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.
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.Share this:
Copyright © Data Based Medicine Americas Ltd.
I guess it could be argued that I am one of those supporters you refer to in your article but I was witness to the cross-examination.
Bayman may be good at his job but, in his cross of you he wasn’t good enough.
The binders were, I imagine, difficult to lift let alone read.
The trial itself was, for me at least, fascinating in as much that we had Paxil, prescribers, patients, regulators and a pharmaceutical company in the spotlight, although we all know there were two pharmaceutical companies.
GSK’s defence was expected,
“It wasn’t our product, it was someone elses.”
“It wasn’t our job to update the label because we already gave the regulator our guidance on the matter.”
“We didn’t prescribe Stewart Dolin the medication, someone else did.”
“Stewart Dolin killed himself because he had a mental disorder.”
A jury of 9 were, it appeared, guided down the usual roads, away from the truth.
Your evidence, along with Dr’s Ross and Glenmullen, persuaded the jury to arrive at its verdict.
Notably, and comedic was Bayman’s closing argument to the jury.
““Don’t you think if these medicines caused suicide someone would have spoken up?”
Dead people don’t have this option and when the survivors of those dead people speak up they are either told, “it wasn’t our drug, it was an underlying illness”, or, as in the Dolin Vs. GSK case, It wasn’t our fault, it was the fault of the victim, the victim’s Dr, and/or the regulatory agency put in place to protect consumers.
You did good and for the most part I stepped outside the advocacy bubble to try and fathom if GSK had a point with their defence. They had many but most were based around points of law. Yes, it wasn’t their drug, but it was their responsibility for the labelling. Yes, they told the FDA but actions speak louder than words. They could have ignored the FDA and warned the public, as per JP Garnier stated in his video deposition.
As for the 9 hours of nit-picking through your personal life, that was just another form of defence. The kangaroo court they asked to hold prior to trial with their endless motions was just another way to try and suppress the truth.
Let’s face it, you aren’t, and never will be, on GSK’s Christmas card list.
Job well done, I say.
Remarkable trial and a great verdict for truth and justice seekers.
It was both refreshing and distressing to witness some of this trial. David Healy’s testimony and demeanor were nothing short of incredible. That was the refreshing part–to see a credible, straightforward expert clearly tell the truth about akathisia, misleading “clinical trials,” drug company and FDA deceptions and failures, etc.
The distressing part was to see how drug companies attempt to blame anyone and anything to avoid accountability for the suffering and deaths they needlessly cause. Death for profit should be their new tag line: It’s simple, short and to the bloody point.
Perhaps GSK attorneys are skilled in their field but suffered from a lack of sleep after dedicating hours to create mammoth binders. (I half suspected their binders were filled with blank pages or nursery rhymes.) I didn’t see GSK’s legal and oratory skills. They had neither polish nor prose.
GSK thought they’d be ringmasters at a legal circus. But in reality, they were the clowns.
What’s really remarkable here is that GSK’s main strategy–what it judged to be its best hope for connecting with the jurors–was to blame the FDA for failure to warn of Paxil’s potential to trigger suicide.
This is very different from the argument we have come to expect: that it has no potential to trigger suicide. Paxil is a wonderful, life-saving drug which cannot possibly trigger suicide (except perhaps in a few very volatile, impulsive teenagers). Adults like Stewart Dolin died from their own mental illness. For years, they claim, he grappled with his own “inner demons”, in ways his closest family and friends were entirely clueless about. In the end those demons won out and “even Paxil could not save him.”
The jury saw that argument fall to pieces in front of them–thanks to Stu’s family, his doctor and his counselor, and thanks especially to David Healy and the other expert witnesses. But I predict it will still be the argument they rely on in public! They won’t want us to know how they actually handled this case in court. (Neither will the FDA, of course…)
That’s one reason it’s so important to talk about it, and get the story out. Thanks, guys.
Gone and Played for Wendy and Won had the Settling Effect despite the Opposition trying to outsmart Dr. David Healy and to a much lesser degree this is what we are dealing with when we attempt to make a singular or multiple criticism on behalf of ourselves and it takes an ‘expert’ witness to show us what was done so professionally ..
‘Bumpkins United’! ..
Reading through the court transcripts, I had to pinch myself periodically to remind myself that what I was reading was, in fact, what had ACTUALLY taken place in a REAL trial! At times it was more like reading a mock-up which had been set up by a group of high school pupils! How the jury kept a straight face at some of the GSK antics I’ll never know.
When David Healy was called back for the rebuttal, GSK’s team nearly burst a blood vessel in their attempt to silence you! I found it quite hilarious reading – had, in fact, thought that Bob had exaggerated the ‘goings on’ in his blogs, but hey, Bob, you were spot on!
Mad..in America ..
davidclark May 9, 2017 at 8:53 am
Excellent article David. Thank you. Even though I worked in this field, and still have an involvement, it still stuns me what goes on… how drug companies get away with what they do, and how the FDA sticks its head in the sand. Disgraceful! Keep up the great work.
