Sir Witty Is On The Way Out..


Article is not great – however the comment on it gets to the crux ..

“…During his period as CEO, Whitty clearly managed to ‘deliver some growth’ in his salary, which in 2015 was 257 times the UK average, at £6,700,000…”

Enjoy the millions Sir Witty….

Don’t lose sleep over all the dead bodies from Seroxat and Avandia


The GlaxoSmithKline boss kept his title and won praise for slashing prices in poor countries – but his executives rather let him down in China

Sir Andrew Witty will be at helm for full-year results.
Sir Andrew Witty will be at helm for full-year results. Photograph: Fabrice Coffrini/AFP/Getty Images

So it’s farewell to Sir Andrew Witty, the boss of pharma group GlaxoSmithKline and one of the few businesses knights who hasn’t disgraced himself enough to have a campaign to strip him of his title.

He’s been on one of those long City goodbyes where he announces he’s off but then stays for a lap of honour, and this week is the final time we will hear Glaxo’s full-year results with Witty at the helm.

It may be a decent time to wean himself off the attractions of the boardroom, too. Analysts at Berenberg muse: “Outside of the HIV business, the rest of the pharmaceuticals business is not expected to deliver much growth. However, GSK does have a deep pipeline, albeit at relatively early stages of development.”

So what will Witty be remembered for? Well, in development circles it will surely be his lauded decision to slash GSK’s prices in the poorest countries to no more than 25% of the UK price.

Yet others may recollect different events, including the company getting whacked with a £1.9bn fine in the US in 2012, after admitting bribing doctors – plus that memorable scandal shortly afterwards involving a GSK executive in Asia, a sex tape and favours given to Chinese doctors for using GSK products. Witty described the latter as “a disappointment”.

What’s Glaxo’s Andrew Witty’s Definition Of ‘Normal Behavior’?


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“It’s difficult to get a man to understand something, when his salary depends on his not understanding it”

Upton Sinclair


A few days ago, I posted a link online to a publicly available document. This document is basically a legal writ (lawsuit/complaint), taken by Peter Humphrey, against the drug company GlaxoSmithKline.(see here)

The gist of Peter’s story with Glaxo has already been discussed in some previous posts, by Bob Fiddaman, on his Seroxat Sufferers Blog. Myself and Bob have been writing about the Seroxat scandal (and GSK’s nefarious conduct) for many years and we know each other quite well, so I am sure he won’t mind me using a summary from his posts, in order to explain some context for my own post on this.

Peter’s story of his experiences with Glaxo (documented in his legal complaint) is both intriguing and harrowing. It reads like something from John Le Carre’s ‘Constant Gardener’. The writ is fascinating, even just in terms of the depth of Glaxo’s dodgy conduct described, and the allegations alone are also shocking (but probably unsurprising for many  Glaxo- observers) however, the most interesting part of his legal complaint (in regards to Glaxo’s conduct)- for me -is contained the following section:

Under the heading (on page 25) :

GSK Lies About Knowledge of Corruption and Refuses to Admit Why It Hired Plaintiffs

The Complaint states-

“…Witty argued, nonsensically, that the previous whistle-blower allegations were “quite different” from the more recent charges, saying, “they are two completely different sets of issues, we fully investigated the first and, of course, this has now surfaced in the last couple of weeks.”

This was a lie,

since “what surfaced” in the PSB investigation and raids of GSK offices in July was precisely the illegal activity that the whistleblower had documented and threatened to reveal in January…”

gsk-lies-1gsk-lies-2


What I find fascinating about all of this is, whenever GSK get embroiled in a scandal- the company’s PR machine seems to think that the public will swallow any crap that they spew out in regards to their conduct. They don’t seem to realize that they have absolutely no credibility with the general pubic. They are proven liars, deceivers, felons, and fraudsters. The company has been proven time and time again to be nothing but utterly corrupt to the core.

So why should we believe anything they say?

In short, we shouldn’t.

If GSK was a living human individual, we would likely consider them to be a compulsive liar, a sociopath, and an utterly reprehensible person. For the amount of damage (and death) that they have caused over the past few decades, we’d lock them up for life and throw away the key. However GSK isn’t a human individual, it’s a corporate entity made up from a hundred thousand individuals with one man at the helm- the CEO- Andrew Witty.

Witty is the boss at GSK, therefore surely he is responsible for the GSK China  bribery crisis because it happened under his watch? The document above seems to suggest that Witty (and indeed GSK) knew much more about the corruption in China, than has been admitted publicly, when it was first exposed.

It’s classic GSK behavior to deny and deflect the truth whenever a scandal occurs about the company. They have proven time and time again to be utterly untrustworthy so why would GSK’s China Bribe scandal be any different? or more to the point-why would GSK’s behavior be any different?..

In an interview with Evan Davis of the BBC, some months ago, Andrew Witty avoided Evan’s questions about GSK’s bribery network in China. Evan asked Mr Witty, in the China case, “was that normal behavior”?

(see clip here)

Evan Davis:

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

Andrew Witty:

-“For obvious reasons, I’m not going to get into all the details of that.”


It’s interesting that Witty chose not to discuss if GSK’s massive bribery scandal in China was normal behavior?

GSK’s China bribe scandal is a can of worms that Witty could never publicly delve into. There’s too much at stake for him, and for Glaxo to ever discuss their abhorrent behavior in China, however that might all change soon…

Glaxo’s conduct in China is shocking, and utterly disgraceful, and it’s a can of worms that’s just about to spill open with the release of details in Peter Humphrey’s recent writ against them.

In Peter Humphrey’s complaint it is alleged:

 – Between 2010-2013 GSK spent nearly $225 million on planning and travel services. Approx 44% of the sampled invoices were inflated and approximately 12% were for events that did not occur.

 – GSK set up a special “crisis management” team in order to bribe Chinese regulators with money and gifts. A GSK executive attempted to bribe a Chinese investigator with an IPad and a lavish dinner. All bribes were approved by the head of Chinese operations, Mark Reilly.


 – GSK planned to suppress evidence of its illegal bribery activities.


 – As far back as 2008, GSK China deliberately falsified its books and records in order to conceal its illegal practices in China. These included, bribery and promotion of drugs for purposes that have not been approved by the Chinese authorities.


 – GSK paid a patient RMB 50,000, who nearly died after being given Lamictal off-label. Despite having knowledge of Lamictal causing near death in this patient, GSK still told its reps to promote the use of Lamictal for off-label purposes.


 – GSK targeted ‘persuasive doctors’ in attempts to influence purchasing decisions at their hospitals. GSK are to said to have forged a connection with these doctors by taking them to expensive lunches and dinners and also giving them gifts and cash.


 – GSK paid between 500 and 1,000 doctors to go on an all-expenses paid holiday to locations such as Brazil, India, Israel, Greece, Japan and Hungary. GSK covered all costs, including cash to cover meals and sight-seeing excursions. These were disguised by GSK as “Conference trips.”


 – Head of Chinese operations, Mark Reilly, received a bribe in the form of ‘sexual relations’ in return for passing business on to China Comfort Travel, a travel agency who organised ‘conference sevices’ for GSK.


 – GSK paid doctors based on their prescription numbers.


 – GSK’s senior legal counsel, Jennifer Huang, asked private investigator, Peter Humphrey, to investigate the Public Security Bureau and to prepare an analysis of the Chinese political regime. Huang told Humphrey that she wanted to find out who’s who regarding the team who were investigating GSK.


 – Humphrey became concerned that GSK were trying to obstruct the investigation and declined to investigate state secrets.


 – Humphrey was also asked, by GSK, to look into the Ministry of Public Security, the Economic Crimes Investigation Department regarding the relationship between them and  the Public Security Bureau. Humphrey, once again, declined.


 – Head of Chinese operations, Mark Reilly, told Humphrey that the alleged whistleblower, Vivian Shi was “coming after him.” (Humphrey).  Reilly then fled China the following day.


 – GSK China told its employees to “destroy all non-compliant promotional materials and gifts.” They also implemented a new email system and deleted emails that were more than a year old. They claimed this was to “reduce unnecessarily legal costs.”…


Humphrey’s complaint against Glaxo is not just important in terms of how it further exposes Glaxo as a truly despicable, unethical, corrupt organization, but it must also be personally important for Peter too. Glaxo’s treatment of Peter and his wife throughout this whole debacle is extremely disturbing and sinister. (read the complaint here and see just how chilling Glaxo’s behavior is towards those who they consider utterly dispensable).

It’s obvious to me that Peter and his wife Yu Yingzeng were scapegoated by Glaxo. GSK’s top man in China Mark Reilly ran the bribery network, he was found guilty by the Chinese, but he got off, and he was sent back to the UK. Peter and Yu were imprisoned instead of Reilly. Their treatment in prison is deplorable, and their treatment by Glaxo, previous to their incarnation, during, and after has been equally bad.

I can relate to mistreatment from Glaxo, unfortunately I was prescribed one of their dangerous shoddy drugs (Seroxat), and if that horrific scandal is anything to go by, we should not be surprised at the depths that this horrible company will stoop in its pursuit of profits at the expense of human life…

From the New York Times:

“…The complaint, filed at the United States District Court in Philadelphia and made public on Wednesday, was brought by Peter Humphrey, who is British, and Yu Yingzeng, his wife, who is American.

The couple were detained in 2013 and found guilty by a Chinese court in 2014 after being asked by Glaxo to investigate a whistle-blower within the pharmaceuticals group.

They were convicted of illegally obtaining private records of Chinese citizens.

The couple said that Glaxo misled them by stating that the whistle-blower’s accusations of widespread corruption within the company were false. The company was fined a record 3 billion renminbi (nearly $500 million) in 2014 for paying bribes to doctors to use its drugs.”


It will be interesting to see how Peter Humphrey’s complaint against Glaxo progresses, and it will be even more interesting to see if Andrew Witty will be called forth as a witness if a trial occurs.

Perhaps the judge will ask Witty, what his definition of normal behavior is…

I guess we will have to wait and see.

However, in the meantime, I would like to ask Andrew Witty does he consider the following things ‘normal behavior’?

Was the off-label promotion of Seroxat/Paxil to teens (based on a bogus study-329) ‘normal behavior’ for Glaxo? (see here)

Is the production of contaminated products at Glaxo’s facilities considered ‘normal behavior’? (see here,  and here)

(For more examples of ‘normal’ Glaxo behavior see the hundreds upon hundreds of posts that I have posted about Glaxo on this blog for the past ten years- see the archives here)

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


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

Thursday, November 17, 2016

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

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

A 42 page complaint was filed on November 15, 2016, by Peter Humphrey and his wife, Yu Yingzeng, in relation to GSK’s nefarious activities in China which saw the pair incarcerated for around 2 years in Chinese slum-like conditions prison cells.

The complaint delves deep into the whole sordid affair and alleges bribery on a huge scale, more importantly, the complaint alleges that GSK hired the services of Humphrey and Yu in efforts to smokescreen the corruption in China, corruption, according to the complaint, that they had known about for many years. Furthermore, the 42 page document alleges that GSK’s CEO, Andrew Witty, lied to the media when he was asked about the corruption in China.

Humphrey and Yingzeng were the founders of ChinaWhys, a professional-services consultancy that specializes in discreet risk mitigation solutions, consulting and investigation services to corporate clients in matters of high sensitivity across Greater China and the Asia Pacific.

On April 15, 2013, Humphrey met with GSK’s Head of Chinese operations, Mark Reilly, April Zhao, GSK China legal counsel and Brian Cahill, also GSK legal counsel. It was at this meeting that Humphrey was told that GSK had been sent a series of emails from a whistleblower alleging widespread corruption – GSK told Humphrey that they believed they knew who the whistleblower was.

Vivian Shi had previously worked for GSK as a government affairs director, GSK had terminated her services with them in December 2012. According to the complaint GSK claimed that Shi had orchestrated a “smear campaign” against GSK involving a total of 23 emails that had been sent to Chinese officials throughout the country, a letter had also been sent to GSK’s ‘top management’ alleging widespread corruption in GSK’s pharmaceutical and vaccine business that had been approved by GSK China’s senior management.

These were allegations brought to Humphreys attention just months after GSK had been fined a record breaking $3 billion by the Department of Justice in America – the fine was handed down after a guilty plea by GSK who, after the settlement, entered into a five-year Corporate Integrity Agreement with the Office of Inspector General of the Department of Health and Human Services. The agreement requires enhanced accountability, increased transparency and wide- ranging monitoring activities conducted by both internal and independent external reviewers.

One month after meeting with GSK officials Humphrey was told that GSK’s global CEO, Andrew Witty, had been made aware that GSK had been using a travel agent to channel kickback to customers and doctors throughout China. Days after Witty had been made aware, the whistleblower also sent a video to him and other senior management that showed GSK China’s Mark Reilly engaged in sexual activity – Reilly later claimed that the woman in the video was his “regular girlfriend”.

GSK officials told Humphrey that they had launched their own internal inquiry regarding the whistleblower allegation and that they were false. They told Humphrey, “There is nothing there”. This, according to the complaint, was a lie.

