Injecting Speed - Why the rush to require the HPV vaccine?

Gardasil isn't exactly an anti-cancer vaccine, but it comes close. It protects girls and women against four sexually transmitted strains of the human papillomavirus (HPV), two of which cause about 70 percent of all cervical cancer. It is also extremely controversial, though the nature of the controversy has changed radically since the treatment was invented. This time last year the issue was whether it would be allowed at all, a matter settled in June when the Food and Drug Administration approved it. Today the question is whether the shots should be required.

Nearly half the states have been considering measures to mandate the vaccine for schoolchidren, with Texas Gov. Rick Perry skipping the debate entirely this month by issuing an executive order which, he insists, cannot be repealed by the legislature. In Michigan, by contrast, such a bill was shot down in January, and in Maryland the proposal was withdrawn before it reached a vote.

Good for Michigan, good for Maryland, and too bad for Texas. The arguments against legalizing Gardasil were silly. The arguments against mandating it are strong.

Since the viruses it protects against are transmitted sexually, Gardasil is most effective when given to people who are not yet sexually active; scientists therefore recommend that girls aged 10 to 14 receive it. Opponents initially argued that this might encourage preteen promiscuity. But the point of early immunization is to protect people before sex is likely to be an issue -- and even a woman committed to avoiding all sex before marriage might still contract the virus via rape, or by marrying a man who has not been as chaste as she. Contrary to certain popular stereotypes, the leaders of the religious right are not all imbeciles; well before the FDA approved Gardasil, groups like the Family Research Council had endorsed the shots, arguing only that the decision to vaccinate should be left in the hands of the families, not the state.

To be clear, a majority of the proposed laws, including the Texas order, are not completely compulsory. Most states allow families to refuse vaccinations on religious grounds, and some extend that exemption to parents with broader objections as well. The details vary from place to place, but in general, the shots would be more of a default setting than an absolute mandate. Even so, there are good reasons to oppose the proposals.

There are really two debates here: whether to require the vaccine at all, and whether to require it now. We'll begin with the second, more moderate question. Just as the Family Research Council refrained from fighting FDA approval of Gardasil last year, the mainstream position in the medical community has been against compulsory HPV vaccines. When Gov. Perry's order was announced, the head of the Texas Medical Association informed the Houston Chronicle that "we don't support a state mandate at this time." Martin Myers, director of the National Network for Immunization Information, has told the Baltimore Sun that "a mandate may be premature, and it's important for people to realize that this isn't as clear-cut as with some previous vaccines." The American Academy of Pediatrics has endorsed the routine vaccination of 11- to 12-year-old girls against HPV but has not called for making the routine a requirement. And the American Academy of Family Physicians has officially adopted the position that "it is premature to consider school entry mandates for human papillomavirus vaccine...until such time as the long term safety with widespread use, stability of supply, and economic issues have been clarified."

It's important to understand that all the people and organizations I just quoted are enthusiastic about the vaccine itself, and that most of them will probably support a mandate a few years down the road. What alarms them is the rush. "In the past," Vaccine author Arthur Allen pointed out earlier this month, "public health authorities usually waited a few to several years before requiring children to get a new vaccine. For example, Merck's chickenpox vaccine, licensed in 1995, did not become mandatory in many states until 1999. The time between licensing and requirement allowed vaccine authorities time to view the safety and effectiveness record of the new vaccine before they ordered children to receive it. Even Jonas Salk's celebrated polio vaccine, licensed in 1955, was not immediately required by any state -- though almost the entire country viewed polio as a menace to be battled together."

So who's campaigning to compel the shots? Mostly it's Merck, which -- surprise! -- manufactures the vaccine. In addition to its direct lobbying, the pharmaceutical giant donates money to Women in Government, an organization of female state legislators that has embraced the mandates. (Also, for whatever it's worth, Texas Gov. Perry's former chief of staff now works for Merck.) The company is also pushing for laws requiring insurers to pay for the shots.

Merck doesn't merely stand to gain if the government requires us to use its product. It stands to gain if politicians mandate the shots sooner rather than later. Another company, GlaxoSmithKline, is working on an HPV vaccine of its own, called Cervarix; it hopes to have it on the market later this year. The Texas proclamation does not mention Gardasil by name, and it could be construed to cover future HPV vaccines as well. But obviously, enacting the law now will give Merck's market share a boost when the competition arrives.

Which leads to the next question: Even if the vaccination isn't compulsory now, should it be obligatory sometime down the road? The knee-jerk libertarian reaction is to say no, and at least one of my knees is a confirmed libertarian. But there are circumstances under which it makes sense to require a vaccine. When a deadly disease can be spread through casual contact, a school would arguably be negligent not to require students to be inoculated against it, just as it would be negligent not to ensure that its roof won't collapse on the children beneath it. The more people are vaccinated, the less likely it is that any of them will transmit the illness. This is especially important when some of the parties present are medically ineligible for the vaccine, as some children inevitably are.

But you don't transmit these strains of HPV by breathing on a playmate or by leaving some spittle on a water fountain. You transmit them through intimate contact. It isn't entirely true, as some opponents of the mandates have carelessly claimed, that HPV is "100 percent avoidable" -- not unless they mean avoiding sex your entire life. But it is 100 percent avoidable in the activities you're supposed to perform in the course of a school day. A person with HPV is not a clear and present danger the way a person with measles or whooping cough is.

