SEROXAT SUFFERERS - STAND UP AND BE COUNTED

James Murdoch to Leave Glaxo Board, Applications Wanted

2012-01-27T20:34:00.000Z

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

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE

Call For Medical Ghostwriters To Be Held Legally Liable

2012-01-25T08:41:00.000Z

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

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE

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

2012-01-21T23:04:00.000Z

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

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE

Australian Psychiatrist Ian Hickie's Lancet Paper Heavily Criticised

2012-01-21T08:05:00.001Z

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

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE

UK SEROXAT LITIGATION - CURRENT STATUS

2012-01-20T13:43:00.000Z

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.

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE

Risperdal Whistleblower

2012-01-19T10:15:00.000Z

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

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE

MHRA Come Under Fire From Lancet Editor

2012-01-18T15:38:00.000Z

"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

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE

Citalopram Inquests

2012-01-17T08:02:00.001Z

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

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
US & CANADA HERE OR UK FROM CHIPMUNKA PUBLISHING

AUSTRALIAN ORDERS HERE

Tamiflu: Yet More Side-Effects

2012-01-16T07:49:00.001Z

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

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
US & CANADA HERE OR UK FROM CHIPMUNKA PUBLISHING

AUSTRALIAN ORDERS HERE

SSRi Birth Defects

2012-01-13T11:36:00.001Z

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
US & CANADA HERE OR UK FROM CHIPMUNKA PUBLISHING

AUSTRALIAN ORDERS HERE

Professor Graham Burrows Accused of "Guinea Pig" Trial

2012-01-13T08:37:00.000Z

Australian psychiatrist Graham Burrows has been accused by a former patient of using a non-approved psychiatric drug on her, 7 News has revealed. The patient told 7 News that when she confronted Burrows he threatened her with involuntary committal in a psychiatric ward

Burrows, whom I have highlighted many times on this blog, faces scrutiny as other former patients have now come forward with the intention of legal action.

Previous posts about Burrows:

News 7: More Complaints Against Prof Graham Burrows

Australian Psychiatrist Graham Burrows Denies Any "Wrongdoing"

Professor Graham Burrows - The "Cosmetic Psychiatrist?"

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
US & CANADA HERE OR UK FROM CHIPMUNKA PUBLISHING

AUSTRALIAN ORDERS HERE

Guest Post: 17 Year Old Caught in the Psych Drug Trap

2012-01-12T07:20:00.000Z

In the past I have urged readers to send me in their stories about their time on Seroxat [Paxil in US]

A reader recently sent me a story that is all too familiar to me and, I'm sure, many other parents out there. It is the story of a 17 year old girl who has had a drastic personality change due to psychiatric drugs given to her by professionals who think they know what they are doing. In truth, they don't. Julie's story is evidence of that.

**Both the names of the grandmother and granddaughter have been changed.

17 Year Old Caught in the Psych Drug Trap

Paula is my 17 year old granddaughter and I have custody of her. She had attitude and behavioral problems due to substance abuse. She also had an eating disorder due to self-esteem issues.

When I found out that on the street she had inhaled a chemical computer keyboard cleaner, they call "duster", and that it could cause death, I instituted drastic measures and placed her in a Wilderness Camp. She had home visits and I am sure she was using on these visits even though she was drug tested on return.

There are two problems here. 1. From reading her Facebook correspondence, I ascertained the kids have some pill, (which, by the way they say it makes them feel is probably worse than the marijuana they are trying to hide,) that enables them to pass a drug test even if they've used. 2. "Huffing” doesn't show up on the drug tests they give.

Paula got kicked out of Wilderness Camp because she kept "running". Not to run away, but just to get away for a time, and then for a joke. She never went alone, and on more than one occasion she had several cohorts, both male and female. This disrupted the camp dreadfully; the director described a night in which he and several staff members spent hours chasing kids, so they kicked Paula  out.

I placed Paula  at this center where they have a restricted unit. (It wasn't long until she was in it.) After Paula  was there a few days, I received a call from a nurse. She very lightly and casually said, " Paula  is anxious and a little depressed." the doctor recommends that she be given Zyprexa for anxiety, Paxil for depression and some Trazodone to help her sleep”. (I had heard of Paxil being related to suicide, but Paula  was not suicidal, so that didn’t register at the time, (I am now aware that it could have made her suicidal,) nor did it register that the nurse failed to mention the connection.) “I do have to tell you that Zyprexa can cause diabetes, but we monitor very closely here for that so you don't have to worry. These meds will just lift her spirits a little bit and help take the edge off so she'll be more receptive to treatment”. I said "OK, give her whatever she needs".

I now realize how incredibly stupid this was of me. The nurse said nothing about them being addictive or anything about the myriad, horrendous, life threatening, debilitating, and life-long side effects. And I did not ask. I had lived my life making a distinction between street drugs and those prescribed for a patient “in a doctor's care”. I had even told Paula there was a difference. I also had blind faith in doctors. I had never questioned a prescription recommended for myself, my two daughters, when they were young, or any of my five grandchildren. I had never had a problem from any medications prescribed for us. Most importantly, I never dreamed a doctor would prescribe something deadly.

A day or so after that, a nurse called me and said, “ Paula  messed up her hand pretty bad”. I asked what happened and she said Paula  repeatedly punched a wall with her fist. I was shocked; Paula  had never done anything like that. The nurse assured me they would take x-rays. When I asked Paula  why, she said, “I don’t know, I just got SO MAD”. At some point in the midst of all this, a nurse called me and told me that Paula  was complaining about not being able to concentrate and that the doctor had ordered some Concerta for her. I gave my consent. (I did not know that Concerta was Ritalin, which I know to be Cocaine.)

After a couple of calls about Paula having to be “restrained”, Paula  kept telling me she didn’t know why she was doing these things, finally, she said “I don’t know, I just “flipped out”. This is a term my family has used in regard to Paula's mother, (who is 37 years old and has been addicted to prescription Ritalin for years,) when she has “psychotic breaks”. I then realized that the drugs were making Paula violent.

I called the nurses’ station and said that the medications were making Paula violent and I wanted them to take Paula off of them. The nurse said I would have to talk to the doctor. She said she would leave a message for her to call me. I had nurses leave messages for the doctor to call me a couple of more times. Then I left a voicemail for Paula's counselor to have the doctor call me and the reason why. The nurses all assured me they had left messages and when I spoke to the counselor, she said she had received my voicemail and she had indeed left a message for the doctor to call me, stating the reason why I wanted to speak with her. It seems like it had been a couple of weeks since I wanted her taken off those medications, when a nurse called me and said Paula had severely scratched a girl’s face. I told her I wanted Paula off those drugs immediately, Dr. or no, the drugs were making Paula violent. She assured me that Paula would not be given any more.

