(Swine flu vax) - Damn the Data! Full Speed Ahead

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http://anthraxvaccine.blogspot.com/

Friday, July 24, 2009

Damn the Data! Full Speed Ahead

There are many federal advisory panels, often

comprised of those with vested interests.

<http://www.dhhs.gov/aspr/omsph/nbsb/members.html>This

panel did as expected, calling for precipitous

vaccine approval. The

<http://online.wsj.com/article/SB124839219994977533.html#mod=whats_news_free?mod\

=igoogle_wsj_gadgv1>Wall

Street Journal reports:

In the U.S., a federal advisory panel said the

FDA should move ahead to approve or license the

new H1N1 vaccine without waiting to receive data

from clinical trials to test its safety and

efficacy. The government and vaccine makers plan

to start human studies of the H1N1 vaccine in the

U.S. in the coming weeks, but the first-look data

from those studies won't be given to the FDA until September.

From

<http://content.usatoday.net/dist/custom/gci/InsidePage.aspx?cId=indystar & sParam\

=35730158.story>Gannett:

But the FDA told its scientific advisers it could

finish the red tape of licensing much of that

vaccine well before the use-it-or-not decision is

made ­ because it's brewed exactly the same as

regular winter flu vaccine, merely using the new

swine influenza virus, part of the common H1N1

influenza family, as the chief ingredient.

Companies just have to take the normal steps

required for each year's regular winter flu

vaccine, such as proving the inoculations are manufactured appropriately.

Taking the same path now will save some important

time because " the virus is ahead of us, " said FDA

vaccine chief Dr. Norman Baylor. This " is not a

rubber stamp. We do need to review some data to

give us some comfort that that vaccine will

provide some benefit and that it's manufactured properly. "

.... Make no mistake: Vaccines containing

immune-system boosters called adjuvants are not

candidates for the easier strain-change approval,

the FDA said. Flu vaccine with this extra

ingredient is widely sold in Europe but never has

been sold here, and there's little information

about their safety in young children or pregnant

women. While both adjuvant-free and

adjuvant-added swine flu vaccine is being tested

in the U.S. and abroad, using it outside of those

studies would require a completely separate government decision.

FDA appears unwilling, currently, to take the

bigger risk of approving novel adjuvants, which

have not been tested in at-risk populations,

without data. But the risk that our federal

regulatory agencies are willing to take is equal

to the risk these agencies took in 1976, when no

new vaccine adjuvants were used. In 1976, 6-8

times as many Guillain Barre Syndrome (autoimmune

paralysis) cases occurred as would have occurred

by chance alone, after vaccination.

Although somewhat reassuring, this is not good

enough. Yearly flu vaccines have traditionally

been approved each year with very abbreviated

testing, compared to other vaccines. Now swine

flu vaccine is being pulled through that same

loophole, because government officials have a

precedent, which makes doing so (bureaucratically) easy.

They need to remember the Guillain Barre precedent also.

Reading the 1978

<http://www.nap.edu/catalog.php?record_id=12660#toc>National

Academy of Sciences report on the 1976 Swine Flu

vaccination program, from which 2009 policymakers

could learn a lot, comes the following:

" Decision-making for the swine flu program had

seven leading features. To simplify somewhat, they are:

Overconfidence by specialists in theories spun from meagre evidence.

Conviction fueled by a conjunction of some preexisting personal agendas.

Zeal by health professionals to make their lay superiors do right.

Premature commitment to deciding more than had to be decided.

Failure to address uncertainties in such a way as

to prepare for reconsideration.

Insufficient questioning of scientific logic and of implementation prospects.

Insensitivity to media relations and the

long-term credibility of institutions. "

Posted by Meryl Nass, M.D. at

<http://anthraxvaccine.blogspot.com/2009/07/damn-data-full-speed-ahead.html>11:0\

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