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

Donald Trump - The Role of Psychiatry

I'm not into politics, particularly American politics. I've often laughed at the whole election process over there. Obscene amounts of money thrown at huge campaigns, even rock stars get in on the act in efforts to persuade their fans who to vote for. Here in the UK it's very low key. On the odd occasion, we may see a minor scuffle outside a polling station on a damp and dreary Thursday ~ It's nothing compared to the firework displays and live bands performing for our American counterparts.

So, if I'm not into politics why am I using my free time on a Sunday to write a blog about Donald Trump?

Well, I'm finding him very interesting. I can't weigh him up though. I know he has a disdain for journalists and I know he tweets a lot. His tweets are causing concern for many as are his speeches, so much so that a number of mental health professionals are claiming that Trump’s speeches and actions make him incapable of serving safely as president. They claim that Trump is showing 'grave emotional instability.'

In a letter to the New York Times, no less than 35 health care professionals, led by Lance Dodes, M.D., claim that:

(Donald Trump's) actions demonstrate an inability to tolerate views different from his own, leading to rage reactions. His words and behavior suggest a profound inability to empathize. Individuals with these traits distort reality to suit their psychological state.

Let's take a look at this closer by using the Merck Manual of personality disorders.

According to the 35 health care professionals, Trump is showing:

- grave emotional instability - Another term for this, I guess, could be 'emotionally detached.'
- profound inability to empathize -

Schizotypal personality disorder
People with schizotypal personality disorder are emotionally detached. In addition, they have odd ways of thinking, perceiving, and communicating similar to those of people with schizophrenia. Odd ways of thinking may include magical thinking and paranoid ideas. In magical thinking, people believe that their thoughts or actions can control something or someone. For example, people may believe that they can harm others by thinking angry thoughts. People with paranoid ideas tend to be suspicious and mistrustful and wrongfully think other people have hostile motives or intend to harm them. Schizotypal personality disorder may be treated with antipsychotic drugs.

Fair to say that Trump, if the 35 professionals assessment of him is correct, would meet the criteria for someone having Schizotypal personality disorder.

But wait, there's more from the Merck Manual:

Antisocial personality disorder
Many people with antisocial personality disorder become frustrated easily and tolerate frustration poorly. As a result, they act impulsively and irresponsibly, sometimes committing criminal acts. In these cases, they act without considering the negative consequences of their behavior and the problems or harm they cause others. There are no medications specifically approved by the Food and Drug Administration to treat antisocial personality disorder. Doctors may prescribe medications for conditions sometimes associated with antisocial personality disorder, such as anxiety or depression, or for symptoms of aggression

Furthermore:

Narcissistic personality disorder
This type is characterized by an inflated view of self-worth (called grandiosity). People with this disorder expect to be treated with deference and may exploit others because they think their superiority justifies it. Their relationships are characterized by a need for admiration, and they often think that others are jealous of or envy them. These people are sensitive to the reactions of others but only as far as the reactions relate to themselves. They are extremely sensitive to failure, defeat, and negative reactions from others, including criticism. Such reactions from others can trigger sudden rages or depression (including suicidal thoughts or actions). There are no medications specifically used to treat narcissistic personality disorder. However, if you have symptoms of depression, anxiety or other conditions, medications such as antidepressants or anti-anxiety drugs may be helpful.

Moving across to the Diagnostic Statistical Manual of Mental Disorders, we see Trump also meets the criteria (If the 35 health care professionals are to be believed) for:

Obsessive-Compulsive Personality Disorder
Empathy: Difficulty understanding and appreciating the ideas, feelings, or behaviors of others. In most cases, medication for this disorder is not indicated unless the individuals is also suffering from another psychiatric disorder. However, newer medications such as Prozac, an SSRI, have been approved for the treatment of obsessive-compulsive disorder and may provide some relief to individuals with the related personality disorder.

In fact, according to the 35 health care professionals, Trump also meets the criteria for Avoidant Personality Disorder and Borderline Personality Disorder, both can be treated with psychiatric medications.

So, my question to these 35 health care professionals is simple, however, I don't expect an answer.

If Trump was your patient would you prescribe him any of the medications listed above and let him continue in office?

I highly suspect the answer would be a defiant 'No' - not because they don't want him to continue in office, not because they believe that Trump is beyond repair either. Neither of these health care professionals would prescribe any psychiatric drug to Trump because of this one Tweet:

Military solutions are now fully in place,locked and loaded,should North Korea act unwisely. Hopefully Kim Jong Un will find another path!

— Donald J. Trump (@realDonaldTrump) August 11, 2017

Why would any psychiatrist or doctor prescribe an antipsychotic or SSRI to someone who throws out a gauntlet like this?

Which brings me nicely to the recent Panorama programme, 'A Prescription For Murder.'

James Holmes, despite telling his psychiatrist he had murderous thoughts, was prescribed the SSRI sertraline, known better by its brand name of Zoloft in the US and Lustral in the UK. Holmes, after taking sertraline for 6 weeks carried out those murderous thoughts regardless. Much was said in the defence of SSRIs prior to and after the airing of the Panorama programme. Those same critics who chastised Panorama are now in a wonderful position. Why not let them decide if a psychiatric drug, which they believe does not induce murderous thoughts, should be administered to President Donald J. Trump?

If they are so cocksure that the benefits of these types of medications outweigh the serious risks they can pose then I'm sure they will pull out their prescription pads and write him a prescription for some medication.

Given what we know about these meds, and what we have been saying for many years about these meds, this is one occasion where psychiatry can prove us all wrong.

I double-dare you all.

Bob Fiddaman

Making Sense About Science Media Centres

I'm worried.

I feel kind of deflated.

I've been blogging for over 11 years and met with many people, most of whom have lost loved ones to antidepressant-induced deaths. I've watched blogs come and go, campaigners who had a fire in their bellies slowly fade away because sometimes it all can get to be too much.

Earlier this week I was alerted to a post on David Healy's popular blog regarding the Science Media Centre. (SMC) I'd never heard of them before so read Healy's 'Honey I Shrunk the Shrinks' with great interest.

As a writer and researcher, I rarely take one post at face value. I always research the subject in question. During my research of the SMC, I became increasingly concerned that this is something we should all be looking into. To say it's alarming is an understatement.

The SMC is like something you would read in a Dan Brown novel. It's the type of organisation that one sees pop up on their daily news feeds on Facebook, usually accompanied by a link that directs you to websites that claim the earth is flat or man has never walked on the moon, you know the type.

What's different about the SMC, however, is they don't hide what they do, nor do they hide who funds them.  Maybe this is a purposeful act, one that shows the minorities that SMC has muscle?

Without naming all their financial backers (there's too many, past and present) I've picked out some of those that cause me great concern.

Present funders include:

Royal Pharmaceutical Society
Institute of Psychiatry, Psychology & Neuroscience (IoPPN)
Medicines and Healthcare Products Regulatory Agency (MHRA)
Merck Sharp & Dohme (MSD) Limited
Association of the British Pharmaceutical Industry (ABPI)
British Pharmacological Society
National Institute for Health and Clinical Excellence (NICE)
Royal College of Psychiatrists (RCP)
AstraZeneca
GlaxoSmithKline (GSK)

Previous funders include:

Daily Express
Eli Lilly & Company
Institute of Mental Health
Mental Health Foundation
Mental Health Research Network
Mental Health Research Network Cymru
News International Ltd
Pfizer Limited
Rethink
Scottish Mental Health Research Network
World Health Organisation (WHO)
Wyeth

There are many more pharmaceutical companies that are or have funded the SMC. I've just focused on those that market and manufacture antidepressants.

So, who exactly are the SMC?

They were formed in 2000 after the House of Lords Select Committee on Science and Technology's third report on "Science and Society." This report claimed there was a better need for more experts in the field of science to offer expert information in the media.

So, why should we be worried?

Well, one doesn't have to go too far back to see an example of the SMC in action, in fact, we only have to go back a couple of weeks to July 26, 2017, just one day before Panorama's 'A Prescription For Murder' was shown on British TV screens. The eagerly awaited programme was dismissed as 'scaremongering' and 'stigmatizing' 24 hours before it aired. The MHRA and the RCP (highlighted above) took to Twitter on the morning of the 26th.

RCP tweets included:

#BBCPanorama claims irresponsible and unfounded. Scaremongering title alone shows real stigma people taking #antidepressants face.

and

More #antidepressant prescriptions=more people getting help. Not more potential murderers. Don't stigmatize people needing help #BBCPanorama 

Whereas the MHRA tweeted:

SSRIs have been used to effectively treat millions of people worldwide & like all medicines, the safety is continually monitored.

More on the MHRA later.

All above board and predictable, one would think, until you dig deep into the SMC and what it is they actually do. It all becomes clear when you read their blurb:

The Science Media Centre’s ultimate goal is to facilitate more scientists to engage with the media. We provide support for scientists to engage with the media when their area hits the headlines, offering expertise of a team with over 10 years’ experience in science media relations. We have an ever expanding database of experts and have strong connections with UK universities, industry, learned societies and scientific institutions.

The SMC also runs off-the-record brainstorms to discuss how the scientific community can effectively coordinate its media relations on controversial issues within science. Occasionally the SMC will run subject-focused advisory sessions in anticipation of big controversial stories.

No surprise then that stories appeared in the British media before and after the airing of Panorama. Most, if not all, the articles featured an "expert" who claimed Panorama was stigmatizing and scaremongering. They were also stating that drugs, such as sertraline, which was heavily featured in the programme, do not cause people to go out and commit murder.

In defence of all these claims I, along with Kristina Gehrki, wrote a blog post entitled 'Panorama: Prescription For Stigma?' It proved to be popular and was shared many times on social media, particularly in the first 24 hours.

Around 8 hours after I went live with my co-written piece, MQ, a mental health website, ran with an eerily similar headline, 'A Prescription For Stigma: Why Evidence Matters.' The article was written by Ed Sykes who, coincidently, is Head of Mental Health and Neuroscience at the Science Media Centre.

In not supporting Panorama's efforts to increase awareness, Sykes wrote something quite striking:

The main evidence the programme seemed to be giving us, alongside the case studies, was the result of a Freedom of Information request to the Medicines & Healthcare products Regulatory Authority (MHRA). The MHRA is responsible for many aspects of healthcare, including a Yellow Card system that records all the bad side-effects linked to any drugs. The Panorama team informed us that their investigation had unearthed 28 cases linking antidepressants to murder and 32 to murderous thoughts. The show did point out that these were just reports, not conclusions that the drugs had caused murder. But what they failed to mention was that these reports to the MHRA can be made by anyone. You or I could go on their website right now and make a report, it doesn’t necessarily mean it was a medical professional who reported it or that the report was supported by strong evidence. 

What Sykes, in his efforts to play down the 28 cases linking antidepressants to murder, failed to mention is the follow-up that the MHRA do when they receive a Yellow Card report. It was a question I put to them back in 2015. Their reply was the bog-standard game of semantics they have played with me for the past 11 years or so, further, they asked for payment to release the information. You can see the correspondence here and here.

Ed Sykes really should have done his homework before throwing out the 'correlation does not equal causation' line.

Before finishing my introduction to the SMC, I'd like to congratulate Prof. Sir Mike Rawlins, former Chairman of NICE (highlighted above) who, a month ago, was honoured by the Queen for his services to the safety of medicines, healthcare and innovation.

Oh, something else: Prof. Sir Mike Rawlins is the current Chairman for the MHRA. Prof. Sir Mike Rawlins also sits on the Board of Trustees at, you've guessed it, the Science Media Centre.

Now, who was it that coined the term 'revolving door'?

Bob Fiddaman

GSK Blame Stewart Dolin in Move for New Trial

One would have thought the case filed against GSK by Wendy Dolin was done and dusted. However, GSK has been adamant that the verdict handed down by the jury in Chicago last April is wrong. (Boo hoo)

Cry Me A River

GSK continues to cry its river of DeNile after being found responsible for Stewart Dolin's Paxil-induced death. Together with its King & Spalding lawyers, GSK now claims:

1)  U.S. District Judge William T. Hart did not properly instruct the jury

2) Dolin's doctor did not properly warn his patient that GSK's product increases suicidality and suicide

3) Ergo, when Dolin started suffering from Paxil-induced akathisia and psychosis, he should have noticed these adverse drug reactions (ADRs) before dying.

To most people, GSKs claims are ridiculous. But for GSK and other pharmaceutical companies, such outlandish claims are just business as usual.

GSK is essentially saying, "Yes, our drug and any generic version of it, has a propensity to cause someone to kill themselves. But we refute any responsibility because, together with the FDA, we wrote a vague warning about these risks. Further, doctors who prescribe our drug should communicate these risks to patients. Then, it is up to Paxil consumers to "choose" whether or not they want to kill themselves when suffering from Paxil-induced akathisia."

GSKs' claims are similar to ones they repeated for six-weeks during the Dolin vs. GSK trial. GSK blamed Stewart Dolin's death on his supposed "illness." GSK blamed Dolin's death on the doctor who prescribed their product. GSK blamed Dolin's death on the FDA. Now, GSK is blaming the judge for the jury's guilty verdict against GSK.

Don't Ya Just Love 'Em?

The jury ruled against GSK because the lackluster King & Spalding legal team couldn't defend the indefensible. Mounds of evidence piled up exposing GSKs greed and guilt. (The jury was likely also shocked to hear about the pile of bodies GSK tried to conceal--those innocent volunteers who died during Paxil's clinical trials.)

Not only did the jury find GSK responsible for Dolin's death; they also found GSK responsible for Dolin's pain and suffering. Therefore, they made two separate monetary awards.

GSK doesn't want to pay nor admit guilt. They are calling for a new trial and repeating their tactic of blaming everyone else for the ADRs their product causes. GSK states:

-  Its hands were tied because supposedly drug regulators would not allow GSK to use the specific warning language it wanted

- The jury instructions didn't entirely separate/7' different elements necessary for liability

- The doctor's testimony shows he was aware of the risk when prescribing paroxetine.

GSK's lackluster defense saw the jury rule in favor of Wendy Dolin and award her $2 million for wrongful death and $1 million for pain and suffering in the days before he took his life. She has yet to see a dime of that award because GSK are crying this river of denial. (De Nile)

Wendy Dolin, via her legal team, Baum Hedlund and Rapoport Law Offices PC, said Stewart's doctor testified that when he decided to prescribe the drug, he relied on the 2010 Paxil label. This Paxil label didn’t warn that Paxil could lead to suicidality in adults over age 24.  Furthermore, GSK failed to alert drug regulators that research showed an increased suicide risk among adults who take Paxil.

In 2007, GSK was invited by the FDA to discuss the inclusion of label language specific to adult suicidality. GSK then failed to meet with the FDA about this labeling issue. GSK did, however, have a duty to warn consumers even if the FDA decided not to. A 2006 video deposition played at trial shows GSK's former head, JP Garnier.

"You can change your label without even getting approval from the FDA, there's a law that allows you to do that, correct?"

Garnier answered, "Yes, but in practice, you don't want to do that."

He was then pressed, "Okay. But you can do it if you want, the law allows that to occur?"

Garnier replied, "Yes, but you do want the FDA to agree with the changes you are going to propose because they have the power to correct what you just said the day before. You know, let's say we decide to inform physicians of some new event affecting our drug, well, the next day the FDA might come back and say, well, we didn't like the way you did this, you have to redo it. So it's considerably disrupting, that's why most companies go through the FDA first, in practice, but you are right, there is a legal right for us to go directly to the public."

So, even Glaxo's own head was agreeing that GSK could have by-passed the FDA if it wanted to. The key phrase here is from Garnier's own mouth, "...there is a legal right for us to go directly to the public."

During the trial, it was revealed that there were 20 adult suicides in paroxetine clinical trials. Supposedly, there were no completed suicides in the paroxetine pediatric trials. (I say "supposedly" because one can never be certain if drug companies and regulators are telling the whole truth.) The clinical trial deaths beg the question: Why would GSK go to great lengths to confuse prescribing doctors with the warning about suicidality for patients under the age of 24?

GSK: A Forked-Tongue Monster 

Seeing GSK in court conjured up images of a forked-tongue monster speaking from both sides of its mouth. On opening day of the Dolin vs GSK trial, GSK's attorneys told jurors Paxil does not cause suicide.

Later, GSK lawyers claimed the company did everything in its power to show Stewart's doctor that Paxil increases the risk of suicidal thoughts and suicidal action among anyone who consumes it.

I'm reminded of a scene from the brilliant Fawlty Towers. Basil (John Cleese) returns to his hotel to discover that the building renovations haven't quite gone according to plan. We see "fault" here being passed around from pillar to post. Basil's reaction is priceless.

I suspect if Stewart Dolin was alive today, this would be his response.

Law 360 write about GSK's latest shenanigans here.

Bob Fiddaman


How the trial unfolded - a day-by-day account

Dolin v GSK - Opening Arguments

Dolin Vs GSK - Day Two - "Jack-In-The-Box"

Dolin vs GSK - Healy 'Rocks Da House'

Dolin Vs GSK - JP Garnier Video Deposition

Dolin Vs GSK - The Dunbar Tape

Dolin Vs GSK - Day 4 - Slam Dunk

Dolin Vs GSK - 8.9 Suicide Increase For Adult Paxil Users

Dolin Vs GSK - Day 6 - Ass Kicking Semantics

Dolin Vs GSK - Day 7 - Abraham Lincoln

Dolin Vs GSK - Day 8 - Get to the Point, Todd!

Dolin Vs GSK - Glenmullen Nails It!

Dolin Vs GSK - "Babes"

Dolin Vs GSK - Wendy's Cross and GSK's Petition

Dolin Vs GSK - Robert "Bling Bling" Gibbons

Dolin Vs GSK: Suicide Prevention Warning "Futile", Claims GSK Exec

Dolin Vs GSK: Jury shown List of the Dead in Paxil Clinical Trials

Dolin Vs GSK: Last Man Standing & The Return of Dr. Healy

Dolin Vs GSK: Closing Arguments

Dolin Vs GSK - The Verdict