Monsanto Roundup Lawsuit

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

Friday, September 15, 2017

Dolin Wins...Again

GlaxoSmithKline (GSK) has been delivered a devastating blow by Judge William T. Hart in their efforts for a new trial against Plaintiff Wendy Dolin who, earlier this year, won her case against GSK after a jury found that GSK had not properly added adult suicide risk warnings to the label of paroxetine, the controversial antidepressant popularly known by its brand names of Paxil, Aropax and Seroxat.

Hart pulled no punches after GSK tried desperately in vain to blame his decisions during the trial, a trial in which they blamed everyone but Paxil for the death of Stewart Dolin.

GSK wasn't happy with the verdict decision by the jury so immediately filed motions for a new trial claiming, amongst many things, that...
 - The jury wasn't reasonable enough because they didn't return a verdict in favour of GSK.
 - Stewart Dolin's Dr should have told Stewart about the Paxil suicide risk in adults, even though GSK never made this clear on the labeling
 - It wasn't their responsibility to change the label, it was the FDA's
 - Stewart killed himself because of an underlying illness, in any event, he took a generic version of their drug and even though they (GSK) were responsible for the label of that generic drug doesn't mean they should be held liable
 - Dolin's expert witness testimony wasn't reliable
 - There is no causal link between Paxil and suicide
 - The judge never instructed the jury properly
So, every possible excuse under the sun then. In not accepting defeat graciously GSK, via their hired suits of King & Spalding have made themselves look like spoiled little brats, and we all know how to treat spoiled little brats, right?

Well, Judge Hart does. He looked at their limp-wristed motions and answered them in stylish fashion. Pay particular attention to his stance of whether or not Paxil can cause suicide.

Regarding Stewart's doctor failing to warn about the adult risk of suicide in adults taking Paxil, Judge Hart ruled that Stewart's Dr was not aware of the suicide risk, further, the Paxil label did not adequately warn of an increased risk of suicide for adults taking Paxil.

He told them they did not provide the court, or indeed the jury, with evidence that the FDA would never have allowed such a warning on the label, adding that because Stewart took the generic form of Paxil does not mean that GSK cannot be held liable.

He disagreed with their claim that Dolin's expert witnesses were unreliable by merely counteracting it with "they were reliable."

He went on to tell GSK that there were no errors in instructing the jury.

Most damning of all was the following...
"There is a causal link between Mr. Dolin’s ingestion of paroxetine, his side effects, and consequent suicide."
For years pharmaceutical companies and global medicine regulators have claimed that correlation does not equal causation - However, unlike Stewart Dolin's widow, Wendy, and her legal team of  Baum Hedlund Aristei & Goldman PC, and David Rapoport and Matthew Sims of Rapoport Law Offices PC., regulators never investigate the suicides so they can always claim that correlation does not equal causation - if they actually went out and spoke to doctors and the grieving family members, they may learn a thing or two.

So, what happens now? Will GSK walk away licking their wounds and cough up the $3 million awarded to Wendy Dolin back in April, or will they retain the services of King & Spalding once again to take this matter to the Supreme Court? King & Spalding had nigh on 6 weeks to cross-examine, they did so with inane questions that were more designed to try and catch witnesses lying rather than strike home the point that Paxil does not cause some adults to kill themselves. They failed on a humungous scale and they may, if given the go-ahead from GSK, try their embarrassing tactics on a bigger stage, that of the Supreme Court. At what point does GSK or, indeed, King & Spalding not realise that the whole of the industry is in a complete state of apoplexy watching their comedic performance? Seriously, Messrs Bayman and Davis, along with the bald-headed guy who filed his fingernails at the King & Spalding table in court, should be up for Best Comedy Performance by a legal team in 2017. That's one presentation I would attend, if only to give them a much-deserved standing ovation as they went to collect their award.

