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Friday, January 27, 2012

James Murdoch to Leave Glaxo Board, Applications Wanted




Multi-millionaire media mogul James Murdoch has decided to call it quits at Glaxo. Murdoch, who last year was the centre of a phone hacking scandal, "has decided not to stand for re-election to the board at GSK's [annual general meeting] in 2012," Glaxo said in a statement.

With this in mind I have decided to apply for a position on the board. My letter of application is below.


Dear Mr Witty,


May I call you Andrew, Andy or do you prefer to be called Sir after your recent knighthood?

I'll cut to the chase, if I may? I'd like a position on your board, I won't accept an annual wage but you could pay for your peers to take me to lunch, feed me some BS about Seroxat withdrawal before shooting off to their next appointment. I think you call that "Dine and Dash" don't you?

It would have been nice to hook up with my old mucka Alistair Benbow, or as he likes to be called, 'Big Al'. Alas, he has now left Glaxo and has hit the comedy circuit where I gather his audiences are no more bigger than a small classroom of school children. A friend of mine caught some of his stand-up routine, apparently he had the small audience in fits of laughter when he cracked the joke about Seroxat not being addictive, my friend almost soiled himself laughing and had beer running down his nostrils. He told me Big Al is a bit like the comedian Jack Dee in as much that he can keep a dead pan face when coming out with one-liners such as 'Seroxat is safe', 'Dr Healy has been proved to be wrong' and the side splitting, 'the evidence, however is clear...these drugs are not addictive'

Imagine the fun we could have if you allowed me onto your board Sir Andy. We could go to Downing Street together and talk with your old chums David Cameron and the other fella who is part of his coalition. Cameron is a Villa fan so he's one of the good guys, right? Maybe he could make me part of his Business Council as he has you and before you your predecessor, old JP Garnier, Jeepers as we all know and love him.

Would I need to be inoculated before I entered the GSK building Sir? What vaccine do you recommend? I know GSK have had terribly bad press about their vaccines, particularly that one they used in Argentina where 14 babies died - I sure do hope I don't have to have that one Sir Andy.

What about attire, would it be okay to wear jeans and a bandana and maybe my FCUK GSK T shirt [Fig 1]

Anyway, I'm sure you have a lot on your hands what with the various legal actions against your company. Don't worry Andy I'll help you put things back on track and maybe we could have a couple of pints together and come up with some ideas about new diseases to treat with existing drugs. Hey, we just change a molecule here and there, repackage the box with a catchy name and VOILA! we have a new drug on the market.

If you need me to send in references then I nominate investigative journalist Evelyn Pringle. Evelyn and I have been friends for some time now, she is, in fact, one of the reasons why I write. It was only after I read her 'Drip, Drip, Drip' article on Paxil that I became interested in Glaxo's unethical practices. Maybe I could get Steph Gatchell or Neil and Rhonda Carlin to write me the other reference, you know who they are don't you Andy?

Anyway, must fly, I have Shania coming over to my place for a game of hide the salami.

Please consider me for a position on the board.
Lots of hugs

Fiddy xxxx



Fig 1 - Gissa job Sir









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Wednesday, January 25, 2012

Call For Medical Ghostwriters To Be Held Legally Liable



An article that has today appeared in the Plos Medicine Journal has called for medical ghostwriters to be held legally liable for infringing academic standards and contributing to fraud.

The co-authored article, written by, Xavier Bosch, Bijan Esfandiari and Leemon McHenry, cites possible avenues where legal action could be taken against those who lend their names to published studies written by pharmaceutical company spin doctors.

The Plos article rightly clams:

"Guest authors lending their names to ghostwritten articles touting the safety and efficacy of a drug have an independent duty to exercise ordinary care and prevent injury to others as a result of their conduct."

Because of this, the authors write, that guest authors may be legally liable and argue that the only way to halt this is through litigation.

Personal Injury Lawsuits
 "Sections 310 and 311 of the Restatement allow injured third parties to recover from a person who has made an intentional and negligent misrepresentation inducing action that involves a risk of physical harm."

Federal False Claims Act (FCA or Whistleblower Statute)
"FCA inflicts civil liability against persons or entities presenting false payment claims or using false records or statements to get claims paid or approved or causing third parties to do so.


