Three GSK clinical trials failed to demonstrate Paxil's effectiveness for treating depression in children

via 

Hooked: Ethics, Medicine, and Pharma:

Inside Paxil Study 329, Courtesy the Justice Department 

July 3, 2012

a couple of excerpts:

"Thanks to the U.S. Justice Dept. complaint in the suit recently settled by GlaxoSmithKline for a record $3B:http://www.justice.gov/opa/documents/gsk/us-complaint.pdf
--we can follow the history of this study in more detail, based on the internal GSK documents discovered during the proceedings, and see just how the data were manipulated for marketing purposes."

"More important, the 11 patients with serious adverse reactions due to Paxil, and the 5 of them with specifically suicidal or agitated symptoms, magically disappeared. In the revised manuscript the investigators suddenly decided that only one of the reactions (headache) was actually caused by Paxil, and the other bad outcomes were unrelated to the drug. When the FDA got its hands on the raw data from 329, it eventually determined that 10 of 93 patients taking Paxil had experienced a potentially suicidal reaction--a far different and scarier picture than that portrayed in any of the drafts or in the final manuscript." read here

via Pharmalot:

Brown University, A Paxil Study And Retractions
By Ed Silverman // February 6th, 2012 // 10:52 am

a couple excerpts:

"The Department of Health & Human Services, by the way, was also reluctant to pursue the matter. In a letter last November to Jureidini, John Dahlberg, the director of the Division of Investigation Oversight in the Office of Research Integrity at the HHS, noted that Paxil effectiveness was “apparently exaggerated.” But he went on to say that his office was unable to pursue an investigation due to the statute of limitations."

"Due to the statute, “…allegations of falsification, fabrication or plagiarism must be made within six years of the alleged misconduct… Further, given the significant lapse of time between the time the study was conducted and concerns raised, the likelihood of being able to conduct a fair and objective review, given the inevitable difficulties in locating records and relying on memories of events well over 10 years ago, seems remote” (here is the letter). Say Jureidini: “We are a bit stuck about where to take it from here.” read here

Thank you Evelyn Pringle for listing all the dirty dogs who put their names on Study 329: 

"Give credit where credit is due. In alphabetical order, the full list of authors who signed on to the ghostwritten and fraudulent Paxil Study 329 includes: Boris Birmaher, Gabrielle Carlson, Gregory Clarke, Graham Emslie, David Feinberg, Barbara Geller, Owen Hagino, Martin Keller, Rachel Klein, Harold Koplewicz, Vivek Kusumakar, Stan Kutcher, James McCafferty, Rosemary Oakes, George Papatheodorou, Neil Ryan,, William Sack, Michael Strober, Michael Sweeney, Karen Wagner, Elizabeth Weller, Nancy Winters"

I wonder, if John Dahlberg, the director of the Division of Investigation Oversight in the Office of Research Integrity has any idea what integrity is. Or if he is aware there are no limits to how many will be harmed or killed because of people who have been promoted to a position that is above their level of incompetence. 

People were not warned of the risks, children and adults have died and have killed others, babies have been born with serious defects and many have died soon after they were born; all for the love of money.  That these horrible things have happened as a direct result of the failures of people who work for the American people; or more accurately, collect a paycheck that is funded by the American people.  In reality, public servants have performed their jobs as if their primary duty was to ensure that marketing campaigns, illegal marketing included, are extremely profitable.  The means being unethical, illegal or deadly was of no consequence, as long as the ends were attained. 

Every one of the doctors named above knew of the risks, it is safe to assume they did not care that people would die because of their subterfuge. They received their paychecks for aiding and abetting a massive fraud that was perpetrated on vulnerable people; a fraud that has caused the deaths of patients; were uninformed so unaware of the risks they faced. The fraud was enormously profitable, in no small part due to the ongoing efforts of psychiatrists who are members of the American Academy of Child and Adolescent Psychiatry, and the American Psychiatric Association; and the cooperation of public servants who work at the FDA, Health and Human Services, and the Centers for Medicare and Medicaid without these public servants' cooperation and abdication of their ethical duty the fraud could not have been perpetrated so successfully, nor could it continue unabated as it has. 