Indeed, it was the co-creator of the measles vaccine, Samuel Katz, who argued in USA Today earlier this month that HPV "isn't transmitted in a classroom to dozens of children. It's not the same thing as infectious diseases that fly through the air with no boundaries." (Katz also declared that a mandate would "just throw oil on the flames of the anti-vaccine folks," creating a backlash that could hurt every vaccination effort.) The bioethicist Bernard Lo struck a similar note last year in BMJ, observing that "the rationale for mandatory vaccination is weaker for HPV than for childhood infections because HPV is not contagious."

As I noted before, most of the proposals being debated would not make the vaccinations absolutely mandatory; families who want to avoid them can find ways to do so. But an opt-in approach is vastly preferable to the opt-out option. It would mean that doctors will have to persuade parents to accept the shots: explaining the benefits, answering their questions, letting them know what other measures they should take to avoid cervical cancer, and, in general, giving them the autonomy and respect that they deserve. To people of a certain mindset -- call them the therapeutic state, call them social engineers, call them something ruder -- this is a roadblock to public health. But in fact it makes us healthier. It means more knowledgeable patients, more involvement in our own care, more trust between doctors and their clients. Outside of emergency conditions, it should be the norm.

Related Story:

AP

Merck Suspends Lobbying for Vaccine

Tuesday February 20, 11:32 pm ET
By Linda A. Johnson, AP Business Writer

Merck Suspends Lobbying for Mandate for Its Vaccine Against Cervical Cancer

TRENTON, N.J. (AP) -- Merck & Co., bowing to pressure from parents and medical groups, is immediately suspending its lobbying campaign to persuade state legislatures to mandate that adolescent girls get the company's new vaccine against cervical cancer as a requirement for school attendance.

The drug maker, which announced the change Tuesday, had been criticized for quietly funding the campaign, via a third party, to require 11- and 12-year-old girls get the three-dose vaccine in order to attend school.

Some had objected because the vaccine protects against a sexually transmitted disease, human papilloma virus, which causes cervical cancer. Vaccines mandated for school attendance usually are for diseases easily spread through casual contact, such as measles and mumps.

"Our goal is about cervical cancer prevention and we want to reach as many females as possible with Gardasil," Dr. Richard M. Haupt, Merck's medical director for vaccines, told The Associated Press.

"We're concerned that our role in supporting school requirements is a distraction from that goal, and as such have suspended our lobbying efforts," Haupt said, adding the company will continue providing information about the vaccine if requested by government officials.

Whitehouse Station-based Merck launched Gardasil, the first vaccine to prevent cervical cancer, in June. It protects against the two virus strains that cause 70 percent of cervical cancer and two strains that cause most genital warts.

Sales totaled $235 million through the end of 2006, according to Merck.

Last month, the AP reported that Merck was channeling money for its state-mandate campaign through Women in Government, an advocacy group made up of female state legislators across the country.

Conservative groups opposed the campaign, saying it would encourage premarital sex, and parents' rights groups said it interfered with their control over their children.

Even two of the prominent medical groups that supported broad use of the vaccine, the American Academy of Pediatricians and the American Academy of Family Practitioners, questioned Merck's timing, Haupt said Tuesday.

"They, along with some other folks in the public health community, believe there needs to be more time," he said, to ensure government funding for the vaccine for uninsured girls is in place and that families and government officials have enough information about it.

Legislatures in roughly 20 states have introduced measures that would mandate girls have the vaccine to attend school, but none has passed so far. However, Texas Gov. Rick Perry on Feb. 2 issued an executive order requiring Texas girls entering the sixth grade as of 2008 get the vaccinations, triggering protests from lawmakers in that state.

Parents in Texas could opt out for their daughters if they state religious or philosophical objections, but several lawmakers there want parents to opt in instead of being able to opt out.

Perry defended his order Tuesday, a day after lawmakers in Austin held a lengthy hearing on the issue but failed to act on a bill to override the order.

Dr. Anne Francis, who chairs an American Academy of Pediatrics committee that advocates for better insurer reimbursement on vaccines, called Merck's change of heart "a good move for the public."

"I believe that their timing was a little bit premature," she said, "so soon after (Gardasil's) release, before we have a picture of whether there are going to be any untoward side effects."

Given that the country has been "burned" by some drugs whose serious side effects emerged only after they were in wide use, including Merck's withdrawn painkiller Vioxx, Francis said, it would be better to wait awhile before mandating Gardasil usage.

She said she also was concerned about requiring a vaccine for a disease that is not communicable and so does not have a big public health impact. While doctors expect Gardasil to have a huge effect in poor countries where women do not get Pap smears, in this country those tests limit the incidence of cervical cancer to about 9,710 new cases and 3,700 deaths each year.

The National Vaccine Information Center has been publicizing reports of side effects -- mostly dizziness and fainting -- in several dozen people getting Gardasil, which is approved for use in females ages 9 to 26. The center, a group of parents worried that vaccines harm some children, questions whether the vaccine was tested in enough young girls.

Officials with the Centers for Disease Control and Prevention, however, say that reports of side effects through the end of January don't raise any red flags.

The vaccine also is controversial because of its price -- $360 for the three doses required over a six-month stretch. Because of that cost and what pediatricians and gynecologists say is inadequate reimbursement by insurers, many are choosing not to stock the vaccine or requiring surcharges to administer it, increasing the cost for many families and making the vaccine hard to come by.

Merck shares were down in after-hours trading on the New York Stock Exchange, falling 35 cents to $44.15 after rising 22 cents in regular trading to close at $44.50.

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