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In the past, the FDA has had to backtrack and withdraw approved drugs or include additional patient warnings of diabetes and other treatment drugs as more problems became known. I was always glad for that protection when unforeseen side effects become known. But of late, the FDA has totally thrown patient concerns and needs out the window. For example, they took away my albuterol inhaler because it "polluted" the air. Forget that it saves lives and was relatively safe - and cheap in generic form. Now patients with asthma can now only purchase one non-generic inferior product that is known to be less effective, has caused deaths - actually making asthma attacks worse - and the FDA knew this when it made its chances, and is far more expensive. We have no choices now when it comes to fast-acting inhalers - we only get the one product now and risk our lives and pay triple the cost because insurance does not have to pay for brand name drugs even when there are no generic options.

Now I have to worry about not getting the best drugs for my diabetes, too? Come on FDA, your job is not to play God. Yout agency is riddled with hypocrisy as you have now ordered pharmaceutical companies to cough up the patent formulas for insulin so others can make it generic which will force consumers to pay full price for currently insured insulins or change to another product? Insulin is a far more complicated drug and yet you will require no studies on generic insulin to ensure safety but will excessively regulate oral meds?

If you were a business, you'd be bankrupt, out of business, and probably criminally liable. It is kind of scary when consumers are now screaming that they trust pharmaceutical companies more than the agency that is supposed to protect us.

Great post, Kelly. I'll be doing a podcast interview with Amy T on December 24th to get the word out about the petition. The FDA risk aversion spans all diseases (I've been writing about what it does to cancer patients, for example). We need to find a balance between risk/benefit. It's the provider's job to explain each drug's risk/benefit analysis to patients, and then let them choose.

Unfortunately, patient choice is being undermined by absolute risk aversion - consider the case of Wyeth vs. Levine. A rare but known risk of phenergan (if erroneously injected into an artery) is tissue necrosis. This drug has been successfully and effectively administered over 200 million times in the US - but in 20 cases, a provider messed up and injected the drug into an artery, causing grave damage. Now one of those cases (literally 1 in 20 million) is suing Wyeth (with lay jury support). What will companies like Wyeth do about this in the future? Maybe they'll stop making good drugs available... Never mind that for every one injury 20 million patients were helped...

We have to educate patients about this kind of thing - and help them to understand that zero risk is not possible. Requiring the FDA to demonstrate a near zero risk profile for new medications before they're approved is going too far. :)

Preaching to the choir...


BTW - I think Scott S. would make an incredible part of your team... you all should explore the opportunites!

Great post Kelly!

Back in March 2008, I responded to the FDA's "Draft Guidance for Industry on Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention" and said exactly the same thing. While it's nice to have others joining me in reaching this conclusion, it would have been nicer to have you join me back then!

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