Tagged: MHRA

More Dolin Trial Bombshells: Former FDA Offical Testifies That Paxil Is Not Safe And Doesn’t Work!…


“…David Ross. The former FDA Medical Advisor was asked if he prescribed Paxil to his patients.

Amid the objections from King & Spalding’s Andrew Bayman, he answered,

“No. I don’t believe that it works and I don’t believe that it’s safe.”….


Well, well, it seems that as the days go by more and more shocking revelations come out from the Stewart Dolin ‘Paxil Induced Suicide’ Trial in the US…

GSK… you evil bastards…

See Bob Fiddaman’s new post for more:

http://fiddaman.blogspot.ie/2017/03/dolin-vs-gsk-89-suicide-increase-for.html


Wednesday, March 22, 2017

Dolin Vs GSK – 8.9 Suicide Increase For Adult Paxil Users

Day 5 – Dolin Vs GSK Paxil Induced Adult Suicide – Chicago.

There was a startling revelation today in the Dolin Vs. GSK trial: Attorneys representing widow Wendy Dolin showed the ratio of Paxil-induced suicidality in adults is a staggering 8.9.  It is not 6.7, as previously claimed and reported by Glaxo. The 6.7 figure is astoundingly high in itself, but the 8.9 ratio is flabbergasting!

Plaintiff witness, Dr. David Ross, said this figure is ‘astounding.’ What you should remember here is that GSK’s 1989 drug application for Paxil said the suicidality odds ratio was 2.6.

Over the years as GSK’s lies were uncovered and more bodies were buried because of Paxil, GSK later changed the Paxil-induced suicide rate to 6.7. But today the world knows the actual Paxil-induced suicidality figure for adults is 8.9. This number is almost a nine-fold increase in adult Paxil patients experiencing suicidal thoughts, suicidal thinking and completed suicide–thoughts that are created by akathisia and other adverse reactions to Paxil and not by any underlying pre-existing condition.

Today at the trial, expert witness, Dr. David Ross, who worked for the FDA for ten years, testified extensively. While working at the FDA, Dr. Ross was responsible for reviewing new drug applications (NDA’s), i.e., he oversaw the statistics.

His evidence started with 6 points about GSK’s responsibilities (or lack of…)

1. Paxil is associated with an increased risk of suicidal behavior in adults beyond the age of 24.

2. GSK was not upfront about Paxil’s suicidal behavior risk.

3. In 2010, GSK had the ultimate responsibility for the Paxil label. GSK was responsible for ensuring the Paxil label did not contain any false, misleading, or inaccurate information about safety.

4. Federal regulations required GSK to warn doctors that Paxil induces adult suicidal behavior, starting in 1992.

5. GSK could have warned doctors by changing the Paxil label. There is no evidence the FDA would have stopped GSK from issuing a Paxil-specific warning in the non-class labeling sections. In fact, the FDA specifically invited GSK to discuss such changes.

6. GSK did not warn doctors of the true Paxil-induced suicidal behavior risks for adults beyond the age of 24.

Dr. Ross further reiterated to the jury what David Healy previously stated: that the responsibility for accurate drug labeling lies with the product manufacturer and not with the FDA. Dr. Ross added, “…the FDA does not do drug trials, we only know what we are shown.” He added, “You have to rely on the drug company.” He also informed the jury that the FDA’s annual budget is $1.3 billion, most of which comes from drug companies.

Another striking statement Ross shared with the jury was, “The FDA is in charge of enforcing the law, and GSK is in charge of following the law.”

Today’s evidence clearly shows that GSK has not followed the letter of the law enforced by the FDA.

Attorney Brent Wisner from Baum Hedlund asked Dr. Ross if he thought GSK’s label regarding adult suicide was adequate. Dr. Ross answered, “No.” and further added, “It was false and misleading and remains so today.”

Ross also told the jury that if he saw a nearly 9-fold increase in suicide in a drug (any drug) that he “Would not prescribe the drug.” In fact, Ross would categorize a 9-fold increase of any drug as a “frequent adverse event on labeling.”

He also told the jury that the term “Emotional lability” that GSK used instead of suicidality, “conceals what is really going on.”

Remarkably, two GSK employees, along with a third author who received funding and/or similar perks from GSK, published a medical journal paper stating Paxil actually reduced suicide in adults. Ross told the jury that he believed this published paper which contains obvious statistical errors should be retracted. The published article, “Reduction of suicidal thoughts with paroxetine in comparison with reference antidepressants and placebo”, by Montgomery, Dunner, and Dunbar was then used by GSK reps to promote the safety of Paxil in adult patients to prescribing doctors, even though GSK knew it was the complete opposite!

Indeed, it was a very bad day for GSK. The standard “Objection!” was lamely shouted out by King & Spalding’s resident Jack-in-the-box, Andrew Bayman, more times than I care to recall. The majority of his objections were overruled by the Honorable Judge Hart.

I’ve long been a critic of both the British and American drug regulators (the MHRA and FDA). Despite ten years of successful blogging, I’m never too old to learn something new, even when the new information is quite tragic: Today I, and the jury learned that drug companies such as GSK hold medical regulators by the balls. Drug companies provide information (to include false data from faulty clinical trials) and medical regulators have to accept drug company information as the truth. GSK should expect ramifications from global regulators after today’s evidence. An almost 9-fold increase in suicidal behavior in adults taking Paxil is appalling, particularly when we know that, for years, GSK continues to claim there is no causal association between suicide and adults taking Paxil.

