“Is it safe?” Reply

Is it safe? Like the Nazi dentist played by Laurence Olivier in Marathon Man, we all want an answer to the question: is it safe? And like the poor victim played by Dustin Hoffman, you can torture us as much as you want but we can’t answer the question if we don’t have the data.

Recall that in the movie the Nazi dentist wants Hoffman’s character to tell him whether it’s safe to pick up a horde of valuable diamonds extorted from the victims of Auschwitz, but Hoffman has no idea what’s going on. The dentist keeps repeating the same question: “Is it safe?”

Last week 33 advisory panel members tried to answer the same question about Avandia: is it safe? And, it could be said, for two days they tortured the data, trying to find an answer. Of course they couldn’t succeed because, just like in the movie, you can’t answer a question if you don’t have enough information. We like to think that medicine, as a branch of science, can give us hard facts and certainty, but the truth is that when it comes to clinical reality the world is usually gray and only rarely black or white.

One big problem is that we like to think in simple binary terms. Is a drug safe? Is a drug effective? But often there’s no simple answer. There’s not enough data. And even when there’s an abundance of data there may be plenty of remaining ambiguities and lots of room for disagreement. Consider the recent discussions about rosuvastatin. Between JUPITER and other trials the drug has one of the largest data sets available. Yet reasonable people disagree over the precise population in which the drug should be used.

With its controversial history and highly questionable data set, the answer to the Avandia question– is it safe?– is even more elusive. Even if TIDE continues and succeeds in answering the question we will remain under the shadow of uncertainty for many years to come.

Here’s the dialog (courtesy of Wikiquote) between the Nazi dentist (Olivier) and Babe, Hoffman’s character, right before Babe is tortured:

Olivier: Is it safe?

Hoffman: You’re talking to me?

Olivier: Is it safe?

Hoffman: Is what safe?

Olivier: Is it safe?

Hoffman: I don’t know what you mean. I can’t tell you something’s safe or not, unless I know specifically what you’re talking about.

Olivier: Is it safe?

Hoffman: Tell me what the “it” refers to.

Olivier: Is it safe?

Hoffman: Yes, it’s safe, it’s very safe, it’s so safe you wouldn’t believe it.

Olivier: Is it safe?

Hoffman: No. It’s not safe, it’s… very dangerous, be careful.

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