Tagged: pharmaceutical industry

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.

Let’s talk (a little) about Mr Ian Hudson….


Mr Ian Hudson was inaugurated as the CEO of the MHRA in the UK (the folks who are supposed to regulate the pharmaceutical industry) in September 2013. As you can see from Mr Hudson’s expense accounts, it’s a fairly lucrative position with some great perks

   The MHRA is supposed to safe-guard the public health- in particular from the dangers of defective and faulty pharmaceutical drugs and devices and also from the deception of pharmaceutical companies. Originally conceived partly because of the horrific Thalidomide crisis 50 years ago- it seems the MHRA has done little to protect consumers from many dangerous and defective drugs since then- drugs which include GlaxoSmithKline’s notorious Seroxat anti-depressant.

   Interestingly, the MHRA head- Ian Hudson- also worked for GlaxoSmithKline at one point during his revolving door career. Even more interesting is the fact that Hudson represented GSK in a high-profile Paxil (Seroxat) liability case in the US involving a Paxil-induced murder suicide (the Donald Schell Case). GSK were eventually found guilty and they had to payout millions to the grieving son-in law- Tim Tobin. According to a 2001 Guardian article, as a witness  (and high level employee) for his employers, GSK – Mr Hudson


“…argued that the occasional suicide or killing by
somebody on Paxil is not sufficient evidence that there is a problem with the
drug, considering the millions who take it.

Tobin is outraged. Virtually all
drugs can cause a bad reaction of some sort in a few people, he says. However
small the effect is, there is no excuse for not investigating what is
happening. “I don’t think they’ve taken a proper look at the whole thing,” he
says. “We’re talking about people’s lives. Whether we are statistically
significant or not, four people dead is too many as far as I’m concerned.”

I… like Mr Tobin… am outraged– and I have been outraged at GSK from the time I came off Seroxat over 10 years ago!
 I am outraged that I was lied to about the side effects of Seroxat. I am outraged that I had to suffer a severe decline in my quality of life because GSK lied about side effects, withdrawal and suicide issues for years despite 4 BBC panorama documentaries and numerous  complaints by patients, their families and doctors about the side effects of Seroxat.
   I am outraged that the regulator is not just inept, but utterly corrupt – not to mention contemptuous of patients, advocates and consumers. I am outraged that GSK were not prosecuted despite a 4 year investigation into their misconduct regarding Seroxat killing children (and adults alike). I am outraged that I was enslaved to a drug for almost 3 years or my life. I am outraged on behalf of all those lied to about SSRI’s and other pharmaceutical drugs.
   I am outraged that people like Mr Ian Hudson have the audacity (utter gall, and brass neck) to sit at the top of a regulatory body which failed to protect vulnerable people from the dangers of a defective medication and a predatory, immoral and sociopathic drug company. A drug company which he himself once worked for and defended in court!.. in a case where they were found guilty!..
   I am outraged that Ian Hudson (a former GSK executive) didn’t even bother to turn up to a parliamentary inquiry about Seroxat a few years ago and has consistently avoided facing the consequences of the Seroxat Scandal… I am outraged at this man’s apparent utter contempt for those he is supposed to represent!
   I am not the only one writing about these scandalous issues and the Seroxat Scandal continues to be a scandal of epic proportions.  Ian Hudson presides over the organization which decides upon which medicines are safe and which are not- he defended the safety of Seroxat in a court of law in the US whilst working for the most corrupt drugs company on the planet (GSK). Seroxat has since proven to be one of the most dangerous drugs since Thalidomide- causing numerous deaths- by suicide, withdrawal, side effects and birth defects.
   Ian Hudson is apparently also a paediatrician! Surely if he is a qualified doctor specializing in children’s illnesses- he would be aware of the infamous Seroxat Study 329? A study which covered up the fact that Seroxat (Paxil/Paroxetine) drove children to commit suicide and self harm?
   Or how about the many thousands of birth defects  in  children -and miscarriages of babies which Seroxat caused for many women users -over the past 20 years? Is Ian Hudson aware of all this? Was he aware of these issues whilst working for GSK and defending Seroxat? Was he aware of this prior to his current tenure as CEO of the MHRA? Does he give a fiddlers?
   This is profoundly disturbing and the Seroxat Scandal is not something which will go away anytime soon. And in my lifetime I will continue to bang the drum about this – until justice is served! And Glaxo are brought to book!
MHRA Annual Report
Bob Fiddaman of Seroxat Sufferers blog is also- understandably- outraged, and he has been for a long time- as is the writer of Seroxat Secrets -who also touched on the Ian Hudson/GSK issues on his own blog Seroxat Secrets:

MHRA and Ian Hudson – still questions to be answered

June 15, 2009 — admin

Things have moved on at the MHRA so they tell us… it wants to be more open, it wants to engage with us…

Well, I’d like it to be more open about one of its employees, Ian Hudson.

I’ve been wanting to get to the truth since January 2005 when the House of Commons Health Select Committee questioned some senior MHRA members about Seroxat (Paxil).

Here’s some background: Ian Hudson worked at SmithKline Beecham for 11 years (Glaxo 2 weeks) as Worldwide Director of Safety. He then joined the MHRA as its Head of Drug Licensing.

During his time at SmithKline Beecham and Glaxo he had “significant involvement” with a number of drugs, especially Paroxetine (Seroxat) and two others. We know this because of this document – Ian Hudson Interests – which he filled in before joined the European Medicines Agency.

