Making medicines safer for all of us

Adverse drug events are now the fourth leading cause of death in hospitals.

It’s a reasonable bet they are an even greater cause of death in non-hospital settings where there is no one to monitor things going wrong and no one to intervene to save a life. In mental health, for instance, drug-induced problems are the leading cause of death — and these deaths happen in community rather than hospital settings.

There is also another drug crisis — we are failing to discover new drugs. [Read more...]

Author Archive for David Healy

Grassy Knoll or Slippery Slope?

Health Warning: Let me put down some markers before riffing on the Grassy Knoll theme. I am a committed believer in what may now be a last millenium concept – the medical model. I think antidepressants – the older tricyclics and ECT, not the more recent SSRI and other antidepressants – can save lives. I figure conflict of interest, crucially important in other areas of life, is of minor importance if not irrelevant in science. Although by science I mean something that can only happen in the presence of publicly available data. 

In the case of the antidepressants and other drugs, do people sit down in closed rooms to hatch a plot against “the people” for the sake of profits? Yep, they do. Is this a conspiracy theory?  No, its out in the open – nothing personal just business.

Is concern about the operations of the Science Media Center legitimate?  Yep. Is it because they’re engaged in a conspiracy? Well – they are in the business of managing perceptions. Is that a conspiracy – even if a well-intentioned one? Difficult call.  Anyone who bases their case on Robert Gibbons and related stuff as Pariente and others in SMC have done is either cynical or thick.  Sticking a litmus strip into the SMC bilge around Panorama caused the litmus strip to dissolve.

The vast bulk of the academic literature on on-patent drugs, excepting the diminishing number of articles talking about adverse effects, is ghostwritten.  Is this a conspiracy? Nope it out in the open but no one spots it on radars in front of them because for most its still as unbelievable as UFOs, or the idea we might incinerate millions of women, children, musicians, artists and scientists.

The entirety of the data from clinical trials of on-patent drugs is unavailable.  No-one gets to see it.  Is this a conspiracy?  Its force majeure – that’s French for fuck off.

The Presidents of American and European Physicians Associations (as well as Royal Colleges) remain quiet about this.  Is this a conspiracy? No. Its political maturity, as modeled by Pius XII in the 1940s.

Spitzer

On June 2 New York State’s Attorney General Elliot Spitzer filed a fraud action accusing GlaxoSmithKline of “repeated and persistent fraud” for concealing known problems with efficacy and safety of Paxil (paroxetine) for children and adolescents. He claimed GSK hid the fact that its Paxil trials failed to show efficacy in adolescents and in some cases it was more likely to cause suicidal thinking.

There was a basis for the charge given that Study 329 and other company pediatric trails may represent the greatest divide in all of medicine between what the academic literature says about the drugs and what the data actually show. There was also a smoking gun document unearthed by Panorama which appeared to show GSK intended to deceive doctors and patients with the publication of the Keller paper in 2001.

Spitzer held a press conference arguing his action would change the course of medicine for ever.  All companies would be pressured into making their data available to doctors – as it should be.  The media attention helped propel him to the Governorship two years later.

On August 26, GSK announced that it had resolved its case with New York.  It would pay a small amount of money and publicly disclose all of its clinical drug trials about the safety of paroxetine for children in a “Clinical Trials Registry”.

Showing a mastery of the art of turning problems into opportunities, GSK’s press release stated:

“We are pleased that the Attorney General believes the Clinical Trial Register we have been developing will provide useful information to the medical and scientific community,” said Mark Werner, Senior Vice President for US Legal Operations at GlaxoSmithKline. “We believe that GlaxoSmithKline’s initiative to launch this register is a responsible step in ensuring transparency of our clinical trial data.”

Spitzer was left seething.

He became Governor in 2006, but two years later he was forced to resign after being found in a compromising situation. The first season of The Good Wife and the last episode of Law and Order are thought to have based on these events. There was no end of speculation as to who was behind his downfall.

The Spitzer action didn’t change medicine one iota.  It may have helped a few weeks after with pushing through a Black Box Warning that FDA up till the last minute was dead set against.  But from GSK’s point of view, Paxil was off-patent, and the warnings may have helped sales of its Lamictal for bipolar disorder – a failure to diagnose which they knew a bunch of doctors were straining at the bit to say was the real reason all these kids were becoming suicidal.

Conspiracy? You have to admire GSK’s nimbleness.

Montgomery

In the late 1980s Stuart Montgomery in London hooked Eli Lilly into a placebo controlled trial of Prozac in patients with recurrent brief depressive disorder, aka intermittent brief depressive disorder, aka borderline personality disorder.  The data are unavailable.  An article was published years later concealing the suicidality data but tucked away in it was mention of the fact that placebo was roaringly better than Prozac.

A few years later Montgomery persuaded GSK to run the same trial in the same patient group, probably using some of the exact same patients, comparing Paxil (Seroxat) to placebo.  The trial ended early. No data were ever published. There was a much higher suicidal event rate on Paxil.

A few years after that again GSK ran a trial in Belgium in the same patient group.  Who know what the real figures are – I’ve seen several different sets.  In all of them there are very high suicidal act rates on Paxil and placebo – which was the point of the trial.

In 2006, under pressure on the suicidality front, GSK put out a press release, containing these figures.

 Paroxetine
Events/Patients
Placebo
Events/Patients
Risk
Major Depression
11/29430/1671Infinite
Brief Depression32/14735/1510.9
Total43/309035/18220.7

What this shows is that you can use a problem you know your drug causes to hide a problem your drug causes. This is effortlessly easy to do by mixing superficially similar but in fact different patient groups together.  It can be done for Parkinson’s disease, Back Pain, Cancers, and works particularly well when both the disorders and their treatment cause a problem.  It’s a harder trick to pull off when you use duloxetine for urinary incontinence and end up with suicidal women.

Anyone like Stuart Montgomery could have sat down and explained to the company what the pay off was going to be from what might have looked like a crazy move.

Company trials are full of moves like this.  Is this a conspiracy?  No – its a game.  On our side, we expect our academics, like Dr Wessely who bills himself as an expert in these kind of things, to spot what’s going on and prevent the buggers from scoring goals.

Goldacre

In 2012, GSK was hit with the then biggest fine in corporate history. As part of its response, as with Elliot Spitzer it took the moral high ground and made a big deal about banning free pens to doctors and eliminating payments to detailers (sales reps) by results. All payments to reps, along with the reps, were being eliminated anyway so this one was easy.

But for Andrew Witty to end up on the front page of the BMJ, just a few weeks after agreeing to the biggest fine in corporate history, billed as the acceptable face of the pharmaceutical industry and the Great White Hope, was a lot more impressive. It must have brought a smile to lots of faces, whatever about the Good Guys in the Department of Justice.

In between paying the fine, and canonization, AllTrials had launched. Most people heard access to trial data but AllTrials proposed nothing like this.  They were focused on efficacy as adjudged by experts not data as trawled by people.  And in a dangerous world, efficacy sells drugs. Its the nuclear option.  Why take risks – nuke it. There is nothing about AllTrials that is not going to increase the sales of drugs.  And all sorts of the great and good were swinging their thuribles and chanting “Transparency”, Transparency” around the new sacrament.

Andrew jumped on board.  What was not to like about this? Nobody rooting through the data to find evidence of a Third Shooter.

Did Ben Goldacre and Iain Chalmers conspire to offer him a Get out of Jail Free card. Its irrelevant. All it needs is someone in GSK to be able to spot a Get out of Jail Free card in front of their nose and able to persuade the CEO to grab it.  And 100,000 people work for GSK so there was every chance this would happen.

The Business Model

The business model of the pharmaceutical industry is:

Pay us what we want because we do research to produce new drugs and if you don’t pay us we will stop doing this and you will die.

Its the next best thing to the barrel of a gun.

They don’t invest the money in making new drugs.  The track record in this area is worse and worse. The money goes into maintaining power. With sufficient lawyers, regulators and academics, its a bit like retaining so many monkeys, you can be sure of ending up with a Mozart symphony or Shakespearean play from time to time.  The other thing as any great sports coach will tell you is Focus.  Industry have a focus – the bottom line.

Medics on the other hand and shrinks in particular are the least focused people in the world – except for those who jump ship into private practice.

Watching Medic behavior however is a good way to check which way the wind is blowing. When there is a dominant power, a bully, medics usually line up to right of the bully. Its called identification with the aggressor. When the Catholic Church held an iron grip on thinking in Ireland, far from offering a voice of liberalism, Irish Medicine took ethical positions on abortion, contraception and everything else to do with sex to the right of the Church.  It often left Church leaders looking rather – well Andrew Witty like.

Anyone who expects doctors to save them would probably have thought the Maginot Line looked wonderful, and voted for the canonization of Pius XII.

(Was that a conspiracy?  Well he did have a woman who looked after him and she was German, wryly described by some as the most powerful German in the Vatican…..).

(Yanis Varoufakis’ Adults in the Room is a wonderful take on what its like to deal with a dominant power and the ventriloquist’s dummies, the Irish or Lithuanians, who do the speaking for them. Or how people will be clapping your back one minute over a stein of beer and then selling you out the next).

 

From the Grassy Knoll

Editorial Note: The image is of Science Media Centre funding from their website. This post links to Whats Going on Here, Honey I Shrunk the Shrinks, and to the two Prescription for Murder Posts on RxISK.   When AF’s email came in first, it seemed far from private as he now claims. The choice of people seemed anything but accidental – especially SW.  It seemed likely SW would engage on the SMC topic. 

From: Wessely, Simon <simon.wessely@kcl.ac.uk>
Date: 6 August 2017 at 20:41
Subject: Re: Thanks David.
To: David Healy <david.healy54@googlemail.com>
Cc: “Summergrad, Paul” , Allen Frances <allenfrancesmd@gmail.com>, Jeffrey Lieberman, Bernard Carroll , Ronald Pies

Honestly David.  This SMC stuff is just daft.   Look at the website and look at the daily digests they do.  They asked a lot of experts to comment on the panorama programme. A lot. If people had given different opinions they would have included them.  They always do.  The facts are that no one on the list did.  A lot were on holiday I grant you but I don’t think that made any difference.

