The Life Of Piacentile: American Doctor (Dr Joe Piacentile’s) Lucrative ‘Whistle Blowing Career’


“…Piacentile is what you might call a professional whistleblower. According to his lawyer, David Stone of the Short Hills, New Jersey, office of Boies, Schiller & Flexner, Piacentile used to be one of the doctors courted with lavish attention by drug companies. Then he stopped going to the fancy parties and started filing False Claims Act suits based on what he’d seen and learned. Not all of his cases have been as spectacularly successful as those against Medco, Bristol-Myers, and Cephalon, but with one-third of the government’s recovery going to whistle-blowers in successful cases, Piacentile doesn’t need to win ’em all…”

“Piacentile is a “serial filer” of whistle-blower complaints, having lodged at least 13 such cases against various companies in federal courts, prosecutors said in documents filed in November seeking to dismiss the case”…

American culture seems to be all about money worship, and although we live in an extremely materialistic world generally and greed is rampant globally,  no place on the planet does greed quite like the Americans.

When I read articles about GSK’s 3 Billion dollar fine, or about people like Joe Piacentile, the articles  invariably mention money in amounts of millions, and (in the case of GSK) often billions too. These amounts of money are unfathomably alien to me. I don’t come in contact with figures containing multiple zeros. Two or three figure sums are a big deal to me; a four figure sum is a lot to me. I just can’t imagine dealing with seven or eight figure sums. I don’t even think I’d be comfortable being rich anyhow. There is too much inequality in this world, and I can’t bear inequality, it’s inequality, and the hoarding of wealth by the few which has the planet in the state its in. The hoarding of wealth and accumulation of stuff, just adds to the landfills. It’s all just more waste, more damage to the environment.

Furthermore, I certainly wouldn’t want to be driven or blinded by money  and thankfully it’s just never been a main motivator for me. I’ve seen people ruined by money, and destroyed by greed; some of them were members of my own family. There is much humility in knowing that greed will never consume you.

Greed consumes the soul.

Money seems to taint almost everyone who comes under its spell. It seems to be human nature for some, to always want more and more.

For some people, enough is never enough.

Dr Joe Piacentile, is (what some journalists have called) a ‘professional whistle blower’.  It is estimated that Piacentile has collected up to 17 million, or more, from his various whistle blowing adventures against pharmaceutical companies over the years.

I can understand one individual blowing the whistle against one pharmaceutical company because perhaps they saw some underhanded, illegal or unethical behaviour, and they decided to report it, but how can one person be involved in several different claims against several different companies at different times in their life?

Is this just cynical opportunism?

Interestingly, on Piacentile’s own web-site (‘Whistle-blowers Against Fraud’), he seems to semi-admit, that it was his company’s own foray into medicaid fraud (‘falsifying medicaid forms’) which first opened the good doctor’s eyes into the mechanics of how the justice system investigates these types of crimes. This, it seems, led Percentile, to the epiphany that there was considerably more money to be made in blowing the lid on fraud then there was in committing it, and 23 years later, Piancentile is now a multi-millionaire from his long and lucrative whistle blowing career.

The American dream, is paved with stories like this isn’t it? In America the harder your neck,  and the more dog eat dog you are, the more you are rewarded- it seems..

From the blurb on his own site (Piacentile foundation), Joe tells us:

“...Joseph Piacentile, M.D., who goes simply by “Dr. Joe,” is the Founder and CEO of Whistleblowers Against Fraud (“WAF”). Dr. Joe has dedicated more than 23 years of his professional career to seeking justice against those who commit fraud against the U.S. government. Dr. Joe has assisted the U.S. government in recovering more than $9 billion. Fighting fraud alongside those whistleblowers courageous enough to step forward and pursue justice is Dr. Joe’s passion.

“…In the mid-1980s, Dr. Joe was a partner in a national durable medical equipment company. In charge of a sales force of 160 employees, Dr. Joe grew sales from $1 million to $20 million in a mere three years. However, this early success did not end well. Dr. Joe and his partners each pled guilty to one count of fraud for reportedly “falsifying Medicare forms.” This brush with the justice system opened Dr. Joe’s eyes to the real damages caused by fraud and gave him a front row seat in observing the inner workings of the justice system’s prosecution of such crimes.”…

A recent article from NBC News reports that Dr Joe (as he likes to be called) attempted to donate $100,000 dollars to President Obama, in the hope that he could swing a ‘presidential pardon’ for his conviction in 1991 for medicaid fraud and tax evasion-

Obama’s fundraisers returned the check and NBC Reported that:

“…In December, Picacentile filed an application with the Justice Department seeking a pardon from Obama in which he expressed remorse over his 1991 felony convictions…”

“The bottom line is that I was the president of a corrupt company that ripped off Medicare for millions of dollars,” he wrote in the application, a copy of which was obtained for NBC News…”

 “… On Feb. 6, with the pardon application pending, Piacentile wrote a $100,000 check to Organizing for Action. The emails obtained by NBC News show that Piacentile’s check was written in response to an OFA fundraising appeal for the dinner and reception with Obama…”

“It is $25,000 per person to attend and for those that raise or write $100K, there will be small clutch with the president,” Maltzman wrote in a Jan. 15 email to another New Jersey doctor and potential donor, Munr Kazmir, who was an acquaintance of Piacentile and invited him to be his guest at the dinner…”

Not content with his 23 years of ‘professional whistle blowing, Dr Joe now offers advice to other potential whistleblowers, through his consultancy role. How much income Dr Joe receives from his ‘whistleblowers against fraud’ enterprise is anyone’s guess, however it seems that Dr Joe also has a somewhat charitable side to him (according to his website anyhow), and apparently he also has a keen interest in ‘social justice’ too.

“…But there is a darker perspective on Joseph Piacentile. Unlike most qui tam relators, he doesn’t blow the whistle as an employee or business partner of the companies he has sued. Instead he relies on secondhand information collected through his own investigations. (Piacentile declined to comment for this article.) Defense counsel call him a professional mudslinger; some qui tam lawyers and former government lawyers say that he’s a parasitic bully who files vague or questionable complaints and then pushes his way into settlements based on his qui tam savvy and his willingness to litigate. And Piacentile has a criminal history of his owna 1991 conviction on fraud and tax charges–which some lawyers say can undercut his credibility as a plaintiff”..

It seems to me that Piacentile is perhaps more interested in his cut from the many cases he has been involved in, then genuinely trying to expose the misdeeds of pharmaceutical companies. I have not seen any articles, websites, or videos of Piacentile, talking about how the fraudulent behaviour of pharmaceutical companies harms patients. I have not seen him asking for the jailing of CEO’s. I have not seen him campaign for patients’ rights, or the rights of those harmed by dangerous drugs like Paxil/Seroxat. Surely, some of this 17 million he received from his various whistle blower suits, could have been spent on exposing the dangers patients face when dealing with these sociopathic drug companies? He is, after all, supposedly a Doctor? If Piacentile was genuinely interested in exposing the dirty tricks of drug companies, and protecting patients from harm, then perhaps he would have invested more time, and money, into activism?

Just a thought..

I understand that some might argue, that people like Dr Joe, are doing a public service, and it is true, blowing the whistle on corruption, is beneficial in societal terms. However in these types of cases, the victims of pharmaceutical crimes do not get a cent from these fines. The government gets its cut, as do the lawyers, and the whistle blowers get theirs- of course. Victims of the crimes get nothing. Some whistle blowers only need to repeat what the first whistle blower said in an FCA complaint and they can get a claim to millions. Some just have to literally sit back, and wait for the cash to come. Personally,  I think this type of whistle blowing is based on greed more than anything else.

Even after a whistle is blown on a drug company’s corrupt practices, it’s often too late for those who have already been harmed. Furthermore, by the time the whistle blower’s claim comes to fruition (some can take a decade), the drug companies usually have continued their corrupt practices up until the case is unsealed. It’s only after they are fined, and they strike a deal with the DOJ, that the company, agrees to stop its unethical practices, and the profits are already made. Therefore, we could ask, who does whistle blowing benefit ultimately? and does the monetary incentive to a potential whistle blower    to expose dangerous and fraudulent practices, make any difference to patient safety in the longer term?

Personally, I don’t believe it does.

As I said, the damage is often already done.

We are not any safer despite these many fines for the pharmaceutical industry. The industry factors in the inevitable fines into their business plans. GSK, for example, paid their DOJ fine with cash already hoarded. The DOJ case made no impact upon their business, and it’s arguable whether it has impacted upon their corporate behaviour either. These settlements give us an illusion of justice which suits the governments and the pharmaceutical companies. It is not a deterrent, it could be doing quite the opposite in fact, because, the companies know the score now, they know what they can get away with. They’ve been given a paradigm to work with. These companies operate above the law, and their high ranking executives do not get punished.

Why are people like Piacentile not drawing attention to this scam and sham pseudo-justice?

GSK were fined 3 Billion dollars in 2012 by the US Department of Justice, for what was effectively, a literal global sociopathic scam fest; involving, mainly, the off label prescribing of many GSK products, spanning over a decade. In the case of one of the GSK drugs, Paxil (Seroxat), GSK promoted this drug to under-18’s despite information from its own trials into the drug revealing that it could be immensely harmful. GSK’s 3 Billion fine has done nothing to raise awareness of the dangers of Paxil.

In fact, the Paxil aspect was played down considerably in The department of Justice complaint (why?). The media, and the DOJ spun this 3 billion slap on the wrist, as if it was actual justice. It wasn’t. It was far from it. This was a token to GSK, it was a gift from Eric Holder. No justice was served. Patients died, and many continue to die from drugs like Paxil, it’s still being prescribed (and Avandia is too). The 3 billion fine, was a sick joke for patients prescribed these dodgy GSK drugs. The Paxil part of the DOJ complaint was an absolute joke.. in fact it was an insult to all those who were harmed.

As far as I am aware, Dr Joe Piacentile was also involved in some capacity in bringing later claims (jumping on board) the original DOJ complaint against GSK. It always seemed odd to me that, whistle blowers, Thomas Gerahty and Matthew Burke, came into the DOJ complaint years after it was first filed by Greg Thorpe. We don’t hear anything about these two individuals, or what they brought to the table, in regards exposing GSK’s corrupt practices at the time that they joined the complaint years later. I suppose this kind of thing frustrates me, because people like Dr Joe, and these two whistle blowers- Burke and Gerahty, they could be driving real change, saving lives, speaking out on national TV, but they choose, to just take the money and go silent. Meanwhile, bloggers like me, we’re left to do all the work, bringing awareness, with no resources. Anyhow, I’m not complaining, I’m satisfied with the work I’ve done, I did it for myself, and to warn others, so that they could be spared Seroxat/Paxil hell- and I achieved what I set out to do.

If anyone has made a difference in regards to bringing awareness to the Paxil/Seroxat scandal it is firstly the BBC Panorama team (in particular Shelley Jofre), and subsequently, bloggers such as Bob Fiddaman, Seroxat Secrets, and my own blog. Between us bloggers alone, we have thousands of blog posts and clocked immeasurable hours of campaigning for social justice, and patients rights, for over a decade. We have consistently blown the whistle on man topics, over many years, and we have tirelessly campaigned for victims of these drugs- not for monetary gain, but because we believe- as survivors of Paxil/Seroxat- we have a duty to warn others of the dangers of these drugs.

I don’t see much social justice campaigning about companies like GSK, or dangerous drugs like Seroxat/Paxil from any of these so called ‘professional whistleblowers’.

Why do they not speak out?

If Dr Joe is reading this, and I have got anything wrong (or perhaps I am off base with my perspective) please feel free to mail me on

Perhaps you can enlighten me to all the activism or causes you have supported -for patients rights to safe drugs- that you have done over the years?  or perhaps you have set up withdrawal clinics in the US for Paxil addicts to come off the poison in a safe, supportive environment? Or maybe you have campaigned behind the scenes for real justice for the survivors of  pharmaceutical crimes? There could be a lot I’m missing here, If so, I will gladly amend this post..

I won’t hold my breath though…

I have received threats through my mail before from certain people (and I don’t respond to threats, in fact- i ignore them- so   people really are wasting their time when they try that) but it’s rare to receive encouragement or support, this leads me to believe that for most whistle blowers, the monetary gain is the prime motivation the rest is mere cynical tokenism.

It seems to me that unless you were the first the blow the whistle, in a cases such as these, then you’re probably  just riding the gravy train…

It takes balls to be the first to blow the whistle..  because the first one is the first to take the risk… it takes courage to be the first.. the ones who follow are merely jumping on board.

They obviously see the dollar signs..

Thankfully, I have received occasional support from genuine people over these years of blogging and creating awareness- support from people who matter: mostly victims of GSK’s drugs, people who can’t get off Seroxat, or those who have lost loved ones to the drug, and some other good people who have sincere intentions.

And it’s these folks, who ultimately, I blog for..

There is an old saying that says, “how much would you be worth if they took away all your money?”

I might not have much in the bank but my soul is invaluable to me..

If my soul is my bank account, then it’s really very full indeed..

Fiddaman Blog: GSK: Motions Denied in Paxil Suicide Case

Saturday, November 21, 2015

GSK: Motions Denied in Paxil Suicide Case

Earlier this year I reported on how GSK, via their team of highly-paid lawyers, had targeted four expert witnesses that were due to give evidence in (Dolin v. SmithKline Beecham Corp. et al., case number 1:12-cv-06403)

For those that don’t know, Wendy Dolin had filed suit against GSK claiming that their antidepressant, Paxil, had induced the suicide of her husband, Stewart. Since filing, Wendy has, just like the four expert witnesses due to give expert opinion supporting her claim, has come under fire from GSK. In fact, Wendy Dolin has been sent more than 30 subpoenas from GSK, they have also made over 70 record requests and have shown the Dolin children their father’s private medical notes. To top it all, GSK’s lawyers have been asking (goading) Wendy about her love life since her husband killed himself.

Not satisfied with targeting a bereaved wife, GSK then turned their attention to four expert witnesses. One of those witnesses, Dr. David Healy, came under heavy fire from Glaxo’s gunslingers, King & Spalding. They had accused Healy of being a radical activist who held an extreme bias against GSK (insert tears here). Furthermore, GSK had probed into Healy’s private life and had, during a 10 hour deposition, talked more about his finances than the actual science behind Paxil and induced suicide.

The decision is in folks and…. (drum roll)..

GSK have been roundly trounced.

Judge James B. Zagel, in summary, said…

“I am denying all four of GSK’s motions to exclude. The Daubert criteria are satisfied when a well-credentialed expert provides well-supported opinions that are relevant and reliable. My decision does not, however, mean that the reliable opinions of all four of these expert witnesses are correct—reliability is a measure of consistency of opinions, not necessarily a measure of correctness. Such a determination will be the job of a fact-finder at trial.”

Healy, along with three other experts, namely; Dr. David Ross, Dr. Joseph Glenmullen, and Dr. Roger Grimson, will now be allowed to offer their expert opinions in the Dolin case, something that GSK have fought desperately hard to suppress and, as I suspect, may now be the factor in some sort of settlement being agreed upon.

This isn’t the first time GSK have faced claims that Paxil induces suicides in adults. In 2001 a jury returned a verdict that Paxil was responsible for inducing homicide and suicide in Don Schell, who had, some years previous, shot to death his wife, daughter and granddaughter before turning the gun on himself.

Glaxo were ordered to pay $6.4 million to the remaining family members.To the layman, it beggars belief why Glaxo would oppose the claims of Wendy Dolin given that they have already lost one Paxil induced suicide case. The mud-slinging and goading of plaintiff and expert witnesses doesn’t surprise me in the least, it’s what I have come to expect of Glaxo and their defence lawyers. Wendy Dolin isn’t the first plaintiff to have pressure put on her by Glaxo, she won’t be the last. Healy et al aren’t the first expert witnesses to have mud thrown at them, again, they won’t be the last.

If anything, this ruling has shown Glaxo that no matter how hard they try to suppress those who wish to seek the truth, they will always fail.

I hope the Dolin case goes the whole hog and isn’t settled. To put Paxil in the public eye (yet again) is something that needs to be done. The message that this antidepressant can cause homicidal and suicidal acts needs to be repeated. It is, in my opinion, a menace to society just as, I believe, GlaxoSmithKline are. Yeh, okay, we will have those that say Glaxo have saved millions of lives with vaccines and have helped millions of people with various respiratory diseases, fair enough, I guess, but that does not give them the right to market and manufacture drugs that can induce homicide and suicide – it’s akin to the defence of a serial killer, ‘He donated to charities every week your honour, so what if he killed a dozen or so adults, he’s a decent man, at heart.”

Glaxo need to step up to the plate. They need to compensate Wendy Dolin for her loss, they need to stop pussy-footing around and acknowledge that defending Paxil in suicide cases is a fruitless exercise, they know it, their shareholders know it and the general public know it. Paxil is a nasty drug that causes more harm than good. Glaxo claim Paxil has helped millions of people worldwide but just like the fictitious serial killer above, they throw a blanket over the darker side of Paxil, the induced homicide and suicide, the birth defects, the horrific withdrawal suffered by those trying to stop Paxil.

It will be interesting to see what Glaxo’s next step is regarding the Dolin case. They’ve thrown pretty much everything at the grieving widow but she has stood firm and remained strong because she knows that the truth will, eventually, out.

Bob Fiddaman

Seroxat: GSK’s ‘Thalidomide Moment’?….

I have long been calling the Seroxat scandal ‘the mental health thalidomide’… I even sub-headed this blog with ‘Seroxat the mental health thalidomide’, when I set it up 9 years ago…

In the following article, by academic Redmond O’ Hanlon, Redmond discusses the implications of GSK’s notorious Seroxat Study 329..

Redmond calls this ‘Psychiatry’s Thalidomide Moment’

I think it was GSK’s thalidomide moment..

Psychiatry has had its thalidomide moment regularly since its inception..

The scale of harm which psychiatry has caused for over a century now is colossal..

Seroxat caused death and destruction on a much larger scale than Thalidomide, and GSK’s 3 Billion dollar Fine (see whistleblower Greg Thorpe’s complaint to the Dept of Justice here) lists endless pages of harm to consumers from several drugs over decades..

GSK have their thalidomide moment regularly too, at least once a year it seems.. Myodil, Seroxat, Avandia, Pandemrix, Wellbutrin…

..they really do live up to their nick-name of ‘Global Serial Killers’..

Study 329: Psychiatry’s Thalidomide Moment, Part 2

Nobody has retracted or apologized for a study that was an academic disgrace—but a marketing coup for GSK—which may well have caused untold numbers of deaths, suicide attempts and irreversible anguish to myriad families. Can we stand idly by when we’re told that it “accurately reflects the honestly-held views of the clinical investigator authors who do not agree that the article is false, fraudulent or misleading.”? What is the current market value of the honestly-held views of people who tell lies?

