Okay, I finally got permission to publish the recording of our Lundbeck meeting (not from Lundbeck but hey, I didn’t give them permission to kill Shane) so here goes:
There is nothing much I want to add to this post, the recording speaks for itself, except Dr. Madsen; you forgot to tell us you are a director of Lundbeck, OOPS, must have slipped your mind!
I honestly believe that this pharmaceutical company, through their medication, are causing a high percentage of people to die by suicide.
The reason that I can be so positive in my belief, that antidepressants caused the death of my son and another young man is very simple, I knew my son and what he was capable of, and being violent towards himself or others was not part of his make-up. Suicide and/or homicide are widely known to be an adverse effect of antidepressants, albeit in a small minority of consumers.
The number of school shootings and familicides carried out by people on Ssri antidepressants, leave little room for doubt what these drugs can do to a persons’ brain.
Lundbeck’s failure to warn and deliberate shirking of responsibilities, in passing the buck to the medicines regulators and doctors, is a serious breach of their supposed pharmacovigilence; a word which means nothing if it is not acted upon!
Their statement that “It’s up to the doctor to warn that the drug can harm an unborn baby” just about sums up the importance of Lundbeck’s pharmacovigilence!
One thing I have to say is how proud I am of my lovely husband, who never once wavered in his belief of Shane and has never shown the slightest bit of trepidation in our battle with Irish psychiatry or Lundbeck; Donnelly you’re amazing!
Anyway I’m waffling, so here it is, our Lundbeck meeting:
Full Transcript below:
Leonie So it’s Doctor Madsen and Anders, is it?
Mr. Schroll Yeah, Anders schroll.
Dr. Madsen Well, Since you asked before, so just, my background so as you know…
Dr. Madsen I qualified as an MD which is a Doctor from the University in Copenhagen. Emm, so I’m just back now and then I went on to do a phd degree in Europe biology, I did some basic research here in Denmark and in the United States and then I went back to Denmark and started training as a psychiatrist.
Leonie You are a psychiatrist, are you?
Dr.Madsen Per…technically I am not. I’ve, I have got most years of what it takes to become one but then I got this job with Lundbeck and I’ve been here since.
Tony How long are you here?
Dr.Madsen emm…coming up on 5 years.
Dr.Madsen So that’s why…..
Leonie That’s why you were elected to answer the questions, yeah?
Dr. Madsen That’s eh, why they chose me as the spokesperson here, but I don’t know which questions.
Leonie I’ll tell you now in a second.
Dr. Madsen Yeah
Leonie Right, do you want me to start?
Dr. Madsen Yeah
Leonie OK, first of all.
Dr. Madsen I know that you are Leonie, I don’t know your
Leonie This is Tony, my husband
Dr. Madsen Tony, do you want to be on a first name basis or
Tony Oh I’m Tony, yeah, that’s fine,
Leonie Yes, whatever, yeah!
Tony Tony and Leonie’s fine
Dr. Madsen I’m Thorsten
Tony Thorsten, right
Leonie OK, first of all, Lundbeck sent this letter to the Canadian Healthcare professionals. I‘m sure you are aware of that. Are you? Admitting to reports of self-harm and harm to others. At Yvonne Woodley’s inquest in the UK, Dr. Christopher Muldoon, representing Lundbeck, said the drug is saftely used by millions of people but it would cause someone to take their life who had not previously thought of doing so. At Charmaine Dragun’s inquest in Australia, Dr. Deborah Pelser from Lundbeck Australia was asked whether Lexapro could have something to do the symptoms exhibited by Ms. Dragun the day she committed suicide and asked if they could have something to do with that drug. She said most certainly, if it is in the product information, so yes it’s possible. So considering these admissions, has there been an inquest that Lundbeck have admitted the drug was responsible? Can you tell me that?
Dr. Madsen I can speak first to how documents like this is done, this is a dear doctor letter so called, here it’s called dear healthcare professional so per the Canadian medical medicinal regulations, this is how they do it. The, it’s dated back in 2004
Leonie That’s right.
Dr. Madsen Emm, the background for, for sending this was the big debate that had gone on since the early 90’s, I believe was the first comment in a scientific journal. Emm Eh., Suspicions on suicide, suicide and, and Fluoxetine which was back then the antidepressant, emm, the first in the class of ssri’s
Dr. Madsen Em, that was investigated ……in the United States em, and they found no reason for em action. Em, then some years went em, and there a bid debate on Paroxetine
Dr. Madsen Some, at which point it was decided, the FDA decided, and eh, soon followed by the European eh, authorities which is basically eh, the EU countries and emm, some others… to investigate more thoroughly, so the FDA requested all eh, manufacturers of eh, these compounds to send in all their data in a format that they could, em, so that they could investigate and have their own statisticians, their own technical, their own data people to investigate, eh the data….. They also asked the companies to, subject to them, em, all their verbatims that they recorded, the verbatims are what the investigator, this is from the clinical trials so we nit-pic, an investigator, if you are an investigator of a company or clinic, em, and giving either, investigate the drug, or a placebo pill or something else, and I tell you doctor I feel eh, ye know, it hurts in my joints or whatever, anything, then the investigator is em, requested, that’s how you do the trials, to, to note down this adverse event….
Leonie I think we know all that already.
Tony But basically Leonie has asked you a question, has there been an inquest that Lundbeck have admitted their drug was responsible? at an inquest? Has there been?
Mr. Schroll You mean Legally?
Leonie Seeing that you have admitted it there already.
Tony At an inquest.
Leonie An inquest, it doesn’t matter whether it’s legal or not. Have Lundbeck ever admitted that their drug has caused this, Lexapro? Citalopram?
Mr. Schroll No
Leonie No… That was the question.
Tony Have you got your PIL’s?
Leonie I have indeed, yeah. OK, there’s the Irish PIL where it mentions suicide and homicide. There’s the FDA one. OK.
Tony Can you read both papers and explain why the Irish PIL
Leonie There’s both
Tony has so little information relating to suicide and violence compared to the American version of Citalopram and Escitalopram?
Dr Madsen That again would require me to give, to speak to…. if you want yes or no… but I would so, again
Leonie It’s really just, why is there three pages to do with suicide and homicide in the FDA one and why is there only about two sentences and it also says in here if you can see “if you are a young adult information from clinical trials have shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an anti-depressant. Can you tell me why that’s there? If you don’t admit it.
Dr. Madsen This em, package inserts, the labels that are associated with any drug is made by the eh, eh, the authority….
Leonie So you just put it in for the sake of it?
Dr. Madsen Pardon
Leonie You just put it in for the fun of it? Yeah?
Tony Why do you put it in, why would you insert two different information PIL’s, like. You-know
Dr. Madsen We don’t put in. We, So the way these package inserts, these labels are made, there is a provision em, in the different companies, so Denmark would want it one particular way, eh, the United States would want in another particular way. In Europe currently there is a trend towards harmonisation of these package inserts.
Tony But surely, I understand what you’re trying to say but surely if you’re manufacturing a pill whether it’s Calpol, the same guidelines, it should be the same for every human being whether they are American, Korean, Irish, English, you know?
Dr. Madsen But the….
Tony And I would, I would feel that the onus is on you then to put the warnings on your packaging initially and not wait for, ye know, the FDA or the IMA or anybody else.
Mr. Schroll Yeah, you can see that they are, em, one thing is that different countries might have different transitions of how they actually prescribe this, maybe eh, eh, eh, they, they present this and want it to be presented and there is the difference between the U.S way of doing things and same that you are doing in Europe.
Leonie It’s the same pill.
Mr. Schroll Yes but, but, but, what, what, that, that, that,
Mr. Schroll There will be differences and it is not up to us
Leonie Three pages – two sentences, there’s that much difference?
Mr. Schroll Yeah, But, but, but, but, that
Tony That’s horrific, yeah.
Mr. Schroll Yeah
Leonie So the Irish people are different to the American people, obviously.
Mr. Schroll No. That is, there are differences between countries how they would like to see this.
Leonie Three pages – two sentences, that’s a big difference.
Tony That’s horrific, yeah.
Mr. Schroll Please? finish? Em, what we do is, when we look at the data, or the safety reporting comes in the clinical trials, etc., we make sure that eh, eh, the, the, the moment, the things that need to be there are in the text because we are not the ones who actually can go in and say that you should have a higher eh, eh, eh, eh, definition of, of what you put in the text.
Tony So surely it would be easier to do that at the point of production.
