Federal hearing rekindles thimerosal-autism debate

As has been widely covered in the media, a significant hearing is underway in Washington, DC, this month, as three Special Masters hear claims from a group of 5,000 plaintiffs alleging a link between thimerosal-containing vaccines (prior to the preservative's removal in 1999) and autism. Directly at stake is whether autism should be included among diagnoses for which compensation can be awarded through the federal government's Vaccine Injury Compensation Program. Advocates of vaccination warn that a ruling in favor of the plaintiffs could bankrupt the compensation program, resulting in dire consequences for U.S. vaccination efforts.

The overwhelming consensus among the medical community remains that no link can be found between thimerosal and autism. (Here's the CDC site on mercury and vaccines.) Critics of this view -- many of whom have close links to children or families affected by autism -- respond that these conclusions are based on flawed or inadequate research, or worse, are the product of a medical and vaccination community with unacceptably close ties to the pharmaceutical industry.

Official information along with audio and transcripts of the proceedings can be found here.

An excellent preview of the proceedings appeared in this story by Shankar Vedantam in last Sunday's Washington Post.

Gardiner Harris of the New York Times reported here on the first day of testimony last Monday, as did this AP story. Over at Slate, Arthur Allen previewed the hearing, and the New Scientist reports on it as well. Both focus on the widely criticized research of Dr. Mark Geier -- undoubtedly the most controversial proponent of a thimerosal-autism link.

Sharyl Atkinson of CBS News offered some very provocative opinions in a web column titled, "Autism: Why The Debate Rages." In the Boston Globe, Paul Offit weighed in via an op-ed titled, "At risk: vaccines -- How a legal case could cripple one of modern medicine's greatest achievements". Offit's op-ed generated a number of critical letters which the Globe printed here.

An interesting sidebar to these proceedings is the reported rift among the autism advocacy community regarding the merits of thimerosal-based explanations for the rise in autism rates vs. other potential explanations. Both the New York Times ("Autism debate strains a family and its charity") and ABC News ("Emotions run high over autism's causes") highlighted the disagreement between members of the Wright family, founders of Autism Speaks, perhaps the most prominent and well-connected autism organization. At The Huffington Post, Robert F. Kennedy, Jr., takes issue with these portrayals of Katie Wright, who believes strongly in a thimerosal-autism link.

The hearing in Washington is scheduled to continue for another week and a half; a decision may take a year.

Info on Kawasaki disease added to RotaTeq label

A colleague from CDC alerted us to this announcement regarding a change to the label of RotaTeq, Merck's rotavirus vaccine recommended to all infants at 2, 4, and 6 months. Here's the first paragraph of the CDC statement:

"The Food and Drug Administration (FDA) approved today a revised label for RotaTeq, a rotavirus vaccine manufactured by Merck and Co., Inc., to include information on reports of Kawasaki disease occurring before and after the vaccine’s licensure in February 2006. FDA has not made any changes to its indications for use of RotaTeq nor has it issued new or revised warnings or precautions. Likewise, the Centers for Disease Control and Prevention (CDC) has not made any changes in its recommendations regarding the use of RotaTeq. Healthcare providers and parents should remain confident in using RotaTeq in infants."

Here's the FDA release and a related story from Reuters (the only media outlet to have reported on this item as of now.)

General info on Kawasaki disease can be found here and here. It's a rare and poorly understood inflammatory condition that affects 4,000 American children annually.

The "label" referred to in the announcements above is actually this document, an 11-page, single-spaced, data-laden product insert unlikely to top the reading lists of most parents (or pediatricians, for that matter).

The FDA statement notes, "The cases reported to date are not more frequent than what could be expected to occur by coincidence," a statement that could also describe its announcement in February regarding intussusception reports among recipients of RotaTeq.

Similar to that earlier occasion, this announcement was seemingly made so that providers and parents may be vigilant in looking for symptoms of Kawasaki disease, in case a connection to the vaccine does exist. However, calling attention to severe conditions for which no evidence suggests a vaccine link may create undue confusion and worry among parents still told to vaccinate their children with RotaTeq. Admittedly, it is a difficult balance that must be weighed by policy-makers, but one that merits further study.

