You may remember that back in July I wrote about the Yugoslavia paroxetine (Seroxat UK, Paxil US) trial (here and here)
In 1988 GSK, then SmithKline Beecham (SKB) sponsored clinical trials in Yugoslavia. The purpose of the trials was to show how Paxil (known as Seroxat in the UK) could, when stopped, cause a relapse in depression. SKB never took into account that those relapsing (after stopping Paxil) could have been suffering withdrawal symptoms.
With the results they wanted, SKB then provided the FDA with apparent evidence that showed patients staying on Paxil continued to enjoy a normal, "depression free" life, but that those abandoning the drug would suffer relapse back into a depressive state.
Seeing as Glaxo are a British pharmaceutical company I decided to write to the British drug regulator (MHRA) to request, under the freedom of information act, information relating to Glaxo's trials in Yugoslavia.
My email to them read...
Dear Sir/Madam, Pursuant to the federal Freedom of Information Act, I request access to and copies of a a clinical trial in Yugoslavia that commenced in 1988. The trial was, as far as I am aware, sponsored by SmithKline Beecham (SKB) and was known as the "Yugoslavia trial" or "relapse trial." I am specifically requesting the protocol for this particular clinical trial and whether or not that protocol included information and/or guidance on Paxil withdrawal. I look forward to your reply within 20 business days, as the statute requires. Thank you for your assistance. Sincerely, -- Bob Fiddaman
The MHRA have now answered this request.
Are you holding your breath folks?
The current Chief Executive of the MHRA is Dr. Ian Hudson. Before joining the MHRA, Hudson was the World Safety Officer for GlaxoSmithKline (then SKB)
Later this year GlaxoSmithKline will be defending allegations in the UK regarding Seroxat withdrawal. One of Glaxo's experts to be called will be Dr. Rashmi Shah. Shah was employed by the MHRA between 1987 and 2004. Positions held were Senior Medical Officer, Senior Clinical Assessor and Senior Medical Assessor.
In summary, In 1988 GSK, then SmithKline Beecham (SKB) sponsored clinical trials in Yugoslavia. The purpose of the trials was to show how Paxil (known as Seroxat in the UK) could, when stopped, cause a relapse in depression. SKB never took into account that those relapsing (after stopping Paxil) could have been suffering withdrawal symptoms.
With the results they wanted, SKB then provided the FDA with apparent evidence that showed patients staying on Paxil continued to enjoy a normal, "depression free" life, but that those abandoning the drug would suffer relapse back into a depressive state.
One thing that was irksome to SKB was that they had to convince the FDA that the relapses shown in the study were not simply patients suffering withdrawal.
SKB decided to massage the problem through back channel communications with Thomas Laughren, MD, a high official in the FDA.SKB felt if they could convince Dr. Laughren of the good "relapse" statistics in the Yugoslavia trial, they could avert the hard questioning of the FDA committee members on the withdrawal issue.Having "FDA" on your side before the FDA committee, it was felt, was good politics and a way to subtly shift responsibility for the issue away from SKB. To implement their tactic, SKB emphasized to Dr. Laughren that the Yugoslavia trial protocol was designed to detect relapse.At the same time, SKB told Laughren, they would do their best to detect and report on Paxil's withdrawal issues during Phase II. Given that "withdrawal" at that moment was not a front burner issue, that explanation satisfied the FDA official.
On October 5, 1992, the FDA's Psychopharmacologic Drugs Advisory Committee voted unanimously that Paxil be recommended for approval for the treatment of depression.
FDA Neuropharmacological Drug Products Division Director Paul Leber, MD, opened the meeting by stating: "The division's clinical review team and its statistical consultants have concluded that the evidence submitted in SmithKline Beecham's NDA for paroxetine convincingly documents that paroxetine...is both a safe and effective antidepressant."
SKB had shown that the 172-patient, 52-week Yugoslavian study of paroxetine for prevention of depression relapse showed "a highly significant difference" between drug and placebo, they showed that in that trial, 15% of Paxil-treated patients relapsed in a year, with an average time to relapse of 30 months, while 39% of placebo patients relapsed in an average of 17 weeks after the study began.
