To: Department of Health (DH)
Copy: Medicines and Healthcare products Regulatory Agency (MHRA)
Copy: National Institute for Health and Clinical Excellence (NICE)
August 29, 2008
The MHRA is failing to act to protect children against the harmful effects of the ADHD drug Strattera
With this letter I want to inform you that the MHRA is failing in its mission to protect children from the harmful effects of drugs – in this case the ADHD drug Strattera. The inactions by the MHRA affect the whole continent as UK is responsible for the “safety work” around this drug in Europe.
The failure of the agency will also mean that psychiatrists within The Guideline Development Group in NICE can push through more “treatment” with Strattera and other ADHD drugs. The MHRA is withholding the clear evidence for harmful effects and the psychiatrists with close relations to the manufacturers of the drugs can unimpeded recommend these “medicines” to unsuspecting doctors and parents.
As known the MHRA has made the following promise: “…we take any necessary action to protect the public promptly if there is a problem.”  Considering the data below it must be stated that the agency works in a completely other direction: delaying warnings and restricting actions as long as possible to protect the pharmaceutical company involved – meanwhile children are dying and are getting psychotic reactions with hallucinations from the drug.
Already more than two years ago the agency knew that Strattera causes mania and psychotic reactions in children. The FDA had made a thorough review of reported cases  and the MHRA got the information.
Since the beginning of this year the MHRA knows that Eli Lilly lied about the number of deaths from Strattera. At least 41 children and adolescents are known to have died while under Strattera “treatment” in the last five years (see more data below).
And on top of this – the drug is causing the very condition it is meant to “alleviate” (see data below about the 700 reported cases of drug induced hyperactivity).
The data mentioned below have been given the MHRA and the important questions have been asked. But the agency has failed to answer – and has done nothing effective to protect the children. With reference to the data below I request actions from the Department of Health.
In three long letters to the MHRA this year I have given data and asked questions about the harmful effects of Strattera. I have got no real answers at all.
In the letter January 2, 2008, I described the “compelling evidence” for a causal association between Strattera and treatment emergent symptoms of psychosis or mania, as well as other harmful effects. In the letter March 9, 2008, I gave further data about the subject and made an analysis of the reports issued by independent researchers at the FDA, and by the manufacturer, Eli Lilly (the latter being the report used by MHRA in its safety analysis).
With reference to these letters:
In 2005 researchers at the FDA analysed the psychosis-inducing effects of Strattera and issued its report March 3, 2006 . Two years later, February 2008, Eli Lilly issued its “analysis” of the same subject, as part of Periodic Safety Update Report 9, sent from the MHRA .
The FDA was very clear about the psychosis-inducing effects of Strattera. The MHRA did not listen. Eli Lilly tried to explain away the results found in its review. (In an article in the Daily Mail this summer, Andrew Herxheimer, editor of the Drug and Therapeutics Bulletin, and emeritus fellow of the Cochrane Centre commented: “Asking a drug company to review its own product is crazy, but it goes on quite a lot”. )
But even if it was crazy to ask Eli Lilly to review Strattera, the company reluctantly wrote in its conclusions – and note this was already in the beginning of the year: “Nevertheless, Lilly will consider adding language regarding psychotic symptoms including hallucinations” to its product information sheet (p. 1279 of the review).
The Swedish Medical Products Agency (MPA) is obviously also waiting for the MHRA to act. In an answer this summer the agency announced: “…UK has the baton.”
But the MHRA has continued to delay the issuance of the warnings – now for more than two years.
In my letter of January 2, I also took up the forgotten 700 cases of psychomotor hyperactivity. The MHRA assessor was questioning how Eli Lilly could exclude all these reported cases from its review.
I would think you agree with me that this area is of extreme importance for the MHRA to handle. We have “700 reported cases of psychomotor hyperactivity [that] were related to an exacerbation of the underlying ADHD”.
If we would apply this to the area of diabetes we could say that the patient got a diabetes medication with resulting increase in blood sugar level. It would probably not take long before such a drug was withdrawn from the market. And considering the accepted rate of underreporting, these reports about Strattera represent an actual incidence of at least between 7000 and 70 000 cases.
The MHRA has not investigated these extremely important reports.
In the letter May 15, 2008, I gave updated information about the reported instances of death from Strattera and about the false information provided by Eli Lilly.
The MHRA has not called in question the false data given by Eli Lilly about instances of death from Strattera and the agency has not started an investigation into all the reported cases of death in connection with Strattera “treatment”.
I now request that the Department of Health takes action. This does not concern “only” the children in UK; it concerns the children in the whole of Europe.
Reporter - investigating psychiatry
129 45 Hägersten
 MHRA, About us, http://www.mhra.gov.uk
 FDA, Psychiatric Adverse Events Associated with Drug Treatment of ADHD: Review of Postmarketing Safety Data, released March 3, 2006. http://www.fda.gov/ohrms/dockets/AC/06/briefing/2006-4210b_11_01_AdverseEvents.pdf
 Eli Lilly, Cumulative review of Spontaneous Case Reports of Mania, Psychotic Disorders, Hallucinations, and Agitation, Appendix 16 to Periodic Safety Report 9 for Strattera, 2008, http://jannel.se/Lilly_psychosis_strattera.pdf
 Daily Mail, Heart attacks and suicides... yet the dangers were all kept so quiet. So how CAN you trust your medicine?July 7, 2008,