Friday, September 19, 2014

GSK Plead Guilty For Being "Very Decent"




Earlier today GSK issued an apology to the people of China, to my knowledge this is the first time an apology has been issued from anyone at GSK - Let's face it, they have a pretty dubious history with regard to a number of their drugs causing birth defects, homicide, suicide and heart attacks. No apology has ever been given to victims of Paxil or Avandia.

The apology, which can be read in full here, comes as a result of GSK  pleading guilty and being handed down a fine of  3 billion yuan ($488.8 million) in the Changsha Intermediate People's Court in Hunan Province earlier today.

The ringleader, or mastermind behind the whole bribery network, Mark Reilly, was given a three year suspended prison sentence and, according to various media reports, will be deported from China.

The one-day trial, held in secrecy, saw a total of four years in sentencing handed down to Reilly and four other managers, Zhang Guowei, Zhao Hongyan, Liang Hong and Huang Hong, all of whom worked for GSK. According to the New York Times, all but one of the sentences was suspended.

According to the court report,  "it (the court) had taken into account that he (Reilly) had returned from Britain to face the investigators, and that he had “truthfully recounted the crimes of his employer,” meriting a relatively lenient punishment"

This must come as a kick in the teeth for Peter Humprey and his wife, Yu Yinzeng, who were jailed back in August for  trafficking 256 pieces of personal information between 2009 and 2013.

Humprey's firm, ChinaWhys, had previously been hired by GSK China to look into allegations of wrong-doing by Mark Reilly. Humphrey's son, Harvey, has maintained all along that GSK were to blame for his father's incarceration at the hands of the Chinese. This from the UK Telegraph...

"They said the allegations were untrue," said Harvey. "Then two weeks later they said actually these things did happen. My father would have changed the conditions of the investigation if he had known. He would have investigated the allegations instead of this one person. I do not think as an investigator you would have taken the risk of investigating a whistleblower before you investigated the allegations."
GSK has insisted that an initial investigation into the claims "did not find evidence to substantiate the specific allegations made in the whistleblower emails".
"When I saw my dad last Friday, I mentioned GSK once. I mentioned Reilly to him once. He expressed a very low opinion of Reilly." 

I'm kind of surprised at the leniency of the Chinese authorities. The reason, they claim, they were so lenient was because Reilly had returned to China and had “truthfully recounted the crimes of his employer” - his employer?

I'm confused, wasn't it Reilly who carried out the crimes unbeknownst to his employer, GSK?

Perfect timing for the trial too. The British press are all over the Scottish 'yes' or 'no' votes so any news that GSK have been pleading guilty to crimes committed in China will have less column inches in the British media. It would be interesting to find out who decided the date of the trial.

Late last year Glaxo CEO Andrew Witty accompanied British Prime Minister David Cameron on a "Business" trip to China.

Cameron defended GlaxoSmithKline's business practices in China calling GSK "very decent".

Let's just take a look at their apology to the people of China again to see how "very decent" their behaviour was...

"Following a comprehensive investigation by the Chinese judicial authorities, GSK China Investment Co. Ltd (GSKCI) has been identified according to Chinese law to have offered money or property to non-government personnel in order to obtain improper commercial gains, and has been found guilty of bribing non-government personnel.
Very decent?

I don't know what David Cameron's definition of the word 'decent' is but to assign it to GSK is borderline madness!

I'm in no doubt that Cameron was influential in helping Reilly escape jail time, no doubt at all.

So, will Reilly, once deported, be arrested when he sets foot back on British soil?

I guess that's a job for the UK's Serious Fraud Office who, earlier this year, announced that they would be investigating GlaxoSmithKline as a result of the Chinese allegations - well, they aren't allegations any more, Glaxo have, today, pleaded guilty.

If you think that the UK's Serious Fraud Office will be standing at Heathrow with handcuffs to arrest Reilly then you may be mistaken, if anything, it will be David Cameron and Andrew Witty that will greet Reilly with open arms... "Well done old chum, our shares are back on the rise".

Meantime, 100 or so plaintiffs in the UK face disappointment after GSK have refused to pay out compensation to them for suffering severe withdrawal reactions to the antidepressant Seroxat [known as Paxil in the US]. This, despite settling over 3,000 cases of Paxil addiction in the US.

Welcome to Britain folks!



Bob Fiddaman.



Back stories.

Cronyism, Chinese Style

Will Cameron Call off the GSK Hounds?

Witty Plays Down China Scandal

Witty Witty Bang Wang. The Glaxo Gangbang...Allegedly

Andrew Witty... I know narrrrrrrrthing

葛兰素史克公司 腐败 For Researching Chinagate

Glaxo's Private Investigator Arrested

Book Your Holidays With GSK Travel

Andrew Witty... I know narrrrrrrrthing - Part II

Hammer to Fall on GSK's Chinese Executives

GSK CHINA - Bribery was Rife 13 Years Ago

Glaxo - The Sex Tape Scandal

Peter Humphrey's 2012 Presentation - Pharma Bribery

GSK's Chinese Whispers and David Cameron 

“GSK were really cagey", Claims Whitehall Official.

Glaxo Hire Ropes & Gray to Delve Into its Chinese Operations.












GSK's Mark Reilly Avoids Jail Time



Wednesday, September 17, 2014

Michigan Prosecutor Just Can't Let It Go






Michigan prosecutor, Kym Worthy, has, according to inquisitr.com appealed the case against Maryanne Godboldo (pictured above), the Detroit mother who tried to protect her daughter from the damaging side effects of the psychiatric drug Risperdal and prevent her child from being snatched by someone purporting to be a Child Protective Services worker.

In 2011, Godboldo had criminal charges against her dismissed by 36th District Court Judge Ronald Giles. Godboldo had been accused of firing a shot into her ceiling after a stand-off with the Detroit Police Department who had been called to Godboldo's home after a Child Protective Services (CPS) worker had turned up to remove Godboldo's daughter because Godboldo has stopped giving her Risperdal, an antipsychotic drug.

