UK Seroxat Litigation - Day 2 - Deathly Media Silence

The mainstream media still seem disinterested in the on-going UK Seroxat litigation in London. Perhaps, they are waiting for some internal documents to surface, you know, something meaty they've never seen before?

Perhaps they are waiting to see if anything pertaining to GSK's Yugoslavia trials are aired?

GSK's Yugoslavia Seroxat Trials

Back in 1988, SmithKline Beecham (SKB) initiated a trial [called the relapse trial]

At this time, SKB was seeking approval of Seroxat and the Yugoslavia trial was to show the FDA (the US drug regulator) how effective Seroxat was in treating depression – they would also try to show the FDA how it was important to keep taking Seroxat and not to stop… because if you did stop then you would go into relapse, in other words, SKB was trying to prove that stopping Seroxat meant the patient’s original illness would return.

The following two posts may be a helpful resource for media outlets, should they ever take an interest in the current Seroxat litigation. Here and here.

Should the media wish to see the data from these trials, they could always contact the MHRA. They may be surprised by the MHRA's answer.

At the very least, it should prompt some serious questions regarding the Yugoslavia Seroxat trials and the way GSK, then SKB, seemingly spun withdrawal into relapse.

Back story - MHRA Missing Key Seroxat/Paxil Withdrawal Information

Because of my involvement with the current trial, I am restricted in writing about it. I can, however, write about GSK's history. That said, tomorrow I will be writing about a case involving Seroxat and birth defects. My previous blogs surrounding this particular case saw an insight into how GSK's attorneys operate, moreover, how they quickly settled out-of-court with a Pennsylvanian woman who had contacted me. An in-depth research of her case showed that GSK had clearly not handed over all items of disclosure to her attorneys, once I went public with this, they offered the woman in question a settlement, despite GSK previously persuading judges to strike her case.

More on that tomorrow.

Bob Fiddaman

The Truth About SSRI Withdrawal/Dependence

The following legal brief has rarely been seen by members of the public. Read through it and you'll understand why.

It's a fascinating read and highlights just how GSK hid the withdrawal issues surrounding their popular antidepressant, Paxil.

Many readers will find the following PDF too much to bear. Many will be angered by it, and rightly so. I hope many of you will pass it on to family, friends and even healthcare professionals.

For me, at least, it's the most damning document to ever surface out of litigation. The litigation in question saw GlaxoSmithKline settle with over 3,000 plaintiffs who had struggled to taper off Paxil. Much of the evidence was sealed as part of the 'gagging order' - However, this legal brief gives us an insight into the incestuous relationship between GSK and the FDA. It also shows us how GSK carefully manipulated the system thus putting thousands of future patients through utter misery with debilitating side-effects of withdrawal.

The Yugoslavia trials, mentioned in the document below, are very interesting. Glaxo sponsored the two phases of these trials. In Phase I all patients were given Paxil, in Phase II some were switched to placebo. It was at this stage that the placebo patients began experiencing severe withdrawal issues. Glaxo chose to define this as "relapse" data. This would give them the ammunition to announce later that patients who stayed on Paxil continued to enjoy a normal, "depression free" life, but those abandoning the drug would suffer relapse back into a depressive state.

Back in 2015 I, under the Freedom of Information Act, requested from the MHRA the protocol for this particular clinical trial and whether or not that protocol included information and/or guidance on Paxil withdrawal. The MHRA wrote me and said they "didn't hold that information."

Here's the legal brief.

Bob Fiddaman

The NYT Addresses Antidepressant Withdrawal Issues

The Lame Defense

You'll hear many lines when discussing the problem of withdrawing from drugs labeled "antidepressants." They include the following:

"These drugs save lives."
"Without them, I wouldn't be here."
"Antidepressants benefit millions of people worldwide."
"They help people get through their daily routine."

While it's not for me to rebut all the above claims, the real issues are that none of the above lines have any relevance into discussing the challenges of "antidepressant" drug withdrawal. Comments such as the above are designed to get people to focus on the purported benefits of "antidepressants" and reduce discussion and/or dismiss discussion about the known risks. These lines are spouted by pharmaceutical companies, pharma-funded "health" and suicide organizations, drug regulators, doctors and consumers of "antidepressants." Some consumers, simply don't care about others who struggle with horrendous and life-threatening adverse drug reactions (ADRs). Perhaps these consumers of "antidepressants" are too frightened to look at the statistics for if they did, many would try to get off these drugs and would then find themselves gaining first-hand experience with SSRI ADRs.

Shifting the blame

If the above illogical responses don't work then the same people use the "shifting the blame" tactic. Some of these tactics include:

"Talk to your doctor."
"You're obviously not ready to come off them yet."
"It's not withdrawal, it's a return of your mental illness."
"Don't believe everything you read on the internet."
"Stop pill-shaming."
"You're a conspiracy theorist."
"Don't you think if these drugs were dangerous someone would have spoken up about them?"

