HPV Vaccine

The campaign to mandate Merck’s Gardasil vaccine may be the biggest boondoggle since the pet rock. But in defense of pet rocks, they were low-priced, people knew what they were getting for their money, and they didn’t cause any adverse health consequences.

The same cannot be said for the Gardasil campaign.

It’s been billed as: A blockbuster breakthrough! The first-ever vaccine against cancer!!! Merck launched an unprecedented marketing and lobbying campaign to convey two messages:

• Sexually-transmitted human papillomavirus (HPV), the cause of cervical cancer, will infect 75% of sexually active American women at some point in their lives, therefore every female needs the Gardasil vaccine.

• Laws to fund and mandate vaccination of all pre-teen girls (before they start having sex and contract HPV) are urgently needed because cervical cancer is “the second most common cancer worldwide among women.”

The statistics are technically true, but largely irrelevant. Here’s why. There is an HPV epidemic. The CDC reports that 20 million Americans are currently infected, and 6.2 million new cases occur each year. Research published last month in the Journal of the American Medical Association (JAMA) found a much higher figure of current infections: almost 25 million American women ages 14-59.

Being infected with HPV does not mean, however, that one is going to get cervical cancer, much less die from it. Most HPV infections are eliminated by one’s immune system; almost 70% are cleared within one year and 91% are cleared within two years. Only about 10% of women infected with HPV will develop persistent infections.

The study found that only 2.3% of women aged 14-59 were infected with one of the two persistent strains of HPV targeted by Gardasil.

Even a 10% likelihood of a persistent infection that could lead to cervical cancer and death seems urgent. But cervical cancer does not morph overnight. It typically takes at least 10-15 years to develop invasive cancer that could become life-threatening.

Since 1955, U.S. deaths from cervical cancer have plummeted 74% due to routine “pap” tests to screen for pre-cancerous cell changes and lesions that can then be eliminated in a doctor’s office or out-patient surgery.

Newer tests — a liquid-based pap test and an HPV DNA test — promise greater accuracy and early detection and treatment.

Dr. Mona Saraiya, a medical epidemiologist in the Division of Cancer Prevention and Control of the Centers for Disease Control (CDC) told the Washington Times last month: “Fewer than one-100th of 1% of the 108 million U.S. women older than 18 (0.009%) get cervical cancer and even fewer die from it.”

So how can Merck claim that cervical cancer is the second most common cancer among women worldwide? Because while U.S. women who are insured or on Medicaid have routine Pap tests at very high rates (approaching 90%), women in the rest of the world do not. Which prompts the question: Why is Merck trying to vaccinate American girls when they face the least risk of any nationality?

Lack of screening is the single most important risk factor associated with cervical cancer.

Women who have never been screened account for 50% of U.S. cervical cancer cases; another 10% occur in women who haven’t been screened in five years.

“Nearly all cases [of cervical cancer] can be prevented if a woman is screened regularly,” says the American Cancer Society: “When detected at an early stage, invasive cervical cancer is one of the most successfully treated cancers, with a five-year survival rate of 92% for localized cancers.”

That is why the Centers for Disease Control ranked cervical cancer 13th in cancer prevalence and 12th in cancer mortalities in 2002.

Here are 2007 estimates on cases of cancer in women:

New cases of all cancers — 678,060

New cases of breast cancer — 178,480

Lung cancer — 98,260

Cervical cancer — only 11,150

Here are the estimates of cancer deaths of women.

Total cancer deaths — 270,100

Breast cancer deaths — 40,460

Lung cancer deaths — 70,880

Cervical cancer deaths — 3,670

Cervical cancer will account for 1.4% of all cancer deaths among women in 2007. Any cancer death is tragic, but this figure is lower than 14 other cancer-related causes of death.

To recap: Despite an HPV epidemic, cervical cancer mortality is low, and can be virtually eliminated through improved access to routine pap screening for uninsured women not covered by Medicaid. Merck stresses that, even with Gardasil vaccination, routine screening will remain essential. Improving access to screening would cost far less than vaccinating every pre-teen girl in the United States at $360 for the three-shot series (not counting office visits and doctors’ charges, which could bring the total price to $600 or more each — and not counting the Gardasil booster shots which may be needed every five or 10 years).

And since most cervical cancers are diagnosed among women in their late 30s and 40s, vaccinating girls at ages 9-12 may not protect them when they are exposed to cancer-causing persistent strains of HPV in their early to mid-20s.

Dr. Jon Abramson, chairman of the CDC Advisory Committee on Immunization Practices, whose committee approved of Gardasil, told Merck, and later told reporters, that he opposes Gardasil vaccine mandates because “a child in school is not at an increased risk for HPV like he is measles.”

His committee’s executive secretary, Dr. Larry Pickering, stated that “more data on its safety, efficacy and cost” were needed before it was made mandatory.

Yet in February, Texas Gov. Rick Perry ordered mandatory Gardasil inoculations and Virginia’s General Assembly passed a law requiring them. Five other states are poised to approve Gardasil funding or mandates — apparently without considering the alternative of wider screening or Gardasil’s adverse effects.

The incidence of arthritis was three times greater among those given Gardasil than in the placebo group. The National Vaccine Information Center reports: “There were twice as many children collapsing and four times as many children experiencing tingling, numbness and loss of sensation after getting a Gardasil vaccination compared to those getting a Tdap [tetanus-diptheria-acellular-pertussis] vaccination. There have been reports of facial paralysis and Guillain-Barré syndrome,” a disorder in which the body’s immune system attacks part of the peripheral nervous system.

Can Gardasil cause harm to an unborn child or affect reproductive capacity? In pregnancies that began within 30 days following an inoculation, five cases of congenital anomaly occurred in the Gardasil group while none occurred in the placebo group.

Examining Merck’s clinical trial data, FDA staff noted that vaccinating women who are already infected with strains of HPV targeted by Gardasil may actually worsen their cervical disease.

Yet testing for prior HPV infection before vaccination is not now being done or recommended. FDA staff also questioned whether other high risk strains not targeted by the vaccine could become more dominant after Gardasil suppresses the two most prevalent strains. Some of the seven strains of pneumococcus in Prevnar, a vaccine recommended for universal use in babies in 2000, were offset by some of the more than 80 other pneumococcal strains not contained in the vaccine.

Lawmakers should study these issues before voting on Gardasil mandates.

Susan Wills’ opinions herein are her own

 and not necessarily those of her employer,

 the U.S. Conference of Catholic Bishops’

 Secretariat for Pro-Life Activities.