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.

Notice of Privacy Practices Effective Date: April 14, 2003 THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW YOU CAN GET ACCESS TO THIS INFORMATION. PLEASE REVIEW IT CAREFULLY. What is this Notice and Why is it Important? As of April of 2003, a...

ACKNOWLEDGEMENT OF RECEIPT OF NOTICE OF PRIVACY PRACTICES We are required to provide you with a copy of our Notice of Privacy Practices, which states how we may use and/or disclose your health information. Please sign this form to acknowledge receipt of the Notice. You may refuse to sign this...

SUMMARY NOTICE OF HIPAA PRIVACY PRACTICESThis notice describes how medical information about you may be used and disclosed and you can get access to this information. Please review it carefully. This is a one-page summary of the longer notice that follows. Please read both the summary and the actual notice.

This email and any files transmitted with it are confidential and intended solely for the use of the individual or entity to whom they are addressed. If you are not the named addressee you should not disseminate, distribute or copy this e-mail. Please notify the sender immediately by e-mail if...

The documents accompanying this transmission contain confidential health information that is legally privileged. This information is intended only for the use of the individual or entity named above. The authorized recipient of this information is prohibited from disclosing this information to any other party unless required to do so by...

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.

Dr. Janicak, you've had a long career in research and academia, and I was hoping you could help shed some light on the various contentious issues surrounding the use of atypical antipsychotics, including the issue of whether there is clearly a difference in metabolic profile among the different medications.