I belatedly looked these drugs up on the internet to see the hazards of stopping them abruptly. This is when I saw the long list of side effects. I considered Paula's being “impulsively aggressive” as life threatening. The side effects of stopping abruptly were the same as using the “tapering regimen”, with added effects that could be excruciating, but were not deadly. A lot of the side effects of staying on the drugs WERE, deadly, debilitating, and lifelong. The next morning I missed a call from the doctor and received this voicemail that I still have on my phone:

Transcript of the doctor's voice mail message on 12/23/2011 @ 11:04am (03:41)

from ___-___-2904 Hi, this is Dr. ________ calling from __________ for Julie -------, Miss -------, I’m the psychiatrist at __________ for Paula and I’d like to talk with you about her medication, I understand that you were concerned, are concerned, about her psychiatric medication and stopped her psychiatric medication last night, and I met with Paula this morning, and she had a very difficult evening and morning, very abruptly stopping both Paxil and Zyprexa is dangerous, she became very labile and got into a fight and not to say there wasn’t some antagonism on the other girls part, however Paula scratched the child’s face quite severely she’s somewhat better this morning however very agitated, very …. very labile, she does feel much better on her medication on the Zyprexa and the Paxil, and she, well I saw her yesterday afternoon, she was calm, she was much better and she really does need to be on the Paxil and the Zyprexa, not on the Concerta, we took her off the Concerta because that was causing her to be irritable and she and I both realized that she did not need that medication, she asked me to put her back on it because she thought she needed it for concentration but she actually had side effects when I put her back on it so we took it away and she felt much better so she really does need to be on the Zyprexa, 10mgs at bedtime the Paxil, 40mgs at bedtime for depression, and the Trazodone for sleep so I really do want you to be aware and consent for her to take those medications or she’s really going to have significant problems and not be able to progress here in the program. She did cause some significant scratches on this other young woman’s face and I’m very concerned about that, I know Paula wants to progress in the program and transition out of the girls more restrictive ________ House and I’m concerned that she may not be able to do that if she remains so “labile” and “impulsively aggressive”. So if you wouldn't mind calling the nurse’s station, I’m gonna be leaving not too long from now the nurses’ station, you might know the number.. ___-___-____ and I’ll be happy to talk with to you on Tuesday when I’m back in the office.

This message infers that the reason Paula scratched the girls face was because I stopped her meds. When in fact, I stopped her meds because, she scratched the girls face.

After hearing this voicemail, I wrote a “To Whom It May Concern”, letter stating that these drugs were making Paula violent and she was not to be given any medications. I also pointed out that Paula has an addictive personality and I did not want Paula to become a "Rageaholic", a person that, as I understand it, can become addicted to the chemical changes in the brain with rage, and is full of rage at all times with frequent outbursts. I reiterated what I had told the nurses and the counselor before, that Paula had never been violent, that Paula and I had “butted heads” a few times since she started using drugs and that I had been “in her face”, I have seen Paula angry and there was never even a “hint” of violence in her. In her seventeen years she had never been close to being in a fight. After being reassured by the nurses that Paula would not be given any more “meds”, I did not fax this letter.

On Christmas Day, I arrived at the Camp to visit Paula . I arrived at 8:30am. I got an audience with the doctor, who again said that Paula needs these medications; I said they were making Paula violent, and I don’t want Paula to take them. The doctor said the side effects of abruptly stopping these medications can be dangerous, I said headaches, nausea, and dizziness, nothing as life-threatening as being impulsively aggressive, right? I took her non response as affirming. She said "we “can absolutely” stop all meds, we can absolutely do that".

After leaving the premises, Paula said that after I had told them no more meds, the doctor had made her take the Trazodone. Paula said that the doctor did not make her take the Paxil, but she did make her take the Trazodone. I had the letter that I had typed on the 23rd of December with me, so when I returned Paula at 9:00pm, on Christmas, I took the letter in, signed it, put the present date, December 25, 2011 by my name, had the nurse make a copy, gave one to the nurse and the other to Paula with the instructions that if anyone tries to give her drugs, she was to hand the letter to them.

----

My comment

As I said in my opening ramble, stories like this are becoming more common. Here we have a 17 year old girl with behavioral problems. Her grandmother, like many people, put her faith in the medical profession. She was thrown a lifeline that, in essence, had sharks on one end and Hades on the other.

Paula was given drugs for no other reason than to calm her down, chemical babysitters, if you will. What followed was a complete change in personality which included fits of rage and acts of voilence.

For a quack to prescribe someone so young 40mg of Paxil was, at best, sheer incompetence. Firstly, Paxil is not recommended for 17 year-olds, in fact no child or teen beyond the age of 24. Secondly, the recommended daily dose is 20mg. I'm also left wondering how Paula's doctor diagnosed her with depression that warranted an all out assault on her brain with such a concoction of medication. Did her doctor merely guess that Paula had depression or did he carry out extensive brain scans? I think we already know the answer to that question, don't we?

To prescribe Trazodone on top of Paxil was utter lunacy too. The 'Drug Information Online' is a database used by many healthcare professionals. It flags Paxil and Trazodone use as a major contraindication. The use of Paxil and Zyprexa has also been flagged on the database as has Trazodone and Zyprexa.

More importantly, and what the prescribing quack failed to understand, is the 'street drugs' that Paula had been taking prior to her admission into the centre. Did he ask her what street drugs she had used, did he check to see if it was safe to administer Paxil, Zyprexa and Trazodone on top of what she had already allegedly taken? Judging by the doctor's reluctance to check if the three aforementioned drugs were contraindicated it would appear that no history check of substance abuse was carried out by the prescribing physician. That's deeply worrying and highlights the incompetence and lack of knowledge these quacks have.

It's fair to say that Julie was at her wits end with her granddaughter, Paula. A profession [ahem] offered Julie a solution but those responsible became irresponsible the minute they started administering a cocktail of mind-altering drugs that interacted with each other and were not recommended for use.

They may as well have given Paula a spoon, a lighter and a syringe.

Paula has an astute grandmother who has read about the dangers of psychiatric drugs. Julie has done her homework, unlike the quack that prescribed her granddaughter a dangerous concoction of toxic medication.

Paula should thank her grandmother for being so astute. There are others, many others, that have been less fortunate because back in the day when pharmaceutical companies and the medical profession had no opposition they were duping parents with their hard sell. They were trusted, they failed, they harmed, they killed. Had those left behind known about the dangers of psychiatric medication, had they have been given the chance to read what Julie had read then those featured in the video [below] would probably still be here today. It is in their deaths that folk like Julie have learned. It is they who are the voices, the regulators...the way to the truth.

It is they who should be respected.

Bob Fiddaman

Fid

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE

MHRA Described As "Toothless Watchdog"

2012-01-10T12:44:00.000Z

MHRA described as "toothless watchdog"

Today's Mail Online is running with an article which describes the British drug regulator as a "toothless watchdog."

The article refers, in the main, to the MHRA's lack of response regarding the silicone breast implant ruptures, a story which I highlighted HERE on the 2nd January.

John Naish's brilliant piece highlights the incompetence of a regulator put into place to help protect the public and it's refreshing to see a journalist raising their past failings.

Naish writes:

Sadly, this is not the first time the agency has been criticised for acting slowly and ineffectually.

In September 2010, for instance, the diabetes drug Avandia was finally banned in Britain after the European Medicines Agency ruled there was a serious risk it could lead to heart attacks or stroke.

Evidence against Avandia had been building since 2007.

And, while denying it had failed to reveal the risks when they showed up, in July 2010 the drug’s maker, GlaxoSmithKline, reportedly paid out £304 million in damages to settle about 10,000 patient lawsuits in the U.S.