Dr. Madsen So, so the way from practical point of view, the way it’s done, is that we have a standard text which includes…
Tony But obviously what Irish people get, two lines is it?
Dr. Madsen Which includes, em, I don’t have it in front of me. Eh,
Leonie So you think there is enough information in that to say that you can get worse and you can become suicidal when you go on an antidepressant, you can also become extremely violent. Do you think there is enough in that?
Dr. Madsen That is to me to decide whether or not that is enough. I think it is a fairly strong wording from a personal point of view.
Leonie You think this is very strong wording? You do?
Dr. Madsen I do. Yes. From my point of view
Leonie Right, ok, can I ask you a question please?
Dr. Madsen I just, yes, just let me finish, we provide all the authorities where Citalopram and the other drugs
Dr. Madsen And others. All drugs that
Leonie I’m talking about anti-depressants. I’m talking about Escitalopram and Citalopram.
Dr. Madsen So for all the
Leonie I’m talking about my son’s medication
Dr. Madsen I realise that, but I am saying that there a, eh, a law and we are required to be abide by it. We think it is a good idea to provide every authority with the same information so every authority has the same
Leonie So it’s to do with the Irish Medicine Board?
Dr. Madsen The Irish Medicine Board, the eh, who decide on the particular wording and really this is a discussion…..
Leonie So they get the same information as the Americans?
Mr. Schroll Yeah.
Dr.Madsen They have, they have the same
Leonie OK, well can I go back to the first one then. Lundbeck have admitted it in England and they’ve admitted it in Australia.
Dr. Madsen No…What. What is it you say we admitted?
Leonie I already told you. The drug is safely used by millions of people but it could cause someone to take their own life who had not previously thought of doing so. That’s in Australia. That was em, a Dr. Christopher Muldoon representing Lundbeck, he said that.
Mr. Schroll What did he say?
Leonie Oh japers….. The drug is safely used by millions of people but it could cause someone to take their life who had not previously thought of doing so. That was admitted by Lundbeck. Now do
Dr. Madsen I am not aware of that particular comment, I must say.
Leonie You’re working for Lundbeck. I’m asking the questions. You’re supposed to be answering them.
Dr. Madsen Yes
Leonie Now do you want me to tell you what they said in England? Or, do you want me to go over that one again?
Mr. Anders Please. In every place, if there has been a case we have looked at the coroner’s inquest, we have eh, brought a response back eh, this is not about admitting or not admitting, eh, this is about that we had a position…..
Leonie Well… this is not a question, this is a statement, you’ve admitted it in Australia and England.
Mr. Anders But, but, but, but
Leonie So that’s a statement, that wasn’t a question.
Lundbeck A Question, what do you mean?
Leonie It wasn’t a question, that was a statement. You admitted it in England and you admitted it in Australia.
Dr. Madsen I’m not familiar with the particular
Leonie Well I can email you them if you like.
Dr. Madsen I’m sure that we have them, I can pick them up
Leonie Hmm, So you can’t answer that one.
Mr Schroll Do you know the outcome of the inquest?
Leonie I, I don’t care what the outcome of the inquest was, I’m just, eh, I was just worried about what the eh, Doctor said at the time, the spokesperson for Lundbeck. So I don’t know, no. Actually, I think the one in England, em, Yvonne Dragoon, was it, what was her name, Yvonne Woodley?
Tony Yvonne Woodley, yeah.
Leonie Hmm… I think that did say the drug had caused it, I’m not actually quite sure because that didn’t bother me. I wasn’t interested in that. Right, you list aggression on the Irish PIL. Does this include homicide? Does aggression include homicide?
Dr. Madsen No……..
Dr. Madsen Agression is aggression, homicide is an aggressive……
Leonie The Irish PIL, I’m going back to this again, for Citalopram and Escitalopram states that a person may be more likely to have suicidal behaviour and worsening depression if you are a young adult less than 25 years of age with a psychiatric condition who is treated with an anti-depressant. Why did Lundbeck lie on the statement to RTE after my son’s inquest?
Mr. Schroll Sorry?
Tony Why did Lundbeck lie in their statement to RTE, the national TV, after our son’s inquest?
Leonie Here’s the statement, a copy of the statement if you want.
Dr. Madsen It seems to me that you are now going eh, very much into a case that has been going on….
Leonie Well it doesn’t matter about Shane, it doesn’t matter, it’s about people, it’s about people that are going to on….You list pharmacovigilence as…
Tony It doesn’t matter if it’s Mickey Mouse, but that’s what, that’s the statement that you made
Mr. Anders But we have, we have not lied if, eh, eh, however, this statement
Tony But you haven’t, you haven’t read the statement. So how could you say you didn’t lie.
Leonie So has your position changed today since 2009?
Mr. Anders No…I expect that this is the position that was in our eh, two years ago.
Tony So is that automatically generated, just every inquest, yeah?
Mr.Anders No, No, of course not. We take these cases very seriously.
Tony On what grounds then did you make that submission?
Tony On what grounds did you make that submission?
Mr. Anders Which grounds? Ok, I think you can explain how eh, eh, the processes are for safety pharmacovigilence and with eh.
Dr. Madsen Every case that Lundbeck becomes aware of, em, eh, on every case that is recorded by a doctor or patient to which other channels we have, which is either per e-mail, phone, eh, eh, the doctors notifications of the local medicines boards. All those em, are sent to us and sent to a Department that we have, working 24/7 in adjudicating all incidents, em, all those are then eh, correlated depending on their seriousness which is another system that is in place, not with the em, very severe and not so severe, emm, they are, we are requested to and we abide by those to notify the proper authorities eh, either immediately or at, emm, which we have to do in anyway, at regular up-dates so every regular …………………….emm, we are eh, mandated to send in all our findings on the reports that have come in on adverse events associated with the eh, drug that we are manufacturing.
Mr. Schroll For Citalopram, it has been used for more than 130 million eh, people around the world.
Leonie I seen that, I think it says it on your statement as well.
Mr. Schroll Yeah. So, so, so, eh, so, eh,eh
Leonie So how many people have committed suicidal on it then?
Mr. Schroll Eh
Leonie Do you know that? Do you know the answer to that?
Dr. Masden How many reports of suicide do we have? Is that the question?
Dr. Madsen I’m going to have to move that up in the paper. I’m sorry I can’t answer
Leonie Ok, well, em, let me see. Do Lundbeck send adverse events reports for Citalopram and Escitalopram to Forest Laboratories?
Dr. Madsen We eh, have that going in, so yes.
Leonie You do.
Dr. Madsen And vice versa
Leonie Lundbeck…Or Forest labs forward adverse events reports for Citalopram and Escitalopram to Lundbeck? Yes?
Dr. Madsen We eh, make sure that we have access to the exact same em….
Leonie They do send reports, yeah?
Dr. Madsen Yes
Leonie Does Lundbeck do a causality assessment on adverse event reports that are not from clinical trials?
Dr. Madsen A causality assessment?
Dr. Madsen Yes, we do. We assume, when we, once we, reports that we get in from doctors, from ……with adverse events are…..
Leonie You do a causality assessment?
Dr. Madsen We have an assumption of causality.
Leonie And yes, but you have already said that you have never admitted that the drug has caused suicide so what’s the point in doing a causality assessment then?
Mr. Schroll Because you can help with another conclusion,
Leonie You can find out what somebodys died, even though it’s not to do with your tablets.
Mr. Schroll Yes, you can come up…
Leonie Why would Lundbeck do that if it’s not to do with their tablets?
Mr. Schroll Because if it came up, that there was a link, then we would end up, contact the authorities
Leonie But it has never come up though, has it?
Mr. Schroll Sorry?
Leonie It has never come up?
Mr. Schroll What?
Leonie It has never come up, has it, that it’s to do with Lundbeck’s drugs, no, never?
Mr.Schroll No, But if you
Leonie No, never, you’re saying?
Mr. Schroll If you treat diseases like depression there will be incidents where patients commit suicide, these events are recorded to us. We make a long story eh, finding out what are the, the, the case story and these are sent to the authorities. Some changes have been made and are also made after it has been, been come to the markets.
Leonie Lundbeck have made changes?
Mr. Schroll To the label? Yes, sure we have. Eh,
Leonie You didn’t make very many changes to the Irish one there. The only one, the actual one change that you did take out of the Irish one was to do with how many pills that you give out. It’s in the FTA one but it’s not in the, in the Irish one, it was in but you took it out.
