Category: GSK unethical behavior

Was the GlaxoSmithKline FCPA resolution a missed opportunity?


Yes!…


 https://www.complianceweek.com/blogs/the-man-from-fcpa/was-the-glaxosmithkline-fcpa-resolution-a-missed-opportunity#.V_2JVtw-04A

Was the GlaxoSmithKline FCPA resolution a missed opportunity?

Tom Fox | October 11, 2016

The U.K. pharmaceutical giant GlaxoSmithKline has resolved an outstanding FCPA matter for the conduct of its China subsidiary, GSK-China that settled an SEC investigation for a fine of $20 million, with no profit disgorgement—quite a favorable move for the company. Even more amazingly, the company received a declination from the Justice Department, even though it was under the equivalent of a Deferred Prosecution Agreement, called a Corporate Integrity Agreement, for the actions unrelated to its FCPA violations in marketing off-labeled marketed products.

Of course these resolutions did not stand alone as the company had been sanctioned by the Chinese government with a fine of approximately $490 million back in 2014 for the actions of GSK-China. Company employees were criminally convicted and non-Chinese senior executives of the China business unit, who were convicted were deported from China. GSK’s sales in China went in the tank and continue to suffer through this date.

Perhaps the U.S. authorities felt the company had suffered enough. However, in this age of increasing international enforcement, it may well be the SEC and Justice Department missed an opportunity to demonstrate how they would give credit for anti-corruption prosecutions, done by other governments, under local anti-corruption laws; such as was done by Chinese authorities with GSK-China. U.S. authorities could have not only cited to the successful use of domestic Chinese laws as an example in the international fight against bribery and corruption but also specifically stated that how the fine and penalty paid by GSK-China was considered in the calculation of the fine by U.S. regulators.

Such an approach would have emphasized the U.S. government’s favorable outlook for greater international sanctions against corruption, as well as shown companies that they would not be whip-sawed by regulators across the globe for the same conduct. It could have been one of the most public examples of how the U.S. government viewed the international fight against corruption.

I think an opportunity may have been missed. 

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GSK scientists indicted for trade secret theft


GSK scientists indicted for trade secret theft

 

Two scientists working at GlaxoSmithKline (GSK) in Pennsylvania, US, have been indicted for conspiracy to commit fraud and allegedly stealing confidential information related to its biopharmaceutical products. The indictment names five people, including scientists Yu Xue and Lucy Xi. If convicted of all charges, each defendant faces a range of punishments, including fines and possible prison terms.

The indictment claims that Xue and Xi used e-mail and USB drives to transmit information about GSK’s procedures for researching, developing, and manufacturing biopharmaceutical products designed to treat cancer or other diseases. Xue and two of the other defendants had formed a company in China called Renopharma in July 2012, allegedly to market and sell the stolen trade secret information.

Wrapping Up 2014..


In January 2015, this blog will be 8 years old. I have blogged consistently during that time  with genuine conviction, about issues which I think are extremely important, but in particular, I have drawn attention to GSK’s unethical promotion of their dangerous and defective anti-depressant, Seroxat (Paxil). However, as anyone can see, from reading the hundreds of posts on this blog, GSK’s sinister activities have gone far beyond Seroxat marketing, bogus drugs and deception.

I will be wrapping up this blog by the end of the year, and I don’t plan to post anything after January 2015, 8 years is enough I think, I have done more than my fair share, and maybe it’s time for others to do their bit. I will leave the blog online though, as I think it’s an extremely important resource, for researchers, patients etc.

Furthermore, I was recently contacted by an anonymous source who is seeking information on GSK and Burroughs Wellcome (a previous incarnation of the company) and their involvement in possible illegal and unethical vaccine trials on Irish orphans. If anyone out there has any information on these trials or anything related to them, can you contact me on truthman30@gmail.com and I will pass on the relevant details to the researchers.

