EPISODE 4
“Ghostwriting, Hiding the Data, and Marketing the Science,” a conversation with Dr. David Healy

Join Heather and Lee for an informative discussion with Dr. David Healy highlighting the fraudulent tactics of industry and health care in hiding the data and marketing the “science.” The conversation addresses the processes of drug approval research, what’s changed, who’s doing the writing, and what data is being used?

TRANSCRIPT

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LEE: Awareness is power.

HEATHER:  And it can save your life.

LEE: Welcome to our podcast, “Know Risks.”

HEATHER:  I’m Heather.

LEE: And I’m Lee. We’re two moms, a lawyer and a nurse, who were brought together by a misfortune. Both our children were harmed by adverse drug reactions.

HEATHER: The purpose of this podcast is to educate people on the risk of any health treatments you put in or on your body.

LEE: We feel if we’d been properly informed and been our own experts, our children would not have been harmed.

HEATHER: In today’s world, with medicines being incentivized for profits, you need to educate yourself. Know the risk of health treatments and it can protect yourself and your loved ones from being harmed.

LEE: Thank you for joining us today on our episode “Ghostwriting, Hiding the Data, and Marketing the Science.” We are honored to be joined again by Dr. David Healy for an informative discussion on drug approval research, what’s changed, who’s doing the writing, and what data’s being used.

Here’s Heather with a little bit more information about Dr. Healy before we get started.

HEATHER: Thanks, Lee.

Dr. David Healy is a world-renowned psychiatrist, psychopharmacologist, neuropsycopharmacologist, scientist, and author. He undertook his doctoral research on the serotonin system on which antidepressants work, while qualifying in psychiatry.  He moved to Cambridge University for higher training in psychiatry and to engage in post-doctoral research.  

He has since been a Professor of Psychiatry in Cardiff University and Bangor University, working clinically in the NHS for 30 years, before recently being appointed as a professor of Psychiatry in the Department of Family Medicine at McMaster University in Canada.

His main area of research includes the contribution of psychotropic drugs to suicide, for which he was one of the very first researchers to make this link; the adverse effects of these drugs; the conflicts of interest between pharmaceutical companies and academic medicine; and the history of pharmacology.

He has published 25 books on medicine, primarily on physical treatments and the development of the pharmaceutical industry, including the standard histories of antidepressants, antipsychotics, and mood-stabilizers.  He has authored over 60 chapters in books on similar issues, over 200 peer-reviewed articles, and over 250 other pieces, for the most part dealing with the impact of medicines on health care. 

He has been involved in numerous legal cases, centered primarily on the harms of treatment.  He has acted as an expert in numerous cases in the United States involving suicide and psychotropic drugs, and he has publicly and internally provided testimony and consultation to the Food and Drug Administration (FDA) regarding psychotropic drugs and their effects. 

Dr. Healy was the leading expert in my son O’Shea’s wrongful death case. You can listen to his testimony and view other materials from the lawsuit on our website, knowrisks.org.

DAVID:  All right, so, let me take you back.  My introduction to all of this came, let’s just say, back in the last millennium, OK, and I had two men who came to me, one of whom I think I put on an SSRI, and this was just after they had come out in the U.K., and one who, for some reason, someone else had put on an SSRI, OK?  I was interested in all this because I had done a Ph.D. on the serotonin system, so I was one of the people that the pharmaceutical industry thought would be a good person to help educate family doctors about these new drugs, tell them a little bit about the serotonin system, et cetera, et cetera.  And of course, it was always useful to be able to use these drugs and see what they really did.  Now, I had a bit of an inside story which was that some of the pharmaceutical companies used to come to the pharmacology lab that I was in, and this is before the drugs came on the market, and then they’d declare to me that — and this was off the record because they weren’t even sure the drugs were going to come on the market — they said, look, these are weaker than the older antidepressants, they aren’t as good as the older antidepressants, but, you know, we’ll probably still bring them on the market.  And that was an eye-opener because, you know, it meant they were reasonably confident about being able to sell junk, to a supposedly sophisticated bunch of people like doctors who think they’re kind of scientists, you know; they know a bit of stuff.  The idea that the industry figured they could fool them pretty easily was a bit of an eye-opener.  But anyway, I was part of the fooling-them apparatus.  You know, I was good to be wheeled out to give talks about the serotonin system, et cetera, et cetera, and I sort of did give some talks about the serotonin system, but very early on I began giving the drugs to a few people and had two men in particular who became suicidal, and in the case of one of them, you know, I said, OK, fine, let’s halt the drug and see if the problem clears up, and it did.  Now, if you become suicidal shortly after you go on a drug, and the problem clears up when you remove the drug, that’s pretty good cause and effect, OK?  And the other man was even more — well, we actually put the first man back on a different SSRI, OK, because at this point in the U.K. when I was working, we had more than one SSRI, whereas in the United States they only had one; they only had Prozac. OK?  So we put this man on a different SSRI and he became suicidal again, so this was very clear cut.  But at this stage, even then, I wasn’t making a clear kind of connection.  I had a separate man at exactly the same time and he goes on — well, he’s put on an SSRI by a different person and gets very agitated and tries to kill himself so he ends up in a hospital under me; we take him off the drugs and we can see him calming down.  Now, he’s an older man and this issue is between his wife and himself.  She seems to be telling him what to do and what to think and things like that and, you know, so naturally we think it’s all her fault, you know?  Nothing to do with the drugs; it’s all her fault.

LEE:  (Laughs.)

HEATHER:  Blame the woman.  (Laughs.)

DAVID:  Oh, yeah, and he gets more tense every time she turns up, so this really proves it, OK?

