MHRA and Strattera

Janne Larsson is a reporter who investigates psychiatry. I've long admired Janne's tenacity and never say die attitude.

Janne has long banged the drum about the dangers of Strattera, an apparent non-stimulant medicine approved to treat attention-deficit/hyperactivity disorder (ADHD)

He has had much correspondence with the MHRA that seems to have hit a brick wall, last I heard they [MHRA] had labelled Janne 'Vexatious'.

Janne recently posted an update regarding the MHRA and Strattera, I feel it deserves an airing here on Seroxat Sufferers.

The following is re-published with the permission of Janne:

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"MHRA and Strattera [atomoxetine] deaths - a follow-up"

Received by email:

"To: Professor Kent Woods

Chief Executive

Medicines and Healthcare products Regulatory Agency MHRA

Copy: Media



Text below in PDF on http://jannel.se/letter.woods.May09.pdf
6 May 2009
MHRA and Strattera deaths a follow-up


This is where we stand today as regards deaths in connection with the ADHD drug Strattera:



87 cases of death with Strattera as Primary Suspect Drug reported to the FDA, 2004 - September 2008.

See http://www.psychdrugdangers.com/StratteraDeathsPS.html



115 cases of death in total with Strattera involved reported to the FDA 2004 September 2008 and in Periodic Safety Update Reports from Lilly/MHRA. See http://www.psychdrugdangers.com/StratteraDeathsAll.html for FDA reports.



The children and teenagers getting Strattera for ADHD can be expected to be healthy normal children and in this group of patients there should be extremely low morbidity and mortality. But 48 children and teenagers have died, 25 of them committed suicide.

See summary http://jannel.se/StratteraDeath3.pdf



MHRA is responsible for the safety work for Strattera in Europe. But so far the agency has done nothing to investigate the cases of death described. And now the agency has decided to not release any more documents or information about its actions around Strattera.



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This story starts in November 2007 when I made a FOIA request to the MHRA about the number of persons who had died while under Strattera treatment. The answer was the Agency didnt know and had to ask the manufacturer, Eli Lilly.



In its answer, January 2008, Lilly said the company up to 30 November 2007 has identified 41 fatal cases in our safety database. But as Lilly only accepted deaths reported by a health care professional (HCP) or regulatory authority, 17 of these cases were right away deducted by the company. They did not count as Adverse Drug Reactions. In Lillys words: Of the 41, only 24 were Adverse Drug Reactions (ADR) with fatal outcomes. (See the letters [1], where Lilly makes a good job trying to convince the Agency not to release this information.)



Other data showed that FDA at that time had received at least 61 reports of death with Strattera as Primary Suspect Drug, 2004-2007. (See below.) So how could Lilly state 41 fatal cases of which only 24 should be counted?



In order to help the MHRA to protect children from further harmful effects I compiled detailed data about cases of Strattera death. In May 2008 I submitted this to the Agency (a compilation of data from cases reported to FDA and from the Periodic Safety Update Reports in Europe). I got no answer. Finally 1October I got a reply from the Scientific Assessor of the Vigilance and Risk Management of Medicines (VRMM) in the MHRA. And 7 October I got an answer from you, Professor Kent Woods, CEO of the MHRA, where you just referred to the letter sent by the Scientific Assessor.

My submitted data about Strattera deaths can be foundin the letterStrattera: Eli Lilly gave false information about deaths from Strattera treatment a request for full investigation from 15 May. [2]


The Agency was in my letter provided with specific data (even ICSR [Individual Case Safety Reports] numbers) about instances of death in connection with Strattera treatment.

In the answer 1 October the Scientific Assessor stated [3]:

in order to calculate the total number of reports with a fatal outcome it is not simply a case of adding up reports with a fatal outcome mentioned in our assessment reports of the PSURs [Periodic Safety Update Reports] and those available on the FDA website as these different sources may contain duplicate information. [Emphasis added.]

I would fully agree to this and it took only a casual reading of my letter from 15 May to find out that much care had been taken to exclude possible duplicates. It was quite easy to see that the data presented was NOT simply a case of adding up reports with a fatal outcome.

It was not clear what the MHRA had done to verify my data, but the letter from the Scientific Assessor gave the impression that some form of investigation had been doneabout the instances of death brought to the Agencys attention. The Assessor wrote:

We have looked at the data you have sent us to see if they can add insight to the statutory sources of data we have received and do not think that they are of benefit as we cannot verify their source or accuracy. (p. 3) [Emphasis added.]


