Study 352 - Paxil & Bipolar Documents Released

Dozens of newly-publicised documents now give the full story of GSK’s ghostwriting campaign for a Paxil (paroxetine) clinical trial report on Study 352.

Charles "Bling Bling" Nemeroff

What is Study 352?

A Double-Blind, Placebo-Controlled, Comparison of Imipramine and Paroxetine in the Treatment of Bipolar Depression. The lead 'author' on the study was Charles B. Nemeroff, a psychiatrist who had close ties to GlaxoSmithKline and other drug companies.

Anyone familiar with GlaxoSmithKline and Paxil will know all about the Paxil 329 study where they [Glaxo] hired a PR firm to draft and, later, persuaded key thought leaders, mainly child psychiatrists to endorse and promote Paxil (paroxetine) at any given opportunity. The 329 study has been dissected by many who are in agreement that it's a piece of fraud. Read more about the Paxil 329 study here.

Not content with one study doing the rounds in various journals and paediatric clinics Glaxo, in their infinite wisdom, hired the services, once again, of a ghostwriting team to pimp out a paroxetine bipolar trial, known as Study 352.

"Study 352" was published in the American Journal of Psychiatry (158:906-912; June 2001) and suggested that Paxil may be beneficial in the treatment of bipolar depression. The study, as mentioned above, cited Charles B. Nemeroff as the lead author. The name Nemeroff is synonymous in the ghostwriting and kickback field. He's made a lucrative living out of speaker fees and pharmaceutical roundtables, although this is classed as 'honoraria' [ex gratia payment]

Glaxo hired the same PR outfit, Scientific Therapeutics Information, [STI] to misrepresent information from Study 352. STI also drafted the original Paxil 329 study, specifically Sally Laden. I've wrote extensively about Laden in the past, see here, here & here.

Just like Study 329, Study 352 also made unsubstantiated efficacy claims and downplayed the adverse event profile of Paxil.

Dr. Karl Rickels

The original 352 study made the following acknowledgement:

This study was conducted with the participation of the following collaborating investigators and sites: Jay D. Amsterdam, M.D. (University of Pennsylvania School of Medicine, Philadelphia)

Amsterdam was asked by Dr. Karl Rickels if he could help out a junior colleague, Laszlo Gyulai, on the study. Rickels had been working on pharmacological treatments for mental health since the 1950's and had previously worked alongside Amsterdam.

Rickels had also previously served in the German army under Rommel. He was captured and brought to America as a POW. After the war he completed medical school and postgraduate training in Germany. When a psychiatric residency position opened at a mental hospital in Iowa, Rickels accepted the opportunity and immigrated to the United States. Later he founded the Mood and Anxiety Disorders Section at the University of Pennsylvania.

Amsterdam, who accepted Rickels offer to work alongside Gyulai, was no stranger to industry sponsored studies. According to Peter Simons, a science writer for Mad in America, "Amsterdam was also on industry panels for over a dozen pharmaceutical companies, giving sponsored talks. It wasn’t until the early 2000s that industry representatives began urging him to deviate from his prepared talks. Once he began to experience pressure to “spin” his results in favor of the drug, he said, “I stopped giving talks.”"

Study 352 Newly-Publicised Documents

According to Los Angeles based attorneys, Baum Hedlund Aristei & Goldman, "Amsterdam was an investigator who treated the largest number of patients in Study 352. However, he was intentionally left off from the review of the data and the drafting of the manuscript because the study sponsor, GSK, and the other “so-called authors” knew Dr. Amsterdam’s professional ethics would not allow him to lend his name to a ghostwritten work, and more importantly, he refused to participate in the alteration and manipulation of data for the sake of marketing Paxil.

"In 2011, Dr. Amsterdam lodged a formal scientific misconduct complaint with the U.S. Department of Health and Human Services’ Office of Research Integrity.

"In the 2011 complaint, Dr. Amsterdam alleged the individuals named above allowed their names to be added to a manuscript that was drafted by a “medical communications company” (STI) hired by SmithKline Beecham (now GSK) and misrepresented information from Study 352, which was funded by GSK and the National Institute of Health (NIH).

