Many readers have wondered why I decided to publish The Carlat Report. Well, back in the day, I was a member of the speaker’s bureau of four pharmaceutical companies. I would typically travel to the offices of primary care physicians nearby and talk up the sponsor’s drug.

1992 was a very big year in the history of the relationship between the FDA and the pharmaceutical industry. That year, Congress passed the Prescription Drug User Fee Act (PDUFA), allowing the FDA to charge pharmaceutical companies hundreds of thousands of dollars per drug for the drug approval process.

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Here’s a scenario for you. You have five medications to choose from. They are all FDA approved for the same indications. Any head-to-head study among them has shown equivalent efficacy. Three of them are associated with significant weight gain, hypercholesteremia, and diabetes risk. Two of them are not. Your job is to take a stand on what you would recommend as "first-line" medication for the disorder in question.

Clozapine (trade name, Clozaril) is a drug that none of us would prescribe if all things were equal. With the potentially catastrophic side effect of agranulocytosis, along with a metabolic side effect profile worse even than Zyprexa’s, the only reason to expose living beings to this medication is that it is reputed to be the most effective antipsychotic under the sun. But is it?

We knew it was about to happen. We just didn’t know it would happen all at once. Between July and September of 2004, Seroquel, Geodon, and Abilify sequentially won approval for the treatment of manic episodes in bipolar disorder.