AstraZeneca (NYSE: AZN) announced that the US Food and Drug Administration (FDA) has approved once-daily SEROQUEL XR® (quetiapine fumarate) Extended Release Tablets as adjunctive (add-on) treatment to antidepressants in adults with Major Depressive Disorder (MDD). SEROQUEL XR is the only medication in its class approved by the FDA to treat both major depressive disorder as adjunctive therapy and acute depressive episodes associated with bipolar disorder as monotherapy.(1)(2)
MDD affects approximately 14.2 million American adults in a given year, and today it is often treated with antidepressants(3). Selective serotonin reuptake inhibitors, or SSRIs, are among the most commonly prescribed class of antidepressant medications for depression; however, in many cases patients fail to respond adequately to treatment(4). Results from a National Institute of Mental Health study, STAR*D, showed that approximately 63% of patients did not achieve remission with the SSRI citalopram when used as a first-line treatment(4). Additionally, this study reported that overall approximately one-third of patients with MDD failed to achieve study defined remission(4). This approval for SEROQUEL XR provides physicians with a new adjunctive treatment option for patients with MDD who have an inadequate response to their current antidepressant.
READ MORE @ MEDICAL NEWS TODAY
Showing posts with label AstraZeneca. Show all posts
Showing posts with label AstraZeneca. Show all posts
Saturday, December 5, 2009
Thursday, November 12, 2009
Drugmaker Paid Psychiatrist Nearly $500,000 to Promote Antipsychotic, Despite Doubts About Research
This story was co-published with the Chicago Tribune.
Executives inside pharmaceutical giant AstraZeneca faced a high-stakes dilemma.
On one hand, Chicago psychiatrist Dr. Michael Reinstein was bringing the company a small fortune in sales and was conducting research that made one of its most promising drugs look spectacular.
On the other, some worried that his research findings might be too good to be true.
As Reinstein grew irritated with what he perceived as the company's slights, a top executive outlined the scenario in an e-mail to colleague
"If he is in fact worth half a billion dollars to (AstraZeneca)," the company's U.S. sales chief wrote in 2001, "we need to put him in a different category." To avoid scaring Reinstein away, he said, the firm should answer "his every query and satisfy any of his quirky behaviors."
Putting aside its concerns, AstraZeneca would continue its relationship with Reinstein, paying him $490,000 over a decade to travel the nation promoting its best-selling antipsychotic drug, Seroquel. In return, Reinstein provided the company a vast customer base: thousands of indigent, mentally ill residents in Chicago-area nursing homes.
During this period, Reinstein also faced accusations that he overmedicated and neglected patients who took a variety of drugs. But his research and promotional work went on, including studies and presentations examining many of the antipsychotics he prescribed on his daily rounds.
READ MORE @ PRO PUBLICA
Executives inside pharmaceutical giant AstraZeneca faced a high-stakes dilemma.
On one hand, Chicago psychiatrist Dr. Michael Reinstein was bringing the company a small fortune in sales and was conducting research that made one of its most promising drugs look spectacular.
On the other, some worried that his research findings might be too good to be true.
As Reinstein grew irritated with what he perceived as the company's slights, a top executive outlined the scenario in an e-mail to colleague
"If he is in fact worth half a billion dollars to (AstraZeneca)," the company's U.S. sales chief wrote in 2001, "we need to put him in a different category." To avoid scaring Reinstein away, he said, the firm should answer "his every query and satisfy any of his quirky behaviors."
Putting aside its concerns, AstraZeneca would continue its relationship with Reinstein, paying him $490,000 over a decade to travel the nation promoting its best-selling antipsychotic drug, Seroquel. In return, Reinstein provided the company a vast customer base: thousands of indigent, mentally ill residents in Chicago-area nursing homes.
During this period, Reinstein also faced accusations that he overmedicated and neglected patients who took a variety of drugs. But his research and promotional work went on, including studies and presentations examining many of the antipsychotics he prescribed on his daily rounds.
READ MORE @ PRO PUBLICA
Sunday, March 1, 2009
AstraZeneca Seroquel Studies ‘Buried,’ Papers Show (Update3)
AstraZeneca Plc “buried” unfavorable studies on its antipsychotic drug Seroquel, according to an internal e-mail unsealed as part of litigation over the medicine.
