Category: Ian Hudson

Ian Hudson of The MHRA (ex-GSK Employee)Bluffs And Blunders His Way Through A Grilling By Andy Vickery At A Paxil Induced Suicide Trial (2000)


I have to say I have been incensed watching a video of Dr Ian Hudson of the MHRA when he was defending (his employer at the time) GSK from allegations that Paxil/Seroxat caused a suicide in the US. Hudson did everything he could to defend Paxil/Seroxat  but in many ways he slipped up. This video was recorded in 2000. At this time I would have been on Seroxat for two years, I had no idea that this trial was even happening, there was no access to the web, or information back then- people like me were left suffering in the dark. Some people didn’t make it through, the side effects were too much, and they killed themselves. Akathsia is one of the most crippling and disturbing side effects of any psychiatric drug. On Seroxat I had weeks, often months of regular bouts of akathisa, I wouldn’t wish it on my worst enemy- it was hell, beyond hell actually, it was utterly devastating. I can understand completely how Akathisia would drive some people to kill themselves, I don’t know how I endured it, maybe my youth had something to do with it- often youth protects us from extreme events because we can endure more- and Seroxat was torture, absolute torture.

At the time that Dr Ian Hudson was defending his employers in a Seroxat suicide trial in the US, and denying that Seroxat was even associated with Akathisia, I was probably  climbing up the walls in my bedroom, rocking like a lunatic, crying and pulling on my scalp, feeling like every atom in my body was on fire, intensely suicidal, feeling like my skin was literally burning and crawling off my bones-  but all the while completely unaware that I was experiencing akathisa from Seroxat.

I didn’t even know what akathsia was.

However, I’m sure that Ian Hudson knew what Akathisa was though..

Ian hudson is now the CEO of the MHRA (the Medicines Regulator in the UK). At the time of his video deposition in this Paxil/Seroxat suicide trial- he was the ‘World-wide safety director’ of GSK (the manufacturer of Seroxat).

Imagine that ‘wordwide safety director’ of one of the most controversial drugs of the past 20 years …

I wonder what Ian Hudson’s view is now of Seroxat?

Does he still think that there is no relationship between Seroxat and Suicide?

Does he still think that there is no evidence of a cause and effect relationship of Akathsia with Seroxat?

If so, then why does GSK warn now of these effects in their PILs?

According to the GSK PIL (screen grab below)- Seroxat can cause Akathsia in around 1 in 1000 people.

Seroxat was prescribed to millions of people since it was first licensed 25 years ago- in 1991. So how many people went on to kill themselves because of Akathsia from Paxil/Seroxat? How many people lost their health? How many people killed themselves in the agonizing withdrawals? Can Hudson give us the new stats on that?

He is, after all, now the chief at the medicines regulator, and although he once defended Seroxat for GSK in court, maybe his new role as a patient protector- as opposed to a drug company lackey- he would be able to re-define his views for us and warn the public about the dangers of Seroxat?

Personally I wouldn’t even trust GSK’s PILs, if they say it’s one in 1000, it’s probably one in 100 or worse… they are proven liars and deceivers, nothing can be trusted from them given their track record. They are totally sociopathic when it comes to harming consumers of their drugs and denying that harm when it is revealed. But even if we take 1 in 1000 as an average estimate, that’s a lot of Akathsia from Seroxat.

But according to Ian- Seroxat doesn’t cause Akathsia, so which is it Ian does Seroxat cause Akathisia or not? The PIL says it does, but you said it didn’t…

Maybe Ian would like to-fulfill his role- and protect others from anymore Seroxat horror?

And maybe Ian would now like to do the right thing and apologize to all the people who killed themselves or felt suicidal, or lost their livelihoods, their relationships, and years of their lives, to Seroxat side effects?…

Or maybe he just doesn’t give a damn…

Either way, the whole thing stinks to high heaven in my opinion..

https://www.medicines.org.uk/emc/PIL.3185.latest.pdf

ian-hudsonseroxat-2

http://www.healyprozac.com/Trials/Tobin/Depositions/hudson-depo.txt

 

   Okay.  Dr. Hudson, does Paxil have an
 
        23  association with akathisia?
 
        24  A.    I've seen some case reports of
 
        25  akathisia.  I'm aware that there have been
 
 
 
                     SPHERION DEPOSITION SERVICES
                            (713) 650-3500

 
                   IAN R. B. HUDSON, M.R.C.P., M.D.
                                                     42
 
         1  some cases of akathisia, so it is something
 
         2  that we have received case reports about.
 
         3  Q.    Do you believe, as Worldwide Safety
 
         4  Director of SmithKline Beecham, that Paxil
 
         5  causes some patients to become akathisic?
 
