Back in 2010, the Food and Drug Administration (FDA) voted to restrict the use of the diabetes drug Avandia to severely ill diabetics. The reason? Avandia was shown to increase the risk of heart attack by more than 40 percent.
Glaxo’s Clinical Trials Called “Seriously Flawed”
Avandia’s manufacturer, GlaxoSmithKline, had naturally run clinical studies; otherwise, it would never have gotten the FDA’s approval. When the uproar began, outside experts claimed that the clinical trial done by Glaxo was “seriously flawed.”
When the FDA ordered an independent review of the Glaxo clinical trial, Glaxo itself paid Duke University to conduct the review. Of course, some experts questioned the objectivity of this review, which basically confirmed the original assertion by Glaxo that Avandia caused no significant increase in the risk of a heart attack.
Why Would Any Kentuckian Take Avandia, Then?
Consider all the reasons not to take Avandia:
- A cardiologist provided proof linking the drug to increased risk of heart attack
- Upon receiving this information, the FDA severely restricted use of the drug
- The review of Glaxo’s clinical trial was paid for by Glaxo
- There are other diabetes drugs available
Then there’s the other side of the argument:
- The risks associated with Avandia are comparable to other diabetes drugs
- Diabetes is difficult to treat, and doctors need options so that they can find the best treatment for each patient
- There are few diabetes drugs that lower blood sugar without causing hypoglycemia
Diabetes patients need to be informed about all of their options, including risks, so they can pursue a treatment plan that works for each of them.
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