In particular, some of the information sought is in regards to the following issues:

  1. Were there additional trials in Ireland?
  2. Were there similar trials in England or elsewhere in the world?
  3. Is there any evidence of money changing hands between the government/health boards/religious orders and the pharmaceutical companies?
  4. Can any inference be drawn from the way the Vaccine Trials Division of the Commission of Inquiry Into Child Abuse was shut down and the Government relationship with GSK?

 

If anyone out there has any information on any of the above, or anything that they feel might be of use in getting to the bottom of these drug trials on Irish orphans, contact me on the e-mail provided, through twitter, or leave a comment.

I won’t be doing any more posting after Christmas, as to be honest, it’s just too time consuming and not feasible to blog anymore. I also had a recent personal experience that I found very disturbing. I won’t go into details about this horrendous event, but what I will say is, I am more than capable of defending myself, but I refuse to respond to bully boy tactics, and veiled threats, I abhor that kind of behavior, and I always disengage when bullies try those tactics on me. The experience was related to this blog and the value of the work I do, and this onerous episode has really been the catalyst for making the decision to give up blogging. Writing a blog, and dealing with the stuff I research, really can be a thankless, lonely role,  at times. However I don’t regret one minute of it, or one post I made, as I know now I have made a  huge difference and the truth is now self evident, and that was the point…

Thanks for reading..

GSK Now Investigating Corruption In United Arab Emirates (UAE)


http://www.reuters.com/article/2014/10/07/us-gsk-emirates-idUSKCN0HW1L420141007

(Reuters) – Drugmaker GlaxoSmithKline, which was slapped with a record $489 million fine for corruption in China last month, said on Tuesday it was looking into allegations of corruption in the United Arab Emirates.

Britain’s biggest pharmaceuticals group confirmed the investigation following allegations of improper payments set out in a whistleblower’s email sent to its top management on Monday. The email, purporting to be from a GSK sales manager in the Gulf state, was seen by Reuters.

The company is already investigating alleged bribery in a number of Middle East countries, including Lebanon, Jordan, Syria and Iraq, as well as Poland.

“As we have already said, we are undertaking an investigation into our operations in the Middle East following complaints made previously. This investigation continues and these specific claims were already being investigated as part of this process,” a GSK spokesman said.

GSK and other major drugmakers are under increased scrutiny in the wake of the high-profile Chinese case and law enforcement agencies in both the United States and Britain are clamping down on overseas corruption by multinational companies.

The China scandal has hit GSK’s drug sales in the country and tarnished the reputation of Chief Executive Andrew Witty.

Other pharmaceutical companies, too, are in the firing line for alleged improper sales behavior.

France’s Sanofi said on Monday it had informed U.S. authorities of allegations of improper payments by its employees to healthcare professionals in East Africa and the Middle East.

Novartis, meanwhile, has been ordered to face a U.S. government lawsuit accusing the Swiss drugmaker of paying multimillion-dollar kickbacks.

And two women in Poland have pleaded guilty to bribery in another case involving an unnamed company.

In the case involving GSK’s practices in the UAE, the anonymous author of the email claimed that the British company made direct payments to healthcare professionals, hospitals, clinics and pharmacies to secure business.

This included payments for educational meetings — regardless of whether or not they took place — as well as schemes to pay customers for taking prescription drugs by giving them bonus over-the-counter products, the author said.

“We have zero tolerance for unethical behavior and we welcome people speaking up if they have concerns about alleged misconduct. We are committed to taking any disciplinary actions resulting from the findings,” the GSK spokesman said.

GlaxoSmithKline has become the ‘poster child for scandal’ (From Ed Silverman at the WSJ)


9:45 am ET
Sep 19, 2014

EMERGING MARKETS

Glaxo Found Guilty of Bribery in China: Can Witty Rehabilitate the Drug Maker?

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After months of anticipation, a Chinese court found the GlaxoSmithKline GSK.LN +0.90% subsidiary in China guilty of bribing doctors, hospital officials and other non-government personnel, and fined the drug maker more than $490 million, The Wall Street Journal reports. This becomes the largest such penalty levied on a company in China.