         6  A.    I've seen no evidence to suggest a cause
 
         7  and affect relationship between Paroxetine and
 
         8  akathisia.  I've seen some case reports, but
 
         9  I've seen nothing that suggests a cause and
 
        10  affect relationship
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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)


Ian Hudson’s 11 Years At GSK/SB…


Ian Hudosn

http://seroxatsecrets.files.wordpress.com/2007/03/dr-ian-hudsons-interests.pdf

Those of you who are somewhat familiar with the Seroxat Scandal will be aware that, when BBC Panorama first exposed the truth about this dangerous drug with their first documentary in October 2002, the chair of the MHRA (medicine regulator) Alasdair Breckenridge (also a former GSK/SB employee) more or less defended GSK and the MHRA. He also seemed to be completely unaffected by the suffering and suicides caused by this horrendous drug. Moreover, despite subsequent panorama documentaries, lawsuits, investigations, blogs, outrage, public outcry etc etc- since that time, people still kill themselves on Seroxat, people are still hooked on it, and people still suffer withdrawals, it’s still being prescribed, and those who suffer long term effects (memory loss, neurological damage etc) have had absolutely no recourse or justice for the harm that was caused to them by a drug which should never have been licensed.

Mr Breckenridge has since retired and Ian Hudson has moved up the MHRA ladder, replacing Kent Woods . Mr Hudson is not only a former GSK/SB employee (11 years in total, 2 weeks GlaxoSmithKline and pre-merger-  11 or so years at SmithKlineBeecham). He also had a significant involvement in  the SB products Seroxat and Avandia.

Seroxat and Avandia have been two of the most controversial drugs of the past decade. Both of them have been found liable in courts for deaths. Both of them have had accusations of fraudulent research, both have been given Black box status, both have been investigated by law enforcement, departments of justice, regulators etc. Both of them have ultimately caused immeasurable suffering to tens- if not hundreds- of thousands of people. It is estimated that Avandia alone has caused in excess of 83,000 heart attacks since it came on the market in 1999. Seroxat has caused birth defects, suicides and worse.

Ian Hudson declared that he had a significant interest in both these killer drugs, Avandia and Seroxat, while he was employed with GSK. He now heads the UK MHRA which licenses drugs and regulates their safety and efficacy. Does this make you feel safe? Does this make you feel that your interests as a patient are being looked after? Does it give you faith in the system of drug regulation?

Seroxat came on the market in 1991, but was re-marketed in 1998. Ian Hudson was working for GSK at this time with an admitted significant interest in Paroxetine (Seroxat), he joined the MHRA in 2001 as director of licensing and his role in GSK was worldwide safety director. He was employed by GSK when these drugs were conceived, launched and unleashed upon an unsuspecting and trusting public.

I don’t claim to know what the role of World Wide Safety director at GSK would specifically entail, (nor do I know what it means exactly to have a significant involvement with a pharmaceutical compound) but it seems to me that considering Seroxat and Avandia have been two of the most defective and dangerous meds in recent times, either Mr Hudson failed spectacularly at his job or there is something else entirely going on…

I repeat, he is now the Chief Executive of the MHRA, the drugs agency which regulates the safety of medicines in the UK…

He was previously, and significantly, involved in two of the most notoriously dangerous, unsafe, and controversial drugs of the past decade – Seroxat and Avandia- whilst he worked for the manufacturers, GSK, for 11 years…

Think about that….

hufdd

Let’s talk (a little more!) about Dr Ian Hudson (of the MHRA/GSK Quango)


Whilst researching Hudson’s GSK career on the web I came across these two very interesting articles. Since this blog was set up 6 years ago in order to document the Seroxat Scandal- and all that it entails -it seems Ian Hudson might be a major player in unravelling the truth about Seroxat- therefore some coverage of him is entirely warranted.

   I would realy like to know what he knows about Seroxat… What was his role at GSK? Did it involve Seroxat? Does he know what GSK have hidden in their Seroxat files? As  the  previous head of “Global Safety” at GSK and now the guy responsible for safe-guarding the UK public from potentially harmful drugs such as Seroxat and Avandia how does Ian Hudson reconcile his conscience when a drug he once defended has been proven to kill?

  Does Ian Hudson still take the stance of his previous employers (GSK) in regards to Seroxat efficacy and safety? It was- after all- way back in 2001 when Ian Hudson defended Seroxat (Paxil) in a case where GSK were found guilty. Since that time- there have been numerous settlements involving Paxil withdrawal cases, suicides and birth defect class actions in the US. There have been petitions, documentaries, web-sites, patient groups and media coverage on the dangers of Seroxat/Paxil and much public outcry about the behavior of GSK (Ian Hudsons previous paymasters). Since 2001, GSK have paid Billions in fines, and been found guilty of numerous crimes of fraud and corruption – crimes and lies which have cost patients their lives. I wonder does Ian Hudson still stand by the credibility of GSK now- in light of their current reputation? Does he still believe their word is trustworthy?…

   What was his role in all of this way back when he was working for GSK defending Seroxat in court cases in the US? As CEO of the medicines regulator, is he on the side of patients or the pharmaceutical industry?

   Interesting stuff…

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

IS THIS THE RIGHT MAN TO HEAD SEROXAT INQUIRY?

10:30 – 11 July 2003

A City MP is demanding to know why the UK is being represented in a European review of the antidepressant drug Seroxat by a man who used to work for GlaxoSmithKline (GSK).

