Tuesday, August 10, 2010

Astrazeneca and Seroquel Escape Lawsuits

Back in April 2010, Astrazeneca settled the federal investigation into its marketing practices for Seroquel for a mere $520 million. I say "mere" because Seroquel alone brings in this much revenue to AZN in a few weeks. They made almost $5 billion on the drug last year. The settlement is barely dissuasive in the financial sense. We all know if you can get your product used in off-label areas where you can be the first atypical used, then your foothold will be strong and marketing costs will stay low. If you happen to get the indication later, then that's just icing on the cake (See Seroquel in Bipolar and Depression and Austism).

Now, Astrazeneca is settling its lawsuits with individuals. Yesterday they announced that 17,500 of the suits had been settled for only $198 million. I don't know which firm AZN retains, but those suits earned every penny. $198 million barely registers. Probably 2 weeks of Seroquel sales. This is all great news for AZN as they work to put the bad press behind them. There are many lawsuits left, which is good because there isn't much time left for Seroquel which goes off-patent in March 2012 if AZN can fend off Teva for that long. That's plenty of time to transition physicians and patients to XR though which currently has a patent through 2017.

Ketamine for Bipolar Disorder

Today, the NY Times reported on a double-blind, placebo controlled study using ketamine to treat severe depressive symptoms in a small group of patients with Bipolar Disorder. As was rightly noted in the article, it's highly debatable that the study truly remained blinded as the effects of ketamine are well-known and were likely evident to the patients within an hour of infusion. However, the study is interesting in terms of understanding how yet another product used off-label can provide assistance to this long-suffering population. Now, the use of an oft-abused drug like Special K in a population prone to dangerous behaviors is another question that should be addressed before physicians start prescribing it.

Wednesday, February 10, 2010

DSM V Changes Will Increase Atypical Antipsychotic Use

The public review period for the proposed DSM V changes has begun, and there is much chatter. One change that I believe is a good one for the reasons discussed here is the creation of the disorder known as Temper Dysregulation Disorder (TDD). This disorder should significantly decrease the diagnosis of bipolar disorder in children. With bipolar seen as a stigmatizing and lifelong disorder, the prospects for children diagnosed with the condition were not good, and the label itself could be self-defeating and self-esteem destroying. To tag a child with such a severe disorder is truly dangerous from a psychological perspective. Nonetheless, psychiatrists must provide diagnoses in order to insure insurance reimbursement for their clients at the least. This new disorder will allow psychiatrists who had been reluctant to label a child as bipolar to have a new more attractive alternative tag to attach that is time-limited to childhood and carries none of the stigma of the bipolar diagnosis.

So, we'll see a decrease in the diagnosis of bipolar disorder, but this will be more than offset by the diagnosis of TDD. I can see the atypical psychotic marketing teams sitting in their conference rooms now correlating the symptoms of TDD and bipolar to see which TDD symptoms they can lawfully market for their product because they also happen to be symptoms of bipolar. It may not even be necessary since atypicals are the clear choice among psychiatric drugs to treat the symptoms of TDD. You might try an anti-depressant, but as soon as the parents complain, the next step will be the atypical.

How long before the first company steps up to bat in a clinical trial to get the first antipsychotic label for TDD? Can anyone say patent extension?