For all the news that the Cockroach Catcher finds interesting!
News Updates: Reuters
The domino effect is not just hitting banks but the big Pharmaceutical companies.
Now it is AstraZenica’s turn, AstraZenica is the maker of Seroquel (Quetiapine).
In the Times Business Section:
AstraZeneca tried to 'bury' bad news on Seroquel drug
March 2, 2009
“AstraZeneca tried to “bury” adverse medical studies about Seroquel, its blockbuster drug, internal company memos released in an American court case have revealed.
"The Anglo-Swedish drugs group is being sued by a total of 9,200 patients, most of whom allege that the Seroquel treatment for psychiatric disorders gave them diabetes. As part of a class-action case before a federal court in Florida, AstraZeneca released 102 documents, including an e-mail in which a member of staff praised a colleague for doing a ‘great smoke and mirrors job’ on company research known as ‘study 15’, which found that Haldol, a cheaper generic rival, was more effective than Seroquel.
"John Tumas, head of the company's publications team, said that it had “buried” three studies and was considering burying a fourth, called Costar. Mr Tumas said:
“The larger issue is how do we face the outside world when they begin to criticise us for suppressing data.” Another e-mail implied that the Costar study showed that Risperdal, a rival medicine, was more effective than Seroquel.”
Just as you might think there is some off-label sex use of Seroquel that you are not aware of, calm down. No such luck.
From Florida (not Alaska) The St Petersburg Times:
Facing numerous Seroquel lawsuits, drugmaker AstraZeneca releases documents By Kris Hundley, February 28, 2009
“The public got a glimpse into the inner workings of a global pharmaceutical company Friday when AstraZeneca released more than 100 sealed documents in a tsunami of lawsuits claiming its powerful antipsychotic Seroquel caused diabetes, weight gain and other health problems.”
Among the documents:
“A Chicago psychiatrist who claimed patients lost weight on Seroquel had his research touted in AstraZeneca's marketing materials — then trashed in interoffice memos.”
Amongst the arguments:
“Steve McConnell, AstraZeneca's attorney, argued that the remaining papers must remain confidential because they contain trade secrets and other proprietary information. Among the sealed documents are results of two clinical studies, sales' reps call notes since January 2004 and correspondence with foreign regulatory authorities.”
“But U.S. Magistrate Judge David Baker was skeptical. ‘What about the public interest in reviewing the integrity of the FDA's administrative process?’ he asked from the bench.”
Could it be this that AstraZeneca wanted to hide?
From BNET Pharma:
AstraZeneca's Sex-for-Studies Seroquel Scandal: Did Research Chief Bias the Science?
By Jim Edwards February 25th, 2009
“An AstraZeneca executive in charge of clinical research on Seroquel had sexual affairs with a researcher and a study writer, plaintiffs in a Florida lawsuit claim. BNET first wrote about the sex-for-secrets aspect of the Seroquel litigation on Feb. 17.
Now Furious Seasons blogger Philip Dawdy revealed a dynamite legal filing describing how Dr. Wayne MacFadden, AZ’s former US medical director for Seroquel and director clincial research in CNS had affairs with a clinical researcher who authored publications favorable to Seroquel, and a medical marketer who promoted Seroquel through medical publications and other means.”
The plaintiffs claim the affairs may have biased the science. AstraZenca is seeking to exclude the evidence.
AstraZenca made this statement to Furious Season (apparently the only organization that did reply and to a blogger!):
“MacFadden became involved in a sexual relationship with an Institute of Psychiatry (London, England) researcher who, as well as being involved in other Seroquel-related projects, participated in the clinical research and abstract preparation relating to the effectiveness of Seroquel for use in the treatment of schizophrenia. Their affair lasted from 2002 to 2006.
“Sometime during 2004, while collaborating with Parexel and while still involved in a sexual relationship with the IOP researcher, MacFadden became involved in a sexual relationship with the Parexel Program Manager responsible for AstraZeneca.
“The nature of their communications suggest a level of control and dependence between Macfadden and these women.
“The IOP researcher suggested that Macfadden would ‘punish’ her if she even looked at studies that were favorable to Seroquel’s competitors. He actively encouraged her to conduct research the results of which would be favorable to Seroquel and AstraZeneca, and promised sexual favors in exchange for intelligence on Astrazeneca’s competitiors.
“In addition to his sexual involvement with the Parexel program manager, it appears he [Macfadden] also provided her with prescription painkillers.”
Now would the FDA need to look at Bolder 1 and Bolder 2 again and revise its approval of Seroquel for Bipolar Disorder. The Cockroach Catcher always feels that there is great snobbery in Psychiatry. Bipolar is an acceptable diagnosis but not Schizophrenia. So drug firms preferred to have their anti-psychotics approved for Bipolar.
An eight week trial for Bipolar (which Bolders were) is hardly long enough in my book but it would not have mattered:
“Macfadden agreed that sexual relationships between clinical researchers and management members of pharmaceutical companies can create bias which can affect the integrity of the science. Macfadden also acknowledged that sexual relationships can affect a person’s judgment. Although Macfadden denies that his multiple sexual relationships with these women created a conflict of interest, he in fact teased the IOP researcher about the obvious conflict of interest as he reviewed drafts of her papers on Seroquel.”
You can download the filing for yourself here.
Last year BNET had an interesting report on AstraZeneca.
AstraZeneca Allegedly Recruits Tigger and Eeyore to Sell Seroquel
By Jim Edwards November 6th, 2008
The domino effect is not just hitting banks but the big Pharmaceutical companies.
Now it is AstraZenica’s turn, AstraZenica is the maker of Seroquel (Quetiapine).
In the Times Business Section:
AstraZeneca tried to 'bury' bad news on Seroquel drug
March 2, 2009
“AstraZeneca tried to “bury” adverse medical studies about Seroquel, its blockbuster drug, internal company memos released in an American court case have revealed.