Parmjit Dhanda, MP for Gloucester, is asking the Government why they allowed Dr Ian Hudson to take part in the European Medicines Evaluation Agency (EMEA)’s review of Seroxat. As well as working as worldwide safety director for GSK – the manufacturers of Seroxat – 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.

But the Government’s Medicines and Healthcare Products Regulatory Agency (MHRA) says it is satisfied Dr Hudson’s previous links with GSK will not compromise the review.

They say he will not be allowed to participate in Seroxat discussions during the review.

Mr Dhanda said: “I am really determined to get to the bottom of this.

“We need to make people aware that there are representatives involved in this inquiry into the drug who have worked with GSK in the past.

“Secondly, we have got to change this completely and we need to get some fully independent people involved.”

Mr Dhanda yesterday tabled four questions in the House of Commons demanding answers from the Secretary of State for Health, John Reid.

Earlier this year, a UK review into Seroxat was disbanded after it emerged many of the members held interests in GSK.

Alongside another representative from the MHRA, Dr Peter Arlett, Dr Hudson is part of a team of 30 experts from across Europe who are evaluating the safety of Seroxat following concerns raised in the UK and in the United States.

Noel Wadhion, head of the post-licensing of human medicines at the EMEA, told The Citizen: “We are looking at safety concerns relating to a potential risk of emotional changes and withdrawal reactions in the use of Paroxetine – the medical name for Seroxat.”

The experts, who began their review in June, hope to announce their results by the end of this year.

According to the EMEA, there are four possible recommendations to come as a result of their review – no action, change advice about the drug given to doctors, suspend the drug or withdraw it altogether.

Their recommendation will then be passed to the European Commission who will then make a final decision to be implemented throughout Europe.

GSK maintains that Seroxat – now the company’s best selling drug – is an effective treatment that has helped tens of millions of patients worldwide to lead fuller and more productive lives.

The appointment of Dr Hudson has angered Seroxat users in Gloucestershire who still hope for a full independent inquiry into the drug they claim has destroyed their lives.

Faye Elliott, spokeswoman for the Gloucestershire Seroxat Support Group, said: “Knowing that the European decision will be final, it is very worrying for the thousands of us who are still suffering with either side-effects or withdrawal symptoms from this drug.

“We would like to see this drug banned, as we believe there is enough evidence to suggest that this drug can cause suicidal ideation and self-harming.”

But the EMEA remain confident of its ability to reach a fair conclusion.

Mr Wadhion said: “We ask all members of our committee if there is any potential conflict of interest that we should be aware of.

“They must declare their interests before a debate can take place and must leave the room if a conflict arises.”

A spokesman for the MHRA said: “The Government actively encourages interchange between the Civil Service and industry, but takes care to ensure that there are no conflicts of interests.

“In line with this principle, Dr Hudson has had no involvement in matters relating to Seroxat since joining the agency and will have no involvement in the referral.”

_________________________________________________________ 

(2)

http://davidhealy.org/burn-in-hell/

Burn in Hell

January 31, 2012 3 Comments

In my last post, Psychotic doubt, we saw the most successful maneuver that has ever been devised for hiding dead bodies and silencing us when we are injured. We saw a mechanism that acts like the authority of a psychoanalyst (when Freud was still in vogue), or an ecclesiastical authority (until recently), to silence dissent and cause someone who has been abused to doubt their sanity and blame themselves for something done to them. This mechanism that allows companies, regulators, and academics to hide dead bodies by an appeal to evidence that in actual fact shows an increased risk of death on treatment is not just psychosis-inducing; it also has a Burn in Hell component to it. This is how it happens. Here is Ronald Krall being deposed in 2007. He is the head of Global Safety at GlaxoSmithkline. Q:             Are you willing to tell the jury under oath that you are not aware of a single side effect that is caused by Paxil? A:              I am prepared to say to the jury that I am not sufficiently familiar with all of the data for all of the adverse events to tell you that there is an adverse event that is caused by Paxil.[1] Here is Ian Hudson being deposed in 2001, then head of Global Safety at GSK, later a member of the British regulatory apparatus, the MHRA:Q.             Okay. So, your view is: It’s simply impossible for SmithKline Beecham to decide whether Paxil did or did not contribute to the homicidal or suicidal behavior of any one given individual; is that your testimony?A.              We would certainly gather all the information, but on an individual case basis it would be impossible to decide whether paroxetine caused an event or not… It is impossible, on an individual case basis, from individual reports, to assign causality especially in a very complicated area such as this. That’s why, when we have issues, we review all the available data and make a determination, on the basis of all the available data, whether there is an issue or not.Q.             Okay. Do you believe that it is possible that Paxil has caused any person, worldwide, to commit an act of homicide or suicide?A:              I have seen no evidence to suggest that at all.[2]If there is even a small possibility the problem could have been caused by chance, then it has been caused by chance.Hudson and Krall are demonstrating the standard company approach to determining causality. In this case GSK had lots of reports of suicide, aggression, birth defects, or dependence. In many cases the doctor, or patient, or a company employee notes that the problem happened soon after the drug was started, cleared up when the drug was stopped, and reappeared when the drug was restarted. As a result in many cases a GSK employee has said the drug has caused the problem. Both men know this, but for Hudson and Krall there is still no evidence that their drug causes a problem — even when the dependence on Paxil (Seroxat) is universally recognized. Why not? For Hudson and Krall and regulators like Bob Temple or Ian Hudson (who is now a member of the British regulatory apparatus), if a clinical trial hasn’t confirmed a statistically significant link between treatment and an adverse event, then the adverse event hasn’t been shown to be caused by the treatment. If there is even a small possibility the problem could have been caused by chance, then it has been caused by chance. The refusal to do a study while events pour in that meet all the standard criteria for causality is the real Burn in Hell moment. While the company avoids doing a sufficiently large clinical trial to test out the link, there will never be any evidence that the drug causes a problem. The refusal to do a study while events pour into the company that meet all the standard criteria for causality is the real Burn in Hell moment. Thousands of reports can pour in, each making a compelling case that the drug has caused the problem, but a Hudson or Krall or Temple will feel comfortable saying under oath they have seen no scientific evidence that the drug causes a problem.