However, in the same month an advisory body to the MHRA warned it that the ‘risks (of Avandia) outweigh its benefits, that it no longer has a place on the UK market’ and called for prompt action.

The MHRA did not reveal this warning to the public; it simply passed its information on to European authorities. A few years earlier, media pressure was required to force the MHRA to act over another prescribed-drug danger. Again, it was a GlaxoSmithKline medicine — the antidepressant Seroxat.

Specialists had been warning for years of the raised risk of suicide in children. But the MHRA, relying on evidence from the manufacturer, issued assurances that there was no suicide link.

AMEN BROTHER NAISH!

On the subject of the Seroxat debacle the MHRA claimed, "...it wanted to require drug makers to share more information about clinical trials — but admitted that, without stronger legislation in place, there was no chance of prosecuting the company for what it called an ‘ethical lapse’."

lapse
noun
A temporary failure of concentration, memory, or judgment.

Glaxo must have been victims of their own product as concentration, memory and judgement are all impaired when taking Seroxat...that's probably why kids have killed themselves whilst taking it!

For the MHRA to even suggest that the suppression of clinical trial evidence was just a lapse smacks of a body of ancient freemasonary types whose fingers are either in the pharmaceutical pie or who are just too scared to speak up against the very same industry that fund them.

It's fair to say that I'm not one of the MHRA's biggest fans, nor they mine. In my book, The evidence, however, is clear, the Seroxat scandal, I write about my past correspondence with the MHRA Chairman, Kent Woods and his failure to accept that Seroxat is a known teratogen. Evidence supplied to the MHRA [taken from disclosure in the Kilker v GlaxoSmithKline trial] failed to alter their stance on whether Seroxat was a proven teratogen.

This from the Kilker 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.

Furthermore, the MHRA have recently sent out an SSRi Learning Module to healthcare professionals in the UK. They have recommended to doctor's that any patient suffering severe SSRi withdrawal should be referred to a 'specialist'. On asking the MHRA exactly who these 'specialists'' were, they could not answer me. Further probing resulted in the MHRA telling me that they would not answer any more questions on the subject.

Boo Hoo!

In truth, these 'specialists' don't exist and it appears the MHRA have shot themselves in the foot by suggesting that they do.

I've labelled the MHRA 'limp-wristed' in the past, 'toothless watchdog' seems so much better.

Read John Naish's article in full HERE

Related:

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

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE

Q: Is It Safe To Take Actos? A: "Talk To Your Doctor"

2012-01-06T18:25:00.000Z

With the MHRA recently rolling out their SSRi Learning Module [Links at bottom of post] and once again buck-passing the emphasis of safety onto healthcare professionals and pretend "specialists" it got me thinking why the MHRA would do something like this.

They refuse to debate with me any more about the fake specialists they conjured out of thin air so, once again, they wish to play by their rules. Sorry guys, that just does not happen in my world.

In the news recently is the Diabetes type 2 drug, Actos.

Actos is manufactured by Japanese pharmaceutical giants Takeda Pharmaceuticals and was seen as a direct competitor to GlaxoSmithKline's diabetes drug Avandia.

Avandia was shelved after it was learned that patients taking it increased their chances of having a stroke and heart attacks. This was known for some time but nobody did anything about it. GlaxoSmithKline, after years of denial, eventually paid out settlements to those harmed by Avandia.

Actos has been reviewed by the European Medicines Agency [EMA]. After reviewing recent data as well as old data they found that there is an increased risk of bladder cancer in patients who take the drug longer than a year.

How do the MHRA respond to the findings?

Advice for patients Patients should not stop taking pioglitazone without consulting their doctor. Patients receiving pioglitazone should immediately report any visible blood in their urine or bladder problems such as pain while urinating or urgency to urinate, to their doctor. Patients receiving pioglitazone will have their treatments evaluated by their doctor at their next scheduled appointment. [LINK]

Were British doctor's privy to the investigation carried out by the EMA? Nup.

Of course, many British healthcare professionals will play down the bladder cancer risk in Actos because they won't want to alarm those patients already on it. Well, they need to and the MHRA should make sure that they do and not just send out warnings, many of which will probably find the bin in the doctor's office.

It's not enough to send out a warning letter. They should be warning the patients taking it and not those prescribing it. A full-page advertisement in the mainstream media papers and a series of radio and TV commercials warning of the dangers would be a start. Alas, the MHRA much prefer to campaign about buying fake drugs over the Internet. A series of cinema and TV commercials saw them team up with pharma giants Pfizer to promote that particular safety issue - so why not do the same with Actos?

MHRA's Promotional Push About Fake Drugs - Made in Conjunction With Pfizer

I'd want to know if the drug I was taking could cause me bladder cancer, I wouldn't want to wait for a doctor to tell me. Although it would come as a complete shock to read about it in a full page advert or see it on TV, it would, at the very least give me the choice to stop taking it. In all honesty I'd sooner pull a rat out of my mouth then be told news that the prescribed medicine I was taking had caused my bladder cancer!

At the start of the year California lawyers Baum, Hedlund, Aristei & Goldman, P.C filed a lawsuit in the Los Angeles on behalf of three couples whose lives have been turned upside down due to taking a drug that should have made their lives more comfortable.

The 12 point cause of actions include failure to warn, defective design and civil code violations. It's also alleged that Takeda Pharmaceuticals knew about the bladder cancer risk but concealed that information from the public. I doubt if a lawsuit will be launched here in the UK, going up against the pharmaceutical industry here one has to overcome many hurdles.

The MHRA won't help if you have been harmed from a drug, in fact, they seem to do everything but help. The on-going Seroxat litigation here in the UK is evidence of that - one only has to look at GlaxoSmithKline's expert witnesses in that case, one being an ex-employee of the MHRA.

So folks, always remember to take your medication, if you feel that you are having trouble with it or that your bladder cancer, heart strokes or suicidal thoughts may be a result of the drug you are taking then you could always talk to your doctor about it. The very same doctor that prescribed it to you in the first place!

More about the Actos bladder cancer link HERE

Related:

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

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE

APA Use Restraints on Blogger

2012-01-04T08:53:00.000Z

Image Capture - .pogo.org

The American Psychiatric Publishing, an arm of the American Psychiatric Association, [APA] have forced a commentator to change the web address of her popular blog because it apparently violated the American Trademark Law.

Suzy Chapman has, for the past two years or so, been voicing her opinion of the proposed new DSM-5, an opinion that has been, in many instances, critical of the biggest book of mythical tales since J.K Rowling's Harry Potter series.

Her original url included the use of the acronym 'dsm' [dsm5watch.wordpress.com/] so the APA decided to send Chapman a threatening 'cease and desist' email, part of which Chapman writes:

On December 22, I was stunned to receive two emails from the Licensing and Permissions department of American Psychiatric Publishing, claiming that the domain name my site operates under was infringing upon the DSM 5 trademark in violation of United States Trademark Law and that my unauthorized actions may subject me to contributory infringement liability including increased damages for willful infringement. I was told to cease and desist immediately all use of the DSM 5 mark and to provide documentation within ten days confirming I had done so.”