I’ve mentioned it before, but Hudson is such an authority on Seroxat that Glaxo used him as one of their defence witnesses in the famous Tobin/Schell case (he gave evidence for Glaxo alongside David Wheadon).

See below for this entry from the Seroxat Timeline.

June 14 2001:
People can’t get hooked on Seroxat as they did on the older drugs such as Librium and Valium, claims GSK.
For over a decade, the company line has been swallowed, along with the pills. But a court case in Wyoming, USA, has changed all that. The jury decided Seroxat – Paxil in the USA – was to blame for Donald Schell killing his wife, daughter, baby granddaughter and then himself.

Enter Ian Hudson, witness for the defence and at the time of his deposition earlier in 2001, worldwide safety director for GSK. That’s Ian Hudson, now director of licensing at the Medicines Control Agency in the UK (later to become the MHRA).

What did he have to say to the evidence of Mr Schell’s closest remaining family and three psychiatrists who all believed the tablets of Paxil/Seroxat Mr Schell took for just two days precipitated him into an unnatural and totally uncharacteristic murderous and suicidal frenzy? His position is that an individual case cannot tell you one way or the other – only randomised controlled trials will do.

But Dr David Healy says that randomised control trials are the wrong tool to establish whether serious side effects are occurring. The way to investigate what is happening is to carry out a challenge-rechallenge trial, where people are given the drug, taken off it and then put back on.

But GSK has not carried out that sort of study to establish whether or not Seroxat can make people agitated, suicidal, murderous or hooked. Nor has it carried out a randomised controlled trial. Here is a black hole. There is no proof that the drug does these things, says GSK, and because of that there is no reason to carry out trials that might decide it one way or the other.

Does Mr Hudson still take that view now he is at the MHRA, which watches over the safety of the British public? “If he takes the position with the MHRA that he took at the trial, then none of us is safe with any drug in the UK at the moment,” says Dr Healy. How would Mr Hudson even be able to blame alcohol for making someone drunk?

So what does Mr Hudson think? As always, the MHRA declines to answer detailed questions.

The MHRA will (?) have been supplied with all the healthy volunteer data before it granted the licence for Seroxat. It doesn’t seem to have been worried then, which makes one wonder who, exactly, was steering them as to what it meant.

More on Hudson here and here.

The strange thing is that on the day the House of Commons Health Select Committee wanted to hear evidence from the MHRA specifically about Seroxat trial data and safety, Professor Alaisdair Breckenridge (MHRA Chairman), Professor Kent Woods (MHRA CEO) and June Raine (MHRA Director of Vigilence and Risk Management) all managed to attend the hearing.

MPs had expected to be able to question Ian Hudson as well… unfortunately Dr Hudson could not attend as he had a prior engagement.

At the time, the UK press reported Ian Hudson’s non-appearance at the House of Commons like this:“Members of the House of Commons select committee on health appeared angry that they were not able to question one of the employees of the United Kingdom’s drug regulatory authority at a session last week looking into the influence of the drug industry. Although several senior figures from the Medicines and Healthcare Products Regulatory Agency attended the session, the committee said that it would also have liked to have heard evidence from Ian Hudson. Dr Hudson is a member of the agency’s executive board and was worldwide director of safety at SmithKline Beecham from 1999 to 2001, having worked for the company since 1989. Dr Hudson joined the agency’s predecessor, the Medicines Control Agency, in January 2001 as director of the licensing division. MPs wanted to question Dr Hudson about the company’s drug paroxetine (marketed as Seroxat in Britain and as Paxil in the United States). They were particularly interested in evidence concerning the safety and efficacy of the drug in people under the age of 18. In June 2003 the agency advised doctors that patients aged under 18 should not be prescribed the drug.”

I know someone who attended the hearing that day as well, and he confirms that David Hinchcliffe, the Chairman of the meeting was angry & exasperated “There was a great feeling of cover up, or at least that’s what I felt sitting there nearby Charles Medawar. Charles Medawar’s overall demeanour was one of anger, alongside David Hinchcliffe who was also angry & exasperated…”

The transcript of the hearing is here, read around question 783 for a flavour of how the committee and Chairman felt.

In response to a Freedom of Information request, the MHRA has made public an email, download here –Witnesses for Thursday.pdf – apparently showing that Hudson’s non-appearance was agreed in a phone call between Lord Warner (government Health minister) and David Hinchcliffe (meeting Chairman) just a few days before the hearing. This email was from Neil Townley at the Dept. of Health to David Harrison – the Clerk of the committee (and copied to Professor Sir Alasdair Breckenridge.

However this exchange from the hearing is most interesting:

Q790 John Austin: I think it would have been useful if Dr Hudson had been here because, as far as I understand, he was at SmithKline Beecham and his department was responsible for the collection of adverse reaction information such as there was with Seroxat.
Professor Sir Alasdair Breckenridge: Yes, I know that, but I—
Q791 John Austin: So he would have been a very key witness.
Professor Sir Alasdair Breckenridge: But I have not discussed that with Dr Hudson.
Q792 John Austin: So you must admit that it is very unfortunate he is not with us today?
Professor Sir Alasdair Breckenridge: Well, I apologise for that, but I think there was some confusion about who was going to attend and I think the Clerk was told that this was where Dr Hudson was going to be.

Why did Breckenridge reply to Q792 as he did? The email that was copied to him on Monday 17 January clearly states Lord Warner and Hinchcliffe had just agreed that it would only be Breckenridge, Woods and Raine who were appearing. For Breckenridge to say “…I think there was some confusion about who was going to attend and I think the Clerk was told that this was where Dr Hudson was going to be…” beggars belief.

