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

MHRA Yell "Barracuda!"

I think I am familiar with the fact that you are going to ignore this particular problem until it swims up and bites you on the ass! ~ Matt Hooper - Jaws

The above photo and caption are from the movie Jaws. Power and money-hungry Mayor Larry Vaughn, played by Murray Hamilton, refuses to acknowledge that the residents of Amity are at risk of a shark attack. If Vaughn doesn't close the beaches, the shark could harm and kill citizens. Matt Hooper, played by Richard Dreyfuss, is an oceanographer with a special interest in the study of sharks. He uses his knowledge to try and convince Vaughn to protect the town, but Vaughn ignores him. Given the popularity of Jaws (it won an Oscar), I assume we all know the outcome of Vaughn's callous ignorance, right?

I'm not Matt Hooper, but lately, I feel like him. For years I've been at loggerheads with the MHRA as I seek answers to improve public health. Today's blog spotlights my latest correspondence to/from the MHRA about the increased risk of adult suicide posed by Paxil.

The MHRA and FDA know SSRIs are not recommended for consumers under the age of 24 because these products increase the suicide risk. In the US there is a black box warning, and in Europe, the patient information leaflet highlights this increased risk of suicide for any consumers under age 24. It is actually printed in bold face font. (See Doublespeak)

What we don't know is how and why regulatory authorities chose to highlight the product's dangers in consumers under 24 and not communicate the increased suicide risk for consumers over 24.

Let's look at the facts regarding Paxil clinical trials. (Paxil is known as Seroxat in Europe.)

In GSK's Paxil pediatric trials, which included more than 1,000 patients treated with Paxil, there were zero completed suicides. We know this because GSK's vice president for regulatory affairs, Dr. David Wheadon, admitted this in a written statement. What we don't know is how many of the children who were given Paxil developed suicidal thoughts and actions. MHRA and the FDA apparently feel this information is not important for the public's viewing.

In GSK's Paxil adult trials, we know 22 deaths occurred, 80% of which were people over age 30. (See here.) What we now know, thanks to the evidence made public in the Dolin vs. GSK trial, 42 people taking Paxil developed suicidal thoughts and actions.(See here)

So, to sum up: No deaths occurred in Paxil pediatric trials, and 22 deaths occurred in Paxil adult trials. Twenty of these deaths were completed suicides, and 80% of these were people over age 30.

Surely, the MHRA never had this information?

Wrong.

Here's a series of emails between myself and the MHRA. Spelling and grammatical errors from the MHRA are as received.


From: Bob Fiddaman
Sent: 31 March 2017 14:54
To: Pharmacovigilanceservice
Subject: Re: Drug labeling

On the current Seroxat Patient Information leaflet (Revised 11/01/2017) it states, under the subheading "Thoughts of suicide and worsening of your depression or anxiety disorder"...

If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.

You may be more likely to think like this:

· If you have previously had thoughts about killing or
harming yourself.
· If you are a young adult. Information from clinical
trials has shown an increased risk of suicidal
behaviour in adults aged less than 25 years with
psychiatric conditions who were treated with an
antidepressant.

Q: Could you please explain why "young adult" is in boldface type font and who made the decision to include "young adult" in a boldface type font?

--

From: Pharmacovigilanceservice
To: Bob Fiddaman
Sent: Wednesday, April 5, 2017 10:44 AM
Subject: RE: Drug labeling

Dear Mr Fiddaman

The SPC for Seroxat includes the following:

A meta‑analysis of placebo‑controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old (see also section 5.1).

As the above suggests that this particular age group are most at risk, the MAH will have suggested the emboldening of the text within the PIL. There are fors and againsts the use of emboldening, but in this particular case it has been considered appropriate.

Kind regards,

Chris Penny 
Pharmacovigilance Service Team Manager

--

From: Bob Fiddaman
Sent: 16 April 2017 15:52
To: Pharmacovigilanceservice
Subject: Re: Drug labeling

Chris,

Just so you know.

Plaintiff’s Exhibit 347: Each picture depicts a real person who completed suicide while taking Paxil in a GSK-clinical trial. The red “Vs” mean their specific suicides were violent in nature. There were multiple suicides using firearms, including a murder suicide by one patient. There were also two deaths from people jumping in front of trains.

When it comes to suicide attempts, GSK did not keep track of all the attempted suicides in their clinical trials because, according to their company witness, it would be too burdensome.

My question.

The MHRA knew about these adult completed suicides, correct?

Attachment added to email

--

From: Pharmacovigilanceservice
To: Bob Fiddaman
Sent: Wednesday, April 19, 2017 12:03 PM
Subject: RE: Drug labeling

Dear Mr Fiddaman

I can confirm that the MHRA is notified of all serious adverse events, as laid out in the Pharmacovigilance Clinical Trial legislation.

Kind regards,

Chris Penny 
Pharmacovigilance Service Team Manager

--

From: Bob Fiddaman
Sent: 19 April 2017 17:08
To: Pharmacovigilanceservice
Subject: Re: Drug labeling

Dear Chris,

For clarification. Were the MHRA notified of the 22 deaths that occurred in paroxetine (Seroxat) clinical trials carried out by GSK (SmithKline Beecham) and that 16 of those deaths (80%) were attributed to adults over the age of 30?

