More On: Judicial Secrecy And Seroquel, Shrouded In Controversy.

This is a follow-up to yesterday’s Judicial Secrecy And Seroquel, Shrouded In Controversy.

The Washington Post has an interesting article, “A Silenced Drug Study Creates An Uproar,” dealing with the Seroquel case. What started out simply as "Study 15" has become a serious problem for AstraZeneca, the makers of Seroquel.

Here's what happened.

Study 15, issued in 1997, the same year the FDA approved Seroquel, raised "serious concerns about an entirely new class of expensive drugs." Nothing gets the attention of a pharmaceutical manufacturer better than the manufacturer’s pocketbook. The thought that Study 15 might jeopardize an entire class of "expensive" pharmaceuticals was more than AstraZeneca could handle, so they buried the study.

AstraZeneca never shared the negative research data of Study 15 with doctors, opting instead to publish positive results for Seroquel based on "less rigorous studies.” Further, AstraZeneca minimized the metabolic problems that might lead to diabetes. In the process, AstraZeneca marketed Seroquel, collecting $12 billion over the past 3 years. That's right "$12 billion."

The details of Study 15 have emerged as a result of lawsuits filed nationwide. Taxpayer-funded research has found that new anti-psychotic drugs such as Seroquel are 10 times more expansive and did not really offer a "real advantage" over older anti-psychotic medications. In fact, they presented risks that AstraZeneca minimized.

The real problem here is more than corporate greed! Rather it's the problem of indifferent conservative judges who enter “secrecy orders” to protect corporate greed and prevent the dissemination of information such a Study 15. Judicial secrecy orders that compromise public health and safety need to stop now!

Judicial Secrecy And Seroquel, Shrouded In Controversy.

Pharmaceutical manufacturers use "judicial secrecy" to protect themselves and hide evidence of a drug’s harmful side-effects, evidence the public has a right to know. But a group of lawyers have had enough.

Here’s what happened.

AstraZeneca manufactures Seroquel, the pharmaceutical trade name for quetiapine, a potent anti-psychotic that some believe mediate through antagonist activity at dopamine and serotonin receptors. Although the FDA had only approved Seroquel for schizophrenia and bipolar disorders, AstraZeneca had been marketing the drug to patients suffering from depression and anxiety, even though all disorders are not the same.

In 2001, Ted Baker, who lives in Bastrop, LA, was diagnosed with post-traumatic stress disorder, a depressive disorder. His doctor prescribed Seroquel. Baker, like many consumers of Seroquel, experienced “drastic weight gain” in a short time period. In 2004, Mr.Baker was diagnosed with Type II diabetes. However, Mr. Baker never knew and was never warned that the Seroquel had this dangerous side effect.

Now, after the fact, AstraZeneca wants the FDA to “expand” the use of Seroquel to include patients with depression and anxiety. Mr. Baker’s lawyers and many other lawyer believe that the “judicially sealed documents” surrounding Seroquel may well shed some light on the side effects of the drug. It seems that AstraZeneca “buried” unfavorable studies on the drug, according to an internal e-mail unsealed as part of litigation over the drug. The lawyers want all of the documents released to the FDA before the drug is officially approved for expanded use.

The problem, here, arises out of "judicial secrecy," which has been on the rise since the 1980s. It reached a climax in the 1990s. Without justification, indifferent conservative judges often willingly issue broad based "secrecy orders," protecting corporate predators and hiding evidence of inferior or bad pharmaceuticals from consumers.

To partially cure the problem, judicious secrecy needs to stop! To completely cure the problem, there needs to be corporate responsibility!

Here is the full release on the AstraZeneca case: Full release on the AstraZeneca case

Also, here are a few links to stories written on the case:

Associated Press: AstraZeneca challenges witnesses in Seroquel suit

Bloomberg: AstraZeneca Seroquel Studies ‘Buried,’ Papers Show (Update3)