Unfortunately, so do the drug-induced homicides and suicides...  

Paxil gif: jeaniejinx photobucket

via Insight:

Insight into how pharma manipulates research evidence: a case study

SKB knew eight adolescents self-harmed or reported emergent suicidal ideas compared to only one in the placebo group but hid this.
Michael Valli

AUTHOR

1. 

   Jon Jureidini

   Professor of Psychiatry at University of Adelaide

TRANSPARENCY AND MEDICINE – A series examining issues from ethics to the evidence in evidence-based medicine, the influence of medical journals to the role of Big Pharma in our present and future health.

Here Jon Jureidini explains what he encountered while examining internal documents as an expert witness in a case against a pharmaceutical company.

It’s well known that academic literature on medication in psychiatry is distorted by selective publication – failing to publish studies with negative results or selectively publishing only positive results from studies with mixed outcomes.

I had the unusual opportunity to see inside the process of how the marketing department of a pharmaceutical company controls and distorts information in the medical literature. This chance arose when I was provided with access to a huge number of internal documents because I acted as an expert witness for a US law firm.

Between 1993 and 1998, SmithKline Beecham (SKB, subsequently GlaxoSmithKline) provided $5 million to various academic institutions to fund research into paroxetine (also known as Aropax, Paxil (GSK) or Seroxat), led by Martin Keller. Keller was from Brown University and received $800,000 for participation in the project.

The results were published in 2001 by Keller et al. in the journal article, “Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial”, in the Journal of the American Academy of Child & Adolescent Psychiatry (JAACAP). The article concluded that “paroxetine is generally well tolerated and effective for major depression in adolescents”.

This was a serious misrepresentation of both the effectiveness and safety of the drug. In fact, when SKB set out their methodology for their proposed study protocol, they had specified two primary and six secondary outcome measures. All eight proved negative, that is, on none of those measures did children on paroxetine do better than those on placebo.

HmanJp/ Wikimedia Commons

The published article misrepresented one of the primary outcomes so that it appeared positive, and deleted all six pre-specified secondary outcomes, replacing them with more favourable measures.

SKB papers also revealed that at least eight adolescents in the paroxetine group had self-harmed or reported emergent suicidal ideas compared to only one in the placebo group. But these adverse events were not properly reported in the published paper. Instead, some were described as “emotional liability” while others were left out altogether.

Although published in Keller’s name, the article was ghostwritten by agents of SKB, and the company maintained tight control of the article’s content throughout its development.

GlaxoSmithKline’s internal documents, disclosed in litigation, show that company staff were aware that the study didn’t support the claim of efficacy but decided it would be “unacceptable commercially” to reveal that.

According to a company position paper, the data were selectively reported in Keller et al.’s article, in order to “effectively manage the dissemination of these data in order to minimise any potential negative commercial impact”.

Ano Lobb/Flickr

As it turns out, the Keller et al. article was used by GlaxoSmithKline to ward off potential damage to the profile of paroxetine and to promote off-label prescribing to children and adolescents.

While problems with the study and the Keller et al paper have been thoroughly exposed in legal actions, the bioethical and medical literature, a book, and a BBC Panorama documentary, the paper continues to be cited uncritically as evidence of the efficacy of paroxetine for treatment of adolescent depression.

Repeated attempts to get JAACAP to retract the offending paper have been unsuccessful.

For paroxetine, the concern is that adolescents are being harmed because well-intentioned physicians have been misled about its safety and effectiveness.

But more broadly, the case raises questions about how widespread such dubious practice is in the academic community, and in the editorial practices of “scientific” journals.

This is the ninth part of Transparency and Medicine. You can read the previous instalment by clicking the link below:

Part One: Power and duty: is the social contract in medicine still relevant?