Chapman complied and changed the name of her blog to dxrevisionwatch.wordpress.com/

The intimidation by the APA has prompted a former Chair of the DSM task force, Allen Frances, to come out in support of Chapman and to write an aptly named post, "Is DSM 5 A Public Trust Or An APA Cash Cow?" on his website.

I, myself, was, sometime ago, contacted by GlaxoSmithKline's lawyer's, Addleshaw Gooddard, in relation to a video I had made. Apparently, my video had caused GlaxoSmithKline's former Head of Psychiatry, Alastair Benbow, great distress. Glaxo also mentioned that I had used their company logo in my slide-show video without their permission. I removed the video from YouTube but it was uploaded by an astute American blogger just 24 hours later. The video that landed me in hot water can be seen HERE and the whole "Videogate" scandal can be read in my book, 'The evidence, however, is clear...the Seroxat scandal.'

Last year two bloggers who voiced their opinions were targeted by lawyers. The anonymous author who writes the Seroquel Lawsuit Blog was, like Chapman, sent a 'cease and desist' email by lawyers because he/she had uploaded a settlement that had been put to plaintiffs by their lawyers Weitz & Luxenberg. The blogger was told to remove the document, he/she didn't and it is still available today.

Irish blogger Leonie Fennell, whose son committed suicide after a short period on the antidepressant citalopram, was also sent a threatening letter by Irish lawyers because she had voiced an opinion about Irish psychiatrist Patricia Casey. Fennell writes about her son's death and included Casey in one of her articles [Casey was present at the inquest of Fennell's son, Shane, representing and observing for Psychiatry Ireland and to ask questions if the need arose.] Fennell posted the letter HERE.

I can't quite see what the APA have to gain by intimidating a critique of the DSM. Often when one in power gets uncomfortable they use that power to threaten, usually in the manner of seeking damages that they know their critique just does not have.

If the APA are correct and a Trademark violation has been breached then what of other blogs/websites that use trademarks as part of their web address? Will this move by the APA be the start of further intimidation to stifle opinion for blogs such as Seroxat Secrets, Prozac Withdrawal, GSK Internal Files, all of which use trademarked names as part of their web address. There are literally hundreds of thousands of others.

It would appear that Chapman's opinions about the DSM-5 have been carefully monitored by the APA, they don't like what they see nor do they like the fact that Chapman has had over 40,000 visitors to her blog during the last two years, a number that was significantly increasing with each post she made.

Blogging is a powerful weapon against the Goliath's of this world, they are a bigger threat to the big boys because they answer to nobody. A newspaper article is run by the Chief editor before it is published, bloggers, in the main, hit the publish button more out of frustration that the mainstream media won't cover what needs to be covered.

And what if Suzy Chapman decided to write her blog anonymously with no contact details on her blog? The APA would have had to go through the laborious process of contacting the webhost, in this instance Wordpress.com, and asking them for an injunction. That would have cost them money so they take the easier route when people, like Chapman, are open and transparent about who they are. It is detrimental these days to be open and honest, how perverse is that?

Chapman continues to critique the proposals for the DSM-5, she has every right to critique a book of apparent psychiatric disorders designed to hook yet more people on mind-altering drugs and make the pharmaceutical industry billions of dollars in sales of their remedies to help 'fix' the problems created out of thin air by the Rowlingesque book.

The field of psychiatry is doing itself no favours by using intimidation tactics against people that criticize their opinion, let's face it, the whole premise of psychiatry is based on opinion, I've not yet seen any scientific evidence of the chemical imbalance the field of psychiatry tout when someone is depressed or has a psychiatric disorder.

Chapman's blog can be read at her new web address HERE. Her work/opinion continues to spread, much to the annoyance of the APA who have probably shot themselves in the foot with their intimidation tactics.

Memo to the APA - Intimidate a blogger and you put them on a pedastal, you highlight what it is that they have to say... here endeth your first lesson in psychology.

Fid

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE

Glaxo Fined £60,000 For Killing 14 Babies

2012-01-03T17:37:00.000Z

Throw a cat in a bin and get massive media coverage and public outrage. Kill 14 babies and our British press don't even give it a small column. We've lost our morals folks. Glaxo are a British company and their wrong-doings should be reported by the British press. With James Murdoch on the board at GSK and with Andrew Witty cupping the balls of the UK government with the threat of moving his business elsewhere, it's left, once again, to bloggers to report on this abhorrent misuse of human life.

What price a human life?

Well Judge Marcelo Aguinsky has fined GlaxoSmithKline 400,000 Argentinian Pesos [about £60,000] for its part in the 2007/08 vaccine trials conducted in Argentina where 14 children died. The charges, writes the Herald, included experimenting with human beings, falsifying parental authorizations so babies could participate in vaccine-trials conducted by the laboratory from 2007 to 2008.

The Buenos Aires Herald reports:

The charges included experimenting with human beings, falsifying parental authorizations so babies could participate in vaccine-trials conducted by the laboratory from 2007 to 2008.

Since 2007, 15,000 children under the age of one from Mendoza, San Juan and Santiago del Estero have been included in the research protocol, a statement of what the study is trying to achieve. Babies were recruited from poor families that attended to public hospitals.

A total of 7 babies died in Santiago del Estero; 5 in Mendoza; and 2 in San Juan.

By my reckoning that's just over £4,000 per child.

"GSK Argentina set a protocol at the hospital, and recruited several doctors working there," Pediatrician Ana Marchese told Continental AM radio in an interview. Adding that:

“These doctors took advantage of many illiterate parents whom take their children for treatment by pressuring and forcing them into signing these 28-page consent forms and getting them involved in the trials.”

“Laboratories can't experiment in Europe or the United States, so they come to do it in third-world countries."

GlaxoSmithKline Argentina are appealing the decision. Medical Director Rosana Felice said in a statement, "None of the deaths are related to the vaccines", and added, "Likewise, Glaxo doesn’t pay any kind of bribes in order to lead any clinical studies here in Argentina or at any other location around the globe."

Phew! Thank goodness for that, for one minute I thought they had actually been rumbled.

The GlaxoSmithKline corporate motto is, "We have a challenging and inspiring mission to improve the quality of human life by enabling people to do more, feel better and live longer."

Based on the findings in the above enquiry I'd suggest that GlaxoSmithKline look up the words 'Inspiring', 'Improve' and 'Quality'.

Full shameful story in the Buenos Aires Herald

Heads up: Pharmalot

Back story: Is GlaxoSmithKline Behaving Badly in Argentina?

On January 1st Glaxo CEO Andrew Witty was knighted.

Nice to see our monarchy getting its priorities in order.

Fid

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE

Another Boob From the MHRA

2012-01-02T12:22:00.000Z

2012 sees the MHRA bowing to public pressure [once again], this time over breast implants.

For years they have fence sat [unsurprisingly] with regard to the safety of breast implants made in France and filled with gel meant for mattresses.

Figures suggest that the MHRA have downplayed the chance of rupture with the implants, in fact, down played by as much as eight times!

Today's Mail Online reports that silicone leaks from the implants are causing agonising pain as well as swelling and lumps under the armpits. Fears have also been relayed that the implants may increase the risk of cancer.

