Monday, April 6, 2009

Spin: change "Seroquel: risky for depression and anxiety, just as it was for schizop, bp" to "Risk for MDD and GAD same as for Schizophrenia, Bipolar"

AstraZeneca is about to sit in front of FDA for a hearing about safety of Seroquel for major depressive disorder MDD and general anxiety disorder GAD. April 08, 2009.

AstraZeneca has posted the info that they have submitted in conjunction with this hearing (partly cuz FDA mistakenly posted it too soon).

A brief look thru it shows an interesting spin:

The reason for the hearing is because Seroquel AKA quetiapine seem to lead to diabetes in a fair portion of people. Some end up with diabetes; many end up with weight gain. With other atypical antipsychotics, Big Pharma had handled this by saying that the drugs caused increased appetite, and the appetite led to weight gain. Or inactivity. Anything but the drug.

It eventually came out that these drugs have diabetes risk. Why? DK. But this is where the research agenda SHOULD be; not on finding me-too atypicals, such as Seroquel.

Some evidence supports a theory that the atypical antipsychotic drugs may kill some special type of cell in the liver - scary - but this has not been fully studied.

In the meantime -
How does AZ spin its own evidence that within a few months of taking Seroquel, your body gets worse at responding to glucose? Which probably sez you are on your way to diabetes?

page 78, section 4.2.10:
"Evaluation of metabolic data from the MDD and GAD populations did not reveal any metabolic findings or suggest potential long term metabolic risks inconsistent with those seen in the currently approved indications of schizophrenia and bipolar disorder."

No evidence Seroquel will be any different for MDD and GAD as it was for Schizophrenia or bipolar.

I wish I could write like that. Somehow, the way they put it, it isounds like no big deal.

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