Part 2 Of Bob Fiddaman’s Posts On Peter Humphrey’s Recently Filed Lawsuit Against GlaxoSmithKline…


http://fiddaman.blogspot.ie/2016/11/chinawhys-vs-gsk-claims-part-2.html

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.”



Bob Fiddaman.

Back Stories from the Fiddaman Blog

Glaxo – The Sex Tape Scandal

GSK’s Mark Reilly Accused of Running a “massive bribery network”

I’m Just a Blogger – Here’s GSK Served on Prawn Crackers

GSK Hiked Product Prices to Fund Bribery Scam

GSK’s Sales Reps Want Their Money Back

GSK’s Private Investigator [The Video]

Peter Humphrey’s 2012 Presentation – Pharma Bribery

GSK’s Chinese Whispers and David Cameron

“GSK were really cagey”, Claims Whitehall Official.

Glaxo Hire Ropes & Gray to Delve Into its Chinese Operations.

GSK CHINA – Bribery was Rife 13 Years Ago

Witty Plays Down China Scandal

Witty Witty Bang Wang. The Glaxo Gangbang…Allegedly

Book Your Holidays With GSK Travel

Andrew Witty… I know narrrrrrrrthing

The Penny Drops for GSK’s Private Investigator.

GSK China Bought Patient’s Silence for $9,000

Lawsuit Alleges GSK’s Witty Lied to the Media – Part I

Bob Fiddaman’s New Post : ” Lawsuit Alleges GSK’s Witty Lied to the Media – Part I “…


http://fiddaman.blogspot.ie/2016/11/lawsuit-alleges-gsks-witty-lied-to.html

Thursday, November 17, 2016

Lawsuit Alleges GSK’s Witty Lied to the Media – Part I

Lawsuit Alleges GSK’s Witty Lied to the Media – Part I  
~ Bob Fiddaman
 

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.



Bob Fiddaman


Back stories.

Glaxo – The Sex Tape Scandal

GSK’s Mark Reilly Accused of Running a “massive bribery network”

I’m Just a Blogger – Here’s GSK Served on Prawn Crackers

GSK Hiked Product Prices to Fund Bribery Scam

GSK’s Sales Reps Want Their Money Back

GSK’s Private Investigator [The Video]

Peter Humphrey’s 2012 Presentation – Pharma Bribery

GSK’s Chinese Whispers and David Cameron

“GSK were really cagey”, Claims Whitehall Official.

Glaxo Hire Ropes & Gray to Delve Into its Chinese Operations.

GSK CHINA – Bribery was Rife 13 Years Ago

Witty Plays Down China Scandal

Witty Witty Bang Wang. The Glaxo Gangbang…Allegedly

Book Your Holidays With GSK Travel

Andrew Witty… I know narrrrrrrrthing

The Penny Drops for GSK’s Private Investigator.

GSK China Bought Patient’s Silence for $9,000

Brilliant New Post From Bob Fiddaman: “GSK China Bought Patient’s Silence for $9,000″…


As usual, Mr. Fiddaman hits the nail on the head…


 

http://fiddaman.blogspot.ie/2016/11/gsk-china-bought-patients-silence-for.html

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!

Bob Fiddaman

Back Stories

Glaxo – The Sex Tape Scandal

GSK’s Mark Reilly Accused of Running a “massive bribery network”

I’m Just a Blogger – Here’s GSK Served on Prawn Crackers

GSK Hiked Product Prices to Fund Bribery Scam

GSK’s Sales Reps Want Their Money Back

GSK’s Private Investigator [The Video]

Peter Humphrey’s 2012 Presentation – Pharma Bribery

GSK’s Chinese Whispers and David Cameron

“GSK were really cagey”, Claims Whitehall Official.

Glaxo Hire Ropes & Gray to Delve Into its Chinese Operations.

GSK CHINA – Bribery was Rife 13 Years Ago

Witty Plays Down China Scandal

Witty Witty Bang Wang. The Glaxo Gangbang…Allegedly

Book Your Holidays With GSK Travel

Andrew Witty… I know narrrrrrrrthing

The Penny Drops for GSK’s Private Investigator.

Neil Carlin Explains How Paxil/Seroxat Metabolizes And Why It’s Often Lethal…


http://fiddaman.blogspot.ie/2016/04/10-years-of-blogging-q-with-neil-carlin.html

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
Age: 64
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.

(1) Dying to be heard: Families, safety advocates often frustrated at lack of action on inquest findings

(2) Higher Antidepressant Doses Increase Suicide Risk for Young Patients

(3) Ontario coroners to retain control of death investigations

Bob Fiddaman.

The MHRA (UK Medicines Regulator) Has No Interest In Seroxat Suicides…


Warningcanofwormsahead

“…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…”

Dr David Healy November 2015

“..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 Atlantic 2015

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-

Dear Sir/Madam,

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.

Kind Regards,

Customer Services
Communications division
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-

http://fiddaman.blogspot.ie/

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?
Sincerely
Bob Fiddaman

Bob Fiddaman Nails Andrew Witty’s Cavalier Attitude About GSK’s Unethical Behavior


“There have been warnings about paroxetine for a long time,” including a 2007 Food and Drug Administration advisory on the risk of increased suicidality when anti-depressants like paroxetine or imipramine are used to treat people age 18 to 24, according to Dr Jon Jureidini of the University of Adelaide in Australia. The authors of the 2001 study did not report this side effect, although the evidence was there, said Dr Jureidini, a co-author of the re-analysis.

“A broad community of people around the world have raised concerns,” he told Reuters news agency.

“Mistakes were made”…. thousands of kids killed themselves because of Seroxat…

All in a day’s work for  GSK’s CEO Andrew Witty..

Minor inconveniences on the road to hoarding his millions it seems…

What’s a few thousand dead kids?

As long as there’s no dent in profits.. that’s the bottom line isn’t it Witty?


http://fiddaman.blogspot.co.uk/2015/10/andrew-witty-art-of-deflection.html

Wednesday, October 28, 2015

Andrew Witty: The Art of Deflection.

Sir Witty should have been a politician. Very adept at answering a question…with a question.

Here’s a recent interview with Evan Davis, Presenter, Newsnight, BBC

Skip to 29.40. Transcript for this section is below video.

Transcript. 29.40

Evan Davis
I’m going to open it to the floor in a second, because we do want to leave half the session for the audience to ask questions. I’ll just finish with kind of a general reflection, because it is interesting, and it’s nice when you talk about the drugs and what they cure, what the treatments are. Don’t you find it very interesting that the pharmaceutical industry has a bad reputation? We read about the China corruption, we read about profits, we read about profiteering. It is an industry that saves lives, no one can dispute that. It’s an industry that produces pills that are completely transforming for people’s welfare. Yet, it’s actually not a terribly popular industry. I just wonder if you can explain that paradox. Is it that you’ve done bad things and that’s been recognized, or is there somehow something the public don’t understand about the industry that makes them feel negative about it? Or am I wrong in thinking there’s a slight [indiscernible] around it?

Andrew Witty
No, clearly – first of all, I think we are, slightly alongside any big industry, or any big institution, there is a bit of that. We are big companies, we’re global. Again, like any big organization, you’re vulnerable to your weakest link in the organization. So if something goes wrong, particularly in today’s social media world – I often think about what it must have been like to run a global company in the 1970s, where you had to wait for the ship to arrive to find out what happened on the other side of the world. Today, the Wall Street Journal calls you before you’ve even heard about something inside your own company. So I do think there is a certain phenomena where – and you see that across many, you look at it in politics, you look at it in newspapers. The hacking stories, all things like that. So I think it’s a bit of that. I do think – let’s be honest, nobody wakes up in the morning hoping that they’re going to need a drug from GSK. You don’t wake up in the morning thinking, actually, if it’s a really good day, I might be diagnosed to be ill and I might need a drug. So we’re not aspirational in that sense. So you start by saying, actually, I’ve got some bad news, because I’ve been told I’m not very well. They then said: we might have some good news, because there’s something we can help you with. Then in some countries, I have to pay for it. Or in Britain, you might go to the doctor and they say: actually, I’d like to give you this, but NICE have said I can’t. So then there’s a whole series of reasonably negative concepts around pricing. So there’s a bit of that. Then you’ve got – actually, we do occasionally make mistakes. Things go wrong. We have inevitably – of course, we go through all the processes with the regulators to get a drug to be as safe and effective as it can possibly be. But the reality is, every time a human takes a drug, it’s like a clinical trial. You don’t really know what’s going to happen. Everybody can react a different way. So on the one hand, what is the story of the drug industry? The story of the drug industry is wonder drugs. On the other hand, it’s danger drugs. Those are the two extremes that we have. It’s kind of unavoidable.

Evan Davis
But you’re saying there are bad apples, and it goes wrong. Is that right, or is it – for example, in the China case. Was it that there was a bad apple and it went wrong, or was it that that was normal behaviour in certain markets, and it just got called out in that particular case?

Andrew Witty
For obvious reasons, I’m not going to get into all the details of that.

Evan Davis
Was that behaviour actually something, or was it just a slight extension of behaviour that is normal?

Andrew Witty
I think the bigger question is, where do you want to go forward?

Evan Davis
No, but just answer that one.

Andrew Witty
There’s no doubt, if you ask the more general question – so there have been concerns over the years of, is the drug industry transparent enough? What’s the relationship of the drug industry with doctors? All of those are kind of concerns – let’s call them concerns or reasons for anxiety, whatever they are. Sometimes they’ve spiked up into real issues. What we’ve really tried to do, and we’re beginning to see some other companies, I think, following a similar direction, is we’ve said: you know what? We get that. We get that transparency is a cause of concern. People are worried that something is being hidden. We didn’t think there was but people – perception is everything, right? So what did we do? We came out and said: we will publish every single bit of clinical data we have in the company. We are the only company to do that at this point. Every single thing. If a researcher wants to know exactly what the data was on patient number – all anonymized, but on Patient 1002, in Clinical Trial 87, from 2002, we will give them that information. All the way through, we’ll do that. We’ve said we will stop all payments to physicians to speak on behalf of the company. It’s a perfectly legal practice, everything the company has done – but we stopped it all.

Evan Davis
But this is a recognition – there is a lot you’ve done to present these things differently. But it is a recognition that it was pretty dysfunctional before, isn’t it? Because publishing data, to me, honestly, doesn’t seem like a great achievement. It just seems to me that that’s what you should be doing with data. Not bribing doctors seems like a thing you would do.

Andrew Witty
I wouldn’t say it’s bribing doctors – it’s perfectly legal to pay. If you went to a physician and said, would you expect to be paid for speaking on behalf of somebody, they will probably say yes. Actually, in most countries in the world, it’s perfectly legal. However, there are risks it can be abused. People can make mistakes. And there are risks that there is a misperception. Just to your point on publication, do you think academics are mandated to publish their data? Do you think universities publish all their failed studies? They don’t, but we do.

One box of chocolates for the first person to tell me how many times Witty deflects the questions put to him.

**Footnote

GSK were forced to be transparent, they didn’t just decide one day that they were going to be the first pharmaceutical company to “open it’s doors” (Halfway)

This from the Department of Justice/GSK agreement

“Among other things, the CIA also requires GSK to implement and maintain transparency in its research practices and publication policies and to follow specified policies in its contracts with various health care payors.”

Also…

“Moving forward, GSK will be subject to stringent requirements under its corporate integrity agreement with HHS-OIG; this agreement is designed to increase accountability and transparency and prevent future fraud and abuse.”

I think the bigger question is why did Witty fail to mention that his company were forced to be more transparent.

I’ll leave the last words to Witty…

“It’s a perfectly legal practice, everything the company has done…”

Bob Fiddaman.

Original video here.

Bob Fiddaman Revisits The Seroxat Yugoslavia Trials…


http://fiddaman.blogspot.ie/2015/08/mhra-missing-key-seroxatpaxil.html

Tuesday, August 18, 2015

MHRA Missing Key Seroxat/Paxil Withdrawal Information

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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.

Bob Fiddaman Exposes All The Dodgy Doctors Greedily Gobbling From The Big Pharma Trough


http://fiddaman.blogspot.ie/2015/07/warning-pharma-payments-may-give-you.html?spref=tw

Thursday, July 02, 2015

WARNING: Pharma Payments May Give You Worms!

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I now have access to the database that shows exactly how many Doctors GSK paid in 2014. I’ll be writing extensively about this over the coming weeks.

In the meantime, here’s a doctor who, it appears, either has some sort of binge eating disorder or has a bad case of worms.

DR. ROGER ABRAHAMS




His specialty is Allopathic & Osteopathic Physicians/Internal Medicine, Pulmonary Disease and he is based, according to the data, at 1265 Pineview Dr, Morgantown, WV 26505-2713

Here’s what GSK gave him for his food and beverages.

**Note how particularly peckish Dr Abrahams was on May 3**

GlaxoSmithKline Payments

FOOD & BEVERAGE
FOOD & BEVERAGE
FOOD & BEVERAGE
FOOD & BEVERAGE
FOOD & BEVERAGE
FOOD & BEVERAGE
FOOD & BEVERAGE
FOOD & BEVERAGE
FOOD & BEVERAGE
FOOD & BEVERAGE
FOOD & BEVERAGE
FOOD & BEVERAGE
FOOD & BEVERAGE
FOOD & BEVERAGE
FOOD & BEVERAGE
FOOD & BEVERAGE
FOOD & BEVERAGE
FOOD & BEVERAGE
FOOD & BEVERAGE
FOOD & BEVERAGE
FOOD & BEVERAGE
FOOD & BEVERAGE
FOOD & BEVERAGE
FOOD & BEVERAGE
FOOD & BEVERAGE
FOOD & BEVERAGE
FOOD & BEVERAGE
FOOD & BEVERAGE
FOOD & BEVERAGE
FOOD & BEVERAGE
1/27/2014
1/27/2014
2/25/2014
4/14/2014
4/21/2014
4/30/2014
5/2/2014
5/3/2014
5/3/2014
5/3/2014
5/3/2014
5/3/2014
5/4/2014
5/4/2014
5/4/2014
5/13/2014
6/6/2014
6/17/2014
6/17/2014
6/20/2014
7/28/2014
7/28/2014
8/11/2014
8/11/2014
8/18/2014
9/11/2014
12/2/2014
12/2/2014
12/11/2014
12/11/2014
$11.57
$1.20
$15.86
$13.05
$7.20
$23.85
$114.94
$17.73
$82.22
$60.81
$126.96
$15.71
$55.72
$49.37
$20.21
$93.40
$2.12
$1.03
$11.82
$47.85
$2.02
$9.58
$0.97
$8.56
$32.25
$13.85
$11.95
$2.85
$9.15
$0.43

And these were just payments from GSK.

Here’s what AstraZeneca paid him. He, it appears, really pushed the boat out on May 5, spending a total of $372 on food and beverages. That’s a fortnight’s groceries to the likes of your average person.

AstraZeneca Payments

Food and Beverage

Food and Beverage
Food and Beverage

Food and Beverage
Food and Beverage
Food and Beverage
Food and Beverage
Food and Beverage
Food and Beverage
02/06/14
3/5/2014
3/5/2014
5/5/2014
5/5/2014
5/5/2014
5/5/2014
6/25/2014
12/18/2014
$14.99
$1.71
$14.16
$55.98
$135.00
$117.17
$63.91
$11.45
$14.67

Next we have Boehringer Ingelheim…


Boehringer Ingelheim Payments

Food and Beverage
Food and Beverage
Food and Beverage
Food and Beverage
Food and Beverage
Food and Beverage
Food and Beverage
1/16/2014
5/21/2014
9/16/2014
10/8/2014
10/12/2014
12/10/2014
12/10/2014
$3.72
$11.46
$12.01
$12.01
$9.03
$40.64
$9.01

The there was Forest Pharmaceuticals…


Forest Pharmaceuticals Payments

Food and Beverage
Food and Beverage
Food and Beverage
Food and Beverage
Food and Beverage
Food and Beverage
Food and Beverage
Food and Beverage
Food and Beverage
Food and Beverage
Food and Beverage
Food and Beverage
Food and Beverage
Food and Beverage
1/22/2014
2/10/2014
2/28/2014
3/26/2014
4/1/2014
4/7/2014
4/21/2014
5/8/2014
5/19/2014
6/9/2014
6/24/2014
7/14/2014
7/30/2014
9/5/2014
$11.72
$1.50
$9.30
$19.63
$15.97
$15.67
$1.78
$2.64
$5.60
$2.29
$1.92
$8.89
$7.28
$5.01

Just a couple of dining expenses from Genentech USA, Inc.

Food and Beverage7/30/2014$7.28 and 9/5/2014  – $5.01

Next up, Meda Pharmaceuticals, Inc.


Meda Pharmaceuticals, Inc Payments

Food and Beverage
Food and Beverage
Food and Beverage
Food and Beverage
Food and Beverage
1/8/2014
5/14/2014
9/24/2014
10/20/2014
12/18/2014
$13.56
$12.90
$10.65
$11.65
$101.35

One from Merck Sharp & Dohme Corporation

Food and Beverage 11/19/2014$15.99

Mylan Specialty L.P. are next…

Food and Beverage 7/1/2014$17.58 and 7/1/2014 $1.76

Other minor one offs with other pharmaceutical companies, then Teva Pharmaceuticals USA, Inc

Teva Pharmaceuticals USA, Inc Payments

Food and Beverage
Food and Beverage
Food and Beverage
Food and Beverage
Food and Beverage
3/20/2014
4/8/2014
5/13/2014
8/27/2014
10/9/2014
$10.35
$12.34
$15.51
$11.23
$13.54

Quite an appetite, I’m sure you’ll agree.

Payments to Roger Abrahams didn’t end there. He was also paid travel expenses and, as we shall see, for other miscellaneous activities.

TRAVEL & LODGING PAYMENTS

Before the integrity agreement was signed by GlaxoSmithKline in the recent $3 billion whisleblower lawsuit, Glaxo reps would often make payments for travel expenses. Blair Hamrick, who, along with others, blew the whistle on GSK, told me, “Back in the day, doctors were given the choice on one first class airfare, or could trade in for two coach tickets on these trips. They would always opt for two tickets and bring someone. After we filed they stopped doing that. “ Blair also informed me that, “There was speculation that a lot of doctors would paddle their expenses, in as much as they would turn in receipts without actually buying anything, to get extra money.”

On the subject of food and beverages Blair told me, “Back when we filed the case, Doctors would always bring spouses or guests. It was like a fully paid vacation. Right after the case was filed, they changed the rules to say that it was Doctors only. I don’t know whether they are sticking to the rule or not these days.”

This, in no way implies that Dr. Roger Abrahams was doing this. I just thought I’d give the reader some background into what Glaxo reps did and what the doctors, back then, chose to do.

Here’s Dr Abraham’s travel and lodging expenses.

AstraZeneca Pharmaceuticals LP

Travel and Lodging
Travel and Lodging
Travel and Lodging
Travel and Lodging
05/04/14
5/4/2014
5/5/2014
5/5/2014
$408.30
$1,115.22
$51.91
$78.71

Boehringer Ingelheim Pharmaceuticals, Inc.
Travel and Lodging
12/10/14
$1,116.70

GlaxoSmithKline

Travel and Lodging

Travel and Lodging

Travel and Lodging
Travel and Lodging
Travel and Lodging
Travel and Lodging
3/28/2014
5/2/2014
5/2/2014
5/4/2014
5/7/2014
8/20/2014
$529.50
$335.26
$44.00
$16.43
$25.76
$44.24

CONSULTING FEES PAID BY

Boehringer Ingelheim Pharmaceuticals, Inc.

1/28/2014 $150.00
3/2/2014      $682.50
3/26/2014 $1,000.00
3/26/2014 $4,000.00

GlaxoSmithKline

8/18/2014 $300.00

As always, I’ve saved the best until last.

The following falls under the vague category of…

“Compensation for services other than consulting, including serving as faculty or as a speaker at a venue other than a continuing education program.”

Boehringer Ingelheim Pharmaceuticals, Inc. AND **Boehringer Ingelheim Pharma GmbH & Co.KG

Compensation
Compensation
Compensation
Compensation
Compensation
Compensation
Compensation
Compensation**
Compensation**
Compensation**
Compensation**
Compensation**
12/15/2014
12/15/2014
12/15/2014
12/15/2014
12/15/2014
12/15/2014
12/15/2014
7/7/2014
7/10/2014
9/8/2014
10/20/2014
10/30/2014
$490.00
$4,321.00
$1,212.00
$1,461.00
$490.00
$1,461.00
$490.00
$188.31
$175.00
$521.86
$1,469.93
$562.00

GlaxoSmithKline

Compensation
Compensation
Compensation
Compensation
Compensation
Compensation
05/05/14
6/4/2014
6/11/2014
6/17/2014
6/19/2014
9/15/2014
$1,300.00
$800.00
$800.00
$800.00
$1,300.00
$1,450.00

Over the coming weeks I’ll be dissecting the database even more.

I’m now off for a sandwich… paid for by myself.

Bob Fiddaman.

Great Post: Bob Fiddaman Investgates GSK’s (SKB’s) Lethal Selacryn Drug…


http://fiddaman.blogspot.ie/2015/06/glaxosmithkline-two-lawsuits-one.html

Wednesday, June 24, 2015

GlaxoSmithKline – Two Lawsuits – One Withdrawal.

 





What is/was Selacryn?

Selacryn – a drug to combat high blood pressure.

Marketed an manufactured by SmithKline Beckman. **(SKB)

Selacryn was introduced in May 1979 and withdrawn by SmithKline the following January. It lasted just 8 months on the American market.

Why was it withdrawn from the market?

In the United States it was reported that there were 36 deaths and at least 500 severe cases of liver and kidney damage linked to Selacryn.

Should we praise GlaxoSmithKline for withdrawing the drug?

One would think, reading the above, that GlaxoSmithKline (then SKB) acted promptly and swiftly.

Think again.

In June 1984, some 4 years after SKB withdrew Selacryn from the market, they were charged with failing to warn consumers and the Federal Government about the dangerous side effects of Selacryn.

In December 1984 SKB pleaded guilty and three of its medical officials pleaded no contest to charges of failing to report to the Food and Drug Administration the lethal side effects of the blood-pressure drug.

In total there were 34 Federal misdemeanor charges against SKB. They pleaded guilty to all of them.

Three officials of SmithKline’s medical affairs department, Dr. Ralph M. Myerson of Merion, Pa., and Dr. Philip J. Tannenbaum of Broomall, and Dr. Theodore Selby of Haverford, a former official, pleaded no contest to 14 counts of failing to file reports.

FDA Fast Tracking

Selacryn was developed by Anphar Laboratories, a subsidiary of Albert Rolland S. A., a French pharmaceutical company. In 1973, SmithKline obtained a license to develop and sell the drug in the United States.

Selacryn was introduced on May 2, 1979, after an unusually speedy review by the F.D.A. Typically the agency’s approval of new drugs follows clinical tests on up to 1,500 patients. But, bizarrely,  in April 1979, after Selacryn had been tested on 533 patients, officials of the agency concluded that no further tests were required.

Also, in April 1979, SmithKline and the three company physicians received reports from Anphar Laboratories that Selacryn had damaged patients’ livers. The information was translated from French to English at SmithKline headquarters in Philadelphia in May 1979.

SKB never reported this. Instead they continued to market the drug for a further 8 months, reaping in the rewards of sales to an estimated 200,000 patients.

The Punishment

In February 1985 Federal District Judge Edward Cahn placed Glaxo on two years’ probation and ordered them to give $100,000 to a child abuse program for failing to promptly report the side effects of a Selacryn. He also ordered them to provide 500 hours of community service.

The three company doctors were sentenced to five years’ probation and ordered to perform 200 hours of community service.

The company and doctors were charged with failing to promptly file reports of the drug’s harmful effects on kidneys and livers with the Food and Drug Administration. They also were charged with falsely labeling the drug with a statement saying no cause-and- effect relationship existed between the drug and liver damage.

Here’s what surfaced during the trial.

In August, 1979, Mervyn Lakin of Phoenix, Ariz., fell ill with an inflamed liver, jaundice, chills, a high fever, the classic symptoms of hepatitis. The 45-year-old internist suspected that a prescription drug he was taking was harming him so he contacted SKB by placing an urgent call on Aug. 9, 1979, to Dr. Ralph M. Myerson, a group director for medical affairs at SmithKline.

Instead of informing the FDA, SmithKline sent a form letter to Lakin in Phoenix requesting additional information. On Sept. 7, 1979, after receiving a brief report from Lakin describing his original symptoms, Selby classified Lakin`s hepatitis as “unrelated“ to Selacryn .

On receiving this assessment from SKB, Lakin carried out a ‘positive rechallenge’ on himself: He stopped taking the drug, and the symptoms of hepatitis disappeared; he resumed taking Selacryn, and they reappeared.

With this finding he, once again, contacted SKB. One day later, according to court records, Selby classified the side-effect as “indeterminate,” recommended that no unusual or unexpected reaction be reported to the FDA, and sent his report to Myerson and Tannenbaum.

Lakin’s adverse reaction report, along with 11 other cases of Selacryn-related liver damage was buried deep in the third volume of a routine, seven-volume, 2,500-page report.

By late December, 1979, or early January, 1980, FDA regulators read the report and realized that a dozen Selacryn users had developed hepatitis symptoms. They called an emergency meeting for Jan. 15, 1980, convening 17 SmithKline corporate officers and medical personnel and 15 FDA officials.

On that day, SmithKline officials revealed to the federal regulators that 40 more Selacryn users had suffered hepatitis reactions. Five of them were dead.

SmithKline’s Drug Application, filed with the FDA in 1977 and 1978, showed that the company never tested the clinical trial data by performing positive rechallenges.

On June 22, 1979, seven weeks after the drug went on the U.S. market, representatives of the French company, Anphar Laboratories, met with SmithKline officials in Philadelphia and told them that they had six cases of positive rechallenges that linked Selacryn to liver damage. SmithKline did nothing.

It’s unknown whatever happened to Messrs. Myerson, Tannenbaum and Selby. Did SmithKline keep them on their books or did they take a nice little early retirement package? It wouldn’t surprise me, in the least, if they went on to higher paid jobs within the company.

Paxil/Seroxat – No Withdrawal

As far as I am aware GlaxoSmithKline or any of their previous names they were known by, never did any positive rechallenges during the Paxil clinical trials. Begs the question, why?