Judge Giles dismissed the charges against Godboldo stating the court order that was used by CPS to try to gain entry into the home invalid.

The prosecutors appealed the ruling and Godboldo found herself back in court again in 2014. Once more charges against her were dismissed, once more on Judge Ronald Giles ruling.

Because no court order was never produced Godboldo did what any parent would have done - she protected her daughter.

In the 2014 appeal Judge Ronald Giles considered the gunshot Godboldo allegedly fired to be a "warning shot" and said it was not aimed at police officers.

He went on to say that Godboldo had the right to use reasonable force to defend her home against an unlawful entry.

So, two failed attempts by prosecutors.

Now, it appears, they want to try [for a third time] to prosecute Maryanne Godboldo!

If you ask me Maryanne Godboldo should be given some sort of human rights award... oh, hang on...









So, why is Wayne County prosecutor Kym Worthy (Pictured above) appealing the decision [once again] of Judge Ronald Giles?

In 2013 Worthy told members of the Wayne County Commission Public Safety Committee that there are nearly 40 known murderers, 180 child abusers and up to 150 sexual predators freely roaming the streets of Detroit and Wayne County. She added that she doesn't have staff members to investigate the cases and secure warrants. [1]

Hardly surprising seeing as she and her office seem hellbent on securing a prosecution against a mother who was making an informed decision on the drug prescribed to her child and a choice of whether or not to open her door to someone (that could have been) masquerading as a Child Protective Services worker.

I'm left scratching my head here. Here we have a woman who makes a decision to take her child off a medication because the said medication was causing an adverse reaction. Next we have some lickspittle turning up at the home to take away the child because they deem her to be in danger if she doesn't take her medication. At no point was Godboldo shown a court order by the lickspittle so she closed the door of her home. Next thing you know armed police surround her home. Confused, frightened and probably frustrated Godboldo fires a warning shot into her ceiling. She's dismissed of all charges yet a prosecutor wants to, it appears, put a feather in her cap by trying to prosecute Godboldo again!

The only crime [unproven] that Godboldo could be charged with here would be one brought by some spider society, claiming that the bullet she fired into the ceiling killed a spider.

It's just absurd that Prosecutor Worthy complains to Public Safety Committees that she doesn't have staff members to investigate crimes of murder and child abuse yet wishes to pursue what appears to be a vendetta against a mother who was protecting her child from a drug that was causing an adverse reaction and a lickspittle sent out to take her child from her.

Maryanne Godboldo continues to fight her corner and meantime a blog created for her, Justice For Maryanne, picks up momentum.

In a Sept 16 post author the 'Edgyrl' wrote:


Kym Worthy has appealed Maryanne’s case – AGAIN. This is the 5th time that the Prosecutor’s office has appealed Maryanne’s criminal charges. ENOUGH IS ENOUGH. Every time Kym Worthy enters an appeal – it costs Maryanne money to pay her lawyers to file an answer and appear in court for her. This is harassment! Call Kym Worthy’s office and tell her to STOP pursuing Maryanne Godboldo. The STATE has done enough harm to her and her daughter. It’s time that they were left alone to heal from the abuse they’ve already suffered at the hands of Kym Worthy’s office, the Detroit Police Department and CPS since BEFORE 2011.

Justice for Maryanne Godboldo Facebook page has also been created here.

A Twitter page can be followed here.

Mental Health watchdog, CCHR International, have been following the case of Maryanne Godboldo since 2011, articles can be found here.



Bob Fiddaman

#justice4maryanne




[1] Wayne County a national laughing stock, says Prosecutor Kym Worthy











Tuesday, September 16, 2014

Interview - Shake & Wake Radio





Interview I did earlier on Shake & Wake Radio with Tina Allain and Christina England



If the player does not work then right click and 'save as' - http://clyp.it/i3fx3dzw.mp3



Bob Fiddaman

Saturday, September 13, 2014

Cymbalta Beads






I was reading through the comments section of an online Cymbalta withdrawal support group yesterday.

'Cymbalta Hurts Worse' is a Facebook support group where readers offer advice in getting off Cymbalta. Reading through brought back so many memories of my time on Seroxat [known as Paxil in the US]

Cymbalta, marketed and manufactured by Lilly, is the subject of a lawsuit in the US. Plaintiffs in the suit have claimed that Lilly deliberately omitted information about the true risk of withdrawal in the product label and in marketing materials, they also claim that Lilly manipulated medical literature and exaggerated the benefits of Cymbalta.

Meantime, the multi-billion dollar pharmaceutical company offer no help whatsover to those addicted to their product.

Here's some of the comments...

POSTER 1: Day one of lowering my dosage...scared for the days to follow but I refuse not to come off of this! I can do it!!!
POSTER 2:  Are you two using the bead method?
POSTER 1: No my doctors takin it slow but I'm doing it with the help of this homeopathic remedy soooo we will see I feel okay today...just scary cause I'm a student and work so I don't want my grades to be affected if I'm feeling the withdraw 
POSTER 2: Good luck to you. If it proves to be too much, consider the bead method. It's the safest way to wean off.
POSTER 1: I tried to come off a few years ago with only one drop down then compeltely off and it was the worst idea of my life!!! Got so sick 
POSTER 3: Bead method taking out a few beads or 1 bead at a time is the only way I know that minimizes dreadful withdrawal effects. Please keep us posted and best wishes.
POSTER 4: I'm on day of 5 of removing a couple of beads per dose as I take one at night and one in the morning, I never thought I could do this but I can and I will. You will be fine as long as you listen to your body and take it slowly, good luck! 

So, what exactly is the "bead method"?

Altostrata, who runs the hugely successful Surviving Antidepressants forum, explains...