HEATHER:  (Laughs.)

DAVID:  But then I do a weird thing.  I sort of put him under hypnosis and ask him about his suicidal events that he hadn’t really been talking about — just he had been suicidal and he told us what he tried to do.  But he made it more vivid.  When under hypnosis he was asked a bit more about these things and there were more attempts than we had heard about, and it was clear that he was really try to kill himself — for no obvious reason.  And then, you know, he had calmed down a lot and was in a much better place and, you know, he and the wife didn’t seem to be lovebirds but they seemed to be getting on OK, and then we put him on a different drug and we can see him, right in front of our eyes, tense up again, OK?  Nothing to do with her.  It becomes clear the drug is doing it, and it turns out that the drug we give him is also a drug that works on the serotonin system. 

So anyway, so I write it up and of course I get in touch with Ely Lilly, the pharmaceutical company that make Prozac, after I’ve written up the cases, and say, hey guys, you know, do you have any other reports of something like this happening on any people?  Now, at this stage, I later find out, there are tons of reports, OK?  But they get back to me and say, oh, no, nothing like this has ever been reported to us before.  (Laughs.) And then, shortly afterwards, I get a message:  Look, we’re trying to set up a consultancy group to help, you know, educate doctors about Prozac and things like that and wouldn’t you like to come along?  OK?  And this was going to be a thing I’d go along to every three months or so and get paid a large amount of money for just going down to London to the most expensive hotel in London, being brought out (for a meal ?) with some big name (professor ?) of psychiatry in the U.K.  There’s a bunch of us all going to be there and, you know, being friendly.  And industry, very quickly, you know, they work out who I might like to be sitting beside, who finds out all about how many children I have and their names and remembers them the next time we meet and things like that.  You know, it’s all very seductive, OK?  Anyway, so that’s their response to me being awkward, to pull me into the tent, make friends, make even better friends with me, OK?  

LEE:  Yeah, keep your friends close but your enemies closer, not that you were an enemy, but —

DAVID:  Not an enemy. 

HEATHER:  They were turning him into a friend.  (Laughs.)

DAVID:  Absolutely.  Yeah, sure, sure, sure.  I mean, I had this one great meeting, a short while later, I was (at them ?) giving my — I mean, I’m — well, I don’t know what word you’d use.  In the middle of all this, I’m still going on at meetings talking about the fact that the SSRIs can make you suicidal, so — (laughs) — you have to work out what you think of my behavior, OK?  (Laughs.)

LEE:  Yeah.  (Laughs.)

DAVID:  So anyway, I’m at a meeting and after the meeting one of the companies who’s there who makes an SSRI has a very attractive sales rep, OK, and later on when I’m in my bedroom that night she turns up at the door with a tray in her hand, bottle of champagne and two glasses and is very scantily clad — 

LEE:  Oh, wow.

DAVID:  — and is inviting herself in.  (Laughs.)  So I, as it turns out, don’t like champagne — (laughs) — so I kind of said, look, I’m in the middle of some work and things like that and et cetera, et cetera. But again, that just gives you a feel for — it’s probably more a case — I mean, it’s more a case of them trying to work out what’s going to work with this dude, OK?  

HEATHER:  Yeah, and I think that’s a huge MO, even now, with taking, you know, the pharmaceutical reps you see going to health organizations; they’re generally not male — (laughs) — they’re generally attractive females who go —

DAVID:  Oh, well, no, no, no, no, no.

HEATHER:  And that is the firsthand knowledge that a lot of our doctors get about these drugs is from these reps.

DAVID:  Yeah, yeah, yeah.  But industry are very good at sending attractive boys along to female doctors.

LEE:  The female — yeah, they work it both ways.

DAVID:  Yeah.  So anyway, yeah, so things were OK.  I mean, there was —

HEATHER:  But that still does — I mean, the bottom line, though, is that obviously you still persisted with this; that’s why — (laughs) — you’re speaking with us today.  I mean, the majority, whether you’re a doctor or whatever field you’re in, the majority of people are going to probably choose the comfort of their livelihood and, you know, the comforts that that provides —  

DAVID:  Sure.

LEE:  I’m curious to hear the rest of this story, though.  You kept speaking?

DAVID:  There is that, except, later on, a few years later, I’m at a big meeting, a really big meeting, and I’m doing the same old thing about talking about the risks of Prozac and SSRIs and they make you suicidal, et cetera, et cetera, and I forget whether — it was either just before or just after the meeting; this very attractive woman come[s] up to me and the story’s not going to go the way you expect. She says:  “Oh, you’re David Healy; I’m so pleased to meet you.  You’re doing more for the sales of Prozac in the United Kingdom than anyone else.”  

LEE:  What?  (Laughs.)