Part Two: Big debts in small packages – the dangers of pens and post-it notes

Part Three: Show and tell: conflicts of interest undeclared for clinical guidelines

Part Four: Eminence or evidence? The ethics of using untested treatments

Part Five: Don’t show me the money: the dangers of non-financial conflicts

Part Six: Ghosts in the machine: better definition of author may stem bias

Part Seven: Clearing the air: why more retractions are good for science

Part Eight: Pharma’s influence over published clinical evidence




This article was originally published at The Conversation.
Read the original article.

Paxil Birth Defects Lawsuits on the Rise

 

viawebwire:                 Tuesday, October 11, 2011 Since the once-touted antidepressant Paxil was first prescribed to a patient in 1992, the number of Paxil birth-defect lawsuits filed against its maker GlaxoSmithKline has skyrocketed. Paxil has been shown to cause heart abnormalities known as atrial and ventricular septal defects, which means that an infant is born with holes in the walls of its heart’s chamber. Paxil may also cause persistent pulmonary hypertension in an infant, which is a potentially fatal lung condition. This malady is caused by abnormally high pressure in the blood vessels of the new infant’s lungs. This keeps the baby oxygen starved, and if it survives, the child may need intensive care for a long period of time.In addition to these serious birth defects GlaxoSmithKline advised physicians in 2005 of even more birth defects caused by PaxilThey include:

• Cranial birth defects that cause an infant’s skull to be deformed.
• Abdominal birth defects such as having the infant’s intestine or other abdominal organs protrude from its navel.
• Neural tube defects, which are birth defects of the infant’s brain and spinal cord.
• Cub foot, which is a birth defect that causes an infant’s foot to be stiff, turned inward and unable to be moved to a normal position.

FDA Issued an Alert

Paxil’s connection to these serious birth defects in babies became apparent in 2005 when the Federal Food and Drug Administration (FDA) issued an alert about the antidepressant. In the alert, the FDA ordered GlaxoSmithKline to put a warning label on the Paxil and advised that doctors not prescribe the antidepressant to any woman who planned to become pregnant or was in her first three months of pregnancy.

Number of Lawsuits Growing

Since then, there have been more than 600 lawsuits filed against the pharmaceutical giant by attorneys representing women who say their babies have been born with serious birth defects as a result of taking the drug during their first three months of pregnancy.The plaintiffs in the very first Paxil birth-defect case were awarded$2.5 million in compensatory damages on Oct. 13, 2009 as a result of their child being born with three cardiac birth defects, according to the Public Record. Since then, the maker of Paxil has paid out more than $1 billion to settle hundreds of similar lawsuits. Because many of these cases are settled quietly between the plaintiffs and corporate lawyers for GlaxoSmithKline, there is no way to be sure how many total cases are still pending.

Don’t let your time limit to file a lawsuit run out

If you or one of your loved ones took Paxil during the first three months of a pregnancy and you or their child was born with one of the above birth defects it’s time to seek legal representation before the time limit runs out. That’s because all lawsuits filed in the United States have an expiration date, although they vary from state to state. Generally, the statute of limitations for filing a Paxil lawsuit expires anywhere from two to six years. Why not contact an attorney who specializes in Paxil lawsuits today by visiting http://paxillawsuitv.com

ACOG Issues Opinion on SSRI Antidepressant Use During Pregnancy

Washington, DC -- The use of selective serotonin reuptake inhibitors (SSRIs) and selective norepinephrine reuptake inhibitors for the treatment of depression during pregnancy should be individualized based on their respective risks and benefits, according to a new Committee Opinion issued by The American College of Obstetricians and Gynecologists' (ACOG) Committee on Obstetric Practice. The Committee also advised that a particular SSRI medication known as paroxetine (Paxil®) be avoided, when possible, by pregnant women or women planning to become pregnant due to the potential risk of fetal heart defects, newborn persistent pulmonary hypertension, and other negative effects. source