SELLING SICKNESS Influence on Influence October 7-8, 2010 Amsterdam, Netherlands “Secret Pharmaceutical Company Documents Obtained in Litigation: Revelations and Release in the Interest of Public Health” By George Murgatroyd, Esq. and Cindy Hall Baum Hedlund Aristei and Goldman, Los Angeles, California U.S.A. www.baumhedlundlaw.com
Presentation Synopsis CONFIDENTIAL Confidential documents obtained in antidepressant litigation in the United States and released into the public domain have revealed pharmaceutical industry misconduct, including exposure of hidden risks and overblown efficacy, selective reporting of efficacy and safety, conflicts of interests and rampant ghostwriting of medical journal articles for marketing purposes. Law firms can play a vital role in gaining public release of company-designated confidential documents from pharmaceutical litigation as the American law firm, Baum, Hedlund, Aristei & Goldman, has successfully done.
Continued CONFIDENTIAL Documents publicly released as a result of Baum Hedlund’s legal challenges to their confidentiality have played a key role in government investigations, oversight and regulation of industry, media coverage of pharmaceutical industry misconduct and academic access and commentary on these subjects. It should be noted that Baum Hedlund strictly adheres to the terms of any confidentiality agreements in force in litigation in which it is involved. Only in those instances where company documents are no longer designated “confidential” are these documents made available to the public.
“The Role of Litigation in Defining Drug Risks” Aaron S. Kesselheim, M.D., J.D. and Jerry Avorn, M.D. “Litigation brought by government agencies and individual patients can help uncover previously unavailable data on adverse effects, questionable practices by manufacturers, and flaws in drug regulatory systems.”
ABC News Primetime“Drug Maker Withheld Paxil Study Data”Greg Fisher, reportingDecember 9, 2004 “New documents uncovered by ABC News suggest GlaxoSmithKline, the maker of the popular antidepressant Paxil, failed to disclose important information about the possibility of an increased risk of suicidal behavior in some children taking the drug... ”
BBC Panorama “Secrets of the drug trials” Shelley Jofre reporting January 29, 2007 http://news.bbc.co.uk/2/hi/programmes/panorama/6317137.stm Shelley Jofre: Malibu, California. It's not where you'd expect to unravel one of the biggest medical scandals of recent times, but that's exactly what this team of lawyers has managed to do. What they've found affects all of us here in the UK, anyone in fact who takes prescription medicine. ... These trade secrets are usually protected by law but through a series of legal challenges the lawyers have forced many of them into the open. Buried in all these boxes are details about secret clinical trials programme that GlaxoSmithKline began over a decade ago for its antidepressant paroxetine. It's a drug that's better known in Britain by its brand name Seroxat.
AP Associated Press CASPPER – “Glaxo Used Ghostwriting Program to Promote Paxil” Matthew Perrone August 19, 2009 “Drugmaker GlaxoSmithKline used a sophisticated ghostwriting program to promote its antidepressant Paxil, allowing doctors to take credit for medical journal articles mainly written by company consultants, according to court documents obtained by the Associated Press. ...”
CONFIDENTIAL San Francisco Chronicle “A Suicide Effect? What Parents Aren’t Being Told About Their Kids’ Antidepressant” Rob Waters January 4, 2004 “In an internal company memo uncovered in a lawsuit, Donnelly described his conversation with Brecher, noting that the FDA ‘does not see [the suicide debate] as a real issue but rather as a public relations problem.’” ... “Critics ... point to company memos, uncovered through legal actions, that reveal a sense of confidence within the companies that the FDA was on their side. Memos from Eli Lilly executives described one FDA official, Paul Leber, as ‘our defender’ and cautioned that faxes should not be sent to him unless he knew they were coming so he could receive them personally.”
New Scientist “Did GSK Trial Data Mask Paxil Suicide Risk?” Jim Giles February 8, 2008 “An appropriate analysis of clinical trial data by researchers at GlaxoSmithKline obscured suicide risks associated with paroxetine, a profitable antidepressant, for 15 years, suggest court documents released last month.” ... “Independent researchers say it was wrong to use washout data as GSK did. ‘I can’t imagine circumstances in which it would be appropriate,’ says Bruce Psaty of the University of Washington in Seattle.”
Guardian.co.uk: The Observer “Revealed: How Drug Firms ‘Hoodwink’ Medical Journals. Pharmaceutical Giants Hire Ghostwriters to Produce Articles – Then Put Doctors’ Names on Them” Antony Barnett “In the United States, a legal case brought against drug firm Pfizer turned up internal company documents showing that it employed a New York medical writing agency. One document analyses articles about the anti-depressant Zoloft. Some of the articles lacked only one thing: a doctor’s name. In the margin the agency had put the initials TBD ... ‘to be determined’.”
