8,787 Seroquel Lawsuits/Some FDA History

Psychiatric News has:
Seroquel Litigation: 8,787 lawsuits Filed Against Astrazeneca

Delawareonline.com has:
Astrazeneca's Seroquel On FDA Warning List

Chicagotribune.com: has:
FDA Lists 20 Drugs Under Scrutiny

Let's roll back the clock.

May 6, 1999 : NDA [New Drug Application] #20-639 / HHS/FDA to Zeneca Pharmaceuticals

"4. The mechanism of action of Seroquel, as well as other antipsychotic drugs, is unknown. Therefore materials that discuss how Seroquel "works" without discussing the theoretical nature of this information are misleading. (e.g. brochures #SQ1059, PR1048)"

March 21 2000: has Former FDA Commissioner Jane E. Henney concerned over consumers purchasing drugs on the internet.

"As you know, the establishment of FDA as it exists today grew out of a time early in the century when consumers were victimized by dishonest purveyors of fraudulent potions and compounds that were ineffective, dangerous, or both."

Her summation:

"1. A significant public health risk exists when a consumer is at risk for harm (1) from the use of the product, (2) as the result of not taking approved drugs for a specific disease or condition, or (3) by delaying medical treatment recognized as safe and effective for a specific disease or condition."

Nov. 22 2000: NYT has FDA Commissioner Dr. Henney proposing simplifying drug package insert labels because the info is "cumbersome" and "dense", ..... so Doctors often ignore them. Medication errors Kill up to 7000 per year versus 6000 deaths from workplace accidents.

Try that in Any other line of work, and See how far you get: Killing your customers because you won't even Try to understand the potentially Lethal product you're selling them. But then again: Psychiatrists make more $ in 15 minutes of Drug Dealing than in 45 minutes of therapy.

January 22, 2001: FDA Commissioner Dr. Henney resignation.

March 27, 2001: FDA Approval Letter

"We have completed the review of this supplemental application and have concluded that adequate information has been presented to demonstrate that the drug product is safe and effective for use as recommended in the submitted final printed labeling (package insert submitted February 28, 2001). Accordingly, this supplemental application is approved effective on the date of this letter."

March, 2001: Seroquel Label

May 10, 2001: has FDA Acting Principle Deputy Commissioner Bernard Schwetz testifying before the US Senate.

"We will ensure that FDA will not become a bottleneck in getting these public health breakthroughs to the public while serving as the trusted, independent, efficient gatekeeper it is now. "

Protecting Volunteers and the Integrity of Data in Clinical Trials

"FDA, whose product reviews depend on the validity of clinical trial data, monitors the entire system. The Agency conducts about 1,200 trial-associated inspections per year (1,100 domestic and 100 foreign), some of which involve extensive interviews with IRB members and examination of their records, procedures, and responsiveness to participants’ concerns. "

Monitors the entire system with 200 Inspectors for 350,000 test sites? Here's 2 Contrarian views from Gardiner Harris of the NYT. [11/19/2004] [9/28/07]

October 10, 2001: has Acting Deputy Commissioner Bernard Schwetz again:

"The primary objective of the American system of public health is to prevent disease before it occurs."

mechanism of action, ..... is unknown?

Seroquel's 1,656 Adverse Reaction/side effects aren't currently "unknown" to the FDA, but it's still on the market.

safe and effective?

8,787 Lawsuits?


So, ..... Who's This Former FDA Commissioner we find, on the Board of Directors of AstraZeneca?