Perception of Safety
If I haven't made it clear enough, my attitude as a practicing cardiologist is pretty simple. If a treatment improves quality of life enough, it is worth considering even if, on average, it shortens life. I would apply this to the COX-2 inhibitors (Vioxx, Celebrex, Bextra) by using them for pain relief when other medicines don't work, IF a patient told me that it was worth the risk for them. That's a personal decision, based on my ability to explain the risks. Since there are now several studies that provide an estimate of risk, the discussion can be focused on risks compared to benefits.
Sometimes, I see other doctors have attitudes that are very different, and that's okay. But I am amazed by some of the attitudes displayed, which may apply to the use of drugs such as these.
Let's take the example of a medicine discussed in the medical journals but which is not currently approved for use. It's called ximelagatran and in theory, would replace the use of the blood thinner coumadin (warfarin). I like the idea of replacing coumadin. Most people are upset when they learn that their medicine is also a popular rat poison (rats eat it and bleed to death - rather brutal). I was on the FDA panel that reviewed the application for ximelagatran and I voted to reject it. Why? Aside from the fact that it seemed possible that it was far inferior in effectiveness relative to coumadin, meaning people would still have some risk of bleeding with this new blood thinner but not be as protected from the risk of strokes and heart attacks, it also may increase the risk, paradoxically, of having a heart attack. Then there's the possibility suggested by the data that it can cause liver failure. That's a big deal, as you can imagine.
So here's the amazing part. Some of the data was published in medical journals and in response, almost 2/3 of cardiologists surveyed (see lower left corner of the landing page of http://www.theheart.org) believe the drug should be approved.
Here's an example of the FDA doing the right thing, acting to protect the public, then publishing on their website several hundred pages of information from the company's application and the FDA analysis, yet doctors are unaware, uninformed and misguided in wanting access to a drug that appears likely to be dangerous and possibly less effective than the standard, coumadin.
Amazing that somehow, somewhere, there isn't a better way to disseminate information to patients and physicians.
<< Home