Humphrey and his wife offered to investigate the whistleblower allegations but GSK declined the offer, opting instead for Humphrey to investigate Vivian Shi, the woman they believed was the whistleblower.

Two months after Humphrey and Yu started their background search of Vivian Shi, GSK received another letter from the whistleblower alleging that GSK China continues to engage in systematic bribery of doctors, this email focused on GSK China’s botox business whereby the whistleblower claimed that…

GSK had a ‘pay to prescribe’ scheme that funneled money through a central source at Beijing Medical College whereby ‘lecture fee payments’ were made to doctors who could “…incentivize and reward doctors for prescribing Botox.”

At no point did GSK show either Humphrey or Yu this letter.

On June 12, 2013, the Wall Street Journal (WSJ) ran an article highlighting GSK China’s massive bribery network. In July of that year 4 senior GSK China executives were arrested and, according to Humphrey’s filed complaint, GSK CEO, Andrew Witty told the worlds media that “…it appears that certain senior executives in the Chinese business have acted outside of our processes and our controls to both defraud the company and Chinese healthcare system.” Witty also claimed that GSK’s Head office in London lacked knowledge of the whistleblower allegations and “had no sense of this issue.”

According to the complaint, this made no sense as since the previous month GSK did, indeed, “have a sense” of the issue since it announced its 4 month internal investigation into allegations of bribery and corruption in China and found “No evidence of corruption or bribery.”

The complaint states…

Witty argued, nonsensically, that the previous whistleblower allegations were “quite different” from the more recent charges, saying, “they are two completely different sets of issues, we fully investigated the first and, of course, this has now surfaced in the last couple of weeks.”

This was a lie, since “what surfaced” in the PSB investigation and raids of GSK offices in July was precisely the illegal activity that the whistleblower had documented and threatened to reveal in January.

The complaint was filed in The United States District Court for the Eastern District of Pennsylvania.

Humphrey and Yu are represented by Boies, Schiller & Flexner LLP

**Coming in Part 2**
– A full and comprehensive list of the allegations made by Peter Humphrey and Yu.
– GSK ask Humphrey to ‘overtly’ obstruct the Chinese government investigation.
– Evidence, including emails, to be destroyed as not to implicate any wrong-doing by the company.



Bob Fiddaman


Back stories.

Glaxo – The Sex Tape Scandal

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

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

GSK Hiked Product Prices to Fund Bribery Scam

GSK’s Sales Reps Want Their Money Back

GSK’s Private Investigator [The Video]

Peter Humphrey’s 2012 Presentation – Pharma Bribery

GSK’s Chinese Whispers and David Cameron

“GSK were really cagey”, Claims Whitehall Official.

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

GSK CHINA – Bribery was Rife 13 Years Ago

Witty Plays Down China Scandal

Witty Witty Bang Wang. The Glaxo Gangbang…Allegedly

Book Your Holidays With GSK Travel

Andrew Witty… I know narrrrrrrrthing

The Penny Drops for GSK’s Private Investigator.

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

Forbes’ Mathew Herper Sucks Up To GSK CEO Andrew Witty…


Quite a nauseatingly sycophantic  article from Mathew Herper from Forbes. No surprise there really, as I have noticed Herper’s style on GSK and Andrew Witty before, and I have to say- I was less than impressed before with Herper, and I am even more than less impressed now. This article would be more accurately described as ‘promotional material’  as opposed to real, authentic, impartial- journalism. There are a number of inconsistencies, inaccuracies and half truths here, of which I will blog about soon.

I am approaching my final blog post soon anyhow, so I will wrap up my thoughts in a final post about the narrative that GSK expect the public to swallow and the real story of GSK which I have followed, documented and blogged about for a number of years now. Personally ,I believe I am way more qualified to tell that story than Forbes. The obsequious, servile and adulatory perspective of Witty’s reign- which Mathew Herper of Forbes chose to display -is clearly nothing more than a glorified  ego wank dressed up as a news article. It’s one lackey back slapping another (you scratch my back I’ll scratch yours kind of thing) and it’s obviously very sloppily strewn together. It seems that Herper probably thought all his Christmases came at once when the almighty Sir Witty chose him to write his farewell piece, and in doing so- Herper couldn’t help but lick Witty’s boots squeaky clean for it. Extremely disappointing from a patient’s perspective, particularly those who have been harmed by GSK meds over the years (of which there have been many thousands).

I have spent ten years blogging about GSK . I was harmed by one of their crappy dangerous meds (Seroxat). I have had direct contact with several whistle-blowers, some of whom Forbes and Herper haven’t even ever mentioned in any of their media. I have spent thousands of hours writing, researching and blogging about GSK. There is stuff on my blog which hasn’t even seen the light of day in the mainstream media and I doubt if Herper has even scratched the surface on the magnitude of GSK’s unethical shenanigans…

I will deconstruct Herpers’s absurd article on Witty’s tenure in a future post soon (It’s going to be a big post).

But for now here’s the ridiculous article from Forbes..

Perhaps some of my readers would care to spot the inconsistencies?

(leave a comment below if you like)

oh and the picture of Witty leaving the open door is just corny…

http://www.forbes.com/sites/matthewherper/2016/09/14/how-glaxosmithkline-took-its-medicine/#165694ad7feb

How GlaxoSmithKline Took Its Medicine

I cover science and medicine, and believe this is biology’s century.

This story appears in the October 4, 2016 issue of Forbes. Subscribe

Sir Andrew Witty, GlaxoSmithKline's Chief Executive

Here’s how Sir Andrew Witty, who is due to end an eight-year tenure as the chief executive of British drug giant GlaxoSmithKline, would like to be remembered: in his shirtsleeves, in sub-Saharan Africa, meeting with impoverished villagers and then persuading first-world politicians of the need for drugs in the developing world. As the chief executive whose company developed a malaria vaccine and was first to test a vaccine for the Ebola virus. As the ethical exec who stopped paying doctors what were essentially bribes to talk up drugs. As the pharma boss who managed to stabilize a drug giant without a big, destructive merger.

“Honestly, I don’t regret a single decision,” says Witty, 52. “Someone smarter than me probably could have done it better. But I think it was the right direction for us to go in.”

History might remember a different Glaxo: the company whose revenues are flat since Witty took over and whose shares have underperformed its peers. The company accused of bribery in a half-dozen countries. The firm that in July 2012 pleaded guilty to civil and criminal charges in the U.S. for marketing in illegal ways drugs like Paxil for depression and Avandia for diabetes, and agreed to pay $3 billion in fines, the largest such settlement ever. After that bruising Witty did something pharma chief executives almost never do. He apologized. “On behalf of GSK, I want to express our regret and reiterate that we have learnt from the mistakes that were made,” he said in a prepared statement.

What kind of mistakes? For one, prosecutors alleged that a decade before Witty took command Glaxo paid Drew Pinsky, who parlayed a radio show giving teenagers sex advice into the celebrity persona of “Dr. Drew,” $275,000 for two months to talk about antidepressants and sex. Dr. Drew gave an interview where he segued from talking about a woman who said she had 60 orgasms in a row to saying how Glaxo’s Wellbutrin was better for the libido than other antidepressants. Pinsky didn’t disclose at the time that Glaxo was paying him; no charges were brought against Pinsky. Similar shenanigans occurred with Avandia and Paxil, which was marketed to adolescents even though it wasn’t approved for them.

The maddening problem for pharmaceutical chief executives is that their tenures will be judged on the results of decisions made decades before they took command. Most of the scandals of Witty’s term predated him, but so did many successes: Glaxo’s malaria vaccine has been in the works for 30 years. These immutable links to the past, and to the future, weigh heavily on Witty as he looks to help choose his successor. “To have an industry with a 20-year product life cycle, but only to think one year ahead, is destined for disaster,” Witty says. “Your strategy needs to be consistent with that time frame. That’s what we tried to do.”

Witty has made some big moves of his own that will help determine whether future Glaxo chiefs succeed. In 2014 he made a deal with Novartis that traded GlaxoSmithKline’s marketed cancer drugs for Novartis’ vaccine and consumer businesses and a $16 billion cash payment. Most other big pharma companies are depending heavily on new cancer treatments, which cost $100,000 and up for a course of treatment. Witty thinks the future of such drugs is at risk because society will not continue to pay for them. In the short run that has hurt him, as insurers in the U.S. have been willing to pony up. He has also focused on countries in Asia and Africa whose pharmaceutical markets are just emerging.

Recommended by Forbes

The share price certainly doesn’t reflect a turnaround. But profits are up, and in the second quarter of this year new-product sales doubled to $1.5 billion, 17% of revenue. Glaxo is forecasting earnings growth of at least 11% for the year.

“His predecessor left an awful lot of issues for him to deal with, an awful lot of settlements that they just kicked into the long grass,” says Richard Buxton, the chief executive of Old Mutual Global Investors, the mutual fund. “I think whoever succeeds him will preside over a better set of outcomes for shareholders.”

0902_glaxo-chart_1200GlaxoSmithKline, which is based in London, was formed on Jan. 1, 2001 by the $76 billion merger of Glaxo Wellcome, the maker of Wellbutrin (depression) and Imitrex (migraines), and SmithKline Beecham, which made Avandia (diabetes) and Paxil (depression). Both companies had storied histories that involved breakthrough drugs, including AIDS drugs and antibiotics. But they were having trouble coming up with enough new hits.

Soon after the merger closed, the controversies began. Critics alleged that SmithKline had failed to publish studies that showed Paxil might increase the risk of suicidal thoughts in adolescents, while publishing studies that showed there was no danger. In 2004 New York attorney general Eliot Spitzer sued the company; the suit was eventually settled when Glaxo agreed to publish on the Internet summary results of its future drug studies.

Then came Avandia. In 2007 Steven Nissen, chairman of cardiology at the Cleveland Clinic, published a paper in the New England Journal of Medicine arguing that Avandia, GlaxoSmithKline’s blockbuster diabetes drug, caused heart attacks. The FDA eventually said no new patients should start taking the drug, ultimately erasing $3 billion of annual sales.

The response from Witty’s predecessor, J.P. Garnier, was tone-deaf at best. “My wish for the media is to be more sophisticated when they report scientific news,” he said in 2008. He predicted that he would be “vindicated” by the FDA. Later that year, when a BBC interviewer repeatedly asked him about the Paxil controversy, he hung up while on the air.

Witty became chief executive in May 2008. He was a 23-year Glaxo lifer, a marketer who had done stints running part of Glaxo’s African businesses before taking over as president of European operations. His first goal, it seemed, was to rehabilitate Glaxo’s image. A series of profiles in newspapers and magazines presented him as concerned about the developing world. In 2009 the Daily Telegraph called him “the friendly face of big pharma.”

But Witty had problems that couldn’t be solved with good press or a friendly face. Patents on GlaxoSmithKline’s top drugs were expiring, meaning that generic competition was going to eat away at sales. Between 2006 and 2009 medicines such as Lamictal for bipolar disorder, Zofran for nausea, Valtrex for herpes and Flonase for allergies went generic, removing billions of dollars from Glaxo’s top line. With the loss of Avandia it all added up to roughly a quarter of the company’s sales.

One way to replace those sales would have been to invent new drugs. Glaxo spends $4.5 billion a year on research and development. Witty doubled down on a strategy put in place by his predecessors: splitting the company’s 10,000-plus R&D staffers into dozens of largely autonomous units that theoretically could function with the agility of biotechnology companies.

Back in 2010 Witty was excited about three potential hits. One was a vaccine to prevent lung cancer from recurring. It failed in 2014. Another was a new type of drug to prevent heart attacks. That medicine failed, too, in 2014. Even if it had succeeded, medical journals revealed a side effect that might have torpedoed the drug: It made an unpleasant scent emanate from many patients’ bodies. The third was a diabetes medicine, Tanzeum, that did reach the market, but behind rival meds from AstraZeneca and Novo Nordisk.

Despite those failures GlaxoSmithKline has gotten 13 drugs through the FDA during Witty’s tenure, more than any company except Johnson & Johnson, according to the InnoThink Center for Research in Biomedical Innovation. But many didn’t amount to much.

Analysts had expected Benlysta, a lupus drug approved in 2011, to generate as much as $5 billion in sales, and in 2012 GlaxoSmithKline spent $3 billion to buy Human Genome Sciences, which had invented the drug. Yet the market just wasn’t there. Sales in 2015 were $350 million, though they grew at a 33% clip. Cervarix, a vaccine, targeted two strains of the human papilloma virus (HPV), which causes cervical cancer. Merck’s rival Gardasil targeted four HPV strains, including two strains that cause genital warts. Sales of Cervarix were $135 million, compared with $1.9 billion for Gardasil.

