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Health Blogs | Mental Health

MHRA: No Deaths in Pediatric Trials, But What About Adults?

July 17th, 2017 by BOB FIDDAMAN




Back in June I wrote to the MHRA regarding a Freedom of Information request I had submitted to them (originally in May 2017)

My request stemmed from evidence submitted during the Dolin Vs GSK trial where it was learned that 22 consumers of Paxil (Seroxat) died, 20 of whom died by suicide, 80% of whom were over the age of 30 - All subjects were taking Paxil at the time of their suicide.

My question, or rather a number of questions, I put to the MHRA was an effort to seek more information regarding other drugs in the SSRI class that were used on both pediatrics and those over the age of 24.

As many of you know, the MHRA wrote me and suggested that such a search performed by them would exceed 600 and take them longer than 24 hours to complete. I wrote back to them the following...

I received your claim that releasing the information requested would be too costly for your office. Given that human lives are at stake (a value far greater than your work hours), I request the following:
1) Please estimate the amount of money you require in exchange for obtaining this information.
2) Please separately estimate the number of hours of work you might have to complete to "research" and answer each of my Freedom of Information questions.
I will set the wheels in motion for public crowd-funding so the answers to these questions can be in the public domain. The same public that have a right to fully informed consent can then decide whether or not they think antidepressants are safe and effective based on the information you seem reluctant to release.
I look forward to working with the public to raise your requested funds.

It would appear that the MHRA are now suggesting that my request isn't actually about money. Their response to me does, however, answer a number of questions regarding pediatric trials and SSRIs. They have now told me that no person under the age of 24 has ever died in any of the SSRI clinical trials, except for trials involving Lundbeck's two SSRI's, Citalopran and escitalopram. The MHRA claim they don't have that information.

So, what about the adult trials?

We know through litigation that GSK's Paxil clinical trials showed that 22 people died, 20 of which were death by suicide. But what about the other clinical trials for other SSRIs?

This seems to be an answer that the MHRA are, for whatever reason, failing to answer.

With this in mind, and also the time it will take the MHRA to 'research' this information I have, once again, responded to their latest reply to me.

First, here's their latest...


My latest response is short.

Dear MHRA,

I wish to narrow my request.

To save you time (and money)

Here is my first.


How many deaths occurred in the persons aged 24 or over in clinical trials for Prozac. How many were by suicide and how many of those patients were taking Prozac at the time of their death?


--

It seems an arse about face way to request all the information on all the SSRI clinical trials in adults but if they wish for me to send them one request at a time, which it appears they do, then I shall comply so we can eventually get to the bottom of this question and, at the same time, maybe save some lives.

I will, of course, update this blog when the MHRA respond, which, judging by previous correspondence with take them, will take approximately one month.

Bob Fiddaman





 
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Tags: Mental Health, SSRI


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