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
Showing posts with label Seroquel. Show all posts
Showing posts with label Seroquel. Show all posts
Thursday, November 12, 2009
Sunday, June 14, 2009
FDA Throws Lifeline to Antipsychotic Pushers
On June 11, 2009, FDA News reported that AstraZeneca’s Seroquel, Pfizer’s Geodon and Eli Lilly’s Zyprexa atypical antipsychotics "won an FDA advisory panel’s recommendations for approval to treat schizophrenia and bipolar disorder in pediatric and adolescent patients."
"The FDA's expanded marketing approval process for antipsychotics, highly toxic drugs, is unaffected by evidence uncovered by the US Justice Department showing that the studies submitted by drug manufacturers were often flawed, if not fraudulent," says Vera Hassner Sharav, president of the Alliance for Human Research Protection, in a June 8, 2009 infomail alert.
"Rather than focus on protecting children's safety, FDA officials are doing their utmost to legitimize irresponsible, off-label prescribing of exceedingly toxic antipsychotics for children--thereby ensuring that far greater numbers of children will be victimized and die," according to Sharav.
A recent report by the consulting firm Decision Resources found antipsychotics makers spent $993,000,000 in 2006, to promote these drugs to doctors and patients, she reports. In 2008, at more than $14 billion, antipsychotic revenues topped all other classes of drugs in the US, even cholesterol and diabetes medications.
READ MORE @ COUNTERPUNCH
"The FDA's expanded marketing approval process for antipsychotics, highly toxic drugs, is unaffected by evidence uncovered by the US Justice Department showing that the studies submitted by drug manufacturers were often flawed, if not fraudulent," says Vera Hassner Sharav, president of the Alliance for Human Research Protection, in a June 8, 2009 infomail alert.
"Rather than focus on protecting children's safety, FDA officials are doing their utmost to legitimize irresponsible, off-label prescribing of exceedingly toxic antipsychotics for children--thereby ensuring that far greater numbers of children will be victimized and die," according to Sharav.
A recent report by the consulting firm Decision Resources found antipsychotics makers spent $993,000,000 in 2006, to promote these drugs to doctors and patients, she reports. In 2008, at more than $14 billion, antipsychotic revenues topped all other classes of drugs in the US, even cholesterol and diabetes medications.
READ MORE @ COUNTERPUNCH
Sunday, April 12, 2009
Atypical antipsychotics: too hard a sell?
Use of drugs such as Abilify, Seroquel and Zyprexa for treatment-resistant depression is gaining ground. Some see an 'unmet need' for medication. Others worry about side effects.
About a year ago, patients began trooping into the office of UCLA psychiatrist Andrew Leuchter, asking whether an antipsychotic drug called Abilify "might be right for them." Few appeared to be delusional, plagued by hallucinations or suffering fearsome mood swings. Mostly, they were depressed or anxious, and frustrated by the pace of their recovery.
Leuchter wondered what was up: Depressed patients didn't usually seek out drugs used to quell psychiatry's most disturbing symptoms.
What was up, he soon discovered, was spending on a new advertising campaign touting Abilify as an "add-on" treatment for depression. For the first time since the arrival of a new generation of antipsychotic medications -- six drugs called the "atypicals" because they work differently from the earlier generation of antipsychotic drugs -- the makers of one, Abilify, had been granted the legal right to market to a vast new population of patients beyond those with schizophrenia or bipolar disorder.
This week, a Food and Drug Administration advisory panel recommended that the agency should grant the makers of a second atypical antipsychotic drug -- Seroquel XR -- similar latitude. The drug giant AstraZeneca wants permission to market the drug as a treatment for depression or anxiety that has not yielded to antidepressants alone.
READ MORE @ LOS ANGELES TIMES
About a year ago, patients began trooping into the office of UCLA psychiatrist Andrew Leuchter, asking whether an antipsychotic drug called Abilify "might be right for them." Few appeared to be delusional, plagued by hallucinations or suffering fearsome mood swings. Mostly, they were depressed or anxious, and frustrated by the pace of their recovery.
Leuchter wondered what was up: Depressed patients didn't usually seek out drugs used to quell psychiatry's most disturbing symptoms.
What was up, he soon discovered, was spending on a new advertising campaign touting Abilify as an "add-on" treatment for depression. For the first time since the arrival of a new generation of antipsychotic medications -- six drugs called the "atypicals" because they work differently from the earlier generation of antipsychotic drugs -- the makers of one, Abilify, had been granted the legal right to market to a vast new population of patients beyond those with schizophrenia or bipolar disorder.
This week, a Food and Drug Administration advisory panel recommended that the agency should grant the makers of a second atypical antipsychotic drug -- Seroquel XR -- similar latitude. The drug giant AstraZeneca wants permission to market the drug as a treatment for depression or anxiety that has not yielded to antidepressants alone.