I’d like to reflect on a few major aspects of Study 329 and the recent BMJ restoration study (RS) which raise fundamental ethical issues, and which pose some theoretical problems or raise other important issues which haven’t yet been scrutinized. And, by counterpointing Paxil against Thalidomide, I shall suggest that a seismic cultural shift has made studies like Keller’s almost inevitable.

1. Ethics and Academic Integrity

Study 329 forces us to confront the ethical question once again, before it’s too late, and question the claim that the investigators were chosen only for their expertise, their interest in the subject and their capacity to recruit volunteers.  Might they not have been in the pay of GSK, or have been friends, ex-students or colleagues of people like Biederman, Keller, Krystal or Nemeroff? Or chosen for their commitment to drug solutions, regardless of awkward research findings, in line with the FDA which wrote at the time that there may be negative findings even in trials of drugs they know really work? Even at the initial stages, then, there was plenty of room for manoeuvre, allowing GSK and its (paid?) investigators to take advantage of a fuzzy diagnostic category, to cherry-pick the subjects most likely to produce favourable outcomes and to discount the gravity or relative severity of an adverse event if it suited their purposes.

The sociopathic lack of remorse and moral consciousness shown by GSK, Keller, et al., became most shockingly apparent early on, in GSK’s serial re-writing and occlusion of troubling data — designed to stop negative results leaking out to doctors, the public or their sales staff. In fact, a GSK internal memo showed that the company knew that their studies had failed to demonstrate efficacy since at least 1998; and in 2003 the MHRA revealed that GSK’s own studies showed that the drug actually trebles the risk of suicidal thoughts and behaviour in depressed children. Outside the Holocaust, I’ve never come across a more chilling, amoral or sociopathic memo than the one they sent out to senior management, clarifying their decision “to effectively manage the dissemination of these data in order to minimize any potential negative commercial impact…It would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine.”  In the same cynical vein, an email from a PR executive working for GSK said: “Originally we had planned to do extensive media relations surrounding this study until we actually viewed the results. Essentially the study did not really show it was effective in treating adolescent depression, which is not something we want to publicize.”

An important ethical barometer is the prevalence of authors’ conflicts of interest (COIs), though it is really a wider, cultural, problem, for a large majority of medical and science journals in the world have no COI policy. While we weren’t told about the authors’ COIs here, we now know those of Keller, Ryan, and of GSK employee Mc. Cafferty, whose affiliation was hidden. We know, for example, that Shelley Jofre sent emails to Dr. Ryan in 2002 asking questions about the safety of Paxil, whereupon this “independent” researcher forwarded them to GSK, asking for advice on how to respond to her! We know also, thanks to Peter Doshi, the extent to which Karen Wagner was beholden to BP. I have since followed up her case: it beggars belief.  Hunting down the COI hare of the other “authors” could bring to light some very damning evidence indeed.

The prevalence of ghostwriting is another disturbing example of ethical indifference: David Healy, who has monitored this phenomenon rigorously for years, estimates that up to 50% of apparently serious academic psychiatric studies are ghostwritten. Could this be a devious way of getting around the ban on off-label promotion?

The rampant, unethical ubiquity of ghost writing has sullied the reputation of numerous academics and their institutions in the U.S. Hannah Arendt’s reflection is apposite here: “When all are guilty, no one is; confessions of collective guilt are the best possible safeguard against the discovery of culprits, and the very magnitude of the crime the best excuse for doing nothing.” Here, however, we have no confession of collective guilt; not surprising, since guilt implies a minimal moral conscience, which was so rare here and among Chemie-Grünenthal’s (C-G) top brass in the thalidomide tragedy, some of whom had seen active service in the camps, and most of whom had impeccable Nazi credentials. This brings to mind those studies some years ago showing that a large proportion of industry CEOs could be classified as sociopaths: another indicator of a huge cultural shift. Are we now simply facing the inevitable consequences of rampant neo-liberal economics?

We could of course argue that this entire affair could be reduced to just one issue: is there any justification for ghost-written academic studies, especially when they have serious safety implications? If it is deemed to be professionally acceptable, then the “authors” of Study 329 have committed no sin at all: it’s just par for the course. After all, PLoS Medicine, which has been leading the charge against ghostwriting, found that only 13 of the top 50 medical schools in the U.S. have a policy that prohibits it.

At a 2011 U. Toronto conference on ghostwriting, Trudo Lemmens, a law professor, said that biomedical ghostwriting is a public health issue needing serious attention, since erroneous use of pharmaceuticals is a leading cause of hospitalization. Many studies, like Keller’s, contribute to that by hiding adverse events, negative data, and over-emphasizing benefits, so academics fronting such studies are responsible for any ensuing prescriptions and harms. Yet there seems to be no backing in law for those wanting to hold academics legally and professionally accountable: ghostwriting is perfectly legal, widely practiced yet officially considered unethical, so universities are nicely protected when they routinely protect shady researchers, who bring them prestige and large research grants. McGill, though, showed commendable rigour and oversight in the Sherwin/Wyeth case.

Doshi and Healy have no doubt that Study 329 was ghostwritten, but I’m not yet absolutely sure about this, though the circumstantial evidence is overwhelming. Keller’s recent letter defending his study and criticizing the RS does indicate that the “authors” were centrally involved at all stages of the study. Could they be forced to take an oath on this, as was Sally Laden? I’m still very unclear about which authors knew what, if anything: the much- compromised JAMA tried, unsuccessfully, to find this out when first offered the article. Keller’s slippery filmed statements and his facial language made me very suspicious indeed, as he repeatedly dodged interviewers with statements like: “I don’t remember matters like this…I never read such tables.”

However, let’s now suppose it wasn’t ghost written, then Keller has painted himself into an inescapable corner, since the only excuse he could proffer for producing scholarly work that drew conclusions contradicting the raw data was that it was, in fact, ghost written. Either that or they produced scholarship that would not have been accepted from an undergraduate, but was accepted by the editor of a prestigious journal who brushed aside THE JOURNAL’S OWN REVIEWERS’ DEEP RESERVATIONS about the study.  Why?

2. Pseudo-science, Lies, Damn Lies, and Statistics

Another ethical casualty of Study 329 was peer review, a protocol designed to guarantee the integrity, independence and rigour of published scholarship: JAMA followed the protocol strictly, and rejected the study, but JAACAP did not. How did it get away with so few official criticisms or sanctions? The story behind the editor’s ultimate acceptance of it could prove very incriminating, and throw up even more serious questions about academe’s failure to uphold minimal standards by publishing a labyrinth of lies, half-truths and lies by omission. The intellectual dishonesty displayed here by members of a prestigious Ivy League university is a bloody blot on the escutcheon of American academic integrity. Standards like this in very high places should not be tolerated by any academic community worth its salt.

The RS also highlighted an area which is rarely discussed: statistical analysis. We have become hung up on whether the results of a trial had statistical or clinical significance, but this study reminds us of the value of patient narratives, “merely anecdotal” reports and descriptive statistics, as did the thalidomide tragedy. Here, the commitment to descriptive statistics was abandoned, probably because they might have allowed non-specialists to make judgments and informed decisions, whereas more sophisticated techniques offered a smokescreen to hide behind for years, thus allowing billions to accrue. How many of us are sufficiently qualified to evaluate what the statisticians tell us, and how they tell it?  Unsurprisingly, GSK told us that they employed the best ones here: this may well have been the only true statement they uttered. It was in their interest to hire the top people, pay them a fortune and make it clear that, without making fools of themselves professionally, they should choose designs, protocols and methods of analysis likely to give the required positive results.

Jureidini’s team forces us to radically critique another untouchable: RCTs, whose status, integrity and even utility must now be thrown into question. Following Breggin, Cohen, Doshi, Harrow, Healy, Kirsch, Moncrieff, Timimi, Whitaker et al., we RCT sceptics now have much more precise ammunition to fight with. In their wake, can we continue to have faith in any previous RCTs and meta-analyses when so many negative trial results are never published and when fundamentals like blinding and adherence to protocols are so flagrantly flouted? Is this just the tip of a very large, murky and treacherous iceberg? After all, Study 329 was published in a top journal, yet deviated from the original protocols, added several new outcome measures, sometimes after un-blinding, and drew conclusions directly at odds with their own findings. In particular, I am deeply suspicious about its level of sustained adherence to blinding protocols.

Over the years, we have had many scandalous instances of unethical manipulation which allowed BP an easy ride. Keller et al. gave us an egregious example of this when they disbanded reliance on Hamilton, but never registered the change, blithely declaring that since the profession had moved beyond Ham-D between 1993 and 1998, they needed to look at other more appropriate measures! As we say in Dublin: ”Pull the other one, it has bells on it!” I know of no evidence that he was right, and their unseemly scratching around for scales, criteria and about 20 new secondary outcomes that might show Paxil in a more favourable light was sad, desperate, even comical.

In short, we’ve had many reasons to be extremely sceptical of RCTs and critical of the uses to which they have been put: Study 329, for example, was merely a super-lucrative advertisement for a dangerous, addictive drug with doubtful benefits and numerous toxic side-effects. (In 2002 over two million paediatric Paxil prescriptions were written in the USA alone, just in time to beat the patent deadline.) Now whereas the law, the FDA and blind faith in RCTs bought an awful lot of time for GSK to make many billions unimpeded in subsequent years, a modest number of academic articles and individual “anecdotal” reports from doctors between 1958 and 1961 stopped thalidomide in its tracks by 1962. They didn’t hang about too long in those days: one critic was scandalized that C-G knew for six whole weeks of the dangers posed by thalidomide!

The RS, then, may well deal a mortal blow to our naïve faith in academic integrity, our bedazzlement by RCTs, and to our easy acceptance of them as gold-standard benchmarks of truth and rigour. It should, at the very least, put them in their place as one potential, yet fallible, tool in the arsenal of psychiatry, but one that should never be allowed to usurp the centrality of the empathic, dialogic relationship between a singular patient and healer, nor the full story of individual suffering, which is obfuscated by algorithms and statistical averages.

On the other hand, the RS might also, paradoxically, provoke a more positive, nuanced view of RCTs, suggesting that some modicum of scientific respectability could be maintained, but NOT IN THE PRESENT VENAL CULTURE: Jureidini et al. have shown us what they might yield if carried out rigorously by top independent researchers putting in Herculean work for no financial gain: had their study appeared in 2003 many wasted billions and many, many lives might have been saved. But how often are we going to get such a highly qualified, deeply committed, hard-working group together in the present climate, with its routine financial inducements? Should we not, perhaps, use the thalidomide case to reconsider the value of strong, repeated “anecdotal” pointers, thus emphasizing individual stories of psychotropic drug use and the withdrawal therefrom? David Healy, Luke Montagu and James Davies have given us a very strong lead in this domain.

Another problem hovering over, but not addressed, by both studies is that of causality: in psychiatric and neuroscientific discourse there’s a lot of slippery semantic skating going on – “linked to,” “associated with,” ”implicated in,” “correlated with,” and the like, but rarely “caused by.” This is not always helpful, but it does bespeak an understandable and judicious reluctance to assign one cause to any outcome.  The Study 329 authors cleverly exploited this difficulty when they tried to minimize serious adverse effects related to treatment by declaring that “causality cannot be determined conclusively.” A single cause for any illness can rarely be proven conclusively – even in cancer, as a number of commentators have pointed out. Thalidomide, however, does appear to have been the sole cause of all those awful deformities; but even in a case like PKU, which is habitually deemed to have a purely genetic aetiology, the gene will not express itself if rigorous environmental controls are put in place – in this case, diet.

Now while it seems clear that judges, biomedical academics and psychiatrists have grossly underestimated antidepressants’ (ADs) contribution to suicidal behaviour, it is also possible to overstate the case by insisting that a given SSRI caused violent, murderous or suicidal behaviour, thus negating the potential impact of other confounding variables. Yet some, but not many judges, taking the advice of people like Peter Breggin and David Healy, have declared that an AD like Prozac had indeed induced a murder.  But, pace both of these great fighters, I’d suggest that legal sanctions would be far easier to obtain if we focussed not on a conclusive single cause for a violent act, but on the very high risk factors associated with a given SSRI and on the full personal and contextual story.

3. The Matter of Suicide

In the opening of The Myth of Sisyphus, Camus argued that suicide is the only serious philosophical question, but for many, suicidal ideation (SI) is a dangerous by-product of SSRI consumption; a serious adverse effect. And further, SI means different things to different researchers.  For some, it is a particular preoccupation with suicide, ranging from regular random thoughts, to more sustained and frequent thoughts of suicide. For others, however, SI includes suicidal gestures or behaviours such as the planning or rehearsing of the act, incomplete attempts, or more serious attempts designed to fail. Even the MedDRA confuses the issue by coding suicidal ideation OR self-harm OR attempted suicide as suicide events. The RS rightly criticizes Keller for using the term “emotional lability” to fudge the severity and differences in suicidal behaviours, but have they not also engaged in some fudging by lumping suicidal thinking and events under one heading, “suicide-related adverse events”?

There is too much fuzzy thinking here: surely logic and scientific rigour oblige us to clarify our terms and avoid assigning the same weight to SI and clear suicide attempts, since most people who have suicidal ideation do not go on to end their lives, even though it must be considered a (low?) risk factor for suicide? To put this in context, it was estimated that in 2008-9 over 8.3 million adults aged 18+ in the U.S. reported suicidal thoughts in the previous year, but of these, only one adult in 140, 60,000 people, actually took their own lives. SI does not usually mean that someone wants to die, but that s/he does have a desperate need to express her/his hopelessness, impotence, overwhelming pain or collapse of meaning. It may often be a natural strategy employed in a hopeless situation: an imaginative rehearsal or symbolic expression of entrapment in the reptilian freeze response; of the impossibility of fight, flight or social engagement, to put it in terms of Polyvagal Theory.

I’m suggesting, then, that we must beware of falling into the trap of dramatizing or pathologizing something that may be absolutely normal, even healthy, in certain circumstances: for example, if one is homeless, disadvantaged or marginalized, living in unbearable social conditions, or trying to deal with overwhelming loss or failure the lack of SI would surely be a highly dissociative move.

Pain, danger and thoughts of suicide often attend the birth-pangs of any major life transition or change in status, as it did for Tolstoy and J.S. Mill. (See James Davies’ fascinating book, The Importance of Suffering.) Camus’s Meursault normalizes suicide  by reminding us that everyone at some time has wanted to kill the one s/he loves: for adolescents needing to separate and carve out their own identity such thoughts are routine, healthy, and not necessarily caused by SSRIs. And for them SI can be one way of managing the maelstrom of hormonal turmoil, passionate intensity, emotional lability and high-risk behaviour attending the scary transition from childhood to adulthood. It may simply well be a way of saying that s/he sees no meaning in life and cannot go on this way any more, especially at a time of collapse in traditional values.

We need to remember, too, that modern adolescence, bereft of mentors, is a particularly fraught, unstable time, in which risky behaviour is far more common than in childhood or adulthood; one in which accidents are the main cause of death, followed by suicide, regardless of any SSRI consumption. (See Sarah-Jayne Blakemore’s research on risk-taking behaviour in adolescents.) For example, in one recent case it became clear that a vicious racism had fueled multiple murders in a local school. In another, a recent school killer’s notebooks showed that he was in a state of absolute despair because doctors had told him he was condemned to live with “a broken brain” for life.

However, well-documented adolescent suicide attempts do have to be taken very seriously, even though they may well be just last-ditch screams for help or understanding: after all, David Healy and others point out that for every eleven suicide attempts there’s one actual suicide.

I believe, then, that it is important to de-emphasize and downgrade SI since the term is used too loosely and can a have a positive valency. Why not confine the term solely to thoughts, and prioritize clear suicidal behaviours? And, taking into account the wider cultural framework, would it not make more sense for judges and researchers to focus on the individual contexts and narratives subtending acts of serious self-harm, clear suicide attempts and very uncharacteristic acts of violence? Drug are usually part of a much bigger story, which we neglect at our peril.  Why not, then, let the law get on with assessing the strength of the circumstantial evidence and decide whether a given drug is a major contributor to a suicide beyond any reasonable doubt?

4. Neo-liberal Culture

Martin Keller recently made the point that since nobody has been able to pin anything on the authors, there’s obviously nothing to apologize for. The terrible thing is that he’s right: they have merely acted in a way that is condoned by academic journals, the FDA and the universities; sanctioned by the psychiatric establishment and the wider culture which makes it so easy for negative findings to run for cover, since there is no firm regulatory obligation to report all the results from clinical trials. In this case, Brown is in the dock, but numerous U.S. academic establishment have been regularly shamed, even though a few of them, like Harvard, have had the courage and integrity to come clean in similar cases, so why not Brown, whose officials conveniently lost some vital incriminating data? (Precisely the same thing happened with a vital incriminating registered letter at the C-G thalidomide trial.) Harvard did take some nebulous action against Biederman et al., but only when the scale of the deceit had become too blatant to hide. It is quite shameful that most U.S. universities routinely offer no comment when the media or people like Senator Grassley ask the tough questions about questionable research or COIs. Indeed, Grassley has said that they seem incapable of monitoring the COIs of faculty. Like the all-powerful gun lobby that even Obama can do little to tame, Marcia Angell’s 800-lb. gorilla has run amok, and thumbs its nose with impunity at the helpless Sorcerer’s Apprentice. And at all of us who protest so loudly and so often. But is this enough? Do the times not demand more concrete, radical action?

Is Study 329, then, not just one more shocking example of the mercantile values and the druggy doxa that permeate our entire culture? Obama’s choice when appointing the new FDA director is a stark incarnation of just how bad things are. So, before we all get too righteous and complacent we mustn’t forget that JAACAP, GSK, Keller et al. are simply following the ethos of our culture in which ethics and transparency have been all but abandoned, even at the top. Earlier this year, Scott, Rucklidge and Mulder studied the adherence, from 2009-13, by the editors of the five leading psychiatric journals to their own pious protocols of oversight and integrity, concluding that “most trials were either not prospectively registered, changed POMs or the timeframes at some point after registration or changed participant numbers.” When such oversight is so loose at the top, to whom do we turn for safe, rigorous research and unbiased guidelines? Quis custodiet ipsos custodes when they countenance criminal acts?

The Study 329 affair, then, underscores the fact that there is strong, but implicit, cultural permission given to BP and amoral academics for their chicanery since trial periods are so short, and post-marketing surveillance so weak and random. Our modern blind-eye culture has no problem with FDA laxity, blatant academic corruption and an increasingly perfunctory oversight by Congress and the law which permits direct-to-consumer marketing and off-label prescription, which in turn allows BP to profitably dispense with honesty, science or FDA approval.

Counterpointing the thalidomide with the Paxil affair, then, helps us to highlight a monumental shift in culture and values that lies very deep in the neo-liberal psyche, transcending Big Pharma, the universities et al. In the thalidomide case, the culture of the 60s enabled the remarkable integrity, rigour and persistence of the FDA’s Frances Kelsey who seems to have been fully backed by the FDA directorate, though one historian of the FDA wrote that she encountered some opposition there. And where she was supported by the wider culture, which subsequently lavished awards and encomia on her, our culture both encourages and rewards the likes of Keller et al. So in 40 years the 1962 amendment, designed to ensure the efficacy and safety of drugs, was emasculated, abused and disempowered by Big Pharma PR and cynical academics. Had thalidomide arrived in 1994 and been researched by such people, the laxity of the FDA, enabled by an ethics-free drug culture, would likely have ensured its continued presence on the market for years, producing millions of deformed babies facing early death or wrecked lives. Fortunately for mothers and new-borns back then academics had integrity: and the meteoric rise of BP power, allied to the prestige and often spurious truth-value of RCTs, was still some way off. Thus a small number of early academic studies, often in the BMJ, and many “merely anecdotal” reports, succeeded in ousting the drug before it got into its stride.

But, once again, what we’re really talking about here is a seismic cultural shift, over 40 years, which is underwritten by government and the law; one which finds no place for ethics, which favours permissive drug regulation, and a neo-liberal ethos in psychiatric practice, academia and the press.

Redmond O'Hanlon

Redmond O’Hanlon is an academic who has taught university courses in Ireland, the U.S. and Oxford, where he wrote his doctorate. He is at present tidying up the final draft of a book  which attempts to bring some insights from the worlds of psychology, philosophy and the arts into critical psychiatry, with special emphasis on the importance of narrative, and on the dangerous fantasy of psychiatric diagnoses. His particular interests are depression, ADHD, trauma, the so-called personality disorders – and the greatest scam of them all, “schizophrenia.”

GSK’s Lamictal Crimes ..

Appendix A: Section IX of United States of America vs. GlaxoSmithKline, PLC: GSK’S OFF-LABEL MARKETING OF LAMICTAL

Appendix A: Section IX of United States of America vs. GlaxoSmithKline, PLC


  1. In December 1994, Lamictal (active ingredient lamotrigine) was FDA approved for use as adjunctive therapy in adults with partial seizures, and as adjunctive therapy in the generalized seizures of Lennox-Gastaut syndrome in adults and pediatric patients ages two and older.
  1. However, despite the narrow indications for which it was approved, GSK heavily marketed Lamictal for the treatment of bipolar disorders both before and during the period it was pending a supplemental new drug application for treatment of bipolar I disorder, which was finally granted by the FDA on June 20, 2003.

2. Off-Label Promotion to Bipolar Patients

  1. GSK’s aggressive marketing of Lamictal prior to its approval for use in the treatment of bipolar I disorder proved extremely lucrative. Lamictal grew by 33% in the year 2000 (with total U.S. sales of $210 million) and continued to grow in the following years. In a press announcement for year 2003 GSK boasted that Lamictal was approaching ‘blockbuster status’ with sales that grew by 31% to approximately $1 billion.
  1. Curiously, there is no data that would support a commensurate rise in partial seizures in adults or Lennox-Gastaut Syndrome, the only approved indications for Lamictal prior to June of 2003.
  1. Ultimately, the aggressive and illegal pre-approval marketing served the dual purpose of reaping significant gains prior to approval for treatment of bipolar I disorder as well as assuring GSK of a nationwide network of health care providers ready to prescribe the drug for bipolar disorders the minute it received FDA approval.
  1. Over the course of nearly ten years of off-label marketing of Lamictal, billions of dollars in sales were generated prior to the 2003 indication for bipolar I, as alleged infra.
  2. Accordingly, GSK, in promoting Lamictal by willfully misrepresenting the FDA approved uses, engaged in egregious and knowing off-label marketing.

3. Off Label Promotion for all Bipolar Disorders

  1. Despite the fact that Lamictal was only FDA approved for treatment of partial onset seizures in 1994, since its launch, sales representatives were trained to promote the drug as an effective treatment for all bipolar disorders.
  1. Although there are several types of bi-polar disorders, as alleged infra, bipolar I is the most severe and the most rare. Notably, the drug was never approved by the FDA for bipolar II disorder or any of the four (4) other variations on bipolar disorder listed below.
  • Bipolar I disorder involves episodes of severe mood swings, from mania to depression.
  • Bipolar II disorder is a milder form, involving milder episodes of hypomania that alternate with depression. Bipolar II is a more broadly defined mental illness and encompasses more patients.
  • Cyclothymic disorder describes even milder mood changes.
  • With mixed bipolar disorder, there is both mania and depression at the same time, resulting in a person having feelings of grandiosity and racing thoughts, often resulting in an irritable, angry and moody feeling.
  • Rapid-cycling bipolar disorder is characterized by four or more mood episodes that occur within a 12-month period. Some people experience multiple episodes within a single week, or even within a single day. Rapid cycling tends to develop later in the course of illness. Women are more likely than men to have rapid cycling. A rapid-cycling pattern increases risk for severe depression and suicide attempts.
  1. Despite the lack of any bipolar related indication until 2003, sales representatives were provided with materials designed to promote the drug for global bipolar disorders. Even after it received approval for bipolar I disorder in 2003, sales representatives were trained not to call attention to the distinctions among the various types of bipolar disorder unless a physician inquired.
  1. As evidence of the pre-indication marketing and training, one need look no further than the 2001 GSK Selling Resource Guide for Lamictal. The Resource Guide provides scripts for sales reps to address requests for information on Lamictal and bipolar depression suggesting that there were numerous inquiries into this usage. 7AC 0000413-0000430.
  1. In furtherance of their bipolar marketing efforts, GSK engaged in an aggressive campaign aimed at pushing sales representatives to use the FaxBack program discussed in the Resource Guide as a marketing tool.
  1. Specifically, in the aforementioned 2001 Resource Guide, sales representatives were instructed to direct the physicians to “Faxback Number 5” for information regarding the use of Lamictal and bipolar disorder. This faxback incorporated the findings of Dr. Joseph R. Calabrese, and others, which positively detailed the use of Lamictal in patients suffering from bipolar I and II, mania, unipolar depression, and as a monotherapy. 7AC 0000419
  1. Most troublesome is the fact that GSK was aware of its illegal strategic use of the FaxBack program, yet made a conscious and deliberate effort to cover up its actions.
  1. For example, at a management training program in July 2002, Relator Hamrick was instructed by a manager-in-training that, with respect to the detailing of Lamictal for bipolar to psychiatrists, the record of every contact report should automatically include the phrase ‘Dr. inquired about bipolar disorder” thereby effectively circumventing the requirements of the FDCA with regards to disseminating literature concerning non-approved uses.
  1. In addition to the FaxBacks, GSK frequently distributed “Lit Alerts” to its sales force allegedly for the purpose of educating the drug reps. The Alerts, essentially a cliff-note version of a drug specific study, were routinely carried by sales representatives to aid in answering any questions posed by physicians. The fact that the Lit Alerts were, by their very nature, off label marketing tools, makes their distribution by GSK even more egregious.
  1. Specifically, in August 2002, a Lit Alert was distributed to Lamictal sales representatives discussing the use of Lamotrigine as an augmentation agent in treatment resistant depression (‘TRD’), a use for which it has never received approval. 7AC 0000431-0000433.
  1. Subsequent to the TRD Lit Alert, in April 2003 GSK distributed another study titled ‘Lamictal as Maintenance Treatment in Recently Manic or Hypomanic Bipolar I Patients.’ This Lit Alert served only to fan the flames of an already rampant bipolar campaign and was referenced widely in sales calls. 7AC 0000434-0000438.
  1. Just as troublesome as the Lit Alerts and Faxbacks, were the numerous studies by Calabrese, distributed by GSK, which suggest the efficacy and use of Lamictal in patients with bipolar II.
  1. Although Lamictal never received an indication for bipolar II disorder, GSK maintained its effective off label campaign and continued to forge strong relationships with its prescribing physicians ultimately pushing the boundaries by suggesting Lamictal’s effectiveness as a treatment option for bipolar II disorder.
  1. In fact, since the dosage of Lamictal must be increased slowly from a subtherapeutic level to a therapeutic level, acute mania and Bipolar II never received an indication.

4. GSK’s Improper Use of National Thought Leaders to Promote the Off-Label Marketing of Lamictal

  1. GSK’s extremely aggressive off-label campaign for Lamictal included spending large sums of money in the form of unrestricted grants, membership on advisory boards and speaker’s fees on physicians and researchers who served as ‘national thought leaders.’ As with campaigns for other drugs, the campaign for the use of the drug Lamictal in the treatment of bipolar disorders began with the widespread promotion of “disease awareness.”
  1. Key figures in GSK’s national promotion of Lamictal for treatment of bipolar disorders prior to its indication were Dr. Joseph R. Calabrese of Cleveland, Ohio and Dr. Charles L. Bowden of San Antonio, Texas.
  1. As previously discussed, Dr. Calabrese, in particular, was GSK’s greatest proponent for the use of Lamictal in the treatment of bipolar disorders and published articles advocating the use of Lamictal in bipolar disorder as early as 1998. Dr. Calabrese has widely published his opinion that there is need for a greater awareness of the prevalence of bipolar disorders in the United States, stating that the disease impacts as many as 4% of the total population (11,000,000 people) yet is ‘largely undiagnosed.’
  1. In his promotion of the use of Lamictal for bipolar disorder, Dr. Calabrese wrote about a new nomenclature (‘above the line/below the line’) advocating that Lamictal was clearly superior to other commonly prescribed medications such as Lithium. Dr. Calabrese also defended the drug from the accusation that the risk of serious side-effects, such as Stevens- Johnson Syndrome4, outweighed the benefits of prescribing the medication.

4 Stevens-Johnson syndrome is a rare, serious disorder in which the skin and mucous membranes react severely to a medication, in this case, Lamictal, or infection. Often, Stevens-Johnson syndrome begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters, eventually causing the top layer of your skin to die and shed. 4612704 117

  1. In addition to journal articles, in 2002 Dr. Calabrese even published a greatly abbreviated, highly commercialized version, of his 1998 study (being careful to identify Lamotrigine by its GSK product title Lamictal) in an internet bulletin called “Fast Breaking Comments.” In this interview, Dr. Calabrese blatantly publicizes his determination that “lamotrigine (Lamictal) is effective in the treatment of patients with rapid cycling bipolar II disorder.” 7AC 0000439-0000441.
  1. To date, Lamictal has not received an indication for rapid cycling bipolar II disorder. However, GSK placed great emphasis on this study and sales representatives were expected to read and be familiar with Dr. Calabrese’s theories and statistics for use in off label marketing.
  1. Dr. Bowden began publishing his opinions concerning the efficacy of Lamictal in the treatment of bipolar disorder as early as 1998. Dr. Bowden became a widely sought after speaker for GSK, and GSK sales representatives nationwide were encouraged to try to persuade Dr. Bowden to make presentations on his findings in their geographical area.

5. GSK’s Off-Label Marketing to Psychiatrists

  1. Seizure disorders – the only approved indication for Lamictal during the 1998 through 2003 period – were treated by neurologists, not psychiatrists. Notwithstanding that fact, GSK began requiring its sales representatives to detail Lamictal with psychiatrists and family practitioners many years before the approval for bipolar I disorder.
  1. It is clear that these ‘details,’ which were prevalent throughout the nation during this period, were directed at persuading physicians to prescribe Lamictal off-label for the treatment of bipolar disorder and through the use of free samples, ‘thought leader’ lunches, dinners and CME’s, and distribution of studies favorable to GSK, particularly the Calabrese 4612704 118 studies, GSK was extremely successful in persuading physicians to begin prescribing the drug off-label.
  1. As confirmation of the detailing of psychiatrists, a quick review of the contact sheets written up by the sales representatives shortly after the physician visits confirm the fact that the purpose of these visits was solely to market Lamictal for the treatment of bipolar disorders. The following is representative of the quantity of the off label physician visits by sales representatives including Ron Crews, Joan Schindler and Betty Hosler5
  • 9/13/00 Dr. Douglas Gregory (psychiatrist) ‘Had long discussion about Lamictal, is afraid of rash….Rash is severe side effect which has caused death in several patients….’Stevens Johnson Syndrome’….Gave him Calabrese article and encouraged him to talk to Marciniak [local GKS ‘thought leader’;
  • 10/18/00 Dr. McClure [Dr. Scott H. McClure, psychiatrist] Is getting more comf w/ lamic, thought it [conference put on by GSK]was informative More comfortable with Lamictal for bi-polar;
  • 10/26/00 Dr. Crandall (psychiatrist) “[D]iscussed Bowdens’ lecture, she is afraid of the rash;
  • 10/30/00 Dr. Gamblin (psychiatrist) ‘very pos. about lam. (Lamictal) has over 50 patients on it’…’Trained with Bowden sorry he missed it ‘ (referring to lecture in Colorado Springs that GSK arranged with Dr. Bowden as the speakers);
  • 10/30/00 Dr. McClure [Dr. Scott H. McClure, psychiatrist] ‘Said he is more comf.with Lamictal as monotherapy [in the treatment of bipolar disorder] after hearing Bowden likes the bottles of 25 only, not the kits (Lamictal) samples’;
  • 1/8/01 Dr. Harazin [Dr. Jeffrey Harazin, psychiatrist] ‘Lamictal is on it’s way’;
  • 03/21/01 Dr. Marciniak [psychiatrist] detailed by GSK District Manager for Lamictal in bipolar;
  • 05/23/01 Dr. Gregory [psychiatrist] attended noon lecture at Pikes Peak Mental Health with Dr. Paul Wender speaking, detailed on Lamictal;

5 These notes have been reproduced exactly as they were written in the contact reports by the individual sales representatives and entered into the Passport system following each sales call.

  • 06/12/01 Dr. Gamblin [psychiatrist] again detailed on Lamictal;
  • 06/19/01 Dr. Richard Marciniak [psychiatrist] detailed on Lamictal and offered a free fly fishing trip;
  • 06/21/01 Dr. Richard Marciniak again detailed on Lamictal and offered speaker/dinner engagement at local restaurant (Warehouse);
  • 07/05/01 Dr. Gamblin again detailed for Lamictal;
  • 07/19/01 Dr. Richard Marciniak again detailed on Lamictal and stated it is his choice for treatment of bipolar, as well as discussing dosage amounts and titration;
  • 07/30/01 Dr. Fred Michel detailed on the use of Lamictal for the treatment of children (‘Uses very little Lamictal in kids but would like to use it more.’);
  • 03/14/02 Dr. Julie Sanford [psychiatrist] detailed for using Lamictal in the treatment of bipolar;
  • 03/15/02 Dr. Gamblin had not yet seen the Calabrese study but did not want to drive to Denver for CME’s;
  • 03/15/02 Dr. James Spadoni [psychiatrist] detailed for the use of Lamictal in bipolar;
  • 03/19/02 Dr. Marciniak agreed to be paid by GSK to speak about Lamictal for bipolar as well as Wellbutrin at a lunch for local physicians in Colorado Springs;
  • 03/19/02 Dr. Stephen Mueller [psychiatrist] confirmed attendance at the bipolar/Lamictal physician’s meeting in Colorado Springs, Colorado;
  • 03/20/02 Dr. Gamblin again detailed for prescribing Lamictal for bipolar disorder;
  • 04/03/02 Dr. Marciniak detailed for Lamictal and confirmed that he would accept paid assignment to do GSK’s CME program on June 7, 2002;
  • 04/03/02 Dr. Spadoni [psychiatrist] detailed for use of Lamictal in bipolar disorder;
  • 04/10/02 Dr. Gamblin detailed for use of Lamictal in bipolar disorder with reference to the Calabreze study;
  • 04/24/02 Dr. David Caster [psychiatrist] detailed for Lamictal in bipolar disorder;
  • 04/25/02 Dr. Rosalyn Kneppel [psychiatrist] detailed for Lamictal in bipolar disorder;
  • 04/29/02 Dr. Nancy Sharpe, a Colorado Springs psychiatrist, was detailed for Lamictal in bipolar disorder; this doctor, who has a large Medicaid practice, asked the GSK sales representative about proper dosage amounts;
  • 05/01/02 Dr. Brian Grabert, a pediatric neurologist, was invited to be on GSK’s advisory board for an upcoming San Diego, California conference; 05/06/02 Dr. Gamblin detailed once again for Lamictal and now said he feels quite comfortable using it;
  • 05/08/02 Dr. Rosalyn Kneppel [psychiatrist] again detailed for Lamictal in bipolar disorder;
  • 05/08/02 Dr. Jeffrey Harazin again detailed for Lamictal in bipolar and now said he uses it ‘first line’ for bipolar disorder;
  • 05/13/02 Dr. Stephen Mueller, psychiatrist, again detailed for Lamictal in bipolar and requested pricing information;
  • 05/17/02 Dr. Marciniak agreed to do a talk and stated that he is using Lamictal more for bipolar now that he has more samples;
  • 05/20/02 Dr. Elliott Cohen, psychiatrist, detailed for Lamictal and he requested more samples;
  • 05/20/02 Dr. Rosalyn Kneppel [psychiatrist] again detailed for Lamictal in bipolar disorder and said she is using half the dosage [recommended for seizures] because of concerns about the rash;
  • 05/20/02 Dr. James Polo detailed for use of Lamictal in bipolar disorder in adolescents;
  • 05/22/02 Dr. Ralph Everett, child psychiatrist detailed for Lamictal in bipolar and after having stated he did not like it, was given a comparison to Zoloft by the GSK rep;
  • 05/22/02 Dr. Scott McClure, psychiatrist, again detailed for Lamictal in bipolar and Dr. McClure asked the GSK rep. how to dose if a patient was already on Depakote for bipolar and was given ‘the Calabrese study’ by the rep;
  • 05/23/02 Psychiatrists Dr. Anne League, Dr. James Spadoni and Dr. Julie Sanford were treated to lunch at a local Colorado Springs restaurant by the GSK sales representative and given American Psychiatric Association guidelines relating to Lamictal;
  • 05/23/02 Psychiatrist Pamela A. Brickers of Colorado Springs, CO was detailed by a GSK representative and was given a copy of ‘the calabrfese [sic] study’;
  • 05/29/02 Dr. Julie Sanford was detailed on Lamictal for bipolar and the GSK rep went over a study/comparison with Zoloft that was favorable to GSK’s product;
  • 05/29/02 Dr. James Spadoni and Dr. Richard Marciniak detailed for Lamictal;
  • 05/30/02 Dr. Brian Grabert detailed for Lamictal for his pediatric patients;
  • 06/05/02 Dr. Brian Grabert again detailed for Lamictal and discussed the rash;
  • 06/17/02 Dr. Honie Crandell again detailed for Lamictal in the treatment of bipolar disorder and confirms that it is her drug of choice for this disorder.
  1. In addition to targeting psychiatrists for detailing, prior to the FDA approved indication for bipolar I, GSK sales representatives were instructed to devote virtually all of their free sampling activities to psychiatrists, rather than neurologists. A routine practice that was documented in the contact reports of physician details as well as the first-hand experience of Relator Thorpe.