DAVID:  Which is it’s getting the Prozac name out — this is a few years later.  In the first few years it was all about artists were taking it, saying, this will make you better than well, but, you know, the name of the drug was (beginning ?) to slip out of the frame, except for my efforts to keep it in the frame.  (Laughs.)  But the thing is, when people read articles about “Prozac makes you suicidal,” all they read — or all they retain, either from a talk or from something written, is the word Prozac, and from industry’s point of view, this is just great.  But so industry would have been very happy with me keeping on doing what I was doing.  The thing that made a difference was when in the United States there was this case called the Forsyth case, which the lawyers — soon after I got email on my computer, one of the first emails I got was from Los Angeles, and I’m wondering why this is happening, and they were saying, look, we’re looking for an expert on Prozac causing people to become suicidal, and it turns out that there were — they couldn’t get a credible expert in the United States; no one was willing to get involved, period, OK?  So you’ve got this crazy person — (laughs) — over in the U.K. who contemplates the idea of getting involved and, as it turned out, by accident.  I was due to go over to the Los Angeles area a few weeks later.  I said, oh, funny accident; I’m due to be coming over your way; why don’t we meet up and we can chat about it, OK?  And we chat about it and it’s clear that they looked at me as though I was something that had crawled out from under a rock, while I was looking at them as though they were something — (laughs) — that had crawled out from under a rock.  And I get involved in the legal case.  That’s when industry changed.  They saw me as a real threat.  I mean, not something that was just going to sell the drugs but, you know, I didn’t realize it but now I was in a different ballgame.  I thought it was still going to be possible to, you know, be involved in a case against Prozac and the other companies would be reasonably relaxed about it.  They would see me as helping their marketing but not helping the Prozac marketing, but didn’t quite work out like that.  But this is where things get interesting.  I don’t get dropped by all of the pharmaceutical companies; I just have problems with Lilly.  And I’m invited to a meeting in London and it’s about a different drug which we had in Europe at the time [that] you didn’t have over in North America called Milnacipran.  Now, you do have a version of it now but you didn’t have it then.  And there was going to be a meeting in London and I was asked to talk and I said sure, fine.  I knew what I wanted to say about this drug, OK? 

So shortly afterwards I get an email from the company saying — well, what they’d asked me, to begin with, was could you come and give a talk, and also, we’re going to be asking all the people who speak at the meeting to write an article for a supplement that’s going to come out of this meeting.  So I agreed to that and shortly afterwards get an email saying, and here is your article.  And I download the article, very curious, OK, and to my surprise this is a really good Healy article; it’s got my name on it; it says things the way I say them; it’s got a bunch of references which are all to my work, and, you know, so much so that I figure that if I was to take a bunch of my articles, including this one, to a group of my friends who thought they knew what I say and read — say and write and think — although I’ve got very few friends who read — (laughs) — anything I ever write, but still.  I asked them to have a look at these articles and work out which is not the Healy article, OK?  I was pretty confident they would not be able to pick this one out; it was that good, OK?  So I write back to the company and say, well, this is a great article but I had plans to write my own article and it’s nearly finished, OK?  You know, so, you know, I don’t need this one that you’ve just sent me.  And they write back and say, well, this is unusual but that’s OK; let’s see what your article looks like.  And I send them the article that I’ve just written and they say, oh, this is rather good, we like it, but there was some important commercial messages in the other article, so what we’ll do is we’ll organize for the guy who’s going to be the chair of the meeting, a guy called Siegfried Kasper, who’s the professor of psychiatry in Vienna, to become the author of the first article that came to me from them, OK?  And the only thing they change is the Healy name at the top for his name.  It’s still a great Healy article with Healy references; the only thing they’ve changed is his name on the top.  So he has had nothing to do with the writing of it, OK, but is quite happy for his — for this article to go out under his name.  A short while later I read some stuff from some pharmaceutical company, a different company, saying, you know, and we’ve got some articles we can give you by Siegfried Kasper who you can believe because he’s over a thousand articles to his name.  Now, you know, the idea is you can believe him because he’s got so many articles.  In actual fact, the reality is you can’t believe him — (laughs) — because he’s got so many articles.  It’s just the opposite.  

HEATHER:  Yeah, but the interesting thing, too, is that they — he actually, in this article you’re referencing, used your articles to promote their message that perhaps you had some issues with.

DAVID:  But he didn’t use a thing.

HEATHER:  Oh, they didn’t use your references?

DAVID:  No, no, no, no.  

HEATHER:  Did he use your references in the article or — 

DAVID:  No.  He didn’t use anything; their ghostwriters used my references and they remain there.

HEATHER:  Well, exactly, yeah.  (Laughs.)

DAVID:  I mean, he has nothing to do with this.  I mean, he just sells his name, in essence.

LEE:  Right.  So that’s a common thing, it’s sounding like, these ghostwriting — and I know that from when I worked a little bit in research is that people — like professors or doctors, they want to have as many publications because that helps them move up and look good, so they’re all quite willing to have more articles under them, and that seems to be what’s happening.

DAVID:  Well, it’s a bit more than that.  Let me explain. Yeah, essentially it’s 100 percent of the articles about — on patent drugs are ghostwritten.  There is nothing about drugs that appears in The New England Journal of Medicine, et cetera, et cetera, that is not ghostwritten.  OK?  I found this out in an interesting way.  A year or two later, again I was involved in a legal action, this time against Pfizer and their drug Zoloft, OK, and as part of the discovery process I get to go into Pfizer’s archive.  This is on 42nd Street, OK, and it’s about a case that involves kids and I’m interested to look at the data, the material on the trials they did on kids, and that’s what’s supposed to be there as part of the discovery process.  There’s millions of pages of stuff there, hundreds of thousands at least, vast amount of stuff, but the kids’ trials aren’t there, OK?  And everything in the place is stamped “Confidential.”  As I usually put it, although it’s not quite true, even the toilet paper is stamped “Confidential.”  (Laughs.)  Articles that have been published years before in major journals are stamped “Confidential,” OK?  But just one of those weird little accidents, I find — rooting through some stuff, I find this document, which has been prepared for Pfizer about Zoloft by a medical writing company and it lists all of the trials that are being done on Zoloft in people who are anxious and people who are depressed and people who’ve got social anxiety and young people and old people, people with liver problems, people with this kind of problem — nothing about the hazard but all about, you know, the way the drug works wonderfully for all these things.  It lists all of the articles and who’s writing them and whose names will be on the authorship line, but the key page is the PTSD page; that’s post-traumatic stress disorder.  Pfizer have done four trials on Zoloft and PTSD; two are just totally negative; two more have a hint of some benefit in women.  Remember, this is the time of the Gulf War, so a drug for PTSD is going to be given to soldiers.  So in four trials there is zero benefit for men, OK, but the page in — you know, the document lists the trials — lists two of the trials that have been done which are going to be published, ones that have shown a minor benefit for women.  And it shows that the papers have been written; one’s going to The New England Journal of Medicine and the other’s going to JAMA.  And then on the opposite side, it has “author TBD,” “author to be determined,” and the authors are going to be people who Pfizer’s marketing department figures are going to be the people who will help sell this drug to other doctors.  They’re going to be the “influencers.”  They’re not scientists; they’re the best influencers for other medical people, OK?  So we had a chance because of that — I forgot to say, the interesting thing about it was, for some weird reason, there was no “Confidential” stamp on this.  So I was able to get it, whole and entire and have been able to talk about it for the last 20 years and show slides of it and write articles about it and it’s been great, wonderful, marvelous, and it’s really helped move things forward. 