It’s nowt to do with them.

RCPsych certainly did provide a lot of media comments – that’s our job. Sadly not my job any more as I stepped down but I was v pleased with them.

Simon

From: Wessely, Simon <simon.wessely@kcl.ac.uk>
Date: 6 August 2017 at 20:43

Presumably david you think that SMC gave the Sunday Times their big splash pre transmission – ‘Killer Pills’

Was that acceptable journalism?

Come on!

From: David Healy <david.healy54@googlemail.com>
Date: 6 August 2017 at 20:52

As far as I know, the ST piece didn’t have a lot to do with panorama.  That was a journalist who has written a rather good book, who has a compelling case for negligent treatment and who had the wit to take advantage of the fact that panorama was due later that week.

I do think SMC are dangerous and I that you need to consider whether it isn’t effectively operating as an outsourced public relations outfit for pharma among others.  I also think its doing the College no favors to be as tightly linked to them as they are.

I think Dr Burns’ credibility is in rather less good shape as a result as her involvement with them

David

From: Wessely, Simon <simon.wessely@kcl.ac.uk>
Date: 6 August 2017 at 21:40
David.  Are you seriously suggesting that the ST trailer was nothing to do with product placement by panorama ?

It’s not a crime.  It’s normal practice and we all know it

And finally – and I mean finally – look at the rules for donations to SMC and the accounts

You have a case.  I don’t think it’s right but no matter.   Have always enjoyed debating you as you very well know and even more enjoyed drinking with you very well know

But you don’t do your corner any good by going into third shooter and grassy knoll territory.

Ok. Hope you are in Berlin. Shorter and I will be downing a few Steins.  I hope you will be there

Simon

From: David Healy <david.healy54@googlemail.com>
Date: 6 August 2017 at 21:57

S

So whats third shooter about this?

https://davidhealy.org/honey-i-shrunk-the-shrinks/

Or the very many other SMC pieces linked to this story since, all of which misrepresent what the program was about

Or what’s third shooter about the college docs showing SMC efforts to co-ordinate my views about the So Long and Thanks for all the Serotonin piece. I can send this if you really want to see them

In my view SMC have done and are doing a lot to degrade the quality of debate in British psychiatry.  In my view no pharmaceutical company could reasonably be expected to be without an SMC.  It would be bizarre for business with so much at stake not to have something like this.  The idea that SMC wouldn’t exist and wouldn’t be doing exactly what I suggest is a fantasy.

As regards your enjoying debating with me – I can’t remember when that was.

David

Science  Media Centre

SMC began in 2002 in part to contain negative media coverage of GM Foods which seemed bad for business in UK PLC. One of the other factors cited early on was the rough time certain academics such as Simon Wessely were getting when they put forward views about Chronic Fatigue Syndrome (CFS). SMC was and is closely linked to Sense about Science, which began at the same time. They had key founders in common.

The Trustees are:

  • Jonathan Baker Professor of Journalism, U of Essex, (ex-Head of Newsgathering, BBC)
  • Adrian Bull External Relations Director, National Nuclear Laboratory
  • Karen Chadwick Head of Commercial Finance, Wellcome Trust
  • Julian Hitchcock Partner, Marriott Harrison LLP
  • Dr Helen Jamison Head of Media Relations, Wellcome Trust
  • Prof. Ottoline Leyser Professor of Plant Development, Sainsbury Laboratory, U of Cambridge
  • Prof. Mike Rawlins Former Chair of NICE
  • Jo Revill Chief Executive, British Society for Immunology
  • Fran Unsworth Director World Service Group, BBC
  • Prof. Simon Wessely Professor of Psychological Medicine, Kings College London

“When a story breaks – whether it’s the latest flu epidemic, health scare or a potential nuclear crisis – the SMC persuades leading experts to drop everything and engage with the story, then contacts journalists at all the major news outlets to offer those experts for interviews or immediate comment”.

“The SMC has a track record of recruiting experts to its media database on topical issues and considerable experience and expertise helping them speak to the media. The SMC should therefore prioritise recruitment of experts working in high-profile fields that attract controversy”.

The people most aware of SMC and SAS up till this have been from the environmental movement – Friends of the Earth etc, as befits the origins of SMC in trying to influence the debate on GM foods.

Their commitment to CFS has been pretty constant too. As one of the comments on What’s going on Here mentions, SMC have recently co-ordinated comments on the PACE study of CFS.  This is a British study that has generated more interest in the US than the UK, in part because the authors have resolutely refused to part with the data and because there has been outcome switching worthy of Study 329.

The brand is obviously working because it has spread to Canada, Australia, New Zealand and elsewhere.  SMC recently forced the Toronto Star to back down over a story about HPV.

There has been a move to America also which generated this US assessment of its background and M.O. – basically endorsing corporate views.  The stated aim is to promote mainstream science but a science that doesn’t question, and get us to question, is worse than salt that has lost its flavor – the appearances of salt are worthless, the appearances of science are dangerous.

Brush with a Hitman

I had a first brush with SMC in 2015 when BMJ commissioned a piece about SSRIs and serotonin mythology. They had difficulties with the idea of calling it So Long and Thanks for all the Serotonin, but eventually it ran. From around the time it came out or earlier there were comments – the one that caught my eye was from Clare Stanford – because like Wendy Burns’ Panorama comments these were bizarre. It came with a whole new idea – Switch on Anti-Depression Today.

The comments about that article were almost identical to the ones about the Panorama program.  Telling people there was no evidence for a serotonin theory and never had been would provoke people to murderous rage, and I would be responsible for this.

To repeat what I wrote then, the powers that be (AF, SW etc) are scared silly of the people. Their reactions scream guilt. They scream that if we ever found out what they had done to us, we would rise up and they would be in trouble.  Just to be clear, I am not advocating anyone rise up, I am describing the body language of the Bishops and Cardinals of medicine.

What I didn’t know then was that the BMJ had sent the editorial and a press release of the piece to SMC.  On April 20th SMC sent both to their bank of experts including the Royal College asking for comments “from my limited understanding this could be quite controversial as it essentially suggests there is no link between serotonin and depression”. It worked its way across a few desks in the College to Dr Wessely’s desk – “this could be a big story Simon.  Would you perhaps like to comment?”

The next brush was over Study 329, an earthquake in therapeutics.  There was very little reaction from GSK to this, other than a perfunctory comment almost coinciding with publication.  This didn’t seem so astonishing; after all they had recently been fined $3 billion linked to this study and so comment was always likely to be constrained.

But it looked very like the ball was passed to GSK’s partners, Sense about Science, and in smart order Tracey Browne, Ben Goldacre and Iain Chalmers all came out to defend this wonderful, most marvelously transparent company.

The God that Didn’t Bark

One of the most surprising things about the Panorama program was that neither GSK nor Pfizer barked. Given a right of reply by BBC they said almost nothing. You will look in vain around other media outlets to find anything from them. No screaming blue murder or irresponsibility.

Thirty years ago when Prozac ran into trouble first, the standard thing was for companies to mobilize “friends” when faced with difficulties.  This is not all bad.  We want companies to defend products. With the right give and take a middle ground can be found.  But over the last few decades like the Cheshire cat, companies have been fading into the background leaving only a grin behind.

Or rather a hell of a lot of barking behind – by what appear to be others.

The Dog that Did

Before the Panorama program came out and before she had seen it Wendy Burns, the new President of the College, who has no background in these issues, had made a fool of herself in the Times commenting on things that had nothing to do with program.  See Honey I shrunk the shrinks.

Wendy Burn

http://www.sciencemediacentre.org/?s=antidepressants&cat=

The same holds true for Carmine Pariente in the Lancet who turns up regularly in these slots.  To have something come out the Lancet so quickly shows a real sure-footedness on the grassy knoll.

Carmine Pariente

www.download.thelancet.com/pb-assets/Lancet/pdfs/S2215036617303127.pdf

A host of tweets from all kinds of people including Ben Goldacre, until he ran into an upper cut from Shelley Jofre, followed.

James Thomas (@James_M_Thomas) | Twitter

My complaint about the #BBCPanorama ‘Prescription for Murder?’ show broadcast … Panorama ?, Science Media Ctr UK … Prof Social Research & Policy at EPPI-Centre

MHRUK (@MHRUKCharity) | Twitter

Check out the latest Tweets from MHRUK … Here’s a blogpost from Science Media Centre on recent #Panorama programme on … news-blog/post /a-prescription-for …

https://twitter.com/MHRUKCharity/status/891589217494740992

Ed Sykes from the Science Media Centre explains why we must rely on research to inform investigative journalism in light of Panorama’s recent episode on the link between antidepressants and homicidal behaviours.   This gushing little piece is laid out in full below  

https://www.mqmentalhealth.org/news-blog/post/a-prescription-for-stigma-why-evidence-matters

BBC News

https://twitter.com/MHRUKCharity/status/890478505514987520

http://www.sane.org.uk/resources/news/show_news/816

Media centre. News releases and … Following last night’s BBC Panorama episode – ‘A Prescription for Murder?’ … The PMCPA is a division of ABPI which is a company …

Following last night’s BBC Panorama episode – ‘A Prescription for Murder?’ – Dr Sheuli Porkess, ABPI’s Head of Medical Affairs and Clinical Research, gives her reaction to the program and its views on SSRI medicines.

http://www.abpi.org.uk/our-work/news/Pages/Having-a-responsible-conversation-about-mental-health.aspx

https://www.rethink.org/media-centre/2017/07/rethink-mental-illness-responds-to-bbc-panorama-prescription-for-murder

http://www.khq.com/story/36030700/mental-health-watchdog-says-uk-tv-documentary-prescription-for-murder-should-prompt-us-investigations-into-psychotropic-drug-violence

Watering the Lamppost

There is a Lamppost on the grassy knoll that dogs use a lot.  Its not clear if the drunks looking for their keys there get the smell.

