Is Glaxo CEO, Andrew Witty, Having A Laugh?


In a news article from Reuters (2015)- GSK CEO, Andrew Witty, discusses the multi-billion dollar market of smoking cessation therapy. E-cigarettes are making big bucks for manufacturers, however Witty claims that GSK won’t be entering the electronic cigarette market any time soon because:

“…Witty said e-cigarettes were “just too controversial” for GSK to want to get involved in at this stage, adding that “there’s not enough data,” to provide robust evidence of the products’ risks and benefits….” (see full article here)

If only Witty and GSK had thought the same before unleashing the horrible Seroxat (drug) on to the anti-depressant consumer market?

I have yet to see ‘robust’ evidence that the benefits of Seroxat (Paxil) outweigh the risks.

For a drug like GSK’s Seroxat (dogged with controversy and scandal) Witty’s claims about e-cigarettes being ‘too controversial’ are extremely ironic…

Where’s the ‘data’ on Seroxat, Witty?..

Where’s the data proving its robust safety and effectiveness?

Will Donald Trump Be Good Or Bad For The Pharmaceutical Industry?


trump

Under Obama we had US Attorney General – Eric Holder– and his revolving door syndrome with GlaxoSmithKline Lawyers – Covington and Burling– and the US department of Justice.

This was arguably a blatant example of a dodgy quid pro quo- conflict of interest.

Trump is more of a wild-card it seems, and considering his stance on vaccines and drug prices, nobody knows for sure what his influence will be on the pharmaceutical industry.

Will it be good or bad?

In the case of GlaxoSmithKline, as an investment, the investor from the article below- seems to think it will bode well.

However perhaps he hasn’t factored in Trump’s negative stance on vaccines.

GSK makes a vaccine called Infanrix, and Infanrix has been embroiled in controversy in recent times due to its alleged dangers (links to Autism etc).

http://www.ageofautism.com/2015/01/recent-italian-court-decisions-on-vaccines-and-autism.html

“….Like the U.S., Italy has a national vaccine injury compensation program to give some financial support to those people who are injured by compulsory and recommended vaccinations. The Italian infant plaintiff received three doses of GlaxoSmithKline’s Infanrix Hexa, a hexavalent vaccine administered in the first year of life.  These doses occurred from March to October 2006. The vaccine is to protect children from polio, diphtheria, tetanus, hepatitis B, pertussis and Haemophilus influenza type B.  In addition to these antigens, however, the vaccine then contained thimerosal, the mercury-containing preservative, aluminum, an adjuvant, as well as other toxic ingredients.  The child regressed into autism shortly after receiving the three doses.  When the parents presented their claim for compensation first to the Ministry of Health, as they were required to do, the Ministry rejected it.  Therefore, the family sued the Ministry in a court of general jurisdiction, an option which does not exist in the same form in the U.S…”


I’d like to think that Trump’s US attorney general will be a lot tougher, and a lot less friendly, to the the Pharmaceutical industry, than Obama’s was..

https://masterinvestor.co.uk/equities/glaxosmithkline-appeal-trump-victory/

GlaxoSmithKline has appeal after Trump victory

By 11 November 2016
5 mins. to read
GlaxoSmithKline has appeal after Trump victory

The reaction to Donald Trump’s election victory has been surprising. First, stock markets sank. Then they rose. Now at the time of writing they are falling once more. Clearly, the only thing that investors can be certain of is that uncertainty will be high over the short to medium term.

Part of the reason for this is that Trump is a known unknown. He has no long-term track record in politics and it is impossible to know exactly what policies he will pursue. In fact, there is a good chance that even he does not yet know exactly how he will seek to improve the US economy. That’s why in my view it’s a good idea to own companies which have a relatively low positive correlation with the economy. One example of this is GlaxoSmithKline (LON:GSK), which I believe will outperform a volatile wider index over the medium term.

Old Trump Vs New Trump

Perhaps the most striking part of election night was Trump’s victory speech. It was a complete contrast to the gung-ho, pumped up and bullish tone which he had struck throughout the election campaign. Trump instead talked about uniting America and being a President for all Americans, words which at the time of writing at least, seem to have placated the markets somewhat.


However, one speech does not instantly erase the policies which Trump has been shouting about in the last couple of years. His desire to protect American jobs and make trading agreements less favourable to other countries mean that the world could take a step back from an era of increasing globalisation. Similarly, his apparent admiration for Vladimir Putin could cause uncertainty in the Middle East and even in Europe, while a tougher stance on China could lead to worsening relations between the two countries.

Volatility looks here to stay

Of course, many commentators are now claiming that Trump may govern with different policies to those on which he campaigned. Whether that proves to be correct or not, in my opinion Trump’s Presidency will include significant change on taxation, spending and foreign policy. Therefore, I believe that the uncertainty seen in stock markets since the election is just the beginning of a period of highly volatile share price movements.

In the current ‘lame duck’ period, uncertainty may not rise beyond the levels seen since the election. Barack Obama is keen to ensure a smooth handover of power and Donald Trump is unlikely to make any controversial comments regarding his plan of action. After all, he can’t do anything in terms of policy-change until he becomes President in 2017.

