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Monday, August 01, 2016

Ian Hudson of the MHRA challenged over the safety of Concerta (Ritalin)

Former Glaxo World 'Safety Officer', Dr Ian Hudson

In an attempt to seek the truth and learn how the regulations of prescription drugs work, Swedish investigative journalist, Janne Larsson, has been, for many years now, corresponding with the British medicines regulator, the MHRA.

Larsson, it appears, is ruffling some feathers at MHRA HQ, none more so than the feathers of the always evasive CEO, Dr Ian Hudson.

You see, the MHRA and Larsson have been going over reports regarding the ADHD drug Concerta, more commonly known as Ritalin.

Head of the MHRA, Dr Ian Hudson, has told Larsson that  “the safety of Concerta is being continuously monitored” - but Larsson is having none of it.

In his latest open email to Dr Ian Hudson, Larsson suggests that Hudson's handling of this whole affair is "scandalous". After reading much of the correspondence between Larsson and the MHRA I must say he has a valid point.

His open email (link at the foot of this post) also calls into question why the MHRA, in particular, Dr Ian Hudson, have not approached Concerta makers, Janssen, with regard to a "distortion of facts" that they presented to the MHRA a few years ago.

Larsson, in his open email to Hudson, points out that Janssen says that Concerta “continues to have a favourable benefit-risk profile for ADHD in children and adults” and that it is authorized for the treatment of ADHD in adults. They also claim that that the benefits of Concerta for adults “are supported by prospective, randomized, active-comparator controlled trials” 

However, Study 3013, the longest of all the Concerta studies, shows something completely different - furthermore, the MHRA, themselves, after reviewing 3013, said, “A causal relationship with Concerta was established for aggression, tics and depression.”

Larsson accuses the MHRA of sitting on this information for over two years.

It's unlike the agency to sit on anything regarding patient welfare. I mean, they have their fingers right on the pulse, huh?

Dr Ian Hudson, is the former World Safety Officer for GlaxoSmithKline (then SmithKline Beecham)

Kind of worrisome that someone sitting on important safety information regarding Concerta used to be in control of safety at one of the most heavily fined pharmaceutical companies known in history.

Here's Janne Larsson's correspondence.

ADHD drugs – MHRA and the Concerta scandal – did this really happen?

Bob Fiddaman.

Back story

Swedish Journalist Takes on British Drug Regulator