Ed Sykes from the Science Media Centre explains why we must rely on research to inform investigative journalism in light of Panorama’s recent episode on the link between antidepressants and homicidal behaviours.

Imagine a pill, taken by millions of people every day, that unwittingly turns some of us into murderers. That was the scenario laid out in the recent Panorama on antidepressants, it was the message trailed in the media in advance of the show and it was the line used in the press release to drum up interest. That ‘s a very powerful and scary message, and when you’re talking about a drug that saves thousands of lives every year – and that already has a bad public image – then we need to be extra careful.

Putting people off antidepressants costs lives.

Antidepressants are not perfect, they have many side-effects, it can take a long time for people to find one that works for them and they don’t solve the problems that drive people into depression in the first place. People should be aware of these problems and we should discuss them openly. At the same time, we should be celebrating investigative journalism because it can be a massive force for good and I’d love to see more of it, but with any topic it needs to be done well, and when there’s a risk of people stopping a life-saving medication then that’s especially true.

So why was I concerned by the programme? What riled so many other people? I fully believe that antidepressants can change someone’s behaviour, and that we should be asking whether the negative side-effects are really outweighed by the benefits.

But to do that, we need to see evidence, not simply be given a case study.

The programme focused almost exclusively on the case of James Holmes, known as the Batman killer after opening fire in a cinema showing the Dark Knight Rises. We were shown the timeline of events leading up to the massacre, we heard from his parents and from a couple of psychiatrists involved in the case. But where was the evidence that the murders were linked to the medication?

I spend my days working with researchers on all aspects of mental health and neuroscience, these are people who dedicate their lives to sifting through the data to see whether we are imagining patterns or are blind to what the stats are telling us. Many of them are investigating exactly these questions around antidepressants.

Professor Seena Fazel is known around the world for his work investigating whether antidepressants lead to an increase in violence. The research doesn’t show any evidence for an increase in people over 25. In younger people, there is evidence of a slight increase but we still can’t say if this is due to antidepressants. It’s complex as young people are taking more alcohol and other recreational drugs, and some of these people are actually suffering from severe personality problems that make them violent in the first place. It’s fascinating work using data from tens of thousands of people and I would have sat engrossed for an hour hearing about what the figures show. But even if Seena’s work did show antidepressants caused people to be more violent, that would still be a big step away from turning someone into a murderer.

It’s not just Seena and his datasets who don’t see the evidence for saying antidepressants turn people into murderers. I contacted around I00 researchers who work on various aspects of depression and antidepressants and the only message that kept coming back to me was that there was just no good evidence to suggest that antidepressants turn people into murderers. Yet in the show we were presented with one psychiatrist who said he thought the drugs weren’t to blame, one who thought they definitely were and one who thought we should be looking into it. It seemed as though the field is split evenly on this and that the evidence is up for grabs – this isn’t representative of the views of the mainstream science community; it may be ‘balanced’ but it isn’t measured.  This kind of false balance has been blogged about many times before.

The main evidence the programme seemed to be giving us, alongside the case studies, was the result of a Freedom of Information request to the Medicines & Healthcare products Regulatory Authority (MHRA). The MHRA is responsible for many aspects of healthcare, including a Yellow Card system that records all the bad side-effects linked to any drugs. The Panorama team informed us that their investigation had unearthed 28 cases linking antidepressants to murder and 32 to murderous thoughts. The show did point out that these were just reports, not conclusions that the drugs had caused murder. But what they failed to mention was that these reports to the MHRA can be made by anyone. You or I could go on their website right now and make a report, it doesn’t necessarily mean it was a medical professional who reported it or that the report was supported by strong evidence . Maybe each of these reports was made by a healthcare professional and was supported by good evidence, but Panorama didn’t show it to us.

The programme did well in reminding viewers not to stop taking medication without speaking to a medical professional first, but it also kept repeating that in rare circumstances these drugs might be turning people into murderers. The EU defines a rare disease as affecting fewer than 5 in 10,000 people, but when there are a lot of people involved then even a rare event should start to appear quite a lot. Around 1 in 10 people in the UK experience some form of depression during their life, there were 61 million prescriptions for antidepressants in 2015 alone, probably more than 500 million during the last three decades. So even if all 60 of the Yellow Card reports to the MHRA had all definitely been a case of the drug turning someone into a murderer that would be around I per 800,000 prescriptions. There are only 600,000 people living in Glasgow. These circumstances aren’t rare, they’ re vanishingly small.

What viewers of this Panorama didn’t see was a measured, proportionate account of the huge wealth of evidence on this topic. Through false balance, by not showing the evidence, and by not giving some much-needed context what could have been an insightful programme left people misinformed. Antidepressants would benefit from investigative journalism – there are good questions about over-prescribing and prescribing for the wrong reasons, but there are also concerns about under­ prescribing and how a really useful drug is still being shunned by many. With a thorough investigation we could learn a lot about how much the drugs do change people’s personalities, whether using them stops us from investing in psychological therapies, if they result in social problems being ignored and even whether they do lead to violence or murder – but to have that debate we need to see the evidence, not just rely on one case study, no matter how distressing.

Ed Sykes is Head of Mental Health and Neuroscience at the Science Media Centre.

 

What’s going on Here?

Editorial Note:  This arrived out of the blue. The list of those copied in makes it look like its anything but spontaneous. Simon Wessely is recently vacated president of Royal College of Psychiatrists, and one of the Trustees of the Science Media Centre.  Paul Summergrad and Jeff Lieberman are former presidents of APA.  JL offered views on the Holmes case. There is no indication AF has actually watched the program.

From: Allen Frances <allenfrancesmd@gmail.com>
Date: 6 August 2017 at 00:53
Subject: Dear David.
To: David Healy <David.Healy54@googlemail.com>
Cc: Simon Wessely , Barney Carroll , Paul Summergrad , Jeffrey Lieberman , Ronald Pies

I have watched this story play out with deep misgivings. I know you meant well, but also know you went way overboard categorically declaring meds to be the causal factor in this mass murder, when there were so many other possible contributing factors and no real proof meds were among them. It reduces your credibility when you make such extreme statements and also makes it harder for people like me who are trying to curb medication excess, while encouraging its proper use (against the false claims of extremists who somehow blame all psych problems on meds). I know how much flak you have already taken and that you must feel backed into a corner. My recommendation would be that you issue further clarification on the difficulty of establishing causality and the essential benefits, as well as the considerable risks, of psych meds. To do otherwise makes you responsible for patients going off, or refusing to start, meds they may desperately need. Protecting people ffrom unneeded meds is your noble calling, but should not result in your unneceessarily scaring people off needed meds. What do you think?

Allen Frances (@AllenFrancesMD) tweeted at 4:06 PM on Sat, Aug 05, 2017:
I constantly caution re misuse of psych meds
But its extreme to blame mass murder on them
Ignores role of psych disorder/guns/social context https://t.co/gpJ2JpHOzw

On Aug 6, 2017 4:36 AM,
“David Healy” <david.healy54@googlemail.com> wrote:

Allen

With all due respects you are a long way wide of the mark.

First, aside from a carefully orchestrated campaign, the response from patients and many others has been very positive.

I think the best way into this is to give you two things to read – a piece in the BMJ by Gwen Adshead attached and a response below.

Re: Antidepressants and murder: justice denied

Dr Adshead misses the point behind this program. This was not a program attempting to prove antidepressants can cause homicide. This has already been conceded by prosecutors, regulators and company personnel. As early as 1982, Pfizer personnel had noted that this class of drug (SSRI) were known to cause these reactions.

Nor was it about whether sertraline caused James Holmes to commit murder. Having spent time with the man, my view is that it did, and more could have been done to persuade viewers of this.

The key issue was this. If it has been conceded this drug can cause events like this, and if a case could be made that it did so in this instance, why did Holmes’ legal team not run it?

The answer in part lies in the fact that academic literature on SSRIs is almost entirely ghost-written and there is no access to the data generated by the RCTs of these drugs. The BMJ and other journals play a part in this situation. This means that to acquit Holmes, a lawyer has to persuade a jury that most academics and journals are guilty of failing to adhere to the norms of science.

Holmes was in a Guildford Four quandary. Paraphrasing Lord Denning in that case ” If his [their] story is right, it is such an appalling vista it cannot be. Wrongfully convicted prisoners should stay in jail rather than be freed and risk a loss of public confidence in the law”.

Holmes had a public defender. If he had been wealthy enough to afford a lawyer who relished the challenge, or if the crime was less horrific, things might have been different. The rest of us who end up on the wrong end of one of the close to 100 drugs, including respiratory, skin and cardiac drugs, that prosecutors or companies have indicated can cause violence risk ending up in the same legal quandary Holmes was/is in.

There have been a lot of comments, coordinated by the Science Media Centre, that this program cast aspersions on a useful group of drugs. We need to find some balance between raising alarms about a drug and ensuring we do not compromise an innocent person’s right to a fair trial.

*#@

Let me spell out some things in further detail. The Panorama program had vastly more detail on Holmes and his assessment than it could deal with and likely ended up being too subtle for its own good (or maybe for my good).  To call this a failure of BBC journalism is as far removed from the truth as you can get.  It was one of the best things they have ever done in my opinion.

Second, they do refer to Pfizer judgments their drug can cause psychosis and aggression – which Pfizer opted to put in the label as of 1994 (See the link below). Vanishingly few doctors understand what is going on here.  They see a label saying something like “there have been reports of violence and psychosis on our drug so we are including these here” and read this as – look at this wonderfully transparent and responsible company who are putting in the label even whacko reports from nutters and scientologists – am I going to believe this?  Don’t be ridiculous.