Cymbalta comes in 20 mg, 30 mg, and 60 mg capsules. 
Cymbalta is tricky to taper. It does not come in liquid form and cannot be compounded into a liquid. To protect the drug, each bead inside the gelatin capsule has an enteric coating to protect the drug from stomach acid, which would destroy the drug. (It is absorbed further down in the digestive tract.) The pellets cannot be dissolved in any liquid without destroying the active ingredient.
You cannot crush the pellets or dissolve them in a solution -- the drug would never get into your system, it would be destroyed in your stomach and you would have immediate cold-turkey withdrawal.
The number of beads in each Cymbalta capsule will vary within a given dosage and across dosages. The capsules are filled by weight. Count your beads carefully. Put unused beads into a clean, dry, capped prescription bottle marked with the dosage of the original capsule and expiration date. You might want to use them later. Do not mix beads from capsules of different dosages, such as 30mg and 60mg.

Patients trying to stop taking Cymbalta are in a tough spot. No help from the manufacturer Lilly, no help from medicine regulators such as the FDA and MHRA, no help from their prescribing physicians

Lilly, the FDA and MHRA are fully aware of the problems patients are facing but do nothing.

So, it's down to support groups such as 'Cymbalta Hurts Worse' and 'Surviving Antidepressants', there are many more too.

R. Brent Wisner, of Baum, Hedlund, Aristei & Goldman, P.C, who are representing plaintiffs had this to say...

“We believe that Lilly’s warning that Cymbalta withdrawal occurs at a rate greater than or equal to 1% is deceptive.  It is just a sleight of hand.  One of Lilly’s own studies shows that over 50% of patients experience withdrawal when they stop Cymbalta.  1% is not 50%, not even close.  A drug label is not the place to play games with words.  It is a place to honestly inform doctors and patients about the benefits and risks of medicines so they can make informed choices.  Our clients feel strongly that they were betrayed by Lilly and we will do all we can to ensure their voices are heard by the courts.” 

The removing of beads to help in tapering from a prescription drug is a patient idea, it's an idea that was forced upon them because the likes of Lilly, the FDA and MHRA have just sat back thumb twiddling and buck passing. Meantime, patients are left to their own devices to try and taper from a prescription drug that they took on faith to help with a diagnosis that has no science behind it at all.

I feel for anyone starting on a tapering process of any antidepressant, particularly those types that have no liquid formulation to help patients withdraw slowly.

Here's the irony.

The definition of the word 'PATIENT' is split into two categories here.

NOUN: A person receiving or registered to receive medical treatment.

ADJECTIVE: Done in a careful way over a long period of time without hurrying.

Perhaps drug-makers and their agents (drug regulators) could define which one is applicable to consumers trying to withdraw from antidepressants.

If you, or someone you know, has suffered the horrific side effects of Cymbalta then you may be eligible to file a personal injury lawsuit. You can contact an attorney at Baum Hedlund here.

Bob Fiddaman.






Wednesday, September 10, 2014

Hanging Their Heads In Shame




"Today is World Suicide Prevention Day , a day when pharmaceutical companies should bow their heads in shame."

Tweet to the pharmaceutical companies and world medicine regulators.




Nothing more to add.

Bob Fiddaman.

Pharmaceutical Companies

@EliLillyCo
@LillyPad
@JanssenUK
@JanssenUS
@JNJNews
@GSK
@GSKUS
@NorWHO_Lundbeck
@LundbeckUS
@pfizer
@pfizer_news

Regulators

@MHRAgovuk
@MHRAmedicines
@FDAMedWatch
@US_FDA
@WHO





Friday, September 05, 2014

MHRA CEO, Paxil and Suicide






Much has been said about the conflict of interest between the British drug regulator, (MHRA), and GlaxoSmithKline. It's obvious to those who know the history of GSK and the MHRA that there is a huge conflict of interest that just cannot be ignored and while such a conflict exists patients will not be safeguarded from the likes of Paxil, a drug marketed and manufactured by GlaxoSmithKline.

I've met with the MHRA are a number of occasions, at one stage I offered to help them with their out of date and deeply flawed yellow card reporting system, a system where adverse events are collected and...well, basically nothing is ever done.

Communications between me and their then CEO, Kent Woods, broke down due to his refusal to acknowledge that Paxil, known as Seroxat in the UK, should be classed as a teratogen. A teratogen is an agent or factor that causes malformation of an embryo.

Much of my communication with the MHRA is in my book, 'The evidence however, is clear, the Seroxat scandal' [1]

In 2013 Kent Woods retired and the MHRA appointed Dr Ian Hudson (pic above) as their new CEO.

Hudson, who after leaving Glaxo in 2001, became the MHRA's Licensing Director, responsible for overseeing the benefits and risks of drugs before they hit the market.

Yup, the man in charge of the agency who have the job of keeping tabs on the drugs you and I take is a former employee of GSK - then known as SmithKline Beecham.

Hudson, whilst working for GSK, was a witness for the defence [GSK] during the Tobin v SmithKline Beecham Pharmaceuticals. In 1998 Donald Schell was put on Paxil [Seroxat]. Forty-eight hours later he put three bullets from two different guns through his wife's head, as well as through his daughter's head then through his granddaughter's head before shooting himself through the head.

Hudson's deposition has been online for sometime in text form, a copy of it can be viewed here.

Sadly, it's been difficult trying to obtain the actual video footage of Hudson being depoed by US attorneys representing Tobin.

We do, however, have a small segment of his video deposition.

In 2002 Investigative journalist Shelley Jofre launched her first installment into the whole Paxil debacle. BBC Panorama's 'The Secrets of Seroxat' was aired and it prompted over 67,000 calls and emails from concerned consumers.

During the documentary Shelley touched on the case of  Donald Schell. The footage in the documentary revealed part of Dr Ian Hudson's video deposition. Remember, at the time, Hudson was a GSK employee.