If I were GSK I'd take a long, hard look at those they hire to defend cases for them. In this instance, King & Spalding, the legal outfit from Atlanta have not only embarrassed themselves, they have embarrassed GSK too. (If that's possible) They have all the traits of narcissism, believing that they are all-empowering. GSK's grandiose sense of self-importance obviously rubbed off on the King & Spalding team when they opposed the judge in this case. Their sense of entitlement is all too plain to see, as is their lack of empathy and unwillingness to recognize or identify with the feelings and needs of others. Finally, their arrogance is staggering - The jury was wrong, Dolin's experts were wrong. the judge was wrong.

It will be very interesting to see how this will now unfold. Will GSK take a look at King & Spalding and think, 'well, that was another bag of money wasted at our stakeholder's expense', or will they continue to argue that black is really white and everybody else is wrong? King & Spalding didn't just fail GSK by losing this case and the chance for a new trial, they failed every other single pharmaceutical company waiting anxiously in the wings to see if they could themselves be held liable in potential future litigation.

As a blogger writing and researching GSK for the past 11 years it gives me great pleasure to write about them and all their failings, their dystopia is my utopia.

Here's another ditty to them.

Sing to the tune of Hot Chocolate's 'So You Win Again' (Lyrics beneath video)

"Dolin Wins Again"

Just to admit one mistake
That can be hard to take
I know you've made them all
Like fools, you come back for more
Being the fool you are
I figured in all your plans, Glaxo
Your endless motions didn't say
About the Paxil deaths, you hid away.

Dolin wins again, she wins again
Here you stand again, the loser
And just for fun you took Stew's life and run,
And now you've been outdone

You can't refute her
But now you know that you're the fool
Who lost your case, you lost it all
If you come back, you'll lose again
And I am proud to say
The Press will have a field day
Now she's the one who's crying
Because of your denying
When will her heartache end?
Will her whole life depend on fading memories
You took his life so stop now, please

Dolin wins again, she wins again
Here you stand again, the loser
And just for fun you took Stew's life and run,
And now you've been outdone

2017 (C) - Fid Chocolate 
(Original lyrics by Russ Ballard 1977)

Coverage of the Dolin Trial

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

Exclusive: Interview With Wendy Dolin

Wednesday, September 13, 2017

From Chicago to New York - The Legacy of Stewart Dolin

Wendy and Stewart Dolin

Death by Deception

A couple of cracking pieces were published in the New York Times (NYT) 48 hours ago about Paxil and the Dolin vs. GlaxoSmithKline (GSK) trial. The articles covered Paxil-induced akathisia and the flawed logic GSK vainly tried to use to defend its Chicago product liability case. (Paxil is a SSRI that, for many unsuspecting consumers, is neither safe nor effective.) Rabin adeptly highlights Paxil-induced akathisia, a serious condition caused by SSRIs that often precipitates iatrogenic suicide. Paxil's drug label, like most SSRI labels, states akathisia is a "feeling of inner-restlessness" and, well, that's about it. But Rabin rightfully communicates that akathisia is "a state of acute physical and psychological agitation."

I tip my hat to Rabin and her balanced, informative articles as major news outlets rarely cover pharma topics without being influenced by industry funding and shady spokespersons. Many organizations that freely provide "expert" sources for quotes and soundbites take drug money and/or have strong industry ties. These include the Science Media Centre, the MHRA, the FDA, National Alliance for the Mentally Ill (NAMI) and the American Foundation for Suicide Prevention (AFSP).

In addition, many newspapers fail to require that authors and sources ethically disclose conflicts of interests. We recently saw this when The Guardian published Mark Brown's article, 'Antidepressants work, so why do we shame people for taking them?' but failed to inform readers of any conflicts of interest the author and sources may have to the pharmaceutical industry and "mental health" organizations. When a reader asked The Guardian if it follows any journalistic standards for ethical disclosure, The Guardian responded with censorship, removed the comment from public view and absurdly claimed the reader failed to "abide by our community standards."