However, beyond the point at which Donald Trump becomes President, I believe that volatility will increase significantly. His plan to reduce taxes on businesses and on individuals while at the same time increase infrastructure spending may bring rewards in terms of job creation and GDP growth. But it also means higher risk, since debt levels are likely to rise in order to fill the hole created by higher spending and lower tax receipts. This could lead to higher uncertainty regarding the US economy’s future and cause share prices to become more volatile.

A stable solution

In such volatile times, companies which offer a consistent, stable and robust outlook could become more popular among investors. That’s why I’m optimistic about GlaxoSmithKline’s future share price performance versus the wider index. Its sales and profitability are less dependent upon the performance of the wider economy than is the case for most companies. This provides GlaxoSmithKline with defensive characteristics which are further enhanced by its diverse business model.

Essentially, GlaxoSmithKline is three businesses in one. It has a consumer goods division which sells products such as Horlicks and therefore benefits from a significant amount of customer loyalty. GlaxoSmithKline also has a pharmaceuticals division and a vaccines division. It is therefore more dependent on the patent cycle than the business cycle. When combined with its consumer division’s customer loyalty, this makes GlaxoSmithKline a robust and reliable performer which could be seen as a means of diversifying away from an uncertain economic outlook.

Future potential

GlaxoSmithKline is much more than just a defensive stock. Its drug pipeline holds significant promise in my view. For example, it spent £3.1 billion on R&D in 2015 and expects to generate a 13% internal rate of return (IRR) on this investment. Over the course of 2016/17, GlaxoSmithKline expects up to 20 Phase II starts and up to 10 Phase III starts. Looking further ahead, it has the potential to file up to 20 assets by 2020, which indicates that its sales could rise substantially over the medium term.


This should help to boost GlaxoSmithKline’s dividend payments. They are being frozen for the next couple of years as GlaxoSmithKline seeks to improve its cash position. Even without dividend growth in the near term, GlaxoSmithKline still has income appeal. It currently yields 5.1% versus 3.7% for the FTSE 100. This will help GlaxoSmithKline to record a positive total return should capital gains be difficult to achieve in a potentially uncertain period for global stock markets.

Outlook

The US and global economies face a highly uncertain future. Although the next few weeks may prove to be a smooth transition, in 2017 I believe that the changes Donald Trump will seek to make to the US will cause share prices to become increasingly volatile. Although he may adopt a more conciliatory approach than he did during the campaign, Trump is likely to implement more radical policies than have been undertaken for a number of years. Even if they are successful in the long run, they are likely to cause investors to become increasingly risk-off in the short to medium term.

In such a situation, GlaxoSmithKline could gain in appeal. It has a well-diversified, stable business model which is not closely tied to the performance of the economy. It also has growth potential via its pipeline and offers a high yield which could appeal to defensive-minded investors. Therefore, in my opinion GlaxoSmithKline is an appealing investment following Trump’s unexpected election victory.

From Fiddaman Blog: Glaxo Destroyed Animal Studies.


http://fiddaman.blogspot.ie/2017/01/glaxo-destroyed-paxil-animal-studies.html

Friday, January 27, 2017

Glaxo Destroyed Paxil Animal Studies

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Nothing new here but this astounding story is in the news once again.

The revelation first aired some years ago in a Paxil birth defect trial (Kilker Vs GSK).

During the trial, the jury saw an exhibit showing minutes from a teleconference for a Paxil project team meeting. Page eight of the minutes stated: “It has already been discovered that raw data from four of the original Ferrosan sponsored toxicology studies conducted at Huntingdon Life Sciences were destroyed by HLS in 1993.”

Now, it appears, Glaxo don’t want this information rehashed in a current Paxil birth defect trial from the state of Ohio where it is alleged that Kathryn Kiker, after taking the Paxil while pregnant, gave birth to her child, who was born with a ventricular septal defect, a serious heart problem.

Glaxo, as in many cases where they wish to keep the jury misinformed, have claimed that evidence that lab notebooks from 1979 animal studies were destroyed in 1993 should not be heard by the jury, they cite that the claim “grossly distorts the regulatory practices in place at the time” and is “a manufactured controversy” likely to make jurors assume malfeasance.

Glaxo have filed many motions in this current Paxil birth defects case. They don’t wish for the jury to see the 2012 plea agreement, in which Glaxo were find a record-breaking $3billion.

I’m surprised that GlaxoSmithKline continue down this road. They have done the same in the current adult Paxil suicide case of Stewart Dolin, ie; they don’t want jury members to know anything about their abhorrent history of witholding evidence that shows that Paxil increases the risk of suicidal thinking and completion in both adults and children who take it.

What I find mind-boggling here is that GSK carried out a series of animal studies in animals, those studies, if supportive of their claim that Paxil is safe during pregnancy, would, for them at least, be worth their weight in gold. However, the studies did not show this so what did Glaxo do, well, it appears that they gave the go-ahead for the studies to be destroyed and kept away from public scrutiny. When being faced with a layperson jury hearing this information they claim that, um, it’s irrelevant.

I’d just love to know what planet GSK and its defence attorneys are on, wouldn’t you?

In any event, the judge heard their motions and denied them, leaving the door open for the jury to deliberate and discuss why Glaxo would not want animal studies in Paxil to be seen, furthermore why they stood by and allowed them to be destroyed.

