Co. said it would stop lobbying states to pass laws requiring that preteen girls be vaccinated against cervical cancer in the face of a growing backlash among parents, physicians and consumer advocates.

Merck's aggressive lobbying campaign was intended to boost sales of its Gardasil vaccine, which received Food and Drug Administration approval last year. Gardasil provides protection against two strains of the human papillomavirus that are thought to cause the majority of cervical-cancer cases.

But unlike a number of other diseases that U.S. schoolchildren are required to be vaccinated against, HPV isn't an airborne virus that can spread easily in a group setting. Rather, it is sexually transmitted. Gardasil also stands apart from other vaccines that are compulsory because of its high cost: $360 for a three-dose regimen.

In recent weeks, opposition to state mandates has grown among parents who want the freedom to make such a medical decision on their own and are worried about exposing their children to the unforeseen side effects of a new vaccine. Physicians and consumer advocates have also questioned the need to immunize young girls against a disease that is no longer very prevalent in the U.S. and doesn't develop until much later in life.

Merck's lobbying efforts have become a distraction from the company's goal of immunizing as many women as possible against cervical cancer, said Richard Haupt, Merck's executive director of medical affairs. Merck has "decided at this point not to lobby for school laws any further."


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Merck stops campaign to mandate gardasil vaccine use (update 3), Bloomberg, 5:27 EST

Feb. 20 - Merck & Co. will stop lobbying state officials to require that girls receive the company's Gardasil cervical cancer vaccine before they can attend school.

Merck made the decision after groups including the American Academy of Pediatrics said there wasn't enough state funding to pay for the $360 vaccine or public acceptance, said Rick Haupt, director of medical affairs for Merck's vaccine division, in a telephone interview today.

Texas this month became the first state, among about 20 considering legislation, to require school-aged girls to get the shot. Merck began its campaign for the vaccine among state lawmakers even before it was approved in June 2006. The company, which is based in Whitehouse Station, New Jersey, decided to stop lobbying states because the focus had shifted to the campaign rather than to preventing cervical cancer, Haupt said.

"Merck's early push was not the way to go,'' said Larry Pickering, executive secretary of the advisory committee on immunization practices for the U.S. Centers for Disease Control and Prevention, in Atlanta. "We want to convince people to use the vaccine because of its benefits.''

"Immediately implementing school laws is not optimal,'' Pickering said in a telephone interview today. "We need to gather more data and reevaluate to see whether this kind of approach is necessary.''

$3 Billion Potential

The vaccine is Merck's most important new product, capable of generating as much as $3 billion in annual sales, analysts have said. Revenue from Gardasil in the fourth quarter reached $155 million.

"Many support vaccine use broadly, but don't think this is the right time to engage in a school requirement,'' Haupt said. Merck will continue to lobby to get states to pay for the vaccine through programs for the uninsured and poor, he said.

Merck's Gardasil is the first approved vaccine against the sexually transmitted human papillomavirus, or HPV, which causes cervical cancer. The virus is common: about half of all sexually active men and women are infected with it at some point of their lives, according to the CDC. Gardasil is administered in three doses costing $120 each.

Groups such as the Family Research Council and Focus on the Family oppose making the shot mandatory and say parents should make the decision for their girls. Other groups have also questioned the need for making the vaccine mandatory because HPV isn't spread by casual contact like the germs that cause measles or polio.

"The mechanism of transmission of HPV is different and people feel school laws are not needed,'' Pickering said.

In the U.S., where Pap smear screening to detect cervical cancer is widespread, about 14,000 women are diagnosed with cervical cancer each year and 3,900 die from it. Of cancers affecting mainly females, only breast cancer strikes more women globally than cervical cancer.

Sixth Grade

Starting in 2008, Texas girls ages 11 and 12 will be required to have the vaccine before entering sixth grade. The shots will cost the state $50 million the first year.

The Texas order allows parents to opt out of the mandatory vaccinations ``for reasons of conscience, including religious beliefs.'' The order directs the state health agency to provide opt-out request forms on line.

A group called the National Vaccine Information Center said yesterday that its analysis of reports to U.S. regulators found cases of serious side effects to Gardasil. One was Guillain-Barre Syndrome, a disorder in which the body's immune system attacks part of the nervous system.


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