Unbelievable though it will seem, lawyers for pharmaceutical companies have recently advised that company coding staff, when faced with convincing evidence a drug has caused a problem (that is, when a problem appears after the drug is started and clears when it is stopped and reappears when it is restarted), should not code this as caused by the drug as they have been doing.

Catch-22

When patients report problems to the company and ask if there is any evidence the drug might be contributing, they are commonly referred back to the doctor who has prescribed the drug — who will be faced with the scientific literature, which will say there is no evidence that the drug has caused the problem. When patients ask for evidence on a drug, they are referred back to their doctor — who will be faced with the literature, which will say there is no evidence that the drug has caused the problem. Here is an unknown woman in 2001 contacting GSK. She terminated her first pregnancy, after radiology showed the baby had a serious heart defect (truncus arteriosus) and would likely not survive. The response from GSK is as follows:

‘We are attaching a copy of our current product information for Paxil… Please review the section on USE DURING PREGNANCY.Further questions about your treatment should be directed to the physician, pharmacist or healthcare provider who has the most complete information about your medical condition. Because patient care is individualized, we encourage patients to direct questions about their medical condition and treatment to their physician. We believe because you physician knows your medical history, he or she is best suited to answer your questions. Our Drug Information department is available to answer any questions your physician or pharmacist may have about our products.

She responds:

‘This response is in regards to an email I sent you preciously [sic].  I was asking to see if you have any, or were in the process of any clinical trials for women who are currently on Paxil and pregnant.  I wanted to find out any information on women who were on Paxil during pregnancy and if they were able to have healthy babies.  I am in no way insinuating your product did this to my child.  I love the product and don’t think that I could have gotten through my panic attacks without the wonderful help of this miracle drug.  I just want to get pregnant again soon.  I do not want to put my unborn child through anything that would hurt him/her.  Please, if you do not have information, where is this information held?  Does anyone do studies like this?  Please any information that you may give me would be great’.

The birth defects this woman’s child had suffered were coded as almost certainly linked to Paxil but neither she nor her doctor were told this. In internal company documents, the birth defects this woman’s child had suffered were coded as almost certainly linked to Paxil but neither she nor her doctor were told this.

This seems eerily reminiscent of appeals by Catholic cardinals to Canon Law (an idiosyncratic take on legal significance) when asked to account for their handling of abuse cases in the Church.

[1] Deposition of R Krall, Head of Global Safety GlaxoSmithKline, 2007.
[2] Deposition of Ian Hudson in Tobin vs SmithKline Beecham, December 15th 2000, 30–33.

– See more at: http://davidhealy.org/burn-in-hell/#sthash.nN1KuCvg.dpuf

______________________________________________________

http://www.thisismoney.co.uk/money/news/article-1509445/Beefing-up-the-Glaxo-probe.html

Beefing up the Glaxo probe

By ALEX BRUMMER and DAILY MAIL REPORTER and ALEX BRUMMERUPDATED: 23:00 GMT, 7 June 2004

http://www.whale.to/v/gsk3.html

“The MCA is of course headed by a former top executive at SmithKline, Dr Ian Hudson.”–Private Eye

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

The riddle of the drug regulators

Critics press for review of licensing system
The resignation last night of Richard Brook, the chief executive of the mental health charity Mind, from an expert working group on antidepressants has prompted calls for a review of the system of regulating and licensing medical drugs.

Mr Brook was appointed as a lay member of the group, set up by the Committee on the Safety of Medicines last year for a thorough look at all the allegations against the antidepressant Seroxat, after years of patients’ and consumer groups’ concern about the side-effects of modern antidepressants. Some people say they cannot stop taking them, because withdrawal makes them feel so bad, others say the drugs have made them violent or suicidal.

On Thursday the CSM issued a warning to doctors about the appropriate dosage of Seroxat, a warning for which Mr Brook had been pressing in the light of trial data more than 14 years old which the CSM failed to consider in three successive reviews of the drug.