But yeah, so that’s — now, there’s one more little story — (laughs) — I should tell you which helps bring it home as well, I think.  And again, it may have been a legal case.  This is going to leave you with the impression I’ve been involved in legal cases all the time, it’s the only thing I ever do.  But no, I don’t.  (Laughs.)  I do a lot of other things.  But this may (have been ?) a legal case and I say that because I had a chance to fly business class.  And if it’s left to me, I don’t have the money to do that, but I was flying business class and so it must have been something like a legal case, and I was settled there in the cabin, the business class bit, figuring this is the way to travel, you know, with my little peanuts and little glass of wine or whatever while we wait for the plane to take off.  And just before the plane takes off, this lady comes on board and she has this big, long tube, OK, which is when people do posters for academic meetings, you know, you’ve got a big poster which is folded up, put into a tube.  It’s a bit like artists and paintings; you know, you can fold them up and put them into a tube.  So it’s a tube like this which she puts in the locker overhead me and takes the seat that’s vacant right beside me and I’m thinking, well, first of all, she’s attractive.  Second, I’m thinking, you know, she looks like she’s a Ph.D. student; Ph.D. students didn’t travel business class in my day, OK?  So I have to ask her is she going to a meeting and is she a Ph.D. student, and she says she is going to a meeting and no, she’s not a Ph.D. student.  She’s going to a meeting in San Diego, I think it was, and it’s to the American Society of Renal Physicians or whatever; it’s going to be 18,000 doctors there and she’s presenting a poster, yes.  But no, she’s not a Ph.D. student; it’s just she’s presenting a poster about a clinical trial and there’s a whole load of academics on the authorship line, none of whom have written the paper or the poster or know anything about the trial.  So the pharmaceutical company needs someone who wrote the study up but has had nothing to do with it, and she’s the ghostwriter and she’s now going to be the ghost actor standing in front of the poster answering all the questions from doctors who walk by who may want to know this, that, and the other about it, who will assume, like me, that she’s a Ph.D. student or a postdoc or whatever when she’s not.  So that’s the world in which we operate.

LEE:  So that — I think it was Zoloft trial that you were saying there’s the two studies with the male that it showed no — for the PTSD it showed no benefit, and then they get the ghostwriter for the other paper.  Do you think those ghostwriters are aware of the other two — the other components not being —

DAVID:  Well, they don’t have the —

LEE:  They’re just looking at — they don’t have all that data, so they would have no knowledge that it really, in another population — 

HEATHER:  Well, it just seems like, yeah, the system is built on, even when you’re saying this whole — whosever pulling the strings, this confidential component, but whosever doing each little piece of this is unaware —

DAVID:  Yes, exactly.

HEATHER: — of a tremendous amount of information.  

DAVID:  Yes.

HEATHER:  They’re all just cogs in a wheel, putting it all together, but there’s no one person, except maybe someone behind the scenes who needs to push this message, who’s aware of how that system works and all the underlying data that is there.  Is that what’s happening?

DAVID:  Oh, sure, yes.  And the key thing is the word data.  So let me take you to that.  First of all, I’ve met a load of ghostwriters and they’re very responsible people, for the most part; you know, they wouldn’t — they can be awfully creative about the way they put things but they don’t outright lie, OK, and industry helped them not to lie by — you know, they give them tables of data which the ghostwriter assumes this is what the data in the trial looks like, but it’s not; it’s been built into a table and a lot of things don’t get transcribed over from the clinical trial paperwork to the data table.  

And the other thing is that what the ghostwriters aren’t seeing and what FDA aren’t seeing when they try to work out what are we going to do about this drug, is they’re not seeing the clinical trial paperwork; they get tables.  It’s a bit like the ghostwriter.  And in a sense, even before the ghostwriter begins to write — and as I said, they’re excellent writers; they can adopt my tone of voice if need be, OK?  But once you make a table, in a sense the conclusions of the paper are already written.  The ghostwriters just put in the words to the table, OK?  But first of all, the table and the figures it contains aren’t the data; the data — something closer to the data is the clinical trial paperwork, some of the figures from which end up in the table, and others don’t, OK?  But it isn’t just that.  If Heather McCarthy is in a trial and I get to see the data from the trial, I might find out that actually the clinical trial paperwork on Heather McCarthy is 300 pages long for this eight-week trial, but oddly enough, in her case, there’s four sets of clinical trial paperwork and one is 200 pages long and one is 300 pages long and one is 400 pages long and one is 500 pages long, and FDA are only going to get see one of these and we don’t know why they’re seeing the one they’re seeing.  I mean, when I say “see,” it’s going to be there and they could look at it, but they don’t.  