"The potential that participating in a ghost authored article can result in liability for conspiracy under the FCA may be another deterrent to the unethical practice of guest authorship."


Anti-Kickback Statute
"Since paying physicians to become honorary or guest authors of a ghostwritten paper may influence their clinical judgment, subsequently increasing product sales (and government health care costs), and putting patients at risk by misrepresenting risk-benefit, both physicians and sponsor companies may be legally liable."


US attorney's Baum Hedlund have issued a press release regarding the Plos article where they write:

Numerous examples of medical ghostwriting have been uncovered in lawsuits involving drugs such as Neurontin, Paxil, Zoloft, fen-phen, Vioxx and Prempro where courts have unsealed formerly confidential internal company documents. In other cases, the extent of medical ghostwriting remains under court seal (e.g., Avandia, Zyprexa, Seroquel, Bextra and Celebrex).


I've always been astounded that pharmaceutical companies who settle with claimaints are allowed to seal documents that are of a massive public interest. On one hand they settle out of court with claimants, on the other they stop documents from reaching the public, in essence, this stops further suits being brought against them.

It's only through items of disclosure that we can get to the bottom of who actually writes what, a classic example would be the, now infamous, Paxil 329 studies that were, for many years, thought to be written by a whole host of key opinion leaders. In fact, the Paxil 329 study was written by GlaxoSmithKline hired ghostwriters who 'bigged up' the use of Paxil in adolescents and claimed, "Paxil demonstrates REMARKABLE Efficacy and Safety in the treatment of adolescent depression."


Years later, after many millions of Paxil prescriptions were written for adolescents, it came to light that the Paxil 329 study was not authored by KOL's, they merely lended their names to it to add credibility and to persuade healthcare professionals that Paxil was indeed safe to use in kids. What the study failed to mention was the suicide link, a key safety issue they conveniently left out. Those who lent their names to the study should have asked questions, they should have requested the raw data. Instead they were each paid handsomely and endorsed a study that put children and adolescents in jeopardy. That's unforgivable and the authors will have to carry that around with them for the rest of their lives, as will the ghostwriting team hired by GlaxoSmithKline.

I echo the sentiments of the authors of the recent Plos article. A slap on the wrists should not be the punishment for allowing a drug on to the market that is basically a bullet. These co-conspirators are, like GlaxoSmithKline, guilty of wanton neglect on the most vulnerable in our society - Children.

That's a crime in anyone's book!

Fid




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Saturday, January 21, 2012

NUMB DVD - Paxil [Seroxat] Documentary Now On Sale.



It gives me great pleasure to announce that the documentary GlaxoSmithKline don't want you to see is now available to purchase on DVD.

Filmmaker Phil Lawrence, who, for 6 months, filmed a fly on the wall documentary about his Paxil [Seroxat in UK] withdrawal, kindly sent me a screener of his movie back in July, review can be read HERE

I have a huge respect for Phil Lawrence. To put one's life on camera in an attempt to educate the masses about the horrific withdrawal problems Paxil causes takes a tremendous amount of courage. Society owes Phil Lawrence a great debt.

The DVD, Numb, can be ordered via the Numb website HERE

If I was Phil I'd send a copy to GlaxoSmithKline...their highly paid defence attorney's too.


Here's a teaser




Fid




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Australian Psychiatrist Ian Hickie's Lancet Paper Heavily Criticised

Prof Ian Hickie


Things have gone belly-up down under, it seems.

Psychiatrist Graham Burrows has recently been in the news for prescribing unapproved drugs to his patients, resulting in a class action lawsuit against him.

Yesterday an article appeared on the subscription based online website The Australian Doctor. Professor Ian Hickie had co-authored a review that appeared in The Lancet, a review that has been heavily criticised for failing to reveal Hickie's ties with Valdoxan [agomelatine] manufacturer, Servier.

Hickie has also been accused of down playing the side effects of  Valdoxan, an antidepressant marketed for the treatment of major depressive disorder.

So far six letters, in response to the Hickie review, have been published in The Lancet, all of which are critical. Hickie and his co-author Naomi Rogers have both replied to the criticism.

