Two articles have crossed my monitor, both of which prove just how diligent we patients must be about the drugs and devices that may be shared with us, and how much -- or how little -- FDA approval plays a role.
Ever heard of Mammosite? It's a radiation device-based procedure that shortens breast cancer radiation therapy for some breast cancer patients from many weeks, to just days. Sounds great, right? It's being recommended for thousands of women, even though there is no published proof that it works. The FDA approved Mammosite through it's "fast track" process called 510(k), a process developed to help devices be approved quickly so they can go on the market. Bottom line, the necessary proof that fast tracked devices work is less important than making sure the device companies can make money from them.
Here's the problem: Doctors who recommend, and then treat patients with Mammosite are making more money on that treatment than they make through the approved, more general radiation treatment. In some cases, they are making twice as much, almost $10,000 more. How convenient that those doctors don't mention that the treatment does not have any long-term proof that it works!
What can breast cancer patients do? Get an opinion from someone who doesn't do the Mammosite procedure in addition to an opinion from someone who does both procedures. Then read everything you can about all recommendations -- and use your intuition about who is providing the best information for you. (Good resource: About.com's Guide to Breast Cancer)
A second article talks about a long-approved and well known helpful drug, aspirin. In this case Bayer Aspirin. It seems Bayer is now selling its aspirin with additives such as calcium, and the packaging claims it may help fight problems like osteoporosis or heart disease. So the FDA has sent Bayer a letter telling them they cannot sell this aspirin with additives over the counter. It must be approved by them.
Do they have a point? Perhaps. But this is simply a problem about the claim they are making and not a problem with the safety of the drug. Look at the orange juice you buy -- it says it contains calcium or antioxidants or a plethora of other "healthy" ingredients. But it doesn't tell you it will prevent anything.
So what we have now is the FDA fast tracking, spending less time, with dangerous and potentially life threatening treatments such as radiation. And we have them spending more time with a problem that will not negatively affect someone's life at all -- wording on an aspirin package.
What can we do about it? Almost nothing. But we can learn that the FDA isn't the end-all-and-be-all for helping us make decisions about the care and treatment we need. We need to take that responsibility ourselves and understand that whether or not something is FDA approved isn't a stamp of approval (or lack thereof) for its effectiveness and safety.
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