This lopsided relationship has terrible ramifications for mental health authorities and suicide nonprofits who unconcernedly take drug company hush money. For years both have claimed antidepressants are a safe and effective treatment for a variety of possible ailments (anxiety, OCD, adult depression, e.tc.) A nearly 9-fold increase in suicidality strongly suggests that both mental health and mental health nonprofits have been duped by the pharmaceutical industry, along with prescribing doctors, medical regulators, and an unsuspecting public.

Just think folks: GSK even tried to get a license for Paxil to be prescribed to children after they knew of the Paxil-induced suicide increases in adults!

Nice ethical company, huh?

I’ll leave the last words to today’s witness, David Ross. The former FDA Medical Advisor was asked if he prescribed Paxil to his patients. Amid the objections from King & Spalding’s Andrew Bayman, he answered, “No. I don’t believe that it works and I don’t believe that it’s safe.”

Trial continues tomorrow.

For now, it’s time for a Guinness, in honour of Stewart Dolin.

Bob Fiddaman.
In Chicago.

Dolin Vs GSK

Dolin v GSK – Opening Arguments

Dolin Vs GSK – Day Two – “Jack-In-The-Box”

Dolin vs GSK – Healy ‘Rocks Da House’

Dolin Vs GSK – JP Garnier Video Deposition

Dolin Vs GSK – The Dunbar Tape

Dolin Vs GSK – Day 4 – Slam Dunk

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(Rolling Stones Star) Ronnie Wood’s Daughter- Leah Woods- Calls For Reform Of The MHRA…


LEAH WOOD

For Reform MHRA

Celebrity Involvement

Model Leah Wood is campaigning for a radical shake-up of the health system to reduce the influence of giant pharmaceutical companies.

Leah, the daughter of Rolling Stones guitarist Ronnie Wood, believes the public has become too dependent on medication prescribed by doctors.

“People need knowledge to judge for themselves what is out there rather than getting prescribed pills for everything,” says the 38-year-old mother of two, who is an organic lifestyle advocate.

 “Pharmaceutical companies have too much power and we have become used to medication instead of seeing what else is out there.”

Leah is backing a petition launched by the pressure group, the National Health Federation, to restructure the MHRA, claiming it is a ‘puppet’ of the pharmaceutical industry.

The call comes in the week the influential Academy of Medical Royal Colleges warned that doctors were giving too many patient test and drugs they don’t need while the British Medical Association called for a dedicated NHS helpline and website where people hooked on prescription drugs can get advice.

“There should be more choice available and we should be able to use alternative ways of healing ourselves providing they are safe,” adds Leah. “People should have the freedom to try other avenues when they are ill.

“It is clear that some of these medicines are not vital and we don’t need our bodies clogged up with chemicals. But the big pharmaceutical companies have too much influence and other remedies are overlooked or banned. I am really concerned that there is a level playing field so everything can be considered.”

Leah’s grandmother Rachel Karslake was diagnosed with breast cancer but used an organic lifestyle to combat the condition. Her mum Jo, an organic pioneer who split from the Rolling Stone seven years ago, revitalized her diet by preparing fresh organic food.

“The doctors gave Nan all these treatments and made her do chemotherapy but she wasn’t getting any better so she decided to take matters into her own hands. She took homeopathic treatments and supplements and my mum and Auntie prepared organic food for her,” says Leah, a fashion model and artist. “We are convinced it helped her.

“Had she been eating badly then I’m sure the cancer would have had little trouble going round her body.”

Rachel died last year, aged 81, from kidney failure.

Leah, who lives in north London with her financier husband Jack McDonald and children Maggie, seven, and Otis, four, adds that the government should also provide more health and dietary information for the public.

“Not enough people know what is inside their food or even if they need the medicines prescribed by doctors,” she says. “We need to look after ourselves as much as possible to prevent illness not to rely on doctors once we get ill.

“It is time there was more knowledge out there and for the public to take a bigger interest in their own health”

She believes in maintaining a healthy lifestyle and not relying on conventional medicines if healthier alternatives are available. “I was brought up with alternative medicines and homeopathy and have been taught the importance of eating well. You are what you eat. I try and stay healthy. I go to the gym, I run, I take vitamins. You can often heal yourself through diet and lifestyle and I think it is important not to overmedicate.

‘I use homeopathy and alternative remedies a lot with my kids. There are so many alternatives but people do not realise they are available because the pharmaceutical message is so strong.”

She is urging the public to sign a petition to reform the MHRA and promote alternative therapies.

Leah adds that her father is still fighting fit and enjoying the demands of parenthood since is third wife, Sally Humphreys, 38, gave birth to twins Gracie Jane and Alice Rose in May.

Ronnie also has son Jesse Wood, with his first wife and former model, Krissy Wood, daughter Leah and son Tyrone from his second marriage, to Jo, and Jamie, Jo Wood’s son from a previous marriage, whom he adopted.

“It’s bizarre, I have so many nieces and nephews and now I have baby sisters and I’m almost 40 years older than them,” she laughs.

“I haven’t babysat yet but I’ve been around and I’ve cuddled them and tried to keep both of them quiet at the same time. They are very, very sweet.