It comes as no surprise, to me at least, that Hickie is seen promoting the use of a psychiatric medication, he is after all part of the DeLorean Mob [EPPIC], a psychiatric service that can jump into the future to see what lays in store for the patients [adolescents] they treat. In a nutshell [pardon the pun], EPPIC can predict if a child may fall foul of psychosis. No prizes for guessing the kind of treatments used for psychosis these days.

Critics slammed Hickie for not revealing his ties [conflict of interests] in the review, something which he has since changed with his response to the critics. One has to question why he never shared this when he and Rogers submitted the review to The Lancet.

I find it difficult to understand how anyone could take his review seriously after reading the disclaimer at the foot of his latest response. Even more so that the disclaimer has only appeared after he was pulled up about it by the critiques.

IBH [Hickie] was previously Chief Executive Officer and Clinical Adviser of beyondblue, an Australian National Depression Initiative. He has led projects for health professionals and the community supported by governmental, community agency, and drug industry partners (Wyeth, Eli Lily, Servier, Pfizer, AstraZeneca) for the identification and management of depression and anxiety. He has served on advisory boards convened by the drug industry in relation to specific antidepressants, including nefazodone, duloxetine, and desvenlafaxine, and has participated in a multicentre clinical trial of agomelatine effects on sleep architecture in depression. IBH is also supported by a National Health and Medical Research Council Australian Medical Research Fellowship. He is a participant in a family-practice-based audit of sleep disturbance and major depression, supported by Servier, the manufacturers of agomelatine. NLR [Rogers] has received grant support from Vanda Pharmaceuticals, Servier, Pfizer, and Cephalon, and has received honoraria for lectures from Pfizer, CSL Biotherapies, and Servier. She has previously received research funding from Vanda Pharmaceuticals, manufacturers of tasimelteon. She has also received an unrestricted educational grant from Servier. Research studies done by IBH and NLR are mainly funded by NHMRC project and programme grants.

Here's just two letters sent to The Lancet in response the Hickie's review, the other four are similar in content. [1]  [2]

Last year I wrote about Hickie regarding his connections to former Australian of the year and psychiatrist Patrick McGorry - Hickierie Dickory Doc - McGorry Turns Back the Clock

Also - The Defence of Prof. Ian Hickie


"If my calculations are correct, when this baby hits eighty-eight miles per hour... you're gonna see some serious shit." - Dr. Emmett Brown [Back To The Future 1985]






Fid




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Friday, January 20, 2012

UK SEROXAT LITIGATION - CURRENT STATUS



20 January 2012 - FOR IMMEDIATE RELEASE


An article, written by Katy Dowell, appeared on thelawyer.com on January 9 2012 that made reference to the current UK Seroxat litigation. Because of legalities I cannot discuss certain aspects of proceedings as they are at a delicate stage at this moment in time.

I can, however, state that the article is based on supposition and, is in fact, wrong.

Katy Dowell writes that a source [lawyer] close to the case informed her that legal aid has been withdrawn from the case. This is untrue.

The public funding certificate [previously known as legal aid] has never been removed from this case.

In October, 2010 the solicitors in charge of the case considered there was insufficient evidence to proceed and advised the litigants to discontinue their claims. Approximately two thirds of the litigants followed this advice. I, along with others, decided to continue the case, despite being told that we may be liable for costs.

A meeting with the Legal Services Commission's Special Committee Review Panel was convened and a barrister and claimant in the Seroxat litigation, along with myself and others, presented evidence as to why we felt the funding should be continued. At no point was the funding discontinued, the meeting with the Legal Services Comission was to decide whether or not it should be.

The Legal Services Commission's Committee considered there was merit in the case, increased the given assessment of prospects of success and agreed that a full review of the evidence should occur.

We are now at the stage where we have presented the Legal Services Commission with evidences to extend further the funding for the Seroxat litigation and we are currently awaiting their decision.

The Seroxat Users’ Group will keep litigants updated and can also be contacted via email janice@seroxatusergroup.org.uk

It would be unethical of me at this stage to comment further on matters related to the Seroxat litigation. I have already been contacted by the media and have told them that I cannot comment. My stance still remains the same.

A statement will appear on the Seroxat User Group page in due course.

The editor of The Lawyer has been contacted but, as yet, has not responded.

Bob Fiddaman.