This indicated that the Agency didnt know anything more about these cases in October 2008 than it knew in November 2007, when I first asked questions about the fatal cases.



I found this very strange as there are clear rules for pharmacovigilance in Europe and very strict requirements for both the medical agencies and pharmaceutical companies in investigating reported serious adverse drug reactions especially fatal drug reactions. I am of course referring toVolume 9A of The Rules Governing Medicinal Products in the European Union (Guidelines on Pharmacovigilance for Medicinal Products for Human Use). [4]



In order to verify the MHRAs adherence to these rules I made a FOIA-request to get the documents that should exist had the Agency actually adhered to the rules. I referred very clearly to all applicable EU rules. See my FOIA request. [5]



I did not get an answer on the FOIA request within the stipulated 20 working days. Finally, in the end of March, almost three months later, I got the answer. It said I could not get any documents and the Agency could not even say if any documents existed.



Instead it was decided that my request was vexatious even obsessive and [we] will not be providing an answer. In an exceptional move the Agency even declared that future FOIA-requests would be denied on the subject of Strattera: We will not engage in any further correspondence with you on Strattera. [6] This decision was, as expected, confirmed by an internal reviewer in the Agency.



My investigation about Strattera has been ongoing since 2005 and I have been in contact with the MHRA about the harmful effects of Strattera since early 2006. No matter how vexatious this can have been for the Agency the vexatious effects of the drug revealed in different documents are far worse. Cardiac disorders, liver disorders, suicidality, aggression, mania, psychosis with hallucinations how can a medical agency allow children to be subjected to these harmful drug effects?



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I now realize that it would have been impossible for the Agency to answer my latest FOIA request in this way: NONE of the documents about Strattera deaths you have requested exist. That would have been the same as saying the applicable rules in the EC Pharmacovigilance Directive was not adhered to. So the only solution was to declare the requester obsessive and so avoid giving any form of answer to the important questions.



We can conclude that the Agency knows as little today about all the cases of Strattera death as it did when I started to ask questions. The only compilation of data in this area available to the Agency seems to be the one I have submitted. No real effort has been done by the Agency itself to find data much less to take action. The manufacturer (Lilly) has been allowed to get away with not knowing, lacking information. The requirement in the EC Pharmacovigilance Directive is clear, the manufacturer should follow-up all reports of serious adverse reactions to their medicinal product(s) to obtain comprehensive information where available. Additional information not available at the time of the initial report should be provided in the form of follow-up reports. This is not done. And the Agency sends no requests to Lilly to rectify the situation (letters that should have been released as part of my latest FOIA-request had they existed).



We also know that the data sent out for consideration to other medical agencies in Europe from the MHRA (UK being the ReferenceMemberState, RMS, for Strattera) will never contain anything of real value when it comes to serious drug reactions. What is stated in the different Periodic Safety Update Reports (PSURs) sent from the MHRA is based on data from Lilly and Lilly says not enough information, details not provided, was unknown, was not identified.



And this is especially clear in fatal cases. It seems in some mysterious way impossible to get relevant data in these cases; and so no actions can be taken.



We now know why.



Yours sincerely,



Janne Larsson

Reporter investigating psychiatry

Snöbollsgränd 22

129 45 Hägersten

Sweden

[email address]





References:

[1] Eli Lilly, Letter to the MHRA, January 2, 2008, (see last 3 pages) http://jannel.se/FOI%2008-011.redacted.letters.Strattera.pdf

[2] Larsson, Strattera: Eli Lilly gave false information about deaths from Strattera treatment a request for full investigation http://jannel.se/Strattera.death2.pdf and StratteraDeath, May 15, 2008, http://jannel.se/StratteraDeath.pdf

[3] MHRA, Re: letter of 9th September 2008 to Assessor responsible for Strattera,October 1, 2008, http://jannel.se/Reply.from%20MHRA.Assessor.October.pdf

[4] European Commission, Volume 9A of The Rules Governing Medicinal Products in the European Union (Guidelines on Pharmacovigilance for Medicinal Products for Human Use) September 2008, http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-9/pdf/vol9a_09-2008.pdf

[5]Larsson, FOIA-request about deaths from Strattera treatment, 10 January 2009,
http://jannel.se/FOIA.strattera.death.pdf

[6] MHRA, letter from 25 March http://jannel.se/MHRA.letter.section14.pdf




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