"The published 352 article falsely concluded that paroxetine therapy is effective in bipolar depression without any meaningful manic or other side effects. According to Dr. Amsterdam’s complaint, the published results were manipulated and manufactured by GSK and STI employees."

Amsterdam alleged that Guylai, had taken his data from the 352 study in which he had recruited the majority of patients, and that Guylai and a team were about to publish an analysis of the data under their own names. In response, Karl Rickels, chief of the mood disorders section of the UPenn Medical Center, told Amsterdam GlaxoSmithKline (then SmithKline Beecham) was in charge of the study and that the authors hadn't even seen the manuscript (CBS News)

Baum Hedlund Aristei & Goldman has now released new documents pertaining to Amsterdam's complaint which include:

• Sally Laden of Scientific Therapeutics Information Inc. (STI), a consulting firm hired by GSK, was the ghostwriter of a Paxil clinical trial report for Study 352 (and Study 329), which effectively spun negative study results into positive results. GSK paid academics to lend their names to the clinical trial report, published as “Double-Blind, Placebo-Controlled Comparison of Imipramine and Paroxetine in the Treatment of Bipolar Depression” by the American Journal of Psychiatry. GSK wrote and reviewed the report before any of the “official” named authors were contacted for their input. The article has never been retracted despite overwhelming evidence of scientific manipulation.

• An American Journal of Psychiatry editor with financial ties to GSK abetted the alleged fraud by intervening to ensure “Double-Blind, Placebo-Controlled Comparison of Imipramine and Paroxetine in the Treatment of Bipolar Depression” was published after the manuscript was initially rejected.

• The University of Pennsylvania, which employs two of the study’s “official” authors, continues to further stonewall investigation into the malfeasance of its faculty in this matter despite numerous attempts on our part to conduct a thorough investigation. The correspondence letters posted on the Baum Hedlund Aristei & Goldman site between the firm, the U.S. Department of Health and Human Services’ Office of Research Integrity (ORI) and the University of Pennsylvania trace the history of events surrounding the alleged scientific fraud of Study 352. It is unclear whether Penn actually submitted the new evidence to ORI as their responses to Baum Hedlund Aristei & Goldman have been ambiguous. Baum Hedlund Aristei & Goldman believe that had ORI reviewed the evidence contained in the 40 STI documents, rather than having relied upon Penn’s investigation, ORI would have come to the conclusion that the academic consultants involved in the 352 trial committed serious scientific misconduct and would have decided in favor of Dr. Amsterdam’s complaint.

Once such document shows how the PR firm, Scientific Therapeutics Information, [STI] has worked on approximately 100 Paxil related projects for GlaxoSmithKline. Another shows a letter from Sally K. Laden to Cornelius (Neil) Pitts who, in 2001, was the Assistant Director, Clinical Research Development at GlaxoSmithKline. In this particular document we see Laden set out the cost of STIs work on the project. The final invoice for ghostwriting Study 352, according to Laden, was $13,286,81.

This letter from Laden to Nemeroff, the nominated lead 'author' for Study 352, shows how Nemeroff would liaise with GlaxoSmithKline whenever Study 352 was criticised.

If you don't feel sick yet then wait until you read the correspondence between Baum Hedlund Aristei & Goldman and the Office of the General Counsel at the University of Pennsylvania, who, it appears, deny there is any wrong-doing!

"The University recognized that the authors collaborated with professional writers when drafting the paper and the University concluded that such collaboration in 2001 did not constitute research misconduct. "

All new documents can be found here, GSK Paxil Clinical Trials | Court Documents.

Fid Rant

Sally K. Laden

Regular readers already know my thoughts on GlaxoSmithKline, Charles "Bling Bling" Nemeroff and Sally K. Laden. Three subjects whom, I feel and believe, are totally void of empathy when it comes to the safety of patients.