The case is set to go to trial later next month.

Kiker is represented by Benjamin Anderson of Anderson Law Offices LLC and Bryan Aylstock, James Barger, Bobby Bradford, Roger Cameron and R. Jason Richards of Aylstock Witkin Kreis & Overholtz.

GSK is represented by Andrew Bayman, Halli Cohn and Meredith Redwine of King & Spalding LLP and William Darrell Kloss Jr., Adam Rusnak and Jessica Goldman of Vorys Sater Seymour & Pease LLP.

Bob Fiddaman.

Related stories.

Ryan, Glaxo’s Non-Viable Fetus – Part I

Ryan, Glaxo’s Non-Viable Fetus – Part II – The Twists

Glaxo’s Swine Flu Jab Pandemrix..


http://www.standard.co.uk/news/health/sleep-disorder-sufferers-await-ruling-over-role-of-swine-flu-jab-a3447096.html

Sleep disorder sufferers await ruling over role of swine flu jab

0

Almost 100 people who claim they developed narcolepsy after receiving the swine flu vaccine hope a landmark case could pave the way to compensation following a seven-year battle.

The Court of Appeal will this week consider a government bid to overturn a 2015 Upper Tribunal ruling that gave £120,000 to a boy damaged by the vaccine Pandemrix when he was seven.

The then-work and pensions secretary, Iain Duncan Smith, had accepted that the trial vaccine caused the incurable daytime sleep disorder in the boy, now 14 and known only as “John”.

However, the Department for Work and Pensions denied his disabilities were severe enough to pass the 60 per cent threshold to trigger a payout under the Vaccine Damage Payments Act. This was rejected by the Upper Tribunal but the Government went on to appeal.

John’s lawyer Peter Todd, of Hodge Jones & Allen, who represents 88 of the 94 UK victims, said: “As narcolepsy is a spectrum disorder, there is a range of severity. John is probably at the most severe end. If he doesn’t qualify then pretty much nobody would.”

25katieclack2301a.jpg

Victim: Katie Clack, who took her own life as a result of the incurable condition

About six million UK residents were given the vaccine during the 2009-10 H1N1 swine flu pandemic.

At the time, no approved vaccine was available so the Government agreed to indemnify drugs giant GSK against future claims in return for the use of Pandemrix, a trial vaccine. At the time, the link with narcolepsy was unknown. More than 1,500 cases of narcolepsy allegedly caused by Pandemrix are registered on an EU database.

In the UK, only two sufferers apart from John have had compensation — Josh Hadfield, 10, from Somerset, and nursery nurse Katie Clack, 23, of Peterborough. Her award was posthumous after she took her own life as a result of the condition.

The Government appeal focuses on its belief John’s level of disability should be measured against another child of that age and exclude the impact of the disability on his later life as an adult.

The DWP said the Government did not accept a general causal link between Pandemrix and narcolepsy. It said: “We await the Court of Appeal judgment and it would not be appropriate to comment further.” Defeat for the Government would trigger civil claims against GSK. The drugs giant declined to comment.

Myodil: Lewin Vs Glaxo..


Date of knowledge and Limitation – Lewin v Glaxo – Case Report
Blog piBlawg

United Kingdom January 18 2017

In cases concerning an allegation of bodily injury, time for the purposes of statutory limitation does not begin to run until the cause of action accrues or the date of knowledge of the alleged victim. The latter may be some months or years after the effluxion of the usual three year limitation period from the accrual of the cause of action. However it is rarely decades as it was in a recent case in the Queen’s Bench Division. In common with much of the extensive corpus of authority as to limitation, Keith Malcolm Lewin v Glaxo Operations Uk Ltd (Sued As Glaxosmithkline Unltd) [2016] EWHC 3331 (QB), turns on its own facts. It is however worthy of summary.

Here, upon hearing the trial of a preliminary issue on the subject, Mr Justice Goss found that the claimant’s claim was not statute-barred despite the claimant making complaint of treatment he received as long ago as 1973.

Some 44 years ago, the claimant underwent a diagnostic procedure during which Mydil was injected into his spine. It was held that the claimant’s date of knowledge arose when he was diagnosed as late as 2015 as suffering from post-Myodil adhesive arachnoiditis.

In the five or so years following the 1973 procedure, the claimant experienced persisting problems in his lumbar and cervical spine. This was investigated further in 1977 when it was considered that whilst the claimant may have had adhesive arachnoiditis, it could not be confirmed and further x-rays were unnecessary. The claimant’s problems continued during the 1990s, but it was not until 2007 when he developed severe left knee pain and thereafter other symptoms. An MRI scan in 20112 showed adhesions to his thoracic spine and the potential link between Myodil and the claimant’s condition was discussed. He underwent surgery in 2013, but it was not until March 2015 when a neurosurgeon concluded that the claimant suffered from post-Myodil adhesive arachnoiditis.

The claimant issued proceedings in October 2015 against the background of the fact that in the early 1990s group litigation had been pursued against the defendant in respect of Myodil in which settlements were agreed without any admission of liability. Over 4000 individuals had notified claims although, in the event, only 426 claims were proceeded with.

