Fwd: Seroquel Litigation Documents

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ALLIANCE FOR HUMAN RESEARCH PROTECTION Promoting Openness, Full Disclosure, and Accountability http://www.ahrp.org and http://ahrp.blogspot.com FYIThe battle over Seroquel documents in Orlando, Fla. continues to rage. Muchlike the battle over Eli Lilly's Zyprexa documents, the Seroquel battlestems out of thousands of victims' claims who allege that AstraZeneca didn'tadequately disclose the evidence to warn doctors and patients that Seroquelcan trigger serious weight gain and diabetes.  More than 6,000 Seroquelcases have been consolidated in the Florida case. A document filed in Federal District Court, Orlando Fla, by plaintiffs "inresponse to AstraZeneca's motion to exclude evidence and argument about Dr.Macfadden's personal relationships," sheds light on yet another facet ofmanipulation--sexual exploitation.The document is posted on Furious Seasons, (a blog maintained by PhilipDawdy) http://www.furiousseasons.com/documents/macfaddenfiling.pdf According to plaintiffs document, during his five-year tenure at AstraZeneca(2001 until his termination, 2006)  Dr. Wayne Macfadden was AstraZeneca's USmedical director for Seroquel and director of clinical research for centralnervous system. He is said to have planned the clinical trials; he wasinvolved in "ongoing diabetes discussions" at AstraZeneca; he advised thecompany on decision-making regarding the monitoring of glucose in clinicaltrials; he was "actively involved" in the marketing and promotion of thedrug and sat on multiple marketing teams, including the so-called bipolarexecution and strategy team (BEST)--and he served as a liaison to "keyopinion leaders," researchers who promoted Seroquel to the medicalcommunity.Furthermore, "In an effort to expand Seroquel prescribing beyond the fieldof psychiatry, Macfadden was consulted on the decision to market Seroquel toprimary care physicians who treated patients with dementia."  According to this court-filed document, Dr.Macfadden acknowledged in sworntestimony, that he had lengthy sexual relationships with two women who wereintimately tied to writing articles favorable to Seroquel and AstraZeneca.One woman was a British researcher at the Institute of Psychiatry, King'sCollege in London, who, among numerous Seroquel-related projects,"participated in the clinical research and abstract preparation relating tothe effectiveness of Seroquel for use in the treatment ofschizophrenia....He actively encouraged her to conduct research the resultsof which would be favorable to Seroquel and AstraZeneca, and promised sexualfavors in exchange for intelligence on AstraZeneca's competitors."The other woman, an American medical ghostwriter, worked at Parexel MMS(Medical Marketing Services) in the US. Among other duties, she assisted inwriting two published academic papers known as BOLDER I and BOLDER II, inthe American Journal of Psychiatry in 2005 and the Journal of ClinicalPsychopharmacology in 2006.  The BOULDER I and II studies were said to be pivotal to Seroquel's approvalby the FDA for bipolar depression in 2006. According to court records, Dr. Macfadden's relationships with the two womenwere characterized by "control and dependence." Clearly, the nature of these controlling relationships presents more than apotential conflict of interest. It raises serious questions about theintegrity of the favorable scientific reports, the trials themselves, andthe favorable communications promoting Seroquel safety and efficacy. Even more troubling (perhaps) is the seeming disinterest shown by thoseentrusted with responsibility for guarding the integrity of science-basedmedicine and the scientific literature.  Requests for comment by PhilipDawdy-- to FDA officials, the journal editors who published the reports, theInstitute of Psychiatry (UK), and Parexel--went unanswered.  AstraZeneca didrespond.  Read more: http://www.furiousseasons.com/Bloomberg News reports that AstraZeneca faces about 9,000 lawsuits with morethan 15,000 plaintiffs in the U.S. over claims that Seroquel causesdiabetes. Seroquel, which generated sales of $4.03 billion in 2007, is theLondon-based company's second-biggest seller. http://www.bloomberg.com/apps/news?pid=20601087 & sid=alsVfUp65MT4 & refer=homeFDA approval process seems not at all deterred by safety concerns--expandingthe market for drugs is the number one concern.On Monday, the Associated Press reported AstraZeneca said it launched itsdrug Seroquel XR as a treatment for bipolar disorder in addition to aprevious approval for schizophrenia. The London-based company will sellSeroquel XR as a treatment for depressive, manic and mixed episodes ofbipolar I disorder, as well as schizophrenia in adults, and acuteschizophrenic episodes. It can also be marketed in combination with twoother commonly used depression treatments, lithium and divalproex.http://www.forbes.com/feeds/ap/2009/02/23/ap6084234.htmlContact: Vera Hassner Sharavveracare212-595-8974http://www.businessweek.com/print/bwdaily/dnflash/content/feb2009/db20090224_413959.htmBUSINESSWEEKSeroquel Case: Must AstraZeneca Tell All?In more lawsuits, companies are being forced to reveal internal informationduring the pretrial discovery phase that otherwise would be kept privateBy Michael OreyA showdown is looming in a Florida courtroom over an issue that has longbedeviled business: How much internal information can a company be forced tomake public simply because it has become a defendant in a