In fact what is going on is Pfizer and other companies have reports that no matter what way they spin it they cannot explain it in any other way but that our drug has probably caused this.

This is consistent with Pfizer determinations from their healthy volunteer studies in 1982 that sertraline can cause behavioral reactions including agitation/suicidality and aggression/ homicidality and that this class of drug (SSRI) are well recognized to do this.  1982 !

Part of the problem the field has is that the data is inaccessible. If anyone can tell me how anyone can offer expert views in the absence of the data, I’d be interested to hear it.  The more we go on with this charade of basing views or guidelines on ghostwritten articles, the less credibility we will all have.  Surely Study 329 brought this point home.

The second point is this.  Before this program came out, the Science Media Centre had lined up statements from high ranking figures including Wendy Burn President of the Royal College of Psychiatrists to slam the program – in terms that had nothing to do with what was in the program – her statement talks about stigmatizing mental illness.  WB later confessed she hadn’t seen the program when she made the statement.  She has no expertise in this area.  It’s not clear to me she authored her view. SMC have continued to coordinate inputs that have little to do with the real issues at the heart of the program.

Who are SMC?  They are linked to Sense about Science.  Simon can probably tell you more. My take is the original idea was reasonable – scientists like him were under attack from what might loosely called activists.  He probably had much less hostility to cope with than I have had defending ECT.  But the idea was to ensure that proper science got a hearing.

The reality today is that funded by public money and almost any major corporation you can think of whose interests intersect with healthcare, SMC get preprints of all articles from BMJ for instance – such as my piece some years ago – So Long and thanks for all the Serotonin – and approach the Royal College to get experts who can diss the piece when it appears.  (I wouldn’t make a statement like this without the documents to back it up).

This is stifling proper science.  It has become nasty and risks being fascist. It’s dangerous for both patients and medics.  As I’ve tried to tell SW on several occasions unless medicine embraces the idea that the magic of medicine and doctors is that we bring good out of the use of a poison, we are fucked.

If the drugs are wonderfully effective, and free from problems other than notional ones, then we are costly prescribers and it is no accident we are at present being phased out.   This may not be a problem for you Allen but it is for my children and everyone else in that generation.

If the drugs do what the guidelines would suggest, then managers can tell shrinks what to do and we are losing our jobs if we don’t comply.  This is not a world in which you had to practice Allen but I can tell you its not pleasant.

As a hard core supporter of the medical model and someone who doesn’t advocate for anything other than physical treatments, I look at the current state of psychiatry and a lot of medicine with increasing dismay and would make sure anyone thinking of taking up psychiatry knows it is an increasingly grim profession where the excitement if any lies in working out how we have messed up so badly and how to turn things round.

Re reducing the burden of over-medication – well 10% of the UK and most other major countries are on antidepressants.  There is no increase in the numbers being put on them year on year.  The yearly increase comes from those toppling over into chronic use at the end of their first year of use.  When I began practicing we figured antidepressants should be used for 3 months – perhaps 6 months occasionally.  Of the 10% of people in the UK on these drugs, 90% roughly are on them for  more than a year primarily because they can’t get off – there are several reasons why this might be.

Here is a link to the P program.

https://www.youtube.com/watch?v=InTukPOs_JE

It’s worth watching.  But remember it’s subtle.  They left out lots – including the healthy volunteer material and the clips of Bill Reid saying he knew nothing about the drugs and there was no point asking him about drugs – you’d better get someone else to comment on that.

After watching, the issues I’d be interested in hearing views on are the following:

  1. Having offered comparatively few views in cases involving SSRIs, mostly views that the drug has played no part in whatever event, I believe there are a number of innocent people wrongly convicted and many people who will never get a fair trial.  What can we do about this?
  2. Recognizing that prosecutors in the case of Zoloft, companies in the case of all these drugs, and the data where it is available, make it close to incontestable that SSRIs in principle can cause violence, and recognizing that patients are far more sensible than we usually give them credit for and can manage a genuine debate, how do we conduct a debate about these issues?
  3. It seems to me we are failing the F Scott Fitzgerald test: “The test of a first rate intelligence is the ability to hold two opposed ideas in the mind at the same time, and still retain the ability to function”.  Why might this be?
  4. Are organizations like SMC a good thing or not and if a good thing do they need a new brief – looking after the interests of a profession rather than the interests of corporations and their products?

David

From: Allen Frances <allenfrancesmd@gmail.com>
Date: 6 August 2017 at 14:20

David,

You make my point much more eloquently & succinctly than I ever could with this quotation at the end of your response:

It seems to me we are failing the F Scott Fitzgerald test: “The test of a first rate intelligence is the ability to hold two opposed ideas in the mind at the same time, and still retain the ability to function”.  Why might this be?

I think you need to address your own question to yourself- why might it be that you (who obviously otherwise have the highest intelligence), are so willing to go propagate the one sided extremes emphasizing the potential for bad complications from meds without being able to hold as well the opposed idea that for many the meds are desperately needed and of very favorable risk/benefit. In my view, your being unable to hold these 2 opposing ideas greatly reduces your effectiveness as reformer of psychiatry and risks disaster for patients who do need meds.

I also don’t understand how you can be so sure of yourself and make such definitive statements about an inherently multicausal act. How can you or anyone prove it was just meds that caused murder. You must know that nothing in psychiatry and human behavior is that simple, but you seem not to know the possible harms that follow when you make it seem so.

I fear that the great good you have done and will do in pointing out the risks/harms of meds is tarnished by your radically extreme position and inability to also appreciate benefits. I know we have been over this many times before and don’t want to make what must be a difficult time more difficult. My goal is not to change your mind, but to open it a little and to suggest that you are now embattled not just because there are some corrupt forces aligned against you, but also because you have gone overboard in taking an indefensible one sided position.

Thanks for the dialog. Even if it goes nowhere I felt compelled to once again raise our differences. Hope the dust settles.

Best Al

David Healy <david.healy54@googlemail.com>
Date: 6 August 2017 at 14:44

Allen

You are either not reading what I’ve written or not thinking about it.

I would hardly say I believe in the medical model probably even more than you and advocate nothing but physical treatments if they didn’t do some good.

I think you are making the mistake of thinking good comes out of the use of a pill – when in fact it comes from doctors use of pills – or not.  And if we don’t keep doctors and patients fully informed of all the effects of pills they are much less likely to be able to bring benefits out of them.

Can you tell me where you get the idea I am embattled from?  I expect an SMC campaign – this is just the rough and tumble that someone who is concerned about patients and the profession has to put up with these days.  Aside from this I am not aware of much else – certainly nothing of substance that engages the issues.

Its not me being so sure of myself.  Companies have been sure in the case of close to 1000 different meds that they have caused psychosis and over several hundred that they have caused violence.

This has been the case for Zoloft for over two decades.  Do you think you’re looking after the interests of patients saying nothing about this?

D

From: Allen Frances <allenfrancesmd@gmail.com>
Date: 6 August 2017 at 18:45

It is not deceiving the public to take a balanced position that meds can benefit and meds can harm.

It is deceiving the public to assert with certainty that you know meds caused this mass murder.

And the vulnerable populations I worry about (& you should too) are not the many worried well who are over medicated, but the few very ill who desperately need meds & will be scared off them by your overly dramatic and unsupportable claims to omniscience that Holmes acted only their influence. Every act can have unintended harmful consequences. You are nobly trying to help people, but the extremity of your views and unwarranted certainty hurts others.

From: David Healy <david.healy54@googlemail.com>
Date: 6 August 2017 at 20:20

Allen

I was puzzled “extremity of my views” – about the medical model or access to data  – until I realized you were talking about my old style twentieth century making a diagnosis as opposed to taking a brain scan.

Having interviewed the man at some length and seen 24 hours of others interview him on tape and having read many other reports – all from people who quite happily say they know nothing about the effects of the drugs, and having had access to vast amounts of other material – computer records, texts etc – and having gone into it not thinking the drug played a part – I only went because the lawyers insisted – yes I am very happy this would not have happened but for the drug in this case.  Holmes has no sense that I thought that.

I remain the only person with any expertise in the drugs in this case who has interviewed him etc – so I don’t really know what basis you have for thinking my views extreme.

I have no idea what it would take to get you to realise this is not about Holmes innocence or guilt – he is gone away forever and would have preferred to be dead.  The issue is that very few people in the US or UK in anything remotely resembling this situation are getting a fair trial.

Long before Holmes I approached ACLU about this issue – who wanted nothing to do with it for fear of jeopardising prisoners access to healthcare.  I realize there is an access to healthcare issue in the US but I don;t think the people on this list need to act like you are an embattled minority.  Your job is to change this so both those not getting care and those not getting justice get a better deal

David.

 

 

Honey I Shrunk the Shrinks

 

Editorial Note: Prior to the Panorama program Prescription for Murder tonight,  a flurry of experts denounced the scaremongering. This didn’t just happen by accident.  The denunciation effort was also more intense than the pressure brought to bear on the original Panorama programs in 2002-2004. The change is in part down to the fact that Sense about Science, which co-ordinates the Science Media Centre/Center, was set up for this and related purposes in 2003.  

It would take a brave investigative journalist to investigate the SMC and SAS. No-one has been brave enough so far.

Some of the comments below are unfortunate.  It seems counterproductive to have the new president of the Royal College defend antidepressants, as her predecessor did, rather than defend psychiatrists.  If the pills are so good and so free of side effects, some politician is going to wake up some day to a new possibility – Honey I shrunk the shrinks and replaced them with nurses and pharmacists and we all are going to save a lot of money. 

From: Edward Sykes [mailto:edward@sciencemediacentre.org]
Sent: 25 July 2017 13:11
To: edward@sciencemediacentre.org
Subject: SMC Roundup: Antidepressants and murder

Science Media Centre Roundup

Expert comments on whether antidepressants can lead people to become a murderer, as is being reported in advance of the upcoming Panorama programme ‘A Prescription for Murder?’*

Prof Wendy Burn, President of The Royal College of Psychiatrists, said:

“We are disappointed with recent coverage about antidepressants, especially since the reporting so far has not included a comment from the College.