The Court was asked to determine the date upon which the claimant’s cause of action accrued; his knowledge for the purposes of section 14 of the Limitation Act 1980; and if the claim was statute-barred, whether the court’s discretion pursuant to section 33 of the same Act should be applied.

The court held that the cause of action accrued when the Myodil caused injury to the claimant, not the date it was injected. On the facts of this case this occurred around 2007.

The defendant argued that by the 1980s the claimant had constructive knowledge sufficient to commence time running (per section 14(3) of the 1980 Act): he knew by 1977 he had a serious back injury and that the possibility of arachnoidiis had been raised sufficient to prompt him to investigate. The claimant argued that no clear cause for his symptoms had been determined. This found favour with the Court which further held that even had the claimant drawn a link, it was not reasonable to have expected him to have investigated it further. It was held therefore that the claimant’s date of knowledge was when the neurosurgeon’s diagnosis in 2015.

Goss J went on to consider whether he would have allowed an extension of limitation in any event. He held that he would have done had it have been necessary on the grounds that the claimant had sustained a very serious injury and the main prejudice to the defendant would have been financial as the matters complained of had already been investigated.

But GSK Is A Rogue Company Sir Philip !?!


In a recent article, GlaxoSmithKline Chairman, Sir Philip Hampton, talked about rogue companies causing problems in British business, however he failed to mention that the company he chairs- GSK- has been one of the most rogue companies (in terms of ethical, legal, and moral transgressions) of recent times.

Read Whistle-Blower – Greg Thorpe’s Legal complaint– which led to a record breaking 3 Billion dollar fine for GSK in 2012, and when you’ve digested that consider GSK’s mass fraud and bribery scandal in China ( costing the company 500 million- the biggest fine ever in China).

When you’ve read through the hundreds of examples of GSK going rogue with ethics- then perhaps read through Sir Philip’s article with your tongue firmly in your cheek, and of course with a great sense of irony and absurdity…

 

http://www.telegraph.co.uk/business/2017/01/24/will-always-have-another-philip-green-sports-direct-says-gsk/

Rogue companies will always exist, says GSK chairman

City
The business world will always have some colourful characters

Rogue businesses and bad bosses will always exist no matter how hard British companies and politicians work to stamp them out, according to Sir Philip Hampton, the chairman of pharmaceuticals giant GlaxoSmithKline and the former chairman of Royal Bank of Scotland.

Sir Philip, who last year published a report on corporate governance and gender diversity, told MPs that it is crucial for independent directors to be able to control domineering executives.

“In overall terms the UK structure for corporate governance is actually pretty good – it is not universally, but we always will have the Sports Directs or the Philip Greens,” Sir Philip told the Business, Energy and Industrial Strategy (BEIS) select committee.

“I don’t think there are any structures that can eliminate it, but the overall structure of governance in UK is admired pretty much globally.”

Sir Philip Hampton is a serial director. Currently chairman of GSK, his previous roles include chairman of RBS and chairman of Sainsbury's 
Sir Philip Hampton is a serial director. Currently chairman of GSK, his previous roles include chairman of RBS and chairman of Sainsbury’s 

The recent scandals surrounding the collapse of BHS shortly after it was sold by Sir Philip Green and the treatment at staff at Sports Direct have shaken confidence in some of the biggest names in British business.

In Philip Green’s case, some MPs have called for the billionaire to lose his knighthood.

Sir Philip Hampton, who has been given the same award, said that business bosses should not routinely be given gongs.

“The rewards for being in business should be primarily financial, and other awards and appreciations probably should be more directed to people who are not getting financial rewards,” the GSK chairman said.

“I think to get both the financial awards and the other marks of recognition is a bit too easy. The honours system has moved away from businesspeople getting awards, and that is right.”

Sports Direct has come under fire for its poor treatment of some workers
Sports Direct has come under fire for its poor treatment of some workers

He also told the MPs that the best way to create more diversity in business is to set targets and deadlines, prompting the machinery of companies to act rapidly.

But he added that there may be too much focus on boards, which are dominated by non-executive directors giving only part-time service, when companies are run on a day to day basis by executives.

“Boards have made a lot of progress, but boards are overwhelmingly non-executive now in our corporate governance framework, and having more women on boards is not the same as women having proper, effective business careers,” he said.

“The bit that we’re missing is the focus on executive committees. Companies are run by their executive committees, the full-time people with the best-paid jobs who really decide most things, when a typical board member is two or three days a month, which is not the same thing. In executive committees there is still noticeable female under-representation.”

 

Glaxo Looks To Bar FDA, Plea Evidence From Paxil Trial


Interesting article on the Paxil (seroxat) birth defect trials that GSK is trying to quash at the moment, particularly these parts-

“…The drugmaker also railed against evidence that lab notebooks from 1979 animal studies were destroyed in 1993, saying the claim “grossly distorts the regulatory practices in place at the time” and is “a manufactured controversy” likely to make jurors assume malfeasance….”

” GSK asked the judge to bar evidence about a 2012 plea agreement and three civil settlements; it pled guilty to one misdemeanor count of drug misbranding. This guilty plea carried no implication of fraud with it, the company said. And the misbranding had to do with Paxil’s use for patients under 18.”..


GSK’s attorneys are lower than gutter slime..