But here’s the other thing:  In Study 329 — this is a trial of paroxetine versus placebo in teenage children.  And when we got to look at the data — well, first of all, when GlaxoSmithKline published the paper, it was a 10-page paper in a leading journal that led to loads of sales of this drug and said the drug worked wonderfully well and was completely safe.  They said a few children became emotionally —

HEATHER:  And that’s Paxil, correct?

DAVID:  Yeah, that’s right.  They said in the paper that a few children become “emotionally labile” on the drug.  Now, the ghostwriter wouldn’t have known what that meant; that’s the words that she put in because that’s what was in the table; five or six children or whatever it was became emotionally labile.  It took a layperson, it took a woman, a young woman, a media person called Shelley Jofre to start asking what does “emotional lability” mean?  And she had no background in health care, OK?  So she just asks some of the key people and notices that when she asks them this question they get a bit worried, OK, so she starts asking it more and more, OK?  Turns out becoming emotionally labile means becoming suicidal and what GSK were reporting in the paper was that five children — when you got behind the term you find out that five children had become suicidal and one had become hostile, OK?  Now, when we got to see the data, what happened because of Shelley Jofre’s work, New York state took a fraud charge against GSK, and as part of the resolution to the action, GSK agreed to put the clinical trial data from their trials of Paxil in children up on the internet, OK, and that meant that, you know, those of us — well, not those — just a few of us who knew it was there were able to get access to it and look a bit more closely at things, and ultimately, at the end of the day, we got involved in trying to restore Study 329 and this meant trying to write it up the way it should have been written if you had access to the data, OK?  Now, the other thing that happened just around the time we began this was GSK got fined $3 billion for the way they were doing business at this time with their clinical trials, including Study 329, so they were on the backfoot, OK?  And we asked them what they put up on the internet was the company report about what this study showed and some appendices, and the company reported that what the study showed was 800 pages long.  The original article was 10 pages, the company report was 800 pages, and the appendices were a further 5,000 pages, OK?  But in the company report, you saw there was Appendices A to H, but what they put up on the internet was Appendices A to G.  Appendix H was missing.  So we asked them for it and they said no, and we asked New York State to ask them for it.  And we then, maybe by accident, just used the right word; you know, we just want to audit things, right, and they must have thought, well, FDA audit things and never find out anything so maybe we can let them audit Appendix H.  So we didn’t get Appendix H, but what they gave us was a portal into GSK which had three locks; you had to log yourself in through three different kind of systems, and the system threw us off quite often and we couldn’t download anything, we couldn’t print off anything, OK?  So Appendixes A to G had 5,000 pages; Appendix H had 77,000 pages, OK?  Now here’s the interesting thing.  Here’s the really interesting thing. It’s when you get all of that — I mean, it’s — you don’t need experts; you don’t even need a pair of smart women like you to analyze this; you just need a pair of kids from — I mean, not a pair; maybe a few kids from college.  What you need to be able to do is just spread things out across the floor and play Memory, as it were.  You know the game that kids have; you’ve got either fruit or birds or words or whatever turned upside down and you’ve got to remember where the pairs are.  That’s the only skill you need to really work out what’s going on here.  It’s not expertise, OK? 

But what became clear was that there was a few people where the kind of — there was four kids taking — I mean we — first of all, we worked out that where the company had said there were five children who became suicidal and one hostile, we had I think 14 children who became suicidal but the rest had disappeared, OK?  But what we even missed — and it only became clear later — was there were four children taking Paxil who disappeared even from the 77,000 pages.  All of a sudden they just go blank.  And you find the company has coded them as “intercurrent illness.”  And intercurrent illness means if, for instance — and this happened in one of the Pfizer trials — if — you might find that a person dies in the actual trial, and if they die the company has to write a narrative report; they have to write a one- or two-page report about what happened, OK, and this particular guy who died in a Pfizer trial, you know, they’d coded his death as burns.  And if you just look at the chart, you see “death by burns,” but if you get to see the one or two pages, then you find that what he’d done was he’d become akathisiac on the drug and had become suicidal and had put petrol over himself and set fire to it but didn’t die for five days, so he gets coded as death by burns, not death by suicide.  But you find out that he was a suicide when you get to read the one- or two-page — 

LEE:  Yeah. Wow.

DAVID:  In the Paxil trials — and this happens in the vaccine trials as well, OK?  In the Paxil trial in kids they had four kids who drop out where there’s no one or two pages; they’re just coded as “intercurrent illness.” And industry have learned that if you somehow develop — like, for instance, if you have a heart attack after the vaccine, they might decide that, well, actually you had a heart condition before the vaccine and we shouldn’t have let you into the trial, so you’re an intercurrent illness, so you just vanish.  In the case of one of these kids who vanished, we — just a sheer freak accident — found out what had happened to him, which is he was 15 years old, he was on Paxil, and he was picked up by the police and brought to hospital, so he should have been a serious adverse event with a one- or two-page report.  He had been picked up by the police, he was out in the street with a gun waving it around threatening to kill people two weeks after he got on Paxil.  This is unquestionably an adverse event caused by the Paxil.  But the company had managed to make him disappear.  Now, what this brings out is, when you ask the question what’s the data, and this is a point that’s key, even in the 77,000 pages, the names of the people have gone missing.  FDA can’t check these names up, CDC can’t check these names up, Joe Biden can’t check the names up, you and I can’t.  But I accidentally find out what has happened to this kid and what you need in all the people entered into, you know, the trial is their names.  Someone needs to be able to to call them up and say, look, in this trial you looked you were doing absolutely wonderfully well, your mood scores were absolutely perfect, you were down to zero, you looked like you totally recovered, and two days later you tried to kill yourself.  What happened?  You know, you need to be able to ask them these things and you hear that, well, actually, I was not doing as well; the doctor kept saying I was doing great, but I wasn’t; I was trying to tell him I was feeling agitated, he just didn’t listen, or I was trying to tell him that I couldn’t make love anymore and this was a big problem for me, you know, and I would never take this drug again but, you know, he ends up looking as though he’s been a wonderful respondent to the drug.  Unless you can contact the person, you don’t know what really happened in this trial.