‘Dad is superfit, but he has to be with the two new babies. There’s no great secret, as a family we always laugh and try to be happy. Even though things can be tough, my upbringing was actually quite stable.’

As well as being a busy mum, Leah is also a designing a baby clothing range and is working on artistic projects.

Mail Online-

http://www.dailymail.co.uk/health/article-3983100/How-Ronnie-Wood-s-drink-drug-addled-past-not-affected-health-model-daughter-Leah-says-s-alternative-medicines.html

Great New Website Calling For Reform Of The MHRA (UK Medicines Regulator)


Great to see my blog highlighted on a new web-site calling for reform of the MHRA.

I think it speaks for itself- check it out-


http://www.mhraremodel.com/why-campaign

 

 

 

MHRA.png

 

Why Campaign?

 A change in practice means  

 THE LIVES OF THOUSANDS 

have a chance to be saved 

Jeremy Hunt – Secretary of State for Health

Ben Goldacre – journalist, author and campaigner.

Consumers for Health Choice – An organisation dedicated to fighting for individual rights and freedom of choice in health matters.

David Tredinnick MP- Homeopathy advocate

Bach Flower Remedies- Nelsons UK- Powerful flower remedy business

ESCOP -The European Scientific Cooperative on Phytotherapy – An umbrella organisation representing national herbal medicine or phytotherapy associations across Europe

Richard Brook – former Chief Exececutive of Mind.

Dr Malcolm Kendrick – Doctor and critic

The Royal London Hospital for Integrated

Medicine (RLHIM) – The largest public-sector provider of integrated medicine in Europe.

Peter Gotzsche, Nordic Cochrane Centre

Stephen Dorrell MP – Former chair of government health committee

Caroline Noakes MP – Campaigns for regulation of diet pills and critic of MHRA

WHO CAN HELP US GET WHAT WE WANT?
LINKS
Examination of horrors committed by GSK, including links to Panorama: 
https://truthman30.wordpress.com/

At $50,000 a round – 
Chemo Kills
Dangerous licensed drugs: 
http://www.drugwatch.com/dangerous-drugs.php

The World’s Most Expensive Drugs – $100,000 a year is nothing:
http://www.forbes.com/2010/02/19/expensive-drugs-cost-business-healthcare-rare-diseases.html

The Medicines and Healthcare Products Regulatory Agency (MHRA) is the government agency which insures that medicines and medical devices work. An undoubtly crucial organisation in the UK. However the organisation we depend on for our health has deep flaws we cannot overlook.

As an example, cancer patients in need of chemotherapy have to foot the bill of £40,000 for only one round of treatment. The reason for this is chemotherapy makes a massive amount of money for the pharmaceutical companies supplying it so these companies do not want a cheaper alternative to become available in the UK. Unfortunately the MHRA who work closely with the Pharma’s have proven links to these organisations.

Ian Hudson, MHRA CEO       Gerald Heddell, MHRA Director

Both former employees of Glaxo Smith Kilne, the world’s second largest pharmaceutical company

There have been many reports criticising the links to pharma. Suggesting that the MHRA not only have past links with pharma but also cover for them in the media. Glaxo Smith Kilne’s (GSK) Cerarix HPV Vaccines for cervical cancer: The MHRA systematically tampered with 6000 reports of adverse reactions to declare the vaccine safe.

http://nsnbc.me/2013/07/28/uk-drug-safety-agency-falsified-vaccine-safety-data-for-6-million/

https://childhealthsafety.wordpress.com/2012/10/25/new-research-shows-how-gardasil-and-cervarix-vaccines-can-silently-kill-your-daughters-and-sons/

Would you say it is a coincedence that the pharma company involved is the previous work place of two board member of the MHRA? 

Let’s take back the MHRA and ban the influence of greedy pharma companies.

THE FLAWED MHRA MODEL

An independent and honest MHRA free from commercial influence will open many doors in terms of medical treatment options.

As members of the UK we deserve the right to be informed on the safety of procedures and treatments available in the country. An independent MHRA would vanish any ulterior motives to hide or cover any medical mistakes.

The right of choice would become ours. There are numerous treatments available in European countries that have been banned from the UK purely due to pharma greed.

Now is the time to act! Inlight of Brexit the Jeremy Hunt will have to rearrange some of the UK’s medical relationships. Why not the MHRA’s?

Help us acheive our goals and together we could save countless human lives!

Dr Ian Hudson (Ex GSK Employee and Current Head Of The MHRA- UK Medicines Regulator) Defends Paxil (Seroxat) In US Court Case… Exclusive- From Bob Fiddaman’s Blog…


 

http://fiddaman.blogspot.ie/2016/09/exclusive-dr-ian-hudson-in-defence-of.html

Monday, September 12, 2016

EXCLUSIVE: Dr Ian Hudson: In Defence of the Suicide Pill

A chance meeting, a discussion, a common interest.

That’s all it needs at times to stumble upon something you’ve been seeking for close to 10 years.

Video depositions have always fascinated me, they are better than the written depositions that we see within court documents. Most notably they show the subject answering questions, they show the subject in a much different light, they show the subject being evasive and choosing not to answer questions that may jeopardise the party he is appearing for. Moreover, they can be seen at later dates, when the subject has moved on to a different company or, in this instance, to head of the British drug regulator, the MHRA.

