Clueless -- the FDA has no idea what you and I want most from the FDA


It’s an age-old rule in writing: avoid cliché. So I’m trying to find another way to explain to the FDA that what you and I want is quality, not quantity.

Still they waste time and money issuing statements about how MANY new drugs they approved this year — ignoring the numbers that really matter: how many people are cured (or hurt!) by those very drugs.

By the numbers

If you happen to have a disease that can be successfully and safely treated with a brand new drug that’s awaiting FDA approval, then yes, the approval of that drug is wonderful news.

But very few of us will ever fit into that narrow category. So what’s with all the celebratory crowing and high-fiving from the FDA?

The answer is pretty simple: They’re making their Big Pharma pals very happy. But they are trying to convince you and me to be very happy, too.

In fact, we should be more wary and suspicious than ever. And maybe just a little terrified.

Here’s what they did: Over the course of the past 12 months (fiscal year 2011), the FDA approved 35 new drugs. This is the second highest amount of approvals within one year in the past decade (there were 37 approved in FY 2009).

That’s quite an accomplishment…if your priority is QUANTITY. As for quality, the FDA is fully aware that it will take years before we’re certain about the efficacy and safety of any of these drugs — but that doesn’t make a very good PR campaign.

Just last week I told you about Xigris, a very expensive septic shock drug that was on the market for a full decade before a study revealed it was no better than placebo.

And then there’s the perfect timing of GlaxoSmithKline executives. On the very day the FDA issued the look-how-speedy-we-are! press release, GSK announced a $3 billion settlement to conclude several federal investigations, including a Dept. of Justice investigation into the Avandia mess.

Remember Avandia? In 2009, the FDA reported that over the previous decade, 48,000 people experienced stroke, heart failure, or death because they used Avandia instead of another type 2 diabetes drug.

No question — thousands of consumers and their families would have been MUCH happier if the FDA had delayed approval of Xigris and Avandia and Vioxx and dozens of other busted drugs to be absolutely sure they were safe and effective before turning them over to the hyper-driven marketing divisions of drug companies.

So let the FDA celebrate. Just be honest that you and I, we’re not invited to that party. It’s exclusively for the FDA’s drug company partners. To them, you and I and all the rest of the consumers in the U.S. are guinea pigs who will make them much richer, no matter how awful this 2011 class of 35 new drugs turns out to be.

“FDA: 35 innovative new drugs approved in fiscal year 2011” FDA News Release, 11/3/11,

“GlaxoSmithKline Reaches Agreement in Principle to Resolve Multiple Investigations With US Government” GlaxoSmithKline press release, 11/3/11

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