“For many milder episodes of depression talking therapies will be recommended as the first line of treatment.  For moderate to severe depression, antidepressants are an evidence based treatment. Their prescription should be reviewed regularly in line with clear national guidance. We know that more of the people living with mental illness now seek medical advice and we believe this explains the increase in the number of people being prescribed antidepressants. For many, these drugs have had a beneficial effect on mood and have helped reduce suicidal thoughts or self-harm.

“In all treatments – from Cancer to heart disease – medicines which do good can also do harm. This applies in psychiatry. Current evidence from large scale studies continues to show that for antidepressants the benefits outweigh the risks, which is why it is important to highlight that the experience raised by the author in the recent Sunday Times article is extremely rare.

“Any patient who is unsettled by this media coverage, or feels pressurised to stop taking an antidepressant drug, should not abruptly discontinue their prescribed treatment. Instead, they should make an appointment with their family doctor or mental health professional to discuss any concerns they might have. They should together make a joint decision about whether to continue antidepressant treatment.

“This decision should be made on their own individual experience and should be informed by how effective their treatment has been in helping to reduce depressive and anxiety symptoms, any side effects which might have occurred, and the risks of a recurrence of illness, if treatment is stopped prematurely.”

Prof Shirley Reynolds, Professor of Evidence Based Psychological Therapies, Director of Charlie Waller Institute, University of Reading, said:

“If the Sunday Times article is correct then the upcoming Panorama (A Prescription for Murder?) focuses on a BMJ study that came out last year that looked at suicidality and aggression during antidepressant treatment. Unfortunately, as we wrote in our letter published in The BMJ, that study had flaws in presentation and logic and the results were further misrepresented by the BMJ press release.

“The term ‘suicide’ was used when the data actually only referred to ‘suicidal behaviour which is a hugely important difference. The data in the study didn’t actually show any instances of suicide in children or adolescents. The authors also stated that antidepressants are known to increase the risk of suicide in children and adolescents, which is not factually correct and the references cited do not support their assertion.

“Furthermore neither the paper itself nor the editorial actually pointed out the significant fact that of the five antidepressants mentioned in the article only two (fluoxetine and sertraline) are currently recommended by the National Institute for Health and Care Excellence for the treatment of depression in young people.

“This matters because if people stop taking their drugs then that really can lead to an increase in suicides. A review of 574 youth suicides reported that only 1.6% had received antidepressants.

“Young people need access to a range of individualised evidence based treatments. The possible risks of harm from antidepressants (or psychological therapy) must always be balanced against the benefits of treatment and the increased risk of suicide in severe, untreated depression, but we must be very careful about turning people away from the very therapies that can help them.”

Prof Carmine Pariante, Professor of Biological Psychiatry, King’s College London’s Institute of Psychiatry, Psychology & Neuroscience, said:

“There is no good evidence that antidepressants increase the risk of violent behaviour, and the extremely rare (and tragic) cases that are cited in support of this theory could be explained by chance: antidepressants are prescribed relatively widely, and so by chance someone on antidepressants will commit a violent act. Moreover, people on antidepressants may be suffering from some forms of mental disorder or distress that may, albeit very occasionally, increase the risk of reacting impulsively or violently.

“With 7% of the UK population and 11% of the US population currently taking an antidepressant, we would have clearly seen an increased risk of violence if there was one. With alcohol, for example, there is a clear evidence that it is linked to at least half of all cases of violent assaults, child abuse, domestic violence as well as homicides and murders.

“In contrast, we know very well that every time an alarm reduces the rates of prescription for antidepressants, suicide rates increase, including in adolescent and young adults. The risk of suicide attempt in patients treated with the commonly use ‘SSRI’ antidepressants is approximately one-third that of patients who are not treated with an SSRI. And this is without even considering the life-saving effects that these medications have on patients’ recovery from their mental health problems.”

Prof Allan Young, Professor of Mood Disorders, King’s College London’s Institute of Psychiatry, Psychology & Neuroscience , said:

“Antidepressants are widely used and at the same time that the MHRA is constantly monitoring reports, scientists are continually doing studies looking into any side-effects. We have to be really careful that there is good evidence for the claims we make and if we find serious effects then we shout about them because we want to help patients.

“If there was good evidence of antidepressants turning people into murderers then we would certainly be looking into that. It is an extremely strong claim and therefore needs to be backed by strong evidence. So many people take antidepressants that we will always be able to find some coincidences, but it takes a lot more evidence to mean it’s more than that.”

Prof Seena Fazel, Professor of Forensic Psychiatry, University of Oxford, said:

“I have spent some years looking at the impact of psychiatric disorders and treatments on violent behaviour and the data is quite complex. The first thing to say is that there is no clear evidence of a link between antidepressants and violent behaviour in older people. In young people the latest stats do show something, but we cannot say that antidepressants are making people more aggressive as we can’t tease apart whether it’s the antidepressants or the fact that young people on antidepressants are also using alcohol, and some actually have severe personality problems which can make them more violent in the first place.

“The whole picture is further complicated by the fact that we don’t have much really high quality data and most data comes from trials which are actually looking at things like verbal aggression, rather than actual violent acts. We are trying to get round this by looking at data from countries where national crime registers can be linked to records of individuals with depression. We can then look for any differences in individuals who are prescribed SSRIs versus those who are not. You can also compare the same person twice – once when they use antidepressants and once when they don’t.

“With colleagues at the Karolinska Institute, we did one such study based on all people in Sweden from 2006 to 2009, which amounted to around 850,000 individuals taking SSRIs. What we found was a complex picture although two patterns emerged – for 80% of individuals who were prescribed SSRIs and were aged over 25 years, there was no clear association with violent crime. In those aged 15-24 years old, there was an association with increased rates of violent crimes (and also violent arrests and non-fatal accidents), however that’s not as clear as it sound as this association was stronger in those receiving sub-therapeutic doses of SSRIs, suggesting that partial treatment of the underlying depression may be one explanation for this link in younger people.”

* As reported in the Sunday TimesDaily Mail and The Sun

Declared interests    None declared

Note to editors

The Science Media Centre is an independent venture working to promote the voices, stories and views from the scientific community to the news media when science is in the headlines. Over 100 supporters including scientific institutions, media groups, charities, universities and corporate organisations provide a donation to support the Centre achieving its objectives. The SMC makes all organisational and editorial decisions independently of funders. This press release contains the personal opinions of those acknowledged, and represents neither the views of the SMC nor any other organisation unless specifically stated.

The Science Media Centre can also help you find an expert on a topical area of science, we have over 2000 media friendly scientists and engineers on our database and you can call us on 020 7611 8300 if you need an expert to interview.

The SMC has asked the experts in the above Roundup to declare any interests which may be regarded by a reasonable and objective third party as giving rise to a conflict, and their responses are included above.

For more details see our website www.sciencemediacentre.org, please e-mail the Science Media Centre with your comments on our service atsmc@sciencemediacentre.org

Dr Edward Sykes
Senior Press Manager and Head of Mental Health & Neuroscience

Science Media Centre
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Tel: 020 7611 8321
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Baby Boomerang

Editorial Note: This post continues a sequence of posts about well-intentioned efforts to produce change that may have produced the wrong change – see Boomerang and Boomerang 2.

The contraceptive pill, the Pill, came into our lives in 1960. Almost immediately there were reports of young women with deep vein thrombosis (DVT) and pulmonary embolus and in some cases death from thrombosis. As expected industry denied there could be a problem – DVTs happen, women are prone to them, pregnancy leads to more of them than anything else. Many medical and religious experts thought there had been shockingly little research on the Pill and it should be banned until a lot more was known about it. AMA and FDA undertook studies and reviewed the evidence and concluded there was nothing to it. In the middle there were a few experts like Louis Lasagna who said that if a bunch of young women start turning up with DVTs while on the Pill, there were compelling grounds to think the pill could cause thrombosis, but having been told the risks women needed to be let make their own minds up about it. This position probably cost him job in Johns Hopkins.

The original Pill was a high dose Estrogen pill. In 1968 a British study reported that high dose Estrogen pills were linked to far more thrombosis that just introduced low dose pills. There was panic.  The British regulator convened meetings.  The options were to phase out the high dose pill or begin to insert information for the patient with each package explaining the risks.  British medicine was against interfering with the doctor patient relationship and so the regulator effectively banned high dose pills.  The change was so rapid that pharmacies didn’t have time to stock up and there was chaos.

The following year Barbara Seaman’s The Doctors Case Against the Pill spread the panic to the United States. Senator Gaylord Nelson convened Hearings on January 4 1970 to review the situation. These hearings gave rise to the photo above – the forerunner of the all male Trump cabinet photo in January this year for the signing of the order limiting access to funding for any organizations having any truck with abortion.

The Nelson experts were all male. One of them John Davis, concealing his financial interests, made a pitch for IUDs and the soon to be introduced Dalkon Shield which had a huge uptake partly because of concerns about the Pill.  The Dalkon Shield caused horrific injuries and put the the company marketing it A.H. Robins out of business – in part because they spent so much time denying there could be a problem.

Girls

Nelson was pro-generic drugs, pro-consumers and generally progressive. So perhaps he did what he did next on purpose!  When two women from the Women’s Liberation Front stood up to protest what was going on, and refused to sit down, he asked the Girls to settle themselves.

All of a sudden a consumer movement that was having difficulties getting heard had hundreds of thousands more followers. Drugs beyond the Pill became an issue for women, who turned up in force at later hearings on tranquilizers.

Bill Haddad’s National Consumer League for Prescription Drugs had women experts and women presenters at hearings, and men began to become a touch more wary about women like Abby Meyer, a self-styled little old housewife from Connecticut, when she began talking about an Orphan Drugs Bill.