Dr. Madsen Well, where there is regular up-dates to
Leonie I’ve seen them on the internet yeah, but what I’m saying is, you used to have, to give out a certain amount of tablets,
Dr. Madsen ………….
Leonie Yeah, you took it out. But you didn’t in the FDA one
Mr. Schroll Yes, but there might also be other kinds of side effects where it comes out…The one thing is when you start
Leonie I’m talking about when you’re going to kill yourself with your tablets,….a months supply.
Mr. Schroll Yes, and if there was a reason where we could see in all the, the sickness coming in that there is a need to up-date it, then we contact the authorities and discuss with them and then they agree or find out what to do
Leonie So you, you contacted the Irish Medicines Board and told them to put the same in as in the FDA?
Dr. Madsen We don’t tell, we are not allowed to tell the Medicines Board to, to…
Leonie But would you tell the Irish Medicines Board, well you list pharmacovigilance as one of your main things. Would you tell the Irish Medicines Board that a month’s supply of tablets is too much to give to somebody because if you’re, if you’re depressed the first thing that some people will do is take them all together which can be fatal. Now that just doesn’t make sense to me. Would you tell that to the Irish Medicines Board?
Mr. Schroll If, if, if, if,
Leonie Have you? Would you?
Mr. Schroll If there was a situation
Leonie That has been a situation, there’s been my son’s situation.
Mr. Schroll Sorry, but please, eh, eh, make understand and I also wrote that to you, we cannot comment on your specific son
Leonie I’m talking about anybody’s son, anybody’s daughter, you can kill yourself on a month’s supply of tablets.
Mr. Schroll If, we come in and see that eh, eh, there are eh, safety… there are links where people commit suicide and there is a link to our product or the way it is treated, all the events, yes, then we contact the authorities.
Leonie So did you? I’m asking you.
Mr. Schroll In this specific case eh, you know the, the, the outcome of the coroner’s inquest and our physician will have seen that and of course we, we, we are still focusing on that and we cannot go into more details about this specific case and I made that clear.
Leonie Well, ok say if I’m not talking about Shane say if I’m talking about somebody’s daughter who has gone on to kill themselves on a month’s supply of tablets, have you told the Irish Medicines Board that you can kill yourself with a month’s supply of tablets, it’s very simple.
Dr. Madsen Again, the safety, if you are referring to an incident where somebody
Leonie No, I’m not referring to anybody, I’m talking about in the future
Mr. Scroll What we do is, we, we are on this causal basis sending adverse events updates to the authorities, so they get an overview of all the different incidents that come in.
Leonie You’re still not answering my question.
Mr. Schroll No, no but, but, so, so based on that, that can be your son, that can other people, they come in and they give that statement and then the authorities, they go back and say ok here we can see that there is a need for changing eh, eh, your, your, your, eh ……
Leonie Do the Irish Medicines Board know that you can kill yourself with a month’s supply of Citalopram and Escitalopram?
Dr. Madsen We can’t answer on behalf of the Irish Medicines Board.
Leonie Well, you can answer because you’re the one that sends them all the information, you just told me that. You’re the one that gives them the information.
Tony …..There’s a flat text
Dr. Madsen The question you are asking is “do they know”?
Leonie Do they know if they can kill themselves. You are supposed to give them the, all the information. So do they know?
Dr. Madsen All information on serious these eh, cases is emm, forwarded to the appropriate….
Leonie So they do know that you can kill yourself with a month’s supply of tablets obviously?
Dr. Madsen They know of the individual cases and they are, all cases are adjudicated
Leonie I’m not talking about deaths. I’m talking about deaths tomorrow. Do they know, did you tell them that you can kill yourself, it is possible to kill yourself with a month’s supply of Citalopram and Escitalopram?
Dr. Madsen You have to ask specifically to the Irish Medicines Board
Leonie No, I’m asking you, did you tell them that? Do they know that? Because did you, did you forward on the information?
Dr. Madsen They have, part of the information you had in this information about, with lower doses, so it’s something that the, that if there are lower doses reported then that is also sent in and it is also reflected in the leaflet.
Leonie So they do know?
Mr. Schroll So they have all the information but you, but, but, but, but, but, but I think what is different is
Leonie Are you going to answer that one, no?
Mr. Schroll Sorry?
Dr. ,Madsen I’m not going to answer to, I do not answer to what the Irish eh, Medicines Board know or don’t know because I, I don’t think that would be fair
Leonie Ok, did you, what about the FDA?
Dr. Madsen They have received the information which, if you’re talking about overdose
Leonie Overdose, that what I’m taking about, can you kill yourself with a months supply of Escitalopram and Citalopram?
Dr. Madsen Overdose eh, so many, em, for suicidal intent take a large number of ….
Leonie Can you kill yourself with a month’s supply of Escitalopram and Citalopram? It’s very simple, yes or no?
Dr. Madsen Are you asking me?
Leonie Well I’m looking at you so yes I’m asking you.
Dr. Madsen Last time you were asking me what the Irish Medicines Board….
Leonie Well you weren’t going to answer that so
Tony You wouldn’t answer that
Dr. Madsen Are there any reported deaths?
Leonie No. I’m asking you, you’re the Doctor. Can you kill yourself with a month’s supply of tablets?
Dr. Madsen Yes, I’m thinking, I’m trying to add up how many milligrams of Escitalopram
Leonie Well Shane was on 20mg – so there you go. I already know the answer but I’m asking you.
Dr. Madsen I’m not going to answer. I eh, It seems that
Leonie You’re not going to, that’s ok
Dr. Madsen that the
Leonie OK, fine…. Do you know that David Healy brought detailed information on the risks of suicidality linked to SSRI’s to Lundbeck in 1999? 10 years before my son died. The company’s response was to lock the material away. Is this the approach of a company that is concerned about patients?
Mr. Schroll We are fully aware that Dr. Healy has been quite eh, open about his standpoint and views and eh,
Leonie No that wasn’t the question. Did you know that he brought it to Lundbeck’s attention in 1999.
Mr. Schroll Eh, I think already at that point of time it was on Lundbeck’s attention because………………………………………….Dr. Madsen told you…..
Leonie So you did know? That in 1999 Professor Healy brought detailed information on the risks of suicidality linked to SSRI’s to Lundbeck.
Dr. Madsen I don’t know what particular information you are referring to but I’m very
Leonie Well I can get you the information, I’ll email to you if you like
Dr. Madsen Em, em, you may. Em, I don’t know. I was not here in 1999 so I…
Leonie So you don’t know
Dr. Madsen I don’t know, but I know that this is a paper dated 2006. Em, I know that in 2001 I believe that once we submitted all the data on the clinical trials that we had conducted with eh, Escitalopram, Citalopram to the eh, FDA em, requesting psychoanalysis. So I do know that the debate has been going on.
Leonie But you didn’t know that David Healy brought it to your attention, no?
Dr. Madsen David Healy has been publishing articles like this
Leonie No, but he brought it to Lundbeck’s attention. I don’t care about anybody, any other drug company, I care about Lundbeck because my son was on Lundbeck, Lundbeck medication so were you aware that David Healy brought detailed information on the risks of suicidality linked to SSRI’s to Lundbeck in 1999.
Dr. Madsen Eh, I was not aware of that particular point. I was aware by 1999 as a personal practising physician that David Healy had brought these thoughts to eh, to the scientific community.
Leonie Has anything changed….?
Tony Are Lundbeck aware?
Mr. Schroll Of?
Tony Of the papers?
Leonie He’s not, no
Mr. Schroll Of the papers?
Tony That he submitted in 1999? Cos, like you just haven’t answered the question and it only requires a yes or a no – that’s all
Mr. Schroll Eh, we are following what people are eh, publishing around ssri’s, so eh, if he has published something, yes we are aware of this,
Tony And he brought it to Lundbeck?
Mr. Schroll Eh, certainly I think that, that you have seen when you contact us we respond to you and I’m sure that that, we also have done at that time but I don’t know, have you talked with Dr. Healy whether he has got a reply to Lundbeck?
Leonie Oh, we have yeah.
Mr. Schroll Yes
Leonie Has anything changed?
Mr. Schroll Did he get one?
Dr. Madsen Did he get one?
Leonie Did he get what?
Dr. Madsen A reply?
Mr. Schroll Healy?
Dr. Madsen Dr. Healy
Leonie Did he get a reply? Oh, I, I’m not going to discuss Professor Healy here
Dr. Madsen But, but sorry to keep going
Leonie I was the one
Dr. Madsen It seems that you are better fit to answer the question than I am…
Leonie I am. If I was here to answer questions but I’m not.
