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.
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Saturday, September 25, 2010

Diabetes Drug Restricted: An Example Of Balancing Safety And Effectiveness

Maybe many of you have a friend or family member with diabetes.  The reputation of the blockbuster diabetes drug Avandia has been tarnished by data suggesting heart complications.

But the data is not yet clear.  I wrote a long piece that appeared in Science-Based Medicine two months ago that looked at the data.  While it was written for Onion Peelers, and included a lot of data, it was a fascinating case of looking at the question of drug safety.  It also showed how the FDA goes about judging safety in the context of politics and lawsuits.

The FDA has now rendered a final opinion, which puts the drug into a category where there are major restrictions on its use.

If a diabetic is already taking the medicine and has no complications, they can continue.  But if a new patient requires treatment, and other drugs don't do the job, the physician has to meet a number of requirements in order to prescribe the drug and meet standards of care.

You can read more about the FDA's opinion here

In the opinion of some, even though the hazard is not well established, the drug should have been banned.  Europe has decided to do so.  But if we adopt an absolute standard for safety, then almost all drugs will need to be banned.  I am not aware of any approved drug that has not caused harm under some circumstances.

Even Tylenol (acetaminophen) can cause death in children if given continually in too high a dose.

So, what's a good standard for safety, when there is no certainty from the scientific data?

Consider also, the prospects for diabetes control when the other alternatives for treatment of diabetes are less effective?  Most of the older drugs have significant side effects.

Or, what happens i fpatients find they are allergic to effective alternatives?  Avandia has only one modern competitor, Actos. 

And Avandia is without risk to almost all diabetics when taken properly and monitored.

Shouldn't we keep some medicines around, even though they have cautions and restrictions, for those occasions when alternatives don't do the job?

Ultimately, I think the FDA did a good job of trying to assess the data we have, and made a decision that balanced the needs of diabetics against safety.

Doc D

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