Payments from GlaxoSmithKline to Nemeroff run into millions of dollars, he is, in my opinion, nothing more than a despicable human being who cares only about the size of his bank balance, he, seemingly, cares not a jot about the safety of patients. Money, and lots of it, has blinkered his rational.  Jay D. Amsterdam, on the other hand, saw the light. He saw how money influenced decisions and put patients at risk. He did the right thing by turning his back on the never ending supply of dollar bills that ultimately meant turning something shit into something smelling of roses.

Laden, and her team at STI, should hang their heads in shame. The 352 Study, which she and her team spun from shit to roses, has been cited many times and used as some kind of half-arsed informed consent to prove that Paxil is safe and effective in the treatment of Bipolar, when in actual fact Laden, at least, knew there were problems. Remember, this isn't the first time Laden has turned Glaxo's shit into roses. She and her team have been paid handsomely time and time again. She has never learned from her mistakes and, like Nemeroff, was never able to see passed the Benjamins. For that sole reason, and the fact that she and her STI team continued to work on projects with GSK, I hold her in complete contempt.

If GSK, Nemeroff and Laden are rotten eggs then what of the University of Pennsylvania? After reading their denials of any wrong-doing, I, personally, have to put them in the same boat as the aforementioned. Protecting their prestigious University name seems to be the issue here, once again it's all, seemingly, about the image rather than protecting the safety of patients.

Drug companies have also paid institutions, such as the University of Pennsylvania, in the past. Pfizer's disclosure report for the University of Pennsylvania, for example, shows Pfizer-sponsored research, totaling $1,199,378. Karl Rickels, who remember persuaded Amsterdam to work alongside Gyulai, on the 352 study, was listed as the principal investigator for a research project with a cash payment of $73,791.

Although there is no evidence to suggest Rickels worked with GlaxoSmithKline on Study 352, it does leave me with my jaw on the floor that a former German POW works amongst the field where patient safety should be paramount.

According to his memoirs, Rickels claims he had no choice but to join the German military. This may be true but having bore witness to one catastrophic event, be it after the event or not, he, seemingly stood by and watched another catastrophic event unfold. It was Rickels who told Amsterdam that GlaxoSmithKline was in charge of the study and that "the authors hadn't even seen the manuscript."

For the second time in his life he, seemingly, stood back and said/did nothing.

GlaxoSmithKline, of course, are the main culprit here but as long as individuals and entities such as Laden, Nemeroff, Rickels and departments within the University of Pennsylvania have a desire for money rather than a desire for patient safety, Glaxo and other drug companies will always be able to turn shit into roses.

It's all rather incestuous isn't it.

Bob Fiddaman

The Lancet Publishes Scaremongering 'Study' Amid Covid19 Crisis

Published: April 15, 2020
Multidisciplinary research priorities for the COVID-19 pandemic

The Lancet

I've read it.

It's based around one word.

Here are my thoughts.

What the published authors claim:

We explore the psychological, social, and neuroscientific effects of COVID-19 and set out the immediate priorities and longer-term strategies for mental health science research.

What this blog has found:

Mental health 'scientists' claim:

"As scientists continue to investigate the brains of people who have mental illnesses, they are learning that mental illness is associated with changes in the brain's structure, chemistry, and function and that mental illness does indeed have a biological basis." (1)

This claim has been debunked many times by professionals in the field. See here.

What the published authors claim:

"We urge UK research funding agencies to work with researchers, people with lived experience, and others to establish a high-level coordination group to ensure that these research priorities are addressed, and to allow new ones to be identified over time."

What this blog has found:

Prediction published March 30, 2020 (2 weeks prior to the Lancet paper being published)

It will be claimed that many have detachment-type disorders and new phobias. Mourning the loss of loved ones will continue to be deemed as a mental disorder if that mourning process goes beyond two weeks. Psychiatric 'medication' prescriptions will increase as will cases of autoimmune diseases, ironically caused by some of 'medications' prescribed. (2)

What the published authors claim:

"Discovery, evaluation, and refinement of mechanistically driven interventions to address the psychological, social, and neuroscientific aspects of the pandemic are required."

What this blog has found:

A distinction must be made here between what a psychiatrist does and what a neurologist does.