Well, I think there was no confusion at all. I think the Clerk was never told that Hudson would appear. I think Breckenridge was lying when he said that. I think it would have been too embarrassing to let Ian Hudson be questioned.

I think this stinks.

Why didn’t Breckenridge simply say that “Ian Hudson is not here today because you, Mr Chairman, agreed his non-appearance with Lord Warner on Monday of this week”… (the hearing was Thursday).

And why, if Hinchcliffe did agree the list of attendees, did he say nothing to explain the confusion to the hearing….

So, the question is just what did Lord Warner say to Hinchcliffe during their phone call on the morning of Monday 17 January 2005?

Come on MHRA – let’s you and me have an open and honest discussion about this then.

GSK and the MHRA: Conflict of Interest?


http://fiddaman.blogspot.ie/2013/09/former-glaxo-safety-officer-becomes.html?utm_source=Paxil+News&utm_medium=twitter

Thursday, September 26, 2013

Former Glaxo Safety Officer Becomes Head of MHRA

Ex Glaxo Employee Ian Hudson. Now in charge of  the safety and well-being of the British public.

Former Glaxo [then SmithKline Beecham] World Safety Officer Director Dr Ian Hudson has took over the role of Chief Executive at the MHRA.

Hudson, who after leaving Glaxo in 2001, became the MHRA’s Licensing Director, responsible for overseeing the benefits and risks of drugs before they hit the market.

It is unknown why Former MHRA chief, Kent Woods, whom I’ve had much correspondence with over the years, retired.

Hudson, whilst working for GSK, was a witness for the defence [GSK] during the Tobin v SmithKline Beecham Pharmaceuticals. Donald Schell was put on Paxil [Seroxat]. Forty-eight hours later he put three bullets from two different guns through his wife’s head, as well as through his daughter’s head then through his granddaughter’s head before shooting himself through the head.

Hudson was appointed GSK’s World Safety Officer in 1999. His department was responsible for adverse events that were sent in by health professionals and members of the public.

Whilst under oath Hudson told Andy Vickery, attorney for Tobin, about his role in reviewing the link between Paxil and aggression.

“We reviewed the topic of aggression last year. At that time we said that we would keep aggression under review.  In addition, there was considerable noise in the media earlier this year about Fluoxetine.  So having said that we would keep this topic under review, we rereviewed this topic this year and it was also prompted by considerable concern being expressed, considerable noise being expressed in the media.  There were a series of articles in the “Guardian”. [British Newspaper]

Hudson was then asked by Vickery what he intended to do with the report once it was finalised, adding; Do you intend to submit it to any governmental agency?

Hudson replied:

“If a Government agency requests information on aggression and Paroxetine, we would, but we do not intend to proactively send it to them at this stage.  This was an internal review. We do many internal reviews on many topics.”

This doesn’t really install confidence in informed consent. If Hudson was back then stating that his findings would not be reported to the drug regulator then one can only assume that he still holds the belief that pharmaceutical companies are entitled to hold on to information that could endanger the public.

Later in the deposition Andy Vickery put the following to Ian Hudson:

“Dr. Hudson, are you aware of the body of literature concerning the relationship between serotonin and suicide?”

Hudson replied with…

“In general.  I’ve seen some summary information on that.  I’ve not reviewed that information in detail.  I would, again, delegate that to people within my department and also other psychiatrists within the company who are more closely involved in Paroxetine then I am, people such as Dr. Wheadon.”

Pushing Hudson for an answer Vickery then asked…

“Let me just ask you this:  Do you know whether or not there is any association between levels of serotonin or the serotonin metabolite 5-HIAA and suicidal behavior?”

Hudson answered…

Yes, I believe there is a correlation. I have seen in the literature summary
information that implies that there is a correlation between low levels of serotonin or 5-HIAA in patients’ suicidal activity.

Vickery later asked Hudson:

“Do you believe that it is possible that Paxil has caused any person, worldwide, to commit an act of homicide or suicide?”

Hudson answered:

“I have seen no evidence to suggest that at all.”

Hudson’s deposition can be viewed in full here.

Now Ian Hudson is the head honcho at the MHRA. If you take the time to read the complete deposition of Hudson you will see how he [whether under instruction or not] clearly deflects the blame of suicide and aggression onto other ‘factors’ rather than implicating Paxil.

And now this guy is in charge of regulating medicines in the UK. Do you think his presence will alter the MHRA’s stance on the safety and efficacy of SSRi type medications?

Well, I have seen no evidence to suggest that at all.

Bob Fiddaman

 

The Psychiatric Bible “DSM 5” and The Medicalization of Grief.


There has been much comment made recently online about the new edition of the psychiatrist’s diagnostic bible- the DSM 5. 

It seems that psychiatrists intend to widen the ‘depression spectrum’ now in order to include ‘grief’ as a form of mental illness. 

It will be interesting to see if this proposal actually goes into the DSM 5 when it is published soon. 

Personally- I think if ‘grief’ becomes medicalized by psychiatry- it would be a great travesty. 

Psychiatrists have already bastardized the human condition to death, and pathologized human behavior to such an extent -that now almost anybody can be diagnosed with a psychiatric illness. 

Is the psychiatric medicalization of the human grieving process a step too far?

One thing is for sure- it will widen the psychiatric catchment and make more billions for the drug companies

And that- seems to be the bottom line- as always.