Watch.... (Hudson was depoed in 2000)

**If the video starts with Andy Vickery talking then click the bar to end of video then press play**




In 2008 the MHRA concluded a four year investigation of GlaxoSmithKline, the crux of which was to find out whether GlaxoSmithKline withheld paediatric safety data pertaining to suicide related to its antidepressant Seroxat. They decided not proceed to criminal prosecution. It's unknown if they interviewed their own Dr Ian Hudson during their four year investigation. [2]

As I said, Dr Ian Hudson is now the Chief Executive of the MHRA, the agency that purportedly protects British consumers of prescription drugs.

I don't know about you but this doesn't really fill me with a sense that I am being protected from dangerous drugs. Does it you?


All four Paxil videos will soon be available in their entirety on Rxisk


Bob Fiddaman


[1] 'The evidence however, is clear, the Seroxat scandal' [US] [UK]
[2] GSK investigation concludes [Link]











Thursday, September 04, 2014

GSK Claim Phone Calls May Shed Light On Suicide






When someone dies as a direct result of a product purchased and ingested, one would expect those that manufactured the said product to be apologetic, nae mortified that they didn't see it coming. That is unless you belong to the circles of British pharmaceutical giant GlaxoSmithKline.

Last month I wrote about the suicide case against GSK currently ongoing in the US. [1]

Wendy Dolin filed suit against Paxil makers GSK after her husband, Stewart, took his own life just 6 days after taking Paxil [paroxetine]

GSK argued that they never had a case to answer because Dolin wasn't taking their brand of paroxetine, he was taking a generic brand manufactured by Mylan.

A ruling earlier this year by Judge James B. Zagel allowed the suit to proceed on the grounds that GSK owed a duty to Dolin. GSK should have expected generics manufacturers, like Mylan, would make paroxetine once the Paxil patent expired, and, according to the ruling, GSK knew the companies would have to follow its label for the drug.

GSK's defence lawyers then subpoenaed Wendy Dolin's cellphone and text message records, her home phone and her late husband's company phone. GSK has so far sent more than 30 subpoenas and over 70 records requests, and shown the Dolin children Stewart Dolin's confidential therapy notes despite Wendy Dolin's objections.

Yesterday GSK defended their corner in requesting Dolin's phone records. They argued that they only sought those records to get a "fuller picture" about his mental health before his suicide.

Wendy Dolin had claimed that taking paroxetine had caused her husband to develop akathisia, a condition that causes psychological agitation.

GSK claim that Stewart Dolin's phone records may shed light on why he killed himself.

They already have something in their vaults that will shed light, namely paroxetine.

Watching this unfold is both comedic and tragic. Comedic because we all know what the outcome is going to be. A trial, a u-turn, a settlement...with a gagging order. Tragic because a grieving wife is being put through the mill by GlaxoSmithKline and their highly paid law team because they will defend their corner until every trick in the book has been used to defend Paxil. It's also a show of rabid fangs by GSK, they want to show others just how they will be treated if they dare try and come up against their mighty power.

Wendy Dolin is essentially being raped by GSK and their lawyers, that's my opinion.

Only time will tell if they get their way or if they dare to go the whole hog and defend the suicide drug Paxil.

Wendy Dolin is represented by Bijan Esfandiari, Michael L. Baum, Frances M. Phares and R. Brent Wisner of Baum Hedlund Aristei & Goldman PC, and Joshua Weisberg and Lindsey Epstein of Rapoport Law Offices PC.

GSK is represented by Alan S. Gilbert and Melissa A. Economy of Dentons, and Andrew T. Bayman, Todd P. Davis and Christopher R. Benson of King & Spalding LLP. Mylan is represented by Robert E. Haley of Swanson Martin & Bell LLP and Clem C. Trischler and Jason M. Reefer of Pietragallo Gordon Alfano Bosick & Raspanti LLP.

Bob Fiddaman.


[1] GSK Sink to New Level in Paxil Suicide Litigation




Wednesday, September 03, 2014

The Bizarre Life of Dr Andy Clayton



 Dr Andy Clayton


Initially I was just going to highlight a segment of a video that featured Dr Andy Clayton [above] speaking about antidepressants and withdrawal. Initially I was going to present him with a 'Burke of the year Award'.

Researching him was easy.

First, here is the segment of the video you should watch. It's taken from the BBC's first Panorama documentary about GlaxoSmithKline's Seroxat. 'The Secrets of Seroxat' was aired in the UK back in 2002. All 4 Panorama programmes about Seroxat will be available soon on David Healy's RXISK website.

Seroxat is known as Paxil in the US and Canada and Aropax in Australia and New Zealand.

Here's the snippet featuring Dr Andy Clayton.



Video also here.


Transcript: [1]

Dr ANDY CLAYTON
Medical Director, Derby Mental Health Trust
They're so simple, you don't kneed to be a genius to prescribe antidepressants and they get 
seven out of ten people better in a couple of months and they're not even very expensive.

JOFRE:  Cheap, effective and apparently even Seroxat withdrawal symptoms can be beneficial.

CLAYTON:  Interestingly I've actually found the withdrawal effect to be quite handy for a few 
people.  I've had several patients who've come to see me in clinic and said: "I actually sort of 
stopped taking my antidepressant doc because I thought I didn't need it.  But after a day or so I 
felt a little twitchy, a little uncomfortable and it made me realise I did need it."

JOFRE:  But wouldn't that just be the withdrawal effect?

CLAYTON:  Well exactly, that's the withdrawal effect that they had noticed for a day or so and it 
had prompted them to go back on the pills which is very helpful.



Very helpful?

I'd not seen 'The Secrets of Seroxat' in its entirety before so, as you can imagine, Dr Clayton's comments startled me somewhat. However, researching Clayton I found something even more startling.

In 2006, some four years after 'The Secrets of Seroxat' was aired, a number of allegations were made against Clayton that dated back many years. After an investigation Clayton was sacked two years later, in 2008.

One year later, in 2009, Clayton appeared in court on charges of  possessing child  pornography.