Has anyone changed, has anything changed in Lundbeck since 1999 that might reassure patients or are the changes ones that are more likely to reassure investors? To reassure patients? Anything changed? Since then, no?
Dr. Madsen Well, I can say that since 1999, on the specific topic of em, improving care for depressive, we’ve been conducting this em, em, our own analysis on eh, on behaviour around suicide, we’ve invested several hundred million Danish Kroner into researching around depression emm, into developing better skills
Leonie But you still can’t admit that it’s caused somebody to kill yourself, that’s good alright.
Mr. Schroll What we also have done since ‘99 is that we have investigated all the information that we have eh, on Citalopram you can see here, a publication for 2006 about Citalopram and suicidality, so yes it is something we have looked into. Also since ’99….
Dr. Madsen ………………has become aware we have been em, again in agreement with the eh, medicines agencies in particular the FDA, requested to more thoroughly investigate em, em, sucidality which is of huge consequence, as I’m sure you know, em, in our clinical trials.
Leonie The warnings that you now have on Citalopram and Escitalopram are evidenced based, yeah? Based on evidence?
Dr. Madsen They are based on the eh, continuous recording and findings em, and investigations…. and so on continuously for both compounds and…. em, compounds also that are eh, so called generic compounds.
Mr. Schroll And then I think It’s important to say that eh, some of the information are based on adverse events on our products and other, eh, some other information is more referred to the class of information so I think that in the beginning you referred to the label in em, in Canada, that was a class warning so it’s not necessarily linked to data…..
Leonie It was em, Lundbeck wrote it.
Mr. Schroll We sent it out
Leonie It doesn’t matter, Lundbeck wrote it. Reports of self harm and harm to others written by Lundbeck. That’s a statement of fact, it’s not a question.
Mr. Schroll ….. the data, the data are based on a class warning, ………. if you seen something in some other products you would like to include some general warnings because we can see this kind of products might have this and it is not only linked to one product. So, so, so when you talk about evidence, say that I believe is a combination of both what has been seen in the clinical trials, in the safety pharmacovigilence for a specific product but also what is the general assessment per a class of product…, I think that is also what you need to, to have in mind. So one thing is what you state in a label about class effects and another thing is if you ask specifically about what is being reported about the specific product. So that might differ
Leonie And based on investigations, yeah? So when Patricia Casey and the Irish College of Psychiatry offer views to the contrary, are they at odds with the evidence or investigation?
Dr. Madsen What particular views are you referring to?
Leonie I’m talking about em, that there’s no risk whatsoever em, with anti-depressants, whether it’s Lundbecks or, and eh, suicide or violence, homicide if you want to call it.
Tony There is no causal link?
Dr. Madsen I think we
Leonie Or is that the spiel they get from Lundbeck
Mr. Schroll We don’t give anybody spiels
Leonie You’re giving me spiel now, you’re not answering the questions
Dr. Madsen But you were referring to causality
Tony Any causal link, yeah
Leonie When they say there is no evidence
Mr. Schroll Yeah, what we have seen and what’s also referred in this, in the latest eh, eh, eh, reports is that there is no causal link between the product and people committing suicide. Then there is a long discussion whether you can eh, you have suicidal thoughts whether that’s linked to the underlying disease. Eh, what we know is, for sure that in the beginning before the treatment occurs, there might still be suicidal thoughts and therefore of course you should be monitored, and that is also reflected in the leaflet.
Leonie So you don’t believe actually what you wrote in, in, what they wrote in, in, what Forest Labs wrote or what the Irish Medicines Board…
Mr. Schroll There was a class distinction..
Dr. Madsen …………… here between also between causuality and association and em, eh, you were asking to a specific is there, can we document a cause and effect eh, around aggressive impulses
Dr. Madsen And em, which, I, I’m not familiar with those particular statements I could take out of the context, I will need to study …… in more detail. So, no, a causual link has not been established, to the effect, to the effect that SSRI‘s can induce aggressive behaviour. It’s been eh, some eh, some evidence to the contrary has been produced also in humans…
Leonie And there has also been evidence that it can
Dr. Madsen There is also data, some
Leonie There’s also been studies, Professor Healy’s done one there, and he will, yeah
Dr. Madsen and
Leonie And Peter Breggin
Dr. Madsen And Peter Breggin
Leonie And Yolanda Lucre from Australia
Dr. Madsen So, Yes, and the scientific community is still debating that, what serotonin does to the eh,
Leonie What they have said already does cause it
Mr. Schroll I think what
Leonie Are those three not from the scientific community, no?
Dr. Madsen I very much regard them, if they have published scientifically, published scientifically so yes but there is
Dr. Madsen It’s not
Tony but you say that you’re debating?
Dr. Madsen But… to the causuality and as long as this is going on, the label is what it is and I just wanted to go back to, to yes it is correct that Lundbeck wrote this because it was sent out by Lundbeck. Lundbeck is in these cases mandated to do so by the authorities.
Dr. Madsen And
Leonie So you’re saying you lied in it – is that it?
Dr. Madsen Hah, So what are you saying? Lundbeck sent the letter. Self-harm and harm to others. A report.
Dr. Madsen Yeah and there must be a class label.
Leonie And actually while we get there, there was, em, it did say somewhere that there was em, suicides in the clinical trials as well.
Mr. Schroll Yeah, but there can be suicides in the clinical trials especially when you talk about a patient who suffered from depression. As you might know there is an increased risk of suicidal eh, suicidality, and that is actually one of main reasons why we debate our treatments like anti-depressants to make sure that we can treat them and make sure they don’t eh, eh, eh, become suicidal.
Tony So you don’t think that it would, it would be a tipping scale, an anti-depressant?
Mr. Schroll Sorry
Tony You don’t think it would be a tipping scale
Mr. Schroll Eh, we don’t think that
Tony At any level? Zero point one one percent no?
Mr. Schroll It is, it is still debated. What we have seen, the debate at the moment…
Leonie By you it’s being debated but not by those three that I’ve just mentioned
Mr. Schroll Sorry?
Leonie It’s being debated by you, by Lundbeck, it has not….
Mr. Schroll And many, and many others, by the authorities and what we can, what we can, can say is that the authorities come up with and what others come up with. Em, it seems like that if you are a lay person you might say that, that doing research on people taking anti-depressants, all medication is based on yes/no answer but I think Doctors are not people who just can take the temperature and then say ok now its 30® and now its 15®. They might have some hypnotises or they might have say ok maybe we have seen something, what is the likely reason. But at the moment the, most people sciences community, the authorities, don’t see that products like anti-depressants causes suicidality. They might say that in the beginning you need to monitor these patients because we know that they are eh, suicidal thoughts, eh, then after some time eh, eh, the treatment should actually bring that down. And that is, that is how, and then there are people like………..
Leonie The FDA, Forest Labs and the Irish Medicines Board are lying?
Mr. Schroll They are not lying but you are linking it to the treatment. Eh, what we also have state and state all the time is that if you are eh, eh, treated with an anti-depressant it’s usually because you are eh, eh, diagnosed with the depression.
Leonie That’s very good, yeah, I’ve heard that one before.
Mr. Schroll Eh, but but that’s the case. And, therefore,
Leonie Hmmm, It wasn’t the case with my son but anyway
Mr. Schroll So, so, so therefore, the risk of suicide is basically the beginning of the treatment is higher, then this debating, is it the product,……. most people, they don’t believe that it is the product but it is the
Tony So you don’t believe it’s the product?
Mr. Schroll Sorry?
Tony You don’t believe it’s the product?
Mr. Schroll We do not believe it’s the product. No. We believe that it is…
Leonie What other answer did you expect Don?
Mr. Schroll ….that it’s the underlying disease. What we know is that it takes time before, it takes time before the effect of the anti-depressant occurs. The citalopram, it can be….
Leonie I don’t know how you can even sit there and say that, there’s been so much evidence to link anti-depressants to suicide, so much evidence, it’s in all the patient information leaflets and you can
Tony You are talking to parents of a child that is dead. Ok. So I think you should at least give us
Leonie at least give us a bit of
Tony courtesy and respect and don’t try to snowball us or whitewash us.
Mr. Schroll No, no,
Tony And I really feel like you are insulting both us and Shane. Ok?
Tony And I think you should have some compassion
Dr. Madsen I have the utmost compassion and…
Tony But it doesn’t, it doesn’t feel like it, neither of you have offered your condolences, since we have come in here.