From Pharmalot: 

http://www.pharmalot.com/2012/12/bereavement-depression-happy-drugmakers-pt-2/

Bereavement, Depression & Happy Drugmakers, Pt. 2

58 Comments

By Ed Silverman // December 27th, 2012 // 8:04 am

In a move certain to create controversy, the American Psychiatric Association has voted to include bereavement in the definition of major depressive disorder, or MDD, that will be contained in the upcoming version of the Diagnostic and Statistical Manual of Mental Disorders, which will be known as the DSM-5, The Washington Post writes.

The decision is significant because the manual is widely considered to be a biblical-like reference tool for psychiatrists and by eliminating the so-called bereavement exclusion – which appeared in the last DSM that was published in 1994 – the APA may generate what some experts contend could be inappropriate diagnoses and treatment (back story).

When the possibility arose last year, The Lancet wrote an editorial noting this would mean “that feelings of deep sadness, loss, sleeplessness, crying, inability to concentrate, tiredness, and no appetite, which continue for more than two weeks after the death of a loved one, could be diagnosed as depression, rather than as a normal grief reaction.”

Such diagnoses could also boost the sale of antidepressants and the Post points out that the upcoming change in the DSM-5 was developed, “in large part, by people affiliated with the pharmaceutical industry,” which helps fund the APA. Moreover, most of the experts on the committee that drafted the new guideline have either ties to pharma.

Eight of 11 members of the APA committee reported financial connections to drugmakers, the Post reports, in the form of speaking or consulting fees, research grants or stock holdings, according to the disclosures filed with the APA. Six reported financial ties during the time that the committee met, and two more reported financial ties in the five years leading up to the committee assignment, according to APA records, the Post writes.

In addition, the paper adds that Sidney Zisook, a psychiatrist at the University of California, San Diego, and a key adviser to the committee, was the lead author of a 2001 study that found the Wellbutrin antidepressant could be used to treat bereavement. Glaxo, which sponsored the study, markets the Wellbutrin and Paxil antidepressants (see this).

As noted last year, he has received honoraria from Glaxo (GSK) and AstraZeneca (AZN), which sells Seroquel, an antipsychotic that is approved for adjunctive treatment of MDD, although he tells the Post that work preceded his involvement in the DSM-5 guidelines.

Such conflicts are not surprising. A paper published last year in PLos Medicine noted that 69 percent of the DSM-5 task force members have ties to drugmakers, which is up from 57 percent of the DSM-IV task force members. The paper also found gaps in the APA disclosure policy of DSM committee members (back story).

As we wrote at the time, 67 percent of the panel for mood disorders, 83 percent of the panel for psychotic disorders and all of the panel for sleep and wake disorders have ties to drugmakers that sell meds for treating these disorders or companies that somehow service the industry.

“It’s not that this is a Machiavellian plot by the pharmaceutical industry,” Lisa Cosgrove, a research fellow at the Edmond J. Safra Center for Ethics at Harvard University and a psychology professor at the University of Massachusetts, tells the Post.

“But when you have so many of these industry relationships on a committee, it creates a pro-industry bias that compromises their ability to be objective,” she adds. Cosgrove was a co-author of the PLoS Medicine paper that last year criticized the APA.

APA ceo James Scully Jr. tells the Post that the organization took steps to reduce conflicts as part of its preparation for the DSM-5. The APA, for instance, required that panel members regularly file disclosures and placed limits on their financial connections to drugmakers, the Post writes.

Each committee member was allowed to receive up to a $10,000 in annual income from drugmakers, hold as much as $50,000 in stock and receive unlimited amounts of money to conduct research. He maintains that, if no financial ties were permitted, many qualified psychiatrists would be excluded because many university studies are funded by pharma, according to the Post.

However, the Post notes that a survey of academic researchers found that 36 percent of full professors at medical schools report no financial connections to pharma in the previous year.

David Healy and Critical Psychiatry


011 Andrew Herxheimer Talk & Panel Discussion with Professor David Healy, chaired by Dr Joanna Moncreiff- with closing remarks a

by APRILPLUS 1 year ago / 

Creative Commons License:

 by

nc

Adverse side effects of medicines and anaesthetics also called adverse drug reactions (ADRs) or iatrogenic illness, is a major public health problem. Admissions to UK hospitals due to ADRs increased by 78% in ten years to 2009.

A remarkable conference to discuss the problems held in 2008, was organised by APRIL charity (Adverse Psychiatric Reactions Information Link. This video clip is the panel session, the end of the conference and features most of the speakers and questions from the audience. Closing remarks by Dr Andrew Herxheimer, Millie Kieve (Founder of APRIL) and Lucille Grant (trustee of APRIL)

The session is chaired by Dr Joanna Moncrieff, psychiatrist, author of ‘The Myth of the Chemical Cure’ and member of the Critical Psychiatry Group who are concerned about over use of psychiatric medication.

GlaxoSmithKline ‘avoided corporation tax bill of £34m’


http://www.thisismoney.co.uk/money/markets/article-2142529/GlaxoSmithKline-avoided-corporation-tax-34m-according-BBC.html

GlaxoSmithKline ‘avoided corporation tax bill of £34m’
By DAILY MAIL REPORTER
PUBLISHED: 20:50 GMT, 10 May 2012 | UPDATED: 20:50 GMT, 10 May 2012

Drugs giant GlaxoSmithKline avoided up to £34m in UK corporation tax last year through a deal with Luxembourg, according to an investigation by the BBC.
The UK firm set up a new company in the European tax haven in 2009 and the next year the subsidiary lent the parent £6.34bn.
In return, the UK firm paid nearly £124m in interest back to the Luxembourg unit – meaning it did not have to pay British corporation tax of 28 per cent on the money.

