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Yes or no decision on HPV vaccine is still tricky

What are young women (and the parents of young women) to think about the human papillomavirus (HPV) vaccine — you know, the one that’s supposed to protect against cervical cancer?

Last June, the conservative group Judicial Watch (yep, the one financed by the billionaire and infamous Clinton-detractor Richard Mellon Scaife) published a scary special report in which they documented (from material they had obtained from the Food and Drug Administration under the Freedom of Information Act) reports of a small percentage of women becoming severely ill — even dying — after receiving the vaccine. (Some conservative groups have opposed the HPV vaccine in large part because they believe it undermines the “abstinence-only” message and promotes sexual promiscuity.)

Now, along comes a study in the Aug. 19 issue of the Journal of the American Medical Association (JAMA) that offers reassuring news. It analyzed 12,424 reports (collected between June 2006 and December 2008) of young women who experienced an adverse health event after receiving the HPV vaccine. The study concluded that the rate of these reports (about 60 for every 100,000 doses given) was no worse than that for other vaccines, except for a higher proportion of reports of fainting and blood clots.

The researchers at the Centers for Disease Control and Prevention (CDC) who conducted the analysis acknowledged that their findings were tempered by the fact that the reporting of adverse events is voluntary (and thus probably underreported). And because such accounts are not collected under the controlled structure of a clinical trial (indeed, many of the most serious adverse event reports for the HPV vaccine, including 12 of the 32 reported deaths, could not be verified through medical records), they’re not considered all that useful in determining whether a vaccine actually caused — or didn’t cause — particular health problems. Large, prospective controlled studies are needed for that.

No resolution
Somehow, I don’t think this finding is going to end the debate about this vaccine — and not just because groups on the political right are opposed to it for so-called moral reasons. There’s another, this time discomforting, HPV vaccine-related study in the same issue of JAMA. Authored by Sheila and David Rothman, professors of public health and social medicine and history at Columbia University in New York, this second study describes in eye-opening (and dispiriting, to this reader) detail how the pharmaceutical company Merck went about selling doctors and public health officials on the idea that all young women should receive the vaccine. Merck markets the vaccine under the trade name Gardasil.

According to the Rothmans, to dodge the sales-slowing obstacles it had encountered 20 years earlier when it launched its hepatitis B virus (HBV) vaccine, Merck devised an aggressive marketing plan that would “avoid limiting the [new HPV] vaccine to high-risk populations, promote it for all women, and secure government reimbursement and mandates.”

And that’s exactly what the company did, largely by giving professional medical associations generous educational grants to produce materials and speakers’ bureaus to promote the vaccine. Merck even channeled money to the American College Health Association (ACHA), which provides health services, including vaccines, to students. With the funding, say the Rothmans, ACHA

created an HPV Vaccine Toolkit for clinicians, including talking points, sample e-mail messages to students and parents, sample press releases, and public service announcements.” One sample letter/e-mail to students announced a new vaccine “that protects against HPV — and it could help save your life.” It listed college students’ everyday worries — dates, examinations, roommates — and declared, “Well, now there’s something you don’t have to worry about anymore. And this worry is a big one. Why worry about cervical cancer?”… Sample letters to parents included the following: “Will she get good grades? Will she call home often? The last thing you want her to worry about is cervical cancer…. Encourage your daughter to “Be Smarter and Get Vaccinated” at the Student Health Service — it could help save her life.” In none of these cases was Merck funding mentioned.

The effort paid off big for Merck. By the end of 2008, more than 23 million doses of Gardasil had been distributed in the United States alone. In 2008, worldwide sales of the vaccine topped $1.4 billion.

And in 2006, report the Rothmans, “Gardasil was named the pharmaceutical ‘brand of the year’ for building ‘a market out of thin air.’”

Benefits vs. risks
Of course, the aggressive marketing of a drug (or vaccine) doesn’t mean it lacks medical merits. But what about this particular vaccine? Do its benefits outweigh its risks? Charlotte Haugh, MD, of the Journal of the Norwegian Medical Association, addresses this question in a thoughtful editorial that accompanied the two JAMA studies:

The theory behind the vaccine is sound: If HPV infection can be prevented, cancer will not occur. But in practice the issue is more complex, First, there are more than 100 different types of HPV and at least 15 of them are oncogenic [potentially cancer-causing]. The current vaccines target only 2 oncogenic strains: HPV-16 and HPV-18. Second the relationship between infection at a young age and development of cancer 20 to 40 years later is not known…. The virus does not appear to be very harmful because almost all HPV infections are cleared by the immune system. In a few women, infection persists and some women may develop precancerous cervical lesions and eventually cervical cancer. It is currently impossible to predict in which women this will occur and why.

This inability to predict with any degree of certainty who will develop cervical cancer from HPV infections makes the risk/benefit analysis regarding the HPV vaccine particularly challenging for young women (and their parents). Says Haugh:

Whether a risk is worth taking depends not only on the absolute risk, but on the relationship between the potential risk and the potential benefit. If the potential benefits are substantial, most individuals would be willing to accept the risks. But the net benefit of the HPV vaccine to a woman is uncertain. Even if persistently infected with HPV, a woman most likely will not develop cancer if she is regularly screened. So rationally she should be willing to accept only a small risk of harmful effects from the vaccine.
When weighing evidence about risks and benefits, it is also appropriate to ask who takes the risk, and who gets the benefit. Patients and the public logically expect that only medical and scientific evidence is put on the balance. If other matters weigh in, such as profit for a company or financial or professional gains for physicians or groups of physicians, the balance is easily skewed. The balance will also tilt if the adverse events are not calculated correctly.

I’m just glad my daughter is of an age to make up her own mind.

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Comments (5)

  1. Submitted by Nancy Hokkanen on 08/19/2009 - 12:54 pm.

    From ABC-TV’s Dr. Timothy Johnson: “For the first time in my career, I cannot recommend a vaccine for its intended population — in this case, young girls.”

    From United Press International: “Medical groups paid for vaccine promotion”
    “Merck acknowledged it paid a total of $750,000 to the American College Health Association, the Society of Gynecologic Oncologists and the American Society for Colposcopy and Cervical Pathology, The Washington Post said Tuesday.”

  2. Submitted by dan buechler on 08/19/2009 - 02:51 pm.

    Did you research or use the MN Dept. of Health website? Our family thinks the benefits outweigh the risks.

  3. Submitted by dan buechler on 08/19/2009 - 07:13 pm.

    From the MN Dept. of Health regular pap smears are still highly highly reccomended. The HPV vaccine protects against 70% of cervical cancers in addition to other aspects like warts. The population most at risk late teens and early 20’s (and often with lower incomes) have lower compliance rates with desired behavior.
    Dear writer I think you need to revisit this topic with the help of a public health official and or a doctor.

  4. Submitted by Gregory Lang on 08/25/2009 - 04:58 am.

    I’ve followed this story for a while. The media has not the Pharm payments to research and advocacy groups. They have not blinked an eyelid at the $100 per shot, $300 price of this. Is this price gouging?

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