Dr. Madsen Well, then belated, I would like to offer my deepest, sorry.
Tony But I think, but with the greatest of respect to both of you, which I don’t think you deserve, ok, you’re just, you’re just rambling away there. You’re giving the same ole spiel. Leonie is asking you questions, I’m asking you questions and I’m listening to your replies and most of them are nonsensical. I have read them all on the internet.
Tony And that’s, that’s how I feel. Ok?
Mr. Schroll What I feel, sitting on the other end, is like that we are sitting in an inquest where you are pointing out that you don’t ask us eh, eh, listen to us before we finish the eh, eh, what we are saying before you ask a new question. We fully understand
Tony Most, most of the questions are, are…
Leonie You’re going off on a tangent there
Tony Would only require simple yes’s or no’s.
Mr. Schroll But, that’s not necessarily how we see it, and we fully respect and, and, and see that being in a situation that you are in is not something that is nice. I can tell you for myself. My father committed suicide when I was 12 years old.
Leonie Was he on Celexa?
Mr. Schroll He was not on Celexa, I would say, I would hope that there was this kind of, of medication at that point of time.
Leonie Oh, he wasn’t on any medication?
Mr. Schroll He was on medication at that point of time. Eh, eh, so, so but that
Tony Was that, did it have
Leone And I offer my condolences to you actually?
Tony …an effect on him? the medication that he was on?
Mr. Schroll Eh, not, not, not an effect, no. I had hoped that there was treatment at that point of time which could have helped him. So, so just…
Tony So basically the medication is still the same. It still has these outcomes. Yeah?
Mr. Schroll No, because it was not the medication that caused him, it was because he was suffering from depression…
Leonie How do you know? you were 12.
Mr. Schroll Sorry?
Leonie How do you know that? You were 12 you said.
Mr. Schroll Yeah, but I, I also have a mother and I also listened to the Doctors, what they say. It is my firm belief that he was committing suicide because he was suffering from a depression. I fully understand…
Leonie We obviously know that that can happen as well.
Mr. Schroll Yeah, I, I fully understand and respect you eh, so, so, so if saw us as something different what I’m just saying that we would ….saying that you just asked us a lot of questions instead of so, so sorry….
Leonie You knew we were here to ask questions.
Tony There are questions we have to ask. I thought that was the purpose of this meeting so that we could ask you these questions
Mr. Schroll Yeah, sure.
Leonie Ok, will I go on?
Mr. Schroll Yeah.
Leonie Eh, I don’t know whether you want to, you said that you were fully aware of the tragic circumstances… to Shane. How did Lundbeck hear about my son? Was it an adverse reaction report? Did you receive an adverse reaction report on Shane? An adverse event report?
Mr. Schroll We have reported your incident, yes.
Leonie Did you receive an adverse event report on Shane?
Mr. Schroll Eh, I don’t have the details of that but I just know that it has been reported…..
Leonie Ok, well any pharmacovigilance, actions, improvements made, based on that, that you can discuss?
Mr. Schroll Eeh, what we do is that you investigate each case and eh, on top of that…
Leonie So have you investigated Shane’s case?
Mr. Schroll We have, our people have investigated all cases and typical of what you also do is you look at a combination of all these different cases and that is what you base eh, the, the report on that you send in. That is included in the overall assessment of eh, Citalopram.
Leonie Since Lundbeck lists as pharmacovigilance as a key part of your policy, do they ask practitioners, the IMB, EMA, and MHRA, FDA, etc, to report possible adverse events directly to Lundbeck or Forest Labs or both? I think you have already answered that one.
Mr. Schroll Hmm? Yes we do.
Leonie How often are adverse events followed up and can you explain the procedure? They’re always followed up, are they? You just said.
Dr. Madsen Yes em, the procedure depends on the seriousness of the event. Em, the seriousness can be em, in the event by whoever reports it or it can be adjudicated by us, you, you see that, em, for the serious in the events we em, immediately take action and we have to within em, 5 working days to notify the various boards for other adverse events eh, timelines are different and some are, some ….important cases ……
Leonie So how do you decide what’s serious and what’s not serious?
Dr. Madsen There’s eh, rules for that.
Leonie What kind of rules?
Dr. Madsen Em, so, em…
Leonie The ones that are in the media maybe?
Dr. Madsen Pardon me?
Leonie Ones that are in the media? Are they followed up more quickly than ones that are not in the media?
Dr. Madsen I don’t believe so.
Leonie You don’t?
Dr. Madsen Eh, but we em, adverse events that are associated with our conversation, em,…. or emerging of disease, or em, examples of what we adjudicate as serious em, by ourselves, obviously the Doctor or whoever reports it can also assess by him or herself.
Leonie Can you explain a chemical imbalance?
Dr. Madsen Eh, I think that’s a fairly open question and you need to give it a bit more
Leonie Eh, Seratonin?
Mr. Schroll (Speaks in Danish……)
Dr. Madsen Eh, I, I assume that…
Leonie Is there any such thing as a chemical or serotonin imbalance?
Dr. Madsen you are alluding to em, what some people know or call depression an imbalance in the serotonin level
Leonie Can you explain that?
Dr. Madsen Em, I would prefer a different explanation, so I would abstain from…
Leonie A different explanation?
Dr. Madsen explaining a chemical imbalance….
Leonie So can you explain a chemical imbalance?
Dr. Madsen No.
I eh, it’s a, to try and ask that direct,…………..working mechanisms of antidepressants in a different way, but I need more than yes or no.
Leonie So that’s a no. Yeah.
Have you heard of Steven Dame. Stephen was a 19 year old boy from Tisbury, Massachusetts, that had dozens of family members that loved him very much. He choked himself on a tie in his room over some minor girlfriend issues after eight days on Celexa. His dad wanted you to know that. That’s all. And I have a letter from him there, that’s Steven’s dad, and that Catherine’s eh, mother from England, they just wanted me to hand that over so, you can read it at your leisure there.
Mr. Schroll Thanks
Leonie Do you think that it is acceptable to prescribe this Citalopram and Escitalopram for anything less than severe depression as most of the “free of industry” data point to a negligible, negligable positive effect over placebo but everybody who is prescribed the drug stands a good chance of suffering one or more of the side effects and, in some cases, such as Shane’s, may die or even cause the death of another?
Dr. Madsen Prescribing of drugs such as also anti-depressant is currently at the discretion of eh, a physician which I think is where it should be. Em, the, the…
Leonie So you think it is?
Dr. Madsen The ….. severity is based on em, what currently what we get from a clinical scale which may not be the best to also assess em, the situation of, of a patient. I think a complete clinical assessment of the case is requested by the physician. I…
Leonie Absolutely, but do you think it is acceptable to prescribe Citalopram and Escitalopram for anything less than severe depression?
Dr. Madsen I would leave that to the prescribing physician.
Leonie But you make the tablets so you, surely you would know
Tony And you are a Doctor. It’s your opinion
Mr. Schroll It is approved for major depressive disorder and eh,
Leonie For which?
Mr. Schroll Major depressive disorder
Mr. Schroll Major depressive disorder
Leonie It’s only approved for major depressive disorder?
Mr. Schroll It is approved for major depressive disorder and within that indication, with our data yes it is safe and efficatious to use it.
Leonie To use for major depression?
Mr. Schroll Yes. Then it’s more a question whether there is eh, eh, eh, eh, the same effect on people with lower levels of depression and they should have other kind of, of, of treatment.
Leonie Do you think it is acceptable? Do you think it’s acceptable?
Dr. Madsen I think it is acceptable to prescribe Lundbeck’s products within the label that they have, Yes.
Leonie Which is only for major depression?
Dr. Madsen It is given for major depressive disorders for em, other anxiety disorders as well and I think within that label I think its em,…
Leonie So…what about a mild depression? Do you think it is acceptable?
Tony From Lundbeck’s point of view, your point of view? You manufactured the drug and you are a Doctor.
Dr. Madsen I’m going to repeat myself, so from my point of view, it’s acceptable to prescribe Lundbeck’s products within the label that they have.
Leonie For mild depression? No, because it’s only major depression. Is that right?
Dr. Madsen I’m going to repeat myself otherwise I, this, statements like this can get me into legal trouble.
Leonie Ok, well I just want to ask you, do you think it’s acceptable for Escitalopram and Citalopram to be prescribed for mild depression? Do you think that’s acceptable? Yes or no?
