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To: GlaxoSmithKline
We demand that GlaxoSmithKline — the manufacturer, distributor and marketer of the drug Paxil — do the following:
Immediately issue a worldwide drug safety recall for Paxil while simultaneously ceasing production of Paxil, and initiating a phased withdrawal of the drug from the marketplace with one caveat: that the company begin production/distribution of Paxil tablets in 1/4, 1/2, 1 and 5 milligram doses so as to give patients dependent upon (i.e. addicted to) Paxil — and who are trying to taper off the drug — "the tools" necessary optimize their chances of success.
Broadcast an apology — delivered by J.P. Garnier, GlaxoSmithKline's Chief Executive Officer — via a live Internet web cast. This apology shall address surviving victims of Paxil, as well as families who lost a loved one to a Paxil-induced act of violence (i.e. suicide or homicide.) This web cast video shall then be permanently archived at GlaxoSmithKline's primary web site.
If GlaxoSmithKline refuses to withdraw Paxil from the marketplace, then the company shall at a minimum:
Discontinue, once and for all, use of the word "discontinuance," and the phrase "discontinuance syndrome," in Paxil's prescribing information, consumer drug labeling, and marketing/public relations lexicon.
Adopt a uniform Paxil prescribing information and consumer drug labeling standard throughout the world.
Preface all Paxil prescribing information and consumer drug labeling with "Black Box" warnings which clearly and unambiguously address the following dangers:
Withdrawal reactions are common; that they can be severe, and protracted; that withdrawal from Paxil should only be attempted under the aegis of a knowledgeable healthcare professional.
Paxil can, and does, cause drug dependency; that withdrawal reactions are a direct consequence of dependency.
Taking Paxil while pregnant can result in a newborn suffering severe and sometimes life-threatening drug withdrawals (i.e. Neonatal Withdrawal Syndrome); that, in fact, pregnant mothers should not take Paxil for this very reason.
First time users of Paxil can sometimes experience a rare but spontaneous and unpredictible akathisia-induced suicidality and/or homicidality.
Established Paxil users can experience suicidality and/or aggressivity — regardless of the initial diagnosis (i.e. MDD) — most commonly when the drug dosage is increased, decreased, or stopped.
That, in Paxil's drug labeling, GlaxoSmithKline highlight the association between use of Paxil and an increased incidence of breast cancer in women (as demonstrated by at least three credible, peer-reviewed scientific studies performed by Canadian medical researchers since the year 2000.)
We further demand that GlaxoSmithKline:
Forfeit a minimum five billion dollars in Paxil profits — a figure derived from estimated revenues extracted from worldwide sales of Paxil during the drug's peak 24 month sales cycle. These funds shall be used for the establishment of a (non-profit) "Paxil Fund." This Fund, wholly independent of GlaxoSmithKline, shall be tasked with the job of a) creation of a worldwide nexus of medical clinics (with in-patient capacity) designed to treat Paxil addict/withdrawal victims at no charge and b) educating the public the world over about the dangers of Paxil.
Compel former United States football star and sports icon Terry Bradshaw — to whom GlaxoSmithKline paid an enormous sum of money to promote its drug Paxil — to retroactively donate that money towards creation of a nexus of international medical facilities dedicated to the treatment of newborn infants suffering from Paxil-induced Neonatal Withdrawal Syndrome (NWS). GSK shall agree to match Mr. Bradshaw's donation dollar-for-dollar using a 100:1 ratio.
Immediately stop its unconscionable marketing of Paxil to women suffering from PMDD. At least three peer-reviewed scientific studies produced by Canadian medical researchers clearly demonstrate a compelling link between use of Paxil and a significant increase in the occurence of breast cancer.