6. GSK’S Off-Label Promotion of Lamictal Resulted in Patient Harm

  1. Although the FDA issued recommended dosing for Lamictal for its seizure indications, there were no such dosing guidelines for use in patients suffering from any form of bipolar disorder prior to the FDA approval in 2003. As such, there existed an acute risk of overdosing and resulting complications.
  1. Since the FDA did not establish a recommended dosage for Lamictal for use off label, and because the potential side effects were so severe if not dosed correctly, once the sales representatives had successfully gotten a physician to inquire about its use for bipolar, they were instructed to use the phrase ‘start low and go slow.’
  1. On information and belief, this “catchphrase” came directly from the GSK marketing department and was used by sales representatives throughout the country as a way to remind physicians to start with a small dose and raise the dosage very slowly in the treatment of bipolar I disorder in children and adolescents especially.
  1. Given the lack of dosing information, coupled with the intense campaign for use as a treatment for bipolar disorders, the contact reports referenced in the preceding paragraphs evidence physicians routinely inquiring about dosage and titration from the sales representatives themselves.
  1. On information and belief, as a direct and proximate result of the lack of proper dosing of Lamictal when used off-label, patients suffered both reported and unreported severe side effects including death.
  1. The Federal Drug and Cosmetic Act (“FDCA”) and its regulations require that adverse events due to prescription medications be promptly reported. However, ample evidence exists of widespread under-reporting of adverse drug reactions, even when drugs are being prescribed for their approved uses. (Mintzes, B., Bassett, K., Wright J.M.. Drug Safety without Borders: Concerns about Bupropion. Can. Med. Assoc. J., 2002;167(5); Moride Y, Haramburu F, Requejo AA, Begaud B. Under-reporting of Adverse Drug Reactions in General Practice. Br J Clin Pharmacol 1997;43(2):177-81; Bates DW. Drugs and Adverse Drug Reactions. How Worried Should We Be? JAMA 1998;279(15):1216-7; Okie, S., Safety in Numbers – Monitoring Risk in Approved Drugs, N.E.J.M., 352:1173-1176, March 2005.)
  1. On February 14, 2003, Relator Hamrick became aware of an incident involving the dangers of off-label prescription particularly when combined with the widespread laxity in adverse event reporting when he called on Dr. J. Vitanza, an allergist.
  1. Mr. Hamrick was informed that one of Dr. Vitanza’s patients had been prescribed Lamictal for bipolar I disorder (prior to its approval by the FDA) and noted in the patient’s chart an incidence of rash. Assuming that the patient’s psychiatrist would report the rash incident, Dr. Vitanza failed to report the occurrence to the FDA. After observing that the physician was not going to file an adverse event report, Mr. Hamrick filed his own, based upon his second-hand knowledge of the incident. 7AC 0000442-0000443.
  1. As a result of the underreporting of rash occurrences, physicians failed to be properly alerted to the potential danger of the rash which had, on a few occurrences, developed into Stevens-Johnson Syndrome.
  1. In addition to the unreported incidents of rash, often resulting from off-label prescriptions, at least one death resulted from the use Lamictal for bipolar I disorder.
  1. Dr. Julie Sanford, a psychiatrist who was consistently detailed by GSK sales representatives to prescribe Lamictal for bipolar disorders, prescribed the drug for a patient that subsequently died. Since Dr. Sanford was not a neurologist likely to be treating a patient for a seizure disorder, it should have been apparent to GSK officials receiving a copy of her adverse event report that the drug was, in all likelihood, prescribed for a non-indicated use.
  1. Nevertheless, in a May 22, 2001 letter to Dr. Sanford from GKS’s “Global Clinical Safety and Pharmacovigilance” division, there is a reiteration of adverse event reporting: the patient, who had been given Lamictal experienced headache and died, and other patients of whom she was aware also experienced rashes subsequent to receiving therapy with Lamictal. 7AC 0000444.
  1. Significantly, the “Global Clinical Safety and Pharmacovigilance” division, while allegedly interested ‘in obtaining as much information as possible concerning reports of suspected adverse reactions for the purpose of continuing to monitor and evaluate drug safety’ made no inquiry into the issue of the purpose of the supposed therapy.
  1. Of even more concern, in a conversation with Relator Thorpe, Dr. Sanford, a psychiatrist married to key opinion leader Dr. Marciniak, revealed that the patient who died was in fact being treated for bipolar I disorder.
  1. Clearly, when combined with the lack of recommended dosage, the off-label use of Lamictal made for a recklessly dangerous combination for patients resulting in severe rashes, including Stevens Johnson Syndrome, and even death.

7. GSK Targeted Federal Health Care Programs for Off-Label Use

  1. GSK’s off-label marketing tactics also helped put their products on Tricare/Champus formularies for uses not approved by the FDA.
  1. For example, GSK focused on psychiatrist Dr. James Polo because of his position at Evans Army Hospital, Fort Carson, Colorado. As a result of the persistence of GSK, Lamictal was actually placed on formulary for treatment of bipolar disorders prior to receiving such an indication.
  1. GSK began seriously attempting to influence Dr. Polo in the late 1990’s by making arrangements for and paying for all of the food and liquor at the annual Colorado Spring Psychiatric Association Christmas party at Dr. Polo’s home, with 60-70 physicians in attendance.
  1. A simple review of just a few GSK contact reports in 2001 and 2002 clearly indicates that GSK sales representatives “detailed” Dr. Polo to enlist his aid in placing Lamictal on the Tricare/Champus formulary at Fort Carson for use in the treatment of bipolar disorders:
  • 4/23/02 Dr. James Polo detailed on Lamictal and Wellbutrin, invited to GSK speakers program, ‘he saw the green journal and asked if on lamictal on formulary, he said yes but for neurology only; he will champion it for p.t.’
  • 5/20/02 Dr. James Polo detailed on Lamictal with note ‘he was not attending the Tricare meeting this week, wsr for pts. w depression and concentration difficulties, lamictal is now a favorite of his and uses it in adol with bi-polar.’
  • 7/15/02 Dr. James Polo detailed on Lamictal and reported that ‘Lamictal is no longer restricted to neurology’ meaning it was now available on the Tricare formulary.
  • 07/24/02 Dr. James Polo detailed on Wellbutrin and Lamictal and reported “Lamictal free for all psyches.’
  1. As evidence of the success of the GSK engineered approval of Lamictal for use as a psychiatric treatment on the Fort Carson Tricare formulary, Dr. Kenneth Gamblin, a high volume Medicaid psychiatrist was told, (according to the July 17, 2002 GSK contact report) about availability of Lamictal on the Tricare formulary. Subsequently, according to the aforementioned contact report, he ‘…has started several new pts.’
  1. Upon information and belief, GSK targeted other high volume federal healthcare providers for off-label use of Lamictal and by the second quarter of 2007, Lamictal held a 14.1% share of the Medicaid market.”


Philip Hickey, PhD

Behaviorism and Mental Health: Philip Hickey is a retired psychologist.  He has worked in prisons (UK and US), addiction units, community mental health centers, nursing homes, and in private practice.  He and his wife, Nancy, live in Colorado, and have four grown children. His posts can also be seen on his website, Behaviorism and Mental Health.

How GSK Corrupts Doctors: Dr Pies, GSK, Lamictal, Dr Calabrese, And Other Shenanigans

Dr Phil Hickey writes for the brilliant MadinAmerica website. His posts can also be read on his own site here. Hickey is an excellent writer, and his observations on the profession of psychiatry, the pharmaceutical industry, mental health, psychiatric drugs (and all the shenanigans which go on at the interface of all of these), are razor sharp, astute and always spot on.

Check out his latest post on the ‘chemical imbalance fraud’, the slippery psychiatrist Dr Pies, GSK’s dodgy Lamictal drug (which was one of the drugs named in the 3 Billion Department of Justice felony claim against GSK) and other issues.

Check out Phil’s post here:

My Response To Dr. Pies

Editor’s note: Dr. Pies’ response to this post is appended to the end of this post.

In the October 2015 issue of The Behavior Therapist (pages 206-213), Jeffrey Lacasse, PhD, and Jonathan Leo, PhD, published an article titled Antidepressants and the Chemical Imbalance Theory of Depression: A Reflection and Update on the Discourse.

I thought the article had particular merit, and I drew attention to it in a post dated November 2.  The post, More on the Chemical Imbalance Theory, was also published on Mad in America.

In that post, I quoted a number of passages from the Behavior Therapist article, including:

“When our physicians are educating us, we prefer they not tell us any lies, white or otherwise.  Unfortunately, characterizing the chemical imbalance metaphor as a ‘little white lie’ communicates a paternalistic, hierarchical approach that sounds suspiciously like the days of medicine that we thought we had left behind.  It’s a ‘little white lie’ if you’re a psychiatrist; if you’re a confused, vulnerable depressed person who agrees to take an SSRI after hearing it, you might not consider it so little.  After all, if your trusted physician tells you that you have a chemical imbalance in your brain that can be corrected with medication, not doing so sounds foolish, if not scary (Lacasse, 2005).  How many patients with reservations about SSRIs have agreed to take medication after being told this ‘little white lie’?”


“Pies blames the drug companies for running misleading advertisements about chemical imbalance, belatedly admits he should have said something sooner, but fails to mention that he was paid to help them promote their products at the time the advertisements were running.”

On November 5, I received the following email, forwarded from Mad In America:

Message sent by: Ronald Pies MD

Message:Dear Mr. Cole:

Philip Hickey\’s blog, \”More on the Chemical Imbalance Theory\”—posted on your website—references a recent paper by Lacasse & Leo (\”Antidepressants and the Chemical Imbalance Theory of Depression\”) which contains incorrect and misleading information re: my views, as well as an unsupported claim re: supposed “conflicts of interest”  Lacasse & Leo impute to me. These misstatements by Lacasse & Leo are, unfortunately, repeated in Hickey\’s blog.  This is unacceptable and must be publicly corrected. In brief, Lacasse and Leo’s misrepresentations are as follows:

1.  They misattribute the phrase “little white lie” to me, with regard to the so-called “chemical imbalance theory.” In reality, this unfortunate phrase was originally used by Mr. Robert Whitaker in an interview with Bruce Levine. The link is:

In the article I subsequently wrote, cited by Lacasse & Leo (, my use of that phrase was in direct reference to Whitaker’s interview and to his own choice of words. I made this clear as far back as April, 2014, in a comment I posted beneath my Medscape article (available online). Careful scholars would surely have observed this and not falsely attributed Whitaker\’s phrase to me. The Medscape article has since been corrected.

2.  Citing information properly disclosed by me over a decade ago, Lacasse & Leo allege that I was “paid to help [pharmaceutical companies] promote their products…” This is categorically false. The allegation by Lacasse & Leo was not based on any direct knowledge of my professional or contractual arrangements dating back to 2003. Never, at any time, have I accepted any monies from pharmaceutical companies (or anyone else) with the intent or purpose of promoting their products. Nor have I ever had any ongoing financial relationships with any pharmaceutical companies.

A detailed rejoinder to Lacasse & Leo will appear in the winter issue of \”The Behavior Therapist,\” where the Lacasse & Leo article originally appeared. However, I respectfully request that you run a correction on your website as soon as possible; e.g., by posting this communication. I consider this a matter that impinges on my professional reputation, and I reserve all rights in pursuit of a just resolution.

Ronald Pies MD Professor of Psychiatry

. . . . . 

My Response

In his email, Dr. Pies raises two objections.  Firstly, he contends that the phrase “little white lie” as applied to the chemical imbalance theory was misattributed to him, on the grounds that the phrase had been used earlier by Robert Whitaker.  Secondly, he states that he has never accepted payment from pharmaceutical companies with the intent or purpose of promoting their products.

The Little White Lie

On April 15, 2014, Dr. Pies published an article – Nuances, Narratives, and the ‘Chemical Imbalance’ Debate in Psychiatry – on Medscape.

The third paragraph of this article reads:

“Now, if you were to give credence to a recent online polemic posing as investigative journalism1, you would probably choose the first or second statement. In the narrative of the antipsychiatry movement, a monolithic entity called ‘Psychiatry’ has deliberately misled the public as to the causes of mental illness, by failing to debunk the chemical imbalance hypothesis. Indeed, this narrative insists that, by promoting this little white lie, psychiatry betrayed the public trust and made it seem as if psychiatrists had magic bullets for psychiatric disorders. (Lurking in the back-story, of course, is Big Pharma, said to be in cahoots with Psychiatry so as to sell more drugs).”

The “polemic posing as investigative journalism” (Ref #1) is an ungracious, and, in my view, unwarrantedly cynical, reference to Bruce Levine’s March 5 2014, interview with Robert Whitaker.  In that interview, Robert is quoted as saying:

“By doing so [promoting the chemical imbalance theory], psychiatry allowed a ‘little white lie’ to take hold in the public mind, which helped sell drugs and of course made it seem that psychiatry had magic bullets for psychiatric disorders. That is an astonishing betrayal of the trust that the public puts in a medical discipline; we don’t expect to be misled in such a basic way.”

It is obvious in this quote, and from the surrounding text, that Robert is using the term “little white lie” as an understatement.  This is clear from the next sentence:  “…an astonishing betrayal of the trust that the public puts in a medical discipline…”.  It is also noteworthy that the phrase is inside quotation marks, which are often used to negate the substance of the enclosed material.

But in Dr. Pies’ statement in the Medscape article, there is nothing to suggest that understatement was intended, and nothing to suggest that the sentiment entailed was anything other than Dr. Pies’ own position.

Specifically, he did not place the phrase inside quotation marks.  And more generally, characterizing the chemical imbalance theory as a “little white lie” is consistent with the psychiatry-exculpating tone of Dr. Pies’ piece.  It is also consistent with the tone of other articles that Dr. Pies has written.  For instance, in Doctor, Is My Mood Disorder Due to a Chemical Imbalance? (2011), Dr. Pies wrote:

“Many patients who suffer from severe depression or anxiety or psychosis tend to blame themselves for the problem. They have often been told by family members that they are “weak-willed” or “just making excuses” when they get sick, and that they would be fine if they just picked themselves up by those proverbial bootstraps. They are often made to feel guilty for using a medication to help with their mood swings or depressive bouts.…So, some doctors believe that they will help the patient feel less blameworthy by telling them, ‘you have a chemical imbalance causing your problem.'”

A little white lie is an inconsequential falsehood, told to avoid causing embarrassment or hurt.  And this is precisely how Dr. Pies is presenting the chemical imbalance hoax in the passage quoted above:  a benign falsehood that will “help the patient feel less blameworthy”.

So, those of us reading Dr. Pies’ “Nuances…” article had every reason to read his description of the chemical imbalance theory as a little white lie, as his own position, and absolutely no reason to infer anything to the contrary.

In addition to this, Dr. Pies himself seems knowledgeable of these matters, and skilled in navigating these kinds of linguistic intricacies.  For instance, in the “Nuances…” article, Dr. Pies states:

“In the narrative of the anti-psychiatry movement, a monolithic entity called ‘Psychiatry’ has deliberately misled the public as to the causes of mental illness, by failing to debunk the chemical imbalance hypothesis.”

Here, Dr. Pies has made it perfectly clear that the characterization of psychiatry as a “monolithic entity” is not his position, but rather that of the antipsychiatry movement.

But no such construction is attached to his use of the phrase “little white lie”.

For Dr. Pies to contend that Drs. Lacasse and Leo misattributed the phrase to him is inaccurate and unreasonable.  The notion that “careful scholars” would have searched through the comments string and found Dr. Pies’ clarification is not convincing.  If Dr. Pies was aware that there was a misleading phrase in the article, he should have corrected it, not relied on his readers to search through a comments string looking for a correction, of whose existence they had no inkling.  The responsibility for the miscommunication sits squarely on his own shoulders.

And there are indications that Dr. Pies clearly understands this.  The “Nuances…” article which appeared in Medscape on April 15 2014, had been published earlier, on March 11, 2014, in Psychiatric Times.  But a month later, on April 11, it was updated on that siteIn the later version, the phrase “little white lie” has been changed to “simplistic notion”.  My interpretation of this at the time was that Dr. Pies had recognized that his earlier statement had been woefully inaccurate, and frankly insulting to people who had been harmed by the falsehood in question, so he made the change.  For some reason, a similar change was not made in the Medscape article until about two weeks ago, when its wording was amended to “simplistic formulation.”  If Dr. Pies didn’t believe that he had misexpressed himself, why did he feel the need to make these amendments?

So, to summarize the “little white lie” issue:

  1. In the original Psychiatric Times and Medscape articles, Dr. Pies characterized the spurious chemical imbalance theory as “this little while lie”. There was nothing in the wording of this statement to suggest that this was anything other than his own position.
  1. At some point in the next few weeks, Dr. Pies realized that his statement was inaccurate, or that he had misexpressed himself, and made an appropriate correction in the Psychiatric Times article, but not in the Medscape piece.
  1. In October 2015, Drs. Lacasse and Leo, accurately and appropriately, attributed the “little white lie” phrase in the Medscape article to Dr. Pies.
  1. Sometime in the last two weeks, the Medscape article was amended to read “simplistic formulation”.
  1. On November 4, 2015, Dr. Pies unjustly accused Drs. Lacasse and Leo of misattributing the phrase to him.

 . . . . . 

Conflicts of Interest

Here’s the entire passage from the Behavior Therapist article:

“Thus, while we don’t know why Ronald Pies himself didn’t speak out on the chemical imbalance issue decades ago, readers should be aware of his past financial relationship with pharmaceutical companies. He sounds vaguely critical of the drug industry in his recent articles and never discloses any history of financial conflicts-of-interest. However, Pies has received funding from GlaxoSmithKline, Abbot Laboratories, and Jannsen Pharmaceuticals—the makers of Paxil, Wellbutrin, Lamictal, Depakote, and Risperdal (Chaudron & Pies, 2003; Pies & Rogers, 2005).  For years, Paxil and Wellbutrin were advertised as correcting a chemical imbalance in the brain. These three companies have recently been fined a combined $6.7 billion for illegal marketing of their products.Pies has also consulted for ApotheCom, a ‘Medical Communications Agency’ that ‘provides services to support the commercialization of new products…[including]….publications planning, [and] promotional communications…’ (Pharma Voice Marketplace, 2015). While useful context, this isn’t uncommon among academic psychiatrists, and some would say it was par for the course in the 2000s.  However, in a public forum, more transparency is preferable.  Pies blames the drug companies for running misleading advertisements about chemical imbalance, belatedly admits he should have said something sooner, but fails to mention that he was paid to help them promote their products at the time the advertisements were running.

