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Even critics would agree. The pharmaceutical giant Merck & Co. hit a home run in the worlds of lobbying and marketing with its new drug Gardasil. The commercial success of the vaccine for the sexually transmitted human papillomavirus, and the legislation that has swarmed around it, models the quintessential art of the lobby. The New Jersey-based company worked its connections with lawmakers and placed contributions in the right hands. The result: a drug that has become in recent weeks almost a household name, and an executive order in Texas that will mandate the vaccine for young girls there beginning next year, prompting similar legislation around the United States. That’s called getting results. According to the Centers for Disease Control and Prevention, HPV is responsible for 70 percent of cervical cancer and 90 percent of genital warts cases. About a dozen types of HPV can cause cervical cancer, and Gardasil protects against two of them, plus two noncancer-causing types of the virus. According to the CDC, Merck’s vaccine has a near 100 percent efficacy in preventing diseases caused by HPV. After the vaccine was approved by the Food and Drug Administration last year, Merck launched an ambitious marketing plan to push its product to become a mandatory vaccine for girls, despite the concern that many conservative groups have recently brought up — that the mandate would send the wrong message to children about sexual activity. But Merck latched onto the universal — and often emotional — fight against cancer, and the campaign was easier than expected. Despite opposition from groups that say a mandate would interfere with what should be a family decision, Merck’s commercial drive and influence on state lawmakers seem to be paying off. A LOBBYING POWERHOUSE In 2004, Women in Government, a nonprofit organization of female state legislators, launched a campaign to eliminate cervical cancer, making the issue one of the organization’s top priorities. Last year, when Gardasil gained FDA approval, Women in Government began to publicly push for requiring young girls to take the vaccine, which has been approved for girls as young as 9.
According to Merck, Gardasil is a vaccine for the prevention of cervical cancer, precancerous or dysplastic lesions, and genital warts caused by human papillomavirus (HPV) Types 6, 11, 16, and 18. A complete vaccination regimen of Gardasil consists of three doses. The wholesale price is $120 per dose. For more information, go to www.gardasil.com.Facts about HPV• People infected with HPV: 20 million• New genital HPV cases that occur each year worldwide: 5.5 million• Cases of cervical cancer diagnosed annually in the United States: 4,000• Women who die annually of cervical cancer in the United States: 50 • Women who die annually of cervical cancer worldwide: 233,000• Strains of HPV: 100• Percent of men and women who will acquire HPV by age 50: 50• Percent of women who, by age 50, will have acquired genital HPV: 80