--

From: Clinical Trial Helpline
To: Bob Fiddaman
Cc: Pharmacovigilanceservice
Sent: Friday, April 21, 2017 5:19 AM
Subject: RE: Drug labeling

Dear Mr Fiddaman,

As stated in the previous email from Chris Penny the MHRA is informed of serious adverse reactions occurring in clinical trials in compliance with current legislation.


The deaths that you are referring to took place between approximately 1983 and 2003. This data would have been submitted to European Competent Authorities and the suicidality risk of paroxetine was formally addressed at a European level in 2003/2004. Class labelling for a risk of suicide and related thoughts and behaviours was adopted for all the SSRIs based on data reviewed in 2004.


Best wishes,

Rosalind
Clinical Trials Unit
MHRA

--

From: Bob Fiddaman
Sent: 21 April 2017 16:29
To: Clinical Trial Helpline
Cc: Pharmacovigilanceservice
Subject: Re: Drug labeling

Thanks Rosalind.

One final question.

The MHRA have no plans to update the Seroxat label regarding Seroxat-induced suicide in adults over the age of 24, correct?

--

From: Clinical Trial Helpline
To: Bob Fiddaman
Cc: Pharmacovigilanceservice
Sent: Tuesday, April 25, 2017 2:05 PM
Subject: RE: Drug labeling


Dear Mr Fiddaman,

As stated before, class labelling for a risk of suicide and related thoughts and behaviours was adopted for all the Selective Serotonine Reuptake inhibitors (SSRIs) based on data reviewed in 2004. Paroxetine is an SSRI. Suicidal ideation and behaviour is already addressed in the Paroxetine Summary of Product Characteristic (SmPC).


Best wishes,

Rosalind
Clinical Trials Unit
MHRA

--

So, there you have it, folks. The MHRA decided to highlight the increased risk of suicide among consumers under age 24, and they decided not to highlight the increased risk of suicide among consumers over 24.

Why didn't the MHRA feel the need to highlight the 22 adult deaths that occurred in the Paxil trials? It appears the MHRA believes Paxil isn't safe for children, but is safe for adults?

Why, in 2017, is the MHRA still not updating the Paxil warning label for adults?

Why do the MHRA continue to highlight the risk of patients under the age of 24?

I think I know why. GSK already knew that their ideal target market for Paxil was not going to be children. GSK is not allowed to promote Paxil to children (but they still did and were fined for their criminal behavior.)

But GSK was not about to lose Paxil profits when it came to capturing the adult market. MHRA helped them out by emphasizing in the patient information leaflet that the risk is only for consumers under 24. By intentionally printing these specific words, "young adults," in bold face type, MHRA is essentially telling older consumers: "Pay no attention to this increased suicide warning if you are over 24. This product poses no increased risk of death."

Obviously, MHRA should warn older adults by highlighting the 22 deaths and including older adults in the warning. Perhaps MHRA's CEO, Ian Hudson, doesn't want to do this because, whilst under oath in 2000, he stated he had seen no evidence to suggest that Paxil "caused any person, worldwide, to commit an act of homicide or suicide."

I'll leave the final words to Ian Hudson, um, Mayor Vaughn who, despite knowing about the risks created by keeping the Amity beaches open, had this to say...

"You yell barracuda, everybody says, "Huh? What?" You yell shark, we've got a panic on our hands on the Fourth of July."


Bob Fiddaman

Related

Former Glaxo Safety Officer Becomes Head of MHRA

EXCLUSIVE: Dr Ian Hudson: In Defence of the Suicide Pill (Full Video Deposition)

Paxil Suicide - The Way GSK Hid the Link

Dolin Vs GSK - 8.9 Suicide Increase For Adult Paxil Users

MHRA Decline to Meet With Human Rights Movement

What is the difference between the British drug regulator, the MHRA, and the human rights movement, the CCHR?

Well, in short, the MHRA claim to protect us from unsafe drugs but...they fail on a grand scale whereas the CCHR continue to fight the corner of the small person on the street, trying to protect the health of the public by raising issues and questions to officialdom.

For those that don't know, MHRA stands for the Medicines Healthcare and products Regulatory Agency. Their job is to monitor the medicines the British public take. They are an agency that is fully funded by the pharmaceutical industry. Their Chief Executive is Dr Ian Hudson, a former World Safety Officer for GlaxoSmithKline [then SmithKline Beecham]

The CCHR stands for the Citizen's Commission on Human Rights. They have many purposes, two of which is to flag growing concerns regarding psychiatric drugs and those that prescribe them. They are a non-profit, non-political, non-religious mental health watchdog. Their UK's Executive Director is Brian Daniels who has no links to the pharmaceutical industry.

Back in July 2013 Brian, representing the CCHR, wrote to June Raine of the MHRA. He had previously wrote to the MHRA some months earlier but they had failed to respond.

The CCHR were concerned about the growing list of antidepressant 'adverse incidents' in the UK and proposed a meeting with the MHRA for an 'open debate'.

The CCHR even offered a database... "A set of data has been compiled consisting of 1637 incidents involving antidepressants. It has been made available on a web site www.antidepaware.co.uk. It came to the attention of this organisation as it aligned with documents gathered over decades regarding this category of drug and the adverse drug reactions."

