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Journal Faces Lawsuit Over Discredited Study Used by GSK to Market Dangerous Antidepressant to Teens

By Brenda Baletti, Ph.D. | The Defender | October 14, 2025

The publisher of a decades-old peer-reviewed article claiming that the antidepressant paroxetine, marketed as Paxil, is safe and effective for teens, said it is reviewing the article.

Meanwhile, a lawsuit filed last month against the American Academy of Child & Adolescent Psychiatry (AACAP) and Elsevier, which publishes the organization’s journal, JAACAP, demands that the journal retract the article.

Attorney George W. Murgatroyd III, acting on behalf of the public, filed the suit in the Superior Court of the District of Columbia Civil Division.

Published in 2001, the article ignited decades of controversy. Critics say it overstated Paxil’s benefits and downplayed its risks, including increased suicide risk among teens.

Known as the “Keller article,” after lead author Dr. Martin Keller, then chair of psychiatry at Brown University, the paper reported partial results from Study 329, an investigation into whether paroxetine was safe and effective for treating depression in adolescents.

GlaxoSmithKline, now GSK, which manufactures Paxil, funded the study.

The article reported that “paroxetine is generally well tolerated and effective for major depression in adolescents” — a claim now widely known to have been based on distorted results.

The study actually found the drug was neither safe nor effective. Internal documents later showed that GSK hired a PR firm to ghostwrite the article, cherry-picking data and recruiting 20 co-authors to lend credibility. The company then used the paper to market Paxil to doctors.

Peer reviewers raised concerns about the study’s data. As soon as the article went live, practitioners wrote multiple letters to the editor asking why statistically significant indications that the drug caused serious adverse events, including “suicidal gestures,” were dismissed in the clinical trials and not addressed in the paper.

According to the complaint, the Keller article became one of the most cited articles supporting the use of antidepressants in child and adolescent depression — even though evidence from two other GSK trials confirmed the drug was ineffective and risky.

Even though the U.S. Food and Drug Administration (FDA), which never approved the drug for use in children and adolescents, raised concerns about the study.

Calls for JAACAP to retract the article began in 2010, bolstered by:

  • A 2015 BMJ reanalysis confirming the drug’s dangers and data manipulation.
  • Evidence from GSK’s internal files and depositions in other Paxil lawsuits.
  • A 2012 U.S. Department of Justice case in which GSK paid $3 billion to settle criminal fraud charges related to Paxil and two other drugs.

Still, the JAACAP and Elsevier have so far refused to retract the article.

Murgatroyd has represented a dozen families whose children died by suicide or were severely injured in a suicide attempt, allegedly as a result of taking Paxil. His litigation team has deposed all the article’s authors and has combed through GSK’s internal documents.

Both JAACAP and Elsevier continue to profit from the article, according to court documents. It costs $41.50 to download from the JAACAP website, and $33.39 to download from Elsevier’s ScienceDirect website.

The complaint asks the court to “redress the knowing publication, distribution, and continued sale of a false and deceptive medical article that has misled physicians, consumers and institutions for over two decades and continues to endanger adolescent mental health and safety as well as public trust in scientific integrity.”

JAACAP last week published an “expression of concern” indicating that the Committee on Publication Ethics (COPE) will manage recommendations and guidance.

COPE is an international, nonprofit organization that provides guidance to journal editors on publication integrity. COPE does not investigate whether there is research or publication misconduct — it only examines whether the journals involved followed its code of conduct.

AACAP did not respond to The Defender’s request for comment. Elsevier responded only that it would need more time to respond to such a request.

Study 329 revealed serious safety risks, including suicidal behavior

Before publishing the Keller article, GSK funded three studies to test the safety and efficacy of paroxetine to treat depression in children and adolescents. The drug failed to demonstrate efficacy in all three trials.

The first study — Study 329, completed in 1998 — also revealed serious safety risks, including suicidal behavior. Later studies confirmed those risks. According to court documents, GSK knew the “disappointing” results of Study 329 would be a commercial disaster for the drug.

However, the study had some minimal positive results, which could indicate the possibility of efficacy. It met 15% of the outcomes the researchers had been hoping for to show that Paxil worked. GSK officials privately conceded these results were not sufficient to show efficacy.

Yet GSK planned to publish selective data from the study in a prestigious medical journal to claim the drug worked.

GSK hires PR firm to write first draft of JAACAP article

The drugmaker hired a private public relations company, Scientific Therapeutics Information Inc. (STI), to write the article. An employee drafted it and sent it to Keller, who was selected to be the lead author and finish the publication process. STI’s role was not listed in the final draft submitted to JAACAP.