Click images to enlarge

Apparently, The Guardian believes the Society of Professional Journalists (SPJ) doesn't have appropriate community standards either. The SPJ code states ethical journalism should "serve the public" and "avoid conflicts of interest, real or perceived." Authors should "disclose unavoidable conflicts."

For all the above reasons, it is refreshing to see Rabin's NYT reporting. Lawsuit Over a Suicide Points to a Risk of Antidepressants.' and 'Suicide Data Incorrectly Reported in Drug Trials', Suit Claimedhave received many comments in the past 48 hours. Some readers share their own experiences with prescription drug-induced akathisia and ignorant doctors. Others refuse to accept that SSRIs can cause unwanted deaths. Many deniers do so because it's difficult to realize their trusted doctors may unwittingly be poisoning them. Other deniers may believe SSRIs like Paxil are helping them when in actuality, the symptoms they experience upon stopping these drugs are caused by withdrawal and not by any underlying illness

Intentional Omission & Labeling

Can you imagine if GSK and other pharmaceutical companies accurately described akathisia on Paxil, Prozac, Zoloft et al. labeling? Few people would buy these products. GSK argued at the Dolin trial that they did everything in their power to change the labeling but the FDA wouldn't let them. Boo hoo and not true: GSK had an opportunity to meet with the FDA, and GSK declined. Pharmaceutical marketing purposefully hides the truth about akathisia because companies want to cover up this deadly adverse drug reaction (ADR). Companies carefully craft SSRI labels and instruct young, pretty drug reps to downplay akathisia when talking to doctors about the products they peddle. Their profitable game of semantics creates a deadly game of Russian Roulette for unsuspecting consumers. However, the public is becoming increasingly aware of fraudulent marketing and akathisia. This progress is due in part to the families of SSRI victims who actively advocate for akathisia awareness and Informed Consent.

Outside the Chicago court house with mothers and wives whose loved ones were lost due to SSRI-induced akathisia and a lack of Informed Consent

My previous coverage of the Dolin trial (links at the foot of this post), showed the ineptness of GSK's attorneys, King & Spalding. It was clear from day one that Wendy Dolin's attorneys--Brent Wisner and Michael Baum of Baum, Hedlund, Aristei & Goldman and David E. Rapoport and Matthew Sims of Rapoport Law Offices P.C.--are more talented lawyers than the clowns from King & Spalding. That they were able to bring the Dolin case to trial was an accomplishment in and of itself given the complexities of this ground-breaking case.

Some might not understand how one can sue a pharmaceutical company who didn't make the actual pill responsible for the victim's death. But Wendy's attorneys correctly looked at the labeling issues. Just who, exactly, is responsible for the product label? It is GSK, the makers of Paxil. The verdict is a landmark result, and one can see why GSK is disturbed. The Dolin verdict opens the door for other Paxil and generic Paxil victims to sue for suffering and death caused by GSK's drug and labeling. The successful Dolin verdict also may lead to similar lawsuits filed by victims of other generic drugs and mislabeling. Wendy's team had all the odds stacked against them, but they succeeded. It shows how compassion can play a vital role in successfully taking these cases to trial. I believe compassion and compelling evidence swung the jury.

King & Spalding offered no compassion nor compelling evidence during the trial. But GSK attorney, Andy Bayman, did utter some words he may now regret. He asked the jury, “Don’t you think if these medicines caused suicide someone would have spoken up?” The jury's verdict showed Bayman and GSK that the dead are speaking up through a very skilled team of compassionate attorneys.

Victim Blaming

I've covered the abhorrent criminal behavior of GSK for 11 years. However, when I attended the Dolin trial I was still a bit surprised to see just how unscrupulous GSK can be. The company is a tight ship run by dodgy captains and crew-members more befitting to a pirate movie starring Johnny Depp. (But the GSK movie would have to carry an R rating or 18 certificate.)