Here's the letter in full.

The MHRA [eventually] replied in their usual classic fashion. They declined to meet with the CCHR citing the previous correspondence they had sent to the CCHR.

I've saw the correspondence, in fact, I have an uncanny ability to predict any correspondence from the MHRA when the subject of antidepressants are concerned... move over Doris Stokes. [1]

Here's the MHRA's bog-standard response they sent to the CCHR... they have sent me the same in the past.

So, 10 years ago, write the MHRA, an 'expert' working group published its findings regarding the balance and risks of SSRi antidepressant use. The 'experts', in relation to suicidal behaviour in adults, concluded that there was a modest increase in the risk of suicidal thoughts and self-harm for SSRis compared to placebo. They added that the MHRA follow up all cases of suicide that are reported to them. Reports can only be sent to them via their yellow card reporting system. 

I don't know about you but if I wanted to learn more about the quality of food served at a restaurant I'd ask a customer and not someone paid by the restaurant manager.

Ben Scott, who wrote the reply to the CCHR, lists himself as the MHRA's 'Customer Services Manager'.

Customer Services?

Nice job Ben. It must have taken you all of three minutes to copy and paste that to the CCHR. I wonder if MHRA clerical staff are given a typing test for such positions. I wonder if Ben, when filling out his application form for the customer services manager position, wrote, "I can type 40 words per minute". I bet my left nut it was met with senior management rolling around the floor laughing. "HAHAHA, guffaw, titter, this Ben chap seems to think we actually type our responses to customers, HAHAHAHAH, has he not heard of our standard stonewalling template?"

I don't mean to have a pop at Ben Scott here, he's probably a decent sort who believes he's working for an agency that really have their finger on the pulse of dangerous medications...even if that finger hasn't been lifted since 2004.

I've had many public spats with the MHRA. I've had meetings with them, I've been labelled by them, I think the term was  "loose cannon". Yeh, I'm a loose cannon, I fire when I need to fire and not when someone tells me to, least of all some lickspittle agency that bends over in front of the pharmaceutical industry merely to 'take one for the team'.

Men, women and children are killing themselves whilst taking antidepressant medication. It's no cause for concern for the MHRA because their 'experts' told us 10 years ago that the benefits outweigh the risks.

Here's what Facebook looked like 10 years ago.

Facebook, unlike the MHRA, have changed. Many, if not all of their changes, have come as a result of listening to what the customer wants.

The MHRA, have remained in the same position regarding their stance on the safety of antidepressants, it's a position highlighted in the following picture...

Take a good look at the picture. It shows two things. It highlights how the MHRA like to bury their head in the sand, at the same time sticking their ass in the air so the Pharmafia can politely butt-fuck them when they step out of line. [Ooops, there's the loose cannon in me rearing its wayward head]

If using profanity is what it takes for this agency to sit up and take notice about the huge SSRi problem then swear I shall.

I ceased communication with the MHRA a few years ago. I have, since, sent them a few minor requests. I publicly noted my reasons for severing my ties with them in my book.

The MHRA will not meet with the CCHR because they don't want the cold, hard facts thrown at them. They don't want to have to go back to the issue of the safety and efficacy of antidepressants because by doing so it will highlight just how utterly incompetent they are as an agency. They don't want their 2008 investigation into GSK rehashed because it embarrasses them greatly. In brief, the MHRA carried out a four year investigation. The investigation  focused on whether GSK had failed to inform the MHRA of information it had on the safety of Seroxat in under 18’s in a timely manner. Despite finding that GSK HAD been slow in releasing this information, the MHRA decided not to prosecute them. Instead they opted to send them a letter asking them not to be naughty again. [GSK really took heed of that 2008 warning huh?]

In the words of Charles Medawar, "They [MHRA] have failed and they have failed miserably"

Bob Fiddaman

[1] Doris May Fisher Stokes, born Doris Sutton, was a British spiritualist and psychic medium.

MHRA - "Your Views Matter"

I think it's safe to say that I, over the years I've been writing this blog, have had a lot of correspondence with the British drug [ahem] regulator, the MHRA.

Most of my correspondence with them, at least 80%, has been bog standard replies that they send out to anyone questioning their stance on antidepressants. I've publicly chastised them on here and in my book many times. Had a meeting with their CEO and met other officials on numerous occasions both in London and Birmingham.

Thing is... they've never really invited me to leave any comment about how I rate their performance.

Imagine my surprise then when I learn that they are now offering that service to members of the public who request information from them.

The MHRA Customer Services Feedback, aptly run via the surveymonkey website, invites you to leave comments regarding their performance of answering requests you have made to them. Hmmm, they have never offered me any such link in any of the emails they have sent me.

Anyway, why look a gift horse in the mouth. Armed with a snipping tool I've filled in the forms on the survey and added them as jpgs for your perusal.

The MHRA recently appointed a new CEO. His name is synonymous with Paxil litigation. Dr Ian Hudson took over the helm from Kent Woods last year. Hudson had previously been depositioned by US Attorneys in a Paxil suicide case. You see, the man who is now head of the MHRA once worked at GlaxoSmithKline, moreover, he was head of World Safety at GSK [Then Smith Kline Beecham] and worked closely with Paxil.

