GlaxoSmithKline Statement - BBC Panorama
January 29, 2007
LONDON, Jan. 29, 2007 - This statement has been issued in anticipation of the BBC Panorama programme, ‘Secrets of The Drugs Trials’ which is to be aired on Monday 29th January.
GlaxoSmithKline (GSK) has provided a written response to the allegations it understands are to be made in the above programme. GSK has not seen the programme but strongly denies suggestions that it has acted in any way improperly. The company has no confidence that its responses will be accurately, or appropriately, represented in the programme, or in the BBC’s publicity materials. GSK therefore wishes to make the following points that include a summary of the information provided to the programme:
We are extremely concerned that Panorama, will again, through misleading and deliberately provocative commentary, alarm patients about using their anti-depressant medication, with potentially serious consequences.
In other words we are using the patient here to defend our corner. On each of the 4 (count them) Panorama programmes aired about Seroxat, there has always been a warning not to suddenly stop taking your medication. What Glaxo are saying here is possibly more frightening thus trying to show the patient that they really are a caring company.
Patients concerned by issues raised in the programme should seek advice from their doctor.
The very same doctor that your reps have convinced Seroxat works?
Depression is a severe and disabling condition. A well-recognised, tragic outcome of the disease, particularly among young people, is suicide. Careful monitoring of all patients is essential, regardless of whether they are taking medication or not.
I put it to you that taking Seroxat is a severe and disabling condition. A well recognised outcome of the drug, amongst all age groups is suicidal thoughts and/or aggression. Another thing, I've heard and read the careful monitoring line numerous times. How can a family practitioner 'carefully monitor' a patient when that patient leaves his/her surgery to go home? More to the point - goes home with a packet of pills known to give rise to suicidal thoughts?
In developing Seroxat, GSK has always been strongly conscious of the duty it owes to the millions of patients, including those under the age of 18, who suffer from depression and we refute any allegation that we have failed in this duty. GSK conducted nine studies, over eight years, to examine the use of Seroxat in treating patients under the age of 18 with depression and other psychiatric disorders, as treatment options for these vulnerable patients are extremely limited.
Top line is a gem isn't it? The rest of this paragraph gets down to the nitty gritty but we shall move on to the next paragraph because this is where it gets confusing.
GSK utterly rejects any suggestion that it has improperly withheld drug trial information. Results from its paediatrics studies were documented and submitted to regulators in accordance with regulatory requirements. Results were also presented publicly, published in scientific journals and are available on GSK’s website.
We know different now though huh? This statement was made in 2007 - just over a year later court documents were unsealed that clearly show this part of your statement to be incorrect. I love the terminology used in this paragraph: "submitted to regulators in accordance with regulatory requirements." The regulatory requirements being that you only have to submit a summary of the trial results... not only that but you can choose which parts of the summary you wish the regulators to see (ie; the positive results).
You also state that results were presented publicly and published in scientific journals and are also available on your website. Again, only the results that you wish the public to see, the same 'results' that you sent to the regulators, the same results that you sent to your opinion leaders. All favourable results and we know that not all the results were favourable don't we?
No suicides were reported in any of the nine paediatric trials conducted by GSK.
But there was a high volume of suicide attempts was there not? Funny how you skate over this issue. Or have you covered yourself by stating earlier: "Depression is a severe and disabling condition. A well-recognised, tragic outcome of the disease, particularly among young people, is suicide." It's clever spin I'll give you that...so clever it is actually hard to argue against. I guess that's why so many people have hired the services of lawyers.
When reviewed individually, none of these trials were considered by GSK or independent investigators to show a clinically meaningful increase in the rate of suicidal thinking or attempted suicide.
Independent? I'd hardly call the opinion leaders you hired 'Independent'. They are afterall (or have been) on the GlaxoSmithKline payroll list are/have they not? Was Breggin not an 'independent investigaor? What about Glenmullen? Was he not also an 'independent' investigator? Or do you only consider favourable results?
Only when all the data became available, at the end of the research programme, and were analysed together was an increased rate of suicidal thinking or attempted suicide revealed in those paediatric patients taking Seroxat .
Oh what a remarkable coincidence! Now you tell us about the suicide attempts and thoughts. Did you not know back then (1989) that there was an increased rate? All you had to do was read the data. The graph here (taken from your own internal memo) will show you the suicidal thought rates in not on children but adults too)
GSK brought this analysis to the attention of the regulatory authorities, including in the UK.
Why wasn't the results of this analysis given to the regulatory authorities first time around? Once again, the clever spin you use can be used as a defence here: "Results from its paediatrics studies were documented and submitted to regulators in accordance with regulatory requirements." In other words you didn't have to give the regulatory authorities the negative results did you? This loophole more or less guaranteed you a license for Seroxat. The fact that you didn't have to submit the negative results is neither here or there. It's really a question of ethics. You, as a multi-million pound company, had a drug that could rival Eli Lilly's Prozac, a drug that around the time Seroxat was about to be launched, was lambasted in the media for causing suicide and suicidal ideation. This was music to the ears for GlaxoSmithKline was it not? You had decided to manufacture a drug that could compete with your biggest threat, that being Eli Lilly. You decide (despite evidence that Seroxat also could cause suicide and suicidal ideation) to send favourable results to the regulator and to opinion leaders. So what do you do? You send them all the favourable results in summary form. You leave out the results of suicide and suicidal ideation... well you 'ham' it up with your bad numbers so it looks favourable. The demise of Lilly's Prozac opened the door for Seroxat and Lilly's downfall could now be used in your marketing strategy but only if you could prove that Seroxat didn't have the side effects that Lilly's Prozac did. So, you hold back the negative results don't you? Why publish them now there seemed to be a lucrative gap in the market?