Judge John Burgess sentenced Clayton to a three-year community order and he was was also banned from working with children under 16 for the next five years. [2]

In 2010 the former joint medical director of Derbyshire Mental Health Services NHS Trust, was removed from the medical register following a ruling by the General Medical Council hearing. This was following his sacking in 2008 where it had been alleged that Clayton, while working at a Swadlincote clinic from 1990 to 2002, was found to have behaved in a sexually motivated and made lewd comments to two patients and a trainee occupational therapist.

The panel was told he also had written a prescription, in January 2009, for a month's supply of an antidepressant for his own personal use, which was a breach of his suspension. [3]

Also, in 2010, a post appeared on a blog entitled, 'Perv Doctor'. The writer alleged the following...

My GP had referred me to this consultant as he was 'a good friend' of his. I didn't much like my GP but I trusted him. My family knew I had self harmed but I was too embarrassed to tell them I had been referred to a psychiatrist.
I went to the appointment alone in a clinic I had never visited before. I went into the room alone and Dr Andrew Clayton and I were alone throughout the appointment. Not once did he ask if I'd like a chaperon He discussed why I had been referred to him and asked me if I was sexually active and how many times a week I had sex. Which I thought was odd.
Worse was to come. He then said that cancer could cause depression and he wanted to examine my breasts. I was horrified but I was young and too polite (??) to object so he examined my breasts. He never talked about treatment, counselling or anything else after the examination and said if I needed to come back to make an appointment or go and see my GP.
I got out of there as quickly as possible with no intention of ever going back. I wasn't about to tell my GP that his friend had examined me inappropriately. I decided if this was the way to treat a depressed teenager then I would have to face it alone and never asked for specialist help again.
I was put on antidepressants a year later after I could no longer cope with the symptoms but had been too scared to go to my GP in case he sent me to a specialist again. I never told anyone about what happened until years later.



On Oct 25, 2012 Clayton was found hanging in his back garden. At the time he was facing fresh sexual allegations [4]

His wife told the inquest that her husband had previously attempted to drown himself in their garden pond two years before his death.

So, it 2002 Clayton claimed that it was "helpful" that patients went back on to antidepressants as a result of suffering withdrawal symptoms.

In 2009 he prescribed himself a months supply of antidepressants.

In 2010 he attempts suicide

In 2012 he completes suicide.

Bizarre.

I don't know about you but I keep playing the 50 second video [above] - I'm quite gobsmacked that a professional could claim that it is helpful for people to go back on to antidepressants as a result of suffering severe withdrawal symptoms while trying to get off them. I know we shouldn't speak ill of the dead but it's when he was alive that I find very peculiar. His whole manner during the 50 second footage is, it has to be said, quite scary. When told by investigative journalist, Shelley Jofre, that these patients may have been suffering a withdrawal reaction to the drug, he agrees but then, in a bizarre jovial manner, claims the withdrawal was helpful because the patient returned to the antidepressant!

Interestingly, Dr Clayton et al investigated a possible link between antidepressant use and self harm in 2000. The study, entitled, 'Deliberate self-harm and antidepressant drugs - Investigation of a possible link', appeared in the British Journal of Psychiatry [5]

Clayton et al found that prescribing safer-in-overdose antidepressants is unlikely to reduce the overall morbidity from deliberate self harm.

The study  received an "unconditional contribution" from Prozac and Cymbalta manufacturers Eli Lilly and... you've guessed it, Seroxat manufacturer, GlaxoSmithKline.



Bob Fiddaman.


[1] The Secrets of Seroxat

[2] Another Derbyshire doctor caught with child porn

[3] Derbyshire doctor struck off over harassment claims

[4] Suicide of psychiatrist facing sex crime claims after child porn shame

[5] Deliberate self-harm and antidepressant drugs- Investigation of a possible link





Wednesday, August 27, 2014

Are Lundbeck Luring Pregnant Mothers With a Red Apple?






After turning into the Witch, the Queen declares that Snow White should suffer "a special sort of death". Looking through her spell book, she comes to the recipe for the Sleeping Death, and, reading of the Poisoned Apple's effects, decides that it's the perfect way to get rid of the princess. She brews the potion and dips an ordinary apple into the brew as the Raven watches silently. The Sleeping Death seeps into the apple, and the Witch raises the apple from the cauldron to reveal that the poison dripping from the apple has formed an image of a skull. This image fades as the apple turns red, to tempt Snow White. - Disney Wiki




I'm confused.

Can citalopram, marketed and manufactured by Lundbeck in Europe, cause birth defects?

It's a simple enough question that should be simple enough to answer. It is, when all's said and done, a very important decision to make for any pregnant mom who may be faced with a choice of taking or not taking citalopram during pregnancy.

Sadly for Scottish mom Cheryl Buchanan this is not an option.

When Cheryl was just 12 weeks pregnant she was told that scans had detected a series of anomalies in her unborn child.

  • Diaphragmatic hernia or eventration
  • Long bone immobility
  • Cystic hygroma 
  • Unilateral cleft hand
  • Microgynathia

A post-mortem revealed that Cheryl's unborn child that half of her daughter's diaphragm was absent, her lungs were very small, some of her organs had moved up into the thoracic region,  her neck had webbing, and her nose was small while her chin was recessed.

Cheryl had been taking Lundbeck's citalopram prior and during her pregnancy. She wrote a guest post for my blog back in 2013 and has since been trying to get answers from the Danish pharmaceutical giant Lundbeck.

What follows is bizarre to say the least.

Cheryl wrote me and asked me to read through a collection of emails sent to her by Lundbeck. I asked for Cheryl's permission to contact Lundbeck directly - she agreed.

Cheryl had previously asked Lundbeck if citalopram could cause birth defects. Their answer, in a nutshell, was that here was no evidence of this.

"...there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects over the background risk in general population (i.e. of mothers not taking citalopram). " - Dr Andrew Jones, Medical Director, Medical Department, Lundbeck

I wrote directly to Dr Jones...