TRM123 May 10, 2017 at 3:18 am
The courage, determination and commitment of all who demonstrated the reality of this SSRI – akathisia induced tragedy is inspirational.
The humility, professionalism and resilience of the expert witnesses under relentless and ruthless endeavours to professionally and personally discredit, restores faith in those members of the medical profession who place care and concern for patients and their families above risk to themselves.
Sincere appreciation for this stunning achievement does not fully describe the depth of respect and gratitude afforded.
TRM 123 Retired Physician.
GSK Bespoke Spy School ..
GSK’s company values, which included: Integrity, Patient Focus, Transparency and Respect for people
Teams were split into groups of four – Secret Agents, Detectives, Major Generals and Central Intelligence.
a Senior GSK Manager – ‘Agent Del’
This – a bespoke task that involved the participants coming up with a witty caption for an image of some GSK colleagues.
What tremendous effort it takes to chip away at this mammoth, inhuman system. This story deserves more press than it’s getting, but we know who owns the press. I’m grateful to Bob Fiddaman for keeping us updated. The wheat and the chaff all grow up together but a day will come when the bullshit will end.
GSK was not immediately available to comment on the report.
Student is suing GlaxoSmithKline claiming wrong medicine dosage caused ‘her skin to burn off’
Ms Shaw says the syndrome left her skin scarred and she is slowly losing her vision
Thursday 11 May 2017 16:44 BST
It is not the first time the drug company has been sued for alleged healthcare fraud.
In 2012, GSK agreed to pay $3bn and pleaded guilty to criminal charges of illegally marketing drugs and withholding safety data from US regulator, the Food and Drug Administration (FDA).
Earlier this month, a US jury in Chicago ruled that GSK must pay $3m to a woman who sued the firm after her husband committed suicide while taking a generic version of the antidepressant Paxil.
The drug company is appealing the decision
One of the most “priceless” moments in this trial was GSK attorney Andy Bayman’s attempt to mock the RxISK.org website co-founded by David Healy. To let the jury know just what kind of ambulance-chasing nut-jobs Healy and his comrades were, Bayman asked if it were true that they believed Benadryl — good old Benadryl — could lead to suicide!
The judge ruled him out of order, but it would have been interesting to hear the answer. Because it’s well-known that Benadryl (a/k/a diphenhydramine), an antihistamine widely used for everything from stuffy noses to insomnia, is one of those anticholinergic drugs that can cause confusion, paranoia and other serious “mental status changes” — especially in the elderly, and especially when used in combination with lots of other drugs.
Here’s a cautionary tale from a Washington Post reporter on what happened when her reasonably healthy and absolutely sane elderly mother took Benadryl for a skin rash:
GSK – DUMPED ..
Frustrated Woodford dumps £1.2bn Glaxo stake
Attack on poor performance is blow for new chief
May 13 2017, 12:01am,
Woodford slams ‘madness’ at GlaxoSmithKline
By Lee Wild | Wed, 24th February 2016 – 14:15
“The board and the executive are pursuing the wrong strategy. The results of the past eight years show that I am right and they are wrong; Andrew Witty is wrong.
“What did Einstein say?
That doing the same thing over and over again and expecting a different result is the definition of madness? Well that is what Witty and the board have done for the past eight years.”
he may not have to badger Witty for too much longer. If reports are correct, the highly-paid Glaxo “lifer” will soon be on his way out after eight years in the top job.
Change in Chicago – Playing Go: Three
I understand that Einstein also observed:
“Great Spirits Have Always Encountered Violent Opposition From Mediocre Minds”.
So unjust that only those with significant financial resources and an impeccible family profile, can get a big injury law firm and brilliant expert witness to fight their case. Congratulations on the win,
Playing Go: Endpoints
AstraZeneca throws a monkey wrench in new GSK CEO’s first hiring decision, suing Luke Miels
by John Carroll — on May 16, 2017 09:17 AM EDT
It sounds like an exhausting process , for the millions around the world who have been severely affected by these goon companies, It almost seems like too much for families to go through to get justice . Especially when usually the outcome is not favouring the victim and the legal bills that may follow. Truly horrible what’s happening but glad one family got some justice
Playing Go: At the Top
Simon Wessely @WesselyS 8h8 hours ago
As we head to my final blog ..
‘happy chappy’ Professor, Sir, Simon, Wessely, has brought to the table his prime time use of psychiatric drugs and the use thereof .. and some of the ‘results’ thereof .. ?
“Pedanticus reminds me that is a rhetorical question. And as Pedanticus takes his final bow, a round of applause please. I would be lost without his belief that getting the facts right, no matter how trivial, matters.”
Wow, I am only in court when we need to justify if someone is or is not fit to plead.
That is already a chore, yours sounds more tedious!
Well, every time you prescribe you put yourself between a rock and a hard place, keeping fingers crossed that, well……