GSK does not promote its medicines for indications for which they are not approved.The company strongly refutes any suggestion that Seroxat was promoted to UK doctors for use outside the terms of the UK marketing authorisation, whether through clinical experts (“Key Opinion Leaders”) or any other route.
The key opinion leaders line is wearing thin. Why did you not hire the services of a leading SSRi expert? David Healy for example? Was it because an actual expert like Healy would want to see the raw data unlike Dr Martin Keller who for all intents and purposes just put his name to a favourable report about Seroxat? So why didn't you ask the World's leading expert on SSRi's? Surely this would have been the route to take. OK I can accept that there probably was no leading expert around at the time of your launch but... and here is the crux... why didn't you seek the advice of an SSRi expert when patients started complaining of withdrawal? We know the answer to that don't we?
Seroxat has never been approved by EU or US regulators as a medicine for those under 18 years of age.
Yeh this was a line spun out by your ex-employee and now Chairman of the UK medicines regulator, Alisdair Breckenridge, in the prevoius Panorama programme aired than the one discussed here. He commented: "Our best evidence is that some 7,000 children a year were ... or children and adolescents were recieving Seroxat" Now if a drug, that has never been approved for this age group, is being prescribed (allbeit on the behest of a doctor) then shouldn't GlaxoSmithKline have issued a warning? Something along the lines of 'STOP! What you are doing is highly dangerous. We have evidence that suggests that Seroxat can cause suicidal thoughts in this age group. Why didn't you? 7,000 prescriptions a year may only be loose change to GlaxoSmithKline but those 7,000 (I beleive the figure to be actually higher - much higher) children, adolescents, young adults - call them what you will - could have been saved from the horrific symptoms of withdrawal had you spoke out. You didn't and that's what pisses so many folk off.
GSK’s UK product labelling has been entirely consistent with that position, and at the time of the events in question, this label stated: “the use of Seroxat in children is not recommended, as safety and efficacy have not been established in this population.”
How many children do GlaxoSmithKline know that are 25? Is it not the position of the MHRA that ALL antidepressants should now carry a warning on the patient information leaflet stating that they could cause suicidal thoughts? They beleive (wrongly, in my opinion) that SSRi's are effective if you are above the age of 25. Let's just condense your labelling at 'that time' shall we?
“the use of Seroxat in children is not recommended, as safety and efficacy have not been established in this population.”
I will ask you again - Do GlaxoSmithKline know of any child aged 25? Come to think of it do they know of any child who is 18,19,20,21,22,23 or 24? You messed up big time on the labelling but in good old Glaxo fashion cover yourselves by putting the onus on the family practitioner who has also never seen the raw data.
Another question for you: Why, did your European medical director for GlaxoSmithKline, Alistair Benbow state in 2003 that he thought Seroxat was safe for children? Why did he state on national television: "Absolutely, it could be, we haven't got a license in children yet." A license in children 'yet'? This is suggestive that you were indeed trying to gain a license for children does it not?
Any decision to prescribe a medicine outside its authorised indications, in the EU or the US, is made by a doctor on the basis of his/her clinical judgement and the interests of their patient.
Thus putting the blame on the family practitioner. You did after all warn them that safety and efficacy had not been proven in this population. In hindsight don't you think a more 'clear' statement should have been made? Something along the lines of 'Seroxat MUST NOT be prescribed to any persons under the age of 25', surely there would have been a clearer understanding with a statement like this rather than 'the use of Seroxat is not recommended in children...'
But no - you had to protect that 'lucrative gap' I spoke about earlier didn't you?
The final paragraph of your statement reads thus:
GSK, in 2004, further demonstrated its commitment to data transparency by creating an unsurpassed on-line database, called the Clinical Trial Register (CTR). This is a record of detailed summaries of more than 2,800 clinical trials conducted in 50 countries to study 52 GSK prescription medicines and vaccines which is available to the public at http://ctr.gsk.co.uk
Demonstrated its commitment? What utter bullshit! You were FORCED to create an online database by Elliot Spitzer when you were found guilty of fraud. It was part of the settlement you made wasn't it? And we all know that you STILL are not forthcoming with the raw data. Again you use summaries. Hell, I could summarize the benefits of anything you wish to throw at me. We can all paint pretty pictures and hide the truth!
Face it - the invetion of the internet has been GlaxoSmithKline's achilles heel. Rob Robinson's Paxil Protest started the ball rolling - here we had a patient (over the age of 25) who decided to fight back because he knew the drug you were selling killed people. You knew it too but did nothing about it and that is utterly shameful.
More 'Fiddy Rants' can be read HERE and also now available on OpEd News
Author of The evidence, however, is clear, the Seroxat scandal
Citizens Commission on Human Rights Award Recipient (Twice)