“Debate Resumes on the Safety of Depression’s Wonder Drugs” Gardiner Harris August 7, 2003 “[E]xperts hired by lawyers suing [antidepressant] manufacturers over claims that the drugs led to suicides question whether the F.D.A. received a full picture of the available research in 1991. “For instance, F.D.A. procedures required Lilly to inform the agency of any concerns about Prozac raised by other national health authorities. But court records show that Lilly never told the F.D.A. or the expert panel that German regulators initially refused to approve Prozac’s sale in 1985 because of concerns over a link with suicide.” REJECTED
Continued “In their analysis of Lilly’s data, the German authorities said that Prozac seemed to have caused a substantial increase in suicide among users, according to court records. Ultimately, the Germans approved Prozac with a warning that physicians should consider using sedatives for patients at risk of suicide. “No such warning is included in Prozac’s label in the United States, although the risk of suicidal thinking is listed among the drug’s side effects. “Gary Tollefson, a Lilly executive who spoke before the 1991 panel, was asked in a deposition why he did not tell the experts about the German concerns. “That was not a question I was asked,’ he said, according to court records, ‘so I did not answer that question.”
Continued “Documents brought to light in other cases suggest that Lilly struggled for years to reconcile suicidal events among patients taking Prozac in its trials. One memo shows that a top Lilly executive asked the company’s own researchers to record suicide attempts as ‘overdose’ and thoughts of suicide as ‘depression.’ “In another memo, a Lilly employee objected to those instructions, making reference to the German health authority, known by its initials as the B.G.A. ‘I do not think I could explain to the B.G.A., a judge, to a reporter or even to my family why we would do this especially on the sensitive issue of suicide and suicidal ideation,’ he wrote.”
White Coat Black Hat, Adventures on the Dark Side of Medicine Carl Elliott Beacon Press, 2010 “As an expert witness against industry, Healy was granted access to internal information and study data that the public never saw. The more information Healy saw, the more he became convinced that the antidepressant manufacturers were hiding and manipulating studies in order to prevent the truth about the risks of antidepressants from coming out.”
STUDY 329 - “Keller’s Findings on Paxil Disputed by Doctors, FDA” Chaz Firestone and Chaz Kelsh September 24, 2008 “[L]awsuits against GSK by families of patients who claimed to have been harmed by Paxil gave Jureidini access to previously unreleased documents.” ... [Through access to court documents,] “Jureidini could now sketch out a timeline of the evolution of [Study 329], from the first draft submitted to JAMA in 1999 to the final draft published in JAACAP in 2001.”
“Direct-to-Consumer Advertising of Prescription Medicines: A Counter Argument” Barbara Mintzes and Dee Mangin December 2009, Vol. 1, No. 9, Pages 1555-1560 News & Analysis “Recent US court cases have uncovered a range of promotional practices of grave concern, such as wide-spread promotion for unapproved uses without evidence of effectiveness, use of physician ‘key opinion leaders,’ sponsored continuing medical education to promote sales and ghostwriting of scientific articles.”
“[O]ver the past 15 years critics have amassed a small mountain of data that point to suicide-related side effects, including reams of medical journal reports, internal FDA memorandums obtained with Freedom of Information Act filings, and unpublished industry documents pried out via discovery in lawsuits.” Fortune“Trouble in Prozac Nation”David Stipp November 28, 2005
Kim Witczak “Going After Goliath” Mary A. Fischer December 2009 After her husband’s suicide while under the influence of Zoloft, Kim Witczak “took on the powerful, global drug company she blames for her husband’s death.” Kim Witczak took her case to court and “numerous corporate documents [were released in the court case] showing that both drug companies and federal regulators were aware of a possible connection between SSRIs and suicide from the earliest days of Prozac. Kim took those documents to Washington” in 2005.
The Wall Street Journal “U.S. Probe of Glaxo’s Paxil Widens” Alicia Mundy June 20, 2008 Lawyers from Baum Hedlund met with attorneys from the United States Justice Department, FBI agents and representatives from the Department of Health and Human Services. The lawyers...“were asked in detail about information they had collected for lawsuits about what Glaxo told the FDA about Paxil’s potential risk of suicidal behavior, between 1989 and 1992, while the drug’s approval was pending.” “Glaxo hasn’t allowed Baum Hedlund’s lawyers to share with the FDA the same sealed information that the company gave the Justice Department. Glaxo’s outside counsel wrote, ‘If the FDA wanted additional information, such as the internal documents you propose providing it, they could have requested them from GSK,’ ...”
http://finance.senate.gov/newsroom/ranking/release/?id=866a168e-e238-4d0a-8657-f4ef878c8202http://finance.senate.gov/newsroom/ranking/release/?id=866a168e-e238-4d0a-8657-f4ef878c8202 United States Senate Committee on Finance Grassley Seeks FDA Scrutiny of Paxil and Suicide Risk Floor Statement - June 11, 2008 Based on his review of newly unsealed court documents, Senator Chuck Grassley (R-IA) told his fellow senators: “Essentially, it looks like GlaxoSmithKline bamboozled the FDA.”