lawsuit?In federal court in Orlando, drugmaker AstraZeneca (AZN) is battling to keepconfidential thousands of pages of correspondence, studies, and othermaterial related to its blockbuster antipsychotic drug Seroquel. On Feb. 13,Bloomberg News, invoking "the public's right of access to judicialdocuments," asked the court to unseal selected filings. A hearing on therequest is scheduled for Feb. 26.The battle grows out of claims by consumers who allege that AstraZenecadidn't adequately disclose that Seroquel can trigger serious weight gain anddiabetes. There is also an unusual allegation of sexual misconduct thatAstraZeneca is trying to keep contained by arguing that it is irrelevant andshould be kept from a jury. More than 6,000 Seroquel cases have beenconsolidated in the Florida case.Cards on the TablePlenty of companies have found their inner workings on public displaythrough material they have disclosed in lawsuits. Details about PhilipMorris' (PM) nicotine research, Firestone's tire designs, Merck's (MRK)Vioxx studies, and Wal-Mart's (WMT) employment practices have all come tolight this way. In some instances the companies failed to get confidentialtreatment for the documents. In other instances, the information has beenleaked, despite confidentiality decrees. That's what happened to Eli Lilly(LLY) in litigation involving its antipsychotic Zyprexa. In a February 2007ruling, a federal judge found that David S. Egilman, an expert witness forthe plaintiffs, helped funnel sealed documents to The New York Times. In2007, Egilman, a community health professor at Brown University, paid$100,000 to Lilly, which donated the amount to charity. Egilman says hethought the documents offered evidence of wrongdoing and he felt he had anobligation to release them.Companies generally accept that evidence presented during a trial enters thepublic domain. Most lawsuits, though, never get that far, and even when theydo, only a limited amount of material ends up being used at trial. But, aswith the Seroquel litigation, confidentiality concerns often arise beforethat stage, in connection with the truckloads of information businessesoften must disclose to their adversaries during the pretrial phase of alawsuit known as discovery. A big fear is that this information can be usedin a selective or distorted fashion to tarnish a company's reputation in thepress, or to fuel additional lawsuits and government investigations. "Themere threat of that often coerces companies into settlement of cases thatthey would otherwise never settle because they feel they have no liability,"says Susan Hackett, general counsel of the Association of Corporate Counsel,a trade group of in-house attorneys.The stakes are high in the Seroquel litigation for London-based AstraZeneca.Nationwide it faces roughly 9,000 lawsuits on behalf of 15,000 consumers.The drug, approved for treating schizophrenia and bipolar disorder, is thecompany's second-biggest seller, ringing up global revenue of $4.4 billionin 2008. So far, things are off to a good start for the company. The firsttwo cases selected for trial in Orlando were tossed out by the judge inJanuary, who concluded that the plaintiffs wouldn't be able to prove thatSeroquel caused the harm they allege.But there are many more cases to go. AstraZeneca says it has turned 50million pages of material over to plaintiffs' attorneys. In an e-mail,AstraZeneca spokesman Tony Jewell says the company is willing to discusslifting its confidentiality claims for "large portions" of the documents.But some should remain under seal, the company argues in a court filing,because they contain trade secrets or because disclosure of incompleteinformation about Seroquel might "mislead the public" and "create apotential public health risk."Strange BedfellowsBloomberg argues that concerns about Seroquel's health risks are preciselywhy the material filed in court should be accessible. It also points to therecent litigation involving Lilly's Zyprexa, which similarly raised concernsabout diabetes risk. While many Lilly documents were filed under seal,courts ultimately ordered them disclosed. Lilly has paid $1.2 billion tosettle Zyprexa claims. A Lilly spokeswoman says the company "stands by thesafety and efficacy of Zyprexa."While the battle over the AstraZeneca and Lilly documents are in manyrespects similar, the Seroquel litigation contains a twist that is unusualfor a drug product-liability case. The plaintiffs have stated in a courtfiling that Wayne MacFadden, AstraZeneca's former U.S. medical director forSeroquel, had sexual relationships with an outside Seroquel researcher andwith another woman who prepared Seroquel medical literature. This, says thefiling, calls into question the integrity of information the company hasdisclosed about Seroquel. AstraZeneca "does not condone the conduct atissue," spokesman Jewell says in an e-mail, noting that MacFadden is nolonger employed by the drugmaker. MacFadden did not respond to messagesseeking comment.The company and the plaintiffs are currently arguing about whether thisinformation should be admitted as evidence at a trial, but some documentsrelating to the debate, including MacFadden's e-mail exchanges with the twowomen, are under seal. Proclaiming itself to be the "eyes and ears of thepublic," Bloomberg is seeking this material, too.Orey covers corporations for BusinessWeek._____________Infomail1 mailing listto send a message to Infomail1-leave =====In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes.