Tuesday, March 28, 2017
Dolin Vs GSK – Day 8 – Get to the Point, Todd!
“…David Ross. The former FDA Medical Advisor was asked if he prescribed Paxil to his patients.
Amid the objections from King & Spalding’s Andrew Bayman, he answered,
“No. I don’t believe that it works and I don’t believe that it’s safe.”….
Well, well, it seems that as the days go by more and more shocking revelations come out from the Stewart Dolin ‘Paxil Induced Suicide’ Trial in the US…
GSK… you evil bastards…
See Bob Fiddaman’s new post for more:
Wednesday, March 22, 2017
Dolin Vs GSK – 8.9 Suicide Increase For Adult Paxil Users
Day 5 – Dolin Vs GSK Paxil Induced Adult Suicide – Chicago.
There was a startling revelation today in the Dolin Vs. GSK trial: Attorneys representing widow Wendy Dolin showed the ratio of Paxil-induced suicidality in adults is a staggering 8.9. It is not 6.7, as previously claimed and reported by Glaxo. The 6.7 figure is astoundingly high in itself, but the 8.9 ratio is flabbergasting!
Plaintiff witness, Dr. David Ross, said this figure is ‘astounding.’ What you should remember here is that GSK’s 1989 drug application for Paxil said the suicidality odds ratio was 2.6.
Over the years as GSK’s lies were uncovered and more bodies were buried because of Paxil, GSK later changed the Paxil-induced suicide rate to 6.7. But today the world knows the actual Paxil-induced suicidality figure for adults is 8.9. This number is almost a nine-fold increase in adult Paxil patients experiencing suicidal thoughts, suicidal thinking and completed suicide–thoughts that are created by akathisia and other adverse reactions to Paxil and not by any underlying pre-existing condition.
Today at the trial, expert witness, Dr. David Ross, who worked for the FDA for ten years, testified extensively. While working at the FDA, Dr. Ross was responsible for reviewing new drug applications (NDA’s), i.e., he oversaw the statistics.
His evidence started with 6 points about GSK’s responsibilities (or lack of…)
1. Paxil is associated with an increased risk of suicidal behavior in adults beyond the age of 24.
2. GSK was not upfront about Paxil’s suicidal behavior risk.
3. In 2010, GSK had the ultimate responsibility for the Paxil label. GSK was responsible for ensuring the Paxil label did not contain any false, misleading, or inaccurate information about safety.
4. Federal regulations required GSK to warn doctors that Paxil induces adult suicidal behavior, starting in 1992.
5. GSK could have warned doctors by changing the Paxil label. There is no evidence the FDA would have stopped GSK from issuing a Paxil-specific warning in the non-class labeling sections. In fact, the FDA specifically invited GSK to discuss such changes.
6. GSK did not warn doctors of the true Paxil-induced suicidal behavior risks for adults beyond the age of 24.
Dr. Ross further reiterated to the jury what David Healy previously stated: that the responsibility for accurate drug labeling lies with the product manufacturer and not with the FDA. Dr. Ross added, “…the FDA does not do drug trials, we only know what we are shown.” He added, “You have to rely on the drug company.” He also informed the jury that the FDA’s annual budget is $1.3 billion, most of which comes from drug companies.
Another striking statement Ross shared with the jury was, “The FDA is in charge of enforcing the law, and GSK is in charge of following the law.”
Today’s evidence clearly shows that GSK has not followed the letter of the law enforced by the FDA.
Attorney Brent Wisner from Baum Hedlund asked Dr. Ross if he thought GSK’s label regarding adult suicide was adequate. Dr. Ross answered, “No.” and further added, “It was false and misleading and remains so today.”
Ross also told the jury that if he saw a nearly 9-fold increase in suicide in a drug (any drug) that he “Would not prescribe the drug.” In fact, Ross would categorize a 9-fold increase of any drug as a “frequent adverse event on labeling.”
He also told the jury that the term “Emotional lability” that GSK used instead of suicidality, “conceals what is really going on.”
Remarkably, two GSK employees, along with a third author who received funding and/or similar perks from GSK, published a medical journal paper stating Paxil actually reduced suicide in adults. Ross told the jury that he believed this published paper which contains obvious statistical errors should be retracted. The published article, “Reduction of suicidal thoughts with paroxetine in comparison with reference antidepressants and placebo”, by Montgomery, Dunner, and Dunbar was then used by GSK reps to promote the safety of Paxil in adult patients to prescribing doctors, even though GSK knew it was the complete opposite!
Indeed, it was a very bad day for GSK. The standard “Objection!” was lamely shouted out by King & Spalding’s resident Jack-in-the-box, Andrew Bayman, more times than I care to recall. The majority of his objections were overruled by the Honorable Judge Hart.
I’ve long been a critic of both the British and American drug regulators (the MHRA and FDA). Despite ten years of successful blogging, I’m never too old to learn something new, even when the new information is quite tragic: Today I, and the jury learned that drug companies such as GSK hold medical regulators by the balls. Drug companies provide information (to include false data from faulty clinical trials) and medical regulators have to accept drug company information as the truth. GSK should expect ramifications from global regulators after today’s evidence. An almost 9-fold increase in suicidal behavior in adults taking Paxil is appalling, particularly when we know that, for years, GSK continues to claim there is no causal association between suicide and adults taking Paxil.
This lopsided relationship has terrible ramifications for mental health authorities and suicide nonprofits who unconcernedly take drug company hush money. For years both have claimed antidepressants are a safe and effective treatment for a variety of possible ailments (anxiety, OCD, adult depression, e.tc.) A nearly 9-fold increase in suicidality strongly suggests that both mental health and mental health nonprofits have been duped by the pharmaceutical industry, along with prescribing doctors, medical regulators, and an unsuspecting public.
Just think folks: GSK even tried to get a license for Paxil to be prescribed to children after they knew of the Paxil-induced suicide increases in adults!
Nice ethical company, huh?
I’ll leave the last words to today’s witness, David Ross. The former FDA Medical Advisor was asked if he prescribed Paxil to his patients. Amid the objections from King & Spalding’s Andrew Bayman, he answered, “No. I don’t believe that it works and I don’t believe that it’s safe.”
Trial continues tomorrow.
For now, it’s time for a Guinness, in honour of Stewart Dolin.
Dolin Vs GSK
Tuesday, March 21, 2017
Dolin Vs GSK – Day 4 – Slam Dunk
Imagine, if you will, a schoolyard bully who tries to impress his fellow bullies. Imagine, if you will, the kind of person who wants to be popular among his peers yet every time he tries to impress them he gets things wrong, so wrong.
Let me introduce you to King & Spalding’s, Andrew Bayman.
Bayman, who on day one of Dolin Vs GSK, claimed that Paxil does not induce suicide, today got to cross-examine Dolin’s first expert, Dr. David Healy.
This was something I was really looking forward to. On one hand, I wanted to see how good King & Spalding were, let’s face it, they’ve made a lot of money defending large corporate companies over the years. As Glaxo’s first choice of defence attorney’s one would assume that they would try and throw the kitchen sink at any expert witness who speaks out against their client, moreover, their client’s product, as is in this case, GlaxoSmithKline’s Paxil.
So, how does one defend the indefensible?
Step forward Andrew Bayman, a guy who struts his stuff by flicking out his arms suggesting that he is ready to spar with any opponent who dares cross the might of King & Spalding or, indeed, GlaxoSmithKline.
It’s fair to say that Bayman failed to deliver today, in fact, if I was GSK’s CEO I’d be deeply disappointed in the performance of King & Spalding’s finest.
So, how does one go about disputing evidence put forward by the world’s leading SSRI expert, David Healy? Does one dispute the science behind the evidence?
As you’d expect from GSK, their attorneys do everything but discuss the science.
I’ve seen excuses made by Glaxo over the years but one today almost had me biting the arm of the front pew where I was seated.
Bayman, in efforts to discredit Healy, asked him about his popular website, Rxisk.org, moreover about the donations to the said website.
Bayman, upon learning that Healy’s Rxisk website received a small donation from an American attorney, went down a road that was laughable, nae embarrassing. In the words of Del Boy, a popular British fictional wheeler and dealer, he made himself look like a right ‘plonker’ (Google it, Todd, you’ll see I’m right)
Bayman, flicking out his arms like a gunslinger from a John Wayne movie, made the assumption that Healy’s Rxisk was merely a platform to attract patients with stories of SSRI side effects so he and his attorney friend, who made the small donation, could, in future, litigate on behalf of any of the patients who leave comments on Healy’s website.
Healy, into his third day of questioning, smiled.
The answer he gave Bayman was simple.
Healy told Bayman, and the jury, that any attorney who donated money to Rxisk.org would possibly be in an awkward position. In fact, upon receiving this small donation Healy told the donator that Rxisk was all about seeking the truth about SSRI’s and any such truth outed would possibly lessen lawsuits filed against the makers of SSRI’s.
Bayman seemed to be at a loss for words with this reply.
Next, faux pas was Bayman showing the jury, via the various screens dotted around the court, a selection of text taken from a book Healy wrote back in 2013. Also various published papers by Healy.
Upon asking Healy if he had written the text highlighted, Healy responded by telling Bayman to scroll down the page to see the reference. There he would see that the highlighted text Bayman had chosen to show the jury was actually a quote by, um…wait for it…someone else.
All day, Bayman was cherry-picking selective text from various articles written by Healy. All day long Healy told him that if the sentence was read in full context then he (Bayman) would see what it actually meant.
You see, Bayman’s job was to try and make David Healy slip up. He wanted the jury to see that Healy contradicts himself. He failed on a grand scale.
“No further questions” came at around 3.40pm and, I must admit, I was surprised that Bayman was severely lacking in the questioning skills that I have become accustomed to reading John Grisham novels.
It was a good day for Dolin and her law team of David Rappaport and Brent Wisner, they made few objections, preferring instead to let Bayman dig himself a hole and look rather incompetent to the watching jury.
I felt embarrassed for Bayman, it was one of those moments one gets when watching David Brent in The Office (UK version) (Google it, Todd)
He tried to serve aces all day long – he just kept hitting the net.
It’s enlightening to know that this is GSK’s defence. Target whoever stands in their way and forget about the 10 years or so that they failed to tell the FDA about Paxil’s suicide risk. A point that Healy also picked up on when he told the jury that if GSK had told the FDA all those years ago about Paxil’s propensity to induce suicide, then many lives could have been saved.
Court resumes again tomorrow morning.
Dolin Vs GSK
Bob Fiddaman has been doing stellar reporting/blogging about the Stewart Dolin, “Paxil Induced Suicide” Trial in Chicago. He has just posted incredible footage of JP Garnier (the former GSK CEO – before Andrew Witty) discussing Paxil/Seroxat in a video deposition (May 2006). Garnier is his usual arrogant, creepy self, however, the deposition itself is incredible. It seems that GSK had a legal duty to warn about serious adverse affects, so why were they passing the buck to the FDA?
Paxil/Seroxat caused much harm, death and destruction to tens of thousands of people, however judging by Garnier’s attitude in this video deposition, he comes across like he couldn’t care less…
In fact, he looks bored..
I guess dead Paxil/Seroxat people are just boring issues to some pharma CEO’s..
What is the point in having a CEO, if they are never held accountable?
Brilliant reporting from Bob Fiddaman at the Stewart Dolin ‘Paxil Induced Suicide’ trial in the US.
More damning evidence that Paxil/Seroxat is a drug that simply should never have been on the market in the first place…
Friday, March 17, 2017
Dolin vs GSK – Healy ‘Rocks Da House’
This is complex, this is time consuming. Two days of evidence presented to the jury, judge and layperson (me included).
Cut through the endless amount of questions (they always lead to the truth where GSK are concerned) – and you will see, through Healy’s evidence, the reasons why this case is a “Slam Dunk” for Dolin et al and why GSK’s hot shot law team bounce up and down crying ‘objection’ at every given opportunity.
Objection! Because they don’t want the jury to know about their previous ghostwritten articles.
Objection! Because they don’t want the jury to know about GSK’s previous fine of $3billion (yes, that’s billion, fine for promoting Paxil off-label to kids.
Objection! Because they don’t want the jury to know about the Paxil withdrawal issue because, “it’s a case that is on-going against them in the UK) – Forget the case of Paxil withdrawal they’ve already settled with over 3,000 plaintiffs in the US, right?
Objection! Because they don’t want the jury to know they lied about the fact that Paxil was safe for kids.
They even objected to Wendy Dolin’s attorneys for wishing the jury had a great weekend, or words to that effect!
What I have witnessed here in Chicago is a law team representing an abhorrent company, the law team being made up of men and women (think about the birth defects Paxil has caused – I mean, their law team has a woman of child bearing years!)
Bayman (King & Spalding) also asked the Judge to reiterate to the jury that they should not “Google” about Paxil or the case in question. Yeah, right, Heaven forbid the jury stumble upon GSK’s abhorrent record and/or disregard for human life, right?
I honestly don’t know how a team with kids, siblings, wives, husbands or any other family members for that matter, can sit there and defend a drug (Paxil) that has caused so much heartache for families over the years. Are they devoid of any compassion, any empathy, any common sense?
My thoughts are, to some, irrelevant – Am I biased? Maybe? With a whole bunch of lawyers sitting on one side of a courtroom defending a drug that, probably, none of them have taken or, none of their loved ones have taken, I feel like I’m banging my head against a brick wall.
King & Spalding’s main two men, Andrew Baymen and Todd (snigger at a name that befits a child) Davis, seem devoid of any compassion and/or rationale – they don’t want to talk about ghostwritten articles, they don’t want to talk about the $3 billion dollar fine their defendant got for the illegal promotion of off-label practises of many drugs, including Paxil. They don’t want to talk about the withdrawal problems that Paxil can cause, and they don’t want to talk about how the company they are defending put children and adolescents at risk when they sent out their work force to promote the safety and efficacy of Paxil.
For these reasons, I am de-humanized from that table (in the courtroom) that represents this truly abhorrent company. A table of psychopaths or people who just want the right to pay their monthly bills? – Psychopaths is a pretty good description, given that they know, and have known of Paxil’s severe side effects for many, many years.
Healy’s expert opinion leaves me wondering if the jury want/need to hear anything more. He told the jury how…
- In 2006, the FDA knew about the increased suicidal risk on Paxil.
- GSK reported that there was no risk f Paxil induced suicide in 1999.
- GSK showed 6 suicide ttempts on placebo,when the actual figure was 1, in fact it was zero!
- GSK claimed that Paxil did NOT cause suicide and this convinced prescribing Dr’s to prescribe Paxil.
Let’s just take a look at some evidence aired today…these are from GSK’s own internal documents. The public, or those who had or have been prescribed Paxil never got to hear about this…
– 50 year-old female patient who became suicidal on Paxil (GSK’s own admission, probable cause!)
– 55 year-old male patient who showed “unrest and agitation” – patient was put on Paxil for 3 days when problems began, Paxil was stopped – patient felt better.
– 59 year-old male – experienced ‘restlessness’, visual disturbances – Patient recovered one day after Paxil was removed!
– 32 year-old male, on day one of Paxil treatment, developed severe akathisia – patient was confused throughout study.
Healy reminded the jury that GSK’s stance was that Paxil, a drug that was used to treat anxiety and Major Depressive Disorder (MDD) actually made, some people develop symptoms that it was, originally, meant to treat!
Many exhibits were aired that further showed how GSK hid the suicide link with Paxil. In fact, it was learned, GSK’s own re-analysis of Paxil (2006) showed an increase of 6.7 patients in Paxil adult patents. (the increase 6.7 times the greater likelihood one who takes Paxil will develop suicidality)
Oh, by the way, Stewart Dolin was 57.
Healy told the court that, based on his own clinical experience, Paxil was the most potent and problematic of all the SSRIs on the market. He also informed the jury that, as a clinician himself, he does not prescribe Paxil and added that the hospital where he works does not have Paxil on their list as a possible medication to treat a psychiatric illness.
To back up the evidence, the jury was shown an email to GSK’s marketing guru, Barry Brand. The email focused on Paxil’s suicide problem.
King & Spalding’s, Andrew Bayman, played his ‘Jack-in-the Box’ routine throughout the day. His sidekick, from King & Spalding, Todd Davis, remained in the wings being as quiet as a mouse – strange because it is “Todd” who has targeted the kids of Wendy Dolin leading up to this litigation. Is Todd married? Does Todd have a regular girlfriend/boyfriend? Does he have children of his own? Is his blinking affliction down to the overuse of a psychotropic medication? Who knows?
That’s poor show from me, I shouldn’t mock the afflicted…then again, these schmucks have defended the indefensible for years – they’ve shown no remorse when people have gone on to kill themselves whilst on Paxil – why would they when they are earning vast amounts of money (by the hour) defending GSK?
GSK are King & Spalding’s cash cow. They tried, through objection, to hide the truth about Paxil to the jury. They failed on a grand-scale.
Most damning, for today at least, was Healy’s claim that he is one of the only people to have read the ‘raw data’ regarding Paxil and suicide, raw data that leaves him firmly believing Paxil can induce suicidality in adults, something that GSK have, for years, denied.
Healy also spoke how GSK used the term ’emotional lability’ when reporting suspected suicidality in clinical trials, a term that would have made, even him, think there was no problem with Paxil. A term that would have made most prescribing doctors think that there was no suicide problem with Paxil!
GSK’s table of attorneys look slick. One aging bald-headed guy even approached the judge at the end of today’s proceedings to complain that Wendy Dolin’s law team had wished the jury a “nice weekend” as they were dismissed.
Objection, objection, objection.
They seem like a stuck record. A team of misfits whose only mission is to blame everything but Paxil opting, instead, to blame the patients for having an ‘underlying illness’.
The questioning of Healy by Dolin’s attorney’s finished today. He will be cross examined by King & Spalding on Monday.
I’ll be there. Stewart Dolin will be there in spirit.
More on the past two days events tomorrow night, in particular evidence that shows how a witness called for GSK in this trial showed how another unrelated drug caused two patients akathisia and they ‘jumped’ to their death.
Stewart Dolin (57) ‘jumped’ in front of a train because Paxil caused psychosis and akathisia, an adverse drug reaction that is so horrible, death can be seen as a welcome alternative.
Sunday, November 20, 2016
ChinaWhys Vs GSK – The Claims – Part 2
Following on from the first parter, Lawsuit Alleges GSK’s Witty Lied to the Media – Part I, today sees part 2 (The claims of ChinaWhys against GSK) – Part 3 (Coming later this week) will focus on the incarceration of Peter Humphrey and his wife, Yu Yinzeng and also the rehiring of accused whistleblower, Vivian Shi)
Here is what Peter Humphrey and his wife, Yu Yinzeng, of ChinaWhys, are alleging…
– Between 2010-2013 GSK spent nearly $225 million on planning and travel services. Approx 44% of the sampled invoices were inflated and approximately 12% were for events that did not occur.
– GSK set up a special “crisis management” team in order to bribe a Chinese regulators with money and gifts. A GSK executive attempted to bribe a Chinese investigator with an IPad and a lavish dinner. All bribes were approved by the head of Chinese operations, Mark Reilly.
– GSK planned to suppress evidence of its illegal bribery activities.
– As far back as 2008, GSK China deliberately falsified its books and records in order to conceal its illegal practices in China. These included, bribery and promotion of drugs for purposes that have not been approved by the Chinese authorities.
– GSK paid a patient RMB 50,000, who nearly died after being given Lamictal off-label. Despite having knowledge of Lamictal caussing near death in this patient, GSK still told its reps to promote the use of Lamictal for off-label purposes.
– GSK targeted ‘persuasive doctors’ in attempts to influence purchasing descions at their hospitals. GSK are to said to have forged a connection with these doctors by taking them to expensive lunches and dinners and also giving them gifts and cash.
– GSK paid between 500 and 1,000 doctors to go on an all-expenses paid holiday to locations such as Brazil, India, Israel, Greece, Japan and Hungary. GSK covered all costs, including cash to cover meals and sight-seeing excursions. These were disgusied by GSK as “Conference trips.”
– Head of Chinese operations, Mark Reilly, reeived a bribe in the form of ‘sexual relations’ in return for passing business on to China Comfort Travel, a travel agency who organised ‘conference sevices’ for GSK.
– GSK paid doctors based on their prescription numbers.
– GSK’s senior legal counsel, Jennifer Huang, asked private investigator, Peter Humphrey, to investigate the Public Security Bureau and to prepare an analysis of the Chinese political regime. Huang told Humphrey that she wanted to find out who’s who regarding the team who were investigating GSK.
– Humphrey became concerned that GSK were trying to obstruct the investigation and declined to investigate state secrets.
– Humphrey was also asked, by GSK, to look into the Ministry of Public Security, the Economic Crimes Investigation Department regarding the relationship between them and the Public Security Bureau. Humphrey, once again, declined.
– Head of Chinese operations, Mark Reilly, told Humphrey that the alleged whistleblower, Vivian Shi was “coming after him.” (Humphrey). Reilly then fled China the following day.
– GSK China told its employees to “destroy all non-compliant promtional maeterials and gifts.” They also implemented a new email system and deleted emails that were more than a year old. They claimed this was to “reduce unnecessarily legal costs.”
Back Stories from the Fiddaman Blog
Thursday, November 17, 2016
Lawsuit Alleges GSK’s Witty Lied to the Media – Part I
A 42 page complaint was filed on November 15, 2016, by Peter Humphrey and his wife, Yu Yingzeng, in relation to GSK’s nefarious activities in China which saw the pair incarcerated for around 2 years in Chinese slum-like conditions prison cells.
The complaint delves deep into the whole sordid affair and alleges bribery on a huge scale, more importantly, the complaint alleges that GSK hired the services of Humphrey and Yu in efforts to smokescreen the corruption in China, corruption, according to the complaint, that they had known about for many years. Furthermore, the 42 page document alleges that GSK’s CEO, Andrew Witty, lied to the media when he was asked about the corruption in China.
Humphrey and Yingzeng were the founders of ChinaWhys, a professional-services consultancy that specializes in discreet risk mitigation solutions, consulting and investigation services to corporate clients in matters of high sensitivity across Greater China and the Asia Pacific.
On April 15, 2013, Humphrey met with GSK’s Head of Chinese operations, Mark Reilly, April Zhao, GSK China legal counsel and Brian Cahill, also GSK legal counsel. It was at this meeting that Humphrey was told that GSK had been sent a series of emails from a whistleblower alleging widespread corruption – GSK told Humphrey that they believed they knew who the whistleblower was.
Vivian Shi had previously worked for GSK as a government affairs director, GSK had terminated her services with them in December 2012. According to the complaint GSK claimed that Shi had orchestrated a “smear campaign” against GSK involving a total of 23 emails that had been sent to Chinese officials throughout the country, a letter had also been sent to GSK’s ‘top management’ alleging widespread corruption in GSK’s pharmaceutical and vaccine business that had been approved by GSK China’s senior management.
These were allegations brought to Humphreys attention just months after GSK had been fined a record breaking $3 billion by the Department of Justice in America – the fine was handed down after a guilty plea by GSK who, after the settlement, entered into a five-year Corporate Integrity Agreement with the Office of Inspector General of the Department of Health and Human Services. The agreement requires enhanced accountability, increased transparency and wide- ranging monitoring activities conducted by both internal and independent external reviewers.
One month after meeting with GSK officials Humphrey was told that GSK’s global CEO, Andrew Witty, had been made aware that GSK had been using a travel agent to channel kickback to customers and doctors throughout China. Days after Witty had been made aware, the whistleblower also sent a video to him and other senior management that showed GSK China’s Mark Reilly engaged in sexual activity – Reilly later claimed that the woman in the video was his “regular girlfriend”.
GSK officials told Humphrey that they had launched their own internal inquiry regarding the whistleblower allegation and that they were false. They told Humphrey, “There is nothing there”. This, according to the complaint, was a lie.
Humphrey and his wife offered to investigate the whistleblower allegations but GSK declined the offer, opting instead for Humphrey to investigate Vivian Shi, the woman they believed was the whistleblower.
Two months after Humphrey and Yu started their background search of Vivian Shi, GSK received another letter from the whistleblower alleging that GSK China continues to engage in systematic bribery of doctors, this email focused on GSK China’s botox business whereby the whistleblower claimed that…
GSK had a ‘pay to prescribe’ scheme that funneled money through a central source at Beijing Medical College whereby ‘lecture fee payments’ were made to doctors who could “…incentivize and reward doctors for prescribing Botox.”
At no point did GSK show either Humphrey or Yu this letter.
On June 12, 2013, the Wall Street Journal (WSJ) ran an article highlighting GSK China’s massive bribery network. In July of that year 4 senior GSK China executives were arrested and, according to Humphrey’s filed complaint, GSK CEO, Andrew Witty told the worlds media that “…it appears that certain senior executives in the Chinese business have acted outside of our processes and our controls to both defraud the company and Chinese healthcare system.” Witty also claimed that GSK’s Head office in London lacked knowledge of the whistleblower allegations and “had no sense of this issue.”
According to the complaint, this made no sense as since the previous month GSK did, indeed, “have a sense” of the issue since it announced its 4 month internal investigation into allegations of bribery and corruption in China and found “No evidence of corruption or bribery.”
The complaint states…
Witty argued, nonsensically, that the previous whistleblower allegations were “quite different” from the more recent charges, saying, “they are two completely different sets of issues, we fully investigated the first and, of course, this has now surfaced in the last couple of weeks.”
This was a lie, since “what surfaced” in the PSB investigation and raids of GSK offices in July was precisely the illegal activity that the whistleblower had documented and threatened to reveal in January.
The complaint was filed in The United States District Court for the Eastern District of Pennsylvania.
Humphrey and Yu are represented by Boies, Schiller & Flexner LLP
**Coming in Part 2**
– A full and comprehensive list of the allegations made by Peter Humphrey and Yu.
– GSK ask Humphrey to ‘overtly’ obstruct the Chinese government investigation.
– Evidence, including emails, to be destroyed as not to implicate any wrong-doing by the company.
Glaxo – The Sex Tape Scandal
As usual, Mr. Fiddaman hits the nail on the head…
Wednesday, November 09, 2016
GSK China Bought Patient’s Silence for $9,000
A truly fascinating read regarding the corruption in China, all committed by the hand of British based pharmaceutical giant, GlaxoSmithKline.
The New York Times (NYT) recently ran a superb article regarding GSK’s nefarious activities in China, activities that saw them plead guilty, a result of which saw them being handed down a $500 million dollar fine.
The article by David Barboza, although brilliant, is tantalizing, in as much that The Times claims to have in its possession emails and documents, none of which they have provided, at least in their entirety.
The China scandal is a story of greed, corruption, cover-ups, bribery and pay-offs, all combined with a sex scandal video and a company burying it’s head in the sand over its China practices – preferring instead to go after the person who blew the whistle on the whole sordid affair.
It’s a subject I covered many times on this blog (Links at the foot of this post) and one that seems to be rehashed with additions on a regular basis.
The Times article throws out some very interesting facts about the case that were previously kept under wraps – one such fact being that they (The Times) have evidence that “Glaxo “almost killed one patient by illegally marketing its drug Lamictal,” said the email, which was obtained by The Times. “GSK China bought the patient’s silence for $9,000.””
Glaxo buying a patient’s silence? Surely not?
There was me thinking they only did that in litigation, Paxil withdrawal (Over 3,000 patients ‘paid off’) – Paxil Birth defects (Over 800 patients ‘paid off’)
So, who was the patient in receipt of Glaxo’s $9,000, moreover, what did this patient have that GSK didn’t want others to see?
According to the NYT…
The email was one of nearly two dozen that the whistle-blower sent over the course of 17 months to Chinese regulators, Glaxo executives and the company’s auditor, PricewaterhouseCoopers.
In 2012 Glaxo plead guilty to a whole host of violations throughout America, the guilty plea resulted in a record breaking fine of $3 billion. At the time, Glaxo Chief, Andrew Witty, pledged, “We’re determined this is never going to happen again.”
Witty, who had been made aware of the unfolding stench in China shortly after the 2012 guilty plea in the US, is stepping down from his CEO position in April next year – It’s quite a legacy he has left behind, one which he took over from former Chief, JP Garnier who, in essence, oversaw the corruption in America and left Witty to suck up the fallout.
What an abhorrent company this is. Corruption, bribery (of officials and patients) and the manufacturer of prescription meds that have either killed people or disfigured them in such a way that they need to continue having surgery for the rest of their lives. Let’s not forget those that have suffered as a result of becoming addicted to GSK’s medications either.
The Times article also digs deeper into the involvement of Mark Reilly, who, at the time, was Head of GSK’s China operations. They claim…
An email alleged that Mr. Reilly, a British national who had helped manage the company’s China operation for four years, was complicit in a bribery scheme tied to a travel agency called China Comfort Travel, or C.C.T. According to the email, Glaxo funneled money through the travel agency to pay off doctors. The travel agency also supplied Mr. Reilly with women, as a way to secure that business.
“In order to acquire more business, C.C.T. bribed Mark Reilly, the general manager of GSK (China) with sex,” the email said. “Mark Reilly accepted this bribery and made C.C.T. get the maximized benefits in return.”
That’s some perk to have! China Comfort Travel bring a whole new meaning to the word ‘comfort’.
Any jobs going whereby the employer offers a bonus of playing hide the salami?
I’m sure red-blooded males would have been first in-line for such a job working for a company complicit in fraudulent activities. Sadly, for those red-blooded males at least, Reilly was offered (and took) the perk – I wonder if he claimed for the 15 minutes of overtime too? (Assuming that Reilly could last that long in the sack)
When faced with over 17 months of emails from the whistleblower Glaxo decided to seek help, they did so by hiring a private investigator, Peter Humphrey and his wife, Yu Yingzeng.
Humphrey did some digging and, at the time, provided information to Glaxo that pointed to the possible whistleblower. Vivian Shi, was a 47-year-old executive handling government affairs in Glaxo’s Shanghai office, I say former because she was previously fired by GSK for their belief (Before Humphrey was hired) that she was behind the whistleblowing allegations. The ‘official’ line of her dismissal was that she had been falsifying travel expenses.
Humphrey, it appears, was merely suggesting that Shi may have been involved – he, at no time, ever provided GSK with any evidence that their former executive was the one who was whistleblowing. Shi, who remember had already left GSK, denied any part in the whole Chinagate scandal.
During his investigations Humphrey obtained information that was deemed to be by false means according to Chinese officials. Both he and his wife were later arrested, charged then sent to prison. Meantime, Reilly, who was the mastermind of the whole scam, was sent back home to the UK – No jail time. It’s unknown what Reilly is doing today, presumably he doesn’t work for GSK in any capacity, although I wouldn’t put it past them to re-hire him, just as they did with Vivian Shi, the very person they had fired because they thought she was the one blowing the whistle on its Chinese operations.
Remarkably, GSK re-hired Shi last year, although it is unclear in what capacity. (See Glaxo and Former Whistleblower Suspect Reunite)
GSK must be a truly great company to work for, not only do they offer, by proxy, free blowjobs to heads of operations but they re-hire you after previously sacking you for, ahem, “falsifying travel expenses.”
The Times article is a must read and once again highlights how GSK prefer to target people who bring the company’s misdemeanors to their attention rather than target the person carrying out the misdemeanors.
GSK Corporate motto claims, “We are dedicated to improving the quality of human life by enabling people to do more, feel better, live longer.” – I just never knew this included blowjobs via complicit bribery deals – the re-hiring after breaking rules – and buying patients silence.
Nice job (blow) Glaxo!
Wednesday, April 06, 2016
10 Years of Blogging – Q&A With Neil Carlin
Today marks the 10th anniversary of this blog. What started as a gripe against the British drug regulator (MHRA) has led me on a journey, one that I could never have dreamed of.
In 2010, four years into blogging I was at a bit of a stalemate, I was finding it increasingly frustrating trying to get the answers from both GlaxoSmithKline and the MHRA as to why I suffered at the hands of Seroxat. Neither of them, to this day, have ever been able to answer me.
Then it happened. The start, or rather the change in direction of this blog of mine.
I stumbled on a post from Canada. A young woman, known as Sara Carlin, had hit the news ~ her parents were seeking an inquest into her death, a suicide in 2007 – May 6 to be precise.
The date is significant as I will mention later.
I reached out to her father, Neil, and we were soon communicating. Sara, his daughter had been prescribed the very same drug that I was asking questions about ~ Seroxat (known as Paxil in Canada)
In 2006, a year or so prior to her death, Sara had been to see her doctor (Dr Stanton) who had diagnosed her with panic disorder and depression. This, he claims, was based on a 30-minute visit to his medical office. Sara, he claimed, had told him that she was having trouble sleeping, that she was having lots of nightmares, that she had no energy and was feeling very negative and depressed.
Sara was prescribed Paxil. She, at the time, was just 17 years-old.
Sara’s parents, Neil and Rhonda, were not told.
The possible increased risk of suicide with Paxil usage was not mentioned by Dr Stanton either.
What happened over the course of a year or so is well documented on this blog (just type Sara Carlin in the search box at the top left of this blog)
Neil and I became quite close during Sara’s inquest, an inquest that, I believe, was incredibly biased into protecting GlaxoSmithKline and its antidepressant. Remarkably, the press just couldn’t see the protective cloak thrown around Paxil during Sara’s inquest, this despite the coroners lawyer, Michael Blain, going in front of TV camera’s on day one of Sara’s inquest and announcing that the court “don’t think that the medication played a role in Sara Carlin’s death” (Video) ~ This before her inquest actually started!
Furthermore, at the end of her inquest the jury was told that they could not name or blame any party in this inquest, including the three doctors from Oakville, Ontario Canada and the drug company GlaxoSmithKline.
Despite these restraints the 5 person jury returned with a list of 16 recommendations, including…
- An arm’s-length body independent from Health Canada dedicated to drug safety funded by the federal government with no money from drug companies with mandated responsibilities to research drug safety, investigate adverse reactions and issue warnings to the public, health-care professionals and hospitals.
- A standard, plain language information leaflet for patients filling a prescription that includes what the medication is for, its risks, under what conditions the drug should not be taken, interactions, proper use, side-effects and what to do about them.
- Mandatory reporting by health professionals of serious drug-related adverse events to Health Canada.
- A provincial-wide suicide prevention strategy, such as Alberta has done.
- Guidelines and training for family physicians on prescribing selective serotonin reuptake inhibitors or SSRI antidepressants.
Fair to say then that despite the restrictions placed on them, the jury were in no doubt certain about the cause of Sara’s death.
Neil and I had an emotional conversation on the final day of the inquest and the following year we both finally met in Canada. I was introduced to his wife (Sara’s mom), Rhonda, and they both welcomed me into their family home. We laughed, we cried. I even spent time alone at Sara’s final resting place.
I’ve always had this connection with Sara, maybe it’s because Sara, played a significant part in how I, as a writer, changed my direction as a blogger/activist. ~ Sara showed me the bigger picture, if you will.
Neil and I have remained in touch all these years and although we don’t talk as much as we used to we still have a tremendous bond. I hope one day to travel to Canada again so I can spend more time with both he and Rhonda.
The significance of the date of Sara’s death May 6, 2007, may not mean a lot to readers.
On May 6, 2012, exactly five years after Sara’s passing, my eldest son phoned me to tell me that his wife had given birth to a baby girl.
They called my granddaughter Ruby-Rose, she, just like Sara Carlin, is, and always will be, a gem and a symbol of life.
Here’s Neil’s Q&A…
Full name: Neil Patrick Carlin
Location: Simcoe County, Ontario, Canada
Q: Neil, as you know Sara has played huge role in putting my blog on the map – My hits went into overdrive when I was reporting on her inquest and really changed the direction of my thinking with regard to writing about the whole pharmaceutical/regulatory aspect of things. It was a tough period in your life, Rhonda’s too. Can you tell me a little bit more about the outcome of Sara’s inquest and if recommendations made have been implemented?
A: Thanks Bob. We truly appreciate your hard work in letting people know what was happening at her inquest. Rhonda & I are forever grateful.
There were 16 recommendations from the jury all of which we thought were quite good – a couple of them were ours. (I think you covered them quite well in one of your past blog posts so I won’t list them here) but to the best of my knowledge none have been acted upon as of this time. In Ontario, as in most parts of Canada, there is no legal requirement for a party to even acknowledge a recommendation directed at them. They do not have to respond in any way to any government agency, which seems to make a sick joke of the whole process. This issue was covered quite extensively in a series of well written articles by Doug Quan of the National Post in 2014 – Dying to be Heard. Rhonda & I were interviewed for that series with a video included at the link for those interested. (1)
Q: Have you at any point corresponded with Paxil manufacturer, GlaxoSmithKline, with regard to Sara’s Paxil induced suicide or have they ever apologised for the role Paxil played in Sara’s induced suicide?
A: No to both questions. We never even received any condolence from any of the doctors involved in Sara’s care.
Q: Since I’ve known you, you have always had a grasp on the role of how metabolism works with regard to antidepressant use. Can you, for the benefit of the readers, explain this in layman’s terms?
A: Wow, that is a big order. You really do ask tough questions. It is a complicated process that I’m still learning about, but here’s my lay person’s explanation.
Metabolism is the process of removing toxins from the body including drugs (pharmaceutical or illicit). Psychiatric drugs including antidepressants are usually formulated as fat soluble agents so they can easily cross the Blood-Brain Barrier to exhibit their targeted effect. For complete elimination, primarily in urine & stool, they must be reduced to inactive metabolites that are more water soluble. This process occurs mainly in the liver and begins with phase I oxidative metabolism by one or more of the CYP enzyme systems or P450 enzymes as they commonly called. There have been dozens of these enzymes identified to date, although only six are thought to be responsible for most of human phase I metabolism. SSRI antidepressant drugs extensively use these enzymes, often in combination. Two areas of importance regarding drug metabolism are 1) Genetic variance in expression of these enzymes – i.e. polymorphisms. 2) Drug-drug interactions.
Paroxetine (Paxil , Seroxat, Aropax), as an example, primarily uses the P450-2D6 enzyme. Its, what’s called, a substrate of 2D6. Somewhere around %10 of the Caucasian population are, genetically speaking, considered to be 2D6 poor metabolizers – they can’t make or synthesise it in significant amounts and may experience adverse effects (because of higher than usual blood concentrations) at low or so-called normal doses.
The other big problem with paroxetine, as I see it, is that as well as being a substrate for 2D6 it is also a potent inhibitor of the enzyme. So as dosing increases, paroxetine will paradoxically shut down synthesis of its own primary metabolic pathway (2D6) resulting in what is called non-linear pharmacokinetics, which simply means that, for example, doubling the dose may more than double the circulating blood concentration. Paroxetine seems to be the only SSRI medication that exhibits this effect, at least to the degree that it does. Some will say that this is not terribly important because paroxetine has large therapeutic range. I don’t buy into that argument because if you increase anything to a large enough level something will eventually break. See this article – ‘Higher Antidepressant Doses Increase Suicide Risk for Young Patients’ (2). This might explain, in part, why paroxetine has been significantly associated with teenage suicide.
You can also get into significant drug interactions because of competitive inhibition – where paroxetine hogs the 2D6 enzyme pushing other drugs off. The pro drugs (where the major metabolite is the active agent) Codeine & the breast cancer drug Tamoxifen are two good examples of other drugs that need 2D6 and can be rendered ineffective by paroxetine.
That’s about as short an explanation I can give.
Q: Spending time with you and Rhonda was, for me, one of the highlights of the past ten years, truly great company. You and I both went to visit Conservative member of the Canadian House of Commons, Terrence Young. Can you tell me the role Terrance has played with regard to stringent warnings being place of prescription medication in Canada?
A: First off, I wish to say that Terence is a great man who has been and continues to be a good friend and staunch supporter of our family.
As you know, Terence testified at Sara’s inquest on the then current state of prescription drug approvals & adverse event reporting/ handling by Health Canada. He did not have anything good to say. He told the jury that Canada badly needed an independent Drug Safety agency to protect patients. The jury listened to him and recommended that the government of Canada develop an independent (from Health Canada) Drug Safety organization. At that time Terence was a sitting MP on the government side and his Minister of Health eventually helped usher through new legislation aimed at beefing up Health Canada’s post-market pharmacovigilance program. This was eventually passed into law and named Vanessa’s Law in memory of his late daughter who died of a prescription drug (Prepulsid) adverse event when she was a young teenager. I know there was a process developed toward implementation of these changes in the law and at this point I can’t tell you exactly where that whole thing presently sits or if it has yet to have had any significant impact on prescription drug safety in Canada.
Q: Both you and Rhonda appear in Kevin P. Miller’s new movie, ‘Letters From Generation RX’. What do you hope that this movie achieves?
A: First off I want to tell you what a wonderful human being Kevin is. The man is a genius with a tremendous empathetic capacity for human suffering. I don’t know how someone can have such unwavering dedication & tenacity for a cause with so many grim stories. Having said that, I think Rhonda & I just wanted to be a part of the message that we think Kevin is trying to deliver. That is, for people to be very cautious regarding psychiatric drugs, and that there are alternative treatments available. Also, that people, being fully informed, should to take their health care decisions into their own hands.
Q: Many people won’t know that you’re an avid guitar player. Can you tell me about the guitars you own and if you have written material for songs?
A: I’m down to a few of my favourites. I have a beautiful Marc Beneteau handmade acoustic guitar I bought nearly 20 years ago when my eldest daughter started taking lessons (and yes it is difficult to teach your own child how to play). Also a Gibson Marauder electric I bought 40 years ago when I was playing in a part-time bar band. A big 40 year old Ventura 12 string with great sound that I got on a trade. A very nice Godin Freeway bass guitar and a Cort classical guitar that is great for finger picking. I have several songs I’ve written over the years. One of my goals in retirement is to re-start my little digital recording studio (a computer with a good sound card and a couple of microphones) and to record them, just for fun of it.
Q: Would you recommend blogging to parents, or anyone for that matter, who had lost someone dear to them through antidepressant induced suicide?
A: I don’t blog so that is probably not something I might suggest. I would only say that they should find something, anything that helps get them through in a non-destructive way. Loss of a child under any circumstance is a horrific loss to suffer through. Suicide has its own challenges and it takes a lot of time to get back a just little bit of your life as you knew it.
Q: Difficult question, but what is your fondest memory of Sara?
A: Yes, that is a tough one as there are many, but I will say that watching her gracefully skate when playing ice hockey is one of my fondest. She started figure skating at age 5 and by 11 made hockey style skating look easy. She could skate backward faster than most could forward.
Q: Have you ever considered writing a book about your journey?
A: I have thought about it but I doubt I ever will. We now have our first grandchild and I want to stay focused on family. However, I would consider doing short pieces on specific topics. In any case, I’m not a naturally skilled writer as are some people I know.
Q: What do you say to people who believe that antidepressants are safe and effective?
A: There is really nothing much I can say if people have no ability to think critically about the harms and benefits of antidepressants or any pharmaceutical drug. If someone believes that medications are significantly improving the quality of their life then I’m glad for them. I will tell them that they are one of the lucky ones.
Q: What advice would you give to Coroners faced with suspected suicides of teenagers?
A: I highly doubt that the Office of the Chief Coroners of Ontario (OCCO) would listen to any advice from me. I’ve tried, believe me.
But I would tell them that they should be doing a proper investigation without just signing off on paperwork. I firmly believe, at the very least, confirming post-mortem toxicology should be done in every case of suicide – not just teens and not only in cases of suspected overdose. Violent suicide should be a red flag for psychiatric-drug-related death. An autopsy with collection of femoral vein blood is now routinely done in these cases. Toxicology should be done in every case of sudden death in a young person. The Swedes routinely do it so why can’t we?
The cardio-toxicity of citalopram & its derivative s-citalopram is a good example of a drug that can cause sudden death that is not a suicide. The information gathered through on-going toxicology and post-mortem examination may help the understanding of how prescribing practices affect public health/ safety. The OxyContin ® disaster comes to mind here.
Q: What advice would you give to parents whose children/teenagers are on antidepressant medication?
A: Watch carefully for untoward changes in behaviour and contact the prescriber if the drug is not helping or appears to be making their teenager worse. If the doctor won’t listen (as in Sara’s case) find another doctor who will (which we did not because of lack of knowledge). The reality is that by the age of 16 years doctors can prescribe anything to teens without parental knowledge or consent. There is not much a parent can do except to contact the doctor/s and threaten them with a complaint to their professional regulator.
Q: For you, what is the most frustrating part about the coronial system?
A: Well at least here in Ontario, coroners must legally be medical doctors. The chief coroner routinely uses family doctors as investigating coroners in their own communities, on a fee for service basis. I think this leaves a serious potential conflict of interest when it comes to these coroners investigating the death of their colleagues’ patients or the investigation of deaths in the hospitals where they may work on rotational ER duties. I often wonder who investigates the death of one of their own patients?
There was an attempt to overhaul the Ontario death investigation system in 2012 – a recommendation that came out of the Goudge Inquiry – but that was successfully beat down (3). There appears to be no political will to overhaul the Ontario death investigation system.
Q: Where do you see yourself in 10 years time?
A: Hopefully above ground and vertical. But seriously I want to be an active granddad still playing rock n roll and enjoying the things I do. But I know how precarious life is so I don’t think too many years ahead.
Q: Finally Neil, some personal questions…
1. What book are you currently reading?
A: The Emperor of all Maladies: A Biography of Cancer by Siddhartha Mukherjee.
His section on tobacco-related lung cancer is quite interesting. The tactics used by the by the pharmaceutical industry today seem to be identical to the ones used by the tobacco industry decades ago. Which are to deny a causative link by stating, as often as possible, that “association does not equal causation”, and then hire academic shills to publish scientific literature to support that position, while at the same time spending millions on advertising. They learned the lessons well.
2. What was the last CD you listened to (in full)?
A: A few months ago – Crosby, Stills & Nash – their self-titled debut album, released in 1969 during my first year in college. There is a track on that album called Long Time Gone that I have always especially liked and wanted to learn to play & sing. It was a Vietnam protest song but I think the lyric lends itself to what is now happening with the psychiatric drugging of children. You should probably have asked what was the last full CD I’ve listened to that is not more than 40 years old.
3. What is the best movie you have seen this year?
A: It is always difficult to pick a best of anything, but if I must I would pick The Revenant starring Leonardo DiCaprio. Without giving away any of the plot, I will only say that I think it is a story about a man who’s driving force for survival was retribution. Something I can relate to.
4. What country would you most like to visit?
A: Scotland, where I was born. My parents immigrated to Canada when I was 5 years old and I’m the only one in my family who has not been back for a visit. Besides my wife Rhonda is a fan of the TV series Outlander and wants to see the highlands. I would include Ireland in that trip, because that’s where my ancestors are from.
5. If you had the choice of being either a defence or prosecution lawyer, which would you choose and why?
A: A criminal defense lawyer. I believe that the good ones are true advocates that keep the justice system honest. Without them we would have many more wrongful convictions. The very best are highly skilled in the art of cross-examination, especially of lying police officers.
“…Study 329 seems to fit the classic picture. It has Big Pharma ghostwriting articles, hiding data, corrupting the scientific process and leaving a trail of death, disability and grieving relatives in its wake…”
“..In 2002 alone, over 2 million prescriptions were written for children and teens, and many more for adults…”
“…Yet this BMJ study deals an especially sharp blow, for it’s only rarely that researchers are able to crack open the tightly sealed file cabinets of drugmakers and look at raw trial data. ”
The MHRA (The UK Medicines Regulator) has been utterly toothless in regards to bringing GlaxoSmithKline to book over the appalling Seroxat scandal. Seroxat was first licensed in 1991, therefore effectively for 25 years the MHRA has allowed GSK to make a profit off a drug which has killed, harmed and maimed many people. This drug should have been pulled from the market in 2001 when the first BBC expose about the dangers of Seroxat suicide, violence and withdrawal first surfaced. However, considering the current MHRA CEO, Ian Hudson, is a former long time GSK employee, who testified in favor of Seroxat (Paxil in the US) before he left to join the regulatory industry, I won’t hold my breath for the MHRA to act in patients’ interests any time soon. They are clearly more interested in protecting Pharma before patients.
In October this year, the BMJ (British Medical Journal)- the most esteemed medical journal in the world- published a damning re-interpretation of a study on Seroxat (study 329). Although, this study showed how dangerous Seroxat is in the under-18’s age group, it also opened up a can of worms about the safety of Seroxat in all age groups. If Seroxat is lethal in under-18′s, and causes them to commit suicide, self harm, and causes other horrible side effects, and the MHRA agree with these findings, then why do the MHRA dispute that Seroxat can cause the same effects in adults? It’s like saying that cyanide is not for kids, but adults are ok. It’s just simply absurd to say that Seroxat is in any way safe for adults; particularly in 2015.
Bob Fiddaman, the author of the Seroxat Sufferers Blog, has been asking the MHRA a very interesting question regarding Seroxat’s ‘safety’ profile; a question which I have been trying to draw attention to also on this blog for quite some time-
With respect, you have not answered my question. I am already aware of the Expert Working Group and their findings.
My question, which I believe, you have not answered, is…
If a patient, at the age of 16, suffers suicidal thinking whilst on paroxetine – but continues to take paroxetine and continues to feel suicidal thoughts. What happens when they reach, 25, 26 or 27, do these suicidal thoughts magically disappear?
The question we are asking here, is extremely important, and it bring the entirety of Seroxat prescribing into question.
The MHRA admit that Seroxat should not be prescribed to under 18’s because it can increase suicidal thoughts in those age groups. But, what happens when an individual is prescribed Seroxat when they are under-18 but continue on it until they are over-18? Does the risk magically disappear?
This question is important because it’s ridiculous to assume that risks from a drug would change so dramatically just because of an over-18 threshold. We don’t automatically change into an adult body, or suddenly become completely different psychologically, biologically or behaviorally, when we turn 18. Growing up, maturing, and the changes which take place both physically and psychologically, happen over a gradual period.
The adolescent brain is different than the young adult brain, and the same could be said for a young adult and an adult’s brain. Nonetheless, peoples’ brains do not suddenly change from adolescent to a young adult on their 18th birthday. The age 18 threshold in regards to Seroxat side effects is ridiculous.
According to recent findings, the brain does not fully mature until at least 25 anyhow, and furthermore, it is also arguable that prescribing an SSRI drug over a long period of time could affect how the young adult brain develops. If SSRI’s cause birth defects so easily, I dread to think what kind of damage they do to our brains (at any age).
Millions of adolescents were prescribed Seroxat (Paxil/Aropax) when they were under 18, particularly in the late 90s/early 2000’s and many of them had serious reactions, but they weren’t warned of the dangers, so many they stayed on the drug until they were over-18, even though it was doing them damage. Many of these teenage Seroxat casualties could not come off it because of the severe withdrawal reactions Seroxat induces, some stayed on it well into adulthood. Some committed suicide because of Seroxat, some got off, and some are still enslaved to it.
The issue of Seroxat causing so much harm to under’18s raises a huge red flag for Seroxat in all ages groups, a red flag which many have been trying to draw attention to for over a decade now. However, the MHRA have no interest in Seroxat harming adults, or children, or Seroxat harming anyone in fact. After 25 years of constant bad press, and clear evidence that Seroxat is a dangerous drug, the MHRA continue to allow it on the market. Why?
Personally, I believe that the MHRA possibly suspect that Seroxat is lethal, but if they pulled it now (after all these years of ineptitude), or admitted that Seroxat harms adults in the same way, they would open themselves up for obvious negligence, and an admittance would open too many cans of worms, therefore they continue to deny, ignore or obfusticate because that’s the only way they know how to deal it. If they were to acknowledge the truth about Seroxat, that would open their whole regulatory system up to scrutiny. Seroxat was the ‘canary in the coalmine’. It serves as a warning that we are not safe, just like thalidomide did in the 1960’s. If we can’t trust the pharmaceutical companies, and we can’t trust the data on their drugs, and we can’t trust the regulators to keep us safe from harm, how do we trust in the efficacy of any pharmaceutical products? We can’t, and we shouldn’t.
The MHRA’s response to Bob Fiddaman on the question of Seroxat harming under-18’s (but still being prescribed to over-18’s despite the known risks) and the conundrum that is presented within the question itself, is the typically glib and sarcastic response that they have been giving for years now. They simply must not care that Seroxat has killed and maimed many people. If they did they would have done something about it by now..
But as we can see from their dismissive response to Bob Fiddaman, they will do anything to avoid opening the Seroxat can of worms..
Dear Mr Fiddaman,
Thank you for your email.
This is a theoretical question which we are unable to respond to as a patient’s health condition will vary for each individual. The clinical care of a patient is the responsibility of their doctor; healthcare professionals are recommended to closely monitor their individual patients on SSRIs for suicidal thoughts and discuss their symptoms with them to determine the best course of action with regards to possible treatment.
Medicines and Healthcare Products Regulatory Agency
It’s interesting how the MHRA are trying to deem that Bob’s question is merely theoretical. It may be theoretical in the way it is phrased, but it is also a real question based on real scenarios, and there are many under 18’s who were prescribed Seroxat and had serious adverse reactions, but because they were in the dark at the time of being prescribed Seroxat, they continued on the drug until adulthood.
The ‘theoretical’ scenario which the MHRA are trying to denigrate and dismiss actually happened to many people. It’s not astrophysics. These events happened to people, and people suffered for it. This is not ‘theoretical’- many people have been harmed from Seroxat. That’s a fact.
It seems to me that when people question GSK about Seroxat they are told to talk to their doctor, but when they ask their doctor their doctor says that its the regulators responsibility to keep us safe from harmful drugs and that they are not responsible for it. If we question the regulator about our concerns about Seroxat, the regulator also tells us that its the doctors responsibility, not theirs. So effectively patients are pushed upon a never ending ‘circle of pass the buck’ with nobody ever taking responsibility. This is just not good enough. Patients deserve better.
I will be interested to see what the MHRA have to say in response to Bob’s last question to them. Their obfuscation tactics, in regards to avoiding the Seroxat Scandal, are really wearing thin after 25 years..
Keep an eye on Bob’s blog for more on this-
Then, based on your answer, pediatrics and adolescents taking SSRi’s off-label are at risk of suicidal thinking but when they reach a certain age (26) they are not at risk, that risk, according to the MHRA SSRi prescribing guidelines, magically vanishes?Currently, SSRi’s are not recommended for anyone up to the age of 25 years, correct?How did the MHRA arrive at this? Was it based on a set of theoretical circumstances?Please explain, in detail, how the MHRA arrived at the decision that any person up to the age of 25 is at a higher risk that those over the age of 25, ie; what criteria did you use?SincerelyBob Fiddaman