Mr. Schroll Yeah, I think that’s up to the Doctor to decide. That is, that is how
Leonie I was talking to the Doctor. You are a Doctor aren’t you?
Dr. Madsen But answering on behalf of Lundbeck to prescribe it, we recommend it, to prescribe,…..
Leonie For mild depression? For mild depression – it is acceptable?
Dr. Madsen We Recommend it to prescribe for the label that we have…
Tony You’re, you’re just not going to…
Leonie You’re not going to answer that one – No?
Tony You’re just giving the company line here, ye know.
Dr. Madsen But I am representing the company……
Tony Absolutely, yeah
Leonie Yeah, but do you think it’s…
Dr. Madsen ….. you need to respect that.
Tony I do but you’ve got to have a conscience as well.
Dr. Madsen And I absolutely do.
Mr. Schroll Our conscious is that we know that this is prescription medication only. You have to see a Doctor and we feel trust that we have a system where the Doctor is able to make this evaluation eh, so, so, so definite yes.
Leonie So you’re not going to answer…..
Dr. Madsen From the Lundbeck point of view
Mr. Schroll That was an answer
Leonie You think it is, it is ok to prescribe for mild depression?
Mr. Schroll What we are saying, what, what we have said is, is that what we can say is that it’s, it’s, it’s, when it’s approved, then it’s up to the Doctor, the Doctor has the free right to choose which medication to prescribe. That is not up to us to say whether
Leonie That wasn’t the question.
Mr. Schroll That is up to, to the Doctor
Dr. Madsen It is in Lundbeck’s interest only to have our, whichever drug we use, to prescribe for people where there is a beneficial effect and we strive to do that every day, we, we, through the information we give to any prescribing physician, through the research that we do, through any channels where we are able to do so we want to understand how our compound is best administered. We are here to help people who suffer from, from instances such as depression.
Leonie Mild depression?
Dr. Madsen Such as depression.
Leonie Mild depression? You’re not going to answer that one are you? That wasn’t an answer and it wasn’t an answer from you either….. it was a different question that I asked.
Mr. Schroll But, but, but you cannot get another answer from people like us. What we do is we produce eh, eh,
Mr. Schroll Anti-depressants
Leonie For major depressive disorders
Mr. Schroll We test it, we get approval of it and what we do is we recommend the approved use. Then the respect, that this is a product which is prescribed by eh, Doctors and they have the free right to prescribe to the purpose that they find of revelance, of course based on what the authorities ect; ect;
Leonie But pharmacovigilance, does that not mean stopping eh, people from harming themselves or stopping Doctors even from harming patients? Is that not listed as pharmacovilgiance? No?
Mr. Schroll Yes, so if we had reports stating that there was a problem giving treatments for instance for mild depression, then it would be listed in the, in the label. So, so then it would be a caution, or it would be stated what to ……..But, but that’s another thing, you say is it acceptable to do it. What we do is, we make sure that there is Data for the approved use, that doesn’t mean that we only get data back from the doctor, within the approved use.
Leonie Well, it’s not approved for mild depression
Tony From Lundbeck’s point of view, is it acceptable to prescribe Citalopram for mild depression?
Mr. Schroll We find it acceptable that Doctors have the right to choose and therefore, we feel comfortable with that.
Leonie So, it’s a yes from you then? But it’s a no from you?
Dr. Madsen Any decision to medicate is between the Doctor and a patient based on his studious clinical investigation of that…
Tony Yeah, you manufacture a pill for depression, yeah?
Dr. Madsen Correct.
Tony Ok. Is it acceptable to use it, for anything other than severe depression?
Dr. Madsen A severe depression, it’s perfectly acceptable to use Lundbeck’s compounds within their registered labels.
Leonie He not going to answer
Leonie Right, will I go on because there’s no point, we’re stuck at that one? Anyway. Do you think that it’s advisable to virtually bathe foetuses in Serotonin given it is now accepted this family of drugs are firmly associated with birth defects?
Dr. Madsen Virtually bathe?
Leonie Foetuses in Serotonin – pregnancy.
Tony Pregnant women.
Dr. Madsen I don’t know what you mean by virtually bathe
Leonie I’m talking about anti-depressants are known to cause birth defects. If you think so, would it not be better if women of child-bearing age were cautioned against, perhaps even contra-indicated from using this drug? Citalopram or Escitalopram?
Dr. Madsen Em, I think in…..
Leonie Your views?
Dr. Madsen In pregnancy?
Dr. Madsen Em, I think em, physicians need to double their efforts to make sure that there is a correct risk versus eh, benefit eh, assessment of the em, of any action.
Leonie Is Citalopram and Escitalopram a teratogen?
Dr. Madsen Em, meaning, what, what, what do you mean?
Leonie Can it cause harm to foetuses? Unborn babies.
Dr. Madsen Em, obviously, in order to have our compounds approved we have done em, a large number of pre-clinical trials em, and we are constantly monitoring and the eh, while the recommendation I believe throughout, is to be, be extra cautious when administering any eh, medications to pregnant women…
Leonie Can it cause harm?….. to unborn babies?
Dr. Madsen Anything can cause harm, can cause harm in any dose
Leonie So yes it can.
Dr. Madsen depending on dose
Em, why if it can cause harm, is this not clearly, clearly stated on the packaging and information leaflet?
Mr. Schroll Do you talk about the patient leaflet or do you talk about the SPC, the label that the Doctors use in order to prescribe the medication?
Leonie I’m talking about a pregnant woman that goes down and gets it in the chemist. Is it on the patient information leaflet?
Mr. Schroll In the patient leaflet it says you have to talk to your Doctor….
Leonie And what does it say in the Doctor’s leaflet?
Mr. Schroll That he has to be extra cautious. I think that if you go to the… to, to the Irish home page, I believe it is like that, it’s like that in Denmark and elsewhere. If you go to the medicines agency authorities
Mr. Schroll the medicines agency authorities you can see what is in the checks that the Doctors and that is up to them to decide…..
Leonie So you are passing the buck back to the Doctor again.
Mr. Schroll I think when it’s prescription medication, yes. If it was eh, eh,
Leonie And will they be told that it can harm their unborn baby?
Mr. Schroll Sorry?
Leonie Will the pregnant woman be told that the drug can, can harm her unborn baby?
Mr. Schroll It would be part of the discussion to talk about the risks and the benefits and that would be up to the Doctor.
Leonie It would be up to the Doctor to tell them that the drug can harm their unborn baby?
Mr. Schroll Eh, now, you’re talking…..
Leonie It’s not up to Lundbeck, no? It’s up to the Doctor to tell the woman that the drug can harm their unborn baby?
Mr. Schroll To be cautious, yes, yes.
Why are you testing this drug which is well-known to be detrimental to children on children as young as 7 years of age in a drug trial? Citalopram and Escitalopram?
Dr. Madsen Em, we have done a number of trials and will do a number of trials. Eh, by one I can speak to the situation now, em, we’re mandated to investigate em, pharmaceutical effects in children also in order to advance the understanding of em, this treatment mortality, also on children.
Leonie So you actually intend to keep doing trials on 7 year olds, yeah?
Mr. Schroll We are not able to get approval of new drugs if we don’t test it in…
Leonie So you have to test them on children? Oh, of course you are looking for U.18’s as well, aren’t you, to make more money Yeah?
Dr. Madsen I think that is …..a certain out of this but per, per, eh, the Medicines Board, we would be mandated to do eh, trials, clinical studies in children.
Leonie So you’re still going to do them then, yeah?
Dr. Madsen If we want to have eh, drugs approved in Europe, then we will probably have to, yes.
Leonie You have to? That’s if you want them, want them approved for U.18’s you mean?
Dr. Madsen No. Also if you want adult drugs approved.
Leonie If you want to have a tablet or medication approved in an adult population, you have to, eh you have to trial them on 7 year olds?
Dr. Madsen Correct
Leonie That’s .….
Tony Would you let your 7 year old go forward?
Dr. Madsen Pardon me?
Tony Would you let your 7 year old go forward ? For a clinical trial?
Leonie I actually don’t believe that. I would be very surprised if that was true.
Tony Would you though?
Dr. Madsen That would depend.
Tony Depend on what?
Leonie Would you let them take Escitalopram and Citalopram in one?
Tony If Lundbeck is doing a clinical trial, would you let your 7 year old son or daughter go for a trial?
Dr. Madsen I, I, my children are currently well so I think the question that I’m not going to answer to…..