At the same time, Mark Reilly, the former head of the Glaxo unit in China, pleaded guilty to bribery-related charges and was given a three-year suspended sentence. There are varying reports, however, whether he will be deported or required to remain in China during that time. Four other senior Glaxo managers in China also received suspended sentences of between two and four years.

As we have noted previously, the drug maker had been accused of running a bribery network in China that was designed to boost drug sales. As part of the scheme, Glaxo employees allegedly bribed physicians and hospital staff members, while channeling kickbacks through travel agencies and trade groups, among others.

The court decisions cap a tumultuous episode for Glaxo, which was already struggling to restore its image and revamp business practices in the wake of a $3 billion settlement with U.S. authorities two years ago. The drug maker had been accused of failing to disclose clinical trial data for certain medicines and improperly marketing drugs, among other things.

Andrew Witty, the Glaxo chief executive, issued a brief statement: “Reaching a conclusion in the investigation of our Chinese business is important, but this has been a deeply disappointing matter for GSK. We have and will continue to learn from this. GSK has been in China for close to a hundred years and we remain fully committed to the country and its people.” (here is the official apology, too).

Despite the contrition, pressure may be mounting on Witty, who has repeatedly emphasized the China and other so-called emerging markets are key to Glaxo growth. As the Journal points out, some investors are starting to question his overall performance and whether the scandal in China may represent a systemic problem.

Indeed, Glaxo previously acknowledged investigating claims employees bribed doctors in Poland, Iraq, Syria, Jordan and Lebanon. Meanwhile, the FBI and the U.S. Securities and Exchange Commission are probing its activities in China. As part of a probe into the pharmaceutical industry, U.S. authorities have been eyeing its overseas dealings since 2010 for possible violations of the Foreign Corrupt Practices Act.

It is worth noting that Witty has now spent half of his six-year tenure trying to overhaul business practices, and has still more fines and investigations to show for his efforts. Granted, cultural differences require varying approaches to success around the world, and Glaxo is not the only drug maker facing this challenge. But Glaxo is now something of a poster child for scandal.

Witty has made headway in other areas. In particular, he has won kudos for his push to make clinical trial data more readily accessible to researchers, a move that has helped Glaxo deflect much of the criticism leveled at the pharmaceutical industry otherwise. In trying to resolve this highly contentious issue, he placed himself and Glaxo in a leadership position.

Whether he emerges unscathed by the latest developments in China – and unfolding events elsewhere – remains to be seen, of course. But Witty may need to have Glaxo executives practice some of the self-criticism that Chinese Communist Party leaders preach as a path toward rehabilitation.

As We Expected.. No Jail Time For GSK’s Mark Reilly In China…


The pharma firm’s former China boss is said to escape jail time as GSK tries to draw a line under a “deeply disappointing” matter.

A Chinese national flag flutters in front of a GlaxoSmithKline (GSK) office building in Shanghai

GSK acknowledged wrongdoing in its statement

GlaxoSmithKline (GSK) has been fined almost £300m by a court in China – a record in the country – for bribing health officials to use its products.

The pharmaceutical firm confirmed the £297m penalty imposed by the Changsha Intermediate People’s Court in Hunan Province, saying it accepted that illegal activities took place and the fine would be paid through existing cash resources.

The Chinese state news agency, Xinhua, reported that the former head of GSK in China and other executives faced jail terms but a GSK source told Sky News that Mark Reilly was to be deported after being handed a three-year suspended sentence.

The company’s statement said the court found that “GSK China Investment (GSKCI) …offered money or property to non-government personnel in order to obtain improper commercial gains.

Mark Reilly of GSK
Mark Reilly used to run GSKCI

“The illegal activities of GSKCI are a clear breach of GSK’s governance and compliance procedures; and are wholly contrary to the values and standards expected from GSK employees.

“GSK has published a statement of apology to the Chinese government and its people on its website.

“GSK has co-operated fully with the authorities and has taken steps to comprehensively rectify the issues identified at the operations of GSKCI.

