The National Vaccine Information Center yesterday warned state officials to investigate the safety of a breakthrough cancer vaccine as Texas became the first state to make the vaccine mandatory for school- age girls.

Negative side effects of Gardasil, a new Merck vaccine to prevent the sexually transmitted virus that causes cervical cancer, are being reported in the District of Columbia and 20 states, including Virginia. The reactions range from loss of consciousness to seizures.

"Young girls are experiencing severe headaches, dizziness, temporary loss of vision and some girls have lost consciousness during what appear to be seizures," said Vicky Debold, health policy analyst for the National Vaccine Information Center, a nonprofit watchdog organization that was created in the early 1980s to prevent vaccine injuries.

Following federal approval of the vaccine in July 2006, a storm of legislation was introduced across the nation that would make the vaccine mandatory in schools. The District and Virginia are part of a group of at least 17 states considering such legislation. A measure had been introduced in Maryland, but it was shelved last week over concerns about the mandatory language in the bill.

Yesterday, Texas Gov. Rick Perry signed an order making Texas the first state to require the vaccine. Girls ages 11 and 12 would receive the human papillomavirus (HPV) vaccine before entering the sixth grade starting in September 2008.

The American Cancer Society estimates there were 9,710 new cases of cervical cancer in the United States in 2006. The District's cancer control center estimates a total of cervical cancer cases in the city last year, and the American Cancer Society estimates that last year Maryland and Virginia each had 210 cases of cervical center.

Merck began marketing Gardasil last year after the Food and Drug Administration approved it for females ages 9 to 26. The vaccine is the first of its kind to build immunity against two strains of HPV, which lead to 70 percent of cervical cancer cases in the United States.

The vaccine is not effective in men, who can get cancer from other strains of HPV.

Its side effects were reported to the Vaccine Adverse Event Reporting System, a federal reporting system for consumers to notify federal regulators of bad reactions to medications. The adverse events began being reported in July 2006, when an advisory panel to the Centers for Disease Control and Prevention recommended girls ages 11 and 12 receive the series of shots.

The types of side effects reported are not cause for alarm, according to the American Cancer Society.

"We have not been informed of an instance that would call into question the overall safety of the vaccine," said Debbie Saslow, director of breast and cervical cancer control at the American Cancer Society, adding that about 70 similar events had been known in October 2006.

Likewise, the CDC will not alter its approval of the vaccine despite the number of adverse events revealed through the reporting system.

"A report to the Vaccine Adverse Event Reporting System does not necessarily mean the adverse event was serious or that it was caused by the vaccine," said CDC spokesman Curtis Allen. "This vaccine has been tested around the world and has been found to be safe and effective."

Merck is heavily promoting the vaccine through its salespeople imploring doctors to provide it and running TV ads urging young women to get vaccinated so there will be "One Less" cancer patient.

But physicians disagree with public health officials over whether Gardasil is the panacea for cancer. Clayton Young, an obstetrician/gynecologist in Texas, objects to Merck's claim that Gardasil will prevent cervical cancer.

"There is no proof Gardasil will stop cervical cancer," he said. "They haven't been studying it long enough to make that claim."

Merck spokesman Chris Loder said the vaccine is effective for five years and the Whitehouse Station, N.J., drug maker is not sure how long afterward the vaccine will work. Critics point out that an additional booster shot may be necessary.

Advocates for a mandatory vaccine say that although the vaccine does not prevent all causes of cervical cancer, Gardasil is an effective vaccine against the most prevalent cause and therefore is a correct public health measure.

Gardasil is delivered in three separate injections that cost $120 to $150 per injection. Blue Cross Blue Shield, an omnipresent health insurer in the Mid-Atlantic region, covers the vaccine for girls in the federally recommended age groups.

Merck revenue from Gardasil reached $155 million for the fourth quarter of 2006 and $255 million for the entire year.

Texas Gov. urged against cancer order

Wyoming News, WY
Associated Press
February 7, 2007

By LIZ AUSTIN PETERSON

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AUSTIN, Texas - Several key Republicans urged Gov. Rick Perry on Monday to rescind his executive order making Texas the first state to require girls to be vaccinated against the sexually transmitted virus that causes cervical cancer.

