Wednesday, January 16, 2013

Pedi Anthrax Trial: Experts Shade their Derrieres

You have to give credit to the two federal advisory committees tasked with advising the government on a trial of anthrax vaccine in children. THEY KNOW THE SCORE, whether they acknowledged it, or not.

The members knew this was one issue that could really burn them. They understood that this is a dangerous vaccine with the dirtiest history imaginable. And they knew they had been set up to take the fall if/when it came out that children were hurt or died.

The National Biodefense Safety Board was told nothing about the trial objectives, protocol, number of children involved, and whether a trial involving thousands of kids--needed for a vaccine safety study--could or would be conducted. Not to worry. The members approved the trial anyway, but added a caveat:  a federal ethics board needed to approve the trial as well. Smart move guys! You hit that hot potato right out of the field!

Kathleen Sebelius wasn't gonna hang on to that hot potato any longer than she had to. She immediately pitched it to the Presidential Commission for the Study of Bioethical Issues.

Were the Bioethical Members pleased? I think not... but they did a phenomenal job of squeaking past the danger. The Commission managed to hold 4 meetings to discuss the proposed trial (during which there were still no details provided about the protocol or why having a trial was so critical). They studiously managed to avoid having even one expert on anthrax or anthrax vaccine testify. Now that is no mean feat! Four meetings over one whole year, and if the devil was in the details, they were hell bent on avoiding those details. They heard not one witness who could answer questions about the government's safety and efficacy research findings for anthrax vaccine. Not from NIAID, FDA, CDC or DOD, all of which have extensive histories of anthrax vaccine research and analysis.

By the fourth meeting there were some terse moments. But the Commission pulled it out!  Twenty minutes before their public discussion of the issue ended, Walter Reed's Dr. Nelson Michael read a prepared statement [starting about minute 55 in the video] which urged that the proposed trial be started in 18-20 year olds, outside the pediatric range but adjacent to it. An age range where the child protection regulations do not apply. If all "went well" (Heh heh) the trial could gradually enroll children younger and younger, till DHHS got whatever it was that it wanted. Immediately after Dr. Michael read his statement, Amy Gutmann, the Chair of the Commission, practically banged a gavel down on the table, saying something to the effect of "Done Deal!"  She could just as well have said "Bingo!  We're kicking your hot potato down the road!"  Now some other expert somewhere will have to determine if the results in young adults permit kids to be tested. Good luck sucker!

Oh, by the way, the Commission is going to ask DHHS to compensate subjects injured in research.  They picked the right time to ask.

Naturally, no one asked how to find the existing but missing-in-action data already collected on thousands of 18 to 20 year old vaccine recipients, swallowed by some DOD, FDA and CDC black holes. Naturally.

After many millions of taxpayer dollars spent to create the appearance of two thoughtful deliberations by our nations's esteemed Biodefense and Bioethics experts, what did the taxpayer receive in return?  Bupkus.  We got to see a lot of grownups show they knew how to speak out of both sides of their mouth, and cared more for their derrieres than for any child subjects.

UPDATE:  I sent this article to the Commission's Communications Director, and asked her to point out any errors in the article, which I would be delighted to fix, were any to be found.

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