Five of Glaxo’s new drugs were for cancer. In 2014 the company’s cancer-drug sales rose 20% to nearly $2 billion. But Witty struck an offer with Joseph Jimenez, the chief executive of Novartis, to sell these marketed drugs, though he made sure to keep the early-stage cancer medicines Glaxo was developing. In return he got Novartis’ vaccine division, including three promising meningitis vaccines, and created a joint venture in consumer health, which included brands like Sensodyne toothpaste and Theraflu for flu symptoms. Many investors thought he was crazy to get out of cancer. But Witty also negotiated a $16 billion cash payment from Novartis, which he says was more than his internal estimates said the cancer drugs would ever be worth. He still insists that by being willing to be unfashionable he got the better part of the deal.

While Witty was trying to make up for lost sales from patent expirations, he was busy with another task: trying to get past the ethical messes that had gotten GlaxoSmithKline in trouble before he took over.

One problem, he decided, was the way the drug industry traditionally paid sales representatives: It incentivized them to push the ethical and legal envelope. The reps were paid based on whether they could get doctors in their territories to prescribe more of a given drug. These incentives, Witty decided, led representatives to do things like pay doctors to speak when they weren’t experts, give away free trips and meals, and use sales pitches that were not in line with language approved by the Food & Drug Administration. Now the reps, Witty says, are measured on technical knowledge and customer service. He considers this change one of the proudest achievements of his career.

But Glaxo is a huge company with 100,000 employees, and its ethical problems didn’t end just because Witty was trying to fix things. In 2013 the Chinese government announced that it was investigating Glaxo for bribery, saying the company had funneled illegal payments to doctors and government officials in order to boost sales. Witty remembers realizing over a period of days how serious the allegations were. It was “distressing,” he says. “It was so counter to everything we were trying to do.” A year later Glaxo was found guilty of bribery in China and ordered to pay nearly $500 million.

In 2013 Witty announced that Glaxo would no longer offer any payments to physicians for speaking or other services. He denies the decision had anything to do with China. At the time, Glaxo, like other companies, was routinely offering U.S. physicians large sums of money–sometimes in the six figures–to give speeches promoting its drugs. Sometimes the practice bordered on institutionalized bribery, as drug reps paid doctors to give speeches as a reward for prescribing medicine. In other cases drug companies would pick only doctors who liked their products, creating an echo chamber in which it seemed like physicians were unanimous in supporting a particular drug.

Witty claims that getting rid of this tried-and-true practice has caused “a complete transformation” of Glaxo’s marketing. “We’d say, ‘Thursday night would you please come to the Holiday Inn, have a chicken dinner, listen to a doctor talking about something?’ ” Witty says. ” ‘Great.’ What if that Thursday night wasn’t convenient for you? What if you’ve got kids?” Now, he says, digital tools mean that Glaxo can engage physicians with questions on their own terms. “ If you want to talk to us at 3 a.m.,” he says, “we’re there at 3 a.m.”

Witty also embraced the idea that Glaxo should publish all its data. Drug companies typically publish only their most positive studies, making medicines seem safer and more effective than they actually are. One analysis of clinical trials for 12 different antidepressants found that only one of 38 positive studies wasn’t published; of 36 negative studies, 3 were published in a way that was accurate, 22 were not published and 11 were published in a misleading way that made the results appear positive when they were not.

Witty insisted Glaxo make public the results of all 1,700 studies the company had conducted since 2000. This was well above and beyond what Glaxo’s settlement with Eliot Spitzer forced it to do. In 2013 he signed a pledge with a group called AllTrials, which required further promises to make data public, to try to push the rest of the industry to follow. The man behind AllTrials, a U.K. doctor and newspaper columnist named Ben Goldacre, had written a book called Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients and had been skeptical about Witty’s previous attempts at transparency. But the day Glaxo took the pledge he was gushing, blogging that Glaxo’s commitment was “excellent and amazing.”

In 2014 Glaxo started its Ebola trial. The next year it received European approval for Mosquirix, the malaria vaccine it had developed with funding from the Bill & Melinda Gates Foundation. Next, the malaria vaccine will be evaluated by the World Health Organization. Witty, who spent years in malaria-ridden sub-Saharan Africa, says one of the most emotional moments of his career happened when he got initial data that showed the vaccine could cut infection rates by nearly half (a number since revised downward).

It would be nice if Witty’s focus on improving the world were also making Glaxo run on all cylinders. But it’s not that simple, and right now there is one big question facing the company: What will happen as generic competition emerges for its top-selling product, Advair, an inhaler for asthma and COPD?

In 2013 Advair generated more than $4 billion, but sales have already fallen 30% as U.S. insurers have switched to other products and managed to negotiate lower prices. Next year the first generic competitor should emerge in the U.S. As more generics are approved, analysts at Jefferies estimate, sales will fall by 90% by 2020. The better Witty’s successor can do at slowing this decline–perhaps by competing with the generics on price–the less nervous shareholders will be.

Glaxo’s heirs to Advair–new inhalers called Breo Ellipta and Anoro Ellipta–could generate $2 billion in sales by 2020, Jefferies says. But ultimately growth will depend on new drugs. One promising entrant is Tivicay, an HIV drug that competes with Isentress, Merck’s $1.5 billion pill. Jefferies forecasts Tivicay will be at least as big within five years. Another promising product is Shingrix, a shingles vaccine that is more effective than Merck’s Zostavax, which has annual sales of $749 million. Glaxo’s consumer health business, Jefferies forecasts, could increase 25% to $12 billion over the next four and a half years.

Of course, managing all of this will fall not to Witty but to his replacement. Internal candidates include Emma Walmsley, the head of consumer business, and Abbas Hussain, who is in charge of Glaxo’s global pharmaceutical division. The board could want an outsider. Whoever gets the job, Witty seems more than ready to pass the baton.

“Is everything right?” he asks. “No. Did we make mistakes? Yes. Did things go wrong? Yes. But it hasn’t put us off trying to improve. And I hope whoever takes over will continue trying to improve. Because there’s still plenty of things to keep improving.

Interesting Take On Andrew Witty’s Tenure By Erika Kelton For Forbes..


It’s good to see at least one mainstream news outlet has the balls to publish the truth about CEO Andrew Witty’s tenure at the helm at GSK over the past decade- however I would like to see more discussion about the 3 Billion dollar fine for what it actually was: a whitewash and NOT justice for consumers or patients- or in the words of Whistle-Blower Greg Thorpe– a mere “gift to GSK“…

Also, Perhaps Erika Kelton (the author of this Forbes article) could further explain to the public, why so little of this Department of Justice complaint involved Paxil (Seroxat/Paroxetine)? Considering that Paxil (Seroxat) has been GSK’s most controversial drug, I would like to know why was the focus of the investigation on Advair (GSK’s least dangerous drug when compared to drugs like Paxil) and also why do the other whistle-blowers- recruited at the time- not speak out about the sham investigation and white-wash fine?

My e-mail is always open to information and discussion Erika (if you’re reading!). I have much more information about GSK than I have published on this blog- several whistle-blowers have contacted me over the years, and some of these stories haven’t even been covered in the news at all, or online even.

Anyhow, here’s her Forbes article…

(ps- most of the info in this article could be gleaned straight from my blog- as I have been documenting GSK for ten years now- and have often done deeper digging than most journalists)


http://www.forbes.com/sites/erikakelton/2016/03/24/with-andrew-wittys-departure-will-glaxosmithkline-say-goodbye-to-fraud/

 

Mar 24, 2016 @ 04:43 PM 3,930 views

With Andrew Witty’s Departure, Will GlaxoSmithKline Say Goodbye to Fraud?

Erika Kelton ,

Contributor

I write about whistleblower matters involving fraud and other issues.

GSK has made headlines during Witty’s tenure, but for all the wrong reasons.

The company should scratch internal prospects off the list.

Glaxo SmithKline recently announced that its CEO, Andrew Witty, will be out the door as of March 31, 2017 – a development many were expecting.

GSK has made headlines during Witty’s tenure, but for all the wrong reasons.

Glaxo needs to make major changes after CEO Andrew Witty (on right) leaves the company next year.

Corruption, bribery, illegal marketing, contaminated drugs and collusion are some of the “highlights” of Glaxo’s business practices that were revealed during Witty’s nine years at the helm.

Witty oversaw Glaxo’s “Hall of Shame” when the following entries were added:

A $3 billion payment to the US to settle whistleblower allegations leading to civil and criminal charges that the company had marketed a number of its top-selling drugs for unapproved uses that in many cases endangered patients’ lives and health. It is the largest healthcare fraud settlement ever paid. (My firm represented the leading whistleblowers.)

A $750 million payment to settle whistleblower allegations that led to civil and criminal liability for manufacturing contaminated drugs at its facility in Puerto Rico and selling them.

A $489 million fine by a Chinese court for bribery and corruption charges based on allegations its China division paid doctors to prescribe Glaxo’s drugs. (A record penalty for China.)

Accusations of bribing doctors to prescribe Glaxo’s drugs in at least 11 other countries: Bahrain, Iraq, Jordan, Kuwait, Lebanon, Oman, Poland, Qatar, Romania, Syria and United

Arab Emirates.

A fine of roughly $54.5 million by Britain’s Competition & Markets Authority for allegedly paying generic drug makers illegally to delay the launch of cheaper versions of Glaxo’s Seroxat, an antidepressant.

A fine of about $9 million imposed by India’s Competition Commission for allegedly colluding with Sanofi India in bidding to supply a meningitis vaccine to the government for Haj pilgrims.

That’s a record that won’t be missed.

On the bright side, Witty’s announced resignation provides an opportunity for Glaxo to clean up its act.

Glaxo reportedly is considering external as well as internal candidates for the top spot. The company should scratch internal prospects off the list.

Witty came up through the ranks and landed in the CEO office after more than 20 years of slogging his way up from management trainee. Although Witty surely knows the business well, he was also part of a culture that was not healthy. Only an outsider with great resolve has a chance of reshaping the business to respect compliant and ethical practices.

Given Glaxo’s recent history, the board of directors should ensure that Witty’s replacement does more than drive up profits. A dramatic cultural shift at GSK is long past due.

A good place to start would be to listen to employees when they blow the whistle internally, particularly given the billions the company has paid to resolve significant problems whistleblowers have exposed. Glaxo will find that being open to whistleblower concerns could be very profitable in more ways than one.

Erika Kelton is a whistleblower attorney and partner at Phillips & Cohen LLP. http://www.phillipsandcohen.com. Follow @Fraudmatters.

Q And A- From GSK’s Andrew Witty And The BBC’s Evan Davis Interview- At Chatham House…


Back in October 2015, GSK CEO Andrew Witty had an interesting discussion with Evan Davis (from the BBC’s Newsnight).

For the majority of the interview Witty waffled on his usual script about how fantastic GSK are, and how their new ethical branding is at the cutting edge of health care etc, however in the last segment the tone changed dramatically.

Davis grilled Witty with some damning questions about the unpopularity of the pharmaceutical industry and about GSK ‘bribing doctors’ etc.

Witty looked extremely uncomfortable and did his bumbling best to deflect Davis’s awkward questions but his finely crafted showmanship fell flat and despite his slick performance at the beginning- in the end segment- he came across as little more than a GSK PR puppet.

Witty it seems, is well versed in GSK’s corporate mantras, but severely lacking in sincere humaneness. He came across as someone who would defend the indefensible (for a huge pay packet and perks of course) and maybe that’s why he got the job as CEO in the first place?

He is, after all, a sales man, and a marketing man, who grafted his way up the corporate ladder- to the top of GSK- over  25 year period. How ruthless would an individual have to be to do that?

You can watch Witty’s performance on Youtube (video above), and it’s very interesting, if only even as just a mere example of how these big corporations wriggle and squirm their way out of any accountability for the crimes that they commit (and in doing so- also- the harm that they cause innocent people- their customers- in the process).

I recently came across a Q and A segment from the Chapham House website, it’s not part of the original video intereview and seems only to be in text format.

Nonetheless, it’s also very interesting in parts.

Particularly this bit:

https://www.chathamhouse.org/sites/files/chathamhouse/events/special/20151022CorporateLeadersSeriesQA.pdf

Question 3
Building on the last question a bit, but perhaps from a slightly more generic point of view, you talked about the breakdown of trust and eroding trust in big pharma, in big business generally, in institutions around the world.

What does a leader do to restore that trust?

Andrew Witty
I think you have to try harder. I think a lot of it is around resilience, because no doubt, when you’re in an industry and I think in any big business where there is challenge, where actually, rightly, you don’t need to have a bloc vote to be heard anymore in this world, right?
You need a Twitter account. You need a way of getting your message around. That’s a good thing but it definitely creates a kind of pressure, so you need resilience.
You need to have a point of view, a point of view which is beyond this week, this quarter. A point of view which is, in my view, multi stakeholder and more and more critically global. I think for a lot of the established global companies, the reality is we’ve been American and Western Europe. The world is rapidly becoming much more than America and Western Europe. So you have to absolutely be thinking about, what’s important to China? What’s important to India?
Where is China going to go, how is it going to open up its western villages and rural areas? What does it need?
How is India going to democratize its health care system? Those are the big elements you have to think about.
Then you have to be prepared to take the rough with the smooth. The criticism is difficult. When things go wrong, it’s obvious, nobody likes to be in a situation when things go wrong. It’s much harder to make the positive change, because actually what you’re doing is you’re standing up in front of your organization, in front of your shareholders, in front of everybody who’s got used to the business model that exists whether they consciously did that or unconsciously, they’re used to the status quo ante. Then you’ve got to stand up and say: I’m going to change all that. Actually that’s the most difficult part, and that’s where you have to be deter mined, resilient and really believe in what you’re trying to drive forward. Hopefully, you generate quick wins, quickly, to give yourself and everybody else confidence you’re moving forward.
Evan Davis
The first thing you have to ask yourself though is, is this a messaging problem that people are not liking, or is it a problem problem that people are not liking? In some of these cases, it has been a public distrust of a lot of people and a kind of distrust in these anonymous big corporations. But some of it has been
Andrew Witty
It’s back to this issue of things like transparency. There’s no question that there is a substance issue there which
Evan Davis

It’s not the PR that’s bad, it’s the behaviour.

Andrew Witty
Again, if you look at our response, we have not, I think, tried to PR our way out of this.
Evan Davis
 
No, the way you get the trust is to behave in a trustworthy way.
There’s no shortcuts.
Andrew Witty
Exactly. If you look at what we’ve done, we’ve changed our commitment to transparency. We’ve changed the IP model. When I stood up and said we’re going to liberalize our IP model for the developing world, people thought I was nuts. People actually wrote to me and said, you are going to destroy the pharmaceutical industry doing this. You know what, the sun still comes up in the morning, even though we figured out there was a different way to manage IP in Africa and the LDCs.
So you have that.
We’ve changed the way our salesforces are managed. People said that’s the end of the world. It’s not. People said doctors won’t speak on your behalf if you don’t pay them. Actually, they will.
Half of the physicians will speak on our behalf. People said you can’t focus on development of medicines which don’t have an economic return. You can. Those are all substantive elements of the business model which we hope, over time
Evan Davis
Over time, in ten years, if you keep it up, people will say, they’re not so bad


I find this exchange between Andrew Witty and Evan Davis extraordinary, it’s as if they are having two different conversations.
Witty is so immersed in GSK’s marketing PR delusions that he fails to see what Davis is trying to say to him. It’s no use claiming to be ethical when you behave unethically. Under Witty’s tenure GSK paid 3 Billion in fines to the US department of Justice in 2012, and the China Bribe Scandal in 2014 happened directly under his leadership.
Witty has never once apologized for the Seroxat Scandal, or multitudes of other scandals that GSK have been embroiled in (and continue to be embroiled in) over the years, therefore, for Witty to claim that GSK have somehow redeemed themselves through a few shallow half baked PR token gestures- in regards to the many decades of fraud, bribery, lies and unethical profiteering (leading to the deaths and harm of thousands of people) is absurd and ridiculous.
Evan Davis called Andrew Witty out on his Bullshit, and I wish more people would..
I was harmed by a GSK drug- Seroxat- as were many others- many of them now friends of mine….
I have at least 40 years left on this planet…  and no amount of shallow PR from GSK will stop me from drawing attention to it.
The Seroxat Scandal is an example of the epitome of corporate evil in this world and people like Andrew Witty make millions by playing their part in this pharmaceutical harm to hundreds of thousands of vulnerable people, year after year. The Big Pharma’s between them kill tens of thousands every year. A lot of it is from defective substandard drugs, and a lot of it is from shoddy trials, hidden outcomes, and some is from just plain lies and deceit.
Witty is well aware of this…
How he sleeps soundly at night, is beyond my comprehension…

 

Prescription Drugs Are Killing Us – Meet One Doctor (Out Of Many) Who Just Published A Paper About It

The most recent example of this kind of corruption in relation to antidepressants comes from a study that was published last week in the British Medical Journal by researchers at the Nordic Cochrane Center in Copenhagen. The study showed that pharmaceutical companies were not disclosing all information regarding the results of their drug trials:

[This study] confirms that the full degree of harm of antidepressants is not reported. They are not reported in the published literature, we know that – and it appears that they are not properly reported in clinical study reports that go to the regulators and from the basis of decisions about licensing.  (source)

Researchers looked at documents from 70 different double-blind, placebo-controlled trials of selective serotonin reuptake inhibitors (SSRI) and serotonin and norepinephrine reuptake inhibitors (SNRI) and found that the full extent of serious harm in clinical study reports went unreported. These are the reports sent to major health authorities like the U.S. Food and Drug Administration.

Tamang Sharma, a PhD student at Cochrane and lead author of the study, said:

We found that a lot of the appendices were often only available upon request to the authorities, and the authorities had never requested them. I’m actually kind of scared about how bad the actual situation would be if we had the complete data. (source)

This is not the first time that pharmaceutical companies have been caught manipulating science in order to get antidepressants onto the shelves. It was only a couple of months ago that an independent review found that the commonly prescribed antidepressant drug Paxil (paroxetine) is not safe for teenagers, even though a large amount of literature had already suggested this previously. The 2001 drug trial that took place, funded by GlaxoSmithKline, found that these drugs were completely safe, and used that ‘science’ to market Paxil as safe for teenagers.

Gotzche’s two main areas of focus are antidepressants and “non-steroidal anti-inflammatory” painkillers like ibuprofen, tylenol, celecoxib, and diclofenac. Another is Vioxx, which was actually withdrawn after it was discovered that it caused more than 100,000 cases of serious heart disease in the United States during the five years that it was on the market.

According to Gotzche, these deaths are just the tip of the iceberg when it comes to the failure of the drug regulatory process to protect patients:

These terms for our drugs are invented by the drug industry. They had a huge financial interest in calling these things anti-inflammatory. It lured doctors into believing that these drugs somehow also had an effect on the disease process and reduced the joint damage.

In his paper he also notes that antidepressants have replaced drugs that were found to be harmful, like Valium and Xanax, but are just as addictive and their side effects just as dangerous.

According to Professor Gotzsche, here’s a list of things you want to avoid:

  • Antidepressants for all, because they probably don’t work for severe cases of depression
  • All brain-active drugs in children
  • Anti-psychotics and other brain-active drugs for the elderly. Psychotropic drugs should be used as little as possible and mostly in very acute situations, as they are very harmful when used long term
  • Non-steroidal anti-inflammatory drugs used for arthritis, muscle pain and headaches, including over-the-counter, low dose ibuprofen. These drugs should be used as little as possible
  • Mammography screening, as it doesn’t prolong life whereas it makes many healthy women ill through over diagnosis and leads to the premature death for some because radiotherapy and chemotherapy increases mortality when used for harmless cancers detected at screening.
  • Drugs for urinary incontinence, as they very likely don’t work

“The case against science is straightforward: much of the scientific literature, perhaps half, may simply be untrue. Afflicted by studies with small sample sizes, tiny effects, invalid exploratory analyses, and flagrant conflicts of interest, together with an obsession for pursuing fashionable trends of dubious importance, science has taken a turn towards darkness.” – Dr. Richard Horton, the current Editor-In-Chief of the Lancet (source)

Here is a great video that I share in most of my articles that have to do with this topic. It’s a clip of Dr. Peter Rost, a former vice president of Pfizer and a whistleblower of the pharmaceutical industry. Author of “The Whistleblower, Confessions of a Healthcare Hitman,” Rost is an insider expert on big pharma marketing.

 

Doctor Ben Goldacre Knows Best…


Page_1

Note to Ben Goldacre (from me):



“….Missing data poisons the well for everybody. If proper trials are never done, if trials with negative results are withheld, then we simply cannot know the true effects of the treatments we use. Evidence in medicine is not an abstract academic preoccupation. When we are fed bad data, we make the wrong decisions, inflicting unnecessary pain and suffering, and death, on people just like us….”

Ben Goldacre 2012

http://www.bibliotecapleyades.net/ciencia/ciencia_industrybigpharma105.htm


“…As one of the authors of the RIAT restoration of Paxil Study 329 who was around for the whole process, I don’t actually know the answer to Leonie’s question about why it was so hard to get our paper published.

I don’t know if a Conflict of Interest had anything to do with that, but in a way, that’s the whole point – when there’s a significant Conflict of Interest, you can’t ever really know.

It’s a variable that can’t be evaluated.

So her question stands whether it can be answered or not. Should the original Study 329 report be retracted?

That’s not in our hands.

My choice would be that it should never have been published in the first place..”

(Comment by Mickey Nardo one of the authors of the BMJ published- RIAT Study on GSK’s Study 329 for Paroxetine in Adolescents on “Club 329”– David Healy’s Blog- ).



There is a fascinating debate happening over on Dr David Healy’s blog about a lecture which  Dr Ben Goldacre gave in Dublin’s Royal College of Surgeons last week. It all started when (patient activist, and blogger) Leonie Fennell (an attendee of the lecture)- published her opinion of Ben’s talk in a post on Dr Healy’s blog (titled ‘Club 329‘). The post seems to be sparking some very interesting reactions, not least from Ben Goldacre himself (who  incidentally has already accused Dr. Healy of misrepresenting his views because the post is published on Healy’s web-page).

Personally I don’t think that Leonie misrepresented Ben at all, and ironically, Ben claims that the audio of the lecture itself confirms this misrepresentation, when in fact- it does the opposite: it upholds, and confirms Leonie’s views.

You can listen to the audio here:

https://soundcloud.com/truthman-thirty/bg-11-06-2016-1333https://soundcloud.com/truthman-thirty/bg-11-06-2016-1333

Ben released it on Twitter, and I thought it might be helpful (for clarity) to cut it to the exact parts which are under debate.

The following is Leonie’s full blog post, on Dr Healy’s blog.

I will follow underneath it with some commentary.


http://davidhealy.org/club-329-part-1/#comments

Club 329: Part 1

June, 7, 2016 | 24 Comments

 


https://seroxatsecrets.wordpress.com/2012/09/22/the-drugs-dont-work-a-modern-medical-scandal-by-dr-ben-goldacre/

The doctors prescribing the drugs don’t know they don’t do what they’re meant to. Nor do their patients. The manufacturers know full well, but they’re not telling. Drugs are tested by their manufacturers, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that exaggerate the benefits.

Reboxetine is a drug I have prescribed. Other drugs had done nothing for my patient, so we wanted to try something new. I’d read the trial data before I wrote the prescription, and found only well-designed, fair tests, with overwhelmingly positive results. Reboxetine was better than a placebo, and as good as any other antidepressant in head-to-head comparisons. It’s approved for use by the Medicines and Healthcare products Regulatory Agency (the MHRA), which governs all drugs in the UK. Millions of doses are prescribed every year, around the world. Reboxetine was clearly a safe and effective treatment. The patient and I discussed the evidence briefly, and agreed it was the right treatment to try next. I signed a prescription.

But we had both been misled. In October 2010, a group of researchers was finally able to bring together all the data that had ever been collected on reboxetine, both from trials that were published and from those that had never appeared in academic papers. When all this trial data was put together, it produced a shocking picture. Seven trials had been conducted comparing reboxetine against a placebo. Only one, conducted in 254 patients, had a neat, positive result, and that one was published in an academic journal, for doctors and researchers to read. But six more trials were conducted, in almost 10 times as many patients. All of them showed that reboxetine was no better than a dummy sugar pill. None of these trials was published. I had no idea they existed.

It got worse. The trials comparing reboxetine against other drugs showed exactly the same picture: three small studies, 507 patients in total, showed that reboxetine was just as good as any other drug. They were all published. But 1,657 patients’ worth of data was left unpublished, and this unpublished data showed that patients on reboxetine did worse than those on other drugs. If all this wasn’t bad enough, there was also the side-effects data. The drug looked fine in the trials that appeared in the academic literature; but when we saw the unpublished studies, it turned out that patients were more likely to have side-effects, more likely to drop out of taking the drug and more likely to withdraw from the trial because of side-effects, if they were taking reboxetine rather than one of its competitors.

I did everything a doctor is supposed to do. I read all the papers, I critically appraised them, I understood them, I discussed them with the patient and we made a decision together, based on the evidence. In the published data, reboxetine was a safe and effective drug. In reality, it was no better than a sugar pill and, worse, it does more harm than good. As a doctor, I did something that, on the balance of all the evidence, harmed my patient, simply because unflattering data was left unpublished.

Nobody broke any law in that situation, reboxetine is still on the market and the system that allowed all this to happen is still in play, for all drugs, in all countries in the world. Negative data goes missing, for all treatments, in all areas of science. The regulators and professional bodies we would reasonably expect to stamp out such practices have failed us. These problems have been protected from public scrutiny because they’re too complex to capture in a soundbite. This is why they’ve gone unfixed by politicians, at least to some extent; but it’s also why it takes detail to explain. The people you should have been able to trust to fix these problems have failed you, and because you have to understand a problem properly in order to fix it, there are some things you need to know.

Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer. When trials throw up results that companies don’t like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug’s true effects. Regulators see most of the trial data, but only from early on in a drug’s life, and even then they don’t give this data to doctors or patients, or even to other parts of government. This distorted evidence is then communicated and applied in a distorted fashion.

