I decided to just say briefly what happened yesterday at the NBSB conference call.
Every member of the NBSB, with the exception of Iowa’s top public health officer, Patricia Quinlisk, MD, voted in favor of testing anthrax vaccine in children. Kudos to Dr. Quinlisk for making clear that her public health background precluded agreement.
Panel member Ruth Berkelman suggested that a sentence be added to the recommendation, asking for a national ethics board to review the trial. Her suggestion was tweaked slightly and accepted by all. Were the panel members relieved to add another layer of review?
Whether the Presidential Commission for the Study of Bioethical Issues or a newly created panel would serve as the ethical-legal reviewing body is uncertain. Vera Sharav, president of the Alliance for Human Research Protection, and I remain of the opinion that the trial is legally unapprovable under the language of 46 CFR 45 Subpart D which would require:
the Secretary …determines that the research presents a reasonable opportunity to understand, prevent, or alleviate a serious problem affecting children’s health or welfare, and, in addition, determines that the research will be conducted in accordance with sound ethical principles and that adequate provisions are made for soliciting the assent of children and permission of their parents or guardians as discussed in 46.408.
Sound ethical principles, of course, means you have to tell the truth about what is known regarding safety and efficacy of this vaccine, and furthermore, tell parents that the HHS secretary has given anthrax vaccine a PREP Act waiver, and the manufacturer cannot be sued for damages.
Reader comments appended to the online news articles about the meeting (Google says there are 289 articles) almost uniformly pan the vaccine trial. The most frequent comments have to do with whose children should be those tested first: those of panel members, DHHS officials, Congress or Obama. It seems everyone except the professionals understands this trial involves human sacrifice, regardless of media reports that the vaccine has been sufficiently tested in adults.
In the end, Assistant DHHS Secretary Lurie told the panel that the department would decide whether to follow their advice, and when. “We’re not ready to make a decision at this time but will continue the dialogue,” Lurie said.
To me she sounded lukewarm. For the first time, the issue of “finding the money for the trial” came up. Reading between the lines, I heard, ‘this seemed like a good idea at the time, but with an election coming up, we don’t need to antagonize yet another constituency.’ If self-preservation is the strongest impulse of a bureaucrat, I don’t see Lurie authorizing this trial in the next 12 months. Maybe never: if it bombs, she’ll take the fall.
On the other hand, there is a lot of money involved, with a new contract inked on October 3 by DHHS for an ADDITIONAL $1.25 BILLION anthrax vaccine for the civilian stockpile. Always follow the money. DHHS didn’t ask where it was going to find the money for that in the federal budget.