AVANDIA: So. . .how exactly did it get approved in the first place?

May 29, 2007

[wddty.co.uk]

The sudden safety alert from America?s drugs regulator, the Food and

Drug Administration (FDA), about the diabetes drug Avandia leaves two

vital questions unanswered. The alert follows a study that has

discovered that Avandia (rosiglitazone) increases the risk of heart

attack by 45 per cent.

Why, in the first place, did the drug get approved? It is part of a

family of drugs known as thiazolidinediones, which were discredited in

the earliest stages of their development. Another thiazolidinedione,

muraglitazar, was withdrawn from the licensing process after early

trials found it increased the chances of heart attack. On hearing the

news, other drug manufacturers abandoned the development of their own

thiazolidinedione.

So how did GlaxoSmithKline?s Avandia slip through the net?

The second question concerns ongoing safety checking. It?s well known

that diabetics are much more prone to heart disease; it?s also known

that the thiazolidinediones increase that risk further. So why is it

that in the eight years since approval, GSK has not undertaken a major

study into Avandia?s safety?

In the event, it took two researchers from the Cleveland Clinic to

review 42 small studies to come up with the alarming ? but hardly

surprising ? conclusion about the drug?s dangers.

Avandia is one of the most popular of the drugs for treating type II

diabetes. It?s not known exactly how many prescriptions have been

written for the drug, but GSK reveals that the drug?s quarterly sales

stand at £414m, or £1.65bn a year, so it?s reasonable to assume that

millions of tablets have been swallowed.

This beggars a third and final question: just how many people have died

because of Avandia, and all the time the doctor was blaming the

diabetes?

(Source: New England Journal of Medicine, May 21, 2007, published online

as: 10.1056/NEJMoa072761).

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