Ian Hudson is the former World Safety Officer for SmithKline Beecham, today they are more commonly known as GlaxoSmithKline or GSK.

On Friday, December 15, 2000, Ian Hudson, who at the time was still employed by GSK, gave a deposition in relation to a case that was to be tried in Wyoming a year or so after this deposition was taken, the result of which found that Paxil was, in fact, a proximate cause of the deaths in this case.

The case in question was brought against GSK by the relatives of a man, Donald Schell, who killed himself and three others after taking the drug Paxil,

Here is Ian Hudson’s video testimony. It’s a bit scratchy in places and the audio drops but it is the first time this has been seen in public.
.
Ian Hudson is the current Chief Executive of the MHRA, the British drug regulator who regulate the drugs you and I take.

You can draw your own conclusions as to whether or not you think Ian Hudson is forthright with his answers in this deposition.

A transcript of the video deposition can be found here.

Ian Hudson was being asked questions by US attorney, Andy Vickery.

(GSK are currently defending another Paxil related suicide in the US – The Stewart Dolin files can be seen here)


Protest To Disband The MHRA (UK Med Regulators) On July 5th 2016


Great to see this inspiring group of individuals get together to protest against the utterly corrupted- pharma-controlled– MHRA in the UK. The MHRA is the UK’s medicines regulator, however it seems that in regards to Seroxat, it wasn’t regulated at all. The revolving door between the MHRA and Big Pharma companies like GSK serves to make sure that the interests of Pharma are always first priority over patient health and well being…

Seroxat survivors know that only to well…

For more on this protest see the Facebook link below:

https://www.facebook.com/Protest-against-the-MHRA-1544624572513720/

And if you haven’t signed this petition, calling to disband the MHRA, please join the other 12,000 or so people who have signed it already.

https://www.change.org/p/house-of-commons-to-disband-the-medicines-and-healthcare-products-regulatory-agency-mhra-a-corrupt-government-body-charged-with-protecting-patients-from-avoidable-harm-in-the-national-health-service-and-in-public-health

MHRA

13557663_1553246621651515_3732350298601062920_n13606697_1553246754984835_97351257695611146_n13614992_1553246571651520_7925396129269878768_n13620712_1553246601651517_4355401918702692561_n

UK’s MHRA Calls Out GSK China Plant Over GMP Non-Compliance


http://www.raps.org/Regulatory-Focus/News/2015/10/23/23467/UK%E2%80%99s-MHRA-Calls-Out-GSK-China-Plant-Over-GMP-Non-Compliance/

UK’s MHRA Calls Out GSK China Plant Over GMP Non-Compliance

Posted 23 October 2015 By Zachary Brennan

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The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday released an inspection report that found a GlaxoSmithKline (GSK) manufacturing facility in Tianjin, China was non-compliant with Good Manufacturing Practices (GMPs).

The site manufactures the heartburn treatment Zantac for markets including the UK, Austria, Belgium, Denmark, Finland, Germany, France, Greece, Ireland, Italy, Netherlands, Norway, Portugal and others.

MHRA inspected the site in June and on Friday issued this statement of non-compliance saying the facility “should not be named on any marketing authorizations whilst this statement remains in place,” according to the EU’s EudraGMDP website.

The warnings follow other issues GSK has had in China, including a bribery scandal from a year ago for which the company was fined nearly $500M.

Specifics

The inspectors identified sterility issues, in addition to primary and secondary packaging deficiencies, as well as problems with quality control testing.

“A critical deficiency was cited with regards to system failures to ensure that the manufacture of medicinal products were fit for their intended use, complied with the requirements of the Marketing Authorisation and did not place patients at risk due to inadequate safety, quality or efficacy,” the MHRA said.

Since 2005, GSK identified tablet discoloration in the stability samples during trials which did not meet the shelf life specification.

“No action was taken to assess the risk of the remaining products in the markets,” MHRA says. “Adverse trends in stability-indicating attributes were observed but not investigated.”

In addition, product impact assessments failed to ensure that the defective product was not potentially supplied to the user, and the company also failed to notify regulators of the discovery of these “defective products.”

GSK was also cited for failing to address the root cause of the issues because of ineffective Corrective and Preventive Actions (CAPA) that weren’t appropriately implemented. The company also failed to conduct effective investigations in a timely manner.

Explosion

A series of explosions on 12 August, which killed more than 100 people in Tianjin, also had an impact on this same GSK manufacturing facility, according to media reports.

GSK told RAPS it’s looking into the situation.

EudraGMDP Filing

– See more at: http://www.raps.org/Regulatory-Focus/News/2015/10/23/23467/UK%E2%80%99s-MHRA-Calls-Out-GSK-China-Plant-Over-GMP-Non-Compliance/#sthash.WbIWzZS1.dpuf

A Petition To Disband The MHRA (UK Medicines Regulator) Is Going Viral… (please sign)


https://www.change.org/p/house-of-commons-to-disband-the-medicines-and-healthcare-products-regulatory-agency-mhra-a-corrupt-government-body-charged-with-protecting-patients-from-avoidable-harm-in-the-national-health-service-and-in-public-health?tk=6JQL7v0z3cv6AjUAWzysRcEYquOn1bwSqdQdLw4d8pk&utm_source=petition_update&utm_medium=email

Disband the Medicines and Healthcare products Regulatory Agency (MHRA) and its big pharma board of directors. The MHRA protects the billion dollar pharmaceutical monopolies by ruthlessly closing down any new effective, inexpensive scientific discoveries.

