HPV Roundup: Gardasil safety worries, Cervarix FDA delays, more on mandates

There's been a flurry of media coverage this week about possible safety issues related to Gardasil. It appears that the attention was initiated by this report released by Judicial Watch, the conservative watchdog group. Like its previous reports alleging numerous deaths and illnesses caused by vaccine, this Judicial Watch report is based on unconfirmed submissions to VAERS, the government's clearinghouse for reports of possible vaccine-related adverse events. Reports to VAERS -- widely described as a 'hypothesis-generating mechanism' -- are later examined by government officials to determine what, if any, role a vaccine may have had in the reported condition.

Numerous other outlets have raised questions about Gardasil's safety in the past few days, most notably this CBS News story by Sharyl Attkinson, the media member who is increasingly at the forefront of reporting on alleged vaccine risks. Other media outlets examining the topic include CNN and WebMD.

In the meantime, officials from CDC and FDA have assured the public that the vaccine remains safe and effective and that reports of possible adverse events will continue to be investigated. Merck responded similarly yesterday, noting the limitations of reports made to VAERS.

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Meanwhile, it appears that the U.S. head-to-head battle between Gardasil and GSK's Cervarix will most likely be delayed until late 2009. Last week, the Wall Street Journal and Reuters, among others, reported the GSK announcement of its timetable for submitting additional trial data requested by FDA. Here is the GSK press release. It notes that Cervarix is already approved in 67 countries, including the E.U., but it's no secret that the U.S. market is by far the most lucrative, as Merck's sales figures from earlier this year illustrated.

From a business standpoint, this is decidedly good news for Merck, as it extends its head start in the U.S. (The news has not all been good, however, as it was announced late last month that Merck's application to expand the indication for Gardasil for women through age 45 will face additional scrutiny and delays. Here's a story from Reuters and the Merck press release.)

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In other news, two papers have recently been published in academic journals on HPV mandates (joining a growing literature on this topic -- including papers by Schwartz, et al., Colgrove, and Zimmerman.) One paper, "Assessing Mandatory HPV Vaccination: Who Should Call the Shots?" (Javitt, et al.) appears in the Summer 2008 issue of the Journal of Law, Medicine & Ethics (subscription required). In short, the authors conclude, "...Mandating HPV vaccination at the present time would be premature and ill-advised."

Also, the May 2008 Harvard Law Review published a paper titled "Toward a 21st Century Jacobson v. Massachusetts (pdf), alluding to the 1905 case that is widely seen as the foundation for state public health powers. The authors argue that a distinction should be drawn between vaccines that are 'medically necessary' (such as smallpox) and those that are 'practically necessary' (such as hepatitis B and HPV, for which other preventive measures are available but not widely used). The paper suggests that current law and policy fail to acknowledge the implications of this distinction.

Belgian parents face jail over non-vaccinated children

The Associated Press today reported on a fascinating story out of Belgium, where two sets of parents were sentenced to five months in prison as a result of failing to vaccinate their children against polio. The story notes that Belgium and France are the only two countries to require polio vaccination as a matter of national law. (Recall that U.S. vaccination requirements occur at the state level, and include various exemption protocols.) The parents' jail terms have been delayed to allow them another opportunity to vaccinate their children. Fines equivalent to approximately $8,000 were also assessed.

The website of the Belgian Federal Public Service includes information on polio and notes that it is the only mandatory vaccine in Belgium.

The story brings to mind the controversial jail threat levied against parents of unvaccinated children in Prince George's County, Maryland, last fall. (Our coverage here.)

According to this WHO website, there have been a total of three confirmed cases of polio in Belgium since 1980, the last occurring in 1989. (For comparison, there were 1307 cases worldwide in 2007 according to the Global Polio Eradication Initiative, the vast majority found in India and Nigeria.) Authorities in Belgium would likely point to the scarcity of polio cases as evidence supporting a strong vaccination requirement.

Threatening (or imposing) imprisonment is perhaps the most forceful tool at the disposal of public health authorities. It is unclear from the AP story whether such action is appropriate here or whether these measures should be reserved for more imminent threats to public health than the comparative minor threat of polio in Belgium given the very high vaccination rate overall.

Recent papers on vaccine-autism history, mandates, vaccine law, and YouTube

There have been an exceptional number of papers published in medical journals over the past several weeks that are worth mentioning...

• "Mercury, Vaccines, And Autism: One Controversy, Three Histories" -- American Journal of Public Health (subscription required for full text; published online ahead-of-print). From Jeffrey Baker, a physician and historian of medicine at Duke, an examination of the multiple histories that have contributed to the nature of current arguments linking vaccines to autism. Baker traces the parallel histories of thimerosal as a vaccine preservative, mercury as a health risk, autism as a diagnosis, and the relatively recent intersection of these stories.

• "Mandating Vaccination: What Counts as a "Mandate" in Public Health and When Should They Be Used?" -- American Journal of Bioethics (subscription required for full text). By Matthew Wynia of the American Medical Association, a commentary on the imprecise usage of the term 'mandate' (with respect to both vaccination and other public health activities) and the implications thereof. A nice introduction to a topic that deserves more attention from scholars.

• "Vaccine Law 101" -- Journal of Law, Medicine, and Ethics (subscription required for full text). Exactly what the title suggests, a high-altitude overview of the many laws, regulations, and types of litigation related to vaccines. A summary of a conference panel session of the same name. Short on insights and argument, but a very useful starting point for those interested in legal aspects of vaccination.

• "YouTube as a Source of Information on Immunization: A Content Analysis" -- JAMA (subscription required for full text). From a research team at the University of Toronto, a review of vaccine-related content posted on YouTube, examining claims made about vaccines and vaccination as well as the general attitude expressed toward vaccines. Slightly more than half of all videos were not expressly positive about vaccination, and those critical of vaccination tended to receive higher ratings from YouTube visitors. Here's a press release about the paper.