Zantac Lawsuit

Researching drug company and regulatory malfeasance for over 16 years
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Wednesday, November 06, 2013

MHRA Consultant Calls for Antidepressant Use in Young

Back in January I wrote an article entitled, 'Tenacity Pays Off For Swedish Journalist Larsson'

In 2010 Goran Isacsson authored a paper that was subsequently published in Acta Psychiatrica Scandinavica.

The 7 page article, entitled, "Antidepressant medication prevents suicide in depression", made claims that only 15.2% of a group of 1,077 persons who had been admitted for psychiatric care for depression had measurable amounts of antidepressants in their blood at the time of suicide.

Janne Larsson, investigated Isacsson's claims and found that Isacsson's figures just did not add up.

In June 2012 Larsson sent a Freedom of Information request to Karolinska Institutet (where Isacsson works) - Larsson takes up the story:

"I specifically wanted to get the document containing the correct percentage of antidepressants for those who committed suicide and who had previously been treated at a psychiatric clinic for depression (the earlier mentioned group of 1077 persons).

"The answer from Karolinska Institutet: This is confidential information, no data can be released. 

"It took a five month legal process to get access to the correct data. During this whole process Karolinska Institutet claimed that all the data in this research project were confidential."

After many legal wrangles the Karolinska Institutet were forced to admit in court that the actual figure quoted by Isacsson [15.2%] was way off the mark. The true percentage of those who had antidepressants in their blood when they committed suicide was a staggering 56%.

As a result of Larsson's tenacity the journal retracted Isacsson's 7 page article. Larsson's investigative research on Isacsson's study can be downloaded here.

Dr Evans of the Medicines Healthcare and Products Regulatory Agency [MHRA]

With one flawed study kicked into touch by a journal we are now faced with another. This time it's closer to home as it appears in the British Medical Journal [Open].

A study published in the BMJ Open is claiming pretty much the same as what Isacsson did back in 2010.

Worryingly, one of it's authors, Stephen J W Evans, is a European Commission appointed Expert member of the Pharmacovigilance (Drug Safety) and Risk Assessment Committee at the European Medicines Agency [EMA], he's also received grants/funding from GlaxoSmithKline. [1] Although there is no mention of this in the BMJ Open paper.

Evans, along with the other authors, have called for a re-evaluation of the current prescription of SSRIs in young people, in other words they are not accepting of the current stance of the MHRA who, in 2003, made recommendations that SSRIs are not recommended for use in children.

Earlier this year Dr Ian Hudson was appointed the new CEO of the British drug regulator, Hudson was the former world safety officer at GlaxoSmithKline, then SmithKline Beecham. [See Former Glaxo Safety Officer Becomes Head of MHRA]

Quite a coincidence that a paper disputing that antidepressants aren't safe for kids would appear in a journal a few months after a former Glaxo employee is appointed chief executive of the MHRA, don't you think?

It leaves me wondering if Hudson is about to reassess the link between suicide and antidepressants, I wouldn't be at all surprised if the MHRA gave them a clean bill of health for use in kids, particularly as Hudson, whilst World Safety Officer at GSK, worked closely with the antidepressant Seroxat [Paxil]

Furthermore, Evans also co-authored the paper, Pregnancy as a Major Determinant for Discontinuation of Antidepressants: An Analysis of Data From The Health Improvement Network, J Clin Psychiatry 2011;72(7):979-985. The object of the study was "To examine secular trends in prescribing during pregnancy, to assess whether pregnancy is a major determinant for stopping antidepressants, and to identify characteristics of those who stopped antidepressants during pregnancy."

Evans and co found, "Although antidepressant prescribing in pregnancy increased nearly 4-fold from 1992 to 2006, pregnancy was a major determinant of cessation of antidepressant medication, and most women did not receive further antidepressant prescriptions beyond 6 weeks of gestation. This finding may be explained by concerns about potential adverse effects of the medications, even though these concerns need to be balanced against the potential harm of inadequate treatment of depression during pregnancy.

So the MHRA have recommended not to use SSRIs during pregnancy. The MHRA have recommended that SSRIs should not be used in kids.

Why is Evans seemingly hell bent on disagreeing with his former employers?

This stance of Evans and his colleagues seems at odds with anyone with an ounce of common sense.

Is Evans that deeply concerned that kids may be missing out on medication that can help them through bouts of depression or is something more sinister playing out here?

Surely Evans is aware that the literature on SSRIs and suicidal events has been skewed by both pharmaceutical companies and their ghostwriters.

Evans et al claim that “concerns that antidepressants need to be weighed against the risk of not treating depression” - Isn't that just turning around the current recommendation from medicine regulators globally?

A couple of weeks ago I wrote two blog posts regarding depression. I highlighted 6 cases of depression that led to bizarre events, first 3 here and the second 3 here.