An Amoeba would have more depth of character …

https://www.law360.com/trials/articles/884297/glaxo-looks-to-bar-fda-claims-guilty-plea-from-paxil-trial

Glaxo Looks To Bar FDA, Plea Evidence From Paxil Trial

Law360, New York (January 24, 2017, 4:49 PM EST) — Jurors in an upcoming trial over birth defects allegedly caused by the antidepressant Paxil must not be told about drugmaker GlaxoSmithKline‘s alleged campaign to defraud the FDA, about destruction of study data or about its 2012 guilty plea on misbranding charges, the company insisted Tuesday.

The company filed a slew of motions seeking to box out evidence it said is irrelevant to mother Kathryn Kiker’s claims that taking the drug while pregnant caused her child’s ventricular septal defect, a serious heart problem. The trial is set for Feb. 21 in the Columbus, Ohio, courtroom of U.S. District Judge Edmund Sargus.

“GSK anticipates that plaintiffs will argue at trial that GSK committed ‘fraud on the FDA’ by not cooperating fully with, and by withholding information from, the FDA regarding adverse events, animal studies and/or clinical trials  … so that the FDA did not undertake regulatory action with regard to Paxil,” the company said. But the claims “are incorrect, irrelevant and inadmissible,” it said. “Furthermore, the U.S. Supreme Court has held that FDA — not a private plaintiff — has exclusive authority to police disclosures made to [the] FDA.”

The drugmaker also railed against evidence that lab notebooks from 1979 animal studies were destroyed in 1993, saying the claim “grossly distorts the regulatory practices in place at the time” and is “a manufactured controversy” likely to make jurors assume malfeasance.

And in another motion, GSK asked the judge to bar evidence about a 2012 plea agreement and three civil settlements; it pled guilty to one misdemeanor count of drug misbranding. This guilty plea carried no implication of fraud with it, the company said. And the misbranding had to do with Paxil’s use for patients under 18.

Even as information about character, the plea deal is not usable, the company said.

“Evidence regarding felonies and any crime whose elements require proof of a dishonest act or false statement may be admissible for impeachment. GSK’s plea to no-intent, strict-liability misdemeanors under the FDCA is inadmissible for impeachment purposes because it does not fall within either category,” it said.

And it requested oral argument on another motion seeking to bar evidence about other lawsuits, investigations or media reports.

In October 2015, an Ohio federal judge ruled that GSK must face the suit because the mother successfully pled fraud.

U.S. District Judge Edmund Sargus denied GlaxoSmithKline LLC’s motion for judgment on the pleadings, rejecting its argument that Kiker’s claims accrued in September 2005, when the company told the medical community about Paxil’s links to birth defects, and are thus abrogated by the Ohio Product Liability Act, which was amended in 2005 and curtailed common-law liability claims in the state.

But the judge sided with Kiker’s argument that her claims accrued when her child, referred to as C.S., was born in 2001.

The judge said that a provision in the 2005 Tort Reform Act includes a discovery rule so that a bodily injury claim may be extended to a date when it was reasonable for the injured party to have discovered her injury was related to a product. The judge also found that the fraud allegations in Kiker’s proposed amended complaint were sufficiently particular, and granted her leave to file the amended complaint.

“At the time Paxil was prescribed to Ms. Kiker, GSK knew … that Paxil was associated with a significant increased risk of cardiac birth defects in babies,” Kiker said. “Other studies showed that increased levels of serotonin, the primary human substance affected by Paxil, had profound effects on the prenatal cardiac development of study animals.”

Despite knowing these risks, she said, GSK suggested Paxil was safer than other available selective serotonin reuptake inhibitors, or SSRIs, and misled the medical community as to its safety. Kiker said GSK did not begin to inform doctors of the risks until September 2005, when third-party research showing the association was released.

The entire time the drug has been on the U.S. market, federal regulations have required stronger warnings in the presence of evidence of a birth-defect link, Kiker said. These FDA regulations specifically state that the link need not be proven and that the company can issue the warning without agency approval.

Kiker is represented by Benjamin Anderson of Anderson Law Offices LLC and Bryan Aylstock, James Barger, Bobby Bradford, Roger Cameron and R. Jason Richards of Aylstock Witkin Kreis & Overholtz.

GSK is represented by Andrew Bayman, Halli Cohn and Meredith Redwine of King & Spalding LLP and William Darrell Kloss Jr., Adam Rusnak and Jessica Goldman of Vorys Sater Seymour & Pease LLP.

The case is Kiker v. Smithkline Beecham Corp., case number 2:14-cv-02164, in the U.S. District Court for the Southern District of Ohio.

–Additional reporting by Emily Field. Editing by Philip Shea.

