"On Monday, The New England Journal of Medicine rushed out an analysis by prominent cardiologist Steven Nissen of data about patients taking Avandia. It suggests they have a 43% higher chance of suffering a heart attack.
The exact numbers aren't known and may be quite small. Glaxo says that the analysis is flawed and that its own studies show the opposite. Either way, users of the drug have a problem. If Avandia boosts the risk of cardiac disease, that is particularly frightening to diabetics, two-thirds of whom die of heart problems. On the other hand, if Glaxo is right, patients would increase their risk by quitting the drug. The FDA isn't helping them make that choice.
Only as the report came out did the FDA acknowledge potential problems and advise people on Avandia to consult with their doctors. It stopped short of warning against taking the drug. It said it was reanalyzing data that Glaxo had provided 'recently.' Recently would be last August, a full nine months ago.
. . .
The Vioxx scandal should have forced big, quick changes at FDA. It hasn't. Last year, the
Government Accountability Office, Congress' watchdog arm, issued a scathing report describing an agency hobbled by turf battles, insufficient resources, poor management and passivity in tracking adverse reactions once drugs are approved.
The FDA is convening an advisory board of experts in September to look at all the evidence it has about Avandia. But it shouldn't have taken alarm bells from an independent analyst to prompt one - and the September date suggests a disturbing lack of urgency."
This is what happens in bureaucracies - they start out with the best intentions and end up squabbling about internal politics. We taxpayers are not getting the protection we're paying for, and we're not getting the medicine we're paying for either. Perhaps big government solutions are actually part of the problem ...
One key question to always ask your doctor - "does this prescription increase or reduce mortality rates?" In other words, find out if it is proven to make you live longer, or just masks symptoms your doctor doesn't like seeing in your lab tests.
Also, you can always do your own comparisons for interactions with other drugs, vitamins, & supplements you take, One web-site for comparisons is Medscape from WebMD, but there are many others to be found with a simple Google search.
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