Dear Dr Jones,

I have seen the attached correspondence you wrote and sent to Cheryl Buchanan regarding citalopram and birth defects.
I understand that you will not be able to discuss with me individual cases but I feel I must press you for some clarification.
You wrote, " "there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects over the background risk in general population (i.e. of mothers not taking citalopram). "
Can you clarify if this is just a personal opinion or if it is the position of Lundbeck.

Initially Dr Jones did not respond so I told him I would make the question to him public. Strangely Lundbeck then checked me out [Fig 1].


Fig 1


Dr Jones replied shortly after Lundbeck had paid a visit to my blog, his reply to me was short...

Dear Mr Fiddaman,
I confirm that this is the position of Lundbeck.

 I wrote the following back to Dr Jones...

Dear Dr Jones,
Many thanks for your reply, although it has to be said that Lundbeck are misleading Ms Buchanan with their rather ambiguous statement regarding the risks of taking citalopram during pregnancy.
As you are probably aware the pregnancy risk with citalopram is classed as a 'Category C', ergo risk cannot be ruled out. To suggest otherwise to a woman of child bearing age is irresponsible and misleading.
Do you or, indeed, Lundbeck, wish to amend your response to Ms Buchanan or do you wish to stand by your position that citalopram does not cause birth defects?
Whilst waiting for a response I fired off an email to Sandy Walsh, Sandy is a press officer at the FDA, more specifically for the Center for Drug Evaluation and Research. I also sent a reminder to Dr Jones that if he did not answer my follow-up question I would make it public on my blog.

Here's the email I sent the FDA...

Dear Sandy,
I'm very confused.
Recently a reader of my blog contacted me regarding the antidepressant citalopram, marketed in Europe by Lundbeck.
She had to abort her fetus due to it developing birth defects inside the womb.
Whilst I am aware that you cannot discuss individual cases with me I'd like to bring to your attention an email that the woman received from Lundbeck.
She asked if citalopram could cause birth defects.
The answer, from Dr Andrew Jones Medical Director, Lundbeck UK, was "there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects over the background risk in general population."
My question to you may clear matters. Could you tell me why the FDA have assigned citalopram to pregnancy category C and whether or not Lundbeck/Forest had any input in arriving at that decision?
Hopefully your answer may clear this confusion up.

Sandy Walsh was very helpful with her response, I've highlighted the relevant parts...

Here is the FDA-approved prescribing information (labeling) for Celexa: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020822Orig1s046lbl.pdf
As noted on page 18, there is a description of why Celexa is category C:   
-----
Pregnancy Category C : 
In animal reproduction studies, citalopram has been shown to have adverse effects on embryo/fetal and postnatal development, including teratogenic effects, when administered at doses greater than human therapeutic doses. In two rat embryo/fetal development studies, oral administration of citalopram (32, 56, or 112 mg/kg/day) to pregnant animals during the period of organogenesis resulted in decreased embryo/fetal growth and survival and an increased incidence of fetal abnormalities (including cardiovascular and skeletal defects) at the high dose, which is approximately 18 times the MRHD of 60 mg/day on a body surface area (mg/m2) basis. This dose was also associated with maternal toxicity (clinical signs, decreased body weight gain). The developmental, no-effect dose of 56 mg/kg/day is approximately 9 times the MRHD on a mg/m2 basis. In a rabbit study, no adverse effects on embryo/fetal development were observed at doses of up to 16 mg/kg/day, or approximately 5 times the MRHD on a mg/m2 basis. Thus, teratogenic effects were observed at a maternally toxic dose in the rat and were not observed in the rabbit.
When female rats were treated with citalopram(4.8, 12.8, or 32 mg/kg/day) from late gestation through weaning, increased offspring mortality during the first 4 days after birth and persistent offspring growth retardation were observed at the highest dose, which is approximately 5 times the MRHD on a mg/m2 basis. The no-effect dose of 12.8 mg/kg/day is approximately 2 times the MRHD on a mg/m2 basis. Similar effects on offspring mortality and growth were seen when dams were treated throughout gestation and early lactation at doses ≥24 mg/kg/day, approximately 4 times the MRHD on a mg/m2 basis. A no-effect dose was not determined in that study. There are no adequate and well-controlled studies in pregnant women; therefore, citalopram should be used during pregnancy only if the potential benefit justifies the potential risk to the Celexa (citalopram HBr) fetus.
-----
Category C means that animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. The pregnancy categories are assigned based on current scientific evidence and can be changed if new information is learned.
The company and the FDA both work together to add drug benefit/risk/safety information into the drug labeling.  So yes, the company plays a role in what is contained in the drug labeling.

The pregnancy categories
If a person has an adverse event, that should be reported by the doctor or patient to the FDA (or European authority), or the drug company, so that it can be properly logged into the official adverse event tracking systems.

I wrote the following back to Sandy Walsh...

Sandy,
Thank you for this.
I have found your help in this, and other matters where I have contacted you before, very helpful.
Can you explain why Lundbeck would be telling consumers/patients that there is no risk during pregnancy?
I can forward you the letter if you wish?

Sandy's response was...

I cannot speak for the company, please ask them.
As noted, the US drug labeling says, "There are no adequate and well-controlled studies in pregnant women; therefore, citalopram should be used during pregnancy only if the potential benefit justifies the potential risk to the Celexa (citalopram HBr) fetus."

Not very satisfying so I pushed Sandy for something more definitive...

The company are, at this moment in time, refusing to answer any further questions from me.
This is potentially dangerous and misleading information they are handing out to women of child-bearing years.
If the company won't give me an answer and the FDA cannot speak about Lundbeck's stance then who can I ask?
Do you have a procedure whereby I can ask the FDA to ask on my behalf?

It's a strange way to safeguard human health, don't you think?

Here's Sandy's response...