LEE:  And the people that did have those reactions, they would probably have no way of knowing if they were — it was actually recorded in that data because nobody sees that data, so one would assume that if your child was in a drug trial and your child was one of the ones that had one of those adverse reactions, you would assume that’s been at least documented, but sounds like it could easily be removed in some scenarios if it didn’t fit the criteria.

DAVID:  We know for sure that even when New York state took a fraud action against GSK and they were fined $3 billion and they agreed there were more kids who became suicidal on their drug than not, we know for sure they did not contact the families to let them know that your child — our drug may have caused your child to become suicidal and you shouldn’t take any other SSRI ever again, and maybe the rest of the family needs to be a little bit worried because they may have the same genes that — we know for sure GSK didn’t do that because they said that was the doctor’s job to do it; we don’t want to interfere with the relationship between the doctor and the patient, so it’s not our job to —

HEATHER:  Oh, now it’s sacred.  (Laughs.)

DAVID:  Yeah, yeah, yeah.  

HEATHER:  In that situation it’s sacred, correct?  (Laughs.)  How convenient.  

LEE:  Wow.  You know, it’s funny and I’m sure that you probably had scenarios in your career, but just listening to these stories and I used to work in asthma education and my son also had asthma, and it was a time that they were trying — you know, people didn’t like to take the inhalers; they wanted always a pill for something, so they came out with this new Singulair.  It was like —

DAVID:  Oh, terrible pill, yeah.

LEE:  Yes.  Well, at the time it was the new thing and we had —

DAVID:  Absolutely, yeah. 

LEE:  — parents coming in and they were like, we don’t want the puffers, we want this new pill.

DAVID:  Pill, yeah.

LEE:  And, you know, we were told by the drug reps that it was actually quite effective, especially for the people that had more, like, nasal symptoms, so my son ended up being one of the ones that, you know, the doctor recommended that that would be good for him, and he went on that and within days he was so irritable and almost like aggressive towards his sister —  

DAVID:  Oh, yeah, totally, yes. 

LEE:  — like, he was six or seven years old and we couldn’t explain it.  So I took him off because I couldn’t figure it out and then I thought I’d give it a while.  I talked to some other people about it and I had other parents coming and telling me a couple things, and I, sadly, was one of those people that kept asking — you know, looking at the literature and drug reps and there was nothing — nothing — about this.  So I actually put him back on and it was my husband at the time that said, is he back on that medication, because he’s acting crazy again, like, without even knowing.  So it was just like you say; you go with a hunch and now that I’m listening to your stories — and sadly, I was one of those people that because I didn’t have that information as a health professional, I also told parents no, it’s not listed as a side effect.

DAVID:  Yeah, yeah, yeah, sure, sure.  And this comes back to — I mean, it needn’t be your hunch, it could be your husband’s.  It’s just — we had an instance that was a bit like that.  One of the people on the research team that I had some years ago, she was a very attractive woman who had minor acne, you know, very minor acne, and went along to a dermatologist who said yes, yes, we’ve got some antibiotics; we’ve got Doxycycline; it’s great, wonderful, marvelous, and talked into taking it.  Now, the thing was we used to have coffee every morning, so, you know, we used to all meet up as a group and have coffee together, so you go to see people and you got to see them over a few days.  And it was very clear in her — I mean, you could see it happening in front of us in the course of about three or four days.  You know, she was clearly getting more tense and I was asking her, is anything wrong?  I didn’t even know she was on the pills, OK?  Is anything wrong?  And she said no, she couldn’t think of anything wrong; the only thing in her life at the moment she was taking Doxycycline for acne for a few days and then it would be fine.  But it was this that was causing [it].  When she stopped it, she went back to normal.  But you could see it, you know.  I mean, it needn’t be gross; people don’t turn blue and grow feathers, but it’s just you can see the change, a bit more irritable or whatever. 

LEE:  Yeah.  Little behavior things that we really noticed with him but I find those things, like especially with Charlie when she was affected by the fluoroquinolone, the psychological things, like the anxiety and she was having, like — she was so afraid of everything.  I didn’t make that connection because it’s harder to connect when it’s not a physical symptom, you know, like a rash or you’re throwing up or something different.  When it’s something — and especially when you’re not feeling it yourself, it’s even worse, because you’re not feeling what your child’s having.  I thought she was reacting that way because her joints were sore.  It wasn’t until later that I realized that that was actually one of the side effects.

DAVID:  Yeah, yeah, sure.

HEATHER:  Yeah, and I think that was what was hard a lot with Shea.  He had a lot of the issues with his heart early on and digestive tract but a lot of the more — where there’s no marker for it, like the mental health issues, you know; it’s more just someone’s impression or diagnosis, but the anxiety.  And David had mentioned, you know, most people don’t even know what akathisia is; it’s a strange word; you know, a lot of doctors don’t even connect.  But so many medications, when a patient has a toxic reaction to them, that’s one of the main, I think, issues that comes to the forefront is this just restlessness.

