Source: Children’s Health Defense

A lawsuit demanding the retraction of a decades-old peer-reviewed article that claimed the antidepressant paroxetine, sold as Paxil, is safe and effective has put the issue of fraud in scientific and medical journals back in the spotlight, Paul D. Thacker wrote today in The Disinformation Chronicle.

The lawsuit, filed last month against the American Academy of Child & Adolescent Psychiatry and its publisher, Elsevier, demands the retraction of a 2001 article in the Journal of the American Academy of Child & Adolescent Psychiatry (JAACAP).

The article was based on Study 329, which the suit claims distorted data to claim Paxil was effective.

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

Study 329 was ghostwritten by Paxil manufacturer GSK — which Thacker discussed in a 2011 report he republished today.

Several of the journal article’s co-authors worked for GSK or went on to hold key positions within the AACAP.

According to Thacker, one of the co-authors, Stan Kutcher, is now a member of the Canadian Senate and co-founded “Science Up First,” an initiative that purportedly targets scientific “misinformation.”

During a roundtable discussion on the weaponization of science that the MAHA Institute organized last week, Thacker cited Study 329 as an example of fraud in scientific and medical publishing.

Brian Hooker, Ph.D., chief scientific officer for Children’s Health Defense, spoke at the roundtable. He said the discussion, in which “panelists described horror stories of their own scientific research under attack through targeted retractions of papers, denial of research funding, and disciplinary actions,” was “stunning.” He added:

“There is a huge cost in falling out of line with established institutions in science and medicine, whether corporate, university or private organizations. And these highly credentialed panelists paid a huge cost for ‘doing the right thing’ in exposing malfeasance and bad science.”

Research scientist and author James Lyons-Weiler, Ph.D., also participated in the roundtable. He said it “explored how science-like activities have been systematically re-engineered to serve political and corporate interests rather than truth.” He said:

“Study 329 exemplifies the collapse of accountability that follows when industry, regulators and journals form a closed feedback loop of self-validation. What’s marketed as ‘misinformation control’ today is often a continuation of that same pattern — protecting narratives, not people.”

‘One of the best documented case studies of corruption in modern biomedicine’

Study 329, completed in 1998 and funded by GSK, revealed serious safety risks — including suicidal behavior — associated with Paxil. Later studies confirmed those risks.

However, the study showed a few minor positive results that suggested possible efficacy, as it met 15% of the outcomes the researchers had initially said would prove Paxil’s effectiveness.

While GSK officials privately conceded these results were not sufficient to show efficacy, they decided to publish selective data from the study in a prestigious medical journal to claim the drug worked.

This led to the 2001 JAACAP article, which became known as the “Keller article,” after lead author Dr. Martin Keller, then chair of psychiatry at Brown University. The article reported only partial results from Study 329.

Peer reviewers raised concerns about the study’s data, but JAACAP has refuted repeated calls to retract the article.

Writing today on her blog, journalist Maryanne Demasi, Ph.D., who also spoke at the MAHA roundtable, said Study 329 is “one of the most infamous cases of scientific fraud in modern psychiatry.” She wrote:

“For years, the fraud stood unchallenged. Regulators issued warnings but never forced a correction. The journal refused to retract. The paper remained in circulation — cited hundreds of times, shaping prescribing habits, and legitimising a lie that cost young lives.”

Thacker has been investigating and writing about Study 329 for almost 20 years, as it stands out as one of the “best documented case studies of corruption in modern biomedicine.” He said the study remains relevant because it highlights and underlines how “immoral academics partner with Big Pharma to make money.”

In his 2011 report, Thacker wrote that GSK “used the study as a tool to market Paxil for use on children — until both the FDA and its British counterpart warned doctors to stop prescribing Paxil to children because it could cause them to commit suicide.”

At the time, Kutcher was a candidate for the Canadian parliament, but was not elected. During his campaign, Kutcher threatened a small Canadian newspaper, The Coast, with legal action, demanding the retraction of a story that had investigated Study 329. The Coast retracted the story and issued an apology.

“Study 329 is a shameful example of scientific misconduct that led to a horrible societal catastrophe,” Hooker said.

Study 329 didn’t just distort data, it “normalized fraud as business practice” and “marketed a dangerous drug to children under a false banner of safety and efficacy,” Lyons-Weiler said.

‘Malpractice disguised as scholarship’

GSK didn’t just fund Study 329. It hired a private public relations firm, Scientific Therapeutics Information Inc., to ghostwrite the JAACAP article.

An employee drafted it and sent it to Keller, who was selected to be the lead author and finish the publication process. The firm’s role was not mentioned in the final draft of the paper.

Writing in 2011, Thacker said corporate-funded ghostwriting “involves a pharmaceutical company that hires a PR firm to write medical studies.” The firm then presents the manuscript to academic physicians, who agree to sign on as co-authors, sometimes making only “minor changes” to the article.

“The professors get credit for a publication and the pharma company gets a study that is ‘authored’ by physicians who are leading researchers in their field and appear to be independent,” Thacker wrote.

According to Thacker, “ghostwriting drives up the costs of healthcare, because these studies trick doctors into prescribing drugs that may be more costly, and sometimes less safe,” he wrote.

These practices have existed for years and continue today, Lyons-Weiler said:

“Ghostwriting is the scientific analog of identity theft. A corporation hires a PR firm to script outcomes and then rents the reputation of compliant academics. Those papers enter the permanent record, shape treatment protocols and become the basis for billions in profits.