The point I was making was simple. Six patients all diagnosed with depression, all given SSRI medication.

1. October 16, 2003 A Boonville, Ind., man remained in recovery Wednesday after shooting himself in the leg on Victoria National Golf Course, officials reported. The 21-year-old man, who police refused to identify during their investigation, is believed to have fired the shots between midnight Saturday and 7 a.m. Sunday. He also allegedly stole a golf cart, and shot one of the greens multiple times.

2. November 4, 2011 A man who stole shopping and milk trolleys has been slapped with a community service order. Thomas Rainey was found to have a stash of shopping and milk trolleys worth £5,000 at his home in Stockport. The retired council flagger, 52, denied he had taken the trolleys to sell them for scrap – claiming he used them to help his businesswoman ex-partner transfer goods from warehouses to her three shops. And he blamed his hoarding behaviour on severe depression and diabetes, a court heard.

3. 09 September 2009 A MAN who admitted running around the Waterside with an axe has been given a three month jail term suspended for three years. Gary Keith Millar, 40, pleaded guilty to possessing an offensive weapon on July 19, 2009. A previous hearing, the court heard that police were called to the Bonds Street area to investigate reports of a man 'running round with an axe in an agitated state. The 40-year-old went into his brother's house and family members were able to remove the top of the axe and give it to police.

4. Leonard O. Parker Thursday was found guilty of all 10 counts in the bank robbery of two banks in January 2006, including the First Citizens Bank branch in the Peachtree section of Cherokee County.
Parker, who previously owned Mountain Max Auto Superstore on the Murphy Highway in Union County, was charged with bank robbery and kidnapping in connection with the January 11, 2006 robbery of the Peachtree bank and the January 6 robbery of the Mooresville Savings Bank in Cornelius, North Carolina. Parker resided in Morganton, GA at the time of the robberies.

5. A Parma man is facing charges after he impersonated a police officer, and is caught by a real police officer he tried to pull over. Micahel Gustafson, 50, faces a five-count grand jury indictment stemming from the Dec. 17 incident. According to police, Gustafson put a blinking blue police light on his dashboard at around 2:30 a.m. He then shined a high-beam flashlight at a woman in a car at the intersection of East 110th Street and St. Clair, in Cleveland. Gustafson reportedly told the woman he was a police officer, and that he stopped her for driving erratically. However, the woman turned out to be a Cleveland police detective, and she quickly called for backup. Police found Gustafson was carrying a gun and had a stolen police radio in his car. A search of his home also revealed more police and law enforcement paraphernalia. Gustafson faces five counts, including impersonating a police officer and carrying a concealed weapon.

6. Mark Douglas-Hamilton, 30, used a pair of wire cutters to hold up a garage in Oxford where he walked away with a packet of cigarettes. A CCTV recording of the event shows his bizarre behaviour, where he joked with customers. Two weeks later, the theatre stage manager stole some CDs from a record shop.
Douglas-Hamilton, who lives near Hereford, was due to face trial  in Oxford on two charges of theft. But the case was unexpectedly dropped by the CPS, which did not give a reason for the discontinuance.

All of the above were diagnosed with depression, the same depression that Evans et al claim that antidepressants should be used for.

Depression did not cause any of the above bizarre incidents. Depression symptoms, do not include holding up garages, impersonating police officers, robbing banks, running around wielding an axe, stealing shopping trolleys and driving a stolen golf cart whilst firing random bullets on a golf course.

Were they all misdiagnosed or did they all have a reaction to the medication [SSRIs] they were taking at the time?

Calling for antidepressant use in children is wrong on so many levels. Are Evans et al ignoring the Paxil 329 study, do they think Glaxo's own trial in kids, that showed a high incidence of suicide related events, really means the opposite? [A half hour documentary showing the fraud behind this study can be watched online here]

Why does Evans et al reference the study of Robert Gibbons when the Gibbons study itself has be proven to be flawed? {See The Real Suicide Data from the TADS Study Comes to Light} - Incidentally, Gibbons has been called as an expert witness to offer evidence on behalf of GlaxoSmithKline in the UK Seroxat litigation as has former MHRA employee Rashmir Shah. The litigation, which has been dragging on for almost 10 years makes claim that patients suffered withdrawal ­effects when reducing, discontinuing or attempting to discontinue use of Seroxat.

I really think the editor/s at the BMJ Open seriously need to reconsider the publication of this study. I anticipate that they will be inundated with evidence that poo-poos the research of Evans et al. I also anticipate that they will not retract it.

As a consultant to the MHRA Evans should know that there have been thousands of reported adverse reactions regarding SSRIs, these reactions range from people claiming they are hooked on them to reports of suicide attempts and suicide completion. The majority of these adverse events come from adults with fully developed brains.

