H1N1 vaccine update: The FDA is off the leash

The more I hear about the H1N1 flu, the more nervous I am.

But it’s not the flu that’s fraying my nerves, it’s our government’s reaction to the flu.

This past April, Health and Human Services declared H1N1 a public health emergency. And that official declaration sets a lot of interesting things in motion. For instance, the FDA is now free to allow the use of unapproved medical products to address the crisis.

Now THAT’S scary!

Recently, Bloomberg reported that the CDC has agreed to pay $415 million to two drug companies to produce an adjuvant that can be added to the H1N1 vaccine in order to stretch supplies. And depending on who you talk to, this adjuvant is either very safe, or completely untested.

A spokesperson for GlaxoSmithKline (one of the two producers of the adjuvant) told Bloomberg that trials have proven the adjuvant safe and effective.

But an FDA official, in a rare moment of candor, told Bloomberg: “Until GlaxoSmithKline and Novartis can show me it won’t harm a rat or guinea pig, I think it’s a bad idea to give it to humans,”

So we’re in a position of wondering who we can trust – a drug company or the FDA.

Now that’s REALLY scary!

Source:
“Swine Flu Shot May Rely on Emergency Use of Additives” Tom Randall and Gary Matsumoto, Bloomberg, 7/29/09, Bloomberg.com