nos-trum. pronunciation: \nos'-trum\. noun. Etymology: Latin, neuter of noster our, ours.
1. a medicine of secret composition recommended by its preparer but usually without scientific proof of its effectiveness.
2. a usually questionable remedy or scheme.
See here for more discussion.

Friday, July 16, 2010

Approving New Drugs: Balancing Risk And Benefit -- Avandia V. Qnexa

The diabetes drug Avandia stays on the market, the anti-obesity pill Qnexa doesn't make the cut.

The FDA issued a second closely-watched decision planned for this week.  After allowing Avandia to remain on the market, but with stronger warnings over its use (designed to limit the risk of heart disease caused by the drug...see my post here), the agency decided that the balance between risk of adverse reactions and obesity benefit didn't favor Qnexa.

Comparing the two decisions, I would say these were wise choices.  Both drugs can cause harm in some patients.  On the one hand, diabetes is caused by a breakdown of the body's ability to regulate itself.  On the other hand, obesity--which can have consequences that are just as far-reaching as diabetes--is a problem of "oral intake" in most cases....that is, our ability to regulate eating.  The regulatory problem in diabetes is something we cannot control, the regulatory problem in obesity is...well...difficult to control.  But the first problem is entirely physiologic, the second has behavioral components.

I've written before regarding my reservations over treating obesity with a drug.  Like the nicotine patch to help smokers quit, it doesn't work unless the commitment is there to change.

To my mind, this weakens the usefulness of drugs targeting obesity.  With that in mind we should weigh more heavily any adverse reactions they cause in deciding whether to approve them.

Even the recommendation for Avandia to retain FDA approval is subject to being revisited.  In several more years we will know whether the restrictions and increased warnings have solved the heart risk Avandia presents.  It may be that further research will lead to a different decision.

That's the way science works.

Doc D

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