A psychiatrist claims to focus on and treat symptoms originating in the brain that lead to abnormal voluntary functions, i.e; human behaviours, whereas neurologists focus on and treat symptoms originating in the brain that produce abnormal involuntary functions.

Confused? I was at first until I looked closer.

One treats symptoms that "lead" to abnormal voluntary functions whilst the other treats symptoms that "produce" abnormal involuntary functions.

So, a psychiatrist treats something that isn't fully manifested whereas neurologists treat something that has manifested. They do this by using technology, usually in the form of Computed tomography (CT) or computer-assisted tomography (CAT) scans, magnetic resonance imaging (MRI), electroencephalography (EEG), nerve conduction studies and electromyography (NCS/EMG), and lumbar puncture (LP) for cerebral spinal fluid analysis.

Most psychiatrists use the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) to diagnose mental health disorders. (3)

The DSM is a manual whereby 'mental health diseases' are voted on by panel members. No technology, such as those used by neurologists, are ever used.

What the published authors claim:

"Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, might infect the brain or trigger immune responses that have additional adverse effects on brain function and mental health in patients with COVID-19."

What this blog has found:

The above looks impressive until you read that they had to add one word. If you blink you'll miss it. It's a word often used in the field of psychiatry and basically means one of two things - [1] It does [2] It doesn't. It covers both bases but only ever talks about one of them.

The word in the above sentence you are looking for is "might."

The published Lancet article hinges on this one little word, a word that sees authors push for more funding. It's a bit like you or I going to the bank for a loan and telling the bank manager that we wish to borrow money for an investment that may or may not (might) bear some fruit.

The common theme running throughout the Lancet paper seems evident, to me at least.

Imagine, if you will, the scene from Oliver Twist. You all know the one, right?

'Please Sir, I want some more'
(Lancet references to funding)

Like all good articles in the media do, they start off with the main message and finish reiterating that message. This Lancet publication is no different.

"New funding will be required to meet these priorities, and it can be efficiently leveraged by the UK's world-leading infrastructure."

"Research funders and researchers must deploy resources to understand the psychological, social, and neuroscientific effects of the COVID-19 pandemic."

"We propose a framework for the prioritisation and coordination of essential, policy-relevant psychological, social, and neuroscientific research, to ensure that any investment is efficiently targeted to the crucial mental health science questions as the pandemic unfolds."

"Given the need to develop the research priorities rapidly to inform immediate funding priorities."

(Final paragraph) "New funding will be required to meet these priorities, and it can be efficiently leveraged by the UK's world-leading neuroscience and mental health research infrastructure. The UK must connect with international funders and researchers to support a global response to the mental health and neurological challenges of this pandemic."

If the begging bowl references don't alarm you then the published piece, you'll find, is littered with words and phrases that are designed to scaremonger, more so than the media are doing with reference to Covid19.

It's quite shocking to see some of the tactics used in this paper based on something that may or may not ever happen (might)

Here's just a small example of scare tactics used by the authors:

"The need to maintain high-quality research standards is imperative."

"An immediate priority."

"There is an urgent need."

"Must deploy resources."

"The research community must act rapidly."

"Growing threats to mental health."

"Clear immediate priorities."

"Need to be repeated more rigorously."

"A risk that prevalence of clinically relevant numbers of people with anxiety, depression, and engaging in harmful behaviours (such as suicide and self-harm) will increase."

"The potential fallout of an economic downturn on mental health is likely to be profound."

"A major adverse consequence of the COVID-19 pandemic is likely to be increased social isolation and loneliness (as reflected in our surveys), which are strongly associated with anxiety, depression, self-harm, and suicide attempts across the lifespan."

"The immediate research priorities are to monitor and report rates of anxiety, depression, self-harm, suicide, and other mental health issues both to understand mechanisms and crucially to inform interventions."

"Data will be vital to determine causal mechanisms associated with poor mental health."

"The digital response is crucial."

"Paramount importance."

Now, if you, like me, have received criticism on Twitter from members of the Royal College of Psychiatrists for raising awareness about the "interventions" they speak of in this Lancet paper, you'll understand why I'm bringing all of the above to the attention of my readers.