“Meanwhile, the actual data are inaccessible, the authorship is fiction and the peer reviewers are misled. It is malpractice disguised as scholarship.”

Epidemiologist and public health research scientist M. Nathaniel Mead, Ph.D., who has ghostwritten scientific articles, said the practice can be performed ethically. However:

“Any time you have paid writers or industry insiders crafting articles that get credited to prestigious academics or widely respected ‘experts,’ there’s a risk to both public health and intellectual integrity.

“Many of these articles will disguise corporate agendas as objective or reliable evidence, often inflating claims of drug efficacy and invariably downplaying risks to boost sales.”

An article published in 2000 in the journal Regulatory Toxicology and Pharmacology about the herbicide Roundup concluded that Roundup “does not pose a health risk to humans.”

However, internal corporate emails released in 2017 as part of federal litigation against Roundup manufacturer Monsanto revealed that the paper was ghostwritten by Monsanto employees, who did not reveal their conflict of interest.

The paper has continued to shape public policy. Even after the 2017 revelations, government documents from public health agencies worldwide — including the Centers for Disease Control and Prevention (CDC) and Health New Zealand: Te Whatu Ora — still cite the paper without warnings or caveats.

‘Regulatory capture of epistemology itself’

In today’s report, Thacker wrote that Kutcher, having successfully secured The Coast’s 2011 retraction, has since “morphed himself into … an expert on misinformation.”

Kutcher launched “Science Up First” in 2021 with Canadian law professor Timothy Caulfield, described by Thacker as a “known misinformation crank.” According to Thacker, the “Science Up First” initiative “purported to attack COVID-19 conspiracies, but really served as a cheerleading squad for Big Pharma.”

In a 2023 op-ed, Kutcher wrote that “Speech is free, but lies cost” and suggested that Canadian authorities develop policies to “effectively identify and address health misinformation.”

Thacker told The Defender:

“Bad information abounds, was around in the past, and will be around in the future. Terms like ‘misinformation’ began popping up in recent years to describe information that academics think is bad. But we often find that ‘misinformation’ has turned out to be true.”

Lyons-Weiler said:

“There is a certain poetic cynicism in watching authors of fraudulent studies recast themselves as guardians of truth. The same individuals who distorted evidence for profit now police public speech for ideology. It’s not redemption — it’s regulatory capture of epistemology itself.”

According to Thacker’s 2011 report, mainstream media like the BBC and The Boston Globe, and scientific publications including The BMJ, investigated the fraud linked to Study 329 in the late 2000s. Thacker said that coverage by mainstream news media and scientific publications has since changed.

He added:

“As the media has compressed in size, more and more reporters simply act as mouthpieces for academics. It’s why I call them ‘scicomm,’ for science communication. They don’t do any actual reporting. They just communicate the science as it’s handed to them by academics.”

Scientific, medical journals under government scrutiny

The integrity of scientific and medical journals has increasingly come under scrutiny by the Trump administration, which in July terminated about $20 million in contracts with Springer Nature, which publishes nearly 3,000 journals, including Nature Medicine.

In a May interview, U.S. Health Secretary Robert F. Kennedy Jr. said he may bar government scientists from publishing in such journals and proposed that federal health agencies create in-house alternatives.

Last month, the White House’s MAHA Commission Report revealed that the National Institutes of Health (NIH) will launch a database tracking payments by the health industry to scientists in an effort to identify conflicts of interest.

According to a letter published last year in the Journal of the American Medical Association (JAMA), Big Pharma paid $1.06 billion to reviewers at JAMA, The BMJ, The Lancet and the New England Journal of Medicine between 2020 and 2022.

Hooker said he is “very pleased that the current administration is addressing conflict of interest issues in medical journals.” He said reform “is way overdue and will help to restore scientific curiosity and inquiry where questions that have been taboo may now be openly asked, challenged and explored.”

In the face of heightened scrutiny, some publishers have doubled down on their existing practices. Earlier this month, the New England Journal of Medicine and the Center for Infectious Disease Research and Policy announced they would launch an alternative to the CDC’s Morbidity and Mortality Weekly Report.

Demasi wrote that the lawsuit against the JAACAP “could reshape publishing,” if a court ruling compels the journal to retract the Keller article. Such a ruling “would also expose the deep entanglement between professional societies, journal editors, and the pharmaceutical companies that fund them.”

In an interview last week on “The War Room” with Steve Bannon, Lyons-Weiler said that Kennedy is aware of 28 scientific studies that were “wrongfully retracted.”

“I think that we’re going to probably see some prosecutions on the basis of defrauding the federal government,” Lyons-Weiler told Bannon.

Thacker said such journals survive because of NIH funding that is now at risk. “I understand this is coming,” Thacker said.

Related articles in The Defender

• Journal Faces Lawsuit Over Discredited Study Used by GSK to Market Dangerous Antidepressant to Teens
• Cuts to Scientific Journal Publishing Giant Driven by Cost, Not Content, HHS Says
• Trump Administration Investigating Publisher of COVID Origins Paper for Corruption, Citing Influence by Fauci
• Pharma Paid $1.06 Billion to Reviewers at Top Medical Journals
• Watch: ‘They Want to Scare Us Into Silence’