Poignant Post On Bob’s Blog…


An interesting post on Bob’s Blog about the implication of Seroxat causing bus driver, Geert Michiels, to kill himself and others in the tragic Sierre bus disaster in Switzerland…

http://fiddaman.blogspot.ie/2017/01/q-with-olga-leclercq.html

Tuesday, January 17, 2017

Q&A with Olga Leclercq

Continuing with the Q&A’s from people that have played a role in my life for the past ten years or so that I’ve been writing this blog…
I’ve covered many stories of antidepressant induced suicide on this blog, each of them as heartbreaking as the next, each of them ignored by the medicines regulators, healthcare professionals and pharmaceutical industry.
If a drug can induce thoughts of self harm and suicide then we can be safe to assume that this can also put others in danger.
In 2012 this assumption became a reality and, it appears, nobody wants to either talk about it or hold anyone accountable for it. It’s one of them cases where authorities have just shrugged their shoulders, in effect, pissing on the graves of those who perished.
Olga Leclercq’s daughter, Eline (Pictured), was one of the 22 children who died when, for reasons (apparently) unknown, Geert Michiels (34) drove a bus into a tunnel wall in Sierre, Switzerland. (Back stories at the foot of this Q&A)
Eline (11)
It’s been established that Michiels was withdrawing from Seroxat (Paxil) at the time of the crash, he had missed his dose on the day of the crash. It’s also been established that Michiels deliberately drove the bus into a wall – a prior investigtion found that there were no mechanical problems with the bus and, more importantly, showed that at no point did Michiels apply the brakes of the bus.
I met Olga in London last year – what does one say to a mother who has lost a child in such horrific circumstances? I’ve wrote about the Sierre bus crash on numerous occasions on this blog, I’ve even corresponded with both the MHRA and the EMA (Medicines regulators) who have basically told me they are not interested and will not be carrying out their own investigations into this Seroxat related homicide.
Olga, along with other parents, are not letting go – why would they after the ‘official investigation’ was deemed to be “inconclusive”?
All of those involved in this investigation have, seemingly, ignored the most obvious cause, namely GlaxoSmithKline’s Seroxat – we see coroners, globally, do the same at inquests, not only where Seroxat has been implicated, but other SSRIs too.
This needs to change and people like Olga are at the forefront of that change.
Here is my Q&A with Olga Leclercq.
 
 
Name: Olga Leclercq
Age: 44
Location: Lommel Belgium
 
 
Q: Olga, this may be a difficult question, so forgive me if it’s painful for you. What is your fondest memory of Eline?
A: That is a difficult question because I have so many fondest memories of her. Eline was a very social girl, who loved to dance. She loved doing things together, it didn’t really matter what, walking the dog, cooking, watching a movie. She often had play dates with the girls in her class, most of them died in the crash as well. She often made cute notes or drawings which she would hide everywhere in the house for us to find. I miss finding those notes and drawings, I am so glad we kept them all.
Q: When did you first make the connection that the bus driver’s use of Seroxat could have been linked to him deliberately crashing the bus?
 
A: Given the trajectory, we knew at a very early stage that this could not have been an accident, the trajectory is way to difficult for that. I didn’t have any experience with antidepressants and when the Swiss authorities confirmed that the driver had Paroxetine in his blood, I started to look for more information.
I never knew these drugs were linked to suicidal ideation and violence. Akathisia was something completely new to me.
We asked the Swiss authorities to investigate a possible link with the Seroxat. They refused to look into this because they claim that only the first weeks are potentially dangerous, the driver was on this medication for 2 years, he was withdrawing at the time of the crash, and in fact had not taken his dosage that day. For the Swiss authorities there is no reason to look into this any further.
Q: Have you at any point corresponded with Seroxat manufacturer, GlaxoSmithKline, with regard to the bus crash or have they ever apologised for the role Seroxat played in Eline’s passing?
A: No, I never have. I know one of the attorneys that worked for them before looked at our website, but there has never been any correspondence between us and them. I doubt if they will ever take any responsibility, especially because the Swiss authorities never wanted to investigate and/or confirm a suicide. Officially it’s just an accident. The case was simply closed  without a solid conclusion. Glaxo never made an attempt to look into this further. They never contacted us or the authorities to see if their drug might have been a cause, directly or indirectly.
 
Q: If you could ask GSK’s Andrew Witty three questions what would they be?
 
A: 1: Your drug Seroxat has been under discussion for more than two decades, many suicides, murders and family tragedies have been linked to your drug, how can you live with yourself?
2: are you willing to take a therapeutic dosage of Seroxat for two years, and then stop as fast as the bus driver did, by just cutting the pills in half? Could you keep a blog, just to show everyone how safe your drug really is?
3: What was one of your attorneys doing at our website? Did you connect the dots between the crash and your drug even before we did? I assume there must have been some curiosity about the cause of the crash, why didn’t you ask the Swiss authorities to investigate further, as we have done?
Q: What do you say to people who believe that antidepressants are safe and effective?
A: Please do your homework before claiming these drugs are safe and effective. Even the drug companies themselves cannot prove their effectiveness, and/or safety.
Q: You have recently received correspondence from the Dutch Prime Minister, Mark Rutte. Can you tell me what that is about?
A: We asked for his help, we asked for the driver’s blood sample a couple of times before but the Swiss authorities refused, so we were hoping for the Prime Minister’s help in requesting this blood sample again. Maybe the request by the government will have more impact than the endless requests of a bunch of parents.
Q: Why is it important to you that the Swiss uthorities release samples of the bus driver’s blood?
A: We would like to have his DNA tested, through his DNA we can see if his body was able to break down his medication properly. Many people miss a certain enzyme (cytochrome P450) which means that they get toxic levels of the medication in their system. In other words: we could see if  the medication was very likely to cause this crash.
Q: Can you tell me more about the Independent Forensic Services in Hulshorst, Netherlands?
A: We turned to them for help. It was a bit more than a year after the crash and we knew that the Investigation by the Swiss authorities were not going to give us any answers about the cause of the crash, all our requests (like a reconstruction) were denied. We were very happy that IFS wanted to take a close look at our case, they did the reconstruction with the help of Eugene Liscio, a forensic 3D expert. It confirmed our fears, it was a deliberate act. The report of the reconstruction and also the other findings were sent to the Swiss procureur. But this also has been ignored.
Q: Have you ever considered writing a book about your journey?
 