Explain why the company, in August of 2003, sent its regional medical director and a medical team to meet with officials from Connecticut's Department of Children and Families — which had stopped dispensing Paxil to children in response to a recent warning issued by the British government stating Paxil (Seroxat) should no longer be prescribed to any patient under the age of 18. Specifically, the company shall answer the question: Was it because this precedent-setting action by a U.S. public agency might spur similar agencies to impose a "Paxil ban," thus imperiling Paxil revenues expected to grow via the spread of the so-called TMAP program?
Describe, not explain, the company's burgeoning role in the creation of the "Texas Math Algorithmic Project," now the subject of federal whistleblower Allen Jones' lawsuit.
Disclose the company's role in the so-called TeenScreen program, masterminded by, and for, "the Pharmas" under cover of Columbia University. (It's just a way to put more people on prescription drugs," said Marcia Angell, a medical ethics lecturer at Harvard Medical School and author of The Truth About Drug Companies.)
Immediately stop all Paxil marketing strategems designed to infiltrate and exploit the pediatrics (under age 18) market. Paxil has been proven — by GSK's own internal studies — to be worthless in the treatment of depression in the pediatric population. Moreover, use of Paxil (Seroxat) in the under-18 population has been banned in the UK.
Admit that the company fabricated the results of Paxil's phase III studies (executed in Yugoslavia) — later presented to the United States Food and Drug Adminstration in October of 1992 — in a (successful) bid to gain agency approval for the drug.
Make good on the company's agreement — as part of its resolving a fraud lawsuit filed by New York attorney general Eliot Spitzer — to create transparency in its clinical drug trials. (They (GSK) are giving nonsense details, Dr. Jeffrey M. Drazen, editor-in-chief of the New England Journal of Medicine said in a May, 2004 interview, They are written in a way that they are trying to hide what they are doing.)
Moreover, we demand GSK provide not only clinical trial summaries, but more importantly, the raw data used to generate those summaries.
Acknowledge the untold thousands of excess suicides in the United States (alone) attributable to the use of Paxil.
Finally, we demand GlaxoSmithKline hold a press conference led by:
Dr. David Wheadon, Vice President GSK Regulatory Affairs and Product Professional Services
Dr. Wheadon shall be tasked with the job of explaining to the press why, in October of 2000, he testified under oath that ... "there have been a number of systematic studies in humans looking at the potential for Paxil for abuse, tolerance and physical dependence. So actually, there is data to date to negate the statement that it has not been systematically studied, because, in fact, it has been."
That is not the case according to the June, 2005 Prescribing Information for Paxil which states Paxil has not been systematically studied in animals or humans for its potential for abuse, tolerance or physical dependence.
Is it GlaxoSmithKline's position that Dr. Wheadon — GSK's Vice President of Regulatory Affairs and Product Professional Services — was simply "mistaken" or "ill informed" at the time of his testimony?
Dr. Tadataka Yamada, Chairman GSK Research and Development
Dr. Yamada shall be tasked with the job of explaining to the press why, in January of 2001, he testified under oath that a GlaxoSmithKline decision to put proper warning labels on one of its drugs (Paxil) is "never a business decision" when a confidential 1997 GlaxoSmithKline document (exposed via "discovery" by Paxil withdrawal plaintiffs' attorneys) reads:
Discontinuation: why this is an issue '97 Seroxat/Paxil sales to end Sept. already exceed $1 BILLION
Beneath this statement is an image of a big black money bag with a giant white dollar sign embedded in its center.
Is it GlaxoSmithKline's position that Dr. Yamada — GSK's Chairman of Research and Development — was ignorant of a company concern that adequate warnings embedded in Paxil's prescribing information could have a huge impact on the burgeoning $1,000,000,000+ revenue stream derived from sales of the drug?
Sincerely,
The Undersigned
The The Paxil Protest Petition to GlaxoSmithKline was created by and written by Rob Robinson (eventcoordinator@paxilprotest.com). This petition is hosted here at www.PetitionOnline.com as a public service. There is no endorsement of this petition, express or implied, by Artifice, Inc. or our sponsors. For technical support please use our simple Petition Help form.
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