This paper is designed to grab funding. Unlike poor young Oliver Twist, they haven't even said, "please."

The covid crisis has been an eye-opener for someone like me. I am fascinated by people-watching. I tend to watch a lot before engaging, I like to weigh up a person. There have been many media reports of people cashing-in during this crisis, you know, local shopkeepers hiking the prices of toilet paper and hand sanitizer. Many people who are ignoring government guidelines are also in the news.

What I've seen from the mental health field is no better than those selfish idiots and greedy shopkeepers as they push their agendas that covid can cause mental health problems. Nope, it will just cause behavioural problems as people adjust to their new normal. It's not a brain disorder nor will it manifest into one. Mental Health big-wigs have seized this opportunity with both hands, hence the need for them to create a problem that isn't there and then try to convince people that it may happen and to tackle it they need funding.

Oliver only wanted more porridge because he was hungry. Mental Health, it appears, want more, much more, to feed their egotistical appetites.

Hey, don't get me wrong, I'm all for sticking someone under a scanner to determine if their brain is or isn't working properly, I just don't think one can determine a brain default by box-checking a guide that was voted on by a bunch of white-coated men who "might" have just been influenced by drug company money.

Multidisciplinary research priorities for the COVID-19 pandemic: a call for action for mental health science can be read here.

Only one of the authors (panel members), Prof Clive Ballard, PhD, reports grants and personal fees ~  from Acadia and Lundbeck; personal fees from Roche, Otsuka, Biogen, Eli Lilly, Novo Nordisk, AARP, and Exciva; and grants from Synexus

Bob Fiddaman

(1) NIH Curriculum Supplement Series 2007

(2) Mother Nature (Mother Earth) and the Invaluable Lesson

(3) How to Diagnose a Mental Health Disorder

Common International Collaborative Platforms Needed for Covid Research

Following on from "Your Drugs May Pose A Greater Risk Than Your Covid" comes another important video. This interview, as with the first, is part of the #COVID19Chronicles.

Journalist, Frank Barat, and  Dr. Joan-Ramon Laporte discuss Hydroxychloroquine, the anti-malarial drug made popular recently by President Donald Trump, clinical trials, and polypharmacy (the simultaneous use of multiple drugs by a single patient, for one or more conditions.)

I've extracted some of the comments from Dr. Joan-Ramon Laporte, these are not verbatim due to time constraints on my part.

The video is worth sharing, so please share across social media platforms and to anyone you know currently working at hospitals etc.

Here are some of the comments by Dr Laporte.

According to the product characteristic label, Ibuprofen can worsen infections or mask infections.

Hydroxychloroquine (anti-malarial) has been mostly used for autoimmune diseases, which have nothing to do with viruses. It has some anti-viral action in the laboratory, in-vitro (taking place in a test tube, culture dish, or elsewhere outside a living organism)

50 clinical trials have recently been started with hydroxychloroquine, none of the researchers or pharmaceutical companies wish to share their information with other researchers or other pharmaceutical companies. The sacred cows of clinical research are still there.

The hydroxychloroquine 'experiment' in Marseille, France, was not a clinical trial as it had no comparators (no placebo group) One or two patients died but were excluded from the analysis.

The World Health Organisation (WHO) need common international collaborative platforms for clinical research.

WHO need to identify all the other drugs we are taking for other indications, like antidepressants, antipsychotics, analgesics, opiates, to see to which extent these drugs can affect your probability of getting the disease (Covid19)

In many countries many old people, who are those most vulnerable to the disease (Covid19) are taking many drugs, for example, in the UK 30% older than 65 are taking 10 or more drugs every day. This is a very dangerous cocktail, not only because these drugs can interact with one another, but also because many of these drugs increase the risk of getting pneumonia. Once a person gets the disease (Covid19) they can develop a more severe form of it depending on the drugs they are taking at the time. The fewer drugs you take, the less your probabilities of getting Covid19, this is important, particularly for elderly people.

