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.

Bioterror: VaxGen stops work on anthrax vaccine; smallpox contract awarded

A few recent items about efforts to develop vaccines against possible agents of bioterrorism:

-- We've been following the saga of the VaxGen anthrax vaccine contract since beginning this site in March 2006 (complete coverage here). When we last checked in -- in January -- the news was that HHS had finally canceled the $877.5 million contract awarded to VaxGen as part of Project Bioshield. Just before Memorial Day weekend (likely deliberately timed to reduce media coverage), VaxGen announced that is was ceasing further development of the vaccine, an all-but-inevitable development without new funding.

Here's the VaxGen press release and a story from CIDRAP News. The press release notes that VaxGen will be laying off 20 employees as a result of this decision, which, amazingly, accounts for 25% of its workforce. There's little doubt that this point will be noted by those who had long criticized the decision to award such a significant contract to a very small, unproven player in vaccine development.

Even more bad news is highlighted in this CQ.com story, which notes the new hurdles VaxGen faces is selling its anthrax vaccine technology developed thus far.

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-- Speaking of CQ.com and bioterror vaccines, following up on this previous post, the anticipated agreement between HHS and Bavarian Nordic for a second-generation smallpox vaccine was completed last week. Here's the HHS press release and an AP story, courtesy of CBSNews.com.

Also in the news: new meningitis vaccine?; ethics of clinical trials

Two other odds-and-ends appearing in our inbox this week:

-- An AP story from late last week proclaims, "New meningitis shot could end fatal epidemics." Not surprisingly, "could" is very much the key word in that headline. As the story points out, the positive data being announced comes from a clinical trial of only 600 toddlers in Africa, and the successful introduction of the vaccine candidate is, at best, years away. More depressing, but no doubt accurate, is this point from the story:

"Even if the new vaccine becomes available, experts think there will be a lag of about 15 years before the majority of Africa’s at-risk population can be vaccinated."

Of course, this 'lag' is present for the introduction of any new vaccine in the developing world, often (as is the case for rotavirus and HPV vaccines) the parts of the world where the greatest vaccine-related benefit is possible.

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-- Speaking of vaccine research and testing in the developing word, the June 21 issue of Vaccine includes a paper titled, "Ethical considerations related to the provision of care and treatment in vaccine trials." (subscription required). Written by Daniel Tarantola, Ruth Macklin, and colleagues, the paper summarizes a meeting exploring the long-disputed question of the type and level of care due to research subjects in the developing world (where the standard of care is typically quite different from the home countries of research sponsors.)

Those looking for a clear recommendation will not find it here. The authors recommend "a structured approach" to decision-making, meaning, "a consultative process with trial communities and other stakeholders in research [that] will ensure that the needs and legitimate expectations of trial participants are appropriately met, obligations towards them are delivered and, as a result, ethical research is facilitated in the interest of public health."

GSK gives to WHO bird flu vaccine stockpile; cell-based seasonal flu vaccine approved in EU

Some influenza-related goings-on this week:

• Yesterday, GSK announced via press release its plan to donate to WHO 50 million doses of its pre-pandemic avian influenza vaccine. WHO responded with a press release of its own, noting some of the many, many still-to-be-answered questions regarding if, when, and how such a stockpile would be used. Here's the AP story on the announcement. While a nice corporate gesture, vaccine doses for 25 million people -- delivered over 3 years, no less -- seems like a drop-in-the-bucket in the event that anything even resembling the estimates of policy-makers comes to fruition. Also, we've discussed the many uncertainties regarding the value of pre-pandemic vaccines previously, but suffice it to say, the benefit of such vaccines is uncertain today, much less three years from now in light of the viral mutation that would precede a pandemic in humans. All that said, this news can be seen as a good start, one could say, but by no means a major step in preparedness.

• In seasonal flu news, the EU approved a cell-based vaccine by Novartis, likely to be the first marketed flu vaccine produced without the use of eggs. Here's the AP story, courtesy of the Washington Post, and the Novartis press release. The story notes that the vaccine will not be available throughout the EU until the 2008-09 flu season and that U.S. approval will be sought next year. In light of the well-rehearsed problems with egg-based flu vaccine production (most notably the 2004 shortage), this may prove to be a major moment in flu vaccine development.

New and improved CDC website for vaccines

Last week the CDC launched a new web home for all of its vaccine-related content -- www.cdc.gov/vaccines. Timed with the creation of the National Center for Immunization and Respiratory Diseases, which replaces the National Immunization Program,
the website has many more resources, is better organized, and is a dramatic visual improvement over the former NIP site.

We're still exploring the new site, but there is clearly a great deal of new information in addition to the expected info regarding the ACIP, recommended vaccination schedules, safety, cost/access, and much more. Also prevalent are links to websites of non-CDC (but like-minded) advocates of vaccination.

There's no doubt that the new CDC vaccines site is the premier source for understanding the federal governments' responsibilities, activities, and recommendations on vaccination.