Artificial structuring: The UK firm set up a new company in Luxembourg in 2009
The Luxembourg tax authorities charged a levy of less than 0.5 per cent – costing GSK just over £300,000, according to Panorama. ‘As a result, GSK potentially avoided up to £34m in UK corporation tax,’ the BBC claimed.
Chancellor George Osborne is trying to crack down on tax avoidance in the UK by major corporations and wealthy individuals. Tax avoidance by big business is reckoned to cost between £1.5bn and £6bn a year.

Former HMRC investigator Richard Brooks said: ‘We’re seeing…exactly how companies avoid tax through a jurisdiction that wants to help them do it.’

GSK struck a deal with HMRC in 2011 and closed down the £6.34bn loan operation through Luxembourg.
In a statement, it said: ‘Both the UK and Luxembourg tax authorities are agreed we have paid all the taxes that are due. We take very seriously our duty to pay tax. But we also have a duty to our shareholders and patients to be financially efficient so we can maximise returns to investors and fund the development of future medicines.’

Glaxo pointed out it has paid more than £1bn in UK corporation tax since 2008.
Tax expert Richard Murphy said the scheme was ‘absolutely, without a shadow of a doubt, legal’. But he added:

‘I’m still able to ask the question, is this acceptable?
‘Look, this is purely artificial structuring which is designed to undermine the tax revenues of the UK.’

Read more: http://www.thisismoney.co.uk/money/markets/article-2142529/GlaxoSmithKline-avoided-corporation-tax-34m-according-BBC.html#ixzz1unMXZr6L

Seroxat Secrets asks : “Can you really believe they said this?”


Great new post over at Seroxat Secrets detailing some (quite amazing) GSK quotes about Seroxat over the years. It really is utterly remarkable how they get away with this crap….

http://seroxatsecrets.wordpress.com/2012/05/12/can-you-really-believe-they-said-this-2012-reprise/

Can you really believe they said this – 2012 reprise
May 12, 2012 — admin
They say hindsight is 20/20 vision.

Well, here are a bunch of quotes I’ve posted over the years for you to consider with the gift of hindsight.

It’s not possible really to measure total serotonin. We do not know with absolute certainty about how any of the antidepressants work.
Alan Metz
Glaxo Vice President for Clinical Development
source: Generation RX

No, we are not misleading them [patients]. The information in the patient leaflet and in the information we supply to doctors, is based on fact.
Dr. Alastair Benbow
Head of European Psychiatry for GlaxoSmithKline
10/13/02

….there have been a number of systematic studies in humans looking at the potential for Paxil for abuse, tolerance and physical dependence. So actually, there is data to date to negate the statement that it has not been systematically studied, because, in fact, it has been.
Dr. David Wheadon
Senior Vice President
GlaxoSmithKline Regulatory Affairs and Product Professional Services
10/19/2000

Physical and Psychologic Dependence: PAXIL has NOT been systematically studied in animals or humans for its potential for abuse, tolerance or physical dependence. While the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic…
GSK Patient Information Leaflet

If ‘discontinuation reactions’ occur in patients stopping [Paxil], the majority will experience symptoms that are mild to moderate in intensity, and are usually limited to two weeks.
Mary Anne Rhyne
GlaxoSmithKline spokesperson
2005

Drugs like Seroxat [Paxil] have been around for almost a decade and help millions of people fight depression. There’s no reliable scientific evidence to show they cause withdrawal symptoms or dependency.
Alan Chandler
GlaxoSmithKline spokesperson

These problems [’discontinuation reactions’] are just the body’s adjustment when you stop taking medicines. It takes more than that to be addictive.
Mary Anne Rhyne
GlaxoSmithKline spokesperson
8/21/2002

The side effects [of Paxil “discontinuance”] are things like dizziness, nausea, headache, um, and are clearly labeled in the information made available to doctors and patients.
Dr. Alastair Benbow
GlaxoSmithKline’s European Medical Director
Source: GSK’s web site 2004

I think patients have nothing to fear from taking Seroxat.
Dr. Alastair Benbow
GlaxoSmithKline’s European Medical Director
6/13/2002

Experts including the FDA and leading physician and mental health organizations agree that antidepressant medications like Paxil are non-habit-forming.
David Stout President
US Pharmaceuticals
GlaxoSmithKline
10/10/2002

It was quite clear from talking to patients and as a doctor that’s very, very important to me, it’s quite clear that the phrase “Seroxat is not addictive” was poorly understood by them.
Dr. Alastair Benbow
Head of European Psychiatry for GlaxoSmithKline
5/11/03

I think you have to develop a culture where if there is bad news you don’t sit on bad news. Bad news does not get any better. It can only get better if it’s admitted, understood and addressed.
Robert (Bob) Ingram
Vice Chairman, GlaxoSmithKline Pharmaceuticals
8/25/2002

We’re reviewing every single process at the company. The environment of the business has changed after Enron. I believe that there was a lack of trust [on the part of] the public for big business, and that lack of trust has been amplified by a few bad apples in the cart. And because of that, there has been a tremendous loss of trust in all big business not just pharma and that has implications to me as a CEO.
Jean-Pierre Garnier
Chief Executive Officer, GlaxoSmithKline
10/4/2004