Nice to have some impartial at the head of a drug regulatory agency, huh?

Hudson, unlike Woods, chooses not to correspond directly with consumers [stakeholders], instead emails are answered by other employees at the MHRA.

Anyway...I've wrote about the conflict of interests at the MHRA many times before. Back to the The MHRA Customer Services Feedback.

Here's my feedback...

Bob Fiddaman

Related

Another Boob From the MHRA

MHRA To 'Re-educate' UK Doctor's on SSRi's Part I

MHRA To 'Re-educate' UK Doctor's on SSRi's Part II "Keeping A Stiff Upper Lip"

MHRA To 'Re-educate' UK Doctor's on SSRi's Part III - MHRA's Ghosts In The Machine

MHRA - More on the Mysterious "Ghost Specialists" 

UK Drug Regulator [MHRA] Cosy Up to Sir Andrew Witty

Pfizer team up with the Medicines and Healthcare Products Regulatory Agency

MHRA: Disrespectful, Uncaring or just Downright Liars?

MHRA Described As "Toothless Watchdog

SEROXAT - The Legal Questions that must be answered

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part I of IV

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part II of IV - Witness For The Defence

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part III of IV - Expert Statistician

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part IV - The Colour of Money

MHRA Consultant Calls for Antidepressant Use in Young

Rebadge, Reinvent and Reap Rewards of ADHD Medication

One thing I've learned over the past 8 years of writing this blog is that the system that is supposed to protect us from dangerous drugs is a system that has been infiltrated by pharmaceutical dollars. Be it the FDA, MHRA or any other drug regulatory agency.

I've also learned that the only way one can change how we, as patients, view these psychiatric medications is by opposing the claims of pharmaceutical companies that they actually work and are safe for human consumption.

Be a pain in the ass, the big man doesn't like it. Ask questions, the big man doesn't like it.

I've got a lot of admiration for other folk who have dedicated their lives to getting to the truth about antidepressant type medication, be they human rights movements, professors, journalists, grieving parents or just folk who have the tenacity to never give up in their pursuit for the truth.

Janne Larsson is one such person.

Larsson, who hails from Sweden, has, for many years, been investigating the drug Concerta, an investigation that has now led him to the doors of the British drug regulator, the MHRA.

What we have here is deception of the highest order...a deception that Larsson wishes to make public.

Larsson has wrote to the new chief at the MHRA, Dr Ian Hudson. The question he has put to the former World Safety Officer for SmithKline Beecham is simple...Will the MHRA handle the Concerta scandal by approving Ritalin for adults?

Larsson, after many years of investigation, has kindly copied me in on the email to Hudson. It makes shocking reading.

He writes...

In the beginning of 2011 secret internal MHRA documents revealed: The application to get the ADHD drug Concerta approved for adults was refused; Concerta was found to have “negative benefit/risk balance” for adults.

The disapproval of the drug for adults has been a well-kept secret: NO information whatsoever has been issued by the MHRA or the other European medical agencies about the disastrous results.

Let’s look on what was hidden for doctors and the public.

This is the not published table over the Adverse Events of Concerta in clinical trials. It is part of the manufacturer Janssen’s “Response Document” (page 84) to the MHRA, from 11 January 2011.

In the Company’s three best (!) studies of Concerta on adults, the ones chosen for Janssen’s application, the following harmful events emerged in the short-term studies (up to 13 weeks), where Concerta was compared to placebo:

·         The persons who received Concerta had a 270% increased risk for heart disorders in form of Arrhythmias;

·         The persons who received Concerta had a 116% increased risk for Aggression;

·         The persons who received Concerta had a 62% increased risk for Depression;

·         The persons who received Concerta had a 225% increased risk for neurological disorders in form of Tics/Dystonias;

·         The persons who received Concerta had a 190% increased risk for Psychosis/Mania;

·         The persons who received Concerta had a 295% increased risk for Anorexia;

Meantime, in Larsson's native Sweden, Concerta prescriptions have risen by 60%, netting the manufacturer, Janssen, a cool 488 million SEK (45 million GBP)

Fear not... If one bad drug can be pushed in one country then expect the very same drug to be pushed in other countries. Step into the fray Novartis, manufacturer of Ritalin, an ADHD drug that is, in essence, exactly the same as Concerta.

Larsson finishes his email to the MHRA with the following...

I am sure Novartis has learned from the failed Concerta submission and that there is a big interest from the officials mentioned above to push through the approval of Ritalin for adults. We can expect that the submitted studies will get a positive assessment this time – no embarrassing questions – and suddenly the concealed and alarming Concerta results can be expected to no longer exist! Janssen will also be saved; no criminal actions will be taken.

But it’s hard to see how the above can fit with the MHRA declaration: “We protect and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.”

So Mr Hudson, will the MHRA take part in this dirty game of approving Ritalin, so that we can forget about the Concerta scandal?

It's a fair enough question but I don't expect an immediate response from Dr Ian Hudson. I wrote him in November as I was concerned about MHRA consultant, Stephen J W Evans and his recent call for a re-evaluation of the current prescription of SSRIs in young people.