READ MORE @ LOS ANGELES TIMES
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, December 8, 2008
AstraZeneca Was Aware of Seroquel Risks in 2000, Records Show
AstraZeneca Plc., facing more than 15,000 consumer claims alleging the antipsychotic drug Seroquel causes diabetes, knew about the risk as far back as 2000, according to company documents shown in federal court.
AstraZeneca Global Safety Officer Wayne Geller concluded there was “reasonable evidence to suggest Seroquel therapy can cause” diabetes and related conditions, according to documents presented yesterday in federal court in Tampa, Florida. Geller drew his conclusions following a review of available studies and internal trials, according to the documents.
The internal documents were shown publicly for the first time during a hearing over the qualifications of expert witnesses the plaintiffs plan to use at trial. They are to testify in a lawsuit over the drug’s effects when the proceeding begins in February. While portions of the documents were shown in court, the filings remain sealed at the request of the London-based pharmaceutical company.
READ MORE @ BLOOMBERG
AstraZeneca Global Safety Officer Wayne Geller concluded there was “reasonable evidence to suggest Seroquel therapy can cause” diabetes and related conditions, according to documents presented yesterday in federal court in Tampa, Florida. Geller drew his conclusions following a review of available studies and internal trials, according to the documents.
The internal documents were shown publicly for the first time during a hearing over the qualifications of expert witnesses the plaintiffs plan to use at trial. They are to testify in a lawsuit over the drug’s effects when the proceeding begins in February. While portions of the documents were shown in court, the filings remain sealed at the request of the London-based pharmaceutical company.
READ MORE @ BLOOMBERG
Monday, October 27, 2008
Zyprexa and Seroquel Side Effects May Increase Heart Disease Risk
New research suggests that Zyprexa and Seroquel may increase the risk of heart disease when compared to other antipyschotic medications.
Eli Lilly’s Zyprexa (olanzapine) and AstraZeneca’s Seroquel (quetiapine fumarate) are both blockbuster medications which are part of a class of drugs known as “atypical” antipsychotics. They are commonly used to treat symptoms of schizophrenia, but have also been widely used for other conditions like bipolar disorder, dementia, autism and obsessive-compulsive disorders.
Both drugs have previously been linked to a number of serious side effects, including severe weight gain, diabetes and pancreatitis. However, a new study published in the October 2008 issue of the journal Schizophrenia Research raises the potential for concerns about a small increased risk of coronary heart disease associated with the drugs.
read more @ AboutLawsuits.com
Eli Lilly’s Zyprexa (olanzapine) and AstraZeneca’s Seroquel (quetiapine fumarate) are both blockbuster medications which are part of a class of drugs known as “atypical” antipsychotics. They are commonly used to treat symptoms of schizophrenia, but have also been widely used for other conditions like bipolar disorder, dementia, autism and obsessive-compulsive disorders.
Both drugs have previously been linked to a number of serious side effects, including severe weight gain, diabetes and pancreatitis. However, a new study published in the October 2008 issue of the journal Schizophrenia Research raises the potential for concerns about a small increased risk of coronary heart disease associated with the drugs.
read more @ AboutLawsuits.com
Saturday, May 17, 2008
AstraZeneca's Seroquel Cleared for Bipolar Disorder (Update2)
AstraZeneca Plc, the U.K.'s second-largest drugmaker, won U.S. approval to widen the use of its Seroquel antipsychotic medicine to treat bipolar disorder, pitting the treatment against Eli Lilly & Co.'s top-selling Zyprexa and Bristol-Myers Squibb Co.'s Abilify.
Patients may take the therapy as an adjunct to the standard treatments lithium or divalproex, London-based AstraZeneca said today in a statement.
Seroquel brought in $4.03 billion last year, making it AstraZeneca's second-best-selling product after Nexium for ulcers. AstraZeneca is trying to broaden the medicine's use to protect sales under threat from generic copies. The drugmaker this month asked the Food and Drug Administration to approve the therapy to treat generalized anxiety disorder.
``Seroquel is increasingly being rolled out for additional indications and may, in due course, become the go-to product for depressive disorders,'' Charles Stanley analyst Jeremy Batstone-Carr said in an e-mail.
READ MORE @ BLOOMBERG
Patients may take the therapy as an adjunct to the standard treatments lithium or divalproex, London-based AstraZeneca said today in a statement.
Seroquel brought in $4.03 billion last year, making it AstraZeneca's second-best-selling product after Nexium for ulcers. AstraZeneca is trying to broaden the medicine's use to protect sales under threat from generic copies. The drugmaker this month asked the Food and Drug Administration to approve the therapy to treat generalized anxiety disorder.
``Seroquel is increasingly being rolled out for additional indications and may, in due course, become the go-to product for depressive disorders,'' Charles Stanley analyst Jeremy Batstone-Carr said in an e-mail.
READ MORE @ BLOOMBERG
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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