Tony I know the answer to that. Let’s be honest about it. I wouldn’t, given the information that I know and I know you wouldn’t and you wouldn’t. I just don’t know why you won’t admit it.
Mr. Schroll Participate in a clinical trial?
Mr. Schroll I don’t think that’s, that’s, that’s a correct answer to say that we wouldn’t, let our children under…… to participate in a clinical trial.
Dr. Madsen I’m not sure
Tony You’re not sure?
Dr. Madsen No
But, but, I eh, your point, I think this is an irrelevant discussion to have, that we were, that the current situation for certain compounds
Tony Is it safe?
Dr. Madsen Emm, under the right circumstances
Tony No but you’re doing the trials, so you don’t know the outcome, it’s obviously an experiment.
Mr. Schroll It’s controlled
Tony Even controlled, it’s an experiment. There has to be a 1% of doubt. Am I right?
Mr. Schroll But there are clear guidelines for how to…..
Tony Absolutely, yeah, I’m not doubting that but what I’m saying is, there has to be at least 1% of doubt and I’m sure there’s more, because you don’t know where you are going, whether your mind’s healthy or unhealthy.
Leonie Would you give your 7 year old, Citalopram and Escitalopram? Lexapro and Cipramil? Would you give your 7 year old Cipramil and Lexapro?
Dr. Madsen No, I think , I honestly think there is a moot question, em, fortunately right now eh, my children are well.
Leonie Are well, are they? I’m glad, I really am glad for you.
Dr. Madsen So am I.
Leonie So you won’t answer that question? Say that your child was unwell would you give him Citalopram, a 7 year old?
Dr. Madsen I’m not going to answer, from my personal life.
Leonie Hmmm, what about you?
Mr. Schroll For my personal life?
Leonie If you had a 7 year old?
Mr. Schroll Yeah, I’m a lay person, I would go and seek help from a Doctor, a psychiatrist and eh, listen to, to their views, eh, I eh,
Tony We did. But they didn’t highlight any, any of the side-effects.
Leonie No because you, Lundbeck had told them, that eh, it doesn’t cause suicide
Dr. Madsen …….I’m sorry but we can’t, I can’t speak to that particular case.
Leonie Well, I’m talking, say if, Say if my daughter tomorrow….
Mr. Schroll If I was in the same shoes as you…
Leonie Lundbeck are telling Doctors that it doesn’t cause suicide and that it doesn’t cause homicide
Mr. Schroll I would seek help, ask, make sure that…
Leonie So the Doctors are free to prescribe it, yeah?
Mr. Schroll …that would be the way that I was doing it.
Leonie Ok. Are there any suicides, suicidal thoughts, homicides, homicidal thoughts reported in the initial Citalopram and Escitalopram clinical trials? Can you tell me that?
Dr Madsen Em, So here is the eh, conclusion from the Citalopram. There were fewer patients in the Citalopram group than in the placebo group who reported a worsening of suicidal thoughts during treatment.
Leonie So there was?
Dr. Madsen Let me see, I’m trying to get the, the numbers.
Leonie I don’t need the numbers, I just want to know was there any in the clinical trials.
Dr. Madsen Em, here is the safety, the clinical safety data for depression of the …..of table two, the number of events was low. There was one fatal suicide during treatment for a patient treated with Citalopram, a 60 year old woman em, and none in placebo, during the follow-up period em, in which no medication was administered, there was one fatal suicide in the placebo group.
Leonie And, what about homicide and homicidal thoughts? Is that put in as aggression or anger or are they all lumped in together there?
Dr. Madsen There was no reports on that.
Leonie You don’t have reports or….
Dr. Madsen I don’t have reports from homicide, I would em, need to check up on where homicidal thoughts are eh, reported…
Leonie Em, ok, so when can you give me them?
Dr. Madsen You can eh, send me an email to anders (Schroll) and I’ll make sure that we
Leonie Ok, I will do, yeah.
Mr. Schroll And the next thing is, it is important to say also in clinical trials but also when we came in, what is reported is adverse events, then that is not nesessarily seen as a causual link between the product. That’s why you actually use and compare between placebo and eh, the product.
Leonie Yeah, I do understand that, but as I already said in, in the first statement, Lundbeck have admitted it twice, once in Australia and once in the UK but you are denying it, now.
Mr. Schroll But I’m not sure that we have
Leonie And you are the Doctor, he’s the PR guy.
Dr. Madsen I need to do the context. I don’t know those statements, I’d really appreciate to see the context.
Leonie Oh no problem, I’ll email them to you. Were the two other Doctors are wrong, are they? ]
Tony Have you no answer then?
Leonie Were the two other Doctors wrong? The two Doctors?
Tony That represent Lundbeck
Leonie And Professor Healy and Yolanda Lucre and Peter Breggin and whoever else. They’re all wrong, in your eyes?
Tony Even speaking for Lundbeck?
Dr. Madsen I think, em
Leonie Or is there a possibility, could you give us that even?
Dr. Madsen Could I, sorry?
Leonie Is it possible that your drugs Lexapro and Cipramil can cause suicide? Is that a possibility or are you just telling me…
Dr. Madsen We have thoroughly investigated that possibility and found no evidence to that.
Leonie So it’s not a possibility?
Tony Two people have…
Leonie Even though those two Doctors have admitted it?
Tony Two doctors from your company.
Mr. Schroll EH, eh, eh, well…
Tony O.K, Well that’s what I’m saying to you, if Leonie emails that to you, ok? You can look at it. They work for you, your company, they represent you, they’re saying that there is a link.
Mr. Schroll But, but let’s see what they say and come back to, to, to you
Leonie Well, you should really know that already.
Tony Will you, will you answer Leonie if she sends them to you? And you see these
Mr. Schroll Like the, like you come here……
Leonie Because they must be sacked if they got it wrong at an inquest, surely.
Mr. Schroll ……we will look into it and we will send it back. Eh, If it’s something specific, we might not be able to …..specifically….
Leonie You don’t know if they still work here, do you? Or work for Lundbeck?
Mr. Schroll But we will look into it
Leonie Dr. Christopher Muldoon and Dr. Deborah Pelser
Tony I’m just asking you a simple question, will you come back to Leonie with
Mr. Schroll We will come back to you
Tony With your response regarding these two statements?
Mr. Schroll We will come back to you with a response, whether we are able to give you specific answers to these questions or we are able to give you general answers to our product
Tony But if these two representatives of your company, both Doctors, have made public statements, surely you can answer us publically? You know, back to Leonie.
Dr. Madsen But, but, I will come to the question that was asked was whether or not somebody lied or somebody was wrong and I think that would be unfair to have us promise the nature of an answer…
Leonie Ok, well I’ll email it to you and then will you answer it?
Tony If they stated it this publically
Dr. Madsen Will we reply?
Dr, Madsen Yes.
Leonie Do you have a tapering guide for Citalopram and Escitalopram? If yes, is this guidance issued to Doctors? Do you have a tapering guide?
Dr. Madsen There is a, em, again in the em, em, in the labelling em, to the Doctors information not to abruptly terminate the treatment.
Leonie Well, they all have that but that’s not a, them…..
Dr. Madsen Which to a means that you need to instruct the patients with
Leonie For how long, a month, a year, 2 years, 10 years? Do you have any idea how long it takes to taper off Citalopram and Escitalopram?
Dr. Madsen Em, I would do it over the period of em, weeks.
Dr. Madsen But em,
Leonie Any, Do you have any idea how many weeks?
Dr. Madsen I’m not going to give a specific…
Leonie So not months or years, you don’t think in your opinion?
Dr. Madsen No
Dr. Madsen Correct
Leonie Ok, what else, can you tell me what are the benefits of taking Citalopram and Escitalopram?
Dr. Madsen To patients who suffer from depression there is a clear documented effect that it alleviates eh, symptoms and it eh, improves
Leonie Improves what?
Dr. Madsen The depression, it makes people feel better
Leonie And it also causes them to kill themselves.
And you are a Doctor, and I’m very surprised if you are a father that you can sit there and say that your drugs can not cause someone to commit suicide because it is a well-known fact with all SSRI’s and you have it, the FDA have it, the Irish Medicines Board have it, two of Lundbeck’s Doctors have admitted it and you’re sitting there telling me that there is no causal link. How can you do that? You have kids. My son was 22. He was perfect. He split up with his girlfriend. He was on Citalopram for 17 days. 5 days when he took an overdose.
Tony He wasn’t depressed, he had a broken heart, it’s an emotion!