In their 40 years of practice after leaving medical school, doctors hear about what works ad hoc, from sales reps, colleagues and journals. But those colleagues can be in the pay of drug companies – often undisclosed – and the journals are, too. And so are the patient groups. And finally, academic papers, which everyone thinks of as objective, are often covertly planned and written by people who work directly for the companies, without disclosure. Sometimes whole academic journals are owned outright by one drug company. Aside from all this, for several of the most important and enduring problems in medicine, we have no idea what the best treatment is, because it’s not in anyone’s financial interest to conduct any trials at all.

Now, on to the details.

In 2010, researchers from Harvard and Toronto found all the trials looking at five major classes of drug – antidepressants, ulcer drugs and so on – then measured two key features: were they positive, and were they funded by industry? They found more than 500 trials in total: 85% of the industry-funded studies were positive, but only 50% of the government-funded trials were. In 2007, researchers looked at every published trial that set out to explore the benefits of a statin. These cholesterol-lowering drugs reduce your risk of having a heart attack and are prescribed in very large quantities. This study found 192 trials in total, either comparing one statin against another, or comparing a statin against a different kind of treatment. They found that industry-funded trials were 20 times more likely to give results favouring the test drug.

These are frightening results, but they come from individual studies. So let’s consider systematic reviews into this area. In 2003, two were published. They took all the studies ever published that looked at whether industry funding is associated with pro-industry results, and both found that industry-funded trials were, overall, about four times more likely to report positive results. A further review in 2007 looked at the new studies in the intervening four years: it found 20 more pieces of work, and all but two showed that industry-sponsored trials were more likely to report flattering results.

It turns out that this pattern persists even when you move away from published academic papers and look instead at trial reports from academic conferences. James Fries and Eswar Krishnan, at the Stanford University School of Medicine in California, studied all the research abstracts presented at the 2001 American College of Rheumatology meetings which reported any kind of trial and acknowledged industry sponsorship, in order to find out what proportion had results that favoured the sponsor’s drug.

In general, the results section of an academic paper is extensive: the raw numbers are given for each outcome, and for each possible causal factor, but not just as raw figures. The “ranges” are given, subgroups are explored, statistical tests conducted, and each detail is described in table form, and in shorter narrative form in the text. This lengthy process is usually spread over several pages. In Fries and Krishnan (2004), this level of detail was unnecessary. The results section is a single, simple and – I like to imagine – fairly passive-aggressive sentence:

“The results from every randomised controlled trial (45 out of 45) favoured the drug of the sponsor.”

How does this happen? How do industry-sponsored trials almost always manage to get a positive result? Sometimes trials are flawed by design. You can compare your new drug with something you know to be rubbish – an existing drug at an inadequate dose, perhaps, or a placebo sugar pill that does almost nothing. You can choose your patients very carefully, so they are more likely to get better on your treatment. You can peek at the results halfway through, and stop your trial early if they look good. But after all these methodological quirks comes one very simple insult to the integrity of the data. Sometimes, drug companies conduct lots of trials, and when they see that the results are unflattering, they simply fail to publish them.

Because researchers are free to bury any result they please, patients are exposed to harm on a staggering scale throughout the whole of medicine. Doctors can have no idea about the true effects of the treatments they give. Does this drug really work best, or have I simply been deprived of half the data? No one can tell. Is this expensive drug worth the money, or has the data simply been massaged? No one can tell. Will this drug kill patients? Is there any evidence that it’s dangerous? No one can tell. This is a bizarre situation to arise in medicine, a discipline in which everything is supposed to be based on evidence.

And this data is withheld from everyone in medicine, from top to bottom. Nice, for example, is the National Institute for Health and Clinical Excellence, created by the British government to conduct careful, unbiased summaries of all the evidence on new treatments. It is unable either to identify or to access data on a drug’s effectiveness that’s been withheld by researchers or companies: Nice has no more legal right to that data than you or I do, even though it is making decisions about effectiveness, and cost-effectiveness, on behalf of the NHS, for millions of people.

In any sensible world, when researchers are conducting trials on a new tablet for a drug company, for example, we’d expect universal contracts, making it clear that all researchers are obliged to publish their results, and that industry sponsors – which have a huge interest in positive results – must have no control over the data. But, despite everything we know about industry-funded research being systematically biased, this does not happen. In fact, the opposite is true: it is entirely normal for researchers and academics conducting industry-funded trials to sign contracts subjecting them to gagging clauses that forbid them to publish, discuss or analyse data from their trials without the permission of the funder.

This is such a secretive and shameful situation that even trying to document it in public can be a fraught business. In 2006, a paper was published in the Journal of the American Medical Association (Jama), one of the biggest medical journals in the world, describing how common it was for researchers doing industry-funded trials to have these kinds of constraints placed on their right to publish the results. The study was conducted by the Nordic Cochrane Centre and it looked at all the trials given approval to go ahead in Copenhagen and Frederiksberg. (If you’re wondering why these two cities were chosen, it was simply a matter of practicality: the researchers applied elsewhere without success, and were specifically refused access to data in the UK.) These trials were overwhelmingly sponsored by the pharmaceutical industry (98%) and the rules governing the management of the results tell a story that walks the now familiar line between frightening and absurd.

For 16 of the 44 trials, the sponsoring company got to see the data as it accumulated, and in a further 16 it had the right to stop the trial at any time, for any reason. This means that a company can see if a trial is going against it, and can interfere as it progresses, distorting the results. Even if the study was allowed to finish, the data could still be suppressed: there were constraints on publication rights in 40 of the 44 trials, and in half of them the contracts specifically stated that the sponsor either owned the data outright (what about the patients, you might say?), or needed to approve the final publication, or both. None of these restrictions was mentioned in any of the published papers.

When the paper describing this situation was published in Jama, Lif, the Danish pharmaceutical industry association, responded by announcing, in the Journal of the Danish Medical Association, that it was “both shaken and enraged about the criticism, that could not be recognised”. It demanded an investigation of the scientists, though it failed to say by whom or of what. Lif then wrote to the Danish Committee on Scientific Dishonesty, accusing the Cochrane researchers of scientific misconduct. We can’t see the letter, but the researchers say the allegations were extremely serious – they were accused of deliberately distorting the data – but vague, and without documents or evidence to back them up.

Nonetheless, the investigation went on for a year. Peter Gøtzsche, director of the Cochrane Centre, told the British Medical Journal that only Lif’s third letter, 10 months into this process, made specific allegations that could be investigated by the committee. Two months after that, the charges were dismissed. The Cochrane researchers had done nothing wrong. But before they were cleared, Lif copied the letters alleging scientific dishonesty to the hospital where four of them worked, and to the management organisation running that hospital, and sent similar letters to the Danish medical association, the ministry of health, the ministry of science and so on. Gøtzsche and his colleagues felt “intimidated and harassed” by Lif’s behaviour. Lif continued to insist that the researchers were guilty of misconduct even after the investigation was completed.

Paroxetine is a commonly used antidepressant, from the class of drugs known as selective serotonin reuptake inhibitors or SSRIs. It’s also a good example of how companies have exploited our long-standing permissiveness about missing trials, and found loopholes in our inadequate regulations on trial disclosure.

To understand why, we first need to go through a quirk of the licensing process. Drugs do not simply come on to the market for use in all medical conditions: for any specific use of any drug, in any specific disease, you need a separate marketing authorisation. So a drug might be licensed to treat ovarian cancer, for example, but not breast cancer. That doesn’t mean the drug doesn’t work in breast cancer. There might well be some evidence that it’s great for treating that disease, too, but maybe the company hasn’t gone to the trouble and expense of getting a formal marketing authorisation for that specific use. Doctors can still go ahead and prescribe it for breast cancer, if they want, because the drug is available for prescription, it probably works, and there are boxes of it sitting in pharmacies waiting to go out. In this situation, the doctor will be prescribing the drug legally, but “off-label”.

Now, it turns out that the use of a drug in children is treated as a separate marketing authorisation from its use in adults. This makes sense in many cases, because children can respond to drugs in very different ways and so research needs to be done in children separately. But getting a licence for a specific use is an arduous business, requiring lots of paperwork and some specific studies. Often, this will be so expensive that companies will not bother to get a licence specifically to market a drug for use in children, because that market is usually much smaller.

So it is not unusual for a drug to be licensed for use in adults but then prescribed for children. Regulators have recognised that this is a problem, so recently they have started to offer incentives for companies to conduct more research and formally seek these licences.

When GlaxoSmithKline applied for a marketing authorisation in children for paroxetine, an extraordinary situation came to light, triggering the longest investigation in the history of UK drugs regulation. Between 1994 and 2002, GSK conducted nine trials of paroxetine in children. The first two failed to show any benefit, but the company made no attempt to inform anyone of this by changing the “drug label” that is sent to all doctors and patients. In fact, after these trials were completed, an internal company management document stated: “It would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine.” In the year after this secret internal memo, 32,000 prescriptions were issued to children for paroxetine in the UK alone: so, while the company knew the drug didn’t work in children, it was in no hurry to tell doctors that, despite knowing that large numbers of children were taking it. More trials were conducted over the coming years – nine in total – and none showed that the drug was effective at treating depression in children.

It gets much worse than that. These children weren’t simply receiving a drug that the company knew to be ineffective for them; they were also being exposed to side-effects. This should be self-evident, since any effective treatment will have some side-effects, and doctors factor this in, alongside the benefits (which in this case were nonexistent). But nobody knew how bad these side-effects were, because the company didn’t tell doctors, or patients, or even the regulator about the worrying safety data from its trials. This was because of a loophole: you have to tell the regulator only about side-effects reported in studies looking at the specific uses for which the drug has a marketing authorisation. Because the use of paroxetine in children was “off-label”, GSK had no legal obligation to tell anyone about what it had found.

People had worried for a long time that paroxetine might increase the risk of suicide, though that is quite a difficult side-effect to detect in an antidepressant. In February 2003, GSK spontaneously sent the MHRA a package of information on the risk of suicide on paroxetine, containing some analyses done in 2002 from adverse-event data in trials the company had held, going back a decade. This analysis showed that there was no increased risk of suicide. But it was misleading: although it was unclear at the time, data from trials in children had been mixed in with data from trials in adults, which had vastly greater numbers of participants. As a result, any sign of increased suicide risk among children on paroxetine had been completely diluted away.

Later in 2003, GSK had a meeting with the MHRA to discuss another issue involving paroxetine. At the end of this meeting, the GSK representatives gave out a briefing document, explaining that the company was planning to apply later that year for a specific marketing authorisation to use paroxetine in children. They mentioned, while handing out the document, that the MHRA might wish to bear in mind a safety concern the company had noted: an increased risk of suicide among children with depression who received paroxetine, compared with those on dummy placebo pills.

This was vitally important side-effect data, being presented, after an astonishing delay, casually, through an entirely inappropriate and unofficial channel. Although the data was given to completely the wrong team, the MHRA staff present at this meeting had the wit to spot that this was an important new problem. A flurry of activity followed: analyses were done, and within one month a letter was sent to all doctors advising them not to prescribe paroxetine to patients under the age of 18.

How is it possible that our systems for getting data from companies are so poor, they can simply withhold vitally important information showing that a drug is not only ineffective, but actively dangerous? Because the regulations contain ridiculous loopholes, and it’s dismal to see how GSK cheerfully exploited them: when the investigation was published in 2008, it concluded that what the company had done – withholding important data about safety and effectiveness that doctors and patients clearly needed to see – was plainly unethical, and put children around the world at risk; but our laws are so weak that GSK could not be charged with any crime.

After this episode, the MHRA and EU changed some of their regulations, though not adequately. They created an obligation for companies to hand over safety data for uses of a drug outside its marketing authorisation; but ridiculously, for example, trials conducted outside the EU were still exempt. Some of the trials GSK conducted were published in part, but that is obviously not enough: we already know that if we see only a biased sample of the data, we are misled. But we also need all the data for the more simple reason that we need lots of data: safety signals are often weak, subtle and difficult to detect. In the case of paroxetine, the dangers became apparent only when the adverse events from all of the trials were pooled and analysed together.

That leads us to the second obvious flaw in the current system: the results of these trials are given in secret to the regulator, which then sits and quietly makes a decision. This is the opposite of science, which is reliable only because everyone shows their working, explains how they know that something is effective or safe, shares their methods and results, and allows others to decide if they agree with the way in which the data was processed and analysed. Yet for the safety and efficacy of drugs, we allow it to happen behind closed doors, because drug companies have decided that they want to share their trial results discretely with the regulators. So the most important job in evidence-based medicine is carried out alone and in secret. And regulators are not infallible, as we shall see.

Rosiglitazone was first marketed in 1999. In that first year, Dr John Buse from the University of North Carolina discussed an increased risk of heart problems at a pair of academic meetings. The drug’s manufacturer, GSK, made direct contact in an attempt to silence him, then moved on to his head of department. Buse felt pressured to sign various legal documents. To cut a long story short, after wading through documents for several months, in 2007 the US Senate committee on finance released a report describing the treatment of Buse as “intimidation”.

