Open letter to Medicines and Healthcare products Regulatory Agency – MHRA
Copy: Professor Kent Woods
Chief Executive, MHRA
August 14, 2008
The ADHD drug Strattera and its harmful effects – response from the MHRA, but where are the ANSWERS?
Your short note says:
“We can confirm that we have just sent a response to your earlier query which you sent in May which we hope will address some of the points raised in your enquiry. Please review our earlier reply and then contact us again if you have outstanding concerns.”
The “earlier query” you refer to is my FOIA-request about Strattera deaths, from May 15.
As I find the response from the MHRA to my FOIA-request of interest for the public and media, I make the response, and my comments and questions broadly available
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In my FOIA-request I submitted extensive information about Strattera deaths and requested more information from the MHRA.
The information submitted in my FOIA-request was similar to that in my letter to Professor Kent Woods, of May 15. Anyone reading this letter can understand that I have quite some data about the subject – data that should be of real interest to the MHRA.
Your response to my FOIA-request of August 12 says:
“There is only one question in your email of 16 May 2008 that meets the criteria of a request for information under the UK Freedom of Information Act. That is the request for "The updated list over ALL fatal cases reported for Strattera, as compiled by the MHRA.
You also asked “Is the agency going to call in question the data given by Eli Lilly (41 deaths, 24 confirmed by HCPs) in light of the now presented evidence (81 deaths in FDA 2004-2007 with Strattera as Primary Suspect Drug and in PSURs, with at least 47 of these 81 confirmed by HCPs; and in total 95 cases of death)?”
And the answer to that became:
“The MHRA holds no data other than that previously released to you under the references 07/355 and 08/011, which was the data provided by the company. If you have any questions about FDA data or the data provided by the company, you should contact those organisations.”
Let’s once again consider the promise by the MHRA – a statement of the very reason for the existence of the agency: “We keep watch over medicines and devices, and we take any necessary action to protect the public promptly if there is a problem.” [See MHRA, About us.]
That is the promise and this is the reality:
I have submitted extensive information about Strattera deaths, compiled from the reports submitted to the manufacturer and to the FDA. The MHRA has received details down to the level of actual ISR numbers (Individual Safety Reports number) and Case numbers. The agency has got clear evidence that the manufacturer Eli Lily gave false information to the MHRA about the number of deaths from the drug.
And I would summarize your response as: We couldn’t care less.
You are not at all appreciating the information compiled and submitted about all reported instances of deaths from Strattera “treatment” (a compilation which should have been done by the agency itself a long time ago), you don’t use your vast resources to investigate further, you don’t make any effort to get a complete list over all reported deaths, you don’t challenge the obvious lies from the manufacturer, you don’t ask the FDA for data.
Instead you tell me to ask the FDA about Strattera deaths – and you tell me to ask Eli Lilly!
But didn’t you notice that I already “asked” the FDA – the data I have submitted to the MHRA is stemming from reports submitted to the FDA. I don’t need to ask any more questions to the FDA.
And didn’t you notice that Eli Lilly already has been asked about this? They were even – on my request – asked by the MHRA itself. And, as shown in my May 15 letter – they lied.
To be honest I find the whole situation to be absurd – for how can one fit the stated purpose of protecting the public with this response to submitted data indicating serious dangers to children.
In your full response to my FOIA-request you further let me know many other things of similar kind. Considering the data I have submitted and the disinterest shown by the agency, do you really expect me to believe the following?
“A variety of sources of data are used to monitor the safety of medicines…All these data sources are carefully evaluated for emerging drug safety signals and particular attention is paid to serious and fatal.”
You asked me: “Please review our earlier reply and then contact us again if you have outstanding concerns.”
Let me make it very clear that I have got no answers to my questions:
The simple question 1: How come the MHRA is delaying the issuance of the warnings even more? [Referred to the warnings about mania and psychosis with hallucinations.]
The simple question 2: Has the MHRA now done an own investigation of these extremely important reports? [Referred to the 700 reports about psychomotor hyperactivity in connection with Strattera, with the assumption that a diabetes drug that caused a heavy increase in blood sugar would right away be withdrawn from the market.]
The simple questions 3: Will the MHRA call in question the false data given by Eli Lilly about instances of death from Strattera and has the agency now started an investigation of all the reported cases of death in connection with Strattera treatment?
The last questions are answered NO in your response of August 12. As this inaction is against the very purpose of the agency my questions need to be asked again.
Yours sincerely,
Janne Larsson
Reporter - investigating psychiatry
Snöbollsgränd 22
129 45 Hägersten
Sweden
[email address]
lettermhra15August2008.doc