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Thursday, January 19, 2012

Risperdal Whistleblower



There has been much in the news recently about the whistleblowing case currently ongoing in Austin, Texas.

Allen Jones is blowing the whistle on Johnson & Johnson’s Janssen unit, whom, he alleges, paid a Texas mental health official to speak around the U.S. about state guidelines on prescribing antipsychotic drugs that gave preference to the company’s Risperdal medicine.

Risperdal is an atypical antipsychotic [2nd generation] and is used for the treatment of schizophrenia, bipolar disorder, and behaviour problems in people with autism. Many children have been prescribed Risperdal because they have been diagnosed with behavioural problems, ADHD being just one of many in a long line of labelled mental disorders that range from the sublime to the ridiculous.

Jones had stumbled across payments that were being made by pharmaceutical giants to state employees to promote the off-label use of Risperdal in children. Off-label because Risperdal is not recommended for children but its usage in children is a huge cash cow that has brought untold riches to its manufacturers. They saw a niche, saw the hurdle, then saw a workaround.

Award winning author Alison Bass wrote a piece on this case yesterday, she writes:

Jones first noticed these illegal payments when he was investigator for the state of Pennsylvania’s Office of Inspector General. He discovered that the state’s top pharmacist, the guy in charge of deciding what drugs should be included in its Medicaid formulary, was receiving hidden payments from J&J, the maker of Risperdal. Jones was fired when he brought those illegal payments to light, but he persevered, and with the help of GAP, won a lawsuit against the state of Pennsylvania and eventually saw the state pharmacist who was on the take fired from his job.

Many other commentators have chipped in with their thoughts and opinions on this particular case, none more so than the blogger who goes by the name of "1 Boring Old Man", his posts are far from boring. 1 Boring Old Man has flown down to Texas for the trial and his perspective on matters is refreshing, evidence of which can be seen HERE.

Last year saw another high profile whistleblower case. Cheryl Eckhard blew the whistle on GlaxoSmithKline.

Eckard's role at GSK [before she was too was fired] was to oversee the quality assurance at various GSK operational plants. One such plant was, the now infamous, Cidra plant in Puerto Rico.

Eckard was appalled at the state of the plant in Puerto Rico, she even told her seniors, for this, it appears, she was fired.

The drugs affected by the Glaxo's conduct included Paxil, Paxil CR, Avandia, Avandamet, Coreg, Bactroban, Abreva, Cimetidine, Compazine, Denavir, Dyazide, Thorazine, Stelazine, Ecotrin, Tagamet, Relafen, Kytril, Factive, Dyrenium and Albenza.

Examples of defective and/or misidentified products that the defendants released to the United States market from the Cidra plant were:

a. Drug product that was mixed up with drug product of a different type or strength, e.g., 30mg and 10 mg tablets of an anti-depressant mixed in the same bottle, and 12.5 and 6.25 mg tablets of a heart medication mixed in the same bottle.


b. A diabetes medication that was sub-potent and/or superpotent.


c. An antibiotic ointment used to treat a skin infection common in small children that was contaminated with a microorganism associated with bacteranemia, urinary tract infections, meningitis, wound infection, and peritonitis.


d. An injectable drug used to treat nausea and vomiting in patients undergoing chemotherapy that was contaminated with micro-organisms.

Lawyers defending the claims of both Eckhard and Jones stop at nothing to protect their clients. My opinion of pharmaceutical defence lawyers is that they are just as bad, if not worse, than the clients they are defending. They know, in the Risperdal case, that children were targeted and they know that this was an abhorrent way of profit-making - yet they defend their client's actions. Okay, everyone, even the likes of Johnson & Johnson and GlaxoSmithKline, are entitled to a defence. In both cases employees were fired from their positions when they brought failings/fraud to the attention of superiors. Life after that became 'uncomfortable' for the whistleblowers. It's all part of the game that defence lawyers and their clients play to 'muddy the waters' of the opposition.

As a blogger I like to cause as much pain and misery to those that have harmed myself and others. It's becoming more apparent that to sue a pharmaceutical company through the UK legal system one needs to jump through so many legal loopholes just to get financial aid, the system is designed in such a way to protect those causing the harm. Imagine, if you will, if serial-killers or murderers had the same protection, our prisons would be empty and those offenders would be given carte blanche to continue doing what they do best...in pretty much the same way pharmaceutical companies are allowed to do.