DTCA

Rather than remove high dose Pills, the FDA resolved the Pill controversy by opting for patient inserts to inform women. The AMA objected. It was the role of the doctor to have discussions with his patients. In the end there was a compromise, dispensing an almost unintelligible and opaque insert was left to the doctor’s discretion.

Some years later in 1978, the Carter Administration announced a Drug Regulation Reform Bill, more often thought of as a Kennedy Bill.   This planned to extend patient inserts to all medication and make them more intelligible.

It also proposed among other things to let companies post the prices of their drugs.  The generic industry was just coming into being and the hunch was that visible evidence of lower prices might help the switch and save costs. The National Consumers Prescription Drug League welcomed these changes. The Carter Bill went nowhere but …..

In 1983, on television in Florida, the Boots Pharmaceutical company ran the first Direct to Consumer Advert for a pharmaceutical.  A brief 40 second slot telling consumers that Boot’s own brand of ibuprofen, the original drug, was cheaper than some of the copies they might be sold.

They were instructed to take down the advert, while the FTC considered the propriety of this move. After thinking about it for two years, during which they had representations from companies like Lilly that this was not a good idea – it would be burdensome for industry – FTC sanctioned the move on the basis that consumers had patient information now anyway and had welcomed information about prices.

Before inserts doctors were the fall guys if something went wrong on a medication – it was their duty to warn. Companies had no duties to warn patients. After inserts and DTCA, doctors remain the fall guy – as GSK’s efforts to pin the blame on Dr Sachman in the Dolin case illustrates. You gotta have a fall guy.

 

Change in Chicago: Boomerang 2

In 1983, the year before Henry Waxman got the Waxman-Hatch Act on the Statute Books he got the Orphan Drugs Act passed.  Here’s how it happened.

In a wonderful 2016 self-publication, Abbey Meyer, a self-styled Connecticut housewife, outlines a story that began when her eldest son David was born in 1968.  The book is downloadable for free and is well written and compelling.

When David was only a few years old he began to show signs of what her doctor called tics. As problems grew at school, she became increasingly concerned for him.

Then one Sunday in a newspaper she read an article about Tourette Syndrome. This led to clinical appointments and treatment.  The standard drug, haloperidol, turned David into a zombie. He was enrolled in a clinical trial of a new drug pimozide, which was better, but supplies were cut off in 1976 when McNeil pharmaceuticals opted not to develop it further. Her doctor used the term orphan drug to explain what was going on.

An Orphan Drug was one that was likely to end up being used by less than 200,000 people – which the pharmaceutical industry figured was their break even point. Unless that many people took the drug, they claimed they were unlikely to make a return on their investment.  Around 1980 concern was growing that this might mean no new drugs for Multiple Sclerosis, or Epilepsy or Lou-Gehrig’s Disease (Amyotrophic Lateral Sclerosis – ALS).

Meyer was astonished. She became active.  Among the first people she tied up with was Marjorie Guthrie, the wife of Woody Guthrie who was campaigning for orphan diseases. A group of women mobilized pretty quickly. Muriel Seligman from Los Angeles had a son Adam with severe Tourette’s.  She approached her Congressman, Henry Waxman.  Waxman convened a hearing in June 1980 inviting all pharmaceutical companies. None turned up. There was no-one at the hearing apart from a few families with rare diseases and a reporter from the Los Angeles Times.

On the back of an LA Times article, Meyer was contacted by Jack Klugman who ran the Quincy MD show a widely watched medical series on TV. Klugman bought the idea of an episode that would have a boy (an actor playing Adam Seligman) testify at a Congressional Hearing in very emotional terms about the damage caused by lack of treatment.

The show Seldom Silent, Never Heard ran in March 1981. Its a must watch. There are 5 minute clips out there showing the key scene when Adam Seligman makes a pitch to Congress – but I can’t find the link at the moment.

Thousands of letters flooded in. Waxman convened a follow up hearing at which Quincy (Klugman) testified in person. There was standing room only. The Wall Street Journal laughed at Waxman and the idea that Congress might take advice from actors.  But Nancy Kassebaum introduced a bill in the Senate, which Waxman introduced in the house that passed both houses in December 1982 and was signed into law by Ronald Reagan in January 1983.

A few days later, Meyer and others formed the National Organization for Rare Diseases (NORD) and began cataloguing all the conditions that might qualify – there were over 6000.

By this stage she had met Bill Haddad. Haddad, as Chair of the Generic Pharmaceutical Industry Association, was chasing a Bill to regularize the position of generic drugs – that later became Hatch-Waxman.  Among other things he had made it clear that if the branded industry didn’t bring orphan drugs to the market, the generic companies would.

Haddad provided funds for an office for NORD in Danbury Connecticut. When the landlord heard what NORD was up to, he asked whether this meant AIDS patients might be visiting the premises. Meyer hadn’t thought of this possibility. The landlord told her she would have to go elsewhere but after a later “meal” with one of her supporters he made a several thousand dollar donation.

AZT turned out to be the first drug approved under Orphan Drug provisions, with almost all other drugs for AIDS and its associated infections being approved in the same way.

A key contact Meyer got from Haddad was Agnes Varis, the owner of AgVar a generic company. Varis was connected to everyone in the generic industry and the Democratic party.

At this stage rare diseases were assuming a shape fronted by ALS, multiple sclerosis (MS) and hemophilia. A drug called copaxone had shown benefit for MS but Meyer couldn’t persuade a branded company to pick it up.  Among other things the patent status was obscure.  It had been discovered in the Weizman Institute in Israel.

Varis strong-armed Teva, a small generic company based in Israel and the US to pick it up.  It was approved under the Orphan Drugs Act and went on to blockbuster status, earning Teva over $1 Billion per year, and making Teva the leading generic company.

Get on the Train

Meyer’s book is a compelling read.  But its difficult to avoid a slight feeling of deliverance from a ghetto on trains that turn up to transport us East to safety.

As of 2016, the branded drug industry is a $1,275 Billion dollar industry half of whose profits ($638 Billion) come from drugs brought to market in the standard way. The other half ($637 Billion) comes from drugs availing of the Orphan Drug provisions which allow for an easier ride through FDA and a longer period of monopoly.

The orphans have included Merck’s Vioxx, Lilly’s Cialis, Astra’s Crestor, Bristol Myers Squibb’s Abilify, Botox and many others among the best-selling drugs of recent years.

While it is possible to close some loopholes that lead to blockbusters being named orphans, the precedent of allowing high prices for drugs that will supposedly only ever occupy niche markets has laid a business model for personalized medicines.  If genetic tests ever permit a tailoring of medicines to specific patient groups, the orphan argument will apply.

For most of this period, the Wall Street Journal had Henry Waxman as one of its prize targets claiming that he was to progress what the Troll under the bridge was in the Billy Goats Gruff.

But without mentioning him, as early as 2005 WSJ was trumpeting the fact that Orphan Drugs Act had been the savior of the pharmaceutical industry – not that an industry earning $638 billion from other sources really needs saving.

 

Change in Chicago: Boomerang

When it comes to branded and generic drugs, the listing of key issues in this image misses a trick. The labels are identical.

This lack of difference is a consequence of the 1984 Hatch-Waxman Act which after two decades of dispute staked out a boundary between generic and branded pharmaceutical companies, part of which in the case of their drugs required the generic companies to take over the label of the branded drug when they entered the market.

The Cost of Drugs

The issue of branded and generic took shape in the 1950s.  Before then the primary way companies controlled drug niches – monopolized on the sale of profitable drugs – was through branding rather than patents. This meant there were a lot of branded generics and a lot of companies who manufactured drugs for other companies who branded and marketed.

The branding and marketing cost money and was the major component of a drug’s price – that and profit taking. If consumers could access “raw” medicines the same way they can access unbranded other products, they would be able to save money. And driving down the price of drugs was the main goal of Estes Kefauver’s hearings on the pharmaceutical industry that led to the 1962 Amendments to the Food and Drugs Act.

Kefauver failed in his goal of containing prices.  Other changes his amendments introduced, such as the need to prove a drug worked before marketing and the use of controlled trials to achieve this, drove the price of drugs up. As prices rose during the 1960s, for a variety of reasons support for the idea of increasing the flow of generic drugs began to grow.

The main block to the use of generics was legal.  Most American states for instance had anti-substitution laws, meaning that, if a doctor wrote a script for a branded drug, a pharmacist could not substitute a cheaper generic drug.

Battle lines were drawn between the consumer movement, a relatively powerful lobby in the 1960s, and the branded industry who for the most part were operating behind a shield of doctors.

The push to repeal anti-substitution laws and greater use of generics was portrayed as a push for socialized medicine and an infringement of the sacred relationship between doctor and patient. Do you want your doctor to give you the best or the cheapest drug?

Pharmacists were warned about the risks of being sued by patients if they were to intervene and swap drugs and something then went wrong.

Staring in 1974 with Kentucky a trickle of states repealed their anti-substitution laws, while Oklahoma refused to do so.  The key moment came in 1978 when New York opted to allow substitution.  This was key because where other states had lists allowing twenty or thirty drugs to be substituted, using cloak and dagger methods Bill Haddad in New York had created a list of 800 FDA supported substitutions.  It was this rather than Haddad’s later involvement with Orrin Hatch and Henry Waxman that brought generics into play.

Tidying Up?

Hatch-Waxman tidied up the loose ends.  It gave the branded industry a modest amount of patent extension and streamlined the process for generic drugs to enter the market.

A central element of the deal involved the label generic companies would run.  Generic companies can make chemicals but the branded companies run the trials and collect the early data on a drug that makes the label and transforms a chemical into a medicine. The best deal seemed to be for generic companies to take over the branded label lock stock and barrel.