Even more bizarre is the fact that in 2011 the MHRA announced that they were going to offer advice to clinical practitioners in the form of an "SSRI Learning Module." [See 3,4,5]. In section 4 of their module they write about psychiatric events whilst on SSRIs:

SSRIs can produce an uncomfortable mental sensation of tension, restlessness or anxiety (akathisia—feeling of restlessness and inability to sit or stand still). This paradoxical state of anxiety can occur when initiating treatment. Severe agitation, psychotic symptoms and suicidal ideation are rare but these serious symptoms must be recognised and addressed.
As far as treating the above symptoms, the MHRA offer this advice:

Anxiety symptoms often settle within a few days of treatment. Regular review and reassurance of the patient may be all that is required. If anxiety symptoms do not abate, the dose of SSRI may have to be reduced. For severe and distressing symptoms use of a benzodiazepine early in the treatment may be considered but, to reduce the risk of benzodiazepine dependence, the duration of such treatment should not exceed two weeks. If symptoms persist, an alternative treatment should be considered.

Shouldn't alternative treatment be offered before prescribing SSRIs?

On page 7 of their 'learning module' they include a section entitled 'SSRI learning module: Withdrawal (discontinuation) effects'

The MHRA relay the following information to clinical practitioners:

Withdrawal effects may occur, particularly after abrupt discontinuation of SSRI treatment. Patients most commonly report dizziness, anxiety, insomnia and vivid dreams, tremor, paraesthesia, headache, nausea, and lethargy. Other symptoms may also occur including, vomiting, ‘electric shock’ sensations, ’flu-like symptoms, agitation, emotional lability, and confusion.
"Discontinuation", "Emotional lability"?

You notice how they painstakingly inform doctors that withdrawal also means "discontinuation" yet fail to explain to doctors what "emotional lability" actually means.

The term "emotional lability" covers a wide-ranged of emotional changes, including suicidal thoughts. Very convenient that the MHRA should leave this particular adverse event out considering the number of SSRI incidents associated with deaths that have been reported to the MHRA via their yellow card reporting system.

"Severe cases may call for specialist advice..." - Name the specialists, what training have they had, who have they been taught by?

I wrote to the MHRA to ask them for a list of the specialists they mentioned in their module, they could not give me one name!

Antidepressant suicide is something that has been played down by pharmaceutical companies, the key opinion leaders they hire and the regulators who, remember, are fully funded by the pharmaceutical industry. Question any of these key opinion leaders or regulators about their statistics and financial ties to the pharmaceutical industry and, more often than not, you will be met with a cold silence.

They'll pass off suicidal acts by people on SSRIs as coincidental or "part of their original illness" and make claims that the benefits outweigh the risks. If these suicides were just coincidental then why did GlaxoSmithKline, in an internal document, claim that the goal of the Paxil 329 study was "to effectively manage the dissemination of these data in order to minimise any potential negative commercial impact....It would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine" [2] The study also logged in 11 serious adverse reactions to Paxil, much more than in the placebo group, including 5 with agitated or suicidal behavior. If suicide was a result of people being depressed then, it's pretty obvious, that the drugs simply do not prevent suicide. If the benefits outweigh the risks then what exactly are the benefits?

This study may or may not persuade regulators to rethink with regard to prescribing SSRIs to kids, it may not be the motive. SSRIs are widely prescribed off-label to kids, the MHRA know this as do medicine regulators worldwide. This study could, perhaps, be reassuring the doctors and psychiatrists that prescribe off-label, to 'carry on what you are doing'. A 'we've got your back' type of message.

One has to ask why people such as Evans, Gibbons and Isacsson keep trying so desperately hard to convince healthcare professionals that these drugs are safe to use in kids. Their "Peer" reviewed studies are, in my opinion, just an attempt to polish a turd. When all is said and done Peer Review studies have shown, that putting "Peer Review studies have shown" in front of just about anything will make people believe it.

The same off-label prescribers will read the latest in the BMJ Open. They'll nod in agreement at the findings and sleep well at night before waking in the morning to promote the safety and efficacy of SSRIs in children, using the evidence from Evans and co to back up their claims.

Suicide-related events in young people following prescription of SSRIs and other antidepressants: a self-controlled case by Linda P M M Wijlaars, Irwin Nazareth, Heather J Whitaker, Stephen J W Evans, Irene Petersen can be downloaded here.

Bob Fiddaman

[1] Stephen J. W. Evans - Declaration of Interests
[2] Failed Paxil drug tests in children concealed - Guardian UK
[3] MHRA To 'Re-educate' UK Doctor's on SSRI's Part I
[4] MHRA To 'Re-educate' UK Doctor's on SSRi's Part II "Keeping A Stiff Upper Lip"
[5] MHRA To 'Re-educate' UK Doctor's on SSRi's Part III - MHRA's Ghosts In The Machine

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