That's Britain. America is a whole different ball game.

US Attorney's Baum, Hedlund, Aristei & Goldman hit the nail on the head when they write:

Whistleblowers play a pivotal role in the detection, investigation and prosecution of fraud against the government. According to Taxpayers Against Fraud, more than 80 percent of cases pursued under the False Claims Act are initiated by whistleblowers. The False Claims Act, also called the Whistleblower Act or the Qui Tam Act, encourages citizens to bring forward evidence of fraud against the government and sue on the government's behalf.

They add:

Many people who step forward and become whistleblowers do so because they feel the risks are worth taking, to save lives, to protect the innocent and to right a wrong. It is because there are risks involved in filing a qui tam claim that the federal False Claims Act provides both whistleblower protection and a substantial reward for the “relator” (whistleblower who files a qui tam claim).

Jones has stepped up to the plate, he witnessed something that he knew wasn't morally right, In essence, children were being used by adults to make a fast profit, it's no better than child slavery. Jones needs to be applauded at every given opportunity, the American people owe him a great debt. Turning a blind eye to this wanton neglect of children is a vile and shameful act. Defending a person or persons when you know what you are defending is an abominable act is even more shameful.

With a bit of luck, courage, ethics, call it what you will, more and more people will start coming forward to whistleblow. Maybe, just maybe, the pharmaceutical companies will then start to get their house in order and come to terms with the fact that children, under no circumstances, should be used to make billions of dollars for a product they are selling.

We, as bloggers, have a moral obligation too. What the press fail to report on is the human aspect of cases such as Eckhard and Jones. We are in a position to whistleblow by proxy and offer our full support to those who stand up to be counted. The usual suspects are covering the Risperdal case, drum-bangers such as Soulful Sepulcher, 1 boring old man, Alison Bass... to name but a few.

I was recently contacted by an ex-pharmaceutical employee who has a story to tell, I won't go into matters [because I don't know the full ins and outs] but it involves yet another act of fraudulent behaviour by a pharmaceutical company. It's too early at this stage to say if this person will become a whistleblower...I sincerely hope they do.

So, do you want to be the next whistleblower? Got something you want to get off your chest? Do you want to put all those wrongs, right?

Good place to start would be Attorney's with a proven track record against the pharmaceutical industry.



**UPDATE -J&J Said to Settle Texas Risperdal Drug Case






Fid


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Wednesday, January 18, 2012

MHRA Come Under Fire From Lancet Editor

 "The operating principle of the MHRA seems to be to do nothing until something goes wrong." -  Richard Horton  The Lancet.



Far be it for anyone to criticize the failure of the UK medicines regulatory agency...they may be labelled vexatious - However, this does not seem to have deterred the editor of The Lancet, Richard Horton.

In an article published in today's Independent, Horton states, "The operating principle of the MHRA seems to be to do nothing until something goes wrong."


His scathing attack comes after Health Secretary, Andrew Lansley, announced last week that there was to be a review of the regulation of medical devices.

Don't hold your breath folks, the MHRA have been criticized for years, they are still in place, still safeguarding human health by monitoring drugs, such as suicidal Seroxat and devices such as substandard breast implants, both of which they were warned about, both of which they did nothing about.

I echo what Richard Horton said although I'd add that even when they [MHRA] do realize something is wrong...they do nothing about it, apart from hold safety reviews with panels of industry-tied relics who tout that benefits outweigh risks...without actually ever trying out the products they review.

The scathing attack from the editor of The Lancet can be seen in full HERE.

Incidently, two questions tabled in parliament today which the MHRA have fence sat on for many years:

Eric Ollerenshaw (Lancaster and Fleetwood): To ask the Secretary of State for Health, what warnings his Department has issued on possible teratogenic effects of the use of benzodiazepines; when such warnings were issued; and on what scientific evidence they were based. 
 and
Eric Ollerenshaw (Lancaster and Fleetwood): To ask the Secretary of State for Health, whether his Department has assessed Seroxat [paroxetine] as being teratogenic. 