Later in 1998, GSK’s second study, number 377, also failed to show efficacy. The study also showed four times the number of serious adverse events related to suicidality as the placebo study, according to court documents.

That same year, although GSK by then knew of two studies showing the drug was ineffective, the drugmaker decided not to publish any data from Study 377 and instead paid “directly or indirectly” three prominent psychiatrists — Karen Wagner, M.D., Ph.D., Dr. Neal Ryan, and Keller, who had worked on Study 329 — to promote Paxil as a safe and effective treatment for adolescent depression at conventions, forums and at a meeting of the American Psychiatric Association.

The third study, 701, concluded in 2001, also failed to demonstrate efficacy six months before the Keller article was published — yet GSK and JAACAP went ahead with publication.

Twenty authors who were psychiatrists were added as authors of the Keller article. Two GSK employees, James P. McCafferty and Rosemary Oakes — the only authors without medical or doctoral degrees — were also added, although their affiliation with GSK wasn’t disclosed.

Testimonies from depositions in other trials indicated that 10 of the authors didn’t even comment on the paper, and none of them had access to raw clinical trial data — although they all said they did.

None of them disclosed conflicts of interest, and all of them signed off on the article as their work.

GSK used Keller paper to sell $1 billion worth of Paxil to teens

Once JAACAP published the article, GSK’s sales team began promoting Paxil as “safe and effective” for teens.

GSK sent the article to all of its 2,000 Paxil sales reps. In the three years that followed the article’s publication, it is estimated that the company made over $1 billion from sales of the drug to adolescents, the court documents state.

In the following few years, regulators in the U.K. and the European Union issued alerts about the dangers of paroxetine based on its link to suicide ideation in teens.

In 2003, the FDA issued a similar warning, saying there was “no evidence” the drug was effective.

In the following years, some of the authors began to discuss their concerns about suicidality internally, although they made no changes to the article, according to court documents.

Have JAACAP and Elsevier refused retraction to protect authors?

The complaint filed last month alleges that JAACAP editors and Elsevier refused to retract the Keller article “in an apparent attempt to shield at least five of the Keller article authors who are prominent members of the AACAP from possible ramifications of retraction.”

Conflicts of interest among the article’s authors are glaring. Keller, Wagner and Ryan all received money to promote Paxil as safe and effective in the years before publication, according to the complaint.

Two authors, McCafferty and Oakes worked for GSK, the complaint said, and did not disclose that in the article.

Several authors of the Keller article went on to hold influential positions within the AACAP. Wagner was president from 2017-2019.

Dr. Gabrielle A. Carlson also served as president of the organization from 2019-2021. Before that, she was chair of AACAP’s Program Committee from 2011-2014, and won AACAP’s Virginia Q. Anthony Outstanding Woman Leader Award.

Dr. Graham Emslie has served on the JAACAP Editorial Board. Dr. Boris Birmaher has chaired committees in the AACAP and published numerous articles, editorials and organizational practice parameters.

The current editor-in-chief of the journal, Dr. Douglas Novins, who was not an author on the article but holds final decision-making power over retraction, has worked closely with some of the authors — co-authoring editorials with both past presidents.

Dr. David Healy, co-author of the BMJ article that reanalyzed the data from Study 329, told The Defender that for years, he and others who had been investigating this issue assumed the journal had been duped by GSK, but later realized the journal “was not duped — it was complicit.”

Keller and then-editor Dr. Mina Dulcan were close friends, Healy said — a relationship revealed in transcripts of interviews Dulcan did for a set of BBC programs.

This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.

October 19, 2025 Posted by | Corruption, Deception, Science and Pseudo-Science | | 2 Comments

Stop Suicide By Helping Big Pharma, Says Shady Suicide Prevention Group

By Martha Rosenberg | CounterPunch | August 23, 2017

Next month, hundreds across the country will participate in “Out of the Darkness” walks to raise awareness about suicide and to support the American Foundation for Suicide Prevention (AFSP).

AFSP and similar groups like the National Alliance on Mental Illness (NAMI) and Active Minds claim there are “stigmas” and “barriers” to treatment for mental illness and there is not enough “awareness.” Two facts are missing in their messaging.

First, with as much as a fourth of some U.S. populations on antidepressants and ubiquitous quizzes and ads for them, there is neither a lack of “awareness” ––or are the drugs working. Why are suicides at an all time high at the same time psychoactive drug use is at an all time high?

Secondly, the groups are funded by Pharma to increase drug use and are widely considered unethical front groups, also called astroturf.