Obviously doctors are very busy people, and their day is packed with patients. The question is how do doctors get information about medicines and new research into treatments and disease, and one of the easiest ways is this kind of presentation [”dine and dash”]. We think this is a benefit to both physicians and patients.”
Mary Ann Rhyne
GlaxoSmithKline spokesperson
11/11/2002

We don’t want to be accused of anything about the way we deal with trials.
Jean-Pierre Garnier
Chief Executive Officer, GlaxoSmithKline
6/21/2004

As a knowledge-based industry we understand full well the value of information, and we want to create a climate of openness where the evidence for prescribing our products is clear.
Richard Sykes
Chairman of Glaxo Wellcome
6/19/2004

I think if, if we’ve been guilty of anything over the past few years, perhaps, um, emphasizing entertainment over education, um, we know that’s what patients really want.
Christopher Viehbacher
GlaxoSmithKline U.S. President
8/16/05

Seroxat does have side effects, but these are clearly stated in the information that’s made available to doctors and to patients.
Dr. Alastair Benbow
Head of European Psychiatry for GlaxoSmithKline
10/13/02

My wife thinks J.P. [Garnier] is the best thing since sliced bread.
Christopher Viehbacher
GlaxoSmithKline U.S. President
7/21/03

We are a high-integrity company. We know what the rules are and we follow them.
Jean-Pierre Garnier
Chief Executive Officer, GlaxoSmithKline
6/6/2004

The vast majority of drugs more than 90 per cent only work in 30 or 50 per cent of the people, I wouldn’t say that most drugs don’t work. I would say that most drugs work in 30 to 50 per cent of people. Drugs out there on the market work, but they don’t work in everybody.
Dr. Allen Roses
GlaxoSmithKline Senior V.P.
Genetics Research
12/8/2003

If anyone thought drugs were without side-effects, hopefully that’s over. All drugs have side-effects. We are having to spend hundreds of millions of dollars on lawyers.
Jean-Pierre Garnier
Chief Executive Officer
GlaxoSmithKline
4/23/2005

We follow the law, and we follow government guidelines.
Mary Anne Rhyne
GlaxoSmithKline spokesperson
8/26/2005

This is a company that is reinventing itself … possibly creating a model for pharma companies.
Jean-Pierre Garnier
Chief Executive Officer
GlaxoSmithKline
7/21/03

The evidence, however, is clear, these medicines are not linked with suicide, these medicines are not linked with an increased rate of self harm.
Dr. Alastair Benbow
GlaxoSmithKline’s European Medical Director
10/3/2004

So we always want to make sure we are serving the good, the right purpose….
Dr. David Wheadon
Senior Vice President
GlaxoSmithKline Regulatory Affairs and Product Professional Services
9/9/2004

I’ll be a hero in three years.
Jean-Pierre Garnier
Chief Executive Officer GlaxoSmithKline
4/5/2004

I am sure it happens because academics are very, very busy people, and they prefer to do research than spend a lot of time writing papers. If the industry puts forward a method of relieving them of that chore, then I am sure that that does happen throughout the industry. That would be true generally. Is it a good idea? I think it can be, as long as everybody is in agreement with what is written at the end of the day, the results and what they are.
Sir Richard Sykes
former Chairman of GlaxoSmithKline
On the industry practice of “ghostwriting medical reports” and “gift authorship.” 12/7/2004

We have acted responsibly in conducting clinical studies in pediatric patients and the dissemination of the results. We would strongly disagree with any allegation that we have done otherwise.
Dr. Tadataka Yamada
Chairman of Research and Development
GlaxoSmithKline
6/19/2004

You can experience symptoms, as you can with other SSRIs and as you can with other kinds of medicines as well.
Mary Anne Rhyne
GlaxoSmithKline spokesperson
12/13/2003

What we have seen in terms of the anecdotal reports [of Paxil withdrawal] is that it happens very rarely.
Dr. David Wheadon
Senior Vice President
GlaxoSmithKline Regulatory Affairs and Product Professional Services
8/25/2000

While GlaxoSmithKline strives to produce medications that safely and effectively treat medical conditions, we’re also committed to protecting the environment.
Dr. Anne Phillips
Chief Medical Officer of GlaxoSmithKline

source: GlaxoSmithKline

As you can see here, few numbers of patients experienced any adverse event after being randomized off [Paxil] into the placebo group and the percentages are certainly very small. But these were the common adverse events seen in that small population in our attempt to systematically assess a discontinuation syndrome.
Dr. David Wheadon
Senior Vice President
GlaxoSmithKline Regulatory Affairs and Product Professional Services Excerpt from a transcript of the FDA Review of Paxil
10/5/1992

I have my iPod and my Bose headphones. You can run anywhere. I’m in a bubble. When I go home I don’t talk about my job. It drives my wife crazy because when we go out she doesn’t know anybody. Socially we see politicians we have to and she knows nothing about the issues. But that’s the way I like it. I want to go home and say, ‘hey what happened to you?’ I have a very demanding job and I don’t want to go home and discuss the same stories.
Jean-Pierre Garnier
Chief Executive Officer
GlaxoSmithKline
4/23/2005

We feel strongly that we have an obligation to speak up both for the millions of patients that Seroxat allows to lead a normal life, and for our employees whose commitment to this important medicine has made such a positive difference to so many people.
Eddie Gray
General Manager
GlaxoSmithKline UK
10/10/2002

My mum, you know, she thinks her son walks on water…..
Jean-Pierre Garnier
Chief Executive Officer, GlaxoSmithKline
4/23/2005

….recognize that in the final analysis success rests on selecting the right people to work with. If you have the right people, the rest will follow.
Jan Leschly
Former CEO of SmithKline Beecham

It’s becoming too easy for many people to attack the pharma industry and hold the pharma industry to standards that are higher than anywhere else. I don’t have a problem with the standards….