I fully anticipate that  the Secretary of State for Health shall contact the MHRA and be given the runaround in his search for the truth.

In the meantime, here's some more evidence of the British regulatory agency causing annoyance. [vexatious].




Another Boob From the MHRA

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

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

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

MHRA In Buck-Passing Specialist Cahoots

MHRA - More on the Mysterious "Ghost Specialists"

MHRA Wishing To Call The Shots



Fid


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Tuesday, January 17, 2012

Citalopram Inquests



Two separate inquests in the space of a month have ruled that the popular antidepressant citalopram, marketed as Cipramil in the UK and Celexa in the US, was deemed to be involved in the deaths of a 23 year-old woman and a 40 year-old man.

Both inquests named citalopram as the cause of death.

Katie was discovered dead in the bedroom of her shared student house in Leeds, the following day.

Recording a narrative verdict, West Yorkshire coroner David Hinchliff said: “A post mortem examination
shows the cause of death to be citalopram toxicity. [SOURCE]

...and

Mr Boyle was handcuffed and taken from the property, and placed on a stretcher, the inquest heard. The cuffs were then removed.

But he was pronounced dead on arrival at the Royal Blackburn Hospital.

His blood alcohol level was four-and-three-quarters the legal driving limit and he had taken anti-depressants.

Home Office pathologist Dr Naomi Carter gave the cause of death as ‘acute alcohol toxicity enhanced by citalopram’ (an anti-depressant). [SOURCE]

Further reading on the side-effects of citalopram can be read on Leonie Fennell's blog. Her son, Shane, was prescribed citalopram and in the space of a few weeks he, uncharacteristically, lost his mind and killed a young man before killing himself.

Leonie has been at loggerheads with the Danish pharmaceutical company Lundbeck, who manufacture citalopram. Last year she, along with her husband Tony, met with Lundbeck officials in Denmark to discuss citalopram side-effects. An audio recording of that meeting can be heard HERE.

Citalopram has also been linked to birth defects which include:


Abdominal Birth Defects / Omphalocele

Autism Spectrum Disorders

Anal atresia (complete or partial closure of the anus)

Cardiac (heart) defects

Cleft lip and cleft palate

Clubfoot (one or both feet turn downward and inward)

Craniosynostosis (skull defect)

Limb Defects

Neural-tube defects (brain and spinal cord, spina bifida)

PPHN (Persistent Pulmonary Hypertension of the Newborn)

More of which can be read about HERE.




Fid

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Monday, January 16, 2012

Tamiflu: Yet More Side-Effects



It's being reported that the swine-flu drug, Tamiflu, is under scrutiny as more and more side-effects have been reported to the MHRA. The Daily Star is claiming that 14 new adverse reactions were added to the drug’s profile in November including back, joint and muscle aches, fever, menstrual pain, herpes, sinusitis and earache.

A small price to pay to fend off a killer virus, which was basically a different strain of the flu.

The MHRA, the agency that regulate the drugs you and I take, have claimed that the benefits of taking Tamiflu outweigh any risks, a standard response when their regulation is put into question.

Swiss pharmaceutical giant Roche, who manufacture Tamiflu, are themselves the subject of an investigation regarding claims that they withheld vital data about the effectiveness of Tamiflu from scientists.

The Cochrane Collaboration, an independent watchdog who are not funded by the pharmaceutical industry [unlike the MHRA] have announced that a report, to be published on January 18 shows how their investigation was hindered by Roche’s refusal to provide full clinical data. The Bureau of Investigative Journalism writes:

This claim was made public today by one of the founders of the Cochrane Collaboration at a British Medical Journal conference held in London.
 Other Cochrane reviewers are to reassert this claim in a further article due to be published by the Public Library of Science (PLoS). In the article, three of the Cochrane reviewers write:
‘In December 2009, after we voiced serious concerns in the BMJ about Tamiflu’s alleged ability to reduce compliations, Roche wrote that it was ‘very happy to have its data reviewed by the appropriate authority or individuals’ and publicly pledged to release 10 ‘full study reports’ in the ‘coming days’”. They went on to state that “despite extensive correspondence over the next year and a half Roche refused to provide any more than portions of the clinical study reports.’
The MHRA were recently in the news for failing to respond quickly enough to faulty PIP breast implants. They have also been criticised for sending out information to UK healthcare professionals regarding SSRi withdrawal and, it appears, have informed doctor's of the existence of SSRi withdrawal "specialists" when no such specialists actually exist. [LINK]



Fid

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Friday, January 13, 2012

SSRi Birth Defects




An article in today's Daily Mail confirms what's been known for some time, at least by those in the know. The British drug regulator, the MHRA, seem to be ignorant on this matter or just prefer to bury their heads in the sand about it.