The Mail online writes:

Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) has been accused of playing down the dangers. Over the last fortnight it has repeatedly urged women not to panic, simply saying that anyone who was worried should contact her surgeon. While it banned further use of the implants, it said that there was only a 1 per cent chance of rupture, compared with a 5 per cent rate reported in France.

But on Friday night the MHRA received new data from one of Britain’s biggest chains of plastic surgery clinics. This placed the rupture rate at around 8 per cent, although it was not clear if the figure applied to patients or to individual implants.

The MHRA have recently slammed the door closed on a line of questioning I put to them regarding apparent SSRi withdrawal "specialists" that they claim exist in the UK. Upon asking them for the names of these "specialists" they, more or less, stonewalled me and told me that they would not answer any more of my questions on the subject.

No problem, I can still speculate, can't I?

I'm left wondering if the MHRA only act when reports of dodgy medical devices, drugs and/or vaccines hit the mainstream press. Their house was supposedly put in order when BBC's Shelley Jofre exposed them in a Panorama documentary and it was only with mounting public pressure that they investigated GlaxoSmithKline for suppressing clinical trial evidence relating to Seroxat - the findings of that investigation were what we already knew, the action taken by the MHRA was to send GlaxoSmithKline's, then CEO, JP Garnier, a "You've been a naughty boy, don't do it again" type of letter.

So, now it appears that the MHRA have received "new data" regarding the breast implant debacle.

One has to ask why the British drug regulator are, seemingly, always last to hear about the dangers of drugs or devices. An agency put in place to monitor the safety of drugs/devices should not only be alert, they should also alert the people they were put in place to protect. The post-marketing surveillance team at the MHRA are clearly unable to do their job...it's left to the British press and/or bloggers to give the MHRA the proverbial kick up the backside.

They are supposed to be a watchdog, I think pharmaceutical lapdog would be a more appropriate term.

Related:

MHRA Wishing To Call The Shots

Fid

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE

Arise Sir Witty of Glaxoshire

2012-01-01T12:23:00.000Z

Glaxo boss, Andrew Witty, has been knighted.

Disclaimer - This is not a parody post.

Yup, it seems that any old Tom, Dick or Harry can be knighted these days, it doesn't seem to matter if those selected have a criminal record or run companies that knowingly put human life at risk.

Today's Telegraph reports that Andrew Witty, the CEO of GlaxoSmithKline, the company that paid out settlements totaling almost $6billion with regard to their diabetes drug Avandia and antidepressant Seroxat [Paxil] has received a knighthood from Her Maj.

One is not amused.

Last year I reported on how Andrew Witty had snubbed consumers suffering at the hands of his company's drug, Seroxat.

Janice Simmons, who operates the Seroxat User Group, last year requested a meeting with Witty, she wanted to discuss how he could help consumers who had become addicted to Seroxat. She was vehemently told by GSK’s UK medical director, Dr Pim Kon, that neither Witty or GSK could discuss or give advice to consumers, Kon added that consumers should talk to their doctors.

A few weeks ago it came to light that the doctor's Kon was recommending had been approached by the British drug regulator, the MHRA, with a new SSRi Learning Module. The MHRA had recommended to UK doctor's that anyone suffering severe withdrawal from Seroxat and other SSRi's should be sent to "specialists".

On asking the MHRA exactly who these specialists were, they could not provide me with an answer. In fact, to date, I have seen no evidence that any such SSRi withdrawal specialist exists, other than Prof David Healy, who met with the MHRA to tell them of this withdrawal problem.

I'm surprised Her Maj hasn't offered the CEO of the MHRA, Kent Woods a knighthood, or maybe the MHRA Chairman, Alasdair Breckenridge who has gone on record claiming there is no problem with Seroxat...for those that don't know, Breckenridge is a former employee of GlaxoSmithKline [then SmithKline Beecham] as is the Head of Licensing at the MHRA, Dr Ian Hudson. I'm also suproised that Hudson hasn't received a Knighthood.

Glaxo's history paints a pretty bad picture, tax evasion, suppression of clinical trial results...the list is endless.

Some pertinent viewing for Her Maj below.

Whatever next eh? Maybe a posthumous Knighthood for Dr Harold Shipman?

Maybe the monarchy could drag JP Garnier from France and give him one too.

Safe to assume then that any act of criminality or putting human beings at risk may just put you on the new year's honours list. Then again, maybe Witty sees suppression of clinical trial evidence as one of the perks of the job?

Congratulations to the monarchy, you have given a whole new meaning to the word 'perverse'.

Any chance of a Seroxat withdrawal protocol from Buckingham Palace?

Fid

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE

Actos...No Better Than Avandia

2011-12-30T09:43:00.000Z

Whilst browsing in a shop the other day I purchased a pair of shoes. The assistant asked me if I would like to purchase a leather care product - Good sales pitch. Obviously, I'd like my shoes the last a long time so purchasing a leather care product would benefit me...and my shoes.

When you or I visit our doctor's we are, occasionally, given bad news. "Mr Smith, I have some bad news for you, I'm afraid you have type 2 diabetes."

The initial shock of hearing such bad news is followed by, "but don't worry, it is treatable."

Years ago, and until recently, doctor's were handing out prescriptions for Avandia, a drug manufactured by GlaxoSmithKline which was recently pulled off the shelves after the European medicines regulator deemed it unsafe, they found that it caused strokes in many of those that were taking it. TheAmerican drugwatch agency, the FDA, didn't feel that it needed to be pulled off the market, opting instead for a more stern warning on the labelling. GlaxoSmithKline apparently knew of the heart stroke link...but decided not to tell anyone until they had made a pretty packet on sales of the drug.

Because Avandia was pulled off the market in Europe and because it received such bad press in America doctor's, naturally, started prescribing an alternative. Enter Actos, a drug manufactured by Japanese giants Takeda Pharmaceuticals.

News of Actos has been circulating recently, and it isn't good. Actos can cause bladder cancer and it's manufacturers knew all along that it could.

My shoe analogy at the start of this post may seem a little odd. But the retailer was warning me that my shoes may become scuffed, hence the offer of the leather care product.

Imagine, if you will, the following scenario.

Doctor: I'm afraid you have diabetes

Patient: Oh no!

Doctor: Don't worry it can be treated with either Avandia or Actos

Patient: Oh fantastic

Doctor: Would you like a heart stroke or bladder cancer with that?

Sounds like a sketch from the Monty Python team doesn't it?

Meantime, people are coming forward because they are now realising that Actos, the drug they took to help their diabetes, has actually made matters worse for them.

A suit, filed yesterday in the State of California, [Los Angeles Superior Court] by Baum, Hedlund, Aristei & Goldman, P.C. alleges that three California residents and their spouses claim the diabetes drug Actos caused their bladder cancer. The full press release can be read HERE

You can read more about Actos and the bladder cancer link at .http://www.actosbladdercancer.com/

Fid

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE

MHRA Wishing To Call The Shots

2011-12-23T18:33:00.000Z

MHRA: "Unless you have enquiries on an entirely different subject, we will not be able to respond to further comments from you."

I've received a reply from someone at the MHRA, once again they failed to add their name to it, preferring to write anonymously or as a ghost spokesperson [how brave]

For those that don't know I wrote to the MHRA regarding their recent recommendations to healthcare professionals in the UK. Their [ahem] innovative SSRi Learning Module tackles, amongst other things, severe SSRi withdrawal and the MHRA recommend to doctor's to seek the advice of "specialists".