Leonie How can you sit there and look me straight in the face and say that
Dr. Madsen I am deeply sorry for what happened to your son.
Leonie I’m sure. Not deeply enough to admit it, for to stop other people. Lundbeck lists pharmacovigilance as one of their main areas and yet you will not warn other people. Do you have any comeback to that, at all?
Mr. Schroll We believe that our
Leonie You are the PR guy, sorry, I’m sorry, I’m not being rude but this is the Doctor. Can you answer me?
Dr. Madsen It was your statement of opinion. I’ve, I’ve, I think I have said a couple of times that we have investigated thoroughly and we will keep investigating,…causuality
Leonie Well, I’m telling you and Shane should be enough, If was given to 150 million worldwide, I’m telling you it caused Shane to die and it killed somebody else. Surely that in itself is evidence, whether it, whether he is one in two billion, it’s evidence and you’re doing nothing about it. You’re going to let it happen again and again and again.
Mr. Schroll ………………we’re not able to comment on a specific case. What we can look at is the outcome of the coroner’s inquest.
Tony Look, yeah but look
Leonie Well, the coroner gave an open verdict actually
Tony All we’re looking to do is to improve standards
Leonie He rejected a suicide verdict which means that Shane didn’t commit suicide
Tony And all you had to do was answer some questions honestly
Leonie So there you go!
Mr. Schroll Yes
Tony …Just change
Leonie And what did you do about it?
Tony And you’re not prepared to do it.
Mr. Schroll I, I can…..
Leonie What did you do about that? The Assistant State Pathologist said this can happen with SSRI. Professor David Healy said it can happen with SSRI.
Tony Professor David Healy actually did a report
Leonie The only one that didn’t was Patricia Casey who’s actually paid by you.
Tony And Lundbeck actually came out and contradicted him.
Leonie So why do, why do you pay Irish Psychiatrists to go around inquests to deny it? It’s an absolute disgrace.
Dr. Madsen We cannot comment on specific cases
Leonie It’s an absolute disgrace
Dr. Madsen We cannot comment on a specific case, you know what our stand point is and we are
Leonie I’m talking about inquests. I’m not even talking about Shane so it doesn’t matter. Shane is dead it doesn’t matter. It doesn’t matter whether it caused Shane or not whether I’m wrong. I could be 100% wrong. I doubt it. But what about other people?
Dr. Madsen Let me just, eh, from the point of view of intending to help people, yes Lundbeck does believe that there is eh, possibilities to help people suffering from mental CNS disorders such as depression. We spent
Leonie And broken hearts? Is that depression too? Yeah?
Dr. Madsen We spend em, an enormous amount of money, at least, the way I see it, eh, researching these em, diseases. We spend, we spend our efforts trying to do what is our eh,….. for being here which is helping developing pharmaceuticals that can help. There is other people who may also try to better improve pre-treatments through other channels which I think are very fine. We are as interested as you were from your last sentence in, in understanding and improving the treatment of these people. We do that, I go to work every day to do exactly that. I
Leonie But you didn’t improve Shanes and a lot of other peoples!
Dr. Madsen I honestly believe that we have thoroughly investigated the cases of suicide, suicidality which are em, devastating and very serious em, incidents in our and we have not been able to, in our database, to establish a causal link.
Leonie You have not been able to establish that. But would you reckon it is a possibility, no?
Dr. Madsen I have spoken and answered to that as well.
Leonie You said no.
Dr. Madsen You, we have not been able to find a link between the intake of these…..there is the warning
Leonie But the warning, you only put that there for the fun of it because em, you don’t actually believe it so.
Dr. Madsen We don’t do stuff like this for the fun of it. I’m sorry, we are…
Leonie Yes, ok well you didn’t do it for the fun of it then. Is it true then?
Dr. Madsen We take this very seriously and do a thorough analysis. We have people working around the clock to adjudicate, to assess, all the adverse event reports that come in, so we exactly understand and help educate, understand ourselves and educate….
Leonie You all know that SSRI’s can cause suicide. You can sit there and lie straight to my face if you like but you all know it. And actually I’ve been told that by one of your Lundbeck reps, John Virapen who worked for you in the Caribbean, he said that you’re just as bad as Eli-Lilly, just as bad! And all the sales reps, all the sales reps know. And he is talking about Lundbeck’s sales reps, by the way. They all know it can cause suicide and, and harm to others, killing other people. What have you got to say to that?
Tony So if the sales reps know, why don’t you know?
Mr. Schroll I don’t think that the sales reps know… They know what we know.
Dr. Madsen I don’t know where, what he refers to again….
Leonie John Virapen
DR.Madsen Yeah. Well I don’t know, in our data, what data he refers to. All the data that is around us has been eh, submitted to the agencies. We are audited
Leonie Yeah, that’s, that’s why it has suicidality on the patient information leaflet because they had your data.
Dr. Madsen Which is completely as it should be. We are in dialogue with the…
Leonie Yeah, and you can sit here and deny it.
Dr. Madsen We are, there is
Leonie You are insulting our intelligence now, just sitting there, just lying to our face.
Dr. Madsen I’m sorry you think that …..
Mr. Schroll Well I think we have said what we were able to say. Eh, we didn’t expect that eh, that you would say that, that ok now we, you have said everything and we are glad, for that, eh, eh, but at least we hope that you could see that we were open to listen to questions and also if you have further questions…
Leonie You weren’t really open to answering them now, were you?
Mr. Schroll We have answered them but maybe not in the way you would like to…
Tony You’ve answered them with a textbook
Mr. Schroll Yeah.
Tony That suits you, but as Leonie has said that if you come back down to that patient information leaflet, you know, that’s what you guys are saying and you guys are contradicting it.
Mr. Schroll Sorry?
Tony You’re contradicting what’s in your leaflet.
Mr. Schroll We will not contradict what’s in the leaflet.
Tony So, there is, there is a link then, is there?
Mr. Schroll Well, what we say is…
Tony with SSRI’s and, and
Mr. Schroll Now we talk about SSR’s in general and see what the problem that there can be a difference between what is …. SSRI’s and described as a concern here and what we have seen as a causal link in our data….. And that is what makes the difference. What we have say to you, is also what’s been public is, the results of the studies that are made, both by us but also by others and that is the data we have, that is the data the authorities have, that is the information that the Doctors have.
Leonie Except that’s why it’s in the information leaflet. Anti-depressants can make you kill yourself in a small minority of people. That’s why it says it in there, because they have your data. Is that not right?
Mr. Schroll Not necessary our data but data in general and that is what, what is the difference. But what is
Leonie So are you saying what’s in the patient information leaflet in Ireland saying that you can, em, antidep…..you are more likely to kill yourself on an anti-depressant is wrong? In the case of Lundbeck, that’s wrong, is it?
Mr. Schroll In the case of eh, eh, of Citalopram, in the case of Citalopram, we, we, we,
Leonie All the other SSRI’s you can kill yourself but in Lundbeck’s you can’t?
Mr. Schroll ….There is no causal link. There is no specific suicides, where there is a causual link
Leonie There was suicides in the clinical trials, I don’t know how you can possibly sit there and say that it’s nothing to do with it.
Mr. Schroll Yes because it a difference between, there’s an event reported or if there is a causal link and as you also saw…..
Leonie Can I just go? There is no point…
Tony Yes, but what’s the difference between the report and the causal link, you know? It’s the outcome. Somebody’s on a clinical trial which you say is perfectly safe and I’m saying to you that there could be 1% of doubt but that’s a different argument and somebody commits suicide
Mr. Schroll Yeah, If….
Tony What chance has the ordinary person out on the street got….?
Leonie On the clinical trials were they on depressed people or were they on people that em, that didn’t suffer with depression?
Mr. Schroll The patient was diagnosed with a depression, yes
Leonie So the suicide, em, the person that committed suicide was suffering from depression?
Mr. Schroll Yes, who was in the trial?
Mr. Schroll Yes.
Leonie They were on eh, because it is usually on the people that….
Dr. Madsen It was a eh, eh, required to enter into the trial
Leonie That you have to be suffering from depression?
Dr. Madsen Yes
Leonie So then if you commit suicide you can blame it on the depression instead of the drug, is that it?
Dr. Madsen That way…eh, as we are investigating the effects of the drug in the person we need to do it….. so that’s a moot point.
Leonie Ok, well I’d like to say it was nice to meet you but …..
Dr. Madsen Oh, nice to meet you.
Leonie Thanks for the opportunity anyway. I thought I might get the truth.