According to The National Institute of Mental Health, in 2015 an estimated 16 million Americans
experienced at least one major depressive episode.
That's almost 7% of the population over the age of 18.
But Big Pharma doesn’t see that number as 15 million people who are suffering, they
look at it as 15 million people they can sell pills to every single month.
There are dozens of different anti-depressants on the market today, with each drug company
trying to capture as many of those 15 million patients as possible.
And while anti-depressants have shown great promise in treating depression, many of them
now carry warnings of an increased risk of suicide.
That’s what happened with Stewart Dolin, a Chicago attorney who committed suicide by
jumping in front of a train after taking the generic version of the anti-depressant Paxil.
Mr. Dolin had only been taking this medication for 5 days when he committed suicide.
Glaxo Smith Kline, the maker of Paxil, had known for years that its medication increased
the risk of suicide in patients, and for the longest time they attempted to cover up these
dangers to keep their profits flowing.
Paroxetine, one of the active ingredients in Paxil, had been studied by GSK since at
least 1989 when the company first developed the medication and submitted their application
to the FDA.
According to some of the earliest studies produced by GSK, Paxil actually showed a decrease
in suicidal thoughts and actions compared to placebo groups or at least, that’s the
way the company presented it.
As it turns out, GSK was actually manipulating their own data to show an increased risk of
suicide and suicide attempts among placebos that didn’t exist in the way it was presented.
And again, GSK did this to convince the FDA that its anti-depressant was safe.
An internal email from the company from 1999 showed that the studies had been manipulated
to count placebo suicide attempts that should not have been counted at all.
The internal email also laid out the many ways that GSK was twisting data for their
FDA approval.
In 2004, the FDA ordered GSK to include a black box warning for its drug showing an
increase in risk of suicide in young users, but it didn’t specifically mention patients
over the age of 24.
In April of 2006, nearly 7 years after GSK's own internal documents showed that the company
knew it was misrepresenting its findings, GSK finally decided to re-analyze’ its data
and found that yes, Paxil does in fact cause a statistically significant increase in suicidal
thoughts and actions in adults with Major Depressive Disorder and yet the product label
was still not updated to reflect this fact.
That brings us back to the case of Stewart Dolin.
Had Glaxo properly warned doctors and patients, and even the FDA, about the dangers they understood
20 years ago, Mr. Dolin might still be alive today.
Joining me now to talk about the dangers of Paxil, is attorney, Michael Baum, one of the
lawyers who represented the widow of Stewart Dolin in court.
Michael, start by telling us about the early studies from Glaxo about what they knew about
the safety of Paxil.
Give us a rundown, if you would.
Well, the very earliest studies for their new drug application during the '80's led
to a safety summary that they generated in 1989 that listed some suicide attempts, and
suicides, that did occur during those clinical trials.
They identified that some of them occurred during the clinical trials and some of them
occurred before the clinical trials, actually began in a phase called the run-in phase.
That was in 1989.
Michael, that should have been enough to put them on notice right then that something's
not right.
Oh yeah.
You look at early signs, this was one of the early signs, wasn't it?
Yes.
They had 42 suicide attempts that they'd listed and that was about a 3% rate at the time.
That should have been viewed as a frequent adverse event.
But they reported as if it wasn't and said it wasn't a significant risk.
They said that people who are depressed tend to commit suicide or have suicide attempts
as a problem.
They conveyed the impression that it wasn't an important risk to consider for labeling
purposes.
The way it appears you tried this case is that you used their own documents against
them.
You used their own internal documents and you said this is what they had in their file
cabinet while they were lying to the FDA.
How did the company present this data to the FDA?
Did the FDA bother to even question their findings?
What's your take on that?
The FDA gave them a pass.
In 1990, there was a study by Teicher and Cole that put the world on alert that there
might be suicidal behavior and suicidal thoughts associated with antidepressants and the serotonin
reuptake inhibitor, new type of antidepressants.
The FDA asked all the manufacturers like GSK to go through their studies and compile their
suicide data.
GSK did that.
When they did it, they did not identify that those events had occurred in the pretrial
period and the run-in period as having occurred before the trials began.
They treated them as if they happened during the trial.
That washed out about a nine times greater rate of suicidal behavior among adults.
I've tried plenty of these cases and I'm always fascinated by what we find in documents.
So many times, the jury actually gets to see the mindset of the company by way of the documents
that you produce.
What did you find from the documents in this case about what they knew, the dangers of
Paxil, and how do you think that impacted the jury in this incredible result that you
were able to get?
What documents stick out in your mind as far as it showed really the culpability of this
company?
What's your thought?
I'd say there's three or four that do that.
The one I was just getting ready to tell you about is the suicide report they gave to the
FDA that reported as if that it reduced suicidal behavior by including events that occurred
during the run-in phase and counting them as if they were placebo events to balance
out the 42 suicide attempts and the five suicides that occurred on Paxil.
By making that risk look lower or non-existent, they actually published papers in 1995 saying
that it reduced suicidal behavior and suicidal thoughts, when it was the opposite.
That's what they gave to their marketing people.
We got one of their marketing documents saying, ‘Hey, use this study that reports this data
that said it will reduce suicidal behavior to give to all of your doctors.’
That's a pretty damning document because all those numbers were false.
What you're describing is just run-of-the-mill fraud.
I mean, that's what you're describing.
There's nothing dressed up about it because it's a pharmaceutical company and they got
the numbers wrong.
This is absolutely black-letter fraud.
How much impact did that have on the jury when they see this is a company selling this
product they know is going to kill people and they're committing fraud in the process?
What's your take?
I think that many of the jurors were very upset about it.
We weren't actually allowed to interview them afterwards.
We don't know exactly what their take was.
I can tell you from reading their body language, and the way they reacted to the documents,
and the way that GSK's lawyers tried to minimize them, they weren't buying it.
They bought what the document said.
There were the GSK's own documents.
The one document you referred to earlier in 1999, where internally one of the guys says,
‘Hey, we've been counting these pre-baseline, pretrial events as if they were post-trial
events.
We actually published an article about that.
Well, that's not actually true because we have an elevated rate of suicidal behavior.
We need to fix that.’
They didn't fix it.
That's a pretty document for them.
Michael, tell us about the case you handled for Wendy Dolin, the widow of Stewart.
We've got about a minute and a half.
Just give me a thumbnail sketch about that case, would you?
This is a guy who had a great life.
A really good guy, well-loved by all his friends, his wife, his kids, was making about a million
dollars a year, was well-respected in his field, was well-respected within his law firm.
Had everything going for him, but he was in the mergers and acquisitions and security
side of Reed Smith, which is, you know, a very high-profile law firm.
During the financial collapse in 2008, 2009, it wasn't good for mergers and acquisitions.
They were going through a rough time.
He personally pulled through it, but was having some anxiety during the time, was a little
depressed about how things were going, but he was having his best year ever.
His doctor thought, ‘Oh, you know, let's give you some Paxil to get you through this.’
He put him on Paxil.
A week later he jumped in front of a train.
This is a guy that had everything going for him.
The jury came back and they looked at this entire story and concluded what?
What was the award in this case?
The jury found that Paxil, the defective Paxil label caused Stewart Dolin's death and awarded
the family $3 million for the wrongful death.
The things that are to takeaway that are important from that is it was generic Paxil and they
found that the brand manufacturer, GSK, was liable for having not made the changes to
the label about the adult suicidality that they knew about.
Okay.
Michael, great job.
You're a fine lawyer.
One of the best on the West Coast.
I've got to commend you.
This is a tough case.
I followed it.
I know how tough it was.
Thanks for being out there.