It’s important to realize that organized psychiatry doesn’t always remain silent, such as when the interests of psychiatric prescribers and pharmaceutical companies converge. In the mid-2000s, press releases endorsed by some of the most prominent psychiatrists in the United States were issued objecting to the FDA black box warning on SSRIs (e.g., American College of Neuropsychopharmacology, 2006; Healy, 2012). The APA also issued a press release defending antidepressants (APA, 2004; Healy, 2006). This was at a time when the chemical imbalance metaphor was omnipresent in direct-to-consumer advertising.  While that was seen as a pressing issue to present to the public, misleading messages on chemical imbalance were not.”  (p 209)

Footnote 1 reads:

“We want to be clear that we are not accusing Ronald Pies of anything.  Conflicts-of-interest are routine in academic psychiatry and many of the major pharmaceutical companies have been fined in the recent past.  We do believe that readers deserve to know of his past financial relationships with the drug companies that promoted their products as correcting a chemical imbalance.  The details of these financial relationships are not publicly available.”

I think the above text is clear, and speaks for itself.  It is noteworthy that Drs. Lacasse and Leo take specific pains to protect Dr. Pies from any kind of unjust criticism (“…we are not accusing Ronald Pies of anything.”)  It is also noteworthy that in his email Dr. Pies does not deny that he has consulted for ApotheCom.  Nor does he deny that he received payment for such consultations.  Nor does he deny that ApotheCom’s business is providing “services to support the commercialization of new products”.  Nor does he deny that he received payments from the other drug companies named.  Nor does he deny that these other companies promoted the spurious chemical imbalance theory in their ads.

Dr. Pies simply asserts that he has never accepted payments from pharmaceutical companies with the intent or purpose of promoting their products, and that he has never had ongoing financial relationships with any pharmaceutical company.  This is an unusual rebuttal, in that Drs. Lacasse and Leo never accused him of either of these activities.  I’ll discuss this in more detail later.

In the interests of clarity, I should point out at this stage in the discussion that the terms “promote” and “promotion” are value-neutral, and subject to degrees.  A person may promote a good thing (e.g. world peace), or a bad thing (e.g. racial hatred), and may promote something minimally or avidly.  In addition, a person might promote something  for payment, or gratuitously.

So, if a psychiatrist were to mention to a colleague, in the course of a private conversation, that he finds such and such a drug helpful in alleviating such and such a problem, he has, in effect, promoted the drug in question.  And, he, presumably, would consider this promotion to be a good thing.  Similarly, if a pharmaceutical company launches a massive advertizing campaign on a particular drug, this would also be considered a promotion of the product in question, and, if it resulted in an increase in sales, would be considered a good thing by the company in question.

Similarly, if a psychiatrist writes and publishes an opinion piece in which a certain drug is mentioned favorably, this is a promotion.  In fact, even a relatively neutral mention of a drug by an eminent psychiatrist could be construed as a promotion, along the lines of incidental placement of commercial products in movies.

Dr. Pies also asserts that the “allegation by Lacasse and Leo was not based on any direct knowledge” of his professional or contractual arrangements dating back to 2003.  And he indicated no intentions to make any such information public.

Here, however, are some facts that are in the public domain, interspersed with my comments and reflections.

1.  In July 2002, Dr. Pies published The ‘softer’ end of the bipolar spectrum in the Journal of Psychiatric Practice. He acknowledges that the article is “supported by an unrestricted grant from GlaxoSmithKline.”  The article is a literature review/opinion piece.  Here’s the abstract:

“The prevalence and diversity of bipolar disorder may be under-appreciated. Recent data suggest that when clinicians look beyond strict DSM-IV criteria for bipolar disorder, we find that as many as 5%-7% of the general public may suffer from some form of ‘bipolar spectrum disorder.’ At the same time, the comorbidity between bipolar disorder and other psychiatric conditions may create understandable confusion in diagnosis and treatment. Recognition of bipolar depression and the ‘soft end’ of the bipolar spectrum demands not only the identification of the hallmarks of bipolarity, but a heightened awareness of the problems of missed diagnosis and inappropriate treatment. By attending to some key historical and clinical clues, the psychiatrist is more likely to detect bipolar spectrum disorder and provide appropriate treatment for it.” [Emphasis added]

And here’s a quote from the “Treatment Recommendations and Conclusions” section:

“In the mean time, recent evidence suggests that lithium is at least moderately effective in many depressed bipolar patients,41 and that the anticonvulsant lamotrigine may be a feasible alternative to antidepressants in some depressed bipolar patients.42” [Emphasis added]

Lamotrigine (Lamictal) is an anticonvulsant made by GlaxoSmithKline.

Reference 42, on which Dr. Pies’ recommendation is reliant, is Calabrese JR, Bowden, CL, et al. A double-blind, placebo-controlled study of lamotrigine monotherapy in outpatients with bipolar I depression, J Clin Psychiatry 1999.  This study was funded by Glaxo Wellcome, which in January 2000 merged with SmithKline Beecham to become GlaxoSmithKline.  Three of the authors, John Ascher, MD, Eileen Monaghan, and David Rudd, PharmD, were GW employees.  In addition, the authors thank Gary Evoniuk, PhD, and Elizabeth Field, PhD for “editorial assistance with the manuscript.”  Dr. Evoniuk was, and incidentally still is, an employee of GSK.  According to her bio, Dr. Field worked for GSK from 1989 to 2001, and with astonishing candor, describes her work there as follows:

“I managed an international department of 24 medical publication professionals who wrote/edited manuscripts for peer-reviewed journals describing the results of GSK-sponsored clinical trials in conjunction with the author/investigators. This group supported almost all products in development and marketed by GSK” [Emphasis added]

So it is clear that GSK had a very considerable input into the wording and presentation of the Dr. Calabrese et al article.  The conclusion of the study was:  “Lamotrigine monotherapy is an effective and well-tolerated treatment for bipolar depression.”

So essentially what we’ve got here is:  Glaxo Wellcome funds, and is heavily involved in the production of, a 1999 study which finds in favor of its drug lamotrigine (Lamictal).  And in 2002, GSK contracts with Dr. Pies to write an article on the “bipolar spectrum,” in which Dr. Pies, largely on the basis of Drs. Calabrese’s and Bowden’s findings, recommends the drug, albeit with a measure of caution, for “some depressed bipolar patients.”

But the plot thickens, for this is the same Dr. Calabrese who was described in United States vs. GSK (2012) as “…GSK’s greatest proponent for the use of Lamictal in the treatment of bipolar disorder…”  Dr. Bowden is also mentioned frequently in the same lawsuit.

To provide context for this discussion, I have attached to this post  – as Appendix A – a copy of the Lamictal section of the GSK lawsuit.  It’s a sordid tale, which describes in close detail how GSK illegally and vigorously promoted Lamictal as a “treatment for bipolar disorder.”  The outcome of this lawsuit was that GSK was fined $3 billion, the largest fine for activity of its sort in American history.

I need to emphasize that my introduction of the GSK lawsuit material is to provide context.  Dr. Pies is not named in the complaint, and there is no suggestion from any source that he was complicit in GSK’s illegal activities.  Nor am I suggesting that Dr. Pies was complicit in the activities of Drs. Calabrese and Bowden.  But Dr. Pies did lend credence to their work, by quoting them, and by relying on their findings, even though the extensive GSK involvement in the creation of their report was, and still is, public information.

There are two paragraphs in the United States vs. GSK complaint that have particular relevance.

“471. Just as troublesome as the Lit Alerts and Faxbacks, were the numerous studies by Calabrese, distributed by GSK, which suggest the efficacy and use of Lamictal in patients with bipolar II.”  [Emphasis added]

In other words, the distribution of the Calabrese studies was an integral part of the illegal promotion of Lamictal for bipolar disorder.  And Dr. Pies, by publicizing, and lending credence to, these studies, became a significant, though unwitting, link in this distribution chain.

Paragraph 474 is also important.

“474. GSK’s extremely aggressive off-label campaign for Lamictal included spending large sums of money in the form of unrestricted grants, membership on advisory boards and speaker’s fees on physicians and researchers who served as ‘national thought leaders.’ As with campaigns for other drugs, the campaign for the use of the drug Lamictal in the treatment of bipolar disorders began with the widespread promotion of ‘disease awareness.'”  [Emphasis added]

In other words, GSK’s awarding of unrestricted grants was also an integral part of their promotional campaign, and as we shall see below, Dr. Pies was the recipient of several unrestricted grants from GSK.  Additionally, Dr. Pies’ opening statement in the “Softer End” article that “… 5%–7% of the general public may suffer from some form of ‘bipolar spectrum disorder.'” sounds very like the “widespread promotion of ‘disease awareness'” mentioned in paragraph 474 above.

Given the extent and vigor of GSK’s illegal promotional campaign, it was perhaps almost inevitable that a person of Dr. Pies’ academic stature and unimpeachable reputation for personal integrity, would become a “target” for GSK’s talent scouts.

In 2008, Nassir Ghaemi, MD, et al published an article Publication Bias and the Pharmaceutical Industry: The Case of Lamotrigine in Bipolar Disorder in Medscape.  The article takes to task the drug industry generally (and GSK in particular) for not publishing, and perhaps even concealing, research studies that show their products in a negative light.  Dr. Ghaemi et al focus specifically on “studies with lamotrigine in bipolar disorder.”  Here’s a quote from their abstract:

“In this paper, we review the case of studies with lamotrigine in bipolar disorder, describing evidence of lack of efficacy in multiple mood states outside of the primary area of efficacy (prophylaxis of mood episodes). In particular, the drug has very limited, if any, efficacy in acute bipolar depression and rapid-cycling bipolar disorder, areas in which practicing clinicians, as well as some academic leaders, have supported its use.” [Emphasis added]

Obviously I don’t know if Dr. Ghaemi et al  had Dr. Pies in mind when they were writing this, but as quoted earlier, Dr. Pies had written in 2002 that “recent evidence suggests that…lamotrigine may be a feasible alternative to antidepressants in some depressed bipolar patients.”

. . . . .

In passing, I should probably comment on the term “unrestricted grant.”  Strictly speaking, this means that the money is given with no strings attached.  The grantee is assured the freedom to express and publish his views with no pressure from the grantor.  In practice, there often are pressures, subtle and otherwise.  Here’s what the distinguished Professor Emeritus of Medicine at UCLA, Jerome Hoffman, MD, wrote on this matter on June 12, 2013, in a guest post on the blog site Common Sense Family Doctor:

“Excuse me, but Pharma doesn’t throw away its money. There is no such thing as an unrestricted grant; if it didn’t buy value in return, why would they pay for it? And if the author didn’t write something they like to read, do you think he’d ever get another unrestricted grant?”

And here’s what the highly-respected psychiatrist Daniel Carlat, MD, wrote on June 17, 2007:

“While the term ‘unrestricted’ implies that the company had no strings attached to its money, the reality is that any physician or MECC (medical education communication company) who receives drug company funding knows that their lecture or article will be closely perused by those with the cash, and that future ‘gigs’ will be dependent on whether the company feels their product is shown in a favorable light.”

As we will see later, Dr. Pies has received several unrestricted grants from GSK.

. . . . . 

2.  In December 2002, Dr. Pies wrote an opinion piece: Combining lithium and anticonvulsants in bipolar disorder: a review, for the Annals of Clinical Psychiatry.  The article was funded “by an unrestricted grant from GlaxoSmithKline.”  Here’s a quote from the abstract:

“More recent reports suggest that lithium may be safely and effectively combined with lamotrigine, and perhaps with topiramate, although controlled studies are required.” [Emphasis added]

Here are some quotes from the body of the article:

“Since 1994, there have been at least 21 open-label, uncontrolled case reports or studies examining lamotrigine in bipolar disorder, with a cumulative control group of over 300 patients (26,27). While a review of this literature is beyond the scope of the present paper, a few points are worth noting. In their own review of 14 open clinical reports involving 207 patients with bipolar disorder (66 with rapid cycling), Calabrese et al. (26) concluded that lamotrigine demonstrated moderate-to-marked efficacy in depression, hypomania, and mixed states; however, efficacy in hospitalized manic patients was not clearly shown, and many of these studies used lamotrigine as add-on (adjunctive) therapy. In the Bowden et al. study (27), lamotrigine was evaluated in patients with refractory bipolar disorder, either as monotherapy (n = 15) or as add-on therapy (n = 60). A total of 23 subjects (31 %) were taking lithium at the initiation of the study; three additional patients received lithium later in the study. Overall, both rapid-cycling and nonrapid-cycling patients experienced symptom reduction and functional improvement over the course of 48 weeks.” [Emphasis added]

Reference 27 is a Glaxo Wellcome-funded study by Drs. Bowden, Calabrese, et al.  Four of the authors were GW employees.

Here are some more quotes from Dr. Pies’ article:

“The patient populations in open studies of lamotrigine have been quite heterogeneous, and lamotrigine has been used as both add-on and monotherapy.  These studies have suggested lamotrigine’s efficacy in depressed, hypomanic, and mixed bipolar patients.” [Emphasis added]

Lamotrigine monotherapy is generally well tolerated.” [Emphasis added]

“From the standpoint of pharmacokinetic interactions, the combination of lamotrigine and lithium appears to pose no significant problems. Specifically, administering lamotrigine with lithium does not significantly alter the pharmacokinetics of lithium (35). Preliminary indications indicate that the combination of lamotrigine and lithium is well tolerated in most patients.” [Emphasis added]

“The addition of lamotrigine to lithium seems most useful for patients refractory to lithium alone who show prominent depressive symptoms and/or rapid cycling.”

But a product can also be promoted by criticizing the competition, in this case, divalproex, (Depakote):

“A larger cohort study of lithium-divalproex [Depakote]combination has yielded mixed results. Specifically, in an open study, Calabrese et al(19) examined large cohorts of rapid-cycling bipolar patients ( N = 271), over a 6-month study period. Of the total group, 215 had comorbid alcohol or drug abuse, 56 did not. In the group as a whole, the combination of lithium and divalproex was associated with marked acute and continued antimanic efficacy in 85% of patients and marked antidepressant efficacy in 60%. However, only one half of patients experienced bimodal mood stabilization.  Premature discontinuation of treatment was disproportionately associated with refractory depression compared with refractory hypomania/mania/mixed states ( n = 41 vs 14). Comorbid alcohol/substance abuse did not directly affect response rates in compliant patients, but did worsen prognosis by increasing rates of poor compliance. The majority of patients receiving lithium/divalproex therapy who required additional treatment were depressed. Indeed, at the time of presentation, most patients with rapid-cycling bipolar disorder are in the depressed phase of illness, which appears to be the “hallmark” of rapid cycling (19).  Given this observation, and that antidepressant use has been discouraged in rapid cyclers, the authors note the pressing need for a pharmacotherapy that markedly reduces depressive symptoms without provoking ‘switching’ or cycle acceleration.” [Emphasis added]

Here again, note that reference 19 which Dr. Pies is citing is a study conducted by Dr. Calabrese, Bowden, et al in 2001, and was funded by Glaxo Wellcome and NIMH.

. . . . .

3.  In October 2002, Dr. Pies published Have we undersold lithium for bipolar disorder? as an editorial in the Journal of Clinical Psychopharmacology. The editorial was funded by an unrestricted grant from GSK.  Here’s a quote from the conclusion:

Lamotrigine looks very promising for bipolar depression and prophylaxis, but more studies are needed to define and solidify its role. The same goes for topiramate. Olanzapine, while useful in mania and perhaps as an adjunctive agent in bipolar depression, has yet to prove itself as monotherapy in bipolar prophylaxis. Furthermore, concerns about the neuroendocrine effects of valproate and olanzapine—both of which have FDA labeling in bipolar disorder—must also give us pause. As for gabapentin, there are still no randomized, controlled studies of monotherapy showing this agent to be effective in any type or phase of bipolar disorder.”  [Emphasis added]

Here’s another quote from the body of the editorial:

“Recently, Calbrese et al.13 presented data from two large, double-blind, placebo-controlled, studies comparing lamotrigine and lithium in the maintenance treatment of bipolar I disorder. While both active agents delayed time to ‘any’ bipolar event, a separate analysis (manic/hypomanic/mixed vs. depressive events) found that lamotrigine had more robust effects than lithium in delaying onset of depressive episodes.” [Emphasis added]

Reference 13 is to: Calabrese JR, Bowden CL, et al. Lamotrigine or lithium in the maintenance treatment of bipolar I disorder [abstract NR 236]. Presented at the American Psychiatric Association Annual Meeting, Philadelphia, PA, 2002.

. . . . . . . . . . . . . . . .

4.  In February 2006, Dr. Pies and Patricia Marken, PharmD, co-authored an opinion piece Emerging Treatments for Bipolar Disorder: Safety and Adverse Effect Profiles in the Annals of Pharmacotherapy. The article was “supported by an unrestricted grant from GlaxoSmithKline.”  Here are the authors’ conclusions:

“Pending the results of ongoing controlled studies, several emerging agents may be useful additions to the therapeutic arsenal for BPD.” [bipolar disorder]

And here are some quotes from the body of the paper:

Lamotrigine [Lamictal] is the only newer AED [anti-epileptic drug] with randomized, placebo-controlled data supporting its use as maintenance treatment in BPD.” [Emphasis added]

Lamotrigine is the most studied of all emerging treatments for bipolar maintenance.72 It appears to be more useful in bipolar depression than in mania.72” [Emphasis added]

Lamotrigine was well tolerated, with an adverse event profile similar to that of placebo. Lamotrigine did not appear to induce mania and was not associated with sexual adverse effects,79 weight gain,80 or withdrawal symptoms.79” [Emphasis added]

Reference 72 is to a study by Drs. Bowden, Calabrese et al, 2003.  It was funded by GSK.  Four of the authors were GSK employees, and a further five GSK employees are acknowledged for assistance “in the preparation of this article.”

Reference 79 is to Bowden et al, 2004.  Three of the six authors were GSK employees.

And at the end of the Drs. Pies and Marken article (before the references) it states:  “We gratefully acknowledge Drs. Jacqui Brooks MBBCh MRC Psych and Laurie Barclay MD for their contributions during the preparation of this manuscript.”  No information is provided as to Dr. Brooks’ or Dr. Barclay’s affiliations, or who was paying for their contribution.  But Dr. Brooks’ bio is online, and according to this, she is currently Senior Vice President Medical Strategy at RMEI [Robert Michael Educational Institute].

