It has been fashionable, in the past few years, to bemoan the extended program that the FDA requires for widespread usage of new drugs. It has become widely known that many ways are in place to circumvent the safeguards put in place by our government. Drugs are available from over the border, in both Mexico and Canada. Also, mail order puts things not approved by the FDA at the fingertips of anyone able to get to their mailbox.

Just today, another drug, Avandia, from giant Glaxo-Smith-Kline, has just been on the receiving end of a large wave of reported side effects. The majority of side effects were known, if not well understood, but considered tolerable.

In fact, the side effects reports have tripled recently, and when the main side effect reported is heart attack, the country needs to sit up and take notice.

When playing craps with life, the person affected should be the one controlling the dice.

Side effects from many prescription drugs are being reported, and while many of them are less harmful than heart attack, one must know all the consequences of the reported side effects to be able to make an informed decision.

Avandia has been shown to control blood sugar effectively, but in doing so it can bring on some of the secondary problems associated with diabetes. Heart attack, already a problem for people afflicted with diabetes, is a much higher risk when cholesterol levels are raised, and fluid build up in the patient occurs. Avandia causes these problems over time.

The FDA has newly scheduled hearings for the discussion of this drug, and it might be restricted, or removed from use. In the past decade, many drugs released have been withdrawn, the only mention now on television, on the news, and those advertisements for lawyers specializing in class action suits. In 2003, there were 2375 recalls, enough to give anyone pause. The problem is that reporting of these usually take a back seat to celebrity fashion news.

 The issues of acceptance rise up again, and for every problem drug, many are used with minimal side effects, over long periods of time.

Those who have been wondering what takes so long for approval, and why it does not happen more quickly should possibly ponder that stance, instead changing to support of longer, more rigorous trial periods.


[tags] FDA, drug acceptance policy, Glaxo-Smith-Kline, side effects, diabetes, heart attack, cholesterol [/tags]