The MHRA has been proven to be a tool of “Big Pharma”, a puppet of the worlds largest pharmaceutical industries.  Charged with the task of protecting the public from harmful health care is in fact protecting the largest pharmaceutical companies from loss of profits instead.  There are many differing alternative ways that people can find to choose from for maintaining or returning to good health.  The MHRA actively prevents us accessing these, our own choice of medications in favour of harmful often unproven drugs from the profiteering big pharmaceutical companies.

www.mhrafraud.co.uk

The MHRA, the UK Drug Safety Agency, Falsified Vaccine Safety Data – Millions of Children At Serious Risk

GSK’s Cervarix HPV vaccines for cervical cancer: The MHRA systematically tampered with 6000 reports of adverse reactions to declare the vaccine safe…………The MHRA’s Director Gerald Heddell and CEO Ian Hudson are both ex GSK, Glaxo Smith Kline.

http://nsnbc.me/2013/07/28/uk-drug-safety-agency-falsified-vaccine-safety-data-for-6-million/

https://childhealthsafety.wordpress.com/2012/10/25/new-research-shows-how-gardasil-and-cervarix-vaccines-can-silently-kill-your-daughters-and-sons/

House of Commons Health Select Committee Report of 2005

“In view of the failings of the MHRA, we recommend a fundamental review.”

http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf

MHRA: Regulators’ trail of deception has been exposed

Andrew Miller, the chairman of a parliamentary select committee, has said that a “trail of deception” has been exposed in the system.

http://www.telegraph.co.uk/news/health/9629337/Faulty-medical-implants-investigation-Regulators-trail-of-deception-has-been-exposed-says-chairman.html

MHRA under fire amid calls for shake-up of regulatory system

31-Jan-2012

The scandal of device regulation in the UK

Horton said: “The MHRA’s mission is ‘to enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe’. The MHRA is, by its own admission, unable to fulfil this mission.

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2812%2960070-1/fulltext?rss=yes

MHRA, The Seroxat killer: Parmjit Dhanda, MP, Gloucester

is asking the Government why they allowed Dr Ian Hudson, the MHRA CEO,  to take part in the European Medicines Evaluation Agency (EMEA)’s review of Seroxat, an antidepressant. As well as working as worldwide safety director for GSK – the manufacturers of Seroxat (Paxil, Paroxetine)– from 1999 until 2001, Dr Hudson acted as witness for the defence in a trial in which Seroxat was accused of triggering a man’s violent and suicidal behaviour.

http://www.seroxat.pwp.blueyonder.co.uk/Gloucester%20Citizen.htm

Paul Flynn MP, Newport:  What credibility does the MHRA have?

Recent events have proven that it is not a watchdog; it is a pussycat that purrs in front of the pharmaceutical industry and does what it is told. It has an incestuous relationship with the big pharmas and has a close association with the Association of the British Pharmaceutical Industry. It has a disgraceful recent record. We can look with gratitude to the work not of the Medicines and Healthcare products Regulatory Agency in protecting the public, but to people such as Sarah Boseley of The Guardian for her exposé of the organisation, to the television programme “Panorama” and to Richard Brook of Mind, who courageously resigned from the MHRA in disgust at its activities.

It is a matter of enormous importance that, in recent history, the regulator is not protecting the 25,000 people who suffered heart attacks and the 7,000 who died from taking a painkilling drug for arthritics that was withdrawn by Merck Sharpe and Dohme in September, after being promoted by the regulator.

http://www.theguardian.com/uk/2004/mar/13/politics.highereducation

MHRA conceals Seroxat causes suicide

  1. “The MHRA had information in its possession for more than a decade that high doses of the anti-depressant Seroxat can lead to aggression and thoughts of suicide. But instead of revealing the truth to the 17,000 people taking high doses and the other half-million Britons on a safer dose, the MHRA sat on its findings. Astonishingly, I was actually threatened with legal action by Professor Kent Woods, chief executive of the MHRA, if I revealed this.”—RICHARD BROOK

http://www.whale.to/a/brook.html/

The MHRA is GlaxoSmithKline, Aventis Pasteur, Merck, Sharpe and Dohme

A Sunday Express investigation found that nearly a third of the 181 experts who sit on the Medicines Control Agency (MCA, now the MHRA) committees are linked to Glaxo Smith Kline, Aventis Pasteur or Merck, Sharpe and Dohme……The MCA has continued to endorse the triple measles, mumps and rubella (MMR) jab despite concerns linking it to autism and stomach disorders. But the extent of the MCA members’ financial ties to MMR manufacturers raises questions about potential conflicts of interest.”–Sunday Express

Licensed drugs are the number 4 killer of mankind

The MHRA’s big brother, the USA’s FDA, admits drugs, ie those the FDA and MHRA license, kill scores of thousands. That’s what happens when the regulator is controlled by the drug companies. The MHRA conceal this.

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/ucm114848.htm

The MHRA is criticised for failing to adequately regulate implants

with grim consequences for some patients. While the board contains retired senior executives from AstraZeneca and Merck Sharp & Dohme, it includes no one from a patient group, or any other body representing people whose health could be damaged by its decisions.