Dr. Brooks’ bio also states:

“Seasoned healthcare executive with strong blend of clinical (trained psychiatrist) and strategic leadership accomplishments. Documented capacity to analyze evolving environments, provide strategic direction, and successfully lead teams in developing innovative, high-quality products and brand strategies. Proven success in business growth and development in the medical communications environment.” [Emphasis added]

There is no indication in Dr. Brooks’ bio that she ever worked as a psychiatrist.  Her employment history shows that from 2002 to 2005, she was working for ApotheCom Associates as VP Scientific Affairs, Senior Medical Director.  ApotheCom describes itself as “…a Global Medical Communications Powerhouse…”  PharmaVoice provides the following description:

“ApotheCom provides services to support the commercialization of new products at a global level as well as promotional programs for the US market. Services include thought-leader optimization, publications planning, promotional communications and education programming.”

Drs. Pies’ and Marken’s “Emerging Treatments…” article was published on January 10, 2006, so was probably developed during 2005, and it seems likely that Dr. Brooks’ contribution to the manuscript was in her capacity as an ApotheCom employee.  I have no way of knowing who was paying for ApotheCom’s services with regards to this paper, but it is in the public domain that in 2002, GSK made an educational grant to ApotheCom Associates for an article by Robert Hirschfield, MD.

Nor have I any information as to what kind of contribution Dr. Brooks might have made to the manuscript in question.  But her career and bio summary suggest that it might have been more in the area of “brand strategies” and “business growth” than psychiatric technicalities.  Why would an experienced and eminent psychiatrist-writer, like Dr. Pies, need help with a manuscript on the treatment of bipolar disorder from a “seasoned healthcare executive”, employed by a company that specializes in thought-leader optimization, publications planning, promotional communications and educational programming?  It is, I think, particularly noteworthy, that in the acknowledgement of Dr. Brooks’ contribution to “the preparation of the manuscript”, no information is provided concerning her affiliations, or who was paying for her services.  This, I suggest, constitutes, at a minimum, incomplete disclosure.

I was unable to find any information on Laurie Barclay, MD.

. . . . . 

5.  In August 2006, Dr. Pies and D.F. MacKinnon, MD, published: Affective instability as rapid cycling: theoretical and clinical implications for borderline personality and bipolar spectrum disorders in the journal Bipolar Disorders.  The article, which is a literature review/opinion piece, was “Supported by an unrestricted grant from GlaxoSmithKline.”

Here are the article’s conclusions:

“The same mechanism may drive both the rapid mood switching in some forms of bipolar disorder and the affective instability of borderline personality disorder and may even be rooted in the same genetic etiology. While continued clinical investigation of the use of anticonvulsants in borderline personality disorder is needed, anticonvulsants may be useful in the treatment of this condition, combined with appropriate psychotherapy.” [Emphasis added]

Note that lamotrigine (Lamictal) is an anticonvulsant.

And here are some interesting quotes from the article:

“To our knowledge, there are only two randomized,  double-blind, placebo-controlled studies of anticonvulsants in well-defined rapid cycling populations, both by the same group, and only one currently in the literature (59). In the published study, 182 rapid cycling patients were randomized to lamotrigine monotherapy or placebo. The study found that 41% of lamotrigine-treated versus 26% of placebo-treated patients were stable without relapse during 6 months of monotherapy. Patients with rapid cycling bipolar II disorder consistently experienced more improvement than did bipolar I patients. Most patients who were assigned to double-blind treatment were in the midst of a depressive episode, suggesting antidepressant effects of lamotrigine in bipolar disorder, consistent with the results of a separate, open-label trial of lamotrigine versus lithium in rapid cycling patients (60).” [Emphasis added]

Reference 59 is to a 2000 Calabrese, JR, Bowden, CL et al study funded by Glaxo Wellcome.  Four of the authors were GW employees, and the authors acknowledge assistance from Gary Evoniuk, PhD and Tracey Fine, MSc “in the preparation” of the article.  Both Dr. Evoniuk and Ms. Fine were GW employees at the time this study was conducted.  Ms. Fine’s position was Medical Publications Specialist.

Here’s another quote from Drs. Pies’ and MacKinnon’s opinion piece:

“Preliminary data suggest that lamotrigine may also have benefits in borderline personality disorder, with or without comorbid bipolar disorder.  In an open case series of eight medication-refractory borderline personality disorder patients without concurrent major mood disorders, lamotrigine produced sustained remission in half of those who completed the trial, with notable benefit against impulsive sexual, drug-taking, and suicidal behaviors.(69)” [Emphasis added]

Reference 69 is to: Pinto OC and Akiskal HS, 1998 which was funded by Glaxo Wellcome.

Here are more quotes from the Drs. Pies and MacKinnon opinion piece:

“Randomized, double-blind, controlled studies using lamotrigine appear warranted in this population; however, until these are completed, the utility of lamotrigine in borderline patients remains uncertain.  Nevertheless, one can conclude from the juxta-position of these studies of anticonvulsants in rapid cycling bipolar disorder and borderline personality disorder that at least some anticonvulsants are effective in alleviating not only the affective instability common to both conditions, but also specific measures of what have heretofore been considered fixed traits among borderline patients.” [Emphasis added]

Note how the initial note of skepticism pending the completion of randomized controlled trials is effectively neutralized by the material after the words:  “Nevertheless one can conclude…”.  And note the strength of the assertion:  One can conclude that some anticonvulsants (e.g. Lamictal?) can remediate what have previously been considered fixed traits!

“Once the biological roots of mood instability are better understood, there may be much more to contribute to the understanding of the development of our conventional notions of character and personality.”

And, presumably, more perceived justification for the use of psychiatric drugs to “fix” problems of personality and character.

“We conclude that in at least a sub-group of cases, borderline personality disorder may be an atypical presentation of a primary mood disturbance, probably related to the broad spectrum of bipolar-like disorders. It is premature to recommend anticonvulsants in the routine treatment of patients with borderline personality disorder; however, it seems that anticonvulsants may belong in the psychiatrist’s armamentarium for treatment of this condition.”

Here again, note how the appropriate cautionary lead-in is neutralized by the statement after the word “however”.  The suggestion that anticonvulsants belong in a psychiatrist’s “armamentarium” clearly entails the notion that these products should be used in the “treatment” of “borderline personality disorder”.

And as mentioned before, a drug can be promoted by knocking the opposition, in this case divalproex (Depakote).

“The second randomized, double-blind, controlled study (61) involved a 20-month, parallel group comparison of 60 patients with a history of recent rapid cycling bipolar I or II disorder.  Patients were randomized to lithium or divalproex monotherapy in a balanced design after stratification for bipolar type I and II. For subjects on either lithium or divalproex, about half suffered a relapse: a third into depression, and one-fifth into mania or hypomania. Although clearly better than placebo, it appears there was no benefit of divalproex versus lithium.”

Reference 61 is to a study by Dr. Calabrese, et al.  The study was funded by the NIMH and the Stanley Medical Research Institute.

. . . . . 


I don’t think there can be any doubt, that in the five papers discussed above, Dr. Pies and his various co-authors did make numerous favorable mentions of the drug lamotrigine, and that the articles were funded by grants from GSK.

Dr. Pies could, of course, respond to all this by stating that he helped promote Lamictal on its merits alone, and that this promotion had nothing to do with the funding and/or manuscript assistance that he coincidentally received from the manufacturer of this product (GlaxoSmithKline).  And he could contend that he cited the studies by Drs. Calabrese and Bowden purely on their merits.  And all of this could well be true.

But as Dr. Pies himself wrote in a Psychiatric Times article – The Age of Conflicts—of Interest – on August 1, 2008:

“…the physician or researcher may not even be aware of his real motivation. We are all quite capable of rationalizing our own self-interest in the name of the patient’s well-being,’  ‘the need for the latest technology,’ and so on.”

Dr. Pies could also argue that in the above examples, I have cherry-picked the quotes, and that his treatment of these topics is more balanced than I have portrayed.  And indeed, there would be an inevitable measure of truth to this contention.  Obviously I can’t quote the articles in their entirety, and Dr. Pies does sometimes mention drawbacks in the sponsor’s drug, and positive aspects of a competitor’s product.  But I have tried to be fair, by selecting quotes that convey the general tone of each piece with regards to lamotrigine, and, I encourage readers to consult the articles in question, and decide this matter for themselves.

Dr. Pies could certainly quibble over any particular quote – or even over any particular paper – as to whether it constitutes promotion of a pharma product.  But of greater importance is the cumulative effect of the multiple passages quoted above in the context provided by the GSK lawsuit complaint and the multiple GSK-sponsored studies.  In this post I have discussed and quoted from five opinion pieces, authored or co-authored by Dr. Pies.  All of the articles were funded by GSK, and all refer to studies conducted by Dr. Calabrese et al.  And remember, Dr. Calabrese is described in the GSK lawsuit as “…GSK’s greatest proponent for the use of Lamictal in the treatment of bipolar disorder…”

In my view, Dr. Pies’ statements in the various articles would appear, to an impartial reader, as recommendations or promotions of lamotrigine.  And it is worth pointing out that I am neither particularly skilled, nor particularly systematic, in conducting literature searches.  It is entirely possible that a more competent searcher would uncover a great deal more material of a comparable nature.  And it also needs to be borne in mind that I have focused on only one drug – Lamictal.  A search of Dr. Pies’ writings concerning other pharma products could conceivably reveal similar complications.  I did, for instance, come across a 2005 article written by Dr. Pies and Winkelman which stressed the efficacy of the sleeping pill eszopiclone (Lunesta), manufactured by Sepracor, now Sunovion.

This reported efficacy was based on Ref # 146, a 2003 study by Andrew Krystal, MD et al.  The Krystal et al study concluded:

“Throughout 6 months, eszopiclone improved all of the components of insomnia as defined by DSM-IV, including patient ratings of daytime function. This placebo-controlled study of eszopiclone provides compelling evidence that long-term pharmacologic treatment of insomnia is efficacious.”

There were seven authors of this study.  Three of the authors are listed as “consultants, investigators and advisory board members to Sepracor.”  A fourth author is listed as a Sepracor consultant.  And the remaining three authors were Sepracor employees.

In their opinion piece, Drs. Pies and Winkelman did not point out that the Krystal et al study was largely a Sepracor in-house project.  Nor did they disclose the funding source (if any) for their opinion piece, but in their acknowledgement section, they wrote:

“The authors would like to acknowledge Sepracor Inc. for its assistance in the preparation of this manuscript.”

I have no way of knowing what this assistance entailed, but it does imply that Sepracor did – at the very least – have some collaborative input in the wording of the article.  It seems unlikely that any such input would work to the detriment of their product.  Why would an eminent psychiatrist of Dr. Pies’ stature need help from a pharmaceutical company to write an opinion piece on the treatment of insomnia?  What kind of help did Sepracor provide?

. . . . . 

It also needs to be stressed that, as far as I know, Dr. Pies has done nothing wrong, in any formal sense of the term.  He has accepted grant money from pharmaceutical companies to write opinion pieces on various psychiatric topics, and if he came down in favor of the grantor’s product, there are no definite indications that his motivations were anything but pure.  It also needs to be stated that Dr. Pies is a prolific writer, and that the articles cited above represent only a tiny fraction of his published work.  It is possible that a more comprehensive review of his writing over the period in question would show that these kind of industry-sponsored opinion pieces constituted a small fraction of his overall output.

A further question in all of this is why Dr. Pies should be so upset at the suggestion that he had received payment to write articles that helped promote psychiatric drugs.  If Dr. Pies believes that the drugs are efficacious and generally benign, why shouldn’t he help promote them, and why shouldn’t he be afforded reasonable compensation for this activity, particularly when he discloses these arrangements in the papers.  Why should the acceptance of payments in these matters have any bearing on his professional reputation?

But over-riding all of this, is the obvious fact that Dr. Pies has mis-read the phrase  “…he was paid to help promote their products…”  Specifically, he has apparently formed the belief that the phrase purports to describe his motivation in these transactions.  In fact, the use of the passive voice (he was paid) makes it clear that it is the payer’s motivation that is the matter of focus, not the payee’s.

To clarify the distinction, compare the two statements:

He was paid to help promote the drugs.


He accepted payment to help promote the drugs.

The first statement clearly entails the notion that the payers were paying the individual with the intention – and presumably expectation – that he would help promote the drugs.  The statement tells us nothing about the payee’s intentions, or even his awareness, of the payer’s intentions.  The second statement, by contrast, clearly purports to describe the payee’s motivation, but Drs. Lacasse and Leo made no statement of that kind.

There is a perfect parallel to this in the drug industry’s widespread use of “thought leaders” to promote their products.  This particular hoax was thoroughly explained by Daniel Carlat, MD, in his 2010 book “Unhinged.”  Here’s how it worked:

A drug rep would approach a psychiatrist and tell him that he – the psychiatrist – was considered a “thought leader” or “key opinion leader” in the area, and that they would like to recruit him to give lectures and presentations to other psychiatrists on the value of a particular drug.  The drug company would train the psychiatrist, and would provide slides and other teaching aids, and would pay the psychiatrist for delivering the presentation.

And this is where it gets subtle.  The psychiatrist thought that the targets of these endeavors were the psychiatrists in the audience – that he was being paid to promote the drug in question to them.  In reality, and this was what Dr. Carlat exposed, the lecturer-psychiatrist himself was the actual target.  By getting him to extol the merits of a drug to his peers, the drug company was actually generating pressure within the lecturer to prescribe the drug more frequently himself.  And the tactic was extremely successful!

So, from the psychiatrist’s point of view, the following statement would be true:

I was paid to give lectures on this drug.

But from the drug company’s point of view, the following statement was true.

We paid him so that he would prescribe this drug more often.

Obviously the psychiatrist in question would object to the latter statement, because he had no knowledge of the drug company’s motivation or tactics.

Similarly, with regards to GSK’s “unrestricted grants, there can be no doubt, given the context outlined above, that GSK was awarding these grants to help promote Lamictal.  And this is the case, even though from Dr. Pies’ point of view, he was merely accepting payment from GSK to write scholarly articles.

In short, like the psychiatrists in Dr. Carlat’s account, he was systematically misled as to the real purpose of the articles.

. . . . . 

It is worth remembering that this matter began with Dr. Pies’ efforts to distance psychiatry from the chemical imbalance theory of depression, and to lay the blame, or at least some of the blame, for this hoax, onto pharma commercials.

The central point of this entire issue is that at the time these deceptive commercials were running, and running very successfully, Dr. Pies was contracting with these same companies to write articles about their products, and his payments came, at least in part, from revenues generated by these very ads.  Dr. Pies’ current condemnations of pharma’s past excesses would be more convincing today if he had lodged clear statements of protest at the time, or better still, if he had refused to accept their grant contracts, on the basis that the money was tainted.


One of my main purposes in writing on this website is to draw attention to psychiatry’s spurious foundations, and to its inherently destructive and disempowering “treatments.”  I also critique the work of writers who seek to promote or exculpate psychiatry, including Dr. Pies.

But my critiques are always directed towards the issues, and are always directed at errors of fact or logic.  In particular, I take special pains to avoid anything that could, even remotely, be construed as a personal attack, or an attack on an individual’s character.  In the case of Dr. Pies, I have always afforded him the respect due to a person of his stature, and have frequently expressed the belief that his primary error is one of loyalty:  that he loves his chosen profession, in the word’s of Shakespeare’s Othello, “not wisely but too well.”

I have read and re-read Dr. Pies email, and in the light of that communication, I have re-read my earlier post.  But I can find nothing in that post that could reasonably be considered false, malicious, or defamatory.

But I’m also a realist, and I recognize the obvious fact that we are all capable of being biased in respect of our own writings.  I am open to suggestions concerning this matter, and if Dr. Pies were to specify which statement or statements on my part have generated a sense of grievance on his, I would be happy to take another look at the document.  And if, in the light of such re-examination, Dr. Pies’ expressions of concern are credibly vindicated, then I will apologize publicly, and retract the statement(s) in question.

* * * * *

Dr. Pies’ response:

Dear Mr. Cole:

I have read Dr. Philip Hickey’s 8400+ word treatise, and I have only the following to say with regard to the two key points at issue:

  1. Notwithstanding my omission of quotation marks in my original Medscape article[1] — for which I take responsibility — the fact remains: I have never believed or argued that the so-called chemical imbalance theory (which was never really a theory) is merely a “little white lie.” It is that point of view—not merely typed words on the page — that has been falsely and carelessly attributed to me.  
  2. I have never received a dime from any pharmaceutical company or private agency with any verbal or written understanding that I would “promote” (elevate, popularize, hype, etc.) a particular drug. If any of the papers I wrote or co-authored over a decade ago had the effect of putting a drug in a favorable light, it was because the best scientific evidence available at that time supported the drug’s benefit. Nothing in Philip Hickey’s belaboring of half-truths, innuendos and guilt by association demonstrates otherwise. 


               Ronald Pies MD   



The MHRA (UK Medicines Regulator) Has No Interest In Seroxat Suicides…


“…Study 329 seems to fit the classic picture. It has Big Pharma ghostwriting articles, hiding data, corrupting the scientific process and leaving a trail of death, disability and grieving relatives in its wake…”

Dr David Healy November 2015

“..In 2002 alone, over 2 million prescriptions were written for children and teens, and many more for adults…”

“…Yet this BMJ study deals an especially sharp blow, for it’s only rarely that researchers are able to crack open the tightly sealed file cabinets of drugmakers and look at raw trial data. ”

The Atlantic 2015

The MHRA (The UK Medicines Regulator) has been utterly toothless in regards to bringing GlaxoSmithKline to book over the appalling Seroxat scandal. Seroxat was first licensed in 1991, therefore effectively for 25 years the MHRA has allowed GSK to make a profit off a drug which has killed, harmed and maimed many people. This drug should have been pulled from the market in 2001 when the first BBC expose about the dangers of Seroxat suicide, violence and withdrawal first surfaced. However, considering the current MHRA CEO, Ian Hudson, is a former long time GSK employee, who testified in favor of Seroxat (Paxil in the US) before he left to join the regulatory industry, I won’t hold my breath for the MHRA to act in patients’ interests any time soon. They are clearly more interested in protecting Pharma before patients.

In October this year, the BMJ (British Medical Journal)- the most esteemed medical journal in the world- published a damning re-interpretation of a study on Seroxat (study 329). Although, this study showed how dangerous Seroxat is in the under-18’s age group, it also opened up a can of worms about the safety of Seroxat in all age groups. If Seroxat is lethal in under-18′s, and causes them to commit suicide, self harm, and causes other horrible side effects, and the MHRA agree with these findings, then why do the MHRA dispute that Seroxat can cause the same effects in adults? It’s like saying that cyanide is not for kids, but adults are ok. It’s just simply absurd to say that Seroxat is in any way safe for adults; particularly in 2015.

Bob Fiddaman, the author of the Seroxat Sufferers Blog, has been asking the MHRA a very interesting question regarding Seroxat’s ‘safety’ profile; a question which I have been trying to draw attention to also on this blog for quite some time-

Dear Sir/Madam,

With respect, you have not answered my question. I am already aware of the Expert Working Group and their findings.