Ironically, I received a reply a few hours ago, not from Hudson but from Sarah Morgan, Group Manager, Benefit Risk Management Group, Vigilance and Risk Management of Medicines.

My query wasn't really addressed by either Hudson or Morgan [no surprise there] - it was the bog-standard "the MHRA has comprehensively reviewed evidence on the benefits and risks of SSRIs" type of email.

I have to take off my hat to Larsson for pursuing this. I hope he is made of strong stuff, my experience with the MHRA and their limp-wristed buck-passing cahoots has been highlighted on my blog and in my book on many occasions.

Good luck Janne!

The full email sent to Hudson from Larsson can be downloaded here.

Bob Fiddaman

MY REPLY TO MHRA CEO, KENT WOODS

Image: angela-stevens.com



Following on from Kent Woods email to me yesterday regarding my criticism of the MHRA.

I would now like to offer you my response.

Before doing so I would like to point out the related links to Kent Woods at the foot of this post.

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

CEO of MHRA, Kent Woods, responds to criticism.

I have received a response from the CEO of the MHRA regarding the recent teratogen correspondence

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

European Regulators And Their Conflicts Of Interest

Image: randi.org


Ed Silverman over at Pharmalot writes about the conflicts of interest involving the pharmaceutical industry, the Irish Medicines Board, the Medicines and Healthcare products Regulatory Agency and the European Medicines Agency.

Findings, published in Social Science & Medicine, suggests there is reason for concern.

They found that the MHRA executive board since 2004 had five people who had industry backgrounds before joining the agency, one went on to an industry job after leaving and one participated in research funded by a drugmaker before joining the MHRA. In total, seven of 25, or 28 percent of MHRA personnel had a relationship with drugmakers.

“We found that of the 26 chairs of various Working Groups, Panels and Expert Advisory Groups 15 had personal interests, 12 had non-personal interests, 6 had both personal and non-personal interests and 10 had neither type of interest,” wrote the researchers. “Our review of the publicly available declarations of interests of the EMEA Management Board found that 25 percent of members declared interests in the pharmaceutical industry…

Read Ed's article HERE

Related links:

TALES OF THE PAROXETINE TERATOGEN BY BOB FIDDAMAN

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Pfizer and MHRA Pushing the Boat Out With Message

It would appear that there is a lot of money being splashed around by pharma giants Pfizer with regard to them 'helping' curb the popularity of people buying prescription drugs online.

The latest, in what seems to be a massive PR exercise, sees a new website called, 'REALDANGER. Get Real, Get a Prescription.'

The venture is led by Pfizer but has gained the support of, amongst others, the MHRA.

One would think that the MHRA have more important things to deal with, if their yellow card adverse reports are to be believed.

The latest number of reported reactions for Seroxat is 32,100 with a reported 169 deaths.

The image Pfizer are using to promote this initiative could also be used for those 169 people.


Image: realdanger.co.uk

Forgive me for being cynical but I do think the MHRA seriously need to get their house in order before they start proclaiming that 'fake drugs' are inferior to the ones that are currently under licence from them!

**Pfizer are the makers of Viagra, a drug that has been targeted by counterfeiters online.

Related posts: Is Seroxat a Teratogen?

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SEVERING TIES WITH THE MHRA

It seems uncanny that the first ever post on this blog, back in 2006, was to highlight the failings of the MHRA. Over three years has passed since that first post, 3 years, 7 months, and 16 days, 1,326 days, to be exact.

I was quite shocked when I worked this out. I've been writing for that length of time about something I am passionate about. I don't get paid for what I write, quite a lot of man hours put in for voluntary work one would think.

During these 3 years, 7 months, and 16 days the MHRA have investigated the safety and efficacy of Seroxat and other SSRis/SNRi's. Each time, they have concluded, that the benefits outweigh the risks.

On the 6th March 2008, the MHRA issued a press release, 'GSK investigation concludes'

Part of that statement reads:

The MHRA has concluded its four year investigation into Glaxosmithkline and its antidepressant drug Seroxat. The investigation focused on whether GSK had failed to inform the MHRA of information it had on the safety of Seroxat in under 18’s in a timely manner.

The investigation was undertaken with a view to a potential criminal prosecution for breach of drug safety legislation. It was the largest investigation of its kind in the UK, and included the scrutiny of over 1 million pages of evidence.

The decision taken by Government Prosecutors, based on the investigation findings and legal advice, is that there is no realistic prospect of a conviction in this case, and that the case should not proceed to criminal prosecution.

It continued with:

Professor Kent Woods, MHRA Chief Executive, said: “I remain concerned that GSK could and should have reported this information earlier than they did. All companies have a responsibility to patients, and should report any adverse data signals to us as soon asthey discover them. This investigation has revealed important weaknesses in the drug safety legislation in force at the time.

It is interesting to note that the deflection away from the behaviour of GlaxoSmithKline is directed toward the drug safety legislation in place at that time.

It is also interesting to note that in the four paragraph press release the MHRA choose not to chastise GlaxoSmithKline.

I, along with others, was never happy with the way this investigation was handled and, as with others, I made my feelings clear on this blog and in various other forms of communication with the MHRA. It was, however, something that I and others had anticipated.