Women in Government is working its clout throughout the nation. For example, Maryland legislator Delores Kelley, a Democrat and member of the organization, introduced a bill last month to mandate the vaccine but withdrew the measure, reportedly amid pressure from parents and teachers. The organization declined to say how much it received from Merck. “Women in Government receives unrestricted educational grants from numerous corporate, governmental, individual, and foundation sources, including Merck,” says Susan Crosby, president of the group. “This means that our bipartisan board of directors, in conjunction with our policy staff, determines the content of our programs. We leave it up to our supporters if they wish to share specific funding information.” GlaxoSmithKline, another major pharmaceutical company that is developing its own HPV vaccine, is another of Women in Government’s big-name sponsors. The company, which has touted successful global clinical trials of its vaccine, announced last month that it would begin new trials to test its competitiveness to Gardasil. Some see Merck’s intense lobbying push as a way for the company to get good business before GlaxoSmithKline’s HPV vaccine gains FDA approval. While Merck was relying on Women in Government to get the word out about the vaccine and push for state mandates, the company was also focusing on national lawmakers. According to Senate lobbying records, Merck spent $2 million on lobbying in 2006, shelling out more than $500,000 to D.C. lobby firms, including Mehlman Vogel Castagnetti, Alston & Bird, Capitol Hill Strategies, Cornerstone Government Affairs, and Sidley Austin and to lobby lawmakers on regulatory and funding issues related to vaccines. Merck did not return several phone calls from Legal Times for this story. In Texas, the drug maker hired yet another lobbyist — one of Texas’ most powerful. Mike Toomey, of the Texas Lobby Group, served as Republican Texas Gov. Rick Perry’s chief of staff from 2002 to 2004. Merck also doubled its lobby spending in the state. What followed was a somewhat astonishing victory. On Feb. 2, Perry became the first governor to bypass state legislators and, through executive order, require Gardasil to be administered in schools. The mandate allows parents to opt out of having their children receive the vaccine. Legislation has also been introduced in 19 states, including the District of Columbia, Virginia, California, and Florida. A pending D.C. Council bill introduced last month by David Catania (I-At Large) and Mary Cheh (D-Ward 3) would require girls to prove they have received the vaccine before entering sixth grade. It also includes an opt-out option. If the Texas order or any other legislation goes through, it would signal the first time schoolchildren as young as 13 would be required to take a drug to fight a sexually transmitted disease. Gardasil would also become the only required single-sex vaccine in the nation. MONEY MATTERS Perry’s executive order mandating the vaccine in Texas was likely the result of years of aggressive lobbying. Merck’s contributions to Perry followed him throughout his governorship. Records from the Texas Ethics Commission show that Merck’s political action committee donated $5,000 to Perry’s 2006 campaign. In 2004, the PAC gave Perry $10,000 and in 2000, it donated $5,000. Among gubernatorial candidates who received contributions from the pharmaceutical giant, Perry was second only to former California Gov. Gray Davis (D), who received $28,000, according to the Montana-based Institute on Money in State Politics. A Perry spokeswoman contends that the nearly 400 Texas deaths from cervical cancer and the 1,000-plus new cases of the disease in 2006 — and not Merck — prompted Perry to make the decision to mandate the vaccine. “The governor has made it very clear that this was not a politically connected move. It was a move to prevent women from contracting cancer. This is a really revolutionary vaccine that allows us, for the first time in history, to prevent cancer,” says Krista Moody, Perry’s spokeswoman. Merck has been pursuing the Gardasil vaccine since the 2000 elections. It has financed races in 40 states, with $4 million going to political candidates in Florida, California, Pennsylvania, and New Jersey. During the 2006 election cycle, Merck, one of the top four U.S. drug makers, made lofty donations to the Republican Party in national races, giving $50,000 to Republican Senate candidates and $28,500 to Democratic candidates. Merck doled out nearly $200,000 to Republican House candidates and about $68,000 to Democrats. Gardasil has seen what the company calls an “impressive sales performance” — $155 million for the fourth quarter and $235 million for the year. “These results clearly set the stage for our performance in 2007 as well as continued progress toward our long-term financial targets,” the company said. At $360 for the three-shot vaccine, Gardasil stands to make Merck billions of dollars in sales if it becomes required in states around the country. It would be a sweet reward for a company facing crippling lawsuits involving its drug Vioxx. In 2004, the company withdrew Vioxx — which reduced pain caused by osteoarthritis, migraines, and menstruation — after a study showed it increased the risk of heart attack and stroke. The same day Perry ordered the Gardasil mandate, the National Vaccine Information Center issued a warning to states, urging them to investigate the safety and cost of mandating Merck’s HPV vaccine for pre-adolescent girls. The NVIC found reports of loss of consciousness, seizures, and joint pain, including reports of adverse effects in Virginia and the District. “The cost is going to break the pocketbooks of parents and break the banks of both insurance companies and taxpayers, when the reality is that almost all cases of HPV-associated cervical cancer can be prevented with annual pap screening of girls who are sexually active,” NVIC President Barbara Loe Fisher says. According to Perry’s Austin office, his spending plan for the drug includes $72 million to cover costs for children who are uninsured or in government health-care programs. His plan calls for sixth-graders to receive the vaccine beginning September 2008. Schoolgirls jumping rope on a neighborhood sidewalk smile and begin a rhythmic chant about Gardasil. The faces of girls of various ethnic backgrounds pop onto the screen as each one praises the new drug and tells the viewer that she is worried no more about having HPV or cervical cancer. What is not mentioned in Merck’s commercial is that the virus is a sexually transmitted disease. The push to require the vaccine in schools nationwide has alarmed many parents, family-centered groups, and even some health professionals who say a vaccine against a sexually transmitted disease should not be a government requirement but a family choice. Some groups even say that mandating the vaccine for girls as young as 9 could send confusing messages about sex. The Texas governor’s executive order has been the focus of a continual firestorm with state lawmakers, many from Perry’s own party, aggressively pushing the state attorney general to overrule the order on grounds that the public and the Texas Legislature should have their say on the controversial issue. Concerned Women for America recently released a statement expressing its concern over the decision. “The governor’s order forces little girls to be shot with a sex-virus vaccine. He has circumvented debate on this controversial matter to the financial benefit of Merck, one of his campaign contributors. An opt-out provision puts parents in the position of having to resist forceful government officials, and puts the burden on parents when it should be on the vaccine maker,” CWA President Wendy Wright said in the release. The opt-out provision would “allow parents to submit a request for a conscientious objection” to the vaccine, according to Perry’s executive order. “Never before have we had an opportunity to prevent cancer with a simple vaccine,” Perry said in a statement shortly after announcing the mandate. “While I understand the concerns expressed by some, I stand firmly on the side of protecting life. The HPV vaccine does not promote sex, it protects women’s health. In the past, young women who have abstained from sex until marriage have contracted HPV from their husbands and faced the difficult task of defeating cervical cancer. This vaccine prevents that from happening.” Although there are no federal laws requiring the immunization of children, various state laws do require immunizations. “Mandating vaccines really goes to the heart of an inherent conflict between the parents’ right and the government’s responsibility to protect the health of children in public in general,” says Louis Cooper, a member of the National Network for Immunization Information. “But they only work when there is a broad public concern that it’s the right thing to do.” Cooper, who is also professor emeritus of pediatrics at Columbia University, says it is unusual that a governor would bypass a state’s legislative body on such a controversial health issue. “The Texas governor did something that I think is unique,” Cooper says. “He went ahead and mandated the vaccine by executive order, and that was a different approach.”

Osita Iroegbu can be contacted at [email protected].

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