My question, which I believe, you have not answered, is…

If a patient, at the age of 16, suffers suicidal thinking whilst on paroxetine – but continues to take paroxetine and continues to feel suicidal thoughts. What happens when they reach, 25, 26 or 27, do these suicidal thoughts magically disappear?

The question we are asking here, is extremely important, and it bring the entirety of Seroxat prescribing into question.

The MHRA admit that Seroxat should not be prescribed to under 18’s because it can increase suicidal thoughts in those age groups. But, what happens when an individual is prescribed Seroxat when they are under-18 but continue on it until they are over-18? Does the risk magically  disappear?

This question is important because it’s ridiculous to assume that risks from a drug would change so dramatically just because of an over-18 threshold. We don’t automatically change into an adult body, or suddenly become completely different psychologically, biologically or behaviorally, when we turn 18. Growing up, maturing, and the changes which take place both physically and psychologically, happen over a gradual period.

The adolescent brain is different than the young adult brain, and the same could be said for a young adult and an adult’s brain. Nonetheless, peoples’ brains do not suddenly change from adolescent to a young adult on their 18th birthday. The age 18 threshold in regards to Seroxat side effects is ridiculous.

According to recent findings, the brain does not fully mature until at least 25 anyhow, and furthermore, it is also arguable that prescribing an SSRI drug over a long period of time could affect how the young adult brain develops. If SSRI’s cause birth defects so easily, I dread to think what kind of damage they do to our brains (at any age).

Millions of adolescents were prescribed Seroxat (Paxil/Aropax) when they were under 18, particularly in the late 90s/early 2000’s and many of them had serious reactions, but they weren’t warned of the dangers, so many they stayed on the drug until they were over-18, even though it was doing them damage. Many of these teenage Seroxat casualties could not come off it because of the severe withdrawal reactions Seroxat induces, some stayed on it well into adulthood. Some committed suicide because of Seroxat, some got off, and some are still enslaved to it.

The issue of Seroxat causing so much harm to under’18s raises a huge red flag for Seroxat in all ages groups, a red flag which many have been trying to draw attention to for over a decade now. However, the MHRA have no interest in Seroxat harming adults, or children, or Seroxat harming anyone in fact. After 25 years of constant bad press, and clear evidence that Seroxat is a dangerous drug, the MHRA continue to allow it on the market. Why?

Personally, I believe that the MHRA possibly suspect that Seroxat is lethal, but if they pulled it now (after all these years of ineptitude), or admitted that Seroxat harms adults in the same way, they would open themselves up for obvious negligence, and an admittance would open too many cans of worms, therefore they continue to deny, ignore or obfusticate because that’s the only way they know how to deal it. If they were to acknowledge the truth about Seroxat, that would open their whole regulatory system up to scrutiny. Seroxat was the ‘canary in the coalmine’. It serves as a warning that we are not safe, just like thalidomide did in the 1960’s. If we can’t trust the pharmaceutical companies, and we can’t trust the data on their drugs, and we can’t trust the regulators to keep us safe from harm, how do we trust in the efficacy of any pharmaceutical products? We can’t, and we shouldn’t.

The MHRA’s response to Bob Fiddaman on the question of Seroxat harming under-18’s (but still being prescribed to over-18’s despite the known risks) and the conundrum that is presented within the question itself, is the typically glib and sarcastic response that they have been giving for years now. They simply must not care that Seroxat has killed and maimed many people. If they did they would have done something about it by now..

But as we can see from their dismissive response to Bob Fiddaman, they will do anything to avoid opening the Seroxat can of worms..

Dear Mr Fiddaman,

Thank you for your email.

This is a theoretical question which we are unable to respond to as a patient’s health condition will vary for each individual. The clinical care of a patient is the responsibility of their doctor; healthcare professionals are recommended to closely monitor their individual patients on SSRIs for suicidal thoughts and discuss their symptoms with them to determine the best course of action with regards to possible treatment.

Kind Regards,

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency

It’s interesting how the MHRA are trying to deem that Bob’s question is merely theoretical. It may be theoretical in the way it is phrased, but it is also a real question based on real scenarios, and there are many under 18’s who were prescribed Seroxat and had serious adverse reactions, but because they were in the dark at the time of being prescribed Seroxat, they continued on the drug until adulthood.

The ‘theoretical’ scenario which the MHRA are trying to denigrate and dismiss actually happened to many people. It’s not astrophysics. These events happened to people, and people suffered for it. This is not ‘theoretical’- many people have been harmed from Seroxat. That’s a fact.

It seems to me that when people question GSK about Seroxat they are told to talk to their doctor, but when they ask their doctor their doctor says that its the regulators responsibility to keep us safe from harmful drugs and that they are not responsible for it. If we question the regulator about our concerns about Seroxat, the regulator also tells us that its the doctors responsibility, not theirs. So effectively patients are pushed upon a never ending ‘circle of pass the buck’ with nobody ever taking responsibility. This is just not good enough. Patients deserve better.

I will be interested to see what the MHRA have to say in response to Bob’s last question to them. Their obfuscation tactics, in regards to avoiding the Seroxat Scandal, are really wearing thin after 25 years..

Keep an eye on Bob’s blog for more on this-

Then, based on your answer, pediatrics and adolescents taking SSRi’s off-label are at risk of suicidal thinking but when they reach a certain age (26) they are not at risk, that risk, according to the MHRA SSRi prescribing guidelines, magically vanishes?

Currently, SSRi’s are not recommended for anyone up to the age of 25 years, correct?
How did the MHRA arrive at this? Was it based on a set of theoretical circumstances?
Please explain, in detail, how the MHRA arrived at the decision that any person up to the age of 25 is at a higher risk that those over the age of 25, ie; what criteria did you use?
Bob Fiddaman

Mental Health Advocate, Gareth O’ Callaghan Speaks Out!..

“…This week GlaxoSmithKline, the makers of Seroxat, are under the spotlight. A 2001 report stated that the drug, which is frequently prescribed to teenagers, was both effective and safe. It turns out that this is not true.

In fact Seroxat is neither as effective or as safe as we were all led to believe. It also turns out that it is more dangerous than we knew. I often wonder how Andrew Witty, the CEO of GSK, feels about running a company that makes a drug that can cause suicidal thoughts and prompts? Does it keep him awake at night? I know that citalopram kept me awake at night.”…

Great post recently by Irish mental health campaigner (author and radio DJ), Gareth O Callaghan, on his facebook page, about the perils of psychiatric (SSRI) anti depressant drugs, and psychiatric (mis) treatment.

I agree fully with Gareth and I commend him for speaking out.

I remember reading Gareth’s first book on depression, ” A Day Called Hope: A Journey Beyond Depression” about his own personal experience of severe depression some years ago now, and being very moved by it.

Gareth is also a fine novelist and radio host. He is genuine and sincere and this comes across.

Keep speaking out Gareth


I was asked today if I was trying to “ruffle a few feathers” with my recent posts here on antidepressant drugs and ECT (electroshock treament). Maybe the posts will make a few so-called professionals uncomfortable, but that’s not the reason I write them.

My posts (based on my own personal experiences) are not written with these people in mind. If they are written for anyone specifically, they are for the unsuspecting patient.

My post on antidepressant medications yesterday was slated by a number of people who don’t have the backbone to show their names publicly. They private-messaged me to tell me I was ‘irresponsible’, and ‘reckless’ with my story. Read my words: it’s my story. You don’t have to read it if you don’t want to.

The reason I write is not to scare people, or ‘advise them to stop their meds’, as one person suggested I was doing. I am doing one thing, and just one thing: I am sharing my own experiences in the hope that it shows others the importance of taking back control of their health issues.

Many psychiatrists will not help you to improve your mental health. Many don’t know how to. If you really want to overcome depression and anxiety issues, get a good therapist/counsellor and talk things through. Study the benefits of mindfulness. Start looking at what you are eating and how you sleep. Adopt a dog from an animal shelter. These are just some of the proven natural antidotes to depression. Drugs are not an antidote in either the short- or longterm. They carry huge risks. In many cases they carry deadly risks.

Shane Fennell died as a result of the toxic effects of citalopram (cipramil, Celexa) six years ago. He had been taking the antidepressant for only 17 days.

In his defence at the Coroner’s Court, renowned scientist, and psychopharmacologist, Dr David Healy said that the antidepressant was the cause of Shane’s behaviour (and violent death). I followed this case avidly not only because of the huge media coverage it received, but also because I too took citalopram many years ago.

I can identify with the Akathisia (restless, aggressive inner anxiety) that Shane suffered as a result of the drug. I could really frighten people here if I was to explain in detail what Akathisia does to the mind. Thankfully I had a chance to stop taking the tablets. Shane didn’t. He died, and in the process killed another man in a shocking knife frenzy that was completely out of keeping with his gentle and caring nature.

Patricia Casey, the emminent psychiatrist, unexpectedly turned up at the hearing. She was not called on by the coroner to give evidence; although she did say after the hearing that David Healy’s evidence was speculative. She stated that she believed Shane Fennell died because of his “illness”, not because of the drug he had been prescribed.

It’s more important to remember here that Shane Fennell was not ill. He had no “illness”, Doctor Casey. He had just broken up with his girlfriend and his heart was broken. Since when did heartbreak become an illness?

This week GlaxoSmithKline, the makers of Seroxat, are under the spotlight. A 2001 report stated that the drug, which is frequently prescribed to teenagers, was both effective and safe. It turns out that this is not true.

In fact Seroxat is neither as effective or as safe as we were all led to believe. It also turns out that it is more dangerous than we knew. I often wonder how Andrew Witty, the CEO of GSK, feels about running a company that makes a drug that can cause suicidal thoughts and prompts? Does it keep him awake at night? I know that citalopram kept me awake at night.

I want to talk here this evening about medicating depression with prescription drugs. Most people don’t want to talk about it. I do. And I talk about it often. And lots of people think I am bitter and uneducated. I am neither. I like truth and honesty. Many people don’t.

Taking antidepressants has become one of those grubby little secrets that many people feel uncomfortable to talk about, let alone admit. And it shouldn’t be like that.

It’s almost as if I need to justify why I take something that makes me feel better; that’s if, of course, it makes me feel better. It didn’t, so I stopped taking them. They made me so sick I can’t understand why I fed into the lie. Maybe back then the truth was hard to find. Maybe the pills made me realise I had to find another way.

I have received many emails and messages from people asking me about my views on antidepressants; some of the emails also criticising my views on mind-altering drugs (some of which are no different from the effects delivered by illegal drugs), and also how to find a way to stop taking them.

Therefore I would like to break this post into a series of different posts because it’s an area that is quite complex and divisive, and it also takes time to explain the importance as to why I want to write about this.

I am regarded as ‘anti-medication’. This is wrong and couldn’t be further from the truth. There will always be an important place for medication, provided we are not being lied to as to why we are being prescribed it, and provided it cures whatever it is being taken for. This is where psychiatry has got it all wrong.

And therein lies my objection to antidepressant drugs. They medicate nothing. Instead they cause serious physical and neurological damage longterm. (I know because I have been left with a number of physiological scars as a result of taking these drugs over a number of years, including a facial spasm under my eye, and hand tremors.)

Depression is NOT caused by a brain chemical imbalance. There is no scientific evidence whatsoever EVER to support this botched theory. It was part of a global marketing campaign that cost millions by the pharmaceutical company that put Prozac on the market in 1987. Prozac was affectionately known as ‘the happy pill’.

Of course there is nothing ‘happy’ about fluoxetine (Prozac), or any other antidepressant – cipramil, lexapro, seroxat, effexor, in fact all of these SSRIs. In more recent years most of them carry a ‘black box’ suicide warning. This is meant to be a precursor that might prevent litigation against the manufacturers by families of kids and loved ones who have killed themselves taking these antidepressants. How can a pill that is meant to prevent suicide cause suicide?!

I took cipramil in 1999. I had the most terrifying reaction to it that I can ever remember. My brain went into meltdown within weeks of starting to take it, and the Akathisia (inner restlessness and aggressive agitation) I suffered almost drove me to take my own life. It was the most horrific time of my life. I will never forget it because I had lost control of my life. I wanted to kill myself. So where’s the therapeutic benefit in that drug?

Ironically during my most depressed days (prior to medicating) I never felt the physically terrifying restlessness and the morbid brain-fear that I started to feel once I started to take the pills. I remember going three weeks without sleep! I felt I could run into a brick wall and break it down. I was demented. I was loose like a horse out of control. That was when I stopped swallowing the poison.

These pills are very dangerous. They drive people to a level of insanity that their original depression couldn’t reach with a big kite on a windy day. But yet doctors and psychiatrists prescribe them – even though they know how dangerous they are.

Psychiatrists claim to know more about depression and anxiety than anyone else. The truth is they don’t. They know very little. If you get depressed, you know more about how you feel than the entire field of psychiatry. You know what’s good for you and what’s not. They don’t.

Many psychiatrists are well rewarded by the large pharmaceutical companies who make these dangerous drugs. They are given free holidays, carribean cruises, concert tickets, and golf memberships, etc., just to promote and prescribe the so-called benefits of these mood-altering toxic drugs. “Take them and you’ll feel better”. Why? And based on what scientific evidence? There isn’t any.

Psychiatry comes from two Greek words: ‘psyche’, which means ‘soul’, and ‘iatris’ which means ‘to heal’. I don’t see too many psychiatrists healing many souls these days.

My life started to improve the day I decided that I needed to stop taking this strange pill. It took a while to wean myself off it and to re-adjust, but it was well worth it in the longterm. If you are reading this post this evening and you can relate to what I have been through and what I am writing, then have faith and trust in the inner strength you have that sustains you. It’s the same inner strength I finally found after a long painful inner struggle when I needed honesty that I wasn’t getting anywhere else.



Unbelievably Misleading Article On SSRI’s On Vox By Elizabeth King (Online Content Writer)


‘Most researchers have long since moved on from the old serotonin model”..

Prof Simon Wessely (President of the royal college of psychiatrists UK)


An influential study which claimed that an antidepressant drug was safe for children and adolescents failed to report the true numbers of young people who thought of killing themselves while on it, re-analysis of the trial has found

Study 329, into the effects of GlaxoSmithKline’s drug paroxetine on under-18s, was published in 2001 and later found to be flawed. In 2003, the UK drug regulator instructed doctors not to prescribe paroxetine – sold as Seroxat in the UK and Paxil in the US – to adolescents.

(The Guardian UK 2015)

I was on Seroxat (Paxil) for almost 4 years in the late 90’s/Early 2000’s. Back then, SSRI’s were relatively new to the market, doctors didn’t know a lot about side effects, and if drug companies knew, they certainly kept most of their knowledge of side effects suppressed from public view. I was told by my doctor that I would need to take Seroxat for life as I had a chemical imbalance in my brain which caused my depression. He didn’t seem to correlate the fact that that my parents marriage breaking down, my father’s alcoholism, or our family home being sold or the stress of a pending eviction from our rented house, would have had anything to do with my mental health as a vulnerable and distressed 21 year old. He didn’t even want to know how I came to be depressed, or about the traumas which led to it, and neither did the psychiatrists who pushed the SSRI on me. This approach was common practice, and apparently still is.

A lot of the bad effects  of SSRI’s (such as increase in suicide, aggression, akathisia, severe withdrawal effects etc) were not disclosed to the public until relatively recent years. This is bog standard behavior for drug companies, they market the disease first, blitz the public with advertising, play down the side effects until they have made a profit, and when the inevitable law suits come, the drug companies have a legal war chest with which to fight them with. They always profit off their drugs, even if these drugs kill and maim people. I’ve been blogging about this stuff for nearly 10 years, and my research on drug companies and their behavior would make your hair stand on end. They are callous and sociopathic, and most drug pushing psychiatrists are not much better.

In the case of Seroxat (Paxil), a steady stream of information has dripped out about it for two decades. First we had the BBC Panorama exposing Seroxat as a very dangerous drug in the early 2000’s, then we had the NY attorney general forcing GSK (the manufacturer) to disclose information on the drug harming kids. After that came warnings about birth defects, and if you look at the gradual changes to the patient information leaflet over the years you will notice that side effects have increased exponentially. Just this year the BMJ published a study which indicates that Seroxat has likely caused many more suicides, and much harm, to thousands of young people, and children, who should never have been prescribed it.

The SSRI’s can cause extremely distressing side effects, but there is no doubt that they work- in the sense that you feel drugged, but of course you would feel different, and of course you would feel drugged, or that the drug works, because you’re on drugs! But they are not somehow defeating your ‘depression’, the effects of the drugs, like the effects of all drugs, affect your perception and feelings about yourself, but this is a dangerous game to play with your own mind. It’s essentially drug induced self deception. You are feeling the effects of a drug, but nothing is being cured. The drugs make you drowsy, sleepy, less interested in your problems, and less interested in most things generally. So do they work? yes they do work in that way because they are psycho-active and psycho-tropic, they make you feel different, just like MDMA or E would release dopamine, serotonin etc. These are drugs that work on similar chemicals, and in similar pathways, in the brain. Just the same as if you drank 8 beers, you might not think about your depression because you’re drunk, or if you smoked some weed, you would be stoned and it might alleviate your mood. You might be too drunk to care about your problems, or to stoned to obsess over your negative thoughts, but that doesn’t mean it’s helpful to chemically alter our minds in order to deal (or not to deal) with our psychological traumas and problems. The root cause of our malaise will always fester, and often drug treatment can exacerbate the conditions they supposedly treat, and sometimes, for some people, SSRI’s can be deadly.

SSRI’s are no different to street drugs, they are chemicals which drug you into a different state of being, however they are not curing anything. If drugging away our problems is considered the most acceptable first line treatment for people with emotional and psychological problems, then we need to seriously re-consider how we approach the human condition, and in particular, the human condition in distress. Medicating with dubious drugs is not the answer for most people suffering emotional or psychological distress, however it’s often the first thing that a doctor will suggest. A depressed person would walk on fire if they were told by a doctor that it helped depression. When you’re depressed you’re vulnerable, and all you want is the pain to end. That’s why is has been so easy for the drug companies, and psychiatrists, to exploit the ‘mentally ill’.

It’s much easier to drug someone, and spin them some yarn about a defective brain, when the patient is desperate for a cure. When you’re desperate you’ll take, or do, anything your doctors tells you to.

I am not anti-medication, I understand that some people might need a drug to give them a chemical lift out of a severe depression, however, the so called ‘science’ behind the prescribing of these drugs has largely been discredited, in particular the myth of the ‘chemical imbalance’ cause of depression. This theory was widely touted in SSRI drug advertisements for at least a decade, and even though you can’t measure Serotonin levels in anyone’s brain, and even though low Serotonin levels have never been proven scientifically to cause depression, that didn’t stop psychiatry and the drug companies from spreading these theories as if they were provable scientific facts. These are potent drugs so they affect your brain- of course (and your gut and other parts of your body)- but they are not fixing any kind of chemical imbalance, serotonin or otherwise. Even if these drugs were more sophisticated than they are, they would still be only addressing the symptoms of depression, not the cause. The causes are usually psycho-social, or emotional, in nature. With depression, there is almost always a trauma, life event, or stressor, preceding it. Depression without an external cause is rare (however it can come as a result of psychical illness, poor diet, etc etc).