Mr Brook’s appointment was a departure from the CSM’s normal practices of drawing on a pool of scientists and drug experts who, with few exceptions, have or in the past had links with the drug companies, from shareholdings to research grants to their universities. All members have to declare their interests and either withdraw from the room or not vote when conflicts arise. Even so, there have been allegations of “institutional bias”.

The suggestion is that the regulating authorities and the drug companies are too closely interrelated. Key figures not only on the CSM but also in the Medicines and Healthcare Products Regulatory Agency – the drug licensing body which it advises – have a history of consultancy, research or even employment by pharmaceutical companies. Ian Hudson, for instance, the worldwide safety director of GlaxoSmithKline (GSK) until 2001, is now director of licensing at the MHRA.

The MHRA and CSM say that they have to draw on the expertise of a relatively small pool of highly qualified individuals who inevitably have gained their experience in the industry, but critics say it would be possible to find academics who are completely independent.

One of the fiercest critics, Charles Medawar of the consumer group Social Audit, will allege in a book to be published on Tuesday, Medicines Out of Control?, that the system is dangerously secretive, riddled with conflicts of interest, and indelibly flawed by chaotic and incompetent procedures for evaluating drug benefits and risks.

“These revelations [of the Seroxat trials] provide compelling evidence of the need for transparency in drug regulation. Had the evidence from these dose-ranging studies been made publicly available the regulators’ errors would have been apparent years ago,” he said.

Mr Medawar believes that there may be problems with the dosage of many other drugs, not only antidepressants. Eli Lilly, he points out, conducted a study of its own SSRI (selective serotonin reuptake inhibitor) drug Prozac in both 20mg and 5mg formulations. About 53% of patients responded satisfactorily to the low dose and 64% to the higher dose. Yet the 20mg tablet was licensed for everybody. “That means 50% of people are being exposed to four times the dose they need.”

Mr Medawar is one of those who are troubled by the revolving door between the drug regulators and the pharmaceutical industry. The MHRA chairman, Sir Alastair Breckenridge, resigned his position on Glaxo’s scientific advisory committee to take up his previous position as chairman of the CSM, although he has usually left the room when Seroxat has been discussed.

“For many years Breckenridge had close ties with the manufacturers of Seroxat, yet he played a key role in the regulation of that drug,” Mr Medawar said. While he was still on GSK’s advisory board Professor Breckenridge took part in the Seroxat licensing discussions, although he did not vote.

The data at the heart of the matter showed Seroxat to be ineffective and unsafe at high doses. An estimated 17,000 patients were put on doses higher than the recommended 20mg last year, according to the Department of Health. Seroxat is made by GSK in 20mg and 30mg tablets. But higher doses are no more effective than the 20mg pill, and carry the risk of increased side-effects.

The data on the drug comes from one of the original trials carried out to establish the effect and safety of different doses before GSK applied for a licence to sell it in 1990. Patients in the trial, which was conducted in 1985-86, were started on 10, 20, 30 or 40mg doses. Many of those on the higher doses dropped out because of the side-effects.

The MHRA and CSM were given this information by the company and they licensed it for depression, with 20mg as the recommended dose.

The MHRA, it is understood, did not employ statisticians at the time of the 1990 licence approval and must therefore have relied on GSK (then SmithKline Beecham) for an explanation of the data.

David Healy, director of the North Wales department of psychological medicine of the University of Wales, who claims that there is a suicide risk for a minority of patients on SSRIs, said: “This would look like a case of the MHRA taking what the company said. It’s only when they get pushed beyond a certain point that they begin to systematically check things out.”

Alastair Benbow, GSK’s head of European clinical psychiatry, said yesterday that GSK did not agree with the MHRA’s interpretation of the early study. He said the dosage study had been carried out in a way that would not be done today and that other studies, which had started patients on 20mg and then gradually increased the dose, should have been taken into account. Gradually increasing the dose was safe and some patients would benefit from taking doses of more than 20mg a day.

___________________________________________________________

http://www.darkpharma.nl/uploads/7/3/2/8/7328594/davidhealy.org__shit_happens_again.pdf

This is an industry that has succeeded in building a culture in which even good descriptions of the effects of drugs are dismissed as anecdotes – except of course for patients reporting stunning benefits on treatment.

An industry where Ian Hudson, then of GSK, now head of Britain’s FDA (MHRA), can get hundreds of reports of a problem like violence on Paxil-Seroxat and still say he has seen no evidence that Paxil-Seroxat causes any problems (See Burn in Hell).

Let’s talk (a little) about Mr Ian Hudson….


Mr Ian Hudson was inaugurated as the CEO of the MHRA in the UK (the folks who are supposed to regulate the pharmaceutical industry) in September 2013. As you can see from Mr Hudson’s expense accounts, it’s a fairly lucrative position with some great perks

   The MHRA is supposed to safe-guard the public health- in particular from the dangers of defective and faulty pharmaceutical drugs and devices and also from the deception of pharmaceutical companies. Originally conceived partly because of the horrific Thalidomide crisis 50 years ago- it seems the MHRA has done little to protect consumers from many dangerous and defective drugs since then- drugs which include GlaxoSmithKline’s notorious Seroxat anti-depressant.