Lawmakers should have been allowed to hear from doctors, scientists and patients before the state implemented such a sweeping mandate, said state Sen. Jane Nelson, chairwoman of the health and human services committee.

"This is not an emergency," said Nelson, adding that she plans to ask Attorney General Greg Abbott for an opinion on the legality of Perry's order. "It needs to be discussed and debated."

Three other Republican lawmakers filed bills that would override the mandate, and several others were working on similar legislation.

Perry defended his decision, saying his fellow conservatives were wrong to worry that mandating the vaccine will trample parents' rights and promote premarital sex.

"Providing the HPV vaccine doesn't promote sexual promiscuity any more than providing the Hepatitis B vaccine promotes drug use," Perry said in a statement. "If the medical community developed a vaccine for lung cancer, would the same critics oppose it claiming it would encourage smoking?"

Perry has ordered the Texas Health and Human Services Commission to adopt rules requiring Merck & Co.'s new Gardasil vaccine for girls entering the sixth grade as of September 2008. The vaccine protects girls against strains of the human papillomavirus that cause most cases of cervical cancer.

Texas allows parents to opt out of inoculations by filing an affidavit objecting to the vaccine on religious or philosophical reasons, but critics say the order still interferes with parental rights.

"I don't think the government should ever presume to know better than the parents what to do with children," Republican Lt. Gov. David Dewhurst said.

Perry also directed state health authorities to make the vaccine available free to girls ages 9 to 18 who are uninsured or whose insurance does not cover vaccines. And he ordered Medicaid to offer Gardasil to women ages 19 to 21.

Doctors say Perry's vaccine mandate for girls is premature
They hail inoculation for cancer-causing virus but cite liability, cost concerns

Houston Chronicle

By TODD ACKERMAN

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Gov. Rick Perry's order requiring schoolgirls to get inoculated against a sexually transmitted virus linked to cervical cancer may be unpopular with social conservatives, but another important group also is lining up against it: doctors.

From, among others, the Texas Medical Association and the American Academy of Pediatrics, many doctors are saying it's too early to mandate the vaccine, which was approved for use last June. It protects against four strains of the human papillomavirus that cause 70 percent of cervical cancers.

"We support physicians being able to provide the vaccine, but we don't support a state mandate at this time," said Dr. Bill Hinchey, a San Antonio pathologist and president-elect of the TMA, which represents 41,000 physicians. "There are issues, such as liability and cost, that need to be vetted first."

Other reasons cited by doctors in Texas and across the country include the vaccine's newness; supply and distribution considerations; the possibility opposition could snowball and lead to a reduction in other immunizations; the possibility it could lull women into not going for still-necessary cervical cancer screenings; gender-equity issues; and the tradition of vaccines starting as voluntary and becoming mandatory after a need is demonstrated.

Hinchey said that TMA leadership expressed their concerns to Perry on Tuesday. He said the TMA arrived at its position after debating the issue in committees in recent days.

A spokeswoman for Perry reiterated Tuesday that the governor stands by the order. She said he is listening to the discussion but thinks the vaccine is safe and effective.

Unexpected opposition

Perry touched off a firestorm Friday when he issued the order, which requires girls receive the three-shot vaccination to enter sixth grade, starting in September 2008. Social conservatives said a mandate makes sex seem permissible. Others complained Perry was circumventing the legislative process, where bills to make the vaccine mandatory had been filed.

Opposition from doctors was less expected. Virtually all hail the vaccine as a great breakthrough and call for the highest possible proportion of girls and women — and boys and men, eventually — to get immunized in hope of one day eliminating the virus.

"But education needs to come first," said Dr. Joseph Bocchini, chairman of the AAP's committee on infectious disease. "Much of the public doesn't know about HPV and its link to cervical cancer and other diseases. You can't put a mandate ahead of that."

HPV is the most common sexually transmitted infection in the United States, infecting 6.2 million new people a year. Though the immune system usually clears the infection, it can lead to cervical cancer, cancer of the penis and anus, and genital warts. Although cervical cancer is declining in the United States, there are 9,710 new cases a year and 3,700 annual deaths attributed to it. Worldwide, it's the second most common cancer in women, resulting in 233,000 deaths a year.