I find it remarkable that one phone call to SKB kicked off a lawsuit against them, particularly when over 9,000 consumers who had experienced Paxil withdrawal signed an online petition where reports of Paxil addiction were summarized by those who signed the petition (Links at bottom)

Here’s just a handful of some of those 9,000+ concerns. (Paxil is the brand name of Seroxat in the US and Canada)

I have tried twice to stop taking Paxil. Each time I tried I got severely sick with shakes, vomiting, severe headache and flu like symptoms where I missed several days of work. I was completely incapacitated, I could not even get out of bed as everything seemed to be spinning around. My doctor finally put me back on Paxil but lowered the dosage. I have been taking Paxil now for three years with no hope of withdrawing any time soon. Before I was put on Paxil, I specifically asked my doctor if this medication is habit forming and I was assured that it is not, however, my experience has been one of desperation and extreme fear that I am now dependent on this medication. I need help. – HH – USA

I thought I was the only one feeling the zaps, extreme dizziness, lumps, and emotional detachments. I’m 28 and have been on 60 mg of Paxil for a year. I am terrified to come off of it – PP – Canada

I tried suicide on Paxil and my 17 year marriage ended. This drug is dangerous. I am not the same person anymore. I am trying to get off Paxil after four and a half years and the symptoms of withdrawal are so severe that I have chosen to stay on it at this time. – MC – USA

I called the company because my symptoms were so severe. The representative told me I was the exception and to go to my doctor. I specifically asked for instructions on what I could be doing to lessen the side effects and they refused to offer me any assistance. I even asked if I could have my doctor contact them directly so that he could assist me and they refused! – DC – USA

Remember, there were over 9,000 of these reports. Are we expected to believe that none of these 9,000 ever contacted GlaxoSmithKline?

We know, through various litigation in the US that GlaxoSmithKline monitor the internet and should act on what they see. Or are these 9,000 reports just anecdotal, ergo meaningless because they wasn’t reported through the ‘official channels’? Why would anyone want to report an adverse reaction to Glaxo anyway, given that adverse reactions to Selacryn were reported then subsequently ignored?

GlaxoSmithKline are due to defend their corner in the UK where consumers allege that they were not warned that Paxil (known as Seroxat in the UK and Europe) had a propensity to cause severe withdrawal reactions. Not warned that they would have to endure months, sometimes years, injecting a syringe of Seroxat liquid into their mouths because breaking the pill in half just wasn’t an option due to the severity of cutting down the dosage by too much. Not warned either about those electric zaps jolting through the head due to the brain trying to readjust to the lack of Seroxat it had come accustomed to over the years. Hey, thanks for that Glaxo!

Despite settling over 3,000 similar Paxil withdrawal/addiction cases in America, GSK believes that there is no merit in the UK litigation. The reason for settling those American lawsuits, claim Glaxo, was to avoid costs for both parties. All 3,000 plaintiffs agreed to sign a confidentiality agreement that a, laid no blame on Paxil for their addiction and b, laid no blame on GlaxoSmithKline. It is unknown how much Glaxo paid to settle this case (All documents were sealed as part of the agreement.)

It takes just one phone call to SKB to spark a lawsuit and investigation into Selacryn.

It takes over 9,000 consumers to report severe withdrawal side effects regarding its best selling antidepressant for GlaxoSmithKline to do… well, um, nothing, at least not for its UK consumers.

How utterly perverse.

Plus ça change, plus c’est la même chose.

Bob Fiddaman.

**Smith, Kline, French, became the SmithKline Corporation in 1976, and then SmithKline Beckman in 1982, after merging with diagnostics company, Beckman Instruments. Glaxo later merged with Wellcome, a company established in the nineteenth century and built up since, to become Glaxo Wellcome. In 2000, the year of the millennium, Glaxo Wellcome and SmithKline Beecham merged to form the name we know today, GlaxoSmithKline.**

Online Seroxat/Paxil Petition.

Seroxat Withdrawal Reports Part I

Seroxat Withdrawal Reports Part II

Seroxat Withdrawal Reports Part III

Selacryn back story here.

Google Selacryn here.

Revolving Door Between GSK And The MHRA


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

Some very interesting views lately on my blog.

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

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

A mere coincidence? or something more?

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

From The Fiddaman Blog:

Friday, September 05, 2014

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

MHRA CEO, Paxil and Suicide

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

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