A: No, it would have been a good thing to do, because now I notice that I’m forgetting things. But I’ve never been keen on writing unlike my daughter Eline, who loved to write stories. My thoughts race from one subject to another, and I don’t have the patience to sit down and write. I wish I had.
Q: Tell me about the Foundation Busramp Sierre website.
 
A: We started this foundation to give background information about the crash and hopefully get some support in what we do and why. Especially in Belgium there is a “let it rest” attitude, and that is something I simply cannot do.
 
 
Q: Finally Olga, some personal questions…
 
1. What book are you currently reading?
 
A: Dr Peter Breggin: Medication Madness. The next one waiting on the shelf is Robert Whitaker, the anatomy of an epidemic and your book of course!
2. What was the last CD you listened to (in full)?
 
A: I mostly listen to the radio, but I have a toddler who loves “Jip en Janneke” that is the cd I even hear in my sleep 😉 I hear that one in full a couple of times a week.
3. What is the best movie you have seen this year?
 
A: I don’t know
4. What country would you most like to visit?
 
A: I would love to go to back to Indonesia.
We went there with the kids, 7 years ago. We travelled around for a month, I would love to do that again.
5. If you had the choice of being either a defence or prosecution lawyer, which would you choose and why?
 
A: Can I choose both? I would like to stand up for everyone who had to deal with a crappy investigation. Sometimes as a defence lawyer to help wrongfully convicted but also as a proscecution Lawyer to help families like us who are basically standing with their backs against the wall.
Bob Fiddaman.
 
Foundation Website
 
Book

Stat: New rule on clinical trial reporting doesn’t go far enough


The clinical trial industry, which I work in, is in crisis.

Roughly half of clinical trials go unreported. Industry-sponsored trials are four times more likely to produce positive results than non-industry trials. And even when trials are reported, the investigators usually fail to share their study results: nearly 90 percent of trials on ClinicalTrials.gov lack results.

Failure to report clinical trial results puts patients in danger. Here’s one example of that: GlaxoSmithKline, the maker of the antidepressant Paxil, recently paid $3 billion for failing to disclose trial data showing that Paxil was not only no more effective than placebo but was also linked to increased suicide attempts among teenagers. The effectiveness of statins, the Tamiflu anti-flu medicine, antipsychotics, and other drugs have come under question due to improperly reported data. Without complete disclosure of trial results, physicians can’t make informed decisions for their patients.

A recently passed final rule from the Department of Health and Human Services now requires that all NIH-sponsored clinical trials be reported on ClinicalTrials.gov. A complementary policy from the National Institutes of Health covers registering and submitting summary results information to ClinicalTrials.gov for all NIH-funded trials, including those not covered by the final rule.

Unreported trials are subject to daily fines of $11,833. Researchers have 90 days after the rule is enacted on January 18, 2017 to comply with it. Excellent summaries of the rule have been published by the NIH and in the New England Journal of Medicine.

The final rule should help address some of the troubling trends in the clinical trial industry. It clears up ambiguous reporting requirements and explicitly requires investigators to submit clinical trial results, adverse events, and statistical methods. These are steps in the right direction that could limit the unscientific practices plaguing the trial industry.

But the final rule doesn’t go far enough, mainly because FDA lacks the staff and the political will to adequately enforce it. As STAT reported in December 2015, the FDA had never levied a single fine for clinical trial reporting violations. Representatives from the FDA cite legal complexities and lack of employees, yet critics have also pointed out the FDA is effectively on the pharmaceutical industry’s payroll. Under the Prescription Drug User Fee Act, the FDA supplements its budget by charging pharmaceutical companies drug application fees that totaled $855 million in fiscal year 2015.

The current FDA commissioner, Dr. Robert Califf, has said that the FDA will not be adding staff to enforce the final rule. That’s a mistake. How else can we expect the rule to be enforced? I work in a research group that conducts more than a dozen clinical trials and know firsthand that researchers don’t have the impetus to report their trials unless there are strong incentives to do so — like enforcement and the threat of fines.

In a perfect world, the FDA would receive more funding to hire employees so it could independently enforce this policy. In the meantime, researchers can check the reporting practices of their own institutions or sign a petition to support the Alltrials campaign. Another project called OpenTrials, a collaboration between Open Knowledge International and the University of Oxford Data Lab, aims to “locate, match, and share all publicly accessible data and documents, on all trials conducted, on all medicines and other treatments, globally.” It is seeking volunteers to contribute clinical trial data.

I know from personal experience that clinical trial reporting can be tedious and seemingly unrewarding work. But the transparent exchange of scientific data is integral to evidence-based medicine and public health. While the new final rule is a step in the right direction, the public and the research community also need to support efforts like AllTrials and OpenTrials.