The one chance at a criminal prosecution being brought against GlaxoSmithKline, scuppered by an antiquated drug safety legislation. To put it into layman's terms, The MHRA and GlaxoSmithKline had squared up for a fight in the ring. GlaxoSmithKline won on points. There was to be no re-match.

The response from GSK into the MHRA's conclusion of this 4 year investigation was more like a 'thank you' note if one reads between the lines. It smacked of smugness and a severe lack of conscience.

Both the MHRA and GlaxoSmithKline rode the storm that ensued, "Today's newspaper is tomorrow's fish and chip paper."

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MHRA Response: Limp-Wristed and Cowardly

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So here is the response the MHRA gave me.



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Is Seroxat a Teratogen? : All in 15 Days work

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It is important, before you continue to read on, that you read the first part of this particular correspondence with the Medicines Healthcare and products Regulatory Agency [MHRA] HERE

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Response From MHRA - "Is Seroxat/Paxil a Teratogen?"

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I first started writing this blog in 2006. I was basically frustrated at the lack of transparency coming out of the MHRA - My first post pointed to a story from 2004, it was, in essence, an article by Richard Brook giving the reasons as to why he resigned from the Expert Working Group who reviewed the safety of antidepressants.

Brook was then the CEO for the mental health charity, MIND, and he had accused the MHRA of failing in its duty by not acting on data showing that thousands of people were taking unsafe doses of Seroxat.

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UK Regualtor and Pfizer: From the silver screen to the small screen.

Earlier this year [Jan 2009] I wrote about the launch of an advertising campaign in cinemas across Britain that featured an advertisement regarding the safety of buying drugs online. The advert showed a man opening a package which contained a packet of pills, he opens the pills, swallows one then seconds later is seen pulling a dead rat from his mouth... this to symbolize how dangerous it is buying drugs online.

Today, the MHRA have announced that the ad is coming to the smaller screen [Television] and the 30 second or so ad will be screened after 11pm because it is 'considered so shocking'.

The ad was made from the money of Pfizer, no coincidence that Pfizer's biggest competitors are those online websites that sell Viagra... or am I just being cynical?

One only has to type the word 'Viagra' into Google to see the competition Pfizer face. [HERE]

Genius marketing spin would have us believe that Pfizer are genuinely concerned for the public taking fake pills. Is the real concern here driven by profits falling?

It's nice to see the regulator talking with advocates but working alongside pharmaceutical companies kind of leaves a bitter taste in my mouth.

Here is the ad that ran in cinemas up and down the country earlier this year.




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UK ADDICTION

An article that has appeared in the Independent newspaper has been sent to me. Thanks to Truthman, Ruth, Cyndi.

It is a report on Britain's epidemic of pill addiction. The Independent writes:

"The Department of Health has launched a review of the million-plus patients addicted to prescribed drugs in the UK in a tacit admission that attempts to control the problem over the last two decades have failed."

The article adds;

On Tuesday, Lord Montagu, the Earl of Sandwich, is to seek details of the Government review in the House of Lords and will say how the problem of addiction has impacted his own family.

He said: “Since January a member of my family has been suffering from acute withdrawal from this prescribed drug [a benzodiazepine]: his dreadful symptoms mean he is confined to his room, unable to work and attend to his family. He receives no government or medical support because there is none.”

A familiar story to those of us that are or ever have been hooked on antidepressants. Remember, SSRi's are not addictive, at least according to the manufacturers and medicines regulator. Benzo's are addictive, for some time now many advocates have been saying the same about SSRi's. Will it take a a member of the Knighthood to highlight the dangers of SSRi's because one of his family members has been affected by them?

The BNF is a guidebook for doctors, it is updated every six months. The current information for benzo's is pretty thorough whilst the information for guidance on SSRi withdrawal is poor, in fact it is very poor.

I cannot go into too much detail but there are movements behind the scenes, the wheels have already been set in motion to edit the poor guidance in the BNF.

Are SSRi's addictive?

The difficulty here lies in those individuals who make claims that 'they had no trouble withdrawing' - I don't dispute that they did but it appears that the MHRA treat these sort of anecdotal reports with a gold star whilst reports of patients suffering withdrawal are currently logged and... well, that's pretty much it.

Last week, Janice Simmons of the Seroxat User Group and I met with the Communications Director of the MHRA, Simon Gregor. I have previously wrote about that meeting here.

We covered the 'addiction' problem quite extensively. Where the MHRA are failing [and they know it] is the system set up to report adverse drug reactions [Yellow Card]

The system, I believe, is not robust enough to collect and correlate data. There is NO mandatory law that states a doctor MUST report an adverse event of a drug. Patients remain largely unaware that such a reporting system exists and many doctors surgeries only carry the odd few yellow cards [normally in the back cover of the BNF]

Credit has to be given to the MHRA for realising that their system is flawed, it has taken them long enough but things are about to change. Simon told both Janice and I that a pilot scheme is soon to be set up in the UK that will try to encourage more reporting of adverse drug reactions from patients. I liked the idea and, I believe, it will improve the current system.

The MHRA are aware that the need to do more to encourage people to report adverse drug reactions is paramount [by both patients and doctors] and this 'pilot scheme' is a step in the right direction. We also spoke about the importance of a wide range of healthcare professionals being "in the loop" both on Yellow Card reporting and on new information/warnings about drugs eg pharmacists, coroners.