   Interestingly, the MHRA head- Ian Hudson- also worked for GlaxoSmithKline at one point during his revolving door career. Even more interesting is the fact that Hudson represented GSK in a high-profile Paxil (Seroxat) liability case in the US involving a Paxil-induced murder suicide (the Donald Schell Case). GSK were eventually found guilty and they had to payout millions to the grieving son-in law- Tim Tobin. According to a 2001 Guardian article, as a witness  (and high level employee) for his employers, GSK – Mr Hudson


“…argued that the occasional suicide or killing by
somebody on Paxil is not sufficient evidence that there is a problem with the
drug, considering the millions who take it.

Tobin is outraged. Virtually all
drugs can cause a bad reaction of some sort in a few people, he says. However
small the effect is, there is no excuse for not investigating what is
happening. “I don’t think they’ve taken a proper look at the whole thing,” he
says. “We’re talking about people’s lives. Whether we are statistically
significant or not, four people dead is too many as far as I’m concerned.”

I… like Mr Tobin… am outraged– and I have been outraged at GSK from the time I came off Seroxat over 10 years ago!
 I am outraged that I was lied to about the side effects of Seroxat. I am outraged that I had to suffer a severe decline in my quality of life because GSK lied about side effects, withdrawal and suicide issues for years despite 4 BBC panorama documentaries and numerous  complaints by patients, their families and doctors about the side effects of Seroxat.
   I am outraged that the regulator is not just inept, but utterly corrupt – not to mention contemptuous of patients, advocates and consumers. I am outraged that GSK were not prosecuted despite a 4 year investigation into their misconduct regarding Seroxat killing children (and adults alike). I am outraged that I was enslaved to a drug for almost 3 years or my life. I am outraged on behalf of all those lied to about SSRI’s and other pharmaceutical drugs.
   I am outraged that people like Mr Ian Hudson have the audacity (utter gall, and brass neck) to sit at the top of a regulatory body which failed to protect vulnerable people from the dangers of a defective medication and a predatory, immoral and sociopathic drug company. A drug company which he himself once worked for and defended in court!.. in a case where they were found guilty!..
   I am outraged that Ian Hudson (a former GSK executive) didn’t even bother to turn up to a parliamentary inquiry about Seroxat a few years ago and has consistently avoided facing the consequences of the Seroxat Scandal… I am outraged at this man’s apparent utter contempt for those he is supposed to represent!
   I am not the only one writing about these scandalous issues and the Seroxat Scandal continues to be a scandal of epic proportions.  Ian Hudson presides over the organization which decides upon which medicines are safe and which are not- he defended the safety of Seroxat in a court of law in the US whilst working for the most corrupt drugs company on the planet (GSK). Seroxat has since proven to be one of the most dangerous drugs since Thalidomide- causing numerous deaths- by suicide, withdrawal, side effects and birth defects.
   Ian Hudson is apparently also a paediatrician! Surely if he is a qualified doctor specializing in children’s illnesses- he would be aware of the infamous Seroxat Study 329? A study which covered up the fact that Seroxat (Paxil/Paroxetine) drove children to commit suicide and self harm?
   Or how about the many thousands of birth defects  in  children -and miscarriages of babies which Seroxat caused for many women users -over the past 20 years? Is Ian Hudson aware of all this? Was he aware of these issues whilst working for GSK and defending Seroxat? Was he aware of this prior to his current tenure as CEO of the MHRA? Does he give a fiddlers?
   This is profoundly disturbing and the Seroxat Scandal is not something which will go away anytime soon. And in my lifetime I will continue to bang the drum about this – until justice is served! And Glaxo are brought to book!
MHRA Annual Report
Bob Fiddaman of Seroxat Sufferers blog is also- understandably- outraged, and he has been for a long time- as is the writer of Seroxat Secrets -who also touched on the Ian Hudson/GSK issues on his own blog Seroxat Secrets:

MHRA and Ian Hudson – still questions to be answered

June 15, 2009 — admin

Things have moved on at the MHRA so they tell us… it wants to be more open, it wants to engage with us…

Well, I’d like it to be more open about one of its employees, Ian Hudson.

I’ve been wanting to get to the truth since January 2005 when the House of Commons Health Select Committee questioned some senior MHRA members about Seroxat (Paxil).

Here’s some background: Ian Hudson worked at SmithKline Beecham for 11 years (Glaxo 2 weeks) as Worldwide Director of Safety. He then joined the MHRA as its Head of Drug Licensing.

During his time at SmithKline Beecham and Glaxo he had “significant involvement” with a number of drugs, especially Paroxetine (Seroxat) and two others. We know this because of this document – Ian Hudson Interests – which he filled in before joined the European Medicines Agency.

I’ve mentioned it before, but Hudson is such an authority on Seroxat that Glaxo used him as one of their defence witnesses in the famous Tobin/Schell case (he gave evidence for Glaxo alongside David Wheadon).

See below for this entry from the Seroxat Timeline.

June 14 2001:
People can’t get hooked on Seroxat as they did on the older drugs such as Librium and Valium, claims GSK.
For over a decade, the company line has been swallowed, along with the pills. But a court case in Wyoming, USA, has changed all that. The jury decided Seroxat – Paxil in the USA – was to blame for Donald Schell killing his wife, daughter, baby granddaughter and then himself.

Enter Ian Hudson, witness for the defence and at the time of his deposition earlier in 2001, worldwide safety director for GSK. That’s Ian Hudson, now director of licensing at the Medicines Control Agency in the UK (later to become the MHRA).

What did he have to say to the evidence of Mr Schell’s closest remaining family and three psychiatrists who all believed the tablets of Paxil/Seroxat Mr Schell took for just two days precipitated him into an unnatural and totally uncharacteristic murderous and suicidal frenzy? His position is that an individual case cannot tell you one way or the other – only randomised controlled trials will do.

But Dr David Healy says that randomised control trials are the wrong tool to establish whether serious side effects are occurring. The way to investigate what is happening is to carry out a challenge-rechallenge trial, where people are given the drug, taken off it and then put back on.

But GSK has not carried out that sort of study to establish whether or not Seroxat can make people agitated, suicidal, murderous or hooked. Nor has it carried out a randomised controlled trial. Here is a black hole. There is no proof that the drug does these things, says GSK, and because of that there is no reason to carry out trials that might decide it one way or the other.

Does Mr Hudson still take that view now he is at the MHRA, which watches over the safety of the British public? “If he takes the position with the MHRA that he took at the trial, then none of us is safe with any drug in the UK at the moment,” says Dr Healy. How would Mr Hudson even be able to blame alcohol for making someone drunk?

So what does Mr Hudson think? As always, the MHRA declines to answer detailed questions.

The MHRA will (?) have been supplied with all the healthy volunteer data before it granted the licence for Seroxat. It doesn’t seem to have been worried then, which makes one wonder who, exactly, was steering them as to what it meant.

More on Hudson here and here.

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 Hudson as well… unfortunately Dr Hudson could not attend as he had a prior engagement.

At the time, the UK press reported Ian Hudson’s non-appearance at the House of Commons like this:“Members of the House of Commons select committee on health appeared angry that they were not able to question one of the employees of the United Kingdom’s drug regulatory authority at a session last week looking into the influence of the drug industry. Although several senior figures from the Medicines and Healthcare Products Regulatory Agency attended the session, the committee said that it would also have liked to have heard evidence from Ian Hudson. Dr Hudson is a member of the agency’s executive board and was worldwide director of safety at SmithKline Beecham from 1999 to 2001, having worked for the company since 1989. Dr Hudson joined the agency’s predecessor, the Medicines Control Agency, in January 2001 as director of the licensing division. MPs wanted to question Dr Hudson about the company’s drug paroxetine (marketed as Seroxat in Britain and as Paxil in the United States). They were particularly interested in evidence concerning the safety and efficacy of the drug in people under the age of 18. In June 2003 the agency advised doctors that patients aged under 18 should not be prescribed the drug.”

I know someone who attended the hearing that day as well, and he confirms that David Hinchcliffe, the Chairman of the meeting was angry & exasperated “There was a great feeling of cover up, or at least that’s what I felt sitting there nearby Charles Medawar. Charles Medawar’s overall demeanour was one of anger, alongside David Hinchcliffe who was also angry & exasperated…”

The transcript of the hearing is here, read around question 783 for a flavour of how the committee and Chairman felt.

In response to a Freedom of Information request, the MHRA has made public an email, download here –Witnesses for Thursday.pdf – apparently showing that Hudson’s non-appearance was agreed in a phone call between Lord Warner (government Health minister) and David Hinchcliffe (meeting Chairman) just a few days before the hearing. This email was from Neil Townley at the Dept. of Health to David Harrison – the Clerk of the committee (and copied to Professor Sir Alasdair Breckenridge.

However this exchange from the hearing is most interesting:

Q790 John Austin: I think it would have been useful if Dr Hudson had been here because, as far as I understand, he was at SmithKline Beecham and his department was responsible for the collection of adverse reaction information such as there was with Seroxat.
Professor Sir Alasdair Breckenridge: Yes, I know that, but I—
Q791 John Austin: So he would have been a very key witness.
Professor Sir Alasdair Breckenridge: But I have not discussed that with Dr Hudson.
Q792 John Austin: So you must admit that it is very unfortunate he is not with us today?
Professor Sir Alasdair Breckenridge: Well, I apologise for that, but I think there was some confusion about who was going to attend and I think the Clerk was told that this was where Dr Hudson was going to be.

Why did Breckenridge reply to Q792 as he did? The email that was copied to him on Monday 17 January clearly states Lord Warner and Hinchcliffe had just agreed that it would only be Breckenridge, Woods and Raine who were appearing. For Breckenridge to say “…I think there was some confusion about who was going to attend and I think the Clerk was told that this was where Dr Hudson was going to be…” beggars belief.

Well, I think there was no confusion at all. I think the Clerk was never told that Hudson would appear. I think Breckenridge was lying when he said that. I think it would have been too embarrassing to let Ian Hudson be questioned.

I think this stinks.

Why didn’t Breckenridge simply say that “Ian Hudson is not here today because you, Mr Chairman, agreed his non-appearance with Lord Warner on Monday of this week”… (the hearing was Thursday).

And why, if Hinchcliffe did agree the list of attendees, did he say nothing to explain the confusion to the hearing….

So, the question is just what did Lord Warner say to Hinchcliffe during their phone call on the morning of Monday 17 January 2005?

Come on MHRA – let’s you and me have an open and honest discussion about this then.

Bob Fiddaman E-mails Ian Hudson (Former GSK Exec and Current CEO of MHRA)


http://fiddaman.blogspot.ie/2013/11/email-to-ceo-of-mhra-ian-hudson.html

Saturday, November 09, 2013

Email to CEO of the MHRA, Ian Hudson

I’ve just flicked the following email to the new MHRA Chief, Ian Hudson.

Any reply will also be made public.

Dear Mr Hudson,

As I understand you are now Chief Executive of the MHRA. I’d congratulate you but we both know that I’d be lying with those congratulations given your past links to GlaxoSmithKline and Seroxat.

That aside, I have to remain professional.

My question to you is one of great concern and one that I shall be making public on my blog http://fiddaman.blogspot.com

Are you, or do the MHRA plan to reevaluate the current recommendations that pediatrics should not be prescribed SSRi’s?

I ask as it has come to light that MHRA consultant, Stephen J W Evans, has recently co-authored a study where he and the other authors call for a re-evaluation of the current prescription of SSRIs in young people – Back story here.

This email, along with your answer, if you are brave enough to answer that is, will be published on my blog.

Best wishes

Bob Fiddaman.

GSK and the MHRA: Conflict of Interest?


http://fiddaman.blogspot.ie/2013/09/former-glaxo-safety-officer-becomes.html?utm_source=Paxil+News&utm_medium=twitter

Thursday, September 26, 2013

Former Glaxo Safety Officer Becomes Head of MHRA

Ex Glaxo Employee Ian Hudson. Now in charge of  the safety and well-being of the British public.

Former Glaxo [then SmithKline Beecham] World Safety Officer Director Dr Ian Hudson has took over the role of Chief Executive at the MHRA.

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.

It is unknown why Former MHRA chief, Kent Woods, whom I’ve had much correspondence with over the years, retired.

Hudson, whilst working for GSK, was a witness for the defence [GSK] during the Tobin v SmithKline Beecham Pharmaceuticals. 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 was appointed GSK’s World Safety Officer in 1999. His department was responsible for adverse events that were sent in by health professionals and members of the public.

Whilst under oath Hudson told Andy Vickery, attorney for Tobin, about his role in reviewing the link between Paxil and aggression.

“We reviewed the topic of aggression last year. At that time we said that we would keep aggression under review.  In addition, there was considerable noise in the media earlier this year about Fluoxetine.  So having said that we would keep this topic under review, we rereviewed this topic this year and it was also prompted by considerable concern being expressed, considerable noise being expressed in the media.  There were a series of articles in the “Guardian”. [British Newspaper]

Hudson was then asked by Vickery what he intended to do with the report once it was finalised, adding; Do you intend to submit it to any governmental agency?

Hudson replied:

“If a Government agency requests information on aggression and Paroxetine, we would, but we do not intend to proactively send it to them at this stage.  This was an internal review. We do many internal reviews on many topics.”

This doesn’t really install confidence in informed consent. If Hudson was back then stating that his findings would not be reported to the drug regulator then one can only assume that he still holds the belief that pharmaceutical companies are entitled to hold on to information that could endanger the public.

Later in the deposition Andy Vickery put the following to Ian Hudson:

“Dr. Hudson, are you aware of the body of literature concerning the relationship between serotonin and suicide?”

Hudson replied with…

“In general.  I’ve seen some summary information on that.  I’ve not reviewed that information in detail.  I would, again, delegate that to people within my department and also other psychiatrists within the company who are more closely involved in Paroxetine then I am, people such as Dr. Wheadon.”

Pushing Hudson for an answer Vickery then asked…

“Let me just ask you this:  Do you know whether or not there is any association between levels of serotonin or the serotonin metabolite 5-HIAA and suicidal behavior?”

Hudson answered…

Yes, I believe there is a correlation. I have seen in the literature summary
information that implies that there is a correlation between low levels of serotonin or 5-HIAA in patients’ suicidal activity.

Vickery later asked Hudson:

“Do you believe that it is possible that Paxil has caused any person, worldwide, to commit an act of homicide or suicide?”

Hudson answered:

“I have seen no evidence to suggest that at all.”

Hudson’s deposition can be viewed in full here.

Now Ian Hudson is the head honcho at the MHRA. If you take the time to read the complete deposition of Hudson you will see how he [whether under instruction or not] clearly deflects the blame of suicide and aggression onto other ‘factors’ rather than implicating Paxil.

And now this guy is in charge of regulating medicines in the UK. Do you think his presence will alter the MHRA’s stance on the safety and efficacy of SSRi type medications?

Well, I have seen no evidence to suggest that at all.

Bob Fiddaman