Apologies, I have a number of other things I’m working on and meetings today.
The FDA is only able to provide the information I’ve given to you – the warnings in the FDA-approved drug labeling   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020822Orig1s046lbl.pdf.
If someone believes they’ve experienced an adverse event, they should contact the drug authority in that country. 
In the U.S., if there is adverse event information to submit, it should be submitted to our MedWatch system along with medical information from the physician, and the information from the company. Here are instructions as to how to do that: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm354560.htm

In other words, sorry you are on your own.

Here we have a pharmaceutical company handing out information to a woman that claims that there is no link between citalopram use and birth defects. The American drug regulator, the FDA, inform me that during animal studies there was an increased incidence of fetal abnormalities (including cardiovascular and skeletal defects)

They add that there are no adequate and well-controlled studies in humans and that  potential benefits may warrant use of the drug in pregnant women despite potential risks.

This is baffling?

If no adequate and well-controlled studies in humans has been carried out [and they never will be because it would be unethical to use a human fetus as a guinea pig] then how can they suggest that there is a chance of "potential benefits"?

If no adequate and well-controlled studies in humans has been carried out then why are doctor's prescribing citalopram to women who are pregnant? There is no gauge here so women just have to trust their healthcare professionals who are prescribing a drug blindly. Who informed the doctor's about the potential benefits of non-existent adequate and well-controlled studies?

How did we get to the stage where a drug that has never been through clinical testing for pregnant humans is now being prescribed on the premise that the benefits may outweigh the risks? What benefits?

You can't claim that a drug has benefits and that they must be weighed against the risk when you cannot even show clinical trials that highlight those benefits.

Bizarre.

This really is a game of Russian Roulette, right?

These findings are even more startling when you consider that Cheryl Buchanan is just one mom, how many more women of child bearing years have been told by Lundbeck that there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects?

Contrast Lundbeck's dismissal of citalopram being linked to birth defects with a 2006 warning regarding Citalopram and birth defects issued by the FDA.

Dr Andrew Jones, Medical Director, Medical Department, Lundbeck has not responded to further questions from me. If he does respond at a later date I will update this post.

Citaloptram is better known by the brand name of Cipramil in the UK and Celexa in the US.

It could be argued that it's akin to the red apple used to lure Snow White.



Bob Fiddaman

If you, or someone you know, has taken citalopram and has had birth defect issues then you may be liable to file a lawsuit [US ONLY] - HERE.





Wednesday, August 20, 2014

Paxil: The Statute of Limitations Defence






The Article

Paxil Birth Defect Action Time-Barred, Fla. Federal Judge Rules
MIAMI — A Paxil birth defect action is time-barred under Florida law because the plaintiffs knew of a possible connection between their injuries and the drug more than four years ago, a federal magistrate judge has ruled.
On Aug. 12, Magistrate Judge Jonathan Goodman of the U.S. District Court for the Southern District of Miami found the mother had notice of the possible invasion of her legal rights by Dec. 20, 1997, when her doctor noted in her medical records that her son’s condition was “apparently due” to Paxil.

The Background 

On January 27, 2012, Iolany Ferez, filed, on behalf of her minor son, Andrew Plascencia,(AP) a product liability action against GSK in Pennsylvania state court. Ferez alleged that Paxil caused A.P. to be born with Tricuspid Atresia, Right Ventricular Hypertrophy, and a heart murmur.

Ferez gave birth to A.P. in 1996. Doctors noted at birth that A.P. had a heart murmur, and diagnosed him with a heart defect the next day.  A.P.’s heart defect was classified as a tricuspid atresia type II‐B, a condition that has required two corrective procedures and regular cardiology visits throughout his life.

According to court documents, Ferez suspected Paxil caused A.P.’s heart defect almost immediately because she had taken it throughout the first six weeks of her pregnancy with A.P.She had not taken anything during her first two pregnancies and both children were born without defects.

Ferez asked A.P.’s cardiologist and her gynecologist whether Paxil may have caused A.P.’s heart condition. Both responded that they did not know.

On December 20, 1997, Dr. Marcio Ferez, Ferez’s father, employer, and primary care physician, noted in Ferez’s medical records that A.P.’s heart defect was “apparently due to” Paxil. In September 2005, GSK mailed a letter to Dr. Ferez and other healthcare professionals advising them of a recent study that showed Paxil was associated with an increased risk of congenital malformations, most commonly cardiovascular. A second letter was sent in December 2005, advising of an additional study showing an increased risk for cardiovascular malformations in infants born to women who had first trimester Paxil exposure.

The GSK Defence

GSK argued that the statute of limitations bars the claim of Ferez because she had actual and constructive knowledge that A.P.’s heart defect may have been caused by Paxil.

Conclusion

Although the Court was sympathetic to A.P.’s condition and injuries and recognizes that Paxil may well be responsible for his birth defect, “liability cannot rest on sympathy alone.”

GSK’s summary judgment motion was granted. (granting summary judgment to defendant in products liability case based on statute of limitations).

Commentary

Iolany Ferez took Paxil during her pregnancy. Her  son was born some time later and it was found that he had a number of birth defects. Ferez put two and two together and came to the conclusion that Paxil may have caused these defects because she had given birth on two previous occasions to healthy babies where, during these pregnancies, she was not taking Paxil.

GSK have claimed that because Ferez made an assumption that it could have been their product that caused her son's defects and didn't file a lawsuit against them straight away, she is out of time to make any such claim for compensation.

Can you imagine if victims of Jimmy Saville, or any other pedophile for that matter, were told that they, or the prosecuting team, couldn't bring any charges against him because they never came forward at the time of the alleged assault?

The Judge ruled in favour of Glaxo, "Although the Court is sympathetic to A.P.’s condition and injuries and recognizes that Paxil may well be responsible for his birth defect, liability cannot rest on sympathy alone."

So, an acknowledgement by the man with the gavel that Paxil may well be responsible for this particular child being born with a birth defect...but, um, tough shit, his mom  should have joined the dots and filed earlier.

What kind of system is this?