The pilot scheme will be launched soon and will involve a promotional push for reporting ADR's.

The failure of the Yellow Card system has been highlighted by many. Charles Medawar was banging the drum about the 'flawed system' many years ago when transparency at the MHRA didn't exist. Myself and Janice and other advocates have also heavily criticised the system over the years.

If enough people bang the drum, the MHRA will not be able to cover their ears from the noise.

I will criticise the MHRA on here and in person if they appear to be failing in certain areas and I will also applaud them if I feel they are doing right. With the pilot scheme they should take a bow. I just hope that it is not a PR exercise to stifle its critics. I genuinely believe it is not.

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Action on Britain's epidemic of pill addiction

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This from today's Independent newspaper.

Action on Britain's epidemic of pill addiction

Peer to use House of Lords speech to reveal relative's addiction to prescription drug.

The Department of Health has launched a review of the million-plus patients addicted to prescribed drugs in the UK in a tacit admission that attempts to control the problem over the last two decades have failed.

An estimated 1.5 million people are addicted to prescription and over-the-counter drugs including benzodiazepine tranquillisers, sleeping pills such as zoplicone - implicated in the death of Hollywood star Heath Ledger - and painkillers containing codeine.

The review, which began in July, was disclosed in a Westminster hall debate last June but has not been formally announced. It followed a report by the House of Commons all-party group on drugs misuse which called for better training for doctors in the risks of over-prescribing, greater awareness of the scale of addiction and more centres for treatment.


The article continues here and highlights the story of a man who was prescribed the SNRi Efexor and Clonazepam, a benzodiazepine, to help him sleep following the failure of a business venture in 2001.

It's a decent article and this subject matter has been raised my myself and other advocates to the MHRA on numerous occasions.

Hat - Tip: Steph & Cyndi

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Yesterday's Meeting with MHRA and Janice Simmons [Seroxat User Group]

Meeting fellow advocates who dedicate their time and energy into helping others can be an uplifting experience. I have corresponded with many but met very few.

Yesterday I travelled to Peterborough to meet up with Seroxat User Group campaigner, Janice Simmons, and MHRA Communications Director, Simon Gregor.

I arrived in Huntington and was greeted by Janice at the train station, we had never met before but the 'connection' was made instantly upon meeting.

Janice has been campaigning and helping thousands of people for years. She, like myself, does this voluntary, she, like me, is concerned about SSRi use, she, like me, thinks the MHRA should be doing more.

We had an hour before Simon Gregor arrived so Janice drove the short journey back to her home. It was there where I saw just how active Janice is in her fight. Her computer room is akin to a vault of printed emails, internal documents, years of hard work and passion.

Janice has met with the MHRA on a number of occasions, she has sat with MHRA CEO, Kent Woods, and aired her concerns, she has provided the MHRA with countless documents. Janice has also met with Prime Minister, Gordon Brown to discuss the problem of SSRi's.

I have nothing but respect for Janice Simmons. With over 40,000 emails sent to her over the years, she logs and answers every single one, in fact it could be argued that Janice receives more emails than the CEO of the MHRA, Kent Woods, unlike Kent, Janice answers every single one, she sees them all as being of equal importance. A lesson that Kent Woods should take on board.

We briefly discussed the new 580 page N.I.C.E. clinical guidance that was released 24 hours previously. We, along with the MHRA, have been waiting for this to be published so we can all move on to 'phase 2', which would be to get the British National Formulary [BNF] to alter the wording with regard to guidance on withdrawal for SSRi's. Currently, the guidance in the BNF is pretty slim to say the least.

The new guidance touches on that word 'addiction' again and it is very interesting, if not contradictory, to see the N.I.C.E. criteria for addiction. I, along with Janice, believe Seroxat is addictive, I have my own personal experience with it where as Janice has over 40,000 emails of people writing her telling of their horrific withdrawal stories. Are all SSRi's addictive? Yes, I believe they can be, I cannot be any broader than that as Seroxat was the 'chosen' one for me.

Simon arrived and, to be fair, was cross-examined by myself and Janice for approx three and a half hours. We spoke of addiction, withdrawal, the pharmaceutical industry, the yellow card system, swine flu - where we [Janice and I] think the MHRA are going wrong. It was another chance to air our grievances and another chance for a representative from the MHRA to sit and listen to patients [or patient advocates].

Simon has took up the mantle of speaking to patients [and/or advocates] because he believes it is a way forward for the MHRA. Without these discussions the MHRA would, I believe, stand still.

Janice and I made a few recommendations with regard to the print-outs for Adverse Drug Reaction reports [ADR's]. As no minutes were taken [because it was basically an informal discussion] I cannot recall each of the printed ADR's Janice showed both myself and Simon. I can recall that there has been over 32,000 ADR's for Seroxat. One recommendation we made was to have the ADR's to be more specific. For instance how many of the 32,000 was due to withdrawal problems?

I think we can safely assume that the 32,000 figure is well below the actual figure, if we multiply that sum by 10 then we have a more realistic figure. So 320,000 ADR's on Seroxat alone - quite alarming. It is unknown how many of these are duplicated [from the same person] but nonetheless alarm bells should be ringing at such as huge figure. We touched on the military and the reporting of ADR's too. To be honest, and I don't think he will mind me saying, the military and ADR's had not occurred to Simon before yesterday's discussion. Evidence that these types of discussions can be beneficial.

Simon Gregor does not have all the answers, he has never professed to have them all. What he clearly has is a tool, a valuable tool. That, ladies and gentlemen, is people like myself and Janice who can take the MHRA down roads where they have never ventured before.

Talking with patients and patient advocates is a step in the right direction. Critics, of which I know there are many, will claim these discussions are pointless and it is merely a way of the MHRA stifling our voices.

Simon and others at the MHRA are more than aware that no discussions or top level meetings will stifle my voice. One could argue that this blog, along with others has opened the doors to these types of discussions. One only has to look at the first ever post on this blog, it was in 2006 - I was pissed off at the MHRA for ignoring me. I never in my wildest dreams envisaged some three years down the line myself and a Communications Director would be in the same room discussing the regulatory system.

Was yesterday beneficial? I think so... I hope so.

The MHRA have a lot of catching up to do because they have previously been about as open as a virgin's legs, about as welcoming as a box of rattlesnakes.

Personally, I believe, huge strides have been made to alter the lack of transparency within the MHRA. They are trying but they still have a long way to go. Their CEO, Kent Woods, should take a good look at what Simon Gregor is trying to achieve. Kent should come to terms with the fact that the most important people are patients and if he genuinely wants to turn things around then he should not only listen but he should correspond too. Just because our names don't have 'Doctor' or 'Professor' before them does not make us or our opinions less valuable.

So, where do we go from here? Who knows? But to be at this stage when approx three years ago I was talking to a wall, is a slight achievement.


Will we meet again? Most definitely. Both Janice and I have a vision of a whole bunch of advocates and pharmaceutical industry executives sitting round a table with the MHRA. Personally, I'd like Glaxo's Alistair Benbow and/or GSK Chief, Andrew Witty, to sit in the same room as me and for them to tell me that my personal experience with Seroxat had nothing to do with their company. I'd then like them to tell me that the thousands of others suffering withdrawal at the hands of their drug had nothing to do with their company. The same would apply to any other patient and pharmaceutical chief.

Nothing is impossible. Talking is a good starting point.

For the record, my travelling expenses was paid for by the MHRA - that being a train ticket from Birmingham to Huntington [and back again].

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Meeting Tomorrow

An early start for me tomorrow. I'm meeting with Janice Simmons from the Seroxat User Group and Simon Gregor, Communications Director of the Medicines Healthcare and products Regulatory Agency [MHRA]. No doubt, this will prompt a barrage of Freedom of Information requests to the MHRA from the sad individuals who have become obsessed with my meetings with the MHRA. [1]

There is no conspiracy but I expect the usual claims from the idiots.

Anyway, I will let you know the outcome when I get back tomorrow

[1] Stalkers Request Information from MHRA

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Press release: Safety monitoring programme up and running for swine flu vaccines

The MHRA have today issued a press release with regard to its Adverse Drug Reaction [ADR] website for reporting suspected side effects to H1N1 [swine flu]

MHRA Chief Executive Kent Woods said, “The MHRA’s first and main priority is to promote and safeguard public health. Even when the balance of benefit and risk is overwhelmingly favourable, as for the swine flu vaccine, we are committed to rapid evaluation of all new information.

“Our robust systems enable real-time safety monitoring and we encourage people to use the Swine Flu Portal to enable quick and effective analysis. We will make this information available to the public regularly on our website.”

Full story and downloadable document HERE

For those that don't know, the swine flu vaccine, Pandemrix, is manufactured by GlaxoSmithKline [GSK]

Seeing as MHRA CEO Kent Woods speaks of Risk/Benefit ratio, I think it only fair to add a link to Evelyn Pringle's 2nd investigative look into, what she terms, 'The swine flu propaganda'. Part one can be read HERE, whilst part two is available HERE

...Meantime, the MHRA have still not yet made a statement regarding GlaxoSmithKline being found guilty of manufacturing a drug that causes birth defects!

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Open Email to CEO of MHRA re GlaxoSmithKline and Seroxat

Dear Mr Woods [and others copied in on this email]

As you will now be aware GlaxoSmithKline have once again been found guilty of withholding important information with regard to their best-selling antidepressant, Seroxat.

As a concerned citizen of the United Kingdom and former Seroxat user I would like to know if the MHRA intend to prosecute GlaxoSmithKline for this particular crime.

You will be aware that a jury in Pennsylvania, United States, found by a majority of 10 to 2 that GlaxoSmithKline were negligent in not warning the mother of Lyam Kilker about the dangers of taking Seroxat whilst pregnant. The jury also found that Seroxat was the causation of Lyam Kilker being born with heart defects. You may wish to read the deposition of Jane Nieman [former GSK Executive] - Your current employee, Dr Ian Hudson even gets a mention!

Now, the way I see it Mr Woods, is that Seroxat and GlaxoSmithKline will pay the Kilker family the compensation awarded then go about their daily business in their usual manner.

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