“This includes fundamentally changing the incentive programme for its salesforces (decoupling sales targets from compensation); significantly reducing and changing engagement activities with healthcare professionals; and expanding processes for review and monitoring of invoicing and payments.”

GSK chief executive Sir Andrew Witty added: “Reaching a conclusion in the investigation of our Chinese business is important, but this has been a deeply disappointing matter for GSK.

“We have and will continue to learn from this. GSK has been in China for close to a hundred years and we remain fully committed to the country and its people.”

The investigation took a number of twists with a British man, who was hired as an investigator by GSK, being jailed for two years and six months in August.

The Chinese authorities claimed Peter Humphrey illegally obtained Chinese citizens’ personal information and sold it to companies including GSK.

Peter Humphrey China Charges GSK
Peter Humphrey’s health is said to be poor

The London-listed firm hired him after an anonymous email, containing a sex tape of Mr Reilly and his Chinese girlfriend, was sent to senior management in January last year.

The email alleged corrupt practices in GSK’s China operation.

GSK’s ethical standards have also been called into question in Lebanon, Iraq, Jordan,Syria and Poland.

Its share price was almost 0.6% higher in the wake of the announcement.

Ooops… GSK Accidentaly Releases 45 Litres Of Live Polio Virus Solution Into The Environment


The accidental release of 45 litres of concentrated live polio virus solution into the environment – Belgium
As reported to ECDC by Belgian authorities, on 2 September 2014, following a human error, 45 litres of concentrated live polio virus solution were released into the environment by the pharmaceutical company, GlaxoSmithKline (GSK), in Rixensart city, Belgium. The liquid was conducted directly to a water-treatment plant (Rosieres) and released after treatment in river Lasne affluent of river Dyle which is affluent of the Escaut/Scheldt river
ECDC’s assessment is that the accidental release in the environment of large amounts of live polio virus represents a risk to public health if susceptible populations, such as areas with low polio vaccine coverage, are exposed to contaminated waters or mud. Particularly since the Lasne and Dyle rivers are joining the Escaut/Scheldt river which flows in the southwestern part of the Netherlands where various orthodox protestant communities present a lower polio vaccination coverage, before reaching the North Sea.

The Guardian: China bribery claims: GSK may not want to stay if punishment seems unfair


http://www.theguardian.com/business/2014/may/14/china-bribery-claims-gsk

If firm accepts evidence of systemic bribery, it’ll have to explain how it could have happened without detection by head office

Ten months ago, when Chinese authorities first made allegations of corruption against GlaxoSmithKline‘s local unit, it was possible to think the affair would be resolved quietly and quickly. GSK might pay a modest fine, pledge to monitor staff more closely and offer the Chinese lower prices on prescription medicines.

That comfortable script looked less likely to prevail as the police investigation dragged on and new allegations were aired regularly in state-owned media.

Now it is obvious that the Chinese authorities are not interested in a quiet settlement. China‘s ministry of public security says it has evidence of “massive and systemic bribery” and has implicated Mark Reilly, GSK’s country head.

No charges have yet been laid but that step appears a formality.

“We take the allegations that have been raised very seriously. They are deeply concerning to us and contrary to the values of GSK,” said the company. As a holding statement, that’s as one would expect. But at some point GSK will have to say something meaningful.

If the company accepts the evidence of systemic bribery, it will have to explain how such corruption could have happened without being detected by head office. If, on the other hand, chief executive Sir Andrew Witty feels Reilly (who, note, is still on the payroll) and his colleagues are being treated unfairly by the less than transparent Chinese justice system, it is hard to understand why GSK would wish to stay in China.

“We want to reach a resolution that will enable the company to continue to make an important contribution to the health and welfare of China and its citizens,” concluded GSK’s statement. Yes, that’s a reasonable ambition. It may prove impossible to achieve.

Forbes Nails Andrew Witty And GSK’s Agenda For What It Is : Utter BS!