Gardasil: CDC response on safety/efficacy; survey on parental support for mandates

The weekly news update from the Immunization Action Coalition alerted us to this CDC Q&A released last week titled "CDC Questions and Answers Concerning the Safety and Efficacy of Gardasil." The three-page document outlines the current status regarding safety monitoring, known safety concerns, the potential need for boosters, and the ongoing necessity of Pap screening.

It seems likely that the fact sheet was this breathless press release from JudicialWatch.org asserting (based on VAERS reports) that "three deaths were related to the vaccine." The CDC fact sheet clearly explains how and why this statement is a misinterpretation of VAERS data, reaching conclusions that are no possible from that information alone. Not surprisingly, a search of Google News suggests that the press release garnered virtually no attention from the print media. While safety concerns linked to Gardasil could still surface, there's no evidence at present to suggest such a connection.

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One other item related to Gardasil: The headline from a survey released by a group at the University of Michigan C.S. Mott Children's Hospital reads: "Majority of U.S. Parents Not in Favor of State HPV Vaccine Mandates." The report is available here, and here is coverage from CBS News and the Washington Times.

However, the headline -- while likely shrewdly written to generate the media coverage sampled above -- is very misleading. The report's own data (Table 1 in the report) lists 26% of parents disagreeing with an HPV mandate, 44% of parents agreeing, and a very significant 30% as 'neutral.'

Therefore, the same data could also carry the headline, "76% of parents not opposed to HPV mandate," which would actually more accurately capture the large percentage of respondents with no opinion for or against a mandate.

ABC "20/20" segment on risks of vaccination

On February 23, ABC News' 20/20 featured a series of reports by John Stossel under the heading "Scared Stiff: Worried in America." Among the topics he explored was the general question "are vaccines safe?" His conclusion: Yes, they are. An article closely based on the piece is available here.

Supporting Stossel's conclusion was Dr. Paul Offit; taking the other side, as usual, was Barbara Loe Fisher. She was hardly portrayed in a positive light by Stossel. Most damning was Fisher's unwillingness to acknowledge that, on balance, vaccines have done more good than harm for society throughout history, a position that all but the most fervent opponents of vaccination readily accept.

Needless to say, Fisher was less than pleased with the program's discussion, Stossel's assessment, and the way in which she and her organization were perceived. Her response can be viewed here.

Renewed attention to possible rotavirus vaccine link to intussusception

A fairly significant amount of alarm was raised by an FDA statement last week titled "Information on RotaTeq and Intussusception". The statement reports 28 cases of intussusception -- the significant intestinal complication that led to the removal of the first rotavirus vaccine, RotaShield, in 1998 -- in children following administration of RotaTeq.

But what may have seemed at first glance to be a major announcement about the vaccine's safety was clarified later in the statement...

"Intussusception can occur spontaneously in the absence of vaccination. Of the reported 28 cases of intussusception, the number that may have been caused by the vaccine, or occurred by coincidence, is unknown."

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"The number of intussusception cases reported to date after RotaTeq administration does not exceed the number expected based on background rates of 18-43 per 100,000 per year for an unvaccinated population of children ages 6 to 35 weeks (CDC, unpublished data)."

In other words, there's no reason to be alarmed about the number of cases reported to date, but the statement, not unsurprisingly, did just that. This AP story by Andrew Bridges originally did not include any information about the background rate, likely contributing to the Alliance for Human Research Protection (and others, no doubt) misinterpreting the FDA item. "Merck rotavirus vaccine linked to 28 reports of life-threatening effect," is how the AHRP item describes the announcement, not at all what the FDA said.

CDC promptly released a statement attempting to clear up confusion. Among the 'key facts' they list:

• "We are not surprised by the number of reported intussusception cases following RotaTeq vaccination."
• "Intussusception, a form of bowel obstruction, occurs spontaneously in the absence of vaccination."
  
• "This notice does not mean there is a problem with the RotaTeq vaccine."

There's been no detectable coverage of this topic in the media since the initial FDA statement last week. It will, however, be discussed at this week's meeting of the ACIP, the agenda for which can be viewed here.