Audio of Lundbeck meeting.

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…

Leonie                    OK

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.

Tony                           Right.

Dr.Madsen               So that’s why…..

Tony                           Right.

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

Leonie                       Yeah

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

Tony                           Right

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….

Tony                           Right

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?

Tony                         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,

Tony                        ……..

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

Leonie                       Escitalopram

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……..

Leonie                       OK

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?

Mr.Anders                 What?

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?

Leonie                       Yes

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?

Leonie                       Yeah

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?

Leonie                      No

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?

Leonie                       Sorry?

Dr. Madsen               Did he get one?

Leonie                       Did he get what?

Dr. Madsen               A reply?

Leonie                       Who?

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

Tony                           Hmmm

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

Leonie                       Exactly

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.

Leonie                       And?

Dr. Madsen               And

Leonie                       So you’re saying you lied in it – is that it?

Lundbeck                  No

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?

Leonie                       Again

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.

Leonie                       emmm…

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

Leonie                       Media?

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,

Leonie                       Anti-depressants

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?

Leonie                       Yeah

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

Leonie                       Yep

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

Leonie                       So,

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.

Leonie                       Ok.

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?

Tony                           Yeah.

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?

Tony                           Yes?

Dr, Madsen               Yes.

Tony                         O.K

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.

Leonie                       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

Leonie                      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.

Leonie                       Exactly.

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?

Leonie                       Yes

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                       Ready?

Tony                          Hmm

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.

7 thoughts on “Audio of Lundbeck meeting.

  1. Both Madsen and Shroll say that people committed suicide because they were depressed and not because they were taking medication. But that is a fallacious argument because they can’t prove that the medication didn’t cause them to go past the tipping point. It would only be a valid argument if the person was depressed and committed suicide but was not taking medication.

    Dr. Madsen said “there was one fatal suicide in the placebo group” in the clinical trial. The problem with that is you don’t know if that person had been previously taking an antidepressant and was suffering withdrawal when they were placed in the placebo group. People can become suicidal days after quitting an antidepressant because of the addictive property of the drug.

    Good work on calling them out for always passing the buck to the prescribing doctor! Good on both of you for confronting those two clowns like that!

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  2. Dr Madsen comes across as a heartless and soulless robot. He failed to answer any of the most difficult and important questions. He just repeats his drug company lines. If he is a director then all he cares about is protecting his companies reputation, and he didn’t even do a good job at that! If anything, he has damaged Lundbeck’s reputation even more, with his absolute disregard of patients lives and health.

    It is really quite frightening how deluded these denials of harm are. The fact that Dr Madsen (and those of his ilk) can detract and avoid the evidence that these drugs can and do cause immense harm is disturbing. And, it is people like Dr Madsen who have blood on their hands…. To Dr Madsen , if you are reading this, how the hell can you live with yourself?… Is your wage from Lundbeck worth all the human lives that your employers destroy? … Ask yourself that!

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  3. Just listening to this again after 4 years, it’s like listening to some Nazi doctor discussing an experimental drug – the Danish psych is so cold, devoid of compassion and clinical when discussing vulnerable people’s lives. I don’t know how he sleeps at night. The usual tripe is uttered, blame the depressive, blame the ‘disease’. SSRI survivors like me must be a pain for companies like Lundbeck, because the SSRI didn’t kill me, it almost did, but it didn’t and I lived to tell the tale and I’ve campaigned for 8 years. These drugs cause homicidal and suicidal thoughts and behaviors, they cause hostility and change your personality, they numb you and turn you into a zombie I experienced this, so did many other SSRI survivors, so you can’t blame the ‘disease’ in cases like ours, it’s not that easy because we are still alive. You can’t dismiss the survivors stories. Shame on Lunbeck and these employees in this recording. Well done Leonie.

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