In previous correspondence with them I asked just who these "specialists" were. They couldn't answer.

Well, they've made it abundantly clear to me now with their final say on the matter. Make note of the final line of their response.

Dear Mr Fiddaman,

We are responding to your email of 15 December.

Below, we provide responses to your further questions. They should be read alongside our replies of 7 December and 15 December to your enquiries.

1. For the record, just so we are clear, are the MHRA suggesting that severe SSRi withdrawal can now be defined as an illness?

Our introductory remarks make no reference to ‘SSRi withdrawal’. We are simply saying that, when necessary, non-specialist health professionals are able to access appropriate specialist services for diverse range of clinical circumstances.

Summaries of product characteristics list effects that may follow SSRI discontinuation under ‘Undesirable effects’.

2. Do you have instances where a health care professional has sought the advice or requested for an SSRi withdrawal specialist?

It is not in the MHRA’s remit to monitor the practice of health professionals. Details about an individual’s care are confidential between the individual and the health professional.

3. Have the MHRA liaised with health professional regulators to determine whether or not 'specialists' have the required qualifications in treating patients with severe SSRi withdrawal?

The MHRA regulates medicines and healthcare products and provides information on these. It is not for the MHRA to set standards for health professionals’ knowledge and expertise or to monitor them.

4. If I were to randomly select 10 healthcare practitioners and ask them if they could refer an SSRi withdrawal specialist to me and, for one reason or another, they could not provide me with any such specialist, would the MHRA then concede that there are, in fact, no SSRi withdrawal specialists with adequate training that can provide help for patients suffering severe SSRi withdrawal?

This point has been dealt with in our response of 15 December. The organisation of health care delivery does not fall under the MHRA’s responsibilities. Details about how health care services (including some specialist services) are organised and how individuals can access them are described by NHS Choices at http://www.nhs.uk/NHSEngland/AboutNHSservices/Pages/NHSServices.aspx

5. [No specific question asked]

We have responded elsewhere to these comments.

6. Professor David Healy has acknowledged that there are a significant number of people on SSRi's that will never be able to stop. Do the MHRA agree with professor Healy's findings?

We do acknowledge that there are some individuals who find it extremely difficult to discontinue treatment with SSRIs and for some it may take many years to stop treatment. We also know that it is not possible to predict those who may be at particular risk of experiencing withdrawal reactions on stopping treatment. However, we have not seen evidence to suggest that a significant number of people will never be able to stop taking SSRIs.

7. You state that the SSRi Learning module was “constructed by MHRA staff and drew on information and evidence in the public domain.”. Please list all references/evidences used.

The introduction to the learning module states:

This learning module is derived largely from summaries of product characteristics (which, in turn, are based on rigorous evaluation of submitted evidence). Supplementary sources such as guidelines from NICE are used to expand on advice on managing specific risks of SSRIs; however, general advice on the management of depression and other disorders is not covered.

The learning module lists key resources under ‘Further information’; these, together with references cited by them, were among the sources we used.

We have responded to your recent emails by providing all the information that falls within the scope of our work. A great deal of information is also available on our website. The answers to some of your questions clearly fall outside this Agency’s role and are not appropriate for us to tackle.

Unless you have enquiries on an entirely different subject, we will not be able to respond to further comments from you.

Kind Regards,

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency
Tel: 020 3080 6000

My response to this:

How novel. Not content with the word 'vexatious' any more?

So, to recap, the MHRA will not answer any more questions relating to this query because my line of questioning is 'not appropriate for them to answer'. Do you only answer questions that you feel comfortable with?

Let's look at the facts.

The MHRA have conjured up SSRi withdrawal specialists. They remain confident that healthcare professionals can call upon the services of these specialists when faced with a patient who is suffering severe SSRi withdrawal.

When the MHRA have been asked to provide a list of specialists [that they have recommended] they cannot provide any such list.

The MHRA have, at least, acknowledged that there are some patients who may 'take many years to stop treatment'. They do not tell us why or offer any solutions other than recommendations to 'specialists' whom don't exist.

To cap it all, the MHRA are now refusing to answer any more questions on this matter. In truth, they cannot answer the questions because they don't have any answers. Any effort to answer would be an admittance of a failure to protect the public.

I put it to the MHRA that your SSRi Learning Module is deeply flawed and that you have made a huge error in recommending specialists that both you and I know do not exist. You are either buck-passing or lying.

If the MHRA lay claim to SSRi withdrawal specialists being available on the NHS then any queries regarding this claim should be answered with proof. At no time have the MHRA provided me with any proof that any such specialist exists.

My recommendation to the MHRA would be for a recall of the SSRi Learning Module and for them to list specialists for doctors to use. Also to explain to doctors that there are some patients who may take many years to stop taking their medication and to explain the reasons behind this.

It's absurd that an alternative is mentioned...yet not mentioned.

If I were to have a conversation with a food critique who was displeased at food offered to him at 'Restaurant A' and I told this critique that there was much better food elsewhere, he would naturally ask where.

If I stood there with a blank expression on my face and told him, "Um, I don't actually know", he would probably laugh in my face or serve my testicles on a platter with a rich red wine and a nice camembert. He certainly wouldn't see me as an expert on the matter of food.

The MHRA should not be making any recommendations to healthcare practitioners regarding SSRi withdrawal, it takes an expert to do that. Maybe the MHRA should have liaised with the ghost specialists they have recommended for healthcare practitioners to use - in truth, they did not because these specialists simply don't exist. To suggest that they do is akin to burying one's head in the sand and hoping the SSRi withdrawal problem will go away. It won't.

To put it mildly, when the MHRA are criticised they either call their critique 'vexatious' or just refuse to answer any more questions. They are the past masters of deflection and will sit around waiting for a solution to fall onto their laps. If they acknowledge that there are some patients who may take many years to stop taking an SSRi then they should, at the very least, contact the pharmaceutical industry who manufacture these drugs and ask them; a; why it takes so long for this group of people and b; how this group of people can be helped. They don't, they just sit around thumb twiddling and deflecting questions put to them by people who actually know the truth about SSRi withdrawal.

I've gone on record before stating that the MHRA are limp-wristed, that was a few years ago. My recent correspondence with you suggests to me that you continue to be limp-wristed and you continue to ignore the banner you fly under, "MHRA - safeguarding public health."

You are solely responsible for the advice you have handed out to healthcare practitioners re SSRi withdrawal. Your invention of SSRi withdrawal specialists is a matter of great concern to me and one that needs further investigation. I, for one, will seek further advice on how to extract the information I need, be it through government officials [highly unlikely] or the court of human rights.

Your arrogance is staggering and your knowledge on SSRi withdrawal is woefully inept.