Jean-Pierre Garnier
Chief Executive Officer
GlaxoSmithKline
6/6/2004

Of course we didn’t follow this advice. Of course we didn’t selectively publicize the data. This is not a smoking gun. It’s a stupid memo and there are lots of stupid memos in every company’s file and it is really unfair to look at the company’s action through the small hole of one memo written among thousands and thousands in 1998. I do regret that those memos exist but I’m not going to lose sleep over the fact.
Jean-Pierre Garnier
Chief Executive Officer
GlaxoSmithKline
6/6/2004

I utterly refute any allegations we are sitting on data, that [we] have withheld data or anything like that. We have provided all the data both relating to safety and efficacy in the pediatric population to the regulatory authorities around the world and have hidden nothing.
Dr. Alastair Benbow
Head of European Psychiatry for GlaxoSmithKline
6/15/2003

Corporate responsibility is not just a job for selected people at GSK, it defines the way we do business. Our ten corporate responsibility principles set thestandard for everyone, since responsible business is only a reality if it is practised by all employees at all times.
Christopher Gent
GlaxoSmithKline Chaiman
Jean-Pierre Garnier
GlaxoSmithKline CEO
GlaxoSmithKline 2004 “Corporate Responsibility Report”

The overwhelming view of independent medical experts and regulatory bodies around the world who have seen the data, is that Seroxat has a well established safety profile and is an effective treatment with experience in tens of millions of patients worldwide since launch in the UK over ten years ago.
Dr. Alastair Benbow
Head of European Psychiatry for GlaxoSmithKline 10/10/2002

Human behavior is we know so little about it, and therefore, to try to speculate on a mechanism for human behavior is very difficult.
Dr. Tadataka Yamada
Chairman of Research and Development GlaxoSmithKline 1/24/2001

Sometimes a system indeed hinders your rise up the ladder but you also have to accept personal responsibility. That translates into realizing that it’s not always someone else’s fault that you didn’t get promoted. You have to ask some serious questions of yourself before you point the finger at someone else. Ask yourself, `What have I done?’ ‘What is my role in this?’ ‘What am I willing to do?’
Dr. David Wheadon
Senior Vice President
GlaxoSmithKline Regulatory Affairs and Product Professional Services
10/26-27/1995

If we meet the test of our highest purpose nothing less than making historic contributions to human welfare then we will surely meet our important responsibilities to other GlaxoSmithKline stakeholders, to the investors who put their trust in our performance, to the communities in which we operate, to our colleagues and to ourselves.
Dr. Tadataka Yamada
Chairman of Research and Development
GlaxoSmithKline from GSK’s web site

We are all in favour of this being scrutinized all the time, because it is not in our interests to have a product on the market that is not safe or effective.
Jean-Pierre Garnier
Chief Executive Officer
GlaxoSmithKline 2/15/2002

I think fundamentally the public needs to be reassured that multinational companies and globalisation are not bad quite the reverse.
Jean-Pierre Garnier
Chief Executive Officer
GlaxoSmithKline
2/18/2003

We take the safety of our medicines extremely seriously….
Dr. Alastair Benbow
GlaxoSmithKline’s European Medical Director
Source: GSK’s web site 2004

First of all let me say that we, as a manufacturer of pharmaceutical products and vaccines, take any report of an adverse event on any of our products, seriously.
Dr. David Wheadon
Senior Vice President
GlaxoSmithKline Regulatory Affairs and Product Professional Services
1/31/2001

Great [GSK] products, however, are not the whole story society expects companies to act responsibly in their pursuit of success. If anything, the fact that our business is about human health makes it even more important that we operate to the highest standards.
Christopher Gent
GlaxoSmithKline Chaiman
Jean-Pierre Garnier
GlaxoSmithKline CEO
GlaxoSmithKline 2004 “Corporate Responsibility Report”

I think to focus on safety is important.
Dr. Tadataka Yamada
Chairman of Research and Development
GlaxoSmithKline
3/01/05

….my experience is that most physicians don’t look at the [a drug safety] label very carefully. And I’m not certain. I personally am not certain whether it would make a difference whether something was in a black box or in a warning section or in a precaution section….
Dr. Tadataka Yamada
Chairman of Research and Development
GlaxoSmithKline
1/24/2001

Responsible business practices are also the key to a good reputation. In 2004, the pharmaceutical industry and GSK continued to come under public scrutiny on how medicines are developed, tested and marketed. To meet this challenge we must act with integrity and be open about our approach to these important issues.
Christopher Gent
GlaxoSmithKline Chaiman
Jean-Pierre Garnier
GlaxoSmithKline CEO
GlaxoSmithKline 2004 “Corporate Responsibility Report”

Our concern is people’s safety.
Jean-Pierre Garnier
Chief Executive Officer, GlaxoSmithKline
3/1/2003

Anybody who suffers side effects of any sort I feel every sympathy for….
Dr. Alastair Benbow
Head of European Psychiatry for GlaxoSmithKline
5/11/03

Everybody who has looked at this the FDA, American Psychiatric Association, National Mental Health Association all those groups agree that SSRIs, like Paxil, are not addicting and not habit forming.
Andrew T. Bayman
attorney for GlaxoSmithKline
King & Spalding