DAVID:  But the heart of what — yeah, I mean, it can be hard for the person to make the link, but the heart of all this, again and again and again for 20, 30 years — and particularly when it’s kids involved but also parents — it’s a mother or a daughter that brings the person along because they know there’s a link, OK?  They don’t quite know what the link is; they end up coming to me because they figure I’m a person who might listen and it turns out it’s very obvious link.  They are absolutely right.  You know, you don’t have to do any work to see that they’re right; it’s a case of just offering them the support that they then need to go out and actually make a difference.

HEATHER:  Yeah, unfortunately, the validation that’s needed — I was in an environment of health professionals, so the validation that I needed was absent, because there’s almost a type of I don’t want to say elitism, but that’s kind of what it is, you know, this issue that, you know, you’re in this context with professionals and you’re trying to have a conversation with them and when you’re made to feel perhaps that, you know, your impressions are somewhat inferior because you don’t have the background, the accolades or the training that they do, that you’re just — you know, and these are groups that you’re interacting with, and I think that’s what almost makes it harder for people who — you would think people who are in the health care system would be the first to recognize this and advocate against it; it’s actually the opposite.  You know, it’s actually it’s almost like the more detached you are from knowing about the health care system, in our country anyways, the more likely it is that you’re going to have an accurate impression and you’re going to be more emphatic when it happens.  I think one of the things that really stalled me was being in that context and unfortunately letting that influence me more than my own child.  And that’s a hard one to swallow, but it’s very difficult to explain, and I’m sure you’ve experienced it, David, and I know you have, too, Lee, because, you know, you worked as a nurse also. 

LEE:  Yeah.

HEATHER:  You know, but I just — yeah, I think that some of the strongest connections and strongest supporters I’ve had are people who’ve either detached from that system or are not a part of it, which is sad because that makes a solution somewhat difficult — (laughs) — you know, when the people who need to be aware of these things don’t have a willingness to even listen.

DAVID:  Well, listen, I had an interesting experience recently that will amuse you, OK?  So I had an opportunity to present some of the things that I’ve told you guys to the powers that be here recently, about the fact that the literature is all ghostwritten and there’s no access to the data and the FDA may approve drugs that don’t work and things like that — some of the most shocking things that I know about and thought the powers that be would be — would at least listen, OK?  And it was clear to me that they weren’t listening.  They were listening to me speak but not listening to the words and not thinking about what the words meant.  At the end of the day I had — this is going to sound funny — I had a female moment.  I realized I was being treated as a woman.  They said, you know, “We can see that you’ve got some very heartfelt views, you know, you feel strongly” —

HEATHER:  A little emotional, David, little emotional.  (Laughs.)

DAVID:  “There there, little woman; you know, we can see you feel very strongly about these things but, you know, we’re not going to pay any heed to.”

HEATHER:  Yeah, and, you know, that’s a tough one; that’s probably a whole nother episode.  But, you know, you come off as angry, you’re like the mad woman in the attic, you know?  You’re crazy.

LEE:  Oh, it’s true.  It’s true.

HEATHER:  There’s no happy medium and it’s such an ugly fight for how it’s affected — because in my case, it was my grief, you know?  That’s what’s causing all this; I just couldn’t cope and — I mean, they tried to put me on these drugs.  You know, it was — it’s mind-boggling, like, how this happens.

LEE:  Yeah, that’s really sad when somebody, you know, like yourself wants to speak out and it’s not necessarily even just an opinion, but you’re just sort of appeased and that’s just, I’d say, probably, from speaking to so many people that have been through what Heather and I have, just not being recognized as being credible or listened to.  That was almost as bad as the reaction, to be honest, for both me and my daughter.  Even family members, to be honest, you know, struggled with — if the doctor says that it couldn’t be from that drug or that drug wouldn’t still be in the system causing this, you know, a lot of my family members — like, the doctor is God so whatever the doctor says, you know.  I think a lot of it has come out now differently, but in the beginning, that’s really hard because you’re standing up for what you know against a lot of people.

DAVID:  Part of the problem is that the doctors think they’re God as well.  I mean, I’ve listened to a bunch of them and they say we are better than the average person because we have seen so much suffering.  I mean, not that they’ve suffered; they’ve seen other people suffer and figure that makes them good people, which doesn’t follow at all, you know, so.

LEE:  Well, I remember going into a doctor and it was actually the doctor that had delivered Charlie so we have known her for, you know, most of Charlie’s life, and she was OK in the beginning but she wasn’t recognizing the symptoms as being correlated as an adverse drug reaction to that drug.  And in Canada the health warning hadn’t come out yet; it had come out at the FDA with the permanent disabling side effects, but in Canada it came out a month after, and I was so excited to get this health warning that it was being recognized by Health Canada as having this permanent disabling side effects that I went into her office — and I don’t know why I felt like I needed to get validation but for some reason I did, and I was like, oh, you know, look — (laughs) — here, it’s out.  She says, oh, yeah, I don’t read those things; they’re, half the time, just garbage.  So she didn’t even read them.  She actually threw — took the pieces of paper and threw them in the garbage in front of me, and that was the last time we went to that doctor.  (Laughs.)  