The drugmaker failed to publicize results of at least three clinical trials of Seroquel and engaged in “cherry picking” of data from one of those studies for use in a presentation, an AstraZeneca official said in a December 1999 e-mail unsealed yesterday under an agreement between the company and lawyers for patients. The London-based company faces about 9,000 lawsuits claiming it failed to properly warn users that Seroquel can cause diabetes and other health problems.
“The larger issue is how we face the outside world when they begin to criticize us for suppressing data,” John Tumas, an AstraZeneca publications manager, told colleagues in the e-mail.
READ MORE @ BLOOMBERG
The drugmaker failed to publicize results of at least three clinical trials of Seroquel and engaged in “cherry picking” of data from one of those studies for use in a presentation, an AstraZeneca official said in a December 1999 e-mail unsealed yesterday under an agreement between the company and lawyers for patients. The London-based company faces about 9,000 lawsuits claiming it failed to properly warn users that Seroquel can cause diabetes and other health problems.
“The larger issue is how we face the outside world when they begin to criticize us for suppressing data,” John Tumas, an AstraZeneca publications manager, told colleagues in the e-mail.
READ MORE @ BLOOMBERG
Thursday, February 26, 2009
Seroquel Case: Must AstraZeneca Tell All?
In more lawsuits, companies are being forced to reveal internal information during the pretrial discovery phase that otherwise would be kept private
A showdown is looming in a Florida courtroom over an issue that has long bedeviled business: How much internal information can a company be forced to make public simply because it has become a defendant in a lawsuit?
In federal court in Orlando, drugmaker AstraZeneca (AZN) is battling to keep confidential thousands of pages of correspondence, studies, and other material related to its blockbuster antipsychotic drug Seroquel. On Feb. 13, Bloomberg News, invoking "the public's right of access to judicial documents," asked the court to unseal selected filings. A hearing on the request is scheduled for Feb. 26.
The battle grows out of claims by consumers who allege that AstraZeneca didn't adequately disclose that Seroquel can trigger serious weight gain and diabetes. There is also an unusual allegation of sexual misconduct that AstraZeneca is trying to keep contained by arguing that it is irrelevant and should be kept from a jury. More than 6,000 Seroquel cases have been consolidated in the Florida case.
READ MORE @ BUSINESS WEEK
A showdown is looming in a Florida courtroom over an issue that has long bedeviled business: How much internal information can a company be forced to make public simply because it has become a defendant in a lawsuit?
In federal court in Orlando, drugmaker AstraZeneca (AZN) is battling to keep confidential thousands of pages of correspondence, studies, and other material related to its blockbuster antipsychotic drug Seroquel. On Feb. 13, Bloomberg News, invoking "the public's right of access to judicial documents," asked the court to unseal selected filings. A hearing on the request is scheduled for Feb. 26.
The battle grows out of claims by consumers who allege that AstraZeneca didn't adequately disclose that Seroquel can trigger serious weight gain and diabetes. There is also an unusual allegation of sexual misconduct that AstraZeneca is trying to keep contained by arguing that it is irrelevant and should be kept from a jury. More than 6,000 Seroquel cases have been consolidated in the Florida case.
READ MORE @ BUSINESS WEEK
Monday, April 30, 2007
Patients Diagnosed Schizophrenic and Bipolar to boost Seroquel Sales
For over a decade, drug makers have been influencing doctors to diagnose patients, especially those covered by public health care programs like Medicare and Medicaid, with mental illnesses to justify the over-prescribing of the new class of drugs known as "atypical" antipsychotics.
For instance, Seroquel, marketed by AstraZeneca, is only FDA approved to treat acute manic episodes associated with bipolar I disorder and schizophrenia, and yet it is one of the most widely prescribed drugs in the world.
Astra reports that over 16 million patients have taken Seroquel since it came on the market in 1997, and the drug had sales of close to three and a half billion dollars in 2006, according to SEC filings.
READ MORE @ Lawyers & Settlements
For instance, Seroquel, marketed by AstraZeneca, is only FDA approved to treat acute manic episodes associated with bipolar I disorder and schizophrenia, and yet it is one of the most widely prescribed drugs in the world.
Astra reports that over 16 million patients have taken Seroquel since it came on the market in 1997, and the drug had sales of close to three and a half billion dollars in 2006, according to SEC filings.
READ MORE @ Lawyers & Settlements
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