GSK strongly stands behind the safety and efficacy of Paxil. Physician organizations, like the American Psychiatric Association, have stated that antidepressants are not habit-forming.
David Stout
President of U.S. Pharmaceuticals, GlaxoSmithKline

GlaxoSmithKline is proud to offer physicians Paxil CR the latest treatment advance in the SSRI class.
David Stout
President, US Pharmaceuticals, GlaxoSmithKline
4/19/2002

We missed something big we missed the fact that the public wasn’t going to necessarily trust us.
Jean-Pierre Garnier
Chief Executive Officer, GlaxoSmithKline
8/13/2005

Seroxat Videos : Staggering …


Bob Fiddaman has just posted links to 49 available Seroxat videos on youtube. This is a staggering amount of web video’s documenting the side effects of a very dangerous drug. And GSK still claim that this drug is effective. Many would beg to differ, GSK.

http://fiddaman.blogspot.com/2012/05/seroxatpaxilaropaxand-some-videos.html

SATURDAY, MAY 12, 2012

Seroxat/Paxil/Aropax…and Some – The Videos

Fid

ORDER THE PAPERBACK ‘THE EVIDENCE, HOWEVER, IS CLEAR…THE SEROXAT SCANDAL’ By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE

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GSK: Seroxat: Insight into how pharma manipulates research evidence: a case study


http://theconversation.edu.au/insight-into-how-pharma-manipulates-research-evidence-a-case-study-4071

5 April 2012, 6.41am AEST
Insight into how pharma manipulates research evidence: a case study

AUTHOR

Jon Jureidini
Professor of Psychiatry at University of Adelaide
DISCLOSURE STATEMENT

Jon Jureidini receives funding from the ARC. He is affiliated with Healthy Skepticism.

The Conversation
The Conversation is an independent source of information, analysis and commentary from the university and research sector—written by acknowledged experts, curated by professional editors and delivered direct to the public. read more
ARTICLES BY THIS AUTHOR

2 February 2012
Time to go back to the drawing board on mental health reform
12 May 2011
You can work it out: shrinks aren’t always the best option

SKB knew eight adolescents self-harmed or reported emergent suicidal ideas compared to only one in the placebo group but hid this. Michael Valli
TRANSPARENCY AND MEDICINE – A series examining issues from ethics to the evidence in evidence-based medicine, the influence of medical journals to the role of Big Pharma in our present and future health.

Here Jon Jureidini explains what he encountered while examining internal documents as an expert witness in a case against a pharmaceutical company.

It’s well known that academic literature on medication in psychiatry is distorted by selective publication – failing to publish studies with negative results or selectively publishing only positive results from studies with mixed outcomes.

I had the unusual opportunity to see inside the process of how the marketing department of a pharmaceutical company controls and distorts information in the medical literature. This chance arose when I was provided with access to a huge number of internal documents because I acted as an expert witness for a US law firm.

Between 1993 and 1998, SmithKline Beecham (SKB, subsequently GlaxoSmithKline) provided $5 million to various academic institutions to fund research into paroxetine (also known as Aropax, Paxil (GSK) or Seroxat), led by Martin Keller. Keller was from Brown University and received $800,000 for participation in the project.

The results were published in 2001 by Keller et al. in the journal article, “Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial”, in the Journal of the American Academy of Child & Adolescent Psychiatry (JAACAP). The article concluded that “paroxetine is generally well tolerated and effective for major depression in adolescents”.

This was a serious misrepresentation of both the effectiveness and safety of the drug. In fact, when SKB set out their methodology for their proposed study protocol, they had specified two primary and six secondary outcome measures. All eight proved negative, that is, on none of those measures did children on paroxetine do better than those on placebo.

HmanJp/ Wikimedia Commons

The published article misrepresented one of the primary outcomes so that it appeared positive, and deleted all six pre-specified secondary outcomes, replacing them with more favourable measures.

SKB papers also revealed that at least eight adolescents in the paroxetine group had self-harmed or reported emergent suicidal ideas compared to only one in the placebo group. But these adverse events were not properly reported in the published paper. Instead, some were described as “emotional liability” while others were left out altogether.

Although published in Keller’s name, the article was ghostwritten by agents of SKB, and the company maintained tight control of the article’s content throughout its development.

GlaxoSmithKline’s internal documents, disclosed in litigation, show that company staff were aware that the study didn’t support the claim of efficacy but decided it would be “unacceptable commercially” to reveal that.

According to a company position paper, the data were selectively reported in Keller et al.’s article, in order to “effectively manage the dissemination of these data in order to minimise any potential negative commercial impact”.

Ano Lobb/Flickr

As it turns out, the Keller et al. article was used by GlaxoSmithKline to ward off potential damage to the profile of paroxetine and to promote off-label prescribing to children and adolescents.

While problems with the study and the Keller et al paper have been thoroughly exposed in legal actions, the bioethical and medical literature, a book, and a BBC Panorama documentary, the paper continues to be cited uncritically as evidence of the efficacy of paroxetine for treatment of adolescent depression.

Repeated attempts to get JAACAP to retract the offending paper have been unsuccessful.

For paroxetine, the concern is that adolescents are being harmed because well-intentioned physicians have been misled about its safety and effectiveness.

But more broadly, the case raises questions about how widespread such dubious practice is in the academic community, and in the editorial practices of “scientific” journals.

This is the ninth part of Transparency and Medicine. You can read the previous instalment by clicking the link below

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