But we are more concerned with the safety and efficacy data. In 2003 the Uppsala drug monitoring group of the World Health Organisation contacted GSK about an unusually large number of spontaneous reports associating rosiglitazone with heart problems. GSK conducted two internal meta-analyses of its own data on this, in 2005 and 2006. These showed that the risk was real, but although both GSK and the FDA had these results, neither made any public statement about them, and they were not published until 2008.

During this delay, vast numbers of patients were exposed to the drug, but doctors and patients learned about this serious problem only in 2007, when cardiologist Professor Steve Nissen and colleagues published a landmark meta-analysis. This showed a 43% increase in the risk of heart problems in patients on rosiglitazone. Since people with diabetes are already at increased risk of heart problems, and the whole point of treating diabetes is to reduce this risk, that finding was big potatoes. Nissen’s findings were confirmed in later work, and in 2010 the drug was either taken off the market or restricted, all around the world.

Now, my argument is not that this drug should have been banned sooner because, as perverse as it sounds, doctors do often need inferior drugs for use as a last resort. For example, a patient may develop idiosyncratic side-effects on the most effective pills and be unable to take them any longer. Once this has happened, it may be worth trying a less effective drug if it is at least better than nothing.

The concern is that these discussions happened with the data locked behind closed doors, visible only to regulators. In fact, Nissen’s analysis could only be done at all because of a very unusual court judgment. In 2004, when GSK was caught out withholding data showing evidence of serious side-effects from paroxetine in children, their bad behaviour resulted in a US court case over allegations of fraud, the settlement of which, alongside a significant payout, required GSK to commit to posting clinical trial results on a public website.

Nissen used the rosiglitazone data, when it became available, and found worrying signs of harm, which they then published to doctors – something the regulators had never done, despite having the information years earlier. If this information had all been freely available from the start, regulators might have felt a little more anxious about their decisions but, crucially, doctors and patients could have disagreed with them and made informed choices. This is why we need wider access to all trial reports, for all medicines.

Missing data poisons the well for everybody. If proper trials are never done, if trials with negative results are withheld, then we simply cannot know the true effects of the treatments we use. Evidence in medicine is not an abstract academic preoccupation. When we are fed bad data, we make the wrong decisions, inflicting unnecessary pain and suffering, and death, on people just like us.

GSK CEO, Andrew Witty Says: “Occassionally We Make Mistakes”…


Pharm

“…Then you’ve got actually, we do occasionally make mistakes. Things go wrong. We have inevitably of course, we go through all the processes with the regulators to get a drug to be as safe and effective as it can possibly be. But the reality is, every time a human takes a drug, it’s like a clinical trial. You don’t really know what’s going to happen. Everybody can react a different way…”

I’m sure most people would be familiar with the film ‘The Devils Advocate’ with Al Pacino and Keanu Reeves. In the movie, Reeves is groomed into his dark corporate role by the Machiavellian Pacino- his boss and mentor. Unfortunately for Reeves his deal with the devil turns out to be just that.

‘The Devils Advocate’ is of course, a work of fiction, however, if you read though the stories and scandals of GSK over the past decade you could be forgiven for thinking you were reading a work of fiction; such is the scale and depth of GSK’s nefarious and suspect activities.

From tax evasion, dodgy factories spewing out defective and contaminated products, to bribery, fraud, prostitutes in China (and that’s not just the doctors on the payroll), corruption, suppression of side effects of their meds – resulting in killing of consumers, Serious Fraud Office investigations, Department of Justice investigations, pay for delay deals, etc etc.

The list goes on… and on… and on….

GSK are as insidiously and (dare I say it)- as evil – as you would imagine any multi-billion dollar international corporation to be…

But scarily- for you (and for me, and for the public)- GSK are real, they are not fiction and they make your toothpaste such as sensodyne, and your kids drinks like Ribena and Lucozade, as well some some really dodgy drugs like Seroxat, Avandia, Imitrex and Pandemrix…

And lets not forget the barbaric Myodil.

https://truthman30.wordpress.com/tag/splinters/

GSK is recalling dozens of lots–3,977,252 tubes–made up of different varieties of Biotene and Sensodyne toothpaste, from the U.S., Puerto Rico and Taiwan. According to the FDA‘s most recent Enforcement Report, “fragments of wood were found when the product was extruded onto a toothbrush.” The toothpaste was actually manufactured for GSK by Oratech, a Utah-based contractor.


http://www.independent.co.uk/news/uk/home-news/lucozade-and-irn-bru-to-carry-hyperactivity-warnings-2034324.html

“….The makers of two of Britain’s best-selling soft drinks, Lucozade and Irn-Bru, have been forced to warn parents that the drinks may cause hyperactivity. A newly introduced EU law compels both drinks to display a warning that they contain artificial colours linked to behavioural problems in young children..”


https://www.theguardian.com/science/2015/sep/16/seroxat-study-harmful-effects-young-people

“…An influential study which claimed that an antidepressant drug was safe for children and adolescents failed to report the true numbers of young people who thought of killing themselves while on it, re-analysis of the trial has found

Study 329, into the effects of GlaxoSmithKline’s drug paroxetine on under-18s, was published in 2001 and later found to be flawed. In 2003, the UK drug regulator instructed doctors not to prescribe paroxetine – sold as Seroxat in the UK and Paxil in the US – to adolescents…”


http://www.forbes.com/sites/matthewherper/2013/05/23/steven-nissen-the-hidden-agenda-behind-the-fdas-avandia-hearings/#67f26f5717a3

“..The most likely explanation: the leadership of the division of the FDA responsible for drug regulation, the Center for Drug Evaluation and Research (CDER), is seeking to avoid accountability for its role in the Avandia tragedy. In 2005 and 2006, GSK secretly conducted an analysis of the cardiovascular safety of Avandia and concluded that the drug increased the risk of heart attacks and related events by about 30%. This observation had grave implications: two thirds of diabetics, the intended recipients of the drug, eventually die of cardiovascular complications. Initially, GSK withheld the internal analysis from the FDA, but in 2006, the company informed CDER of the findings. FDA statisticians confirmed the risks, but, incredibly, CDER and GSK agreed privately to conceal this hazard from patients and practitioners…”

So be very careful when you ingest a GSK product because GSK are notoriously known for not telling you the truth about the products they sell you…

And even if the GSK label says the side effects are blah, blah, blah… don’t rely on them to be honest in the PIL either..  they often omit a lot of the truth..  they are notorious for lying and deceiving, often adding side effects (for years later) to their products’ information leaflets- long after millions of people have ingested them…

It’s easy to say, GSK are greedy, sociopathic, evil and callous, and they are (because most multi-billion dollar corporations are- they have to be because capitalism encourages them to be). However, it’s also easy to forget that GSK are a corporation run by people making the decisions for the company.

So could we then apply the same characteristics of greedy, sociopathic, evil and callous to the people running GSK?

Perhaps, in some cases, justifiably we can..

Take for example  (outgoing) GSK CEO Andrew Witty…

Before he was crowned CEO of GSK, Witty had worked in a number of roles in the company- many of them high level.

Witty once promoted the highly controversial Zyban (an anti-smoking drug)-  (also known as  Wellbutrin and promoted as an anti-depressant):

LONDON, UK — January 16, 2007

“Wellbutrin XR is an important new medicine for doctors and patients in Europe,” comments Andrew Witty, president, GSK Pharmaceuticals, Europe.

“Depression can be a crippling condition that is often difficult to treat.

With its unique mode of action, Wellbutrin XR offers a real alternative to the depressed patient.

We hope its profile will help patients stay on their therapy, which would address a significant unmet need in the area of antidepressants.”

http://www.theguardian.com/business/nils-pratley-on-finance/2016/mar/17/glaxosmithkline-gsk-andrew-witty-neil-woodford-break-up

“…It is even hard to say who is the leading candidate within the core pharmaceutical business. Is it Abbas Hussain, head of the division, or Patrick Vallance, head of research and development? And perhaps Emma Walmsley, boss of consumer healthcare, a bigger unit after being beefed via a shuffle of assets with Novartis, is a decent outside bet….”

So how much did JP Garnier and Andrew Witty know about GSK’s bad behavior over the years they spent crawling up the greasy ladder within the company?

I’d say they knew a lot..

There is a rumor that that the next head of GSK might be Emma Walmsley..

I wonder what price you have to put on your soul to become CEO of a company like GSK?

“John Milton:..You sharpen the human appetite to the point where it can split atoms with its desire; you build egos the size of cathedrals; fiber-optically connect the world to every eager impulse; grease even the dullest dreams with these dollar-green, gold-plated fantasies, until every human becomes an aspiring emperor, becomes his own God… and where can you go from there? As we’re scrambling from one deal to the next, who’s got his eye on the planet? As the air thickens, the water sours, even bees’ honey takes on the metallic taste of radioactivity… and it just keeps coming, faster and faster. There’s no chance to think, to prepare; it’s buy futures, sell futures… when there is no future. We got a runaway train, boy. We got a billion Eddie Barzoons all jogging into the future. Every one of them is getting ready to fistfuck God’s ex-planet, lick their fingers clean, as they reach out toward their pristine, cybernetic keyboards to tote up their fucking billable hours. And then it hits home. You got to pay your own way”..

 

(Al Pacino/John Milton- “The Devils Advocate”)

Emma-Walmsley

CH7YOanVAAANoD3

http://fortune.com/most-powerful-women-europe-middle-east-africa/emma-walmsley-24/

The London-based pharma exec runs the world’s leading over-the-counter pharma company—a $9.5 billion joint venture between GSK and its Swiss competitor Novartis, officially launched in March. Walmsley led the integration of the businesses, which resulted from a complex deal struck in April 2014. The company’s products are sold in 160 countries, with 42% of sales coming from emerging markets. In July, Walmsley, a lover of Italian red wine and Bikram yoga, was appointed to the board of Diageo. —Erika Fry

“Fuzzy Boundaries”:Andrew Witty, GSK, And The “Perfectly Legal” Bribing Of Doctors…


Evan Davis
“….But this is a recognition there is a lot you’ve done to present these things differently. But it is a recognition that it was pretty dysfunctional before, isn’t it?
Because publishing data, to me, honestly, doesn’t seem like a great achievement. It just seems to me that that’s what you should be doing with data.
Not bribing doctors seems like a thing you would do…”
14
Andrew Witty
“….I wouldn’t say it’s bribing doctors
It’s perfectly legal to pay. If you went to a physician and said, would you expect to be paid for speaking on behalf of somebody, they will probably say yes. Actually, in most countries in the world, it’s perfectly legal. However, there are risks it can be abused. People can make mistakes. And there are risks that there is a misperception. Just to your point on publication, do you think academics are mandated to publish their data? Do you think universities publish all their failed studies?
They don’t, but we do….”

 

For those of you who haven’t seen the video (above) of GSK CEO Andrew Witty squirm in his seat under the heat of some serious questioning it’s well worth viewing…

There’s a lot of issues raised in just that short clip that are worth discussing but I’d like to focus on what the interviewer (Evan Davis) calls ‘Fuzzy Boundaries’ in the (so called) ‘perfectly legal’ (Andrew Witty’s words) bribing of doctors by GSK.

Andrew,

Just because it’s ‘perfectly legal’ to pay doctors to speak on behalf of drug companies does not mean it’s ethical. People aren’t stupid, the public instinctively feel that doctors who are paid consultants to drug companies are bound to be biased and easily influenced, and they would be right in thinking that.

The 2012 Department of Justice complaint (of which your company paid a 3 billion fine for) is riddled with examples of doctors literally prostituting themselves, and their reputations, to GSK. If these are the ‘perfectly legal’ scenarios which you think are ok then you really are out of touch with the public sentiment.

If your ‘perfectly legal’ bribing of doctors was reasonable and acceptable, then we wouldn’t need things like psychiatrist Peter Gordon’s sunshine act for Scotland. Peter has been taking Seroxat for over 17 years and he cannot come off it. He also works within the mental health system as a psychiatrist and he is trying to change things. Maybe you should team up with people like Peter and ask for his input?

That is, of course, if you really are serious about transparency?..

Here is a small sample of his work (and various videos) from his tireless campaigning for transparency on his blog:

 

https://holeousia.wordpress.com/about-me/a-sunshine-act-for-scotland/

 

A Sunshine Act for Scotland

Over two years ago I raised a petition with the Scottish Parliament to urge the Scottish Government to introduce a Sunshine Act for Scotland.

The official Scottish Parliament page for my petition can be 
accessed here. This page includes the petition history of PE1493 
and all the written submissions made on behalf of this petition.

Peter-Sunshine,-Jan-2015

A Sunshine Act would make it mandatory for healthcare workers (and hopefully academics and all allied health professionals) to declare fully any payments including payments in kind. The argument I presented was that a single, searchable, independent register underpinned by statute would ensure transparency, promote scientific integrity, reduce the potential for harm and save money

Current Guidance in Scotland (HDL62 issued by the Scottish Government) has failed for more than 13 years. Other governance bodies, such as the Royal Colleges, have separate systems which also appear to have failed to ensure transparency of financial payments. These overlapping, but ineffective systems of governance duplicate costs and bureaucracy to nobody’s gain

My petition was closed earlier this month by the Scottish Parliament as the Scottish Government had committed to “update guidance”.