"The Anglo-Swedish drugs group is being sued by a total of 9,200 patients, most of whom allege that the Seroquel treatment for psychiatric disorders gave them diabetes. As part of a class-action case before a federal court in Florida, AstraZeneca released 102 documents, including an e-mail in which a member of staff praised a colleague for doing a ‘great smoke and mirrors job’ on company research known as ‘study 15’, which found that Haldol, a cheaper generic rival, was more effective than Seroquel.
"John Tumas, head of the company's publications team, said that it had “buried” three studies and was considering burying a fourth, called Costar. Mr Tumas said:
“The larger issue is how do we face the outside world when they begin to criticise us for suppressing data.” Another e-mail implied that the Costar study showed that Risperdal, a rival medicine, was more effective than Seroquel.”
Just as you might think there is some off-label sex use of Seroquel that you are not aware of, calm down. No such luck.
From Florida (not Alaska) The St Petersburg Times:
Facing numerous Seroquel lawsuits, drugmaker AstraZeneca releases documents By Kris Hundley, February 28, 2009
“The public got a glimpse into the inner workings of a global pharmaceutical company Friday when AstraZeneca released more than 100 sealed documents in a tsunami of lawsuits claiming its powerful antipsychotic Seroquel caused diabetes, weight gain and other health problems.”
Among the documents:
“A Chicago psychiatrist who claimed patients lost weight on Seroquel had his research touted in AstraZeneca's marketing materials — then trashed in interoffice memos.”
Amongst the arguments:
“Steve McConnell, AstraZeneca's attorney, argued that the remaining papers must remain confidential because they contain trade secrets and other proprietary information. Among the sealed documents are results of two clinical studies, sales' reps call notes since January 2004 and correspondence with foreign regulatory authorities.”
“But U.S. Magistrate Judge David Baker was skeptical. ‘What about the public interest in reviewing the integrity of the FDA's administrative process?’ he asked from the bench.”
Could it be this that AstraZeneca wanted to hide?
From BNET Pharma:
AstraZeneca's Sex-for-Studies Seroquel Scandal: Did Research Chief Bias the Science?
By Jim Edwards February 25th, 2009
“An AstraZeneca executive in charge of clinical research on Seroquel had sexual affairs with a researcher and a study writer, plaintiffs in a Florida lawsuit claim. BNET first wrote about the sex-for-secrets aspect of the Seroquel litigation on Feb. 17.
Now Furious Seasons blogger Philip Dawdy revealed a dynamite legal filing describing how Dr. Wayne MacFadden, AZ’s former US medical director for Seroquel and director clincial research in CNS had affairs with a clinical researcher who authored publications favorable to Seroquel, and a medical marketer who promoted Seroquel through medical publications and other means.”
The plaintiffs claim the affairs may have biased the science. AstraZenca is seeking to exclude the evidence.
AstraZenca made this statement to Furious Season (apparently the only organization that did reply and to a blogger!):
“MacFadden became involved in a sexual relationship with an Institute of Psychiatry (London, England) researcher who, as well as being involved in other Seroquel-related projects, participated in the clinical research and abstract preparation relating to the effectiveness of Seroquel for use in the treatment of schizophrenia. Their affair lasted from 2002 to 2006.
“Sometime during 2004, while collaborating with Parexel and while still involved in a sexual relationship with the IOP researcher, MacFadden became involved in a sexual relationship with the Parexel Program Manager responsible for AstraZeneca.
“The nature of their communications suggest a level of control and dependence between Macfadden and these women.
“The IOP researcher suggested that Macfadden would ‘punish’ her if she even looked at studies that were favorable to Seroquel’s competitors. He actively encouraged her to conduct research the results of which would be favorable to Seroquel and AstraZeneca, and promised sexual favors in exchange for intelligence on Astrazeneca’s competitiors.
“In addition to his sexual involvement with the Parexel program manager, it appears he [Macfadden] also provided her with prescription painkillers.”
Now would the FDA need to look at Bolder 1 and Bolder 2 again and revise its approval of Seroquel for Bipolar Disorder. The Cockroach Catcher always feels that there is great snobbery in Psychiatry. Bipolar is an acceptable diagnosis but not Schizophrenia. So drug firms preferred to have their anti-psychotics approved for Bipolar.
An eight week trial for Bipolar (which Bolders were) is hardly long enough in my book but it would not have mattered:
“Macfadden agreed that sexual relationships between clinical researchers and management members of pharmaceutical companies can create bias which can affect the integrity of the science. Macfadden also acknowledged that sexual relationships can affect a person’s judgment. Although Macfadden denies that his multiple sexual relationships with these women created a conflict of interest, he in fact teased the IOP researcher about the obvious conflict of interest as he reviewed drafts of her papers on Seroquel.”
You can download the filing for yourself here.
Last year BNET had an interesting report on AstraZeneca.
AstraZeneca Allegedly Recruits Tigger and Eeyore to Sell Seroquel
By Jim Edwards November 6th, 2008
A. A. Milne /E. H. Shepard
“According to Ed over at Pharmalot, ‘the idea was conveyed at a national sales meeting and on field rides with sales reps, who were told to use Tigger as a bipolar patient and Eeyore — the down-in-the-mouth donkey — as a depressed patient. The reps were allegedly encouraged to use Tigger dolls (licenced to Disney) as giveaways, for instance.’”
Tigger bipolar! Com'on, something should remain sacred for our children’s sake.
Related Posts:
Old and New: Multiple Sclerosis & Elgar
Lithium Bipolar and Nanking
Bipolar Disorder in Children
Bipolar and ADHD: Boys and Breasts
Antipsychotics: Really?
No comments:
Post a Comment