SKB had finally got their foot on the bottom rung of the antidepressant ladder, it had taken longer than usual because around the time another antidepressant, Prozac, was making news.
Here's the legal brief again...
There had been press reports that Prozac, originally appearing on the market in 1988, had caused many suicides.FDA was thus compelled to review Prozac and--obviously--considered it in their own interest to tread softly before approving additional SSRI's for the market.Condemning Prozac and acknowledging the suicide issue, however, would suggest in many quarters that FDA was to blame for allowing a dangerous drug on the market in the first place. Few bureaucracies admit they are wrong, and all have a tendency to herald the status quo.Thus while assuring Congress and the media that they would thoroughly investigate the recent Prozac allegations, the FDA was actually in cahoots with the SSRI manufacturers on the suicide issue. On October 3, 1990, an FDA official, the Director of Neuropharmacological Drug Products, telephoned SKB headquarters. He asked to speak to SKB's Regulatory Affairs director, a Ph.D. The call was made at a location that could not be traced back to the FDA official's office. This person making the call was the senior FDA official responsible for Paxil's application. The official made clear to SKB his purpose. It was not to "lay down the law" and ensure SSRI testing was refined. It was to tell SKB how to get around the suicide problem for Paxil's upcoming application--and further not to worry.
By the way, the "legal brief" I am referring to is the entire formal complaint brought against SmithKline Beecham that was filed in California on August 19, 2000. (Nguyen & Farber, plaintiffs vs. SmithKline Beecham Corporation) - The full brief is publicly available and makes very interesting reading. You can download it here.
When the FDA committee convened on October 5, 1992 there were 6 panel judges who would decide whether or not Paxil would be 'good to go'.
Dr. Laughren told the panel, "There was no systematic effort really to look at the withdrawal syndrome, but in looking at the patients coming off of...(Paxil)...in the clinical trials, there was no strong suggestion of a withdrawal syndrome."
Do you, like me, find this statement utterly bizarre?
If there was no efforts made to look at withdrawal then how did he, or SKB for that matter, arrive at, "...there was no strong suggestion of a withdrawal syndrome?"
When SKB addressed the panel they pulled out all the stops.
Here's the legal brief...
SKB boldly went to the next level.SKB asserted to the committee that SKB had studied "whether or not there is a discontinuation syndrome in patients who are abruptly discontinued from Paxil."The SKB representative continued:"To end with a brief discussion of whether or not there is a clear withdrawal syndrome, we have pulled upon the ...(Yugoslavia trial)..."Then, SKB made an outrageous and categorical falsehood. The SKB representative told the committee SKB in the Yugoslavia trial attempted to "systematically assess a discontinuation syndrome."This statement was in direct contradiction of Dr. Laughren's earlier statement in the day that "There was no systematic effort really to look at the withdrawal syndrome."Having refuted the FDA representation that there were no "systematic" tests on Paxil withdrawal, SKB then further claimed the tests were successful in that regard.The SKB representative told the committee they examined the data on the Phase II placebo group and that "few numbers of patients experienced any adverse event after being randomized off...(Paxil)...into the placebo group and the percentages are certainly very small."What SKB failed to add was that no "adverse events" were reported on the placebo group because the eighteen (18) placebo victims' symptoms were reported by SKB to have been "relapse" symptoms.
Dr. Laughren, on hearing SKB contradict his earlier statement,
The legal brief...
Dr. Laughren interrupted the SKB speaker.From his perspective sitting in the audience, Dr. Laughren understood there were "crossed signals" before the committee between the FDA staff and SKB, and that the discrepancy required immediate correction.Dr. Laughren additionally understood there was now a gap in the testimony.Dr. Laughren understood the placebo group's statistics meant nothing without comparison to the Paxil group. He then yelled up to the podium to the SKB representative, and the following exchange occurred: Laughren:"Unfortunately you did not contrast...(the placebo group)...with the rates...(of adverse experiences)...in the patients who continued on...(Paxil)..." SKB:"Right. I know the point you are going to raise, that it really does not look that different..." Laughren:"That was my impression." SKB:"...from what you saw in the...(Paxil)...group, and that is a well founded point. So we very much agree with your earlier conclusion that there is no clear withdrawal syndrome but this was our attempt to try and investigate it in somewhat of a controlled fashion." In effect, SKB had just pulled off a coup. SKB had successfully and deceitfully maneuvered Dr. Laughren into making the case before the committee that withdrawal tests were conducted, and they proved Paxil "clean" on the withdrawal issue. SKB got Dr. Laughren to do their heavy lifting before the committee on a subject the FDA official had no personal knowledge of. SKB simply stepped aside and put icing on the cake with a polite "we very much agree with...(Dr. Laughren's)...earlier conclusion that there is no clear...(Paxil)...withdrawal syndrome." SKB's tactic to skirt the withdrawal issue at the committee hearing was thus successful.After representation to them that Paxil had been systematically tested for withdrawal and that the tests were successful, the committee voted to approve Paxil.
The legal brief, as I mentioned earlier, was filed some years after the above FDA meeting. In Nguyen & Farber, plaintiffs vs. SmithKline Beecham Corporation, plaintiffs filed suit against GSK because they had suffered serious adverse withdrawal reactions when trying to stop Paxil. The case was resolved and over 3,000 plaintiffs received undisclosed compensation. They also had to sign confidentiality agreements that, in essence, laid no blame on Paxil or SKB.
2015 UK Seroxat litigation.
Almost 9 years ago a group action was filed against GlaxoSmithKline by UK patients who alleged pretty much the same as the 3,000 or so in the Nguyen & Farber, plaintiffs vs. SmithKline Beecham Corporation case.
No effort has been made by GlaxoSmithKline to resolve the UK litigation. At the time of filing a GSK spokesperson said, "We believe there is no merit in this litigation. Seroxat has benefited millions of people worldwide who have suffered from depression.''
Meantime, the UK group action continues in its fight to seek damages for those British patients who, just like American patients, suffered severe withdrawal at the hands of Seroxat.
If the difference between judicial law in America and the UK show one thing in this case, it's timescales. Nguyen & Farber, plaintiffs vs. SmithKline Beecham Corporation was filed in 2000 and resolved in 2002. The UK litigation was filed in 2008 and GlaxoSmithKline, it appears, remain unconvinced that they have a case to answer.
More on the UK Seroxat litigation at a later date.
Very little is known publicly about the Yugoslavia paroxetine (Seroxat UK, Paxil US) trial. What is public, makes very interesting reading. Interesting because it covers the subject of withdrawal, something which GSK have denied for years is a problem with their antidepressant.
I'm going to try and break this down so it's easily digestible. The information was taken from a Paxil lawsuit that was filed in California on August 19, 2000. (Nguyen & Farber, plaintiffs vs. SmithKline Beecham Corporation) GSK resolved the suit in January 2002. The results of the resolution, including any settlement by GlaxoSmithKline, were never announced.
The legal brief for the lawsuit is a very interesting document, in as much that it mentions clinical trials carried out in Yugoslavia (as the country was known then)
During this time GlaxoSmithKline were known as SmithKline Beecham (SKB)
According the the legal brief, here's what happened...
In 1988, a clinical trial in Yugoslavia commenced. The trial was sponsored by SKB and could have (should have) been an ideal opportunity for SKB to address the withdrawal issue. The trial was known as the "Yugoslavia trial" or "relapse trial."
At this time, SKB were seeking approval of Paxil and the Yugoslavia trial was to show the FDA (the US drug regulator) how effective Paxil was in treating depression - they would also try to show the FDA how it was important to keep taking Paxil and not to stop... because if you did stop then you would go into relapse, in other words, SKB were trying to prove that stopping Paxil meant the patient's original illness would return.
Here's how they achieved this...
First off, participants in the clinical trial had to have suffered a major depressive disorder and experienced a history of recurring depression.
In "Phase I" of the trial ALL patients were given Paxil. "Phase II," of the trial saw those same patients split into two groups. One group (Group A) remained on Paxil while the second group (Group B) shifted to placebo, a sugar coated pill.
Those in Group B would have, in essence, been going through a cold turkey withdrawal of Paxil - something that GSK have clearly stated that no patient should do when coming off Paxil. For the purposes of this particular clinical trial, however, it appears that they wanted patients to suffer withdrawal symptoms so they could present the FDA with evidence that Group B were suffering a relapse of their original illness - ergo, the illness had returned once they had stopped taking Paxil. In actual fact (my opinion and the opinion of many others) SKB were suggesting that those experiencing withdrawal issues were actually experiencing a return of the original depressive symptoms. Win-Win for SKB.
It was SKB's intention to show the FDA that Paxil patients do not "relapse." So, it appears they masked the results. From a business point of view I can understand this. Understand but not agree with.
Shortly after Phase II of the trial commenced it is alleged that the placebo group (Group B) began experiencing massive Paxil withdrawal symptoms. This occurred in 1989 and 1990. In the Yugoslavia trial, when the placebo patients walked into the doctor's office suffering withdrawal symptoms, the SKB agents saw relapse criteria, not symptoms of withdrawal.
Here's the clever bit...
When clinical trials are set up they must have a protocol, an official procedure or system of rules. The protocol in the Yugoslavia trial was, it has to be said, genius.
Doctors were not looking for a withdrawal problem, they were, according to the protocol, looking for a relapse.
This from the legal brief...
When a patient goes to the doctor's office, scientifically validated medical procedures should be followed by the physician in order to attain an accurate diagnosis. In the case of ongoing clinical trials, however, as with the "Hamilton" suicidality indices, the physicians as well as the patients are on a pre-planned glide path in accordance with the trial protocol. Given this was a relapse study, medical ethics require the responsible clinician to abandon the trial for patient emergencies and safety, and to always follow sound medical procedures. Nevertheless, the high stakes nature of the clinical trials likely prevailed in the PI's mind. This does not necessarily suggest that the PI is intentionally cheating. What is does suggest are that test objectives taint the prism through which the PI observes patient symptoms. In the Yugoslavia trial, when the placebo patients walked into the doctor's office suffering withdrawal symptoms, the SKB agents saw relapse criteria, not symptoms of withdrawal. Alternatively, it is alleged on information and belief that many physicians in Phase II of the Yugoslavia study indeed detected and reported Paxil withdrawal symptoms for what they were. They did this in written patient summaries submitted to SKB headquarters. However, because of SKB's study design and desire to avoid the "withdrawal" issue at all costs, SKB chose to interpret the withdrawal data as "relapse" data and reported it as such to the FDA.
Here's how SKB spun the data.
At the six month mark in Phase II, SKB reported placebo patients suffered 450% more relapse incidents than did the Paxil patients.
Eighteen placebo patients suffered "relapse" while only four Paxil patients did. This published result was to show that patients staying on Paxil continued to enjoy a normal, "depression free" life, but that those abandoning the drug would suffer relapse back into a depressive state.
Coming soon, Part II where I'll be showing how SKB tried to keep a lid on the Yugoslavia trial to avoid detailed scrutiny by the FDA. They did this by manipulating (according to the legal brief) Dr. Thomas Laughren, an FDA official.
Cake stars Jennifer Aniston as Claire, a member of a support group for people who are affected by chronic pain. As she learns that one of her fellow group members attempted suicide, Claire becomes obsessed with the woman's story, gets to know the woman's husband, and faces her own inner demons.
I've not seen the movie yet and, to be honest, I had no intentions of seeing it, until, that is, I recently learned that the screenplay for the movie was written by Patrick Tobin.
So, who is Patrick Tobin?
Patrick Tobin
Feb. 13, 1998
Before killing himself, Donald Schell, 60, killed his wife, Rita Schell, 55. their daughter, Deborah Tobin, 31; and Alyssa Tobin, 9 months. Tobin's widower, Tim Tobin, and Donald Schell's sister, Neva Hardy, filed a wrongful-death lawsuit against GlaxoSmithKline (then known as SmithKline Beecham) because they believed that Don Schell acted out of character due to the antidepressant he had been prescribed, Paxil (known as Seroxat in the UK and Europe). Schell had taken just two Paxil pills prior to shooting family members and then himself.
On June 7, 2001, a jury in Cheyenne, Wyoming, found SmithKline Beecham liable for the deaths caused by a Schell. Furthermore, the jury concluded that Paxil could cause someone to commit suicide or homicide and that the drug was in fact a proximate cause of the deaths in this case.
The jury attributed 80 percent of the fault in the case to the drug maker and 20 percent to Donald Schell. Verdict here.
SmithKline, being SmithKline, appealed the decision which saw Tim Tobin et al awarded $6.4 million.
The Tobin family were represented by Andy Vickery and James Fitzgerald. SmithKline Beecham were represented by Thomas Gorman, Charles Preuss and Tamar Halparin.
During the trial SmithKline internal documents surfaced and showed how they was aware that a small number of people could become agitated or violent from Paxil. Despite this knowledge, Paxil packaging did not include a warning about suicide, violence or aggression.
Before the trial date attorneys representing SmithKline Beecham filed a motion which, if granted by the presiding judge, would have excluded expert testimony from Andy Vickery's two expert witnesses, British psychiatrist Dr. David Healy and Dr. John T. Maltsburger, an associate clinical professor of psychiatry at Harvard Medical School. Their motion was not granted.
Why did SmithKline try to file this motion? Well, they knew that, in the instance of Healy, that he had had access to SmithKline documents that showed results of a Paxil test involving more than 2,000 healthy volunteers taking either the drug or a placebo.
The test showed results of volunteers who had adverse reactions - ranging from insomnia or anxiety to attempted suicide - that Beecham doctors said were either "possibly," "probably" or "definitely" caused by Paxil. Plaintiff attorney, Andy Vickery, pointed out that volunteers in the Paxil test experienced anxiety, nightmares, hallucinations and other side effects definitely caused by the drug - within two days of taking it. As early as four days, one volunteer experienced akathisia, a form of agitation that increases the risk of violence and suicide. Two volunteers attempted suicide after 11 and 18 days, respectively.
SmithKline's attorneys argument was basically that two pills didn't cause this crime but evidence produced during the trial proved otherwise. Vickery showed results of SmithKline's own Paxil test that showed a whole range of adverse reactions that had, in the main, all occurred within a day or two of the healthy volunteers taking Paxil.
What is striking about the depositions in this trial is the lengths that SmithKline Beecham would go to keep this evidence away from the public, healthcare professionals and medicine regulators.
Ironically, at the time, Dr Ian Hudson, was head of World Safety at SmithKline Beecham. Today, Dr Ian Hudson is the Chief Executive of the British medicine regulator, the MHRA. Parts of his deposition can be seen in the video (The Secrets of Seroxat) below. The documentary was aired on British TV a year after the Tobin verdict.
I'm a bit of a geek when it comes to reading court documents, particularly depositions, none more so than the deposition, in this case, of Dr. Tadataka Yamada who, at the time of his deposition, was Chairman GSK Research and Development at SmithKline Beecham.
During his deposition Yamada was asked the following. I include this because I wish to highlight how SmithKline employees, including Ian Hudson, specialised in answering questions about the Paxil suicide link - One can only assume that their evasiveness was engineered by the attorneys representing SmithKline during this particular trial. I'm also including it because it's a fascinating exchange.
Q. Suicide is a risk of depression, correct?
A. That's correct.
Q. Now, if a patient is on an antidepressant such as Paxil and they become suicidal or more suicidal or actually kill themselves or attempt to do so, then the question that confronts us as we examine that situation is well what caused it or contribute to it. Was it the depression, was it the drug, was it a combination of both, were there other factors. Would you agree with me that that's the case?
A. Uh huh. Yes.
Q. But if the patient was not depressed and had no other physical condition that we know about that would cause them to become suicidal and yet they became suicidal on the drug, that's the kind of thing that would sort of make us, make our antenna go up, make red flags go off or bells go off? In other words, concern us; wouldn't it? If people from a healthy study which means that they didn't, did not have any underlying disease process that put them at risk for suicide became suicidal on taking Paxil or any other SSRI drug, would that be a cause for concern that the drug may be causing or contributing to this suicidality? A. We would look at all of the data obtained in our healthy volunteers and examine in the proper context. I can give you an example, examples of drugs that caused people to faint in Phase I studies that we took forward in the clinical studies, because viewed in the proper context the fainting episode was not relevant to the effect of the drug. We have had other circumstances when people would have altered rhythms of the heart during the course of a Phase I study. That would not necessarily prevent us nor would it the FDA prevent us from continuing on those clinical studies, because bad things happen to people all the time and the temporal relationship does not necessarily imply causation. Q. We can certainly agree on that. Can we also agree that if the bad thing happens to a person on a drug and that person is a healthy volunteer that at east we can take some underlying disease process out of the equation in trying to figure out what caused Mr. Jones to have this bad result?
A. No. I think the reason why I answered your question originally the way that I did was because nobody's healthy. See, healthy. I mean you're not healthy and I'm not healthy. We all tomorrow could have some event that we didn't know about, and that event might be temporally associated with drinking a cup of coffee or signing your name. You know, one can develop a lot of superstitions about what may or may not be associated between an illness and supposed causation that was association, associated in the events starting that illness. So, you know, some people may feel a cold coming on. They'll do certain things because they think it makes them, it will prevent the cold. It doesn't mean that whatever they're doing will either prevent the cold or one fact have any bearing on the evolution of that cold. This is the reason why the FDA and also pharmaceutical companies always take any event that occurs in healthy volunteers in the context of the overall phase of our program to make a decision about whether a Phase, further patients should be exposed to the medication.
In essence here, Yamada cannot give a straight answer regarding healthy volunteers who became suicidal whilst taking Paxil. Instead he deflects it all by claiming that nobody is healthy. It baffles me, then, why SmithKline would label such studies as 'healthy volunteer studies'. Surely, given Yamada's deposition, these studies should be called, 'The we don't know if they are healthy volunteer studies'?
I mean, what is the point of putting healthy volunteer studies into place when you can't even agree if the volunteers are healthy?
What is also striking about the deposition of Yamada is that he testified that a GlaxoSmithKline decision to put proper warning label on Paxil is "never a business decision."
Yet an internal 1997 GlaxoSmithKline document showed otherwise (Fig 1)
Fig 1
Cake.
I've yet to see the movie, Cake, but look forward to it, if only to see if Patrick Tobin's screenplay relates to the shocking incident of his extended family.
The video below highlights the Tobin case and also shows the difficulty people have had when taking or trying to stop Seroxat. It was the first Seroxat documentary screened in the UK in a series of Panorama specials. The BBC commissioned a further three documentaries after this. To date, there has not been any other drug that has been covered regarding its side effects more times than GlaxoSmithKline's Seroxat.
The video will show you yet more evasiveness from the current CEO of the MHRA, Dr Ian Hudson, who remember, at the time, was the World Safety Officer for SmithKline Beecham.
Pay special attention also to GSK's Alistair Benbow. His answers to Shelley Jofre's questions are, at best, staggering!
Bob Fiddaman.
Tobin v SmithKline Beecham Pharmaceuticals Depositions can be found here. Tobin v SmithKline Beecham Pharmaceuticals Transcripts can be found here.
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]
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 viewed here.
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]
A state appellate court panel has sided with pharmaceutical giant GlaxoSmithKline in a Paxil wrongful death claim that had been filed by a woman who maintained she was essentially forced to have an abortion because her unborn child developed severe, in-utero birth defects due to her use of the antidepressant medication during pregnancy.
In a non-precedential decision filed on Nov. 27, the three-judge Superior Court panel wrote that a Philadelphia Common Pleas Court judge was correct in July 2012 to issue summary judgment to the drugmaker in a case initiated by Joanne Thomas on behalf of her deceased child, Ryan Swindle. [Source - Pennsylvania Record]
Want to know why it's wrong?
I'm about to drop a bombshell for GSK and their attorneys, King & Spalding, something I'm sure they are already aware of as they searched frantically through a series of Paxil posts on this blog 5 days ago. [Fig 1]
Fig 1
All one had to do was join the dots...but nobody did... until now.
Who was it that said GSK's history of fraud and concealment was just part of an era?
Funnily enough, I was prepared to let this go but Glaxo, it appears, just don't want to play ball with a woman they have known for some time, 2001 to be precise.
Stay tuned for the exclusive.
Meantime here's some food for thought for King & Spalding.
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?"
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.