I've heard all these retorts and imagine you've heard some, too. Once again, these retorts are thrown out willy-nilly in an illogical attempt to reduce honest discussion and purposeful action to solve the withdrawal problem caused by drugs labeled "antidepressants." It's an illogical argument and a selfish "I'm alright, Jack" response.

Many people who chant the above retorts state ADRs only happen to a "handful" of people. Even if this were true, how would the claims above help those suffering from severe "antidepressant" ADR's? Does society believe there is a certain magic number of victims that have to be reached before wanting to reduce avoidable suffering? How many people have to die from SSRI ADRs before it is deemed a public health issue worthy of positive action? Are some lives more important than other lives? Considering children and the elderly are two groups most at risk for ADRs, is this a sign our society cares less about children and the elderly?

Do we have to wait until we have inconclusive evidence that shows antidepressants cause severe ADRs in more than half of those who take them?

Time for Broader Discussions

Yesterday, the New York Times published an article entitled, "Many People Taking Antidepressants Discover They Cannot Quit." It's a decent article and the authors, Benedict Carey and Robert Gebeloff, seem to have done their homework with one exception. They stated, "withdrawal has never been a focus of drug-makers or government regulators." This is not accurate and I'll tell you why:

The Yugoslavia Trials 

The Yugoslavia Trials did, indeed, flag the issue of withdrawal surrounding paroxetine (Paxil, Seroxat).

In summary, in 1988 GSK, then SmithKline Beecham (SKB) sponsored clinical trials in Yugoslavia. The purpose of the trials was to show how paroxetine could, when stopped, cause a relapse in depression. SKB never took into account that those relapsing (after stopping paroxetine) 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 irked SKB was that they had to convince the FDA that relapses shown in the study were not simply patients suffering withdrawal.
(You can read my coverage of the Yugoslavia trials at the foot of this post.)

Buck-Passing

Further, back in 2011, the British equivalent of the FDA, the MHRA, launched an "innovative" SSRI Learning Module for prescribing doctors. In it, they stated...

"Symptoms after sudden SSRI discontinuation usually last about one to two weeks and then resolve spontaneously, but they can persist for longer in some patients. Close clinical observation is required to ensure that withdrawal symptoms are not getting worse. Severe cases may call for specialist advice and possible switch to an SSRI with longer half-life before gradual tapering."

I was interested in the "specialist advice" they were recommending to doctors who had patients suffering from worsening withdrawal symptoms. I, therefore, wrote to them and asked for a list of these "specialists." I asked them what training do these specialists have, where do they get this training and by whom?

Despite many weeks of emails back and forth and the usual game of semantics played by the MHRA, they could not provide me with one specialist. The links to the launch of the SSRI Learning Module are below.

Now that is has been more than 7 years since I asked MHRA for a list of specialists and they couldn't list a single one, I pose the question again: Can MHRA provide a list of specialists who are trained to help patients safely withdraw from drugs labeled as "antidepressants."?  I also pose the same question for patients suffering from benzo withdrawal.

The New York Times article is long overdue but I suspect it may well be wrapping up someone's fish & chips tomorrow because that's how this works. Pleas for help go unanswered because the strategy from the psych and pharma industry is to shift blame and change the conversation. They aim to avoid honest discussion of these serious medical issues despite that discussion and awareness would reduce suffering and save lives.

If the Yugolslavia trials don't show you how corrupt this system is, your definition of corrupt is far different than Webster's. 

Bob Fiddaman


Yugoslavia Trial

The Seroxat/Paxil Yugoslavia Trial Part I

The Seroxat/Paxil Yugoslavia Trial Part II

SSRI Learning Module

MHRA To 'Re-educate' UK Doctor's on SSRi's Part I 

MHRA To 'Re-educate' UK Doctor's on SSRi's Part II "Keeping A Stiff Upper Lip" 

MHRA To 'Re-educate' UK Doctor's on SSRi's Part III - MHRA's Ghosts In The Machine 

MHRA In Buck-Passing Specialist Cahoots 

MHRA - More on the Mysterious "Ghost Specialists" 

MHRA Wishing To Call The Shots

MHRA Missing Key Seroxat/Paxil Withdrawal Information

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.

You can draw your own conclusions.

Bob Fiddaman.

The Seroxat/Paxil Yugoslavia Trial Part II

Following on from Part I.

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.

Enter Dr. Thomas Laughren of the FDA.

This from the legal brief.

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.



Bob Fiddaman.

The Seroxat/Paxil Yugoslavia Trial Part I

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.

PART II

Bob Fiddaman.