It is quite remarkable to see a mainstream corporate news agency like Forbes really nail the problems of GSK and the various ethical/integrity issues that surround Andrew Witty’s tenure as CEO. Great article, and It would be great to see more like it from the mainstream media.

We- the bloggers- have been calling out GSK on their hypocritical corporate bullshit for years now- so it’s good to see some journalists, from the mainstream, are finally catching up. Well done  to Forbes for having the balls to tell it like it is. Kudos. 

http://www.forbes.com/sites/erikakelton/2014/04/28/glaxosmithklines-spin-doctoring-doesnt-cure-corruption-problems/

Erika KeltonErika Kelton Contributor

I write about whistleblower matters involving fraud and other issues.

INVESTING 4/28/2014 @ 5:02PM 1,737 views

GlaxoSmithKline’s Spin Doctoring Doesn’t Cure Corruption Problems

Andrew Witty, GlaxoSmithKline GSK -0.49%’s CEO, has been a busy man over the past couple years, taking every opportunity to convince the public that the company has reformed its culture and marketing practices.

But despite the full-on PR campaign, claims continue to surface about Glaxo using bribes to induce doctors to prescribe Glaxo drugs. Allegations of Glaxo’s bribery in China have hung over the company for nearly a year, and just recently similar concerns have been raised publicly about the company’s marketing practices in Poland, Iraq, Jordan and Lebanon – in all, a list that is becoming as long as an Amazing Race itinerary.

It has been less than two years since Glaxo paid the US government a record-setting $3 billion to settle a range of fraud and bribery allegations, including allegations that it paid kickbacks to doctors to prescribe Glaxo drugs and that it marketed many of its drugs for unapproved uses, making unsubstantiated claims about results. (A number of those allegations were raised by whistleblowers my firm represented.)

Untitled

 

GlaxoSmithKline Chief Executive Officer Andrew Witty said “displaying integrity” is a company priority, but the recent spate of bribery allegations belie those words. 

If the latest allegations are true, Andrew Witty will need to work overtime to dispel the conclusions that Glaxo simply “off-shored” illegal sales tactics first developed in the United States and that the pharma giant continues to foster a culture where bribery and kickbacks are considered standard sales practices.

CEO Witty promised in 2012 that GSK would make “displaying integrity in everything we do” a priority. However, the temptation of rapidly growing markets in Asia, the Middle East and Europe may have proven too difficult to resist. After all, it’s harder to convert “integrity” into rising share prices than it is to boost profits through questionable business practices.

The flood of bribery allegations is a test even for Glaxo’s professional spin doctors who, rather ironically, try to distract the public from bad news on the ethical front by announcing the company’s latest steps to reinvent itself as an ethical business venture.

For example, prior to its November 2011 announcement that the company would pay $3 billion to resolve the U.S. liabilities, Glaxo moved to pre-empt the bad news by announcing it was changing its US sales representatives’ compensation structure so that they would no longer be rewarded based on the volume and value of prescriptions sold. Such incentive-based compensation is considered to encourage illegal practices that drive sales.

But as the latest alleged bribery revelations suggest, limiting those changes to the US sales force left the rest of the world – including Glaxo’s most rapidly growing markets – open to questionable practices encouraged by incentive compensation structures that Glaxo failed to change outside the US.

In 2013, dogged by numerous media stories that it was bribing doctors in China to prescribe its drugs, Glaxo tried to blunt the fallout by belatedly announcing that all of its sales representatives worldwide would be compensated under the same terms as its US sales force, replacing financial incentives based on sales with ones based on the quality of service sales reps provide doctors and other healthcare providers.

Then in March, a top Glaxo official said in a media interview that Glaxo would hire doctors in-house to market its drugs, rather than pay physicians to speak to other doctors about its products. Within just a few weeks, like clockwork, allegations of GSK bribing physicians in Iraq, Jordan, Lebanon and Poland surfaced.

One gets the feeling that Glaxo’s compliance efforts are geared more to pre-empting bad news than they are to making meