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 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
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, reporting
December 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
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.
http://news.bbc.co.uk/2/hi/programmes/panorama/6317137.stm
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. ...”
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.”
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.”
Fortune
“Trouble in Prozac Nation”
David Stipp
November 28, 2005
“[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.”
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,’ ...”
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.”
http://finance.senate.gov/newsroom/ranking/release/?id=866a168e-e238-4d0a-8657-f4ef878c8202
The Emperor Has No Clothes