HEATHER:  You know, even with Shea, I was on our hospital board, on our local hospital board system, I was a practicing attorney, I knew numerous doctors, I, you know, had worked in the health care system, the mental health care system, but I still had contacts with everyone in my area.  I couldn’t even get a doctor to look at these records. Oh, you know, be careful, you might not like what you’ll find in them.  Be careful, be careful.  I mean, it reminds me of what David said about, you know, they had to go — the L.A. lawyers had to go overseas for him.  I had to stalk him from the States because I’m like, I think this guy might listen to me, because no one will even speak to me about this, you know?  You know, there’s a real (uncomfortableness ?) with losing a child and death and then, you know, on top of that, to actually think that one of your colleagues might have been the problem. And not only that, I’m an attorney; I couldn’t — and we’re going to talk a lot more about this in other episodes, but I couldn’t even get an attorney to sit down with me as a colleague, you know?  And, you know, I was on boards with some of the top attorneys in the area.  There’s just a real — it’s just an aversion to all of it because it’s some emotional reaction as opposed to you know what, someone really F’d up here and it wasn’t me and it wasn’t my son; you know, it was you.  And I don’t know.  Thank God for people like you, David, because I’ll tell you, I’m fairly confident I would have lost my sanity at some point because to not be listened to, I can’t imagine what Shea went through, because he was telling everyone, and here’s his family, who love him dearly and who he loved, you know, “tell your doctors everything, tell these guys everything.” I knew these guys, and this was the outcome.  It’s real frustrating, but now when I hear people treat me the way David just talked about being treated like a woman, I know I’m having an impact because something in them is provoking — (laughs) — them to treat me that way, you know?  And, you know, you figure out ways to navigate and address that being gaslit and, you know, give me your little sympathy, no thank you, but —

LEE:  You’ve rised (sic) above it and you’ve persevered and that’s why we’re here today, and, I mean, this has just been a great opportunity to talk with you, David, and we’re just so thankful for all that you’re doing for everybody and for all your knowledge.

DAVID:  Well, forget that for a second.  Hold on, hold on.  Let me just quickly chip in two brief things before Heather leaves.  I want to shock you both.  

One is that doctors get no training in how to work out, is a drug causing a problem or not?  Literally none.  So while they may throw things in the bin and things like that, you know, which they do, it’s a little bit because they don’t know how to handle the thing, OK?  But the next thing is even more shocking, the most shocking thing, I think, that I’ve ever seen.  I spent time looking at it and thinking about it and still get shocked, OK, when I actually see it. 

In the course of the Study 329 story, Paxil given to kids, we come across a document, OK, which is GSK have filed Study 329 and two other trials done in depressed kids with FDA; they want to get Paxil on the market to treat kids, teenagers who are depressed, OK?  They’re doing that because the year before Prozac has got Prozac on the market for treating kids who are depressed, OK?  Now, there’s two shocks here.  One is that GSK give the data to FDA and write up the whole thing and FDA approve Paxil for kids.  No one knows this.  They write GSK approvable letter saying, yeah, we’re happy to go ahead and approve it; there’s one or two bits we need to iron out.  In the letter, it says, we agree with you that the three studies you’ve shown us are negative but we’re still happy to approve the drug on the basis of those three negative studies and we also agree with you that we should not let anyone know that we know the studies are negative.  We should not mention it on the label of the drug.  Now, there’s a big shock and this — (inaudible).  Nobody actually knows about this document; this didn’t actually come out in the crisis, OK? But if you think about it, FDA are quite willing, with the vaccine maybe, for all we know, to approve something that the company has told them is negative, even though they’re telling the rest of us something totally, totally different.  But, you know, you can’t depend on FDA to ensure that this drug actually— or vaccine actually works.  But the other thing is, part of the reason they probably did it was the previous year they had approved Prozac on the back of negative trials.  The FDA document says these trials are negative.  Now, we’ve got 30 negative trials of antidepressants in depressed teenagers and you would have thought that’s — I mean, all the trials done are negative; you would have thought that would stop the use of these drugs, but it’s escalating.  Teenagers are taking more and more and more of them every year.  It’s a weird situation.

HEATHER:  And suicide rates are going up and up and up —

DAVID:  Oh, yes, yeah, sure.

HEATHER:  — every year.  And again, it’s just another issue:  We’re watching it with our eyes; anyone could see you’ve got more people on these treatments than you’ve ever had and you have your — you know, the rates of suicide are through the roof.  Hello!  (Laughs.)

DAVID:  But it isn’t just that.  In the United States the recovery rate has gone below the rate it should be for the population to stay where it is.  Women are not having children.  Of course, the people who are now taking these drugs in ever-increasing amounts, which interfere with your ability or interest to make love and increased rates of miscarriages, are women more than men.  Teenage girls and early 20s women are on these drugs in ever-increasing rates, and what do you know, the population recovery rate has fallen below the rate that it is going to keep the population the same size.

HEATHER:  Yeah, and what’s rarely talked about, too — it’s getting talked about now is it’s very hard to get off those drugs —  

DAVID:  Yeah.

HEATHER:  — once you start, even being confronted with all this information.  Just physically it’s hard to stop taking them.   

LEE: David, I’d just really like to thank you for your time and for all your knowledge. It’s been incredible to talk to you and, you know, have some of your insight into, you know, our stories and so much more, and we’re hoping that you’ll join us for future podcasts and just work on more topics.

DAVID: Well, Lee, you’ve talked about some of the things that I’ve been able to share with you but what people haven’t heard, at least in this bit of the podcast, is all the things you shared with me the last time we talked about sort of the lengths you had to go to get the truth out in the case of Charlie, for instance, and, you know, it’s been just as extraordinary as anything that I might have been involved in.

LEE: Well, thank you.

Thank you for joining us today on this episode of “Know Risks,” and remember, being your own expert is the best way to prevent yourself or your loved one from being harmed.

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