Point of contact an issue

The 60,000-member AAP circulated a statement last week that lays out many concerns about a mandate. The statement, written before Perry's order, notes that 24 states and the District of Columbia have introduced or prefiled legislation requiring adolescent girls to get the vaccine.

Among the statement's points is that mandating a vaccine for a disease not spread by casual or occupational contact — and currently only available to one gender — represents a departure from past practice. Such school immunization requirements came into existence, it says, to protect schoolchildren from outbreaks of contagious disease in that setting, not to compel vaccination. (The quickest a vaccine has gone from approval to mandatory in Texas was the chickenpox vaccine, which took 5 1/2 years.)

The statement also says the costs of such a program will further strain state vaccine programs already short on resources. It says states that choose to add the HPV vaccine to school entry programs should provide additional funding and insurance coverage.

Perry's order said the vaccine would be covered under the federal Vaccine for Children program, which supplies vaccines to those uninsured, underinsured or on Medicaid or the Children's Health Insurance Program. The order said nothing about coverage by private insurers, many of whom aren't yet including the shot in their popular plans. The vaccine costs from $120 to $200 a shot.

Reaction from doctors

Dr. Patricia Sulak, a professor of obstetrics- gynecology at the Texas A&M Health Science Center College of Medicine, said health-care providers she knows were shocked by the order. "It's such a new vaccine — they haven't had time to explain it to patients," said Sulak. "I think everyone was happy with the CDC's Advisory Committee for Immunization Practices' recommendation that it be routinely given. But this makes it seem like it's being shoved down people's throats."

Hinchey and others emphasized that although the vaccine is considered safe, there are questions of whether there is enough experience with it to warrant a mandate. They say that some girls eventually may experience rare adverse effects not yet identified.

One medical ethicist was willing to give Perry's order a chance.

"Perry gave a classic public-health-ethics rationale for the program," said Laurence McCullough, a professor in Baylor College of Medicine's Center for Ethics and Health Policy. "But he needs to present to the legislature a cost analysis and funding source so other priorities are not displaced."

McCullough added that Perry likely would have avoided controversy if he'd signed on to proposed legislation and led public debate rather than issuing an executive order.


todd.ackerman@chron.com

Moves to Vaccinate Girls For Cervical Cancer Draw Fire

As Merck Lobbies States To Require Shots, Some Fret Over Side Effects, Morals

The Wall Street Journal
February 7, 2007; Page D1

By JOHN CARREYROU

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Bills being drafted in some 20 U.S. states that would make a cervical-cancer vaccine mandatory for preteen girls are sparking a backlash among parents and consumer advocates.

The bills coincide with an aggressive lobbying campaign by Merck & Co., the maker of the only such vaccine on the market. Called Gardasil, the three- shot regimen provides protection against the human papillomavirus, a sexually transmitted virus that is responsible for the majority of cases of cervical cancer.

If the state bills become law, they would guarantee the Whitehouse Station, N.J., drug maker billions of dollars in annual revenue from the vaccine.
Proposed legislation varies from state to state, but the bills generally would require girls to show proof that they have received the inoculation in order to enter school. A number of immunizations -- including those for measles, chicken pox and polio -- are mandatory for U.S. schoolchildren because they block highly contagious diseases that can be spread easily in a group setting. But HPV is different because it is transmitted sexually. At $360 for the three shots, Gardasil is also costlier than many vaccines (a measles-mumps-rubella shot costs about $42.85 per dose, for instance), though it is generally covered by insurance.

Conservative Christian groups have long voiced opposition to the vaccine, saying it would conflict with their message of abstinence because it would, in effect, condone premarital sex. However, concern has spread beyond the religious right as momentum has grown for making inoculation mandatory. A growing number of parents are worried about exposing their children to the unforeseen side effects of a new vaccine to protect them from a disease that is no longer very common in the U.S. and often doesn't develop until much later in life.

Tina Walker, the mother of an 11-year-old girl in Flower Mound, Texas, says 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.

Last week, Texas Gov. Rick Perry issued an executive order mandating that the vaccine be administered to all girls entering the 6th grade in the state as of September 2008. The Texas executive order, which includes an opt-out clause for religious or other "reasons of conscience," enabled the governor to bypass what would have likely been a heated debate in the Texas Legislature.