One of the actions of the Government in response to my petition was to commission a public consultation:

Gathering public views on Sunshine Act

Last week the public voice of Scotland was revealed: the Scottish Public want sunshine:

Majority said mandatory register of financial interests is required

The majority of participants felt that the publication of financial payments to healthcare professionals should be made mandatory. There is substantial evidence from other  countries that the only effective way to make transparency mandatory is to have statutory legislation.

This is a landmark decision in the United Kingdom. By the voices of Scotland.

Of course there is much more to be done which requires energy and light.

However I have faith that the Scottish Government can provide this:

Shona-Robison---22-March-2016--mandatory-payments

I want to thank a number of people:

◾the participants in the Public Consultation

◾Eleanor Bradford Health Correspondent for the BBC who first 
suggested that I submit a petition to the Scottish Parliament

◾the Petitions Committee and its hard-working and dedicated clerks

◾John Pentland, MSP, former Convener, for being the first 
in Parliament to agree that statutory measures were required

◾Chrys Muirhead, friend, activist, and critical thinker 

◾The President and Vice President of the Royal College 
of Psychiatrists (the College I am member of) for doing 
their very best to improve transparency within the limitations 
of current guidance

Peter - parliament 12 Nov 2013

[above] At Scottish parliament presenting my petition (12th November 2013)


3821363

http://www.heraldscotland.com/news/14206293.Consultation_on_payments_to_doctors_is_flawed__says_psychiatrist/

Consultation on payments to doctors is flawed, says psychiatrist
Psychiatrist Peter Gordon at home in Bridge of Allan

Psychiatrist Peter Gordon at home in Bridge of Allan

15 Jan 2016 / Stephen Naysmith, Social affairs correspondent
Share:

A CONSULTATION about whether doctors should be forced to declare payments they have received from drug companies is biased, according to the medic whose action led to the move.

Dr Peter Gordon, a former consultant psychiatrist at NHS Forth Valley, has petitioned the Scottish Parliament to introduce a Sunshine Act, which would demand healthcare workers be open about their financial interests related to the medical industry and pharmaceutical companies.

However, he says the Scottish Government’s consultation has presented “unbalanced” information which will not give the public the full picture about the status quo.

NHS staff receive around £38.5 million from the pharmaceutical industry annually, and Dr Gordon estimates up to £4m of this may go to workers in Scotland, with no way to judge whether it has an impact on activities such as prescribing decisions.

Dr Gordon said: “Only a tiny proportion of the £4m known to be paid to healthcare workers by the pharmaceutical industry has been recorded in NHS Scotland registers.

“As petitioner my overwhelming concern is that by presenting unbalanced information the Scottish Government has arranged consultations which will lack in validity.”

After a series of hearings, Holyrood’s petitions committee agreed to commission a public consultation about whether changes were needed to improve transparency for patients and the public.

But Dr Gordon says the consultation, being carried out by the Scottish Health Council (SHC), is not giving people the full facts and could render the process invalid or even look like manipulation.

A briefing being used for the meetings implies that existing rules on transparency may be sufficient and are currently working.

Dr Gordon says that is not the case, and key details have been excluded. “The petition would not have been raised, nor indeed considered by the committee, had it not been for… evidence which has not been provided to the discussion groups,” he said.

He said no NHS Scotland board has fully complied with official government guidance issued in 2003 requiring chief executives to set up registers of interests for all employees including GPs.

Continuing medical education is in some boards entirely supported by sponsors such as the pharmaceutical industry, Dr Gordon said, and patients have no way of knowing if a doctor prescribing drugs has been paid by a drug company or been trained by people who have received such payments.

Dr Gordon added: “If healthcare workers are ‘educated’ by those whose first loyalty is to shareholders, then scientific impartiality may suffer.”

The briefing was prepared for the SHC by the Scottish Government. It says figures from the Association of the British Pharmaceutical Industry show healthcare professionals receive payments for a range of activities including training, clinical trials, media work and market research. An ABPI register of payments is expected to be implemented this year.

A spokesman for the Scottish Health Council said: “One of the key functions of the Scottish Health Council is to ensure that members of the public have the opportunity to give their views on key healthcare issues.

“Following a request from Scottish Government, the Scottish Health Council organised and facilitated a series of discussion groups to gather views from the public on whether there should be a register of interests for NHSScotland.

“Twelve discussion groups have been held around Scotland so far and more are planned to provide further opportunities for people to comment on this issue. People taking part in the discussion groups have been drawn from a range of sources including local community contacts, Public Partnership Forums and voluntary organisations.

“Once the programme of discussion groups is complete, the Scottish Health Council will publish a report on the views gathered.”

Health Secretary Shona Robison said Dr Gordon had been given the chance to comment on the consultation before it began and added: “We look forward to seeing the outcomes of the Scottish Health Council work.

“The Scottish Government commissioned this work to gather views on what a robust, transparent and proportionate response to this issue should look like.

“It is important that this is done in the context of existing legislation, the role of professional and regulatory bodies and the significant progress towards voluntary registers by the pharmaceutical industry.”

 


“”The public have a right to know what that money was for and who received it,
particularly when those involved were influencing what treatments and
medications are used in our hospitals and sugeries.”

He added: “I’m not a whistleblower but I am someone who believes the drugs, medications and treatments doctors use to help patients must be chosen on the basis of scientific evidence, not advertising.

“I could spend forever listing heavily advertised and promoted drugs and treatments hailed as the next best thing only for them to be withdrawn when it was shown they caused harm. That’s what we have to protect against. Transparency is the only way forward.”

An investigation in July revealed health staff in England who help choose drugs for the NHS were paid to work as consultants to pharmaceutical firms.

It found some NHS managers were charging up to £15,000 to organise meetings, sometimes in luxury hotels.

Read more at http://www.dailyrecord.co.uk/news/scottish-news/campaigners-call-action-after-report-6391200#rYOhJGPPQ0VVqVBU.99

Glaxo’s Imitrex Kids…


Page_1

“….Mr. Witty explained that consumers may not be actively visiting their physician for a chronic problem like migraines, so when new drugs come along, they must find out about them through advertising….”

(Andrew Witty -then VP-General Manager of Marketing for GSK- speaking in the Advertising Age October 1997)

“...The new “breakthrough” Imitrex (sumatriptan) turned out to be a big disappointment. The pain magically disappeared for a time, but then the zigzag would return out of the blue a few hours later. It was almost worse than letting it happen to begin with. Other variations of Imitrex didn’t help much more…”

(Imitrex user in Salon.com article 2015).

According to Greg Thorpe’s Department of Justice Complaint which led to the 2012 fine of 3 billion dollars for GSK:

GSK maintained an elaborate illegal marketing regime for the prescription drugs included in today’s settlement, including, according to filed documents:

  • Paying physicians (who could be counted on to influence their peers) as much as $25,000 for being a GSK “advisory board” member;

  • Enrolling 49,000 physicians and health professionals to be part of its speakers bureau;

  • Identifying physicians in academia to pay to speak on behalf of one of the company’s drugs;

  • Creating the PowerPoint “slide kits” that  physicians would  use to deliver canned presentations;

  • Using an elaborate “FaxBack” system allowing drug marketing reps to suggest articles related to off-label uses. The physicians would order these -off-label promotional materials by calling a toll-free number, and thus not appear to be responding to an illegal marketing effort by the drug marketing representative;

  • Pushing Imitrex, an adult medicine for migraine, for mild headaches, as well as for use in children, despite the FDA’s rejection of GSK’s application for child use due to lack of efficacy;

  • Pushing Lamictal, a drug approved only for partial seizures, in adults for other diagnoses.  In at least one case a patient died from a reaction that the company had evidence could occur;

  • Marketing Paxil, the antidepressant, to children under 18 when it had not been approved for youngsters, and despite GSK’s own clinical trails that had shown that the drug was ineffective for children  and also heightened the risk of suicide or other self-harming behavior three-fold; and,

  • Marketing the antidepressant Wellbutrin as superior to other antidepressant alternatives due to increased sexual functioning and weight loss, pushing the drug as the “happy, horny, skinny drug,” to concisely encapsulate GSK’s off-label Wellbutrin marketing campaign.

If Andrew Witty was Glaxo’s VP-General Manager of Marketing in 1997, then what did he know about the various marketing scams, suppression of side effects etc- which went on in the company at that time?

I was prescribed Seroxat in 1998 and information (or misinformation) about side effects was likely contained in some kind of ‘educational’ promotion to doctors back then. How much was Witty aware about Seroxat prescribing to kids? or Seroxat side effects generally? how much input did he have in the promotion of these drugs?

And how much was he aware about Imitrex, or off label prescribing of Imitrex in kids? He seemed to be involved in Wellbutrin marketing also, and Wellbutrin was one of the drugs named in the complaint, alongside Imitrex, and Paxil of course.

According to the aforementioned AdAge article from 1997, Mr Witty, as VP general manager of marketing, was very much involved in all aspects of GSK’s marketing of its drugs at this time-

“…We started experimenting with DTC early and made a relationship with the rulemakers,” says Mr. Witty.

Indeed, Glaxo has been the top advertiser in DTC prescription drug advertising-a business expected to hit $1 billion this year-for two years running. Last year alone, Glaxo’s nasal spray Flonase received $32.7 million in support, migraine remedy Imitrex got $20.4 million, Serevent asthma inhaler had $16.4 million.

Mr. Witty also is adding more product firepower this year with Glaxo’s new anti-smoking pill Zyban getting an estimated $55 million in support (the brand is even getting TV teaser ads prior to its launch)….”


We know now that Seroxat/Paxil was extremely dangerous for under-18’s (causing kids to kill themselves, self harm etc).

The RIAT study proved that beyond doubt.

We also know that GSK’s Zyban also proved to be dangerous also, resulting in suicidal and neuro-toxic side effects similar to the one Seroxat/Paxil induces (see my recent post on Zyban here)

And what do we know about Imitrex (sumatriptan)? The drug which Witty mentions in the 1997 article above?

Well, we know it was illegally pushed off label to kids and according to a recent comment to me by GSK Whistle-blower Greg Thorpe, in regards to Imitrex he said (in a very brief synopsis):

“….Selling to kids , very young as migraines tend to run in families. They told us for years, the indication for kids was weeks away, seriously so everyone pushed it… also we paid off hundreds of physicians to promote it with lectures…not only for kids…but sinus headaches, tension headaches, menstrual migraine etc
 
 All off label ..and yes it was a dangerous drug. ..a Vasoconstrictor one that not only worked on cranial blood blow, but also cardiovascular blood flow. Not for kids, and despite years of studies it was never proven safe or effective in kids under 18.
In spite of that at least 25% was underage and another 25% off label.
More money was spent making hundreds of docs, literally millionaires, speaking to groups about off label use.
I can name many of them and did…”

However after nine years of decimating (or ignoring) Greg’s Formal Complaints, GSK paid nothing for promoting the use of Imitrex in children, or any other off label use (for that matter) he also mentioned that-
-The lead investigator, Sarah Bloom, at the end of the 9 year saga, told Greg…that “she was unaware that Imitrex never was proven safe or effective in children”..

As with Imitrex, this was also the case on some 8 other drugs- including Paxil/Seroxat- where they diminished his ability to mine government data, even as the Federal Court gave him permission to do. Furthermore, in spite of a clear order  by a Federal Judge, the DOJ did not let Greg data-mine any data including a lot of specifics on Paxil marketing that only he claimed.
Greg was the only major whistle-blower who was retaliated against and terminated by GSK and also the only one who reported misconduct to the company first, and did not do it for a possible  award.
All of the others were terminated and/or planners and initiators of GSK Fraud and corruption, some slipping into the case some 8 years after Thorpe’s initial complaints in 2001.
Greg went on to comment upon other aspects of the department of justice investigation- he said :

“….Although, I did not directly sell Paxil, I witnessed everything the Paxil reps said and did. I believe with what I knew and looking in the right places, a fine of much greater than 3 billion should have been paid for Paxil alone, and at least the same for Imitrex.
GSK sold 3 billion dollars of Paxil the year I filed, 2003..most off label, and denying addictive properties.
Obviously the DOJ was in coverup mode. Who was the ringleader,  Sarah Bloom ?
I highly doubt it. I also highly doubt they will do anything serious in other countries,  after seeing what was done here”….

I found an old article online from around 2004/2005 (advertising disguised as objective medical information) which shows the lengths Glaxo were willing to go in order to push this dangerous drug to kids.
If you google the article, you’ll see that it was widely disseminated online at that time.

OFF-LABEL USE OF MIGRAINE DRUG GIVES CHILDREN RELIEF, STUDY SAYS

COLUMBUS, Ohio – A new study suggests that when over-the-counter medications fail to help children who suffer from chronic migraine headaches, those children may find relief with a drug traditionally prescribed to adults.