The American Foundation for Suicide Prevention, founded in 1987, is steeped in Pharma money. In 2008, AFSP merged with the Suicide Prevention Action Network USA or SPAN which had announced in 2004 that “SPAN USA’s efforts to develop and expand its suicide survivor network received a major boost with a recent grant from Eli Lilly and Company Foundation,” and “The foundation generously provided funding to support training, education and collaborative opportunities for SPAN USA’s existing network and enable further expansion into all 50 states.” No lack of transparency there.

In AFSP’s 2009 report, its leading donors were Pharma companies and it attributes a new screening project to “funding from Eli Lilly and Co., Janssen, Solvay Pharmaceuticals Inc. and Wyeth Pharmaceuticals.” It also credits Eli Lilly for printing its brochures. No lack of transparency there, either.

In 2011, AFSP appointed psychiatrist Charles Nemeroff president of the organization until his troubles began. Nemeroff became the subject of a congressional inquiry and was found to have so much unreported Pharma income, the $9.3 million National Institutes of Health (NIH) grant to study depression that he managed was suspended, which happens rarely. He left Emory University in disgrace.

A 1999 textbook written by Nemeroff and his colleague Alan Schatzberg was found, in 2010, to be written and funded by GlaxoSmithKline. Both Nemeroff and Schatzberg remain at AFSP and are termed “leaders.”

AFSP’s 2012 annual report reveals a $100,000 donation from Forest Laboratories, and donations from Eli Lilly, Pfizer and five other Pharma companies.

“AFSP also boasts the honor of having a former president – David Shaffer – who was responsible for leading the development of the now somewhat infamous TeenScreen,” writes Mad in America. “TeenScreen is a controversial tool that Marcia Angell (Harvard Professor and former editor-in-chief of the New England Journal of Medicine)…described as, “just a way to put more people on prescription drugs.”

The now defunct TeenScreen which screened young people for early signs of depression had “ties to the pharmaceutical industry,” reported the Scientific American.

Screening and intervention are widely accepted now to be nothing but sales tools—even to the mainstream medical establishment. In “How We Do Harm,” Dr. Otis Brawley, chief medical and scientific officer of the American Cancer Society and an oncologist, devotes a chapter to how prostate screening is often done just for money sometimes with disastrous and deadly results.

AFSP’s annual report names Pharma companies Sunovion, Janssen, Forest, Pfizer and Otsuka America Pharmaceuticals as financial donors. AFSP also named Phil Satow, former Forest executive, to its Project 2025 Advisory Committee. Satow has worked for many Pharma companies and is co-founder and board chair of the very pro-drug JED Foundation.

Preventing Suicides or Causing Them?

While SSRIs can be useful in some depressions, they can also cause suicide–a fact written clearly on all their package inserts. In 2005, after meeting with parents whose children killed themselves on the drugs and public health officials, the FDA attached the following “Black Box” warning to SSRI antidepressants.

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of PAXIL [one SSRI] or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber.

One chilling demonstration of the danger to young adults is seen in the military where SSRI use and suicides have reached astounding proportions. More than a third of the deaths were in soldiers who never deployed so combat stress was not a factor.

Both NAMI and Active Minds swoop down on campuses after suicides to suggest that not enough antidepressants are being prescribed–despite the clear dangers posed for that age group and sometimes without knowing if the victim was already on the pushed drugs. To remove the fabricated stigma to mental problems, Pharma funded groups visit public schools to suggest more young people should be on drugs. They even produce posters with the message that mental illness is “cool.” Their efforts may not help the young people but they sure help Pharma.

Martha Rosenberg is an investigative health reporter. She is the author of  Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health (Prometheus).

August 23, 2017 Posted by | Deception, Science and Pseudo-Science, Timeless or most popular | , , | Leave a comment

Medicated to Death: SSRIs & Mass Killings

The EyeOpener Report | April 17, 2014

SSRI stands for Selective Serotonin Reuptake Inhibitor, and it is a class of drugs that is often used to treat depression and anxiety. It includes Prozac, Zoloft, Celexa, Paxil and a host of other commonly prescribed antidepressants. And the perpetrators of a raft of school shootings, mass murders and other violent incidents in recent years have been taking them.

Find out more about the correlation between SSRIs and mass murder in this week’s edition of the EyeOpener Report with James Corbett.

Transcript

By James Corbett | BoilingFrogsPost | April 16, 2014

[CLICK HERE for a French translation of this video.]