The web of unelected bodies functions as a kind of shadow government, drafting and enforcing policies, disbursing money, regulating – or failing to regulate – business, quietly, unobtrusively, without effective public scrutiny or restraint. When it is unbalanced, crawling with conflicts of interest, it makes a nonsense of democracy.

http://www.theguardian.com/commentisfree/2012/mar/12/nhs-health

The MHRA protects the monopolies of the billion dollar pharmaceuticals (who charge, eg. £40,000 for a round of chemotherapy), and ruthlessly closes down inexpensive, effective treatments wherever it can.

Even the courts know the MHRA is corrupt

The MHRA has never successfully prosecuted a company since it was established nearly 10 years ago.   (It seems judges won’t accept evidence from so corrupt a source.)

http://www.theguardian.com/business/2012/jul/08/pharma-misbehaviour-gsk-fine     -see last paragraph.

Revolving Door Between GSK And The MHRA


A lot of people are beginning to realize that the MHRA and GSK are perhaps way too close for comfort…Webstats

Some very interesting views lately on my blog.

The Webstats can tell you quite a bit of information, about who is viewing the blog etc.

I noticed today that GSK and the MHRA were both viewing at the same time.

A mere coincidence? or something more?

https://truthman30.wordpress.com/2014/09/05/ian-hudson-gsk-and-the-inherent-corruption-in-the-mhra-bob-fiddaman-investigates/

From The Fiddaman Blog:

Friday, September 05, 2014

http://fiddaman.blogspot.ie/2014/09/mhra-ceo-paxil-and-suicide.html

MHRA CEO, Paxil and Suicide

Much has been said about the conflict of interest between the British drug regulator, (MHRA), and GlaxoSmithKline. It’s obvious to those who know the history of GSK and the MHRA that there is a huge conflict of interest that just cannot be ignored and while such a conflict exists patients will not be safeguarded from the likes of Paxil, a drug marketed and manufactured by GlaxoSmithKline. I’ve met with the MHRA are a number of occasions, at one stage I offered to help them with their out of date and deeply flawed yellow card reporting system, a system where adverse events are collected and…well, basically nothing is ever done. Communications between me and their then CEO, Kent Woods, broke down due to his refusal to acknowledge that Paxil, known as Seroxat in the UK, should be classed as a teratogen. A teratogen is an agent or factor that causes malformation of an embryo. Much of my communication with the MHRA is in my book, ‘The evidence however, is clear, the Seroxat scandal‘ [1] In 2013 Kent Woods retired and the MHRA appointed Dr Ian Hudson (pic above) as their new CEO. Hudson, who after leaving Glaxo in 2001, became the MHRA’s Licensing Director, responsible for overseeing the benefits and risks of drugs before they hit the market. Yup, the man in charge of the agency who have the job of keeping tabs on the drugs you and I take is a former employee of GSK – then known as SmithKline Beecham. Hudson, whilst working for GSK, was a witness for the defence [GSK] during the Tobin v SmithKline Beecham Pharmaceuticals. In 1998 Donald Schell was put on Paxil [Seroxat]. Forty-eight hours later he put three bullets from two different guns through his wife’s head, as well as through his daughter’s head then through his granddaughter’s head before shooting himself through the head. Hudson’s deposition has been online for sometime in text form, a copy of it can be viewedhere. Sadly, it’s been difficult trying to obtain the actual video footage of Hudson being depoed by US attorneys representing Tobin. We do, however, have a small segment of his video deposition. In 2002 Investigative journalist Shelley Jofre launched her first installment into the whole Paxil debacle. BBC Panorama’s ‘The Secrets of Seroxat’ was aired and it prompted over 67,000 calls and emails from concerned consumers. During the documentary Shelley touched on the case of  Donald Schell. The footage in the documentary revealed part of Dr Ian Hudson’s video deposition. Remember, at the time, Hudson was a GSK employee. Watch…. (Hudson was depoed in 2000) **If the video starts with Andy Vickery talking then click the bar to end of video then press play**

In 2008 the MHRA concluded a four year investigation of GlaxoSmithKline, the crux of which was to find out whether GlaxoSmithKline withheld paediatric safety data pertaining to suicide related to its antidepressant Seroxat. They decided not proceed to criminal prosecution. It’s unknown if they interviewed their own Dr Ian Hudson during their four year investigation. [2]
As I said, Dr Ian Hudson is now the Chief Executive of the MHRA, the agency that purportedly protects British consumers of prescription drugs.
I don’t know about you but this doesn’t really fill me with a sense that I am being protected from dangerous drugs. Does it you?
All four Paxil videos will soon be available in their entirety on Rxisk.
Bob Fiddaman
[1] ‘The evidence however, is clear, the Seroxat scandal’ [US] [UK]
[2] GSK investigation concludes [Link]

Please sign (and share) the petition (from MHRA Corrupt Site) to disband the MHRA


“The MHRA had information in its possession for more than a decade that high doses of the anti-depressant Seroxat can lead to aggression and thoughts of suicide.

But instead of revealing the truth to the 17,000 people taking high doses and the other half-million Britons on a safer dose, the MHRA sat on its findings.