Bob Fiddaman

Related articles:

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"

Fid

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE

Jingle Bells [Pharma Version]

2011-12-22T18:29:00.001Z

Jingle Bells [Pharma Version]

Dashing through the court

With lawyers by our side

Paid to stop and thwart

Cos someone's child has died

Denying all the way

It's not our drugs, you see

Your child was feeling down

Not guilty is our plea

Oh, jingle bells, phrama sells

KOL's to pay

Oh, what fun it is to lie

It really is child's play

Jingle bells, phrama sells

KOL's to pay

Oh, what fun it is to lie

It really is child's play

Earlier this year

We set aside some cash

We're so insincere

Some people call us trash

Our drugs caused heart attacks

And suicide as well

Birth defects, withdrawal grief

But we will never tell

Oh, jingle bells, phrama sells

KOL's to pay

Oh, what fun it is to lie

It really is child's play

Jingle bells, phrama sells

KOL's to pay

Oh, what fun it is to lie

It really is child's play

Oh, jingle bells, phrama sells

KOL's to pay

Oh, what fun it is to lie

It really is child's play

Jingle bells, phrama sells

KOL's to pay

Oh, what fun it is to lie

It really is child's play

Bob Fiddaman 2011

MERRY CHRISTMAS TO YOU ALL

Fid

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE

Paxil Documentary Set for 2012 Release

2011-12-22T09:36:00.000Z

Filmmaker Phil Lawrence, who, for 6 months, filmed a fly on the wall documentary about his Paxil withdrawal, has recently announced that his film, Numb, is set for a DVD release in January 2012.

Phil kindly sent me a screener of his movie back in July, review can be read HERE

In the meantime here's a short trailer to whet the appetite.

Visit the official Numb website HERE

Fid

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE

Involuntary Transformation - Guest Post From Becky

2011-12-18T17:26:00.000Z

In the past I have offered people the opportunity to send in stories about their horrific withdrawals from Seroxat. I decided, upon reading their stories that they should appear on my blog 'as is', so to speak.

Tonight the author of the popular blog, Involuntary Transformation, tells her story. It's one that is all too familiar, it's also yet another fine example of dogged determination and sheer tenacity. 'Becks' is added to my sisterhood list. Here's her story.

I am the mother of two wonderful adult sons. My youngest son has needed intensive mental health services since he was in preschool. At this time in our lives, my children were in the State of Washington's foster care system due to my own mental health issues...it is what it is. Isaac was placed in a home where he was severely traumatized and that was when his need for mental health services started.

It has been a long road for our family, and I am so very lucky to have my sons, and feel that being their Mom is the best thing that has happened to me.

I started writing my blog, Involuntary Transformation on September 4, 2010. That was the day that "it" hit me like a ton of bricks. "It" was the fact that crimes committed in which my son was the victimized; were never going to be investigated by the State of Washington. In spite of the struggles over the years in attempting to get appropriate and recommended treatment for Isaac; I had held onto the hope and the belief that justice would not be denied my precious son. I do not know that I no longer believe it possible so much as I have come to know that whether justice is served or not; what is important is that we, have as a family have come through some very painful experiences intact. It is this, above all else, that gives my life meaning and value.

Isaac's need for the psycho-social and cognitive-behavioral therapy recommended for his complex PTSD was ignored; and worse, were substituted with Family Preservation Services. This is a program that is meant to prevent out of home placement---it is not anything like what was recommended, but it was what was provided along with "med management" for years. I can not tell you what it is like to have a child need treatment which is denied to be given drugs which did not help. Drugs that did not "treat" the symptoms of the complex PTSD; drugs which caused further trauma . The PTSD which was caused by being beat up and locked in a closet by a foster parent when he was three.

Ultimately, my son spent much of his childhood being further traumatized by the Child Welfare and the public Mental Health service system which medicates symptoms of distress and symptoms of trauma, whether it helps or not; and then blames victims who do not get better. The failure to get better is the result of lack of proper therapeutic treatment!.

For the first (and hopefully only) time in my life, in the summer of 2010 I did not believe in and could not feel the presence of my creator within myself. I could not believe that forgery, perjury and psychiatric assault were committed and again my son was harmed; and none of these crimes were going to be investigated. My now adult son, who can not effectively defend, protect or advocate for himself, due to the cognitive damage done by the drugs; was victimized by employees of a local Mental Health agency when he sought help; and there was not going to be anything done about it. No investigation, no charges filed for felony crimes committed, NO JUSTICE served.

Until last summer, I had not told our story in a public forum because Isaac did not want me too. After the events at the end of July and the beginning of August, he said it was now alright to share his story. My thinking was that I can make no one do a damn thing, and believe me I've tried! But, I can tell the world what was done to my son; what continues to be done to children, adults and families who seek and receive mental health care. It is not right, and it is not therapeutic, and practiced like it was in the "treatment" of my son, psychiatry is not "medicine."

I am a mother. I am a warrior if need be, for my children. My son spent more that half his childhood in psychiatric inpatient facilities---and was ultimately used in Drug Trials, without consent. The Medical Director of Child Study and Treatment Center gave my son virtually every neuroleptic drug made; and told me I had no say in what he was doing! Federal, State and International Law e.g. the Nuremberg Code say otherwise. Nevertheless, Jon McClellan acted as if he had special authority, and this "research psychiatrist" did not conform with the law or the Ethics Guidelines for Informed Consent of the medical profession when drugging my child. I know now, none of the drugs were approved for pediatric use, and many were not approved for the purpose prescribed. I also am so very aware that I am fortunate many times over that my son survived Jon McClellan’s “treatment” at all.

If my life, and what was done to my son and my family means anything at all, it's meaning for me must be derived from sharing what I have learned and working to keep it from happening to anyone else. I must share what I've learned to hopefully spare another family the same experiences. None of us will ever 'be the same' and life can be bittersweet. I am grateful to know the truth.

Becky
--
...choose for yourself this day whom you will serve. - Joshua 24:15

Read Becky's blog, Involuntary Transformation HERE

Fid

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE

MHRA - More on the Mysterious "Ghost Specialists"

2011-12-15T17:35:00.002Z

Following on from MHRA In Buck-Passing Specialist Cahoots, the MHRA have now replied to my series of questions. My follow up response can be seen at the foot of this post.

Dear Mr Fiddaman,

Thank you for your recent enquiry to the MHRA.

Our reply of 7 December did not include a reference number as we (in the Central Enquiry Point) only assign reference numbers to requests under the Freedom of Information Act, and to requests passed to our Information Scientists for interrogation of our licensing database. We do not always include a name against our responses because the Central Enquiry Point often channels input from relevant technical experts in the Agency to prepare answers to enquiries. Colleagues in other parts of the Agency have prepared the response to your questions. However, in case it helps, I have included my name on this response.

Responses to each of your specific questions follow some general remarks.

You comment on our learning module on SSRIs. As we have mentioned, the learning module is written for health professionals and it should be read in conjunction with other information which covers the diagnosis and management of the relevant conditions.

Health professionals regularly work with others to give patients the best possible care—where necessary they routinely contact specialist services either for advice or with a request to take over the care of a patient. Once a patient is referred to such service, the specialist will treat the patient and, if necessary, contact other specialists within the network. This mechanism for care applies throughout the NHS whether a patient needs surgery, has cancer or suffers from other physical or mental illness.

The following address your specific questions:

1. You, as a regulator, do not have a list of these so-called specialists yet, without any qualms or vetting them, you are advising doctor's to use their services. Why?