When the Supreme Court ruled in 2011 that generic companies could not be sued in a failure to warn case, because they had not done the warning, this set up a predictable clash.  In 2001 when Prozac went off patent and Barr Laboratories brought out a generic fluoxetine, it was clear that at some point the question of suicide on a generic SSRI would become an issues.

The Dolin case is where the rubber hits the road. Some higher court will have to decide on the merits of allowing GlaxoSmithKline to be sued when Stewart Dolin committed suicide while taking generic paroxetine rather than Paxil.  This may take some years to sort out, with every iteration in the legal process cementing Stewart Dolin’s name in legal history.

Boomerang

Meanwhile, the cost of branded drugs around 1962 was less than $10 Billion per year.  In 1984, the year of Hatch-Waxman, it was slightly over $20 Billion per year.  It is now a $1,200 Billion per year operation.

Somehow every action in the pharmaceutical sphere has a way of turning out exactly the opposite of what its promoter intended.

 

Change in Chicago: Whose Problem?

Courts are not a place you can make jokes. I started off with a confident pitch:

If you owe a bank a million pounds, you have a problem but if you owe the bank a billion …

I didn’t get much further.  It felt like several GSK lawyers popped up, addressing the judge with words to the effect that he’s talking about banking your honor, this is not his area of expertise. The judge accepted their objections and I didn’t get to complete the analogy.

Nobody knew what I was talking about anyway – pounds?  What are pounds?

Judge Hart also ruled out the following image.  So the jury never got to see it.

A lot of my testimony centered on working through each of the ways to hide the data listed here. The exhibit couldn’t be shown but this is what was covered – in some ways too well. There were documents showing correspondence between GSK and FDA on many of these points leaving the jury wondering whether GSK or FDA were more to blame.

Many of the things that were done were shocking. GSK and other companies dumped withdrawal related suicidal acts into the placebo arm of trials, inflating the risks of placebo and breaching FDA regulations in the process. A good deal of this was so blatant that the jury must have been left wondering whether FDA reviewers were asleep or out to lunch.

Suicidal events were coded under the heading of emotional lability.  When a journalist and lawyers independently spotted  this coding trick and it became a public issue,  emails circulated within FDA asking what emotional lability actually was, and where it had come from.  But Andy Bayman for GSK could show the jury the documents sent into FDA which showed suicidal events clearly coded as emotional lability. This naturally cast doubt on whether FDA could have been as ignorant of what was going on as FDA head honchos later claimed to be.

Another egregious trick was the use of patient exposure years.  This gives rise to the Space Shuttle fallacy.  If you calculate lives lost per miles traveled the Space Shuttle may be the safest means of transport in the universe. But it takes a brave person to go on one.

This is because in terms of exit from and entry to earth’s atmosphere the shuttle is highly risky – just like antidepressants where its the starting and stopping that are the problem.  GSK and other companies continued some people who were happy as clams on their paroxetine for lengthy periods of time and mixed these with the patients having difficulties to dilute the problem.  All of sudden, per year on treatment, the antidepressants looked safe. This is a legitimate approach for some problems but not for this one.

Another trick was putting suicidal events in a neurological category that also included dizziness and headache. These happen so commonly they drown out the signal from suicidal events.

Every time a maneuver like this was exposed, GSK looked bad.  They looked like they owed the jury and the public money – a million dollars.  The problem is though, they hold all the data.  No one could give the jury the data from these GSK trials and say “here you are – its not rocket science – you work out what this data shows”.

While this is the case GSK effectively owe us Billions and its us who have the problem.  They own us. And don’t seem to be under any onus to stop owning us.

But GSK interrupted my efforts to lighten the jury’s day by making this remark. A Court is not a place for this kind of thing.

 

 

Change in Chicago:  Dr. Welby on the Witness Stand

Editorial Note: This is part three in the Change in Chicago series covering the Dolin trial and its implications.  Like part 1 it is written by  Johanna Ryan – The Dolin Verdict and Playing Go

By twenty-first century American standards, Stu Dolin’s medical care was close to ideal.  That’s a hard idea to swallow, given what happened to him in the end, but it’s true.  The real paradox is why it wasn’t enough to save him – and how his doctor became a victim as well.

In June 2010, while taking a generic version of the antidepressant Paxil, Dolin jumped in front of an oncoming subway train in downtown Chicago.  His family was convinced that the medication had caused his suicide.  Last month, a federal jury agreed.  They found GlaxoSmithKline (GSK) liable for Dolin’s death, and awarded $3 million to his widow Wendy – two million for her own loss, and one million for Stu Dolin’s own suffering in his last week of life.

Few people succeed in suing the drug company when a loved one dies from the effects of his medication.  It’s far more common to sue the prescribing doctor.  Plenty of lawyers are willing to take on a malpractice insurer with limited loyalty to the doctor, and a lively interest in a reasonable settlement.  To face off against a multinational corporation with an unlimited war chest, which will fight like hell for the reputation of its product, is something else entirely.

An even bigger barrier is something called the Learned Intermediary Doctrine.  Under American law, drug companies have no obligation to level with you, the patient, about the potential hazards of the drug.  Their only obligation is to tell your doctor about those risks.  He or she is then expected to function as a “learned intermediary” – a sort of educated bodyguard who will tell you what you need to know, in language you can understand, and see to it that no harm comes to you.   The drug’s official label (that enormous, technical document folded up and stuffed into the drug package) is written with your doctor, not you, in mind.

But what if that official label does not tell the whole truth about the drug’s hazards?  That was the situation faced by Martin Sachman, M.D., Stu Dolin’s family doctor, who became a key witness in the Dolin lawsuit.

Marcus Welby M.D. – the old-school family doctor

That’s not Martin Sachman in the picture at the top of today’s blog – it’s Robert Young in the title role of Marcus Welby, M.D., the popular prime-time TV drama from the 1970’s.  To most of us, Dr. Welby represents the family doctor we wish we could have – the one our parents had in the good old days.  He was a settled presence in the neighborhood; he’d known you and your family for years.  You could go to him for advice on just about anything, and you tended to trust what he told you.

For Dolin, Marty Sachman was that kind of doctor.  Since about 2005, Sachman has had what’s known as a “concierge” practice.  For an annual fee of about $2,000 (over and above their usual insurance costs), patients can get something close to a Marcus Welby level of care from a doctor of this type.  They can be reached on weekends, may even make house calls from time to time, and you’re almost never limited to a ten-minute appointment.

Sachman had been Stu Dolin’s doctor for at least ten years. He was also a close personal friend.  (That’s unusual enough these days that attorneys rushed to assure the jury there was nothing “unethical” about it.  A generation or two ago it was fairly common, especially in small towns.)   Often, faced with a difficult medical decision, there’s one question we really want to ask the doctor: Would you give the same advice to a loved one or a best friend, if they were in my shoes?  Mostly, we don’t have the nerve to ask.  Stu Dolin was lucky enough to know the answer would be yes.

A Job For A General Practitioner

Most family doctors take that Learned Intermediary business fairly seriously.  It’s one reason why they refrain from handling “specialty” drugs for complex or serious conditions, which may require expert management.  Chemotherapy for cancer; biologic drugs for Crohn’s disease, MS and other autoimmune disorders – those are best left to specialists.

When he began practicing medicine in the 1980’s, Sachman explained, antidepressants were in that category.  The older ones were more problematic, with more side effects, and were reserved for people with relatively severe symptoms.  Rather than try to treat such patients  himself, he’d refer them to a psychiatrist.

This changed when Paxil, Prozac and the other SSRI drugs came out in the early 1990’s.  They were depicted as being safe enough to be handled by general practitioners, and a reasonable option for patients whose troubles didn’t warrant seeing a psychiatrist.  By the mid-2000’s, this had become the first-line option for dealing with both depression and anxiety.

As Dr. Sachman saw it, if a patient had mild to moderate depression in response to some trouble or stress in his life that was a “reactive” depression for which he could prescribe SSRI’s.  If they had serious problems with sleep and appetite, a slowed-down or unusually agitated appearance, and an inability to function in daily life, that was true “clinical depression,” and they should see a psychiatrist.

Dr. Sachman knew Stu Dolin well, and the anxiety he complained of in June 2010 did not alarm him.  Stu was just going through “one of his stress periods, on account of his work responsibilities.  He seemed to be getting through it like he did the other times.”  Dr. Sachman’s diagnosis was situational anxiety.  A drug like Paxil could help people get through a rough period like this.  The condition was fairly benign—and like the overwhelming majority of his colleagues, he considered Paxil to be a fairly benign drug.

A “Warning Label” that failed to warn

By 2010, the official label for Paxil gave physicians no reason to doubt that assessment – at least for adult patients.  It warned that any antidepressant could trigger agitation and suicidal impulses in children and youth up to the age of 24.  However, it also stated that “short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24,” and showed lowered suicidality in those over 65.

The warning added two more crucial sentences:

“Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide.   Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality or unusual changes in behavior.”

As psychiatrist Joseph Glenmullen told the jury, this label effectively blinded doctors to the risks faced by adults:  “What this tells me as a practicing psychiatrist is that if I’m treating a 57-year-old patient, and I put them on Paxil, Paxil couldn’t make them worse.  Paxil couldn’t make them suicidal.”  If they did feel worse, said Glenmullen, “it would be, and it says explicitly, their depression or other underlying psychiatric condition.”

Worst of all, he said, “if the patient gets worse and it might be the drug, what do you do?  You take them off the drug to see.  If they get worse and it couldn’t be the drug but it’s the depression, what do you do?  You increase the drug, which is going to worsen the risk.  So it’s very dangerous.”

The regulatory history of Paxil and the other SSRI’s was almost Byzantine.   For years they carried no warnings of a risk for suicide.  In 2004, after thousands of troubling reports, a Black Box warning was finally issued for children and adolescents.  A number of medical experts felt the warning should apply with equal urgency to adults.