Astonishingly, I was actually threatened with legal action by Professor Kent Woods, chief executive of the MHRA, if I revealed this.”—RICHARD BROOK

https://www.change.org/p/house-of-commons-to-disband-the-medicines-and-healthcare-products-regulatory-agency-mhra-a-corrupt-government-body-charged-with-protecting-patients-from-avoidable-harm-in-the-national-health-service-and-in-public-health

Petitioning House of Commons

Disband the Medicines and Healthcare products Regulatory Agency (MHRA) and its big pharma board of directors. The MHRA protects the billion dollar pharmaceutical monopolies by ruthlessly closing down any new effective, inexpensive scientific discoveries.

The MHRA has been proven to be a tool of “Big Pharma”, a puppet of the worlds largest pharmaceutical industries.  Charged with the task of protecting the public from harmful health care is in fact protecting the largest pharmaceutical companies from loss of profits instead.  There are many differing alternative ways that people can find to choose from for maintaining or returning to good health.  The MHRA actively prevents us accessing these, our own choice of medications in favour of harmful often unproven drugs from the profiteering big pharmaceutical companies.

www.mhrafraud.co.uk

The MHRA, the UK Drug Safety Agency, Falsified Vaccine Safety Data – Millions of Children At Serious Risk

GSK’s Cervarix HPV vaccines for cervical cancer: The MHRA systematically tampered with 6000 reports of adverse reactions to declare the vaccine safe…………The MHRA’s Director Gerald Heddell and CEO Ian Hudson are both ex GSK, Glaxo Smith Kline.

http://nsnbc.me/2013/07/28/uk-drug-safety-agency-falsified-vaccine-safety-data-for-6-million/

https://childhealthsafety.wordpress.com/2012/10/25/new-research-shows-how-gardasil-and-cervarix-vaccines-can-silently-kill-your-daughters-and-sons/

House of Commons Health Select Committee Report of 2005

“In view of the failings of the MHRA, we recommend a fundamental review.”

http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf

MHRA: Regulators’ trail of deception has been exposed

Andrew Miller, the chairman of a parliamentary select committee, has said that a “trail of deception” has been exposed in the system.

http://www.telegraph.co.uk/news/health/9629337/Faulty-medical-implants-investigation-Regulators-trail-of-deception-has-been-exposed-says-chairman.html

MHRA under fire amid calls for shake-up of regulatory system

31-Jan-2012

The scandal of device regulation in the UK

Horton said: “The MHRA’s mission is ‘to enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe’. The MHRA is, by its own admission, unable to fulfil this mission.

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2812%2960070-1/fulltext?rss=yes

MHRA, The Seroxat killer: Parmjit Dhanda, MP, Gloucester

is asking the Government why they allowed Dr Ian Hudson, the MHRA CEO,  to take part in the European Medicines Evaluation Agency (EMEA)’s review of Seroxat, an antidepressant. As well as working as worldwide safety director for GSK – the manufacturers of Seroxat (Paxil, Paroxetine)– from 1999 until 2001, Dr Hudson acted as witness for the defence in a trial in which Seroxat was accused of triggering a man’s violent and suicidal behaviour.

http://www.seroxat.pwp.blueyonder.co.uk/Gloucester%20Citizen.htm

Paul Flynn MP, Newport:  What credibility does the MHRA have?

Recent events have proven that it is not a watchdog; it is a pussycat that purrs in front of the pharmaceutical industry and does what it is told. It has an incestuous relationship with the big pharmas and has a close association with the Association of the British Pharmaceutical Industry. It has a disgraceful recent record. We can look with gratitude to the work not of the Medicines and Healthcare products Regulatory Agency in protecting the public, but to people such as Sarah Boseley of The Guardian for her exposé of the organisation, to the television programme “Panorama” and to Richard Brook of Mind, who courageously resigned from the MHRA in disgust at its activities.

It is a matter of enormous importance that, in recent history, the regulator is not protecting the 25,000 people who suffered heart attacks and the 7,000 who died from taking a painkilling drug for arthritics that was withdrawn by Merck Sharpe and Dohme in September, after being promoted by the regulator.

http://www.theguardian.com/uk/2004/mar/13/politics.highereducation

MHRA conceals Seroxat causes suicide

“The MHRA had information in its possession for more than a decade that high doses of the anti-depressant Seroxat can lead to aggression and thoughts of suicide. But instead of revealing the truth to the 17,000 people taking high doses and the other half-million Britons on a safer dose, the MHRA sat on its findings. Astonishingly, I was actually threatened with legal action by Professor Kent Woods, chief executive of the MHRA, if I revealed this.”—RICHARD BROOK

http://www.whale.to/a/brook.html/

The MHRA is GlaxoSmithKline, Aventis Pasteur, Merck, Sharpe and Dohme

A Sunday Express investigation found that nearly a third of the 181 experts who sit on the Medicines Control Agency (MCA, now the MHRA) committees are linked to Glaxo Smith Kline, Aventis Pasteur or Merck, Sharpe and Dohme……The MCA has continued to endorse the triple measles, mumps and rubella (MMR) jab despite concerns linking it to autism and stomach disorders. But the extent of the MCA members’ financial ties to MMR manufacturers raises questions about potential conflicts of interest.”–Sunday Express

Licensed drugs are the number 4 killer of mankind

The MHRA’s big brother, the USA’s FDA, admits drugs, ie those the FDA and MHRA license, kill scores of thousands. That’s what happens when the regulator is controlled by the drug companies. The MHRA conceal this.