Sadly, Judges are bound by statute instead of common sense. Knowing the statute of limitations inside out is a must for any attorney representing the pharmaceutical industry. They cannot defend the drug because physical evidence shows the harm the drug causes - instead they rely on a statute that was, in my opinion, designed to help the mighty to continue being mighty and for the lowly to know their place.

In the meantime, the son of Ferez, who has Tricuspid Atresia, Right Ventricular Hypertrophy, and a heart murmur, has to go through a life of uncertainty. His mom has to pick up all the medical bills which can run into many thousands of dollars.

GSK have once again shown that their corporate motto that GSK is a  "global healthcare company that is committed to helping people to do more, feel better and live longer", is misleading and should be altered accordingly.

How have they helped the son of Iolany Ferez to do more?

How have they helped the son of Iolany Ferez to feel better?

How have they helped the son of Iolany Ferez to live longer?

This isn't the first time GSK have used a statute of limitations defence. They did so in the case of Joanne Thomas.

Thomas had to abort her fetus due to a number of defects caused by Paxil.

GSK argued she was out of time filing a lawsuit, the Judge agreed.

Research, carried out by myself and Thomas, showed that she wasn't out of time and that GSK knew that she wasn't. Attorney's involved in the case drew up a settlement between Thomas and GSK. There was no media coverage, apart from my own, about Glaxo knowing that Thomas had contacted them via email many years before she filed suit.

It's unknown if Thomas agreed to settle. Good luck to her if she did.

Ryan, Glaxo's Non-Viable Fetus - Part I



Bob Fiddaman.







Tuesday, August 19, 2014

Antidepressant Aggression, the MHRA Perspective








Last month I wrote a piece entitled, 'Antidepressants: The Power To Harm' which, basically, highlighted the Japanese drug regulator and the Japanese Ministry of Health, Labour and Welfare. [MHLW]

A 2009 review of antidepressants in Japan [1] resulted in MHLW issuing an alert to patients and their families to pay due attention to changes in patient condition during the course of treatment. On May 8, 2009, MHLW required marketing authorization holders [MAHs] to revise precautions in package inserts.

They found that causality between SSRi antidepressants and harmful behavior to others could not be denied in 2 cases of reported adverse reactions associated with fluvoxamine maleate and 2 cases of reported adverse reactions associated with paroxetine hydrochloride hydrate. For the remaining 35 cases of adverse reactions, causality between the drug and adverse reactions was considered unknown.

After reading this review I wrote to the British drug regulator, the MHRA.

Dear Sir/Madam,
I would like to know if the MHRA have any information, be it by study or review, regarding SSRi adverse reactions of aggression including harmful behavior to others (including injury). 
Please state if any alerts to patients and their families have ever been sent out regarding this issue.
Please state if any revision to package inserts have been made regarding this issue.

The MHRA have now answered and, it has to be said, it would appear that patient welfare is far higher on the list in Japan than it is in the UK.

First off, their cover letter to me.




I like the final paragraph...

"The information supplied in response to your request is the copyright of MHRA and/or a third party or parties, and has been supplied for your personal use only. You may not sell, resell or otherwise use any information provided without prior agreement from the copyright holder."

I'm not going to bother asking the MHRA if I am allowed to republish, what I deem as, important safety information regarding SSRi use and aggression. They've used this threat before with me, see 'The evidence, however, is clear, the Seroxat scandal'. [2]


The MHRA have provided me with 30 pages of information with regard to the question I put to them, much of which is redacted [blacked out]

It would be pointless to post all 30 pages but those wishing to scrutinize can request a copy from me by emailing me.

Some points...

The information sent to me from the MHRA was taken from meetings that occurred between the years 1996 and 2001.

Contrast that to the Japanese information on SSRis and aggression. Their information is more up to date, in fact it is 8 years more up to date than what the MHRA have given me.

The MHRA, or the data they sent me, points to two SSRis causing aggression. Fluoxetine and Paroxetine, namely, Prozac and Seroxat (Paxil)

Remarkably these findings of aggression with Prozac and Seroxat use have been played down by claiming that the reporting rates of aggression increased when stories started appearing in the media. The MHRA do not balance this claim, for instance, (i) the reporting rates may have increased because patients may not have known that the MHRA actually collected such reports and (ii) consumers may have attributed their aggression and suicidal thinking to their illness, opposed to it being a possible adverse reaction to the drug they were taking.

Page 23 of the 30 page document they sent me is quite telling. [Fig 1]


Fig 1

So, when there is a clear sign that aggression is occurring during Prozac and/or Seroxat treatment it has, if you believe the above, nothing to do with the drug/s, it is possibly a "separate event from the underlying illness" or it's "part of a discontinuation syndrome", or maybe the aggression has appeared because of the removal of the therapeutic benefits of the drug.

Once again, the suggestion of media reports on antidepressants and the suicide link are mentioned. It's almost as if they [the committees who reviewed the aggression link in SSRi use] are putting something in place. Rather than look at the blindingly obvious problem they chose to deflect and lay the blame on intense media reporting.

Now, contrast this stance with those of the Japanese.

2009:

The Japanese Ministry of Health, Labour and Welfare issued an alert to patients and their families to pay due attention to changes in patient condition during the course of treatment. On May 8, 2009, MHLW required marketing authorization holders [MAHs] to revise precautions in package inserts.

The above was based on a review where they found an association with SSRis and aggression.

No pussy-footing around, no blaming the media, no blaming a discontinuation syndrome or no blaming the underlying illness causing the aggression. Moreover, the  Japanese Ministry of Health, Labour and Welfare sent an alert out to patients and their families about their findings.

I don't know about you but if one regulator flags a warning about patients becoming aggressive on antidepressants then other regulators around the world should act promptly.

Judging by the material sent to me by the MHRA, they put the SSRi aggression link to bed in 2002 and have done nothing more about it since then.

The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.

Oh really?



Bob Fiddaman


1. 2009 Selective Serotonin Reuptake Inhibitors and Aggression [Japanese Review] [Link]
2. The evidence, however, is clear, the Seroxat scandal. [Link]