However, in 2007, the FDA decided on a uniform warning for all antidepressants, old and new.  This was the “24 and under” label attached to both brand-name and generic Paxil in 2010.  This suited GSK just fine.  The FDA invited the company to discuss whether additional warnings were needed for Paxil, but GSK never took them up on it.

More importantly, it never fully shared with the FDA—and still less with doctors in the community—what it knew about the real risks of its product.  In fact, GSK had known since 1989 that its drug could trigger akathisia, an agonizing combination of physical restlessness and emotional turmoil that could lead to suicide.  The risk applied to both teenagers and adults; at least twenty suicides had occurred in patients on Paxil in clinical trials, the majority of them in people over age thirty.

A Doctor Taken Hostage

Thanks to GSK, that information never reached Marty Sachman.  If it had, he testified, he would never have prescribed Paxil for Stu Dolin.  There were plenty of other options—other drugs, and non-drug strategies – for treating situational anxiety.  Because of the warning label, he said, he had never prescribed Paxil to a patient under 25; the benefits didn’t seem worth the risk.  He had a few adult patients who seemed to do well on Paxil; if they had been on it for several years and wanted to continue, he would refill it.  However, in the seven years since Stu Dolin’s death he had not written a single new Paxil script:  “I don’t trust the labeling,” he said.  “I don’t trust the company, to be honest.”

Marty Sachman’s anguish—and his sense of betrayal—was apparent to everyone in the courtroom.  Physicians like himself, he said, “rely on truth and honesty from pharmaceutical companies, and to falsify information or hold back information is totally criminal. How can we treat people effectively and safely if we can’t depend on that?”  They couldn’t.  Instead, he had prescribed a drug, and a patient had died.  That alone would have been traumatic for any honest doctor; that the patient was his best friend made it devastating.  It was not like being a Learned Intermediary; it was more like being a hostage.

So what about the average Joe?

Dr. Sachman never got the chance for a follow-up visit with Stu Dolin; within six days of starting Paxil, he was dead.  If he had, it’s just possible he could have spotted his longtime patient’s real problem. Maybe even stopped the Paxil.  We’ll never know.

In 2010, the year Stu Dolin died, doctors wrote 259 million antidepressant prescriptions.  For most patients, who don’t have access to anyone remotely resembling Dr. Welby, the situation is even scarier.  They may get a script for an SSRI in a ten-minute encounter with an overworked stranger, based on a checklist left in the waiting room so that every patient can be “screened” for depression.  The potential number of doctors taken hostage – and patients tossed overboard – is hard to imagine.

I have to think genial old Marcus Welby, M.D. wouldn’t stand for it.  What about us?

 

 

 

Change in Chicago: Playing Go

Editorial Note: This is a second post in the Change in Chicago Series looking at the Dolin trial and its verdict.  There will be two more in the series. 

Being cross-examined in a legal case involving Pharma is rarely fun.  The lawyers will have done their homework in spades.  As one of them put it to me once: Dr Healy, I have read everything you have ever written. Looking straight at him, I was quite prepared to believe this included every email I’d ever written. Between raking over an expert’s financial affairs, and private lives and any view ever expressed on anything, the assault on the expert can take any shape and rarely involves an engagement with the “science” of the issue. The results can be bloody.

In a deposition in the Dolin case two years previously that was supposed to be about the science of paroxetine, after a quick hour on the science, Dr Tamar Halpern and Bob Glanville for GSK spent nine hours instead picking over my relations with Betsi Cadwaladr University Health Board,  my dealings with all sorts of people before finally producing several large binders containing every post on this and on the RxISK blog – something like 800,000 words and 500 blog posts, fishing fro statements to snag me on.

At trial, Andy Bayman, GSK’s lead lawyer made a show of presenting me with two huge binders of prior depositions and testimony.  I didn’t have the wit to count up all the words and pages and hours of testimony but it was likely 10,000 plus pages, a million plus words and over 3000 hours worth of being grilled under oath.  The usual tactic is to pick out a phrase deep in the folder and triumphantly present that to the Court as representative of “your views Dr Healy”.

This is where any prior use of irony, or jokes, or effort to take the views of those who have an opposite point of view to mine into account can become a liability.

One trick is just to ask: “Did I read that correctly Dr Healy” – and move quickly on. In Dolin I had what I thought was a minor triumph when Andy Bayman tried this and I had the wit to respond “No”. This was something he didn’t expect, particularly as he had all the words correct. I explained that he’d missed the note of irony.

Overall the cross in Dolin didn’t seem to be too bad.  Mr Bayman was more than averagely pleasant – it seemed. He didn’t argue too much when I seemed to score points – as I thought. At the end some of those on the plaintiff’s team congratulated me on having done a good job – but they probably say that to all witnesses. Several people reading the transcript later commented on a job well done but they were supporters to begin with.

So, after the trial was over, I turned to the closing arguments from both sides with interest. What would Andy Bayman say?  I was a little surprised to begin with.  Surprise turned to consternation. What was this – it seemed like someone called David Healy was the prize witness for GSK.  Again and again they quoted that nice Dr Healy as saying FDA knew of the problem decades previously.  Dr Healy showed you that FDA saw exactly what GSK had done and you didn’t hear him mention any quibbles.

A lot of the points I thought I had scored with looked like own goals. No wonder Andy Bayman didn’t contest some of what I thought were my most effective shots.  No wonder he was so nice.

The full transcripts and exhibits are available on the Baum Hedlund website and will be on SSRI stories.

In trials like the Dolin trial, the plaintiff’s team try to make sure the jury blames GSK rather than the man himself or his doctor.  At the end of this trial, they thought they had done a good job and the jury might not be out for much more than a few hours.  The jury was out for days. And when they came back it became clear they were wrestling on the issue of who to blame. But Stewart Dolin wasn’t in the frame. Nor was his doctor. The dilemma was whether FDA were more culpable than GSK.

This was like playing Go, where it can look like the black counters on the board have white encircled until white puts down one more piece and all of a sudden it wins.

As someone who knows Andy Bayman, I was interested to see what Andy Vickery would make of what had happened. Vickery is a Houston lawyer who in 2001 won the Tobin case – a first ever verdict against a pharmaceutical company for a behavioral effect of one of their drugs – which should have led to a Black Box Warning for Adults on Antidepressants.   He might say he was “just a lil ol’ country lawyer, but momma Vickery didn’t raise no fools …  But it would be tongue in cheek if he did. 

Andy Vickery.

In the end, the Jury got it right. They usually do. The citizens who decided the Dolin Paxil suicide case in Chicago last week held GSK accountable for the wrongful death of Stewart Dolin, by all accounts a very good man. And, although the verdict was only a fraction of the daily profits that GSK garnered from Paxil during its lengthy monopoly money patent protected marketing days, the verdict still holds the company that made those billions of dollars in profits — the company that had both the legal authority and moral responsibility to change the label — liable for damages.

But it was not easy. By all appearances, the Jury struggled at length with the beguiling arguments of GSK’s very talented lead counsel, Andy Bayman. He told them that the FDA were a “neutral group of scientists” who did not have a “dog in this fight.” And that the FDA had “spoken loudly” on the issue of SSRI induced suicide. It was excellent advocacy, but a sleight of hand.

The truth is that the FDA stuck its head in the sand on this issue when it was first raised regarding Prozac in 1990, and, with the exception of a minor nod for the protection of pediatric patients in 2004, it has kept its head in the sand. In this respect, I share Mr. Bayman’s perspective that the FDA has, indeed, “spoken through its silence.” The FDA’s abysmal abdication of its duty to protect patients was, indeed, another “proximate cause” of Stewart Dolin’s death. Its “silence” killed Stewart Dolin.

BUT, the FDA is immune from suit. To be sure, the FDA could argue that one of the reasons that it was silent is that GSK “cooked the books” on Paxil suicidality. There is ample evidence to support that. But the “whole truth” is that the FDA had plenty of information which should have caused it to act proactively and to protect the American populace, and it willfully neglected its duty to do so.

The issue first arose in 1989 in the wake of a scientific study by two highly credentialed Harvard neuropsychopharmacologists. They cited 6 cases in which Prozac was the likely precipitating cause in adult suicide attempts, and they posited a “biologically plausible” explanation for how and why that happened.

In response, the FDA assembled an ostensible “blue ribbon” panel to advise it. It was a total farce. Several of the panel members had to obtain “waivers” of their extensive ties to Big Pharma in order to serve at all, and the Chairman of the Committee wore a bullet-proof vest at the public hearing because he feared a family member of an SSRI suicide victim might shoot him!

When a citizen’s group petitioned the FDA to take action, to require warnings, it said, not now, but if ever there is a “court judgment” we will sit up and take notice. Our law firm provided that verdict in June of 2001 in the Tobin case in Wyoming. After hearing all of the scientific evidence from both sides, the Jury specifically found that “Paxil can cause some people to commit homicide and/or suicide,” that it had caused the four deaths in issue there, and that damages for those deaths were $8MM. Our principal expert was Dr. David Healy (who also testified on behalf of Mrs. Dolin, and who has been grossly and unfairly maligned by GSK for years).

In the wake of our 2001 verdict, the FDA could and should have required full, robust warnings. But they did not. Three years later they required “Black Box” warnings for pediatric patients, but, although the adult data was almost exactly the same, they permitted the drug companies to phrase the warnings as if to appear that they did not apply to adults over the age of 24.

Stewart Dolin was 57. And Mr. Bayman used the FDA’s “silence” and its pathetic endorsement of the “pediatric” only warning to good purpose. He argued effectively that the FDA has “never said” that Paxil causes suicide and that it had taken “no action” for the last 10 years (since it finally received all of the adult data regarding SSRI suicidality). In this, he was right. The FDA has taken “no action.” Shame on them! Andy Bayman was also on target when he said that Dr. Healy “laid the blame at the FDA’s feet.” He did so because the FDA was wrong all along!

Many, many good people have died because the FDA stuck its head in the sand on this issue. It should now pull its head out of the sand, and hang it in total shame.