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/ucm114848.htm

The MHRA is criticised for failing to adequately regulate implants

with grim consequences for some patients. While the board contains retired senior executives from AstraZeneca and Merck Sharp & Dohme, it includes no one from a patient group, or any other body representing people whose health could be damaged by its decisions.

The web of unelected bodies functions as a kind of shadow government, drafting and enforcing policies, disbursing money, regulating – or failing to regulate – business, quietly, unobtrusively, without effective public scrutiny or restraint. When it is unbalanced, crawling with conflicts of interest, it makes a nonsense of democracy.

http://www.theguardian.com/commentisfree/2012/mar/12/nhs-health

The MHRA protects the monopolies of the billion dollar pharmaceuticals (who charge, eg. £40,000 for a round of chemotherapy), and ruthlessly closes down inexpensive, effective treatments wherever it can.

Even the courts know the MHRA is corrupt

The MHRA has never successfully prosecuted a company since it was established nearly 10 years ago.   (It seems judges won’t accept evidence from so corrupt a source.)

http://www.theguardian.com/business/2012/jul/08/pharma-misbehaviour-gsk-fine     -see last paragraph.

Letter to
House of Commons
To disband the Medicines and Healthcare Products Regulatory Agency (MHRA) a corrupt government body charged with protecting patients from avoidable harm in the National Health Service and in Public Health.
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Ian Hudson Bumbles His Way Through A Grilling In A Tamiflu Inquiry


If you want to see how people like the MHRA’s Ian Hudson run rings around public inquiries in regards to dubious drugs (in this case Roche’s Tamiflu) check out this recent video on the Tamiflu debacle.

It”s all very monty python-esque, and in true British style, nobody is held to account for a waste of over half a billion of UK tax-payers money on a useless drug for a fake pandemic..

 At least he turned up to this inquiry I suppose, because he didn’t bother to turn up to the Seroxat inquiry many years ago and the explanation for his absence was even more dubious than a dose of Tamiflu or Seroxat…

http://seroxatsecrets.wordpress.com/2009/06/15/mhra-and-ian-hudson-still-questions-to-be-answered/

The strange thing is that on the day the House of Commons Health Select Committee wanted to hear evidence from the MHRA specifically about Seroxat trial data and safety, Professor Alaisdair Breckenridge (MHRA Chairman), Professor Kent Woods (MHRA CEO) and June Raine (MHRA Director of Vigilence and Risk Management) all managed to attend the hearing.

MPs had expected to be able to question Ian Hudsonas well… unfortunately Dr Hudson could not attend as he had a prior engagement.

Scroll to around 17.18.30 on the video and watch Ian Hudson avoid answering questions about Tamiflu.

http://www.parliamentlive.tv/Main/Player.aspx?meetingId=16130


From Bob Fiddaman at Seroxat Sufferers Blog

http://fiddaman.blogspot.ie/2014/10/mhras-ian-hudson-grilled-over-clinical.html?spref=tw

 

Tuesday, October 21, 2014

MHRA’s Ian Hudson Grilled Over Clinical Trial Data

Yesterday [Monday 20 October] UK Parliament broadcast a committee meeting regarding Tamiflu, a prescription medicine used to treat the flu (influenza) in people 2 weeks of age and older.

In January this year, drawing attention to the lack of transparency over the results of clinical trials of the antiviral medicine, stockpiled for use in an influenza epidemic.  The Commons Select Committee concluded that the failure of manufacturers to share the full results of clinical trials with doctors, researchers and clinicians, undermined their ability to make informed decisions about treatments and the use of medicines by the NHS.

Yesterdays meeting probed the lack of transparency further.

It’s very interesting particularly as we can see Chief Executive of the MHRA, Ian Hudson, being grilled by Richard Bacon, MP. Hudson was asked just one question but seemed very reluctant to give any straight forward answers.

Basically, the UK government have claimed that it would not be feasible for the full methods and results of clinical trials to be made available to doctors and other healthcare professionals.

Ian Hudson was asked why he thought it was not feasible.

The exchange between Hudson and Richard Bacon, MP reminded me of David Brent, a fictional character played by Ricky Gervais in The Office. Brent, when questioned about his management methods was always evasive – Hudson’s response to Bacon’s question is so very similar. Whereas Brent speaks of pies and charts, Hudson speaks of Freedom of Information requests and policies…without actually answering the question.

Hudson is being really evasive here, just as he was when giving evidence for GlaxoSmithKline in a video deposition back in 2000. [1]  Hudson, was employed as GlaxoSmithKline’s World Safety Officer before eventually landing his role of CEO of the agency that protects the public from unsafe prescription medication.

Time and time again he avoids the question put to him by Bacon, time and time again Bacon reiterates his question, leaving Hudson to waffle on in the style of David Brent. You can even see a man and a woman at the back of the room laugh at Hudson’s avoidance to answer a simple question.

Kind of ironic that Hudson is being grilled by an MP whose surname is Bacon, doncha think? 🙂

Here’s the MHRA’s Ian Hudson playing David Brent yesterday [Skip to 17.44.46] [LINK]

Just like The Office there is no canned laughter.

Now compare with David Brent.

Bob Fiddaman.