If you have a fever and the fever is not bothering you, let the fever be because fever is a defence mechanism of our body, it's not something bad.

Bob Fiddaman

"Your Drugs May Pose A Greater Risk Than Your Covid"

Fresh off the press. Such an important video. This interview is part of the #COVID19Chronicles.

Please share far and wide. We owe it to ourselves and our loved ones.

This video struck a chord with me as I posed the following question on Twitter last week, a question that we should, I feel, all be asking.

The video, below, is an interview between journalist, Frank Barat, and Dr David Healy.

Healy's words resonate and make you wonder if this is another reason why the coronavirus fatalities in the elderly are high. Maybe this is something scientists need to be looking into as it may give them insight as to why certain people get severe cases of the Covid19 virus compared to others.

Polypharmacy 
Polypharmacy is the concurrent use of multiple medications by a patient. Polypharmacy is most common in the elderly, affecting about 40% of older adults living in their own homes. ... Definitions have ranged from two medications at a time to 18, or to more medications than clinically necessary.

"A lot of these drugs, from antidepressants to pain killers to all sorts of other drugs, may compromise our immune system to make us more vulnerable to catching Covid and the other thing they can do is they can compromise the body's ability to fight back if we get Covid making us more likely to get pneumonia. When you look at the people who seem to be dying it's older people and particularly people who are in residential homes who are on a whole lot of drugs, sometimes it seems just to keep them quiet rather than treat an illness." ~ Dr David Healy, psychiatrist, psychopharmacologist, scientist, and author

Bob Fiddaman

Medications compromising Covid Infections

Zantac (Ranitidine): The Heartburn Carcinogen

Earlier this week the US Food and Drug Administration (FDA) requested that manufacturers pull all prescription and over-the-counter ranitidine drugs, known by the brand name Zantac, from the market immediately. Zantac was given US approval in the early 1980s.

The FDA has determined that levels of  N-nitrosodimethylamine (NDMA) in the heartburn medications increase over time and when stored at higher-than-normal temperatures, pose a risk to public health.

According to the FDA's announcement, letters are now being sent to all manufacturers of ranitidine requesting that they withdraw products from the market, and consumers are advised to stop taking any ranitidine tablets or liquid medications they currently have. As a result of this immediate market withdrawal request, writes the FDA, ranitidine products will not be available for new or existing prescriptions or over-the-counter (OTC) use in the U.S.

Sanofi, one of the companies that produces the Zantac brand, stopped doing so in October. It said in a statement that “We take this issue seriously and continue to work closely with the F.D.A. to evaluate any potential safety risks associated with Zantac.”

Ranitidine was launched in the UK in 1995 as an OTC product. At the time the recommended dosage of the product was one tablet, although if symptoms persisted for more than one hour another tablet could be taken. Consumers were told, "the maximum recommended daily dose is four tablets."

The British drug regulator, the MHRA, is not following in the footsteps of their American counterparts. In October last year, they stated, "the health risk of discontinuing the medicine is higher than the potential risk presented by the contaminant N-nitrosodimethylamine."

Los Angeles trial lawyers, Baum Hedlund Aristei & Goldman, PC, who are in the process of filing lawsuits, state on their website, "Mounting evidence allegedly shows that Sanofi and Boehringer Ingelheim, the big pharma companies that make Zantac (ranitidine hydrochloride), concealed the Zantac cancer link from millions of people who took the drug for heartburn, gastric and duodenal ulcers, gastroesophageal reflux disease (GERD), sour stomach, Barrett’s esophagus, acid reflux, and other issues. This deception came as the companies made unprecedented profits from Zantac, the first drug to generate $1 billion in sales."

Baum, Hedlund, Aristei & Goldman attorney R. Brent Wisner discusses the latest revelations surrounding the popular drug Zantac (ranitidine). How did the FDA find out about the link between Zantac and cancer? What do Zantac and rocket fuel have in common? Is Zantac causing a cancer epidemic? Wisner answers your Zantac questions in this short video.

If you, or anyone you know, developed cancer after taking Zantac please contact Baum Hedlund here.


Bob Fiddaman