Many of the state bills contain opt-out clauses, but a few don't. The bill pending in Florida would bar students ages 11 or 12 from being admitted to public or private school in the state unless they can provide proof that they have been vaccinated or that their parents opted them out after receiving information about cervical cancer and the vaccine.

Merck says cervical cancer is the second-leading cancer among women around the world, but the disease's prevalence 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.

Adding to some parents' concern, 82 adverse events among both teens and adult women have been reported since Gardasil became available last June. Many involve common immune-system responses to vaccines, such as nausea, fever or rashes. But a number of patients suffered syncopes, or fainting spells.

Richard Haupt, Merck's executive director of medical affairs, says the syncopes are caused by patients' anxiety at having a needle stuck in their arm and not due to any neuro-immune reaction to the vaccine. Mr. Haupt adds that the number of adverse events is small compared with the hundreds of thousands of doses of the vaccine administered so far in the U.S.

However, with any newly approved drug or vaccine, side effects often don't become apparent until a regimen has been on the market for a while, leading some patient and consumer advocates to urge states to hold off on requiring vaccination until Gardasil's safety is more clearly established.

Of the more than 25,000 patients who participated in clinical trials of Gardasil, only 1,184 were preteen girls. "That's a thin base of testing upon which to make a vaccine mandatory," says Barbara Loe Fisher, co-founder of the National Vaccine Information Center, an advocacy group that lobbies for safer vaccines.

Gardasil is approved for females ages 9 to 26, and the three-dose regimen is the same for all age groups. The vaccine protects against four strains of HPV that cause 70% of cervical cancer cases. So it would not eliminate the need for vaccinated women to have regular Pap smears to detect cancerous cells caused by other HPV strains. HPV is also the virus that causes genital warts.

Merck acknowledges that it doesn't know yet whether an initial vaccination will offer lifetime protection or whether patients will need booster shots. So far, the company has shown only that the vaccine lasts five years.

Merck started lobbying state legislatures to pass laws requiring vaccination last year after the Centers for Disease Control and Prevention's Committee on Immunization Practices recommended that all girls get the vaccine when they turn 11 or 12. Another HPV vaccine, called Cervarix, is in development from GlaxoSmithKline PLC, but so far Gardasil is the only regimen on the market.

As part of its lobbying campaign, Merck has been funding Women in Government, a Washington, D.C.- based advocacy group made up of female state lawmakers. An executive from Merck's vaccine division, Deborah Alfano, sat on Women in Government's business council last year, and many of the bills across the country have been introduced by members of the group.

Merck declined to say how much money it has funneled into its lobbying campaign, or contributed to Women in Government. A spokeswoman for Women in Government, Tracy Morris, declined to say how much it had received from Merck. In Texas, one of Merck's lobbyists is Gov. Perry's former chief of staff, and Merck's political action committee contributed $6,000 to the governor's re-election campaign.

"Parents should be concerned that the only company that makes this vaccine is pushing behind the scenes for mandatory laws," says Maryann Napoli, associate director for the Center for Medical Consumers, a consumer group based in New York.

At a Merrill Lynch conference yesterday, Margaret McGlynn, the president of Merck's vaccine division, acknowledged the company's aggressive lobbying campaign but said, "States decide what works for them." She added that she had her own daughter vaccinated with Gardasil and "immunizing females against cervical cancer is absolutely the right thing to do."

Mandatory vaccination across the U.S. would make Gardasil an automatic blockbuster for Merck at a time when the patents on some of its bestselling drugs are expiring and it's desperate to replace their revenue streams. Gardasil's sales in 2006 were $235 million.

Cervical cancer is a much bigger problem in the developing world, which accounts for more than 80% of cases of the disease. Merck says it's committed to bringing the vaccine to developing countries, but for now its availability is limited there to a few studies and demonstration programs.


Write to John Carreyrou at john.carreyrou@wsj.com

POINTS OF CONTENTION

Concerns over mandating shots:

• Some parents say a vaccine for HPV, the sexually transmitted disease that can cause cervical cancer, effectively condones premarital sex.

• Long-term efficacy and risk of side effects are unclear. There have been 82 reports of adverse events associated with the vaccine.

• Gardasil is typically covered by insurance, but is costlier than many other common vaccines.