Chris Cai is a clinical research coordinator at Massachusetts General Hospital in Boston.

Psychiatric Drug Carnage…


https://www.adn.com/opinions/2017/01/12/misguided-mental-health-system-needs-an-overhaul/

Misguided mental health system needs an overhaul

Esteban Santiago is taken from the Broward County main jail as he is transported to the federal courthouse in Fort Lauderdale, Florida, U.S., January 9, 2017. Amy Beth Bennett/South Florida Sun Sentinel via REUTERS

Esteban Santiago is taken from the Broward County main jail as he is transported to the federal courthouse in Fort Lauderdale, Florida, U.S., January 9, 2017. Amy Beth Bennett/South Florida Sun Sentinel via REUTERS

The glaring failures surrounding Esteban Santiago, resulting in the tragic killing of five people and wounding of eight others in Fort Lauderdale, Florida, prompts me to make some points about our misguided mental health system.

First, psychiatrists have no ability to predict who is going to be violent. In a Jan. 3, 2013, Washington Post article, “Predicting violence is a work in progress,” after reviewing the research, writer David Brown, reported:

• “There is no instrument that is specifically useful or validated for identifying potential school shooters or mass murderers.”

• “The best-known attempt to measure violence in mental patients found that mental illness by itself didn’t predict an above-average risk of being violent.”

• “(S)tudies have shown psychiatrists’ accuracy in identifying patients who would become violent was slightly better than chance.”

• “(T)he presence of a mental disorder (is) only a small contributor to risk, outweighed by other factors such as age, previous violent acts, alcohol use, impulsivity, gang membership and lack of family support.”

In hindsight, the danger Santiago represented seems clear, but psychiatrists simply cannot predict violence.

Second, the mental health system clearly did not help Santiago. The system is fundamentally misdirected towards drug treatment for the completely unproven, and likely untrue, theory that what gets diagnosed as mental illness is the result of some brain defect.

It seems fair to assume what would most likely have benefited Santiago was help dealing with his traumatic war experiences. Because of patient confidentiality we don’t know, but it seems likely Santiago was instead just given psychiatric drugs.

Third, it is known psychiatric drugs are the cause of just the sort of inexplicable mass-shootings perpetrated by Santiago. As the International Society of Ethical Psychology and Psychiatry said in a statement following the Sandy Hook school massacre:

• Christopher Pittman was on antidepressants when he killed his grandparents.

• Eric Harris, one of the gunmen in the Columbine High School shooting, was taking Luvox. His partner, Dylan Klebold, had taken Zoloft and Paxil.

• Doug Williams, who killed five and wounded nine of his fellow Lockheed Martin employees, was on Zoloft and Celexa.

• Michael McDermott was on three antidepressants when he fired off 37 rounds and killed seven of his fellow employees in the Massachusetts Wakefield massacre.

• Kip Kinkel was on Prozac when he killed his parents and then killed two children and wounded 25 at a nearby school.

• In 14 recent school shootings, acts committed by persons taking or withdrawing from psychiatric drugs resulted in over 100 wounded and 58 killed.

• In other school shootings, information about the shooter’s prescription drug use and other medical history were kept from public records.

Fourth, the over-reliance on psychiatric drugs is extremely harmful and counterproductive. These drugs are so physically harmful that those diagnosed with serious mental illness by the mental health system have a lower life expectancy of 20-25 years.

In addition, it has been shown a noncoercive approach, that selectively uses neuroleptics (mismarketed as “antipsychotics”), can achieve an 80 percent recovery rate, while our system of “drugs for everyone forever” results in only a 5 percent recovery rate.

Dr. Loren Mosher, former chief of the Center for Studies of Schizophrenia at the National Institute of Mental Health, testified in one of my cases that he probably had more experience with unmedicated psychotics than anyone alive. He said he has never had to involuntarily commit anyone because he always made it a point to establish a relationship with his patient so they could agree on a course of action.

He testified that if somebody was about to do grievous harm he would stop them in any way needed, but he had never had to because of his approach.

Locking people up and drugging them against their will is not the answer. In addition to the drugs, the violence against patients by the mental health system begets violence from some of them.

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We need noncoercive programs that help people deal with their problems and the traumatic events in their lives. We need to make people feel safe, listen to what they are telling us are their problems, and what assistance they would like.

Even the craziest person is telling us something useful if we take the time to listen and interpret. There are places that successfully do not use force against psychiatric patients.

We should start doing what works and provide noncoercive, truly helpful services for people diagnosed with serious mental illness.

Jim Gottstein was a plaintiffs’ attorney in the 1 million-acre mental health lands trust litigation, resulting in the creation of the Alaska Mental Health Trust Authority. For the past 14 years, he has donated his services to the Law Project for Psychiatric Rights. He has won five Alaska Supreme Court cases regarding involuntary commitment and forced drugging on the grounds both are unconstitutional or illegal.

The views expressed here are the writer’s and are not necessarily endorsed by Alaska Dispatch News, which welcomes a broad range of viewpoints. To submit a piece for consideration, email commentary@alaskadispatch.com. Send submissions shorter than 200 words to letters@alaskadispatch.com. 

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