In recent years, psychiatry has backed away from this ‘chemical imbalance’ theory of depression, but conveniently it has never thought to inform the general public that it no longer fully endorses it. However, you will notice, that they have gradually tried to make it seem that they really never promoted the theory much anyway (this is untrue though- psychiatrists were the main promoters of this theory to the public).

Many doctors, and critical psychiatrists (and even- it seems- the head of the UK college of psychiatry), now  acknowledge that the ‘serotonin theory’ for depression was little more than a marketing myth which was heavily promoted in order to sell, drugs, and the the ‘disease’ model of depression to the general public.

“…. The disease-model, however, is ultimately not helpful, as well as being unfounded. For all its attempts to incorporate social factors, the disease-model renders depression meaningless, because biology effectively trumps other influences. It conveys the message that we are powerless to change ourselves or our situations. When things go wrong, it persuades us we need a pill to put them right. This approach may appeal to some people, and I am in no way disparaging those who chose to follow it. But it is important that everyone knows how little evidence there is to support it….”

(Dr Joanna Moncreiff 2014)

Although the Serotonin theory, and ‘chemical imbalance myth’ has been largely debunked in the scientific community, and many professionals are now moving away from it in droves, the ‘disease model’ and anti-depressant ‘chemical cure’ still profoundly permeates mental health discourse. Many people still mistakenly think that SSRI drugs fix a chemical imbalance in their brain, and some doctors are still promoting this myth to patients.

In a recent article on by Elizabeth King (an online content writer) illustrates this perfectly. The misinformation in this article, and the general premise of it, is extremely dangerous. Her article on her experiences with SSRI’s exemplifies what I have just talked about: the depressed and misinformed patient goes to their doctor- their doctor spews some nonsense about a chemical imbalance, the patient – desperate and vulnerable- swallows the ‘depression as disease’ myth hook line and sinker, along with month after month’s supply of SSRI pills. Drugged and chemically altered, the patient now goes about telling everyone about how wonderful SSRI’s are. I don’t blame Elizabeth for wanting to believe that her depression will go away with a simple little pill, and I don’t blame her for wanting to believe that she can keep taking her little pill forever. I wanted to believe that too. Most people who end up on SSRI’s are willingly deluded, that’s how they get you on the pills. However, writing online content which potentially thousands of misinformed, vulnerable and desperate people will read, and further misinforming them, based on your own willful naivety, is highly irresponsible.

SSRI’s are seductive- all drugs are. All addictions are too. The psychological and physical dependence that SSRI’s induce is incredibly powerful, that’s why it is so difficult to come off them. That’s why the withdrawal effects are crippling, particularly in cold turkey or if you’re on them long term, and try to come off them. That’s also why the SSRI’s are a multi-billion dollar industry. They keep people in a chemical cloud of denial all the time they are on them, and who wouldn’t want that? Being on psychiatric drugs, even with the horrible side effects, makes you think that you’re treating your ‘illness’ right? and that’s validating isn’t it? It’s strangely comforting to think that you’re helping yourself by taking a treatment isn’t it? – even if that treatment involves reliance on a pill to do all the deep psychological work that you don’t want to face. You really want to believe that the drugs will keep your depression in check. And who would want the depression boogeyman to come knocking again? Much easier to have faith in the pills, and believe that you need them than actually going through the pain of soul crippling depression isn’t it? That would take actual work!

Getting off them though…now that’s another story…

A horror story..

Here are some quotes from the article:

“…I wanted to feel what I thought of as “normal,” my default state neutral instead of panicked. My therapist suggested SSRIs —selective serotonin reuptake inhibitors, common antidepressants that work by balancing the levels of serotonin in the brain. He told me they had been very beneficial for other clients with similar backgrounds. But I stubbornly resisted. I didn’t want to take SSRIs, I told myself, because I was determined to conquer my mental health issues “on my own.”...

Eventually I didn’t care how much I didn’t want to explore medication; I was willing to do whatever it took to feel better. I relented. I got a recommendation for a psychiatrist from a friend, made an appointment, and tried to keep an open mind

I left my psychiatrist’s office with a prescription for Lexapro and filled it at the pharmacy the same day. I swallowed my first dose the minute I got home.

I sat there for a second, tilting my head and focusing my hearing as if I’d be able to sense the medicine’s effects right away. Nothing happened, of course: It can take as long as six weeks to know if an SSRI is working. Eventually, mine did.

Today I’ve reached nearly a year of treatment on two antidepressants, Lexapro and Wellbutrin, and the results I’ve experienced were unimaginable to me before I started taking medication.

I was resistant to medication for so long because I didn’t understand what taking medication meant. I had bad information and bad assumptions. Here’s what I wish everybody understood about SSRIs: the good, the bad, and the anorgasmic.

I was cautiously hopeful when I started the meds. I wanted them to work more than anything in the world, and each day when I woke up, I wondered if this would be the day that I started feeling something different. For days, I thought it might be happening: My daily mood felt better, but it was hard to tell — what if I was just unusually hopeful, or experiencing some kind of placebo effect?

My troubles weren’t over, of course. My psychiatrist warned me during my first appointment that it can take as long as a year for some patients to find the right mix of SSRIs. Antidepressant medication is not like antibiotics: The same pills won’t cure the same disease in nearly everyone. We tinkered with my dosage of Lexapro and with combining Wellbutrin over the course of several months. But I was improving, and after seeing what one medication could do for me, I was eager to discover what was possible as my doctor and I fine-tuned my treatment.

While not everyone benefits from SSRIs, the zombie effect just isn’t universal, or even particularly common. It certainly wasn’t true for me. When they work, SSRIs do for your brain what a healthy brain would be able to do on its own: regulate healthy levels of serotonin in the brain so that you aren’t depressed or anxious by default.

I embraced SSRIs in part when I accepted that not all of my emotional troubles were the result of situational stress. Yes, having an uncertain love life, financial worries, and concerns about the future exacerbated my mental health issues. But they weren’t the root trouble. The “real cause” of unhappiness in depression and anxiety is often a chemical imbalance in the brain, something that can’t be talked out of existence any more than a headache.

With time, the anorgasmia faded and I was able to get off again, but by that point, my sex drive was down the drain. I could have an orgasm, but I didn’t really care if I did or didn’t. This was the first and biggest downside to my treatment, and one I wasn’t content to put up with for any great length of time.

I made another appointment with my psychiatrist. I told him that it wasn’t acceptable for me not to have a sex drive while on meds. I was a little nervous to bring it up: I didn’t want him to dismiss my concerns as frivolous or, worse, dirty.

Thankfully, he completely understood and prescribed me a second antidepressant — Wellbutrin — to help alleviate the sexual side effects. I was lucky: The combination worked well for me, and today my sex drive is more or less back to its pre-medication state.

When I began taking SSRIs, my psychiatrist told me that while some patients require medication for only a few months or a few years, others are in it for “the long haul.” He told me there isn’t a good way to predict how long a patient will need SSRIs, so I have no idea how long I may need to take mine. That worries me: What if I need to take my meds every single day until the day I die?

According to a recent Consumer Report on antidepressants, some antidepressants cost as little as $25 for a month’s supply, but others can cost more than $500 (certain dosages of Prozac can be very costly, for example). Unfortunately, the medicine that works best for a particular patient might not line up with what works best for her bank account.

Despite my newfound enthusiasm for SSRIs, I know that covering the costs of care could present a greater challenge in the future than it does now, and that scares me

When you’re in the worst throes of depression, it’s easy to believe that you have no chance of feeling better. Hopelessness, extreme nervousness, and feelings of shame are all classic symptoms of depression and anxiety. Before giving up on the idea of SSRIs, consider whether the very fears holding you back might be allayed by the treatment itself.

For many of us with chronic mental illness, taking the plunge and trying medication is the best single step we’ve taken for ourselves. It was for me.

If you even suspect that medication might help you live a fuller and healthier life, discuss it with a doctor. There’s no shame in trying. Even if the medication doesn’t work at first, or never works at all, you owe it to yourself to fight for your happiness in any way you can, and that’s the best chance any of us has to make it through.

Elizabeth King is a writer, feminist, and pop culture fiend living in Chicago. Follow her on Twitter at @ekingc.

I have already had a spat with Elizabeth on twitter, and I have tried to explain to her that her article is full of misinformation and unprovable, discredited- psycho-babble- about SSRI’s, but she is having none of it. Apparently , according to Elizabeth, I am a ‘troll’ who has ‘poor and minimal evidence for my beliefs’. Oh well, what can I say? good luck on your SSRI journey Elizabeth, don’t stay on them too long. Two to three years on SSRI’s and you’ll be coming close to the end of the honeymoon period. Soon your liver will start to get toxic, the sweats will get worse, and the bowel movements will become more than a drag. You’ll be functioning, but in a manic way, you’ll want to be on the drugs, even though deep down you know that you’re just running away from yourself. The nightmares, and muscle spasms will start to become more noticeable than the serotonin haze, but you’ll kinda not really care about that. If you do want to come off them, be sure to wean, that way you can take the edge off the homicidal and suicidal thoughts that they induce. I wasn’t told about these side effects and withdrawals when I was on them, some years ago, but there’s plenty on the net about them now.

I wish you the best..

And oh…

Here’s a link to Dr Terry Lynch’s ground breaking work on SSRI’s and depression. I know you think that it’s just me and Terry Lynch quacking on about this bogus theory Elizabeth, but I assure you, Terry’s research won’t fail to impress. We’re not the only ones, that’s for sure.

It’s called ‘Depression Delusion – the myth of the brain chemical imbalance” and it has been endorsed globally by many of the top progressive mental health professionals in their field. Perhaps that’s not NEMJ or Harvard standard peer review enough for you, but hey! Can’t say I haven’t tried to warn ya!

Here’s a review by Phil Hickey (from the excellent Mad In America Site)

Book Review: Depression Delusion by Terry Lynch, MD, MA

In this truly remarkable — and meticulously researched — volume, Dr. Lynch annihilates psychiatry’s cherished chemical imbalance theory of depression.  Every facet of this theory, which the author correctly calls a delusion, is critically analyzed and found wanting.  Example after example is provided of psychiatrists promoting this fiction, the factual and logical errors of which are clearly exposed in Dr. Lynch’s lucid, seamless, and highly readable prose.

The book runs to 343 pages, and is laden with factual details, case studies, alternative perspectives, and hard-hitting commentary.  Dr. Lynch does not sit on the sidelines, nor does he seek any kind of collegial compromise with the chemical imbalance theory, which he unambiguously denounces as a groundless and destructive falsehood.  Here are some quotes that I think will convey something of the content, style, and cogency of this vitally important work.

“The world is engulfed in a mass delusion regarding depression.  The widespread belief that brain chemical imbalances are present in depression has no scientific basis.  In fact, this is a fixed belief that meets all the criteria of a mass delusion.  If you are one of the millions of people who believe that biochemical brain imbalances are known to occur in depression, then you too have become seriously misinformed.” (p 1)

“Despite the obvious complexity of the brain, some psychiatrists and GPs profess an understanding of this organ that is highly inconsistent with current scientific knowledge.  Their comments smack of a level of arrogance that in my opinion is downright dangerous.” (p 65)

“The brain chemical imbalance delusion has dominated medical, psychological and public thinking about depression for the past fifty years.  Parties with a vested interest see nothing wrong with this.  Nor do the vast majority of the general public, for whom the depression brain chemical imbalance idea feels as familiar and logical as raised blood sugar in diabetes.  There are two main reasons why psychiatrists and GPs have embraced the biochemical imbalance delusion with such enthusiasm.  This notion portrays doctors and their drug treatment in a positive light, as real doctors treating biological abnormalities consistent with the treatment of diseases generally in medicine.  Secondly, having observed for thirty years how my medical colleagues in psychiatry and general practice work, I do not believe they know any other way of understanding or responding to depression other than as an assumed biological abnormality.  I remain unconvinced that there is sufficient breadth of vision within mainstream psychiatry or medicine to see or to move beyond the rigidly held belief that depression is primarily a biological disorder.  Yet, the majority of the experiences categorized as depression are primarily emotional and psychological or have a significant emotional input.” (p 77)

“It is misleading to state that the brain chemistry of depression is not fully understood, when in truth it is really not understood at all.  It is also misleading to state that ‘research suggests’ that ‘depression is caused by an imbalance’ of brain chemicals.  It is drug companies, doctors and researchers who suggest this, not the research itself. As outlined in detail earlier the research itself does not suggest this at all and indeed contradicts this notion.” (p 149)

“In twenty years as a medical doctor, I have never, ever heard of a patient anywhere having their serotonin levels checked.”(p 153)

“Low serotonin cannot ever be identified since brain serotonin cannot be measured and we do not know what serotonin levels should or should not be.” (p 165)

“Providing societies with an apparently trustworthy rationale for avoiding the reality of human distress has resulted in increasingly costly mental health services within which recovery is a far rarer outcome than it should be.  Since the core issues are repeatedly side-stepped, they are not addressed or recognized within these mental health systems.  It is not surprising that the costs of such systems keep increasing with little hard evidence that these systems are providing value for money in terms of recovery.” (p 237)

“The most beneficial position for psychiatry is therefore the one that currently pertains.  By nailing its colours to the biological mast, psychiatry has successfully set itself apart from talk therapies.  As long as no biological abnormalities are reliably identified, there is no threat that their bread and butter will be removed from them to other medical specialties.  Maintaining the myth that biological solutions are just around the corner satisfies the public and maintains psychiatry’s position quite satisfactorily from psychiatry’s perspective, albeit between a rock and a hard place.  This position has no solid scientific foundation, but as long as the public do not realize this and psychiatry does not attempt to encroach on the territory of other medical specialties such as neurology, psychiatry’s position is secure.”  (p 277)

“When basic principles of correct reasoning and science are applied to the brain chemical imbalance idea, the flaws and inconsistencies of this belief become obvious.  When the depression brain chemical imbalance idea is rigorously examined, we find that like the emperor, it has no clothes.  These flaws and inconsistencies were known prior to Prozac coming on stream in 1988.  They were dismissed because they risked ruining a great story, from which many groups could profit enormously.” (p 342)

For those who wish to pursue topics further, there is a reference list at the end of each chapter.  There is also a comprehensive index and table of contents which make it easy to find specific sub-topics.

Pharma-psychiatry’s chemical imbalance theory of depression is one of the biggest and most destructive hoaxes in human history.  Dr. Lynch’s Depression Delusion might well be the work that finally lays this hoax to rest, and exposes the self-serving deceptiveness that has become a routine part of psychiatry’s endeavors.

Please read this book, keep it close to hand for reference, and encourage others to read it also.  Ask your library to buy a copy.  The spurious chemical imbalance theory is now so widely accepted that it will take enormous efforts to dislodge it.  In any debate on this matter, Dr. Lynch’s book will, quite literally, put the facts at your fingertips.

Access: MSF launches global action against Pfizer and GlaxoSmithKline to cut the price of the pneumonia vaccine

Access: MSF launches global action against Pfizer and GlaxoSmithKline to cut the price of the pneumonia vaccine

MSF dumps US$17 million in fake cash at Pfizer’s New York HQ, the amount the company makes in one day of pneumonia vaccine sales

New York – Médecins Sans Frontières (MSF) launched a global petition today, World Pneumonia Day, calling on pharmaceutical companies Pfizer and GlaxoSmithKline (GSK) to reduce the price of the pneumonia vaccine to US$5 per child (for all three doses) in all developing countries and for humanitarian organisations.

After years of fruitless negotiations with both companies to lower the vaccine’s price for use in its projects in developing countries and in humanitarian crises, MSF called on the public to help put pressure on the companies. Pneumonia is the leading global cause of childhood death and kills nearly one million children each year.


“The pneumonia vaccine is the world’s best-selling vaccine, and last year, Pfizer brought in more than US$4.4 billion in sales just from this product,” said Dr Manica Balasegaram, Executive Director of MSF’s Access Campaign. “Pfizer and GSK charge such high prices for the pneumonia vaccine that many governments and humanitarian organisations aren’t able to vaccinate children. After combined sales to date of more than US$28 billion for the pneumonia vaccine alone, we think it’s pretty safe to say that Pfizer and GSK can afford to lower the price so all developing countries can protect their children from this childhood killer.”

With Pfizer earning more than US$17 million in sales per day from the pneumonia vaccine alone, MSF kicked off the petition campaign on World Pneumonia Day with a stunt outside the company’s headquarters in New York, attempting to deliver more than US$17 million of fake cash to Pfizer’s CEO Ian Read. MSF also placed an advertisement in the bus stop shelter directly in front of the Pfizer building, which posed the question: “Hey Pfizer, why are your vaccines priced out of reach of children in need?”

In January, MSF released its vaccine pricing report, The Right Shot: Bringing Down Barriers to Affordable and Adapted Vaccines, which showed that in the poorest countries, with the addition of new vaccines, it is now 68 times more expensive to vaccinate a child than in 2001, with many parts of the world unable to afford new high-priced vaccines like that against pneumonia.

“As doctors who have watched far too many children die from pneumonia, we’re not going to back down until we know that all countries can afford the vaccine,” said Dr Balasegaram. “We’re asking you to join our global effort by signing the petition to tell Pfizer and GSK it’s time to drop the price of the pneumonia vaccine.”

In May, 193 governments met in Geneva for the annual World Health Assembly, where they unanimously passed a landmark resolution demanding more affordable vaccines and increased transparency around vaccine prices. The governments of over 50 countries underlined the rising inequities among them caused by the increased financial burden of new vaccines, with many stating the high price of new vaccines, such as the pneumonia vaccine, either prohibited them from introducing it or threatened their ability to sustain it in their routine immunization programmes.

“What’s the point of a life-saving vaccine if the most vulnerable people can’t afford it?” asked Dr Balasegaram.


Each year, MSF teams vaccinate millions of people, both as outbreak response to diseases such as measles, meningitis, yellow fever and cholera, as well as routine immunisation activities in projects where it provides health care to mothers and children. In 2014 alone, MSF delivered more than 3.9 million doses of vaccines and immunological products. MSF has purchased the pneumococcal conjugate vaccine in the past for use in its emergency operations. MSF is scaling up its use of the pneumococcal conjugate vaccine and other vaccines with a particular focus on improving its work in routine immunisation, as well as extending the package of vaccines used in humanitarian emergencies. MSF has vaccinated children caught in emergencies with PCV in Central African Republic, Ethiopia, South Sudan, and Uganda.