In May 1998, 15 year old Kip Kinkel murdered his parents and two classmates, as well as injuring 25 others, after engaging in a shooting spree that ended up in his school’s cafeteria. In the investigation it emerged that he had been taking popular antidepressant medication Prozac since the summer of the previous year.

In December 2000, Michael McDermott went on a shooting rampage at his workplace, Edgewater Technologies, killing seven of his co-workers. During his trial, the court heard testimony that in the weeks before the shooting, McDermott had tripled the dosage of his antidepressant medication, Prozac, from 70 milligrams per day to 210 milligrams.

In March 2005, 16 year old Jeff Weise shot and killed nine people, including five students at Red Lake Senior High School in Minnesota, before turning the gun on himself. It was later revealed he had been undergoing treatment for depression and had been on Prozac at the time.

In September 2008, Finnish post-secondary student Matti Saari shot and killed ten other students on campus before killing himself. The official Finnish government report on the incident revealed that he had been taking an SSRI medication at the time of the shooting.

SSRI stands for Selective Seratonin Reuptake Inhibitor, and it is a class of drugs that is often used to treat depression and anxiety. It includes Prozac, Zoloft, Celexa, Paxil and a host of other commonly prescribed antidepressants. And the perpetrators of a raft of school shootings, mass murders and other violent incidents in recent years have been taking them.

And so it was perhaps not surprising when the culprit of this month’s mass shooting at Fort Hood, Specialist Ivan Lopez, turned out to be taking unnamed antidepressants himself.

Although it has yet to be reported (and may in fact never be revealed) precisely what type of antidepressant Lopez was taking or whether it was an SSRI, the number of confirmed SSRI shooters in recent years has raised the question of a causal link between the medication and incidents of violence.

Although the drug manufacturers are quick to downplay this connection as anecdotal or coincidental mounting scientific evidence points to a strong correlation between the use of psychiatric drugs in general, and SSRIS in particular, and violent behavior.

In 2010, the Public Library of Science published a study titled “Prescription Drugs Associa
ted with Reports of Violence Towards Others” which examined how 484 drugs were associated with 1,937 documented cases of violent behaviour. Of those 484 drugs, 31 of them were responsible for 79% of the violence, including 11 antidepressants.

When incidents of school massacres in the US are charted against prescription of psychiatric medication, the correlation is undeniable. Further research is needed to establish if there is a causal linkage between these pharmaceuticals and the incidents of violence, but critics of the big pharmaceutical manufacturers complain such research is hampered by the low standards for reporting that these companies are held to.

One such critic, David Healy, author of over 150 peer-reviewed papers in the field of psychiatry and the author of numerous books, including Pharmageddon, joined me on The Corbett Report last week to discuss this issue.

Further complicating the issue is the fact that the general public is often, as in the case of the Fort Hood shooter, left in a state of limbo regarding the medical history of the perpetrators of these mass shooting events. Often stories are reported with vague and unconfirmed details about “antidepressants” or sometimes just medication. It can be difficult for the average person to sort through the daily reports of adverse and violent effects of these types of drugs.

One website that helps in that effort is SSRIStories.org. Begun in the 1990s, it is a repository of over 5000 news articles in which prescription drugs were linked to adverse events, including incidents of violence. Last week Julie Wood, one of the proprietors of the site, joined me to discuss the problem of sorting through the often incomplete information from these reports.

In the final equation, the question of the causal linkage between SSRIs and indeed other forms of psychiatric drugs and incidents of violence needs to be taken seriously. There are many factors at play here, from differences in individual reactions to the fact that people who are more likely to commit violent acts in the first place are often the people who are prescribed these drugs.

But the threat of violence has been taken seriously enough that the FDA in the US, the Ministry of Health in Japan and other similar bodies in countries around the world have added a warning in their guidelines for antidepressants. According to the Japanese Ministry of Health, “There are cases where we cannot rule out a causal relationship [of hostility, anxiety, and sudden acts of violence] with the medication.” And in the FDA formulation: “Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.”

How can it be seen to be a good thing for anyone but the drug manufacturers themselves that these drugs have been on the market for decades and the bodies in charge of regulating them still can only offer such wishy-washy, non-evidence based statements? The issue of drug-linked violence is one that we as a society need to start discussing and acting on soon, otherwise we will continue to let the status quo be ruled not by doctors or patients or their loved ones, and certainly not by the victims of these mass murders, but by the men in the board rooms of these pharmaceutical companies who have been shown time and time again to care about nothing other than their own bottom line.

June 14, 2014 Posted by | Corruption, Deception, Science and Pseudo-Science, Timeless or most popular, Video | , , , , , , , , , , , , , | 1 Comment