Healthcare in the UK is regulated by several bodies each of which has a specific remit. While this Agency regulates medicines and healthcare products, others register health professionals and set standards for their competence (http://www.chre.org.uk/regulators). It is the health professional regulators who are responsible for setting standards of competence in line with current health knowledge and technology.

2. If I were to ask my GP to consult the RCP and RCGP will they be able to give him a list of specialists in SSRI dependence and withdrawal that he can consult?

A general practitioner will be very familiar with accessing specialist mental health services. These specialist services can then ensure that the patient is cared for by a specialist with appropriate skills.

3. Do you not feel, as a regulator, that you should, at the very least, see what training these specialists have had in the field of SSRi withdrawal?

The MHRA cannot encroach on the role of health professional regulators specifically created to set the standards of behaviour, competence and education of health professionals. The MHRA’s remit and expertise is in the regulation of medicines and healthcare products, not education and training of health professionals.

4. You, at my request, also met with Professor David Healy who has acknowledged that there are a significant number of people on SSRi's that will never be able to stop. Have you relayed this information to healthcare specialists, do you agree with Professor Healy's advice or do you think the advice is wrong?

During our discussion with Professor Healy he was clear that the focus should be on highlighting to GPs that withdrawal reactions could be serious and prolonged in some patients and agreed that NICE and the BNF would be reasonable routes. We have liaised with both the BNF and NICE to stress the importance of highlighting the risk of withdrawal reactions in their respective publication and guidance. We provided input into the consultation for the most recent revision of the NICE depression guideline and have also inputted into changes to the section in the BNF on the risk of withdrawal reactions with SSRIs.

5. As I understand, you promised to liaise with Professor Healy should any more concerns arise re SSRi withdrawal. To my knowledge you have not liaised with him since your 2010 meeting with him. Why?

You are correct that we have not had further meetings with Professor Healy since 2010 but this is because no significant new data on the risk of withdrawal reactions and their management that alters our previous discussions has come to light since then and therefore further discussions have not been considered necessary.

1. What input did you receive from the pharmaceutical industry for your SSRI learning module?

No input was sought nor received from the pharmaceutical industry on the MHRA learning module on SSRIs. It was constructed by MHRA staff and drew on information and evidence in the public domain.

2. Please list any grants/funding you, may or may not have, received for your SSRI learning module.

The MHRA receives no external funding for this work. The material has been assembled by MHRA employees as part of their routine work and towards meeting the MHRA’s objective of providing information to healthcare professionals and promoting good practice in the safe use of medicines.

...and my response, sent today...

Follow-up questions to Ref: FOI 11/475

In reference to your 2nd para:

Health professionals regularly work with others to give patients the best possible care—where necessary they routinely contact specialist services either for advice or with a request to take over the care of a patient. Once a patient is referred to such service, the specialist will treat the patient and, if necessary, contact other specialists within the network. This mechanism for care applies throughout the NHS whether a patient needs surgery, has cancer or suffers from other physical or mental illness.

1. For the record, just so we are clear, are the MHRA suggesting that severe SSRi withdrawal can now be defined as an illness?

2. Do you have instances where a health care professional has sought the advice or requested for an SSRi withdrawal specialist?

3. You state that “It is the health professional regulators who are responsible for setting standards of competence in line with current health knowledge and technology” Have the MHRA liaised with health professional regulators to determine whether or not 'specialists' have the required qualifications in treating patients with severe SSRi withdrawal?

4. You state that “A general practitioner will be very familiar with accessing specialist mental health services. These specialist services can then ensure that the patient is cared for by a specialist with appropriate skills.” If I were to randomly select 10 healthcare practitioners and ask them if they could refer an SSRi withdrawal specialist to me and, for one reason or another, they could not provide me with any such specialist, would the MHRA then concede that there are, in fact, no SSRi withdrawal specialists with adequate training that can provide help for patients suffering severe SSRi withdrawal?

5. You state “The MHRA cannot encroach on the role of health professional regulators specifically created to set the standards of behaviour, competence and education of health professionals.” I disagree, if the MHRA are recommending specialists then the MHRA have a duty to patient healthcare that those specialists be adequately trained in the field of SSRi withdrawal. In essence, you are recommending a service that you do not know exists. In a nutshell, you are recommending to healthcare professionals to seek specialist advice from 'specialists' who have had no training or have received no guidelines to help patients suffering severe SSRi withdrawal.

6. You state “During our discussion with Professor Healy he was clear that the focus should be on highlighting to GPs that withdrawal reactions could be serious and prolonged in some patients and agreed that NICE and the BNF would be reasonable routes. We have liaised with both the BNF and NICE to stress the importance of highlighting the risk of withdrawal reactions in their respective publication and guidance.” With respect, the question was - 'You, at my request, also met with Professor David Healy who has acknowledged that there are a significant number of people on SSRi's that will never be able to stop. Have you relayed this information to healthcare specialists, do you agree with Professor Healy's advice or do you think the advice is wrong?' I'll ask again. Professor David Healy has acknowledged that there are a significant number of people on SSRi's that will never be able to stop. Do the MHRA agree with professor Healy's findings?

7. You state that the SSRi Learning module was “constructed by MHRA staff and drew on information and evidence in the public domain.”. Please list all references/evidences used.

Bob Fiddaman.

Fid

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE

GSK Show Their Teeth To Colgate

2011-12-14T16:38:00.001Z

I'm in shock.

GSK, the company that helps people to do more, feel better and live longer, have actually gone and won a battle.

Glaxo, who normally are on the receiving end of such battles, complained that a rival toothpaste to its Sensodyne was using misleading statements in its advertisements.

Colgate Sensitive Pro Relief claimed "Proven instant relief" and "Superior lasting protection".

Glaxo complained to the Advertising Standards Authority [ASA] citing that the ads could 'mislead the consumer' - The ASA agreed and now the ads have been banned.

This has irony all over it doncha think?

GlaxoSmithKline citing that a product other than theirs can mislead the consumer? I have to admit that when I was first sent this story I rolled onto the floor into a state of apoplexy whilst biting hard on a cushion.

I'll just pick up on one way Glaxo used to advertise Paxil. You will note from the commentary that apart from claiming Paxil is "non-habit forming", they also claim that "a chemical imbalance could be to blame" and that "Paxil works to correct this imbalance"

Then we have Glaxo's Poligrip and the fact that a lawsuit was filed in the U.S. District Court for the Eastern District of New York on behalf of two couples who alleged that severe and disabling injuries were caused by zinc poisoning from Super Poligrip denture adhesive. More lawsuits have been filed - you see, naughty Glaxo failed to warn the consumer about the levels of zinc found in its product.

Hey, let's not forget GSK's failure to warn consumers that its diabetes drug, Avandia increased the risk of heart attack and death. Avandia has now been banned in Europe. Let's not forget either Glaxo's huge $£billion payout in settlements during 2011, settling 'out of court' for things such as their product causing birth defects.

Hey, as far as I can make out, Colgate were only promoting their product the way Glaxo have promoted theirs over the years. As far as I'm aware, Colgate toothpaste never caused anyone severe withdrawal...or worse still, death!

Those Colgate guys can advertise their wares on my blog if they wish. I'd love nothing more than to promote a product that got GSK bosses baring their teeth.

Big up to Colgate.

The complaint and decision can be read in full HERE

Related Videos

Fid

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE