Merck Stops Campaign to Mandate Gardasil Vaccine Use

Bloomberg News
Feb. 20, 2007

by Shannon Pettypiece and Angela Zimm

Feb. 20 (Bloomberg) -- 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.

To contact the reporter on this story:

Shannon Pettypiece in New York at
spettypiece@bloomberg.net

Angela Zimm in Boston at
azimm@bloomberg.net

For Cancer Information CLICK HERE

More about Merck's- Help Pay for Vioxx

News reports about Merck's aggressive marketing campaign aimed at obtaining state government mandates forcing 11 and 12 year old girls to be vaccinated with its Human Pappilomavirus (HPV) vaccine, Gardasil, is the latest example of irresponsible marekting targetting America's female population. Another is the recruitment of female students at university campuses who are asked to enroll as human subjects in an experimental Herpes vaccine trial co-sponsored by GlaxoSmithKline and the National Institute of Allergy and Infectious Diseases. . Below is a form letter sent out to all female students at the Unviersity of Maryland offering $358. Since doctors agree that condoms are the safest and most effective protection against sexually transmitted diseases-- Why are only females being sought for risky experimental vaccine trials?

Gardasil is touted as prevention for cervical cancer which Merck says is the second-leading cancer among women around the world. But as The Wall Street Journal reports (below) the prevalence of cervical cancer is actually low in the U.S. The American Cancer Society estimates that 11,150 women will be diagnosed with cervical cancer and 3,670 will die from it in the U.S. this year. That's equivalent to 0.77% of cancers diagnosed in the U.S. and 0.65% of U.S. cancer deaths each year. By comparison, the society estimates that 178,480 American women will get diagnosed with breast cancer in 2007 and 40,460 will die from it.


These numbers underscore Merck's strictly commercial motivaiton: Gardasil's price tag is exorbitant-three shots at $360 each-is being forced on American children-not because they are at particular risk-but rather to ensure that the company profits hugely. So what is the justification for even considering mandatory vaccination of children?

Since 80% of cervical cancer occurs in underdeveloped countries, clearly, those who might benefit the most are denied access because they can't afford the vaccine. The WSJ confirms that Merck is "desperate" for funding streams and "vaccination across the U.S. would make Gardasil an automatic blockbuster." The campaign has been dubbed: "Help pay for Vioxx" litigation.

Inexplicably, influential media sources have demonstrated a blind willingness to accept without evidence, unsubstantiated promises about a new vaccine from a company whose ignoble record of fraudulent claims and illegal marketing of a lethal drug caused thousands of preventable deaths. Prominent among these is The New York Times which rendered its position on the side of commerce in an editorial (below) reflecting a faith-based belief rather than a critical appraisal of evidence. Not only does the editorial endorse Merck's vaccine for all preteen girls, it offered "congratulations to Texas for becoming the first state to REQUIRE vaccinating young schoolgirls-ages 11 and 12"-even as it acknowledges that "many parents are appalled at the notion of vaccinating such young girls against a sexually transmitted disease."

"GARDASIL has not been shown to protect against disease due to non-vaccine HPV types.The health-care provider should inform the patient, parent, or guardian that vaccination does not substitute for routine cervical cancer screening. Women who receive GARDASIL should continue to undergo cervical cancer screening per standard of care." [Link]

Gardasil will not prevent cancer--it does not protect against ALL HPV types [e.g., 31, 33, 35] . The vaccine will merely result in a change of prevalent serotypes.

"Tina Walker, the mother of an 11-year-old girl in Flower Mound, Texas, told The Wall Street Journal that she would prefer to wait until the vaccine has been on the market for several years before subjecting her child to it. "We are the guinea pigs here," she says.

Under what moral authority do the editors of New York Times decree that Tina Walker's rights as a responsible parent should be nullified-and her daughter exposed to potential harm by a company that has a proven record of concealing the lethal hazards of its products?

The Times editors would do well to examine how often the Times got it wrong when it endorsed any number of medical treatments that proved harmful. For example, on November 18, 1994, Times health columnist, Jane E. Brody, gave a ringing endorsement to hormone replacement therapy (New Therapy For Menopause Reduces Risks, [Link]), reporting that it protects women "not only against the risk of uterine cancer but heart attacks as well." In time, these claims were overturned by science-but not before untold number of women died as a result of bad medical advice.

Furthermore, Merck does not deserve our trust in disclosing all we need to know about its products. Merck marketed Vioxx as an effective, safer alternative to non-steroidal anti-inflammatory drugs for the treatment of pain associated with osteoarthritis, but-as its secret documents later uncovered during litigation revealed--Merck concealed the fact that Vioxx increased the risk of cardiovascular disease. What guarantee do we have that Gardasil is not another Merck hoax?