The Daily Mail's Jenny Hope opens her article with:


Women taking antidepressants such as Prozac during pregnancy are more likely to give birth to children with life-threatening high blood pressure problems, researchers say.


They found that the risk doubles among those taking selective serotonin reuptake inhibitors – the most heavily prescribed antidepressants – in late pregnancy.

I'm pretty passionate about this issue. I've made many friends during my time writing this old blog of mine, many of whom have first hand experience of SSRi related birth defects.

The Daily Mail has published something today that needs to be highlighted. A warning on a packet of pills claiming that taking a pill during pregnancy benefits any risk is merely a smokescreen to the real problem - a weak regulator who cannot/will not acknowledge the teratogen link in SSRi's.

The article mentions a study carried out by researchers at the Centre for Pharmacoepidemiology at Karolinska Institutet in Stockholm Sweden, who reviewed 1.6 million births in total between 1996 and 2007 in five Nordic countries: Denmark, Finland, Iceland, Norway and Sweden.

The study analysed several drugs, including Prozac and our old friend Seroxat, and findings showed that out of 11,014 mothers who used antidepressants in late pregnancy, 33 babies (0.2 per cent) were born with persistent pulmonary hypertension after assessment at 33 weeks.

SSRi birth defect litigation is rife in the US, to my knowledge no such litigation has been started in the UK. It's a sad state of affairs that women and infants have no protection from the UK drug regulator, an example of which becomes apparent when you read the classification of Seroxat in the US.

In the US, Paxil [Seroxat] is classed as a 'Class D' drug. This classification was given by the Food and Drugs Administration [FDA] - The FDA are the American equivalent of our MHRA. [Fig 1]

Fig 1


Furthermore, I have wrote to Seroxat manufacturers GlaxoSmithKline and asked them if Seroxat was a teratogen, their answer?

"GlaxoSmithKline works within the guidelines set out in the Code of Practice of the Association of the British Pharmaceutical Industry (ABPI). This does not allow us to provide advice on personal medical matters to individual members of the public so that we do not intervene in the patient/ doctor relationship by offering advice which properly should be in the domain of your doctor. We would therefore recommend you discuss your concerns with him or her."

The same question was put to the MHRA, their response could only be described as toothless. They would not admit, one way or the other that Seroxat was teratogenic. Their full response is in my book, The evidence, however, is clear...the Seroxat scandal.

I posed this question to both GlaxoSmithKline and the MHRA because items of interest were aired in a US birth defect trial regarding Seroxat.

This from the Kilker v GlaxoSmithKline Birth Defect Trial:

Doctor Sloot's paper demonstrated that Paxil [Seroxat] was a clear teratogen, that it was not just an effect of developmental or birth-weight related effect, that it was a direct teratogen, and that there was a spectrum of defects observed in rat embryos at low doses, establishing that it was a very potent teratogen, more teratogenic than cocaine and retinol, clear teratogens in their own right.

Court documents from the Kilker v GlaxoSmithKline trial, where Glaxo were found guilty of Seroxat being the causation of Lyam Kilker's heart defects, can be found HERE.

Only in America folks.

I get many hits from America on this blog, for those wishing to seek action against pharmaceutical companies who have knowingly put their infants at risk, I suggest the following websites where advice can be sought.

Antidepressant Birth Defects

Prozac Birth Defects

Celexa Birth Defects

Lexapro Birth Defects

You will learn that Baum Hedlund report far more birth defects related to SSRi drugs, defects not mentioned in today's Daily Mail article.

If any British law firms show an interest then I'll big them up on this blog too. Sadly, litigation against pharmaceutical companies in this country is proving to be extremely difficult. The MHRA's failure to acknowledge the teratogen link is proving to be pharma's 'ace up the sleeve'.

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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