GSK and their ill-prepared attorneys futilely tried to blame everyone for Stewart's death. They claimed it was the FDA's fault. They claimed it was the doctor's fault. They claimed it was Stewart's fault. They claimed Dolin was mentally ill and, hence, jumped in front of a train after a normal business lunch. What I saw at the trial was shameless victim blaming--a PR tactic akin to the mental health industry's recent imaginary "pill shaming" campaign.

During the Dolin case, it emerged that 20 subjects died by suicide in Paxil clinical trials, and 80% of these deaths were consumers over the age of 30. All were taking Paxil and not placebo at the time of their deaths. Paxil, like other SSRIs, does not discriminate by age when it comes to causing akathisia. It, like other SSRIs, does not discriminate by age when it comes to creating withdrawal ADRs. I was flabbergasted when Dolin's brilliant attorneys showed the following display in court. I think the jury was surprised too, as Wendy's attorneys vividly highlighted the truth.

Plaintiff's Exhibit 347

GSK didn't vigorously deny its product causes akathisia and suicide. They focused more on keeping evidence out instead of downplaying the evidence that was already in. During the trial when Paxil withdrawal and birth defects were mentioned, GSK's legal clowns repeatedly objected. Heaven forbid the jury to hear that Paxil not only can cause violent, unwanted deaths, but that Paxil also causes harm to fetuses and severe withdrawal ADRs.

Since the Dolin verdict, I've been at loggerheads with British drug regulator, the MHRA, to learn why there is no stringent warning for adults taking SSRIs. It is bizarre that a regulator would refuse to place a suicide warning on a drug that causes akathisia and death. When I've requested data from the MHRA, they play the pharmaceutical industry's game of semantics or ask that I pay for information. They made the payment request claiming it will take them too much time to research and reply. This information should be free and available to the public.

Nevertheless, the public is increasingly becoming aware of akathisia--a word with a melodic rhythm that sounds like some sort of sweet tasting pudding, not a condition that causes suicidal thoughts and suicide. GSK, Pfizer, Eli Lilly, et al. have known about akathisia for decades but choose to hide the truth to make a buck. They could use some of their dollars to wipe their blood-stained hands after each avoidable death their greedy business plan creates. But some people don't mind blood on their hands and would never waste an ill-gotten dollar.

Preventing Prescribed Suicide

As for Stewart's widow, Wendy, she continues to bang the drum for drug safety. A $3 million award from the jury, of which she has not yet seen a penny, doesn't dampen her resolve to ensure other families don't bury loved ones whose avoidable deaths were precipitated by prescriptions. For more information about akathisia, see the Medication-Induced Suicide Prevention and Education Foundation in Memory of Stewart Dolin website. MISSD is a non-profit organization whose mission is to raise awareness and educate the public about the dangers of akathisia. In October, MISSD will hold its third annual fund raising event in Chicago.

September is National Suicide Prevention Month, organizations such as AFSP and NAMI could join MISSD to reduce deaths caused by prescription drugs. However, given that the pharmaceutical companies are some of their biggest financial donors, it is doubtful they will ever earnestly work to reduce iatrogenic suicides.

AFSP's financial report is here. One of their largest donors, Johnson & Johnson, was forced to pay a $2.2 billion fine for fraudulently marketing the antipsychotic Risperdal to children. (Source)

NAMI's financial report is here. They conceal the amount of drug money they take, but one of their biggest "supporters" is Pfizer Pharmaceuticals, makers of the SSRI Zoloft. Pfizer was forced to pay a $2.3 billion fine for "misbranding" and provided kickbacks to health-care providers to encourage them to prescribe drugs including Zoloft. (Source)

Bob Fiddaman

Coverage of the Dolin Trial

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

Exclusive: Interview With Wendy Dolin

Monday, September 04, 2017

The Pill Shaming Myth

There seems to be a new Goebbels-type saying doing the rounds, it's picking up momentum and it's often used as a line of defence when one speaks out about the dangers of SSRIs, or any psychiatric drug for that matter. I don't know who coined the term but it's not only being used by patients, it's also being used by healthcare professionals and The Royal College of Psychiatrists.