Ann Pakalnis

Around one out of every 10 children experience chronic migraines, said Ann Pakalnis, a study co-author and a clinical associate professor of pediatrics and neurology at Ohio State University and Columbus Children’s Hospital.

She and her colleagues treated 57 children with sumatriptan (Imitrex) nasal spray. More than three-quarters of the families in the study reported good to excellent relief of their child’s headaches after using the spray, and nearly 100 percent of the children in these families continued using the drug.

But sumatriptan isn’t approved by the U.S. Food and Drug Administration for use in children. The participants in this study were prescribed sumatriptan on an off-label basis, a common practice in which a medication is used to treat a group of people or a problem it wasn’t originally intended to treat.


“A nasal spray is the preferred way to deliver sumatriptan to children as their migraines tend to be very short, and the spray starts working in about 15 minutes.”


“By the time children see us at the headache clinic, they’ve already tried over-the-counter medications or milder prescription drugs,” said Pakalnis. “Their parents want a more aggressive treatment. They understand that it’s probably the best thing to do for their child, even if means an off-label use.”

The findings appear in a recent issue of the Journal of Child Neurology. Pakalnis conducted the study with Donna Kring, a nurse at Columbus Children’s Hospital, and Juliann Paolicchi, a pediatrician at the hospital.

The researchers took a retrospective approach to appraising sumatriptan’s effectiveness in children. They reviewed the medical charts of children 5 to 12 years old who were patients at Columbus Children’s Hospital, tallying the number of children prescribed the nasal spray. Each child’s family then received a questionnaire asking about the child’s use of the spray, its effectiveness and any concerns regarding the off-label use of the drug.

The majority (77 percent) of the 57 families who responded to the questionnaire reported that sumatriptan nasal spray had significantly helped their child, and 93 percent of these families noted that their child still used the drug.

Thirteen patients (23 percent) reported side effects from using the spray. Each of these children said the spray tasted bad, and five in this group stopped using it altogether. Sumatriptan nasal spray tastes very bitter and metallic to some children, Pakalnis said. Four of the 13 patients complained of dizziness. Two children found the spray difficult to use, and stopped using it.

“A nasal spray is the preferred way to deliver sumatriptan to children as their migraines tend to be very short, and the spray starts working in about 15 minutes,” Pakalnis said. “Some kids have a lot of nausea and vomiting with their headaches, which rules out giving them a tablet. Injection is another choice, but not a great option for children.”

Migraine triggers such as dehydration, fatigue and hormonal changes cause changes in nerve impulses that in turn affect blood vessel diameter and biochemical release. Blood vessel dilation causes pain, which analgesics can help alleviate. But analgesics don’t address the symptoms that often accompany migraines, such as nausea, vomiting and sensitivity to light and sound, which are usually caused by blood vessel constriction.

Sumatriptan and related drugs stop pain by restoring the nervous system’s ability to block pain impulses and help constrict blood vessels. And the triptans also help dilate the constricted vessels that contribute to they symptoms that accompany migraine attacks.

About 30 percent of the patients coming to Pakalnis’ office seek help for migraines. She and her colleagues currently prescribe sumatriptan nasal spray to about three-quarters of these patients.

“It’s an effective and safe treatment for children who don’t respond to over-the-counter pain killers,” she said.

The study was supported in part by Glaxo Smith Kline, makers of sumatriptan nasal spray.

#

Contact: Ann Pakalnis, (614) 722-4605; pakalnisa@pediatrics.ohio-state.edu
Written by Holly Wagner, (614) 292-8310; Wagner.235@osu.edu


So if Glaxo were misleading their drug reps to sell drugs like Imitrex to under-18’s, and obviously the marketing department were creating content for product placement disguised as objective information (such as the article above) then who (or whom) was directing this behavior from the top?

You’d have to wonder, would Andrew Witty  have allowed any of his kids to take drugs like Imitrex, or Seroxat, or Avandia, or Pandemrix?

I very much doubt it…

Because he would have known their full side effect profiles perhaps wouldn’t he?..

Or he would have at least been aware of the rumors about their dangers within the company…

If you look at the latest prescribing information leaflet (PIL) for Imitrex you will notice that it’s just as frightening as Seroxat..

How many kids and adults were misinformed and harmed?

See document (directly) below (from Greg Thorpe’s complaint) for an example of how GSK pushed Imitrex off-label.

 Imitrex doc


IMITREX®
(IM-i-trex)
(sumatriptan succinate) Injection

Read this Patient Information before you start taking IMITREX and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

What is the most important information I should know about IMITREX?

IMITREX can cause serious side effects, including:

Heart attack and other heart problems. Heart problems may lead to death.

Stop taking IMITREX and get emergency medical help right away if you have any of the following symptoms of a heart attack:

  • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

IMITREX is not for people with risk factors for heart disease unless a heart exam is done and shows no problem. You have a higher risk for heart disease if you:

What is IMITREX?

IMITREX Injection is a prescription medicine used to treat acute migraine headaches with or without aura and acute cluster headaches in adults who have been diagnosed with migraine or cluster headaches.

IMITREX is not used to treat other types of headaches such as hemiplegic (that make you unable to move on one side of your body) or basilar (rare form of migraine with aura) migraines.

IMITREX is not used to prevent or decrease the number of migraine or cluster headaches you have.

It is not known if IMITREX is safe and effective in children under 18 years of age.

Who should not take IMITREX?

Do not take IMITREX if you have:

  • heart problems or a history of heart problems
  • narrowing of blood vessels to your legs, arms, stomach, or kidneys (peripheral vascular disease)
  • uncontrolled high blood pressure
  • severe liver problems
  • hemiplegic migraines or basilar migraines. If you are not sure if you have these types of migraines, ask your healthcare provider.
  • had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation
  • taken any of the following medicines in the last 24 hours:
    • almotriptan (AXERT®)
    • eletriptan (RELPAX®)
    • frovatriptan (FROVA®)
    • naratriptan (AMERGE®)
    • rizatriptan (MAXALT®, MAXALT-MLT®)
    • sumatriptan and naproxen (TREXIMET®)
    • ergotamines (CAFERGOT®, ERGOMAR®, MIGERGOT®)
    • dihydroergotamine (D.H.E. 45®, MIGRANAL®)
      Ask your healthcare provider if you are not sure if your medicine is listed above.
  • an allergy to sumatriptan or any of the ingredients in IMITREX. See the end of this leaflet for a complete list of ingredients in IMITREX.

What should I tell my healthcare provider before taking IMITREX?

Before you take IMITREX, tell your healthcare provider about all of your medical conditions, including if you:

  • have high blood pressure
  • have high cholesterol
  • have diabetes
  • smoke
  • are overweight
  • have heart problems or family history of heart problems or stroke
  • have kidney problems
  • have liver problems
  • have had epilepsy or seizures
  • are not using effective birth control
  • become pregnant while taking IMITREX
  • are breastfeeding or plan to breastfeed. IMITREX passes into your breast milk and may harm your baby. Talk with your healthcare provider about the best way to feed your baby if you take IMITREX.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

IMITREX and certain other medicines can affect each other, causing serious side effects.

Especially tell your healthcare provider if you take anti-depressant medicines called:

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How should I take IMITREX?

  • Certain people should take their first dose of IMITREX in their healthcare provider’s office or in another medical setting. Ask your healthcare provider if you should take your first dose in a medical setting.
  • Use IMITREX exactly as your healthcare provider tells you to use it.
  • Your healthcare provider may change your dose. Do not change your dose without first talking with your healthcare provider.
  • For adults, the usual dose is a single injection given just below the skin.
  • You should give an injection as soon as the symptoms of your headache start, but it may be given at any time during a migraine or cluster headache attack.
  • If you did not get any relief after the first injection, do not give a second injection without first talking with your healthcare provider.
  • If your headache comes back or you only get some relief after your first injection, you can take a second injection 1 hour after the first injection, but not sooner.
  • Do not take more than 12 mg in a 24-hour period.
  • If you use too much IMITREX, call your healthcare provider or go to the nearest hospital emergency room right away.
  • You should write down when you have headaches and when you take IMITREX so you can talk with your healthcare provider about how IMITREX is working for you.

What should I avoid while taking IMITREX?

IMITREX can cause dizziness, weakness, or drowsiness. If you have these symptoms, do not drive a car, use machinery, or do anything where you need to be alert.

What are the possible side effects of IMITREX?

IMITREX may cause serious side effects. See “What is the most important information I should know about IMITREX?”

These serious side effects include:

  • changes in color or sensation in your fingers and toes (Raynaud’s syndrome)
  • stomach and intestinal problems (gastrointestinal and colonic ischemic events).
    Symptoms of gastrointestinal and colonic ischemic events include:
  • sudden or severe stomach pain
  • stomach pain after meals
  • weight loss
  • nausea or vomiting
  • constipation or diarrhea
  • bloody diarrhea
  • fever
  • problems with blood circulation to your legs and feet (peripheral vascular ischemia). Symptoms of peripheral vascular ischemia include:
    • cramping and pain in your legs or hips
    • feeling of heaviness or tightness in your leg muscles
    • burning or aching pain in your feet or toes while resting
    • numbness, tingling, or weakness in your legs
    • cold feeling or color changes in 1 or both legs or feet
  • hives (itchy bumps); swelling of your tongue, mouth, or throat
  • medication overuse headaches. Some people who use too many IMITREX injections may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with IMITREX.
  • serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using IMITREX, especially if IMITREX is used with anti-depressant medicines called SSRIs or SNRIs.
    Call your healthcare provider right away if you have any of the following symptoms of serotonin syndrome:
  • mental changes such as seeing things that are not there (hallucinations), agitation, or coma
  • fast heartbeat
  • changes in blood pressure
  • high body temperature
  • tight muscles
  • trouble walking
  • seizures. Seizures have happened in people taking IMITREX who have never had seizures before. Talk with your healthcare provider about your chance of having seizures while you take IMITREX.

The most common side effects of IMITREX Injection include:

  • pain or redness at your injection site
  • tingling or numbness in your fingers or toes
  • dizziness
  • warm, hot, burning feeling to your face (flushing)
  • discomfort or stiffness in your neck
  • feeling weak, drowsy, or tired

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of IMITREX. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store IMITREX Injection?

  • Store IMITREX between 36°F to 86°F (2°C to 30°C).
  • Store your medicine away from light.
  • Keep your medicine in the packaging or carrying case provided with it.

Keep IMITREX and all medicines out of the reach of children.

General information about the safe and effective use of IMITREX

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use IMITREX for a condition for which it was not prescribed. Do not give IMITREX to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about IMITREX. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about IMITREX that is written for healthcare professionals.

For more information, go to http://www.gsk.com or call 1-888-825-5249.

What are the ingredients in IMITREX Injection?

Active ingredient: sumatriptan succinate

Inactive ingredients: sodium chloride, water for injection

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

Patient Instructions for Use

IMITREX STAT dose System

Read this Patient Instructions for Use before you start to use the IMITREX STATdose System. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. You and your healthcare provider should talk about IMITREX Injection when you start taking it and at regular checkups.

Keep the IMITREX STATdose System out of the reach of children.

Before you use the IMITREX STATdose System

When you first open the IMITREX STATdose System box, the Cartridge Pack and the IMITREX STATdose Pen® are already in the Carrying Case for your convenience.

The grey and blue Carrying Case is used for storing the unloaded Pen and the Cartridge Pack when they are not being used.

The Cartridge Pack holds 2 individually sealed Syringe Cartridges. Each Syringe Cartridge holds 1 dose of IMITREX® (sumatriptan succinate) Injection. The Cartridge Pack for the 4-mg strength of this medicine is yellow, and the Cartridge Pack for the 6-mg strength is blue (as shown). Refill Cartridge Packs are available.


http://lighthouselegal.com/imitrex-lawsuit-can-go-forward-in-washington

Imitrex lawsuit can go forward in Washington

Dr. David Wilson can pursue a medical malpractice lawsuit against the hospital where his daughter, Dr. Sandra Wilson, was on staff and received treatment prior to her death in 2006, reports the Yakima Herald-Republic. Individuals in need of financial assistance to pursue medical malpractice lawsuits can often secure legal loans.

The lawsuit alleges doctors at Sunnyside Community Hospital improperly administered a migraine medication, Imitrex, to 35-year-old Sandra Wilson, who sought treatment for symptoms including nausea and speech problems, the Herald-Republic reports. The news source says Wilson began having seizures after being on the medication for three days. She died after being transferred to a Spokane hospital, where it was discovered the Imitrex had exacerbated a preexisting constriction of one of her major brain arteries.

According to the Herald-Republic, a previous ruling in the case found David Wilson could not sue Sunnyside in part because his daughter had been a contracted physician there. An appeals court recently reversed this dismissal, meaning the case will go to trial if a settlement is not reached.

Before the tablet version of Imitrex went on the market in 1995, Mother Jones reported on Dianne Riley, a 41-year-old mother of four who died from a heart attack that seemed to be the result of an adverse reaction to the drug.

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