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Citizens Commission on Human Rights Award Recipient (Twice)
Humanist, humorist

Monday, August 28, 2017

MHRA Mumblings








More correspondence from the MHRA.

First off, you may recall last month that the MHRA's enforcement officer, Danny Lee-Frost found himself in hot water regarding comments he made about antidepressants on Sky TV.

I wrote to both Lee-Frost and Sky News for clarification. Lee-Frost told me, "My reference to suicides was in relation to a case that the MHRA is aware of involving addiction to Zopliclone." Whereas Sky News informed me that they edited Lee-Frosts's original statement after the MHRA contacted them about their blunder. (Back story)

I wrote back to Lee-Frost the following:
Dear Mr. Lee-Frost,
Thanks for your rapid response. It was the fastest reply I've ever received from MHRA in more than a decade of correspondence.
Your response is appreciated but has further confused me about several issues. I hope you and other MHRA staff can help clarify.
1. Your original Sky News interview quote was:
"The sleeping pills and antidepressants are a lot more dangerous. People have committed suicide as the ultimate resort to try and get off them. These are fiercely addictive."
Sky News has now changed your quotes and deleted most of your references to antidepressants. Please help me understand why Sky News would inexplicably change your direct quotes. Did you or other MHRA staff contact Sky News regarding your original statements?
2. Your reply to me also states "Sky did not include the interview in its entirety in their piece." Do you mean to imply that by not running the entire article, Sky News misquoted you and misrepresented MHRA's views? If so, will MHRA please set the record straight by requesting that Sky News release the full article? Doing so can help MHRA clearly communicate serious risks to the public it professes to serve.
3. You specifically mentioned “antidepressants” twice on Sky News, and the entire point of my email to you was about your reference to antidepressants. Given this, it is peculiar your reply made no mention whatsoever to antidepressants. What you did state is “My reference to suicides was about a case that the MHRA is aware of involving addiction to Zopiclone”. You mention “a case” – i.e. one instance – in relation to Zopiclone.
Given the importance MHRA has placed on this single Zopiclone death, when can the public expect MHRA to release a report or press interview about the multiple cases of suicides precipitated by drugs labeled "antidepressants?" (There is no shortage of well-documented and reported antidepressant-induced deaths in the last 20 years.) It is my understanding antidepressants are so dangerous that their packaging now contains an explicit warning regarding suicidal thoughts and antidepressants.
4. As previously noted, Sky News later changed your direct quote to, "Sleeping pills particularly, they can be addictive. People have committed suicide as the ultimate resort to try and get off them. These are fiercely addictive."
As I understand you were referring to Zopiclone when you mentioned the "sleeping pills," correct?
Your reference to addiction and withdrawal-induced "suicides" confuses me because nowhere on the product labeling does it suggest Zopiclone can be addictive when first starting it. Moreover, the SPC label does not mention suicide as a result of consumers trying to withdraw from the drug. Can you or other MHRA staff show me otherwise? Also, please clarify for me, to what class of drug does Zopiclone belong?
The  SPC-DOC_PL 41684-0003.PDF is hosted on the MHRA website and last updated on 02/06/2017 
5. In your reply, you also state "matters of clinical diagnosis are not in my area of expertise."
This statement is a surprising inclusion given that issues relating to clinical diagnosis have nothing to do with either the Sky News article, your original interview quotes, nor my first email to you. As Head of Enforcement with the MRHA, it is absolutely within your remit to make such statements about prescribed drugs such as antidepressants and tranquilizers--as you indeed did.
Thank you for your time and attention; I look forward to your reply.
Lee-Frost, without going into any detail about the Zopiclone question I put to him, wrote back:
Dear Mr Fiddaman,
Thank you for your response to my email. I hope I am further able to clarify matters for you.
When I was interviewed by Sky News it was about the dangers of buying medicines from outside the regulated supply chain, either from websites operating illegally or through websites like Facebook. During the interview, Diazepam and Zopiclone were two specific medicines that we discussed and I misspoke when I referred to them as anti-depressants.
My discussion points were anecdotal. During the preparation for, and discussions with the Sky journalist I emphasised that as I am in the Enforcement Group, I am only able to make statements relating to criminal activities involving medicines. The point about the piece was to highlight the dangers of illegally operating websites and the health dangers of buying medicines without the supervision of a treating physician who is able to appropriately prescribe medicines and monitor the patient’s treatment.
The article merged several statements together and did not include quotes in their entirety. We requested Sky to use the quotes in their proper context so the message we were conveying could get through. As the online article now reflects the topics we discussed in their proper order, we will not be asking Sky to release anything further as we believe that the piece highlights the dangers of buying from illegally operating websites as intended. However, you are free to contact Sky if you so wish.
I trust this explanation clarifies the position for you, and any further correspondence should be directed through the appropriate channel: info@mhra.gov.uk
Kind regards,
Regards
Danny Lee-Frost MSc
---

Make of that what you will. It appears to me as if he is saying he was wrong, without actually admitting he was wrong. I won't be writing back to the address he provided.

More Mumblings

As regular readers know I have, for some time, been at loggerheads with the MHRA regarding SSRI clinical trials. The MHRA have, for whatever reason, been reluctant to release that information to me, citing that it would cost too much money to release such information (I had asked them six questions) - I offered to crowd fund to get the money they requested and they backtracked, claiming that it was a mistake and I didn't need to pay anything. I then asked them a slimmed down version of my original 6 questions, namely; 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?

Their answer, which took a further 20 working days:

Thank you for your most recent FOI request dated 17th July 2017. You have asked for 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?

The MHRA do not hold individual case details from fluoxetine clinical trials and are therefore unable to provide a specific analysis of individuals aged 24 years or over. 

Quite why they couldn't have told me this over 3 months ago when I fist asked them still remains a mystery.

Back stories:

SSRI Deaths in Clinical Trials

MHRA Seek Payment For Info on Deadly Drugs

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

It hardly seems worth it to ask them about other SSRIs, they'll either not have that information or by the time they answer me someone would have invented a time machine!

The whole SSRI clinical trials question came to light during the Dolin Vs GSK trial in Chicago. Evidence presented at trial showed that during the Paxil (Seroxat) clinical trials 20 patients had died by suicide, all 20 were taking Paxil at the time of their suicide, all were over the age of 30. (Dolin Vs GSK : Jury shown List of the Dead in Paxil Clinical Trials)

It's obvious to me that the MHRA are failing on a grand scale to safeguard the British public, moreover, doing everything, it seems, to protect their own interests rather than those they are served to protect. I can only assume is obvious to those who read my blog too.

Yet more stalling

A week or so ago I asked them a simple question. It did not need to be treated as a Freedom of Information request, however, for some bizarre reason it has. My question was simple and, as yet, has not been answered:

Why do SSRI patient information leaflets list the risks yet don't list the benefits?

I'll let you know when they send me further mumblings.

Bob Fiddaman


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