Takeda Whistleblower

I'm loving all these whistleblower suits. Last year Cheryl Eckard blew the lid on GlaxoSmithKline's factory in Peurto Rico. A combination of poor quality pills, contamination and alleged black market selling of drugs from the plant saw Glaxo pay out a hefty fine. Eckard was earlier fired from her position after she brought it to the attention of her seniors that the Peurto Rican plant was in an appalling state.

Last week Allen Jones, another whistleblower, was vindicated for blowing the whistle on Johnson & Johnson. He learned that they were using underhand tactics to market their drug risperdal to children. A secret bank account was found by Jones that led him to the fraud. Like Eckard he too was fired from his position after he brought it to the attention of his peers.

Now we have a new whistleblower case set to hit the headlines.

Helen Ge was a former contractor at Takeda Pharmaceutical Co. Ltd. She learned that Takeda have been playing down risks of three of their drugs, particularly when combined with other drugs. Again, she was fired from her position when she brought this to the attention of her seniors, alleges the lawsuit filed by Baum Hedlund Aristei & Goldman PC and Ashcroft Sullivan LLC

The complaint alleges that Takeda knowingly steered doctors away from prescribing cheaper generics of Uloric, Prevacid and Dexilant, and also failed to report adverse events to the U.S. Food and Drug Administration.

“Takeda disregarded its duty to deal honestly with the government and with knowledge that its concealment and intentional misrepresentations would result in hundreds of millions, and perhaps billions of dollars in damage to government health care programs,” alleges the complaint.

What's startling about this particular whistleblower suit is that it appears that the elderly were at risk from Takeda's concealment, many elderly patients used Takeda's medication/s in combination with other drugs, drugs that Takeda allegedly knew could cause them serious problems and in some cases death.

This will be an interesting case to follow, particularly as Takeda are already under scrutiny for failing to warn patients taking their diabetes medication, Actos. A suit was filed in December last year that alleges Actos causes bladder cancer, the suit also makes claim to negligence, failure to warn, defective design and deceit by concealment.

More and more whistleblowers are coming forward it seems, which can only be good news for those of us that have been banging the drum loudly about the fraud that exists in Big Pharma.

Full complaint can be read 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

James Murdoch to Leave Glaxo Board, Applications Wanted

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

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


Dear Mr Witty,


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

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

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

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

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

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

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

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

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

Please consider me for a position on the board.

Lots of hugs

Fiddy xxxx

Fig 1 - Gissa job Sir

Call For Medical Ghostwriters To Be Held Legally Liable

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

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

The Plos article rightly clams:

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

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

Personal Injury Lawsuits

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

Federal False Claims Act (FCA or Whistleblower Statute)

"FCA inflicts civil liability against persons or entities presenting false payment claims or using false records or statements to get claims paid or approved or causing third parties to do so.


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

Anti-Kickback Statute

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


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

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

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

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


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

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

That's a crime in anyone's book!

Fid




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.

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

Australian Psychiatrist Ian Hickie's Lancet Paper Heavily Criticised

Prof Ian Hickie

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

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

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

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

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

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

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

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

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

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

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

Also - The Defence of Prof. Ian Hickie


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

UK SEROXAT LITIGATION - CURRENT STATUS

20 January 2012 - FOR IMMEDIATE RELEASE


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

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

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

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

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

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

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

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

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

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

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

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

Risperdal Whistleblower

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

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

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

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

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

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

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

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

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

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

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

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

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


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


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


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

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

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

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

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

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

They add:

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

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

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

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

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

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

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

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






Fid


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

 "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

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.

Tamiflu: Yet More Side-Effects

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

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

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

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

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

This claim was made public today by one of the founders of the Cochrane Collaboration at a British Medical Journal conference held in London.

 Other Cochrane reviewers are to reassert this claim in a further article due to be published by the Public Library of Science (PLoS). In the article, three of the Cochrane reviewers write:

‘In December 2009, after we voiced serious concerns in the BMJ about Tamiflu’s alleged ability to reduce compliations, Roche wrote that it was ‘very happy to have its data reviewed by the appropriate authority or individuals’ and publicly pledged to release 10 ‘full study reports’ in the ‘coming days’”. They went on to state that “despite extensive correspondence over the next year and a half Roche refused to provide any more than portions of the clinical study reports.’

The MHRA were recently in the news for failing to respond quickly enough to faulty PIP breast implants. They have also been criticised for sending out information to UK healthcare professionals regarding SSRi withdrawal and, it appears, have informed doctor's of the existence of SSRi withdrawal "specialists" when no such specialists actually exist. [LINK]



Fid

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

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

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?"

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

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"

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"

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