Pill Shaming

I had to go to the Urban Dictionary to find out more about this term.

The action or practice of making mocking or critical comments about people who take medication.
Pill shaming is most-often directed at people who take/endorse taking psychotropic medicactions as part of a mental health relapse-prevention/recovery plan. As with fat shaming, pill shaming achieves little other than frustrate and humiliate individuals who may already be feeling self-conscious and vulnerable..
Those who indulge in pill shaming are often ideologically driven (eg: scientologists), but sometimes they're just ignorant fools. Since 2013 the act of pill shaming is sometimes called-out on Twitter with the hashtag #pillshaming.

In my 11 years of research, I have not met one single person who has ever mocked or been critical of another person who has decided that medication is their best course of action. Not one.

One would have thought with the line of work that I do that I would have met many.

Maybe the mothers I've spoken to over the years who have lost children to SSRI-induced suicide, or maybe those who have lost loving partners or even surviving siblings of those who have lost a loved one to SSRI induced suicide.

The answer is still no. Not one of the above mentioned has ever, to my knowledge, "pill-shamed."

So, if I've never met anyone then where are these so called 'pill shamers'?

It was a question I put to Consultant Clinical Neuropsychologist, Annie Hickox on Twitter after she had tweeted the following:
Her tweet was in response to an article President of the Royal College of Psychiatrists, Wendy Burn, had earlier tweeted:

With this in mind, I asked Hickox if she could give me an instance of this "shaming". She tweeted back to me the following:

I understand that people have to work. I was, however, surprised to learn that for the next two hours Hickox continued to tweet and retweet on her page. Maybe she found the question I put to her too difficult to answer, or maybe, she just didn't have any examples of instances where pill shaming had occurred?

The term pill shaming has often been used against me for speaking out regarding the dangerous side of antidepressants, normally followed by "they save lives" or "you're a conspiracy theorist."

I talk about this in a recent podcast I did with James Moore via the Mad In America website. You can listen to it here.

I do hope Wendy Burn and her colleagues at the Royal College of Psychiatrists tune into it too.

And Consultant Clinical Neuropsychologist, Annie Hickox. They might learn a thing or two and may just start listening to patients rather than throwing labels around.

Coming later this week is a blog post about the Guardian article both Burn and Hickox were promoting on Twitter. The Guardian, it appears, were stifling voices in the comment section of the article. More on this later in the week. In the meantime, here's the article.

Bob Fiddaman

Friday, September 01, 2017

The Prognosticator Pariante

Earlier this week the British tabloid, The Evening Standard, ran with an article that posed the question, Why are prescriptions of antidepressants at an all-time high?

Finally, I thought, evidence to show why antidepressant prescriptions have risen by 92% in the UK over the last ten years.

Alas, I was wrong. The article rolled out the standard fare and it appeared that the column inches were given to two members of the Science Media Centre (SMC). You can read about the SMC here.

A day later, another British tabloid, this time The Guardian, rolled out an article from Mark Brown, this one was entitled, Antidepressants work, so why do we shame people for taking them?

Leading the push to increase the 92% increase in prescriptions for antidepressants was none other than Swedish professor of pharmacology, Elias Eriksson who, in the past, has been on advisory boards and/or received speaker's honoraria from Eli Lilly and H Lundbeck, both of whom, you've guessed it, promote and manufacture antidepressants. Swedish friend and fellow investigative journalist, Janne Larsson, who has been researching Eriksson for years, told me, "You should know that his next target is children; to make a “reanalysis” of the studies on antidepressants done by the companies, to show that the pills are “safe and effective” also for children and that the claims about increased suicidality are completely wrong."

Today, however, I wish to concentrate on the Evening Standard article because it throws up yet another popular myth from the field of psychiatry.

Last month the Royal College of Psychiatrists (RCP) ran a disastrous PR campaign via Twitter, this coming after the BBC had aired A Prescription For Murder. The RCP, it seemed, wanted to orchestrate the general consensus that Panorama was scaremongering when they dared to point out that an antidepressant called Zoloft could have been implicated in the slaying of cinema goers in Aurora, Colorado (2012).

Spearheading this initiative was, amongst others, Carmain Pariante and Wendy Burn, both of whom have strong connections to the RCP and SMC. It was an initiative that backfired as hundreds of people, concerned about the side effects of antidepressants, pushed questions at them. In the end, they were forced to concede that the chemical imbalance theory, that they had been promoting for many years, was now something that they no longer agree with. No apology, no explanation as to why they ever promoted this nonsense, just a tweet...

So, with one myth busted what do they, the RCP do? Well, they create another one, once again offering no proof whatsoever. They, after confessing that they no longer supported chemical imbalance theory wrote this...

So, the story of Hansel and Gretel and the mysterious hut made of sweets continues. Hansel and Gretel, although I say so myself, is a good analogy to use here - they too were duped into believing the mysterious hut was everything they could wish for, what kid wouldn't like to see a hut made of sweet tasting candy, right? They were basically lured into the hut by the wicked witch who, in some versions of the old fairy-tale, was a cannibal.

Now, I'm not suggesting for one minute that Wendy Burn and Carmain Pariante are your modern day versions of the wicked witch or, indeed, cannibals, but the antidepressants they, seemingly, promote are aimed at the public in pretty much the same way of luring (making false promises).

You see, for many years people have questioned where depression comes from. Logical people will tell you that it's more than likely down to circumstances in your life, you know, financial woes, relationship problems, work related stress, etc.

The pharmaceutical industry, along with the field of psychiatry don't know why people get depressed, nobody does. So, to sell a pharmaceutical product one has to create a problem that it can cure or, as with the case of antidepressants, stabilize. That's why the chemical imbalance theory was born and, as you can see above, later (much later) officially thrown out of the pushchair by the RCP.

However, with one myth gone they had to create another - let's face it, without antidepressants a good 80% of psychiatrists would be unemployed. So, along comes the 2017 version of the chemical imbalance, in that antidepressants increase new brain cells. You see, anyone can say pretty much anything about the human brain because it's an organ that has been studied by the medical establishment for many years, they have guessed, second guessed and created theories because, well, because if they look at the workings of the brain on a rat and then treat that rat with a chemical then that treatment will, more than likely (they claim) work on the brain of a human.

So, is it possible to actually create new brain cells? There are many who claim that this is, indeed, is a possibility. However, those that make these claims outside of the incestuous industry do so by offering the fruits of mother nature.

Blueberries, dark chocolate, Omega-3 fatty acids, turmeric, and green tea are also said to create new brain cells, as is sex. To my knowledge, none of the above carry any risk of suicide or any withdrawal problems.

If it's true that these natural products can create new brain cells then why is Pariante jumping on the back of mother nature and now claiming that antidepressants do the same? The Evening Standard article quotes him:

"The action of antidepressants is more complex than that and involves stimulating the birth of new brain cells and regulating stress hormones."

Nowhere in the article does Pariante offer any evidence to back his claim. Why would he? For years people like him continued to tout the chemical imbalance nonsense - for years he, just like many others, refused to budge, resulting in millions of prescriptions to unsuspecting members of the public who were told by their general practitioner that they had something chemically wrong going on inside their brains...but fear not, there is a product on the market that can correct it.

The latest creation of new brain cells myth will, no doubt, go unanswered for many years, is it true, isn't it true? It doesn't really matter whether it is or not, at least not to the likes of Pariante et al. He just needs something in place to deflect the reasons why he and his colleagues duped so many people for years.

Just like the witch did to Hansel and Gretel.

Bob Fiddaman

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:
Kind 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

Sunday, August 13, 2017

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


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:

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

Thursday, August 10, 2017

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)
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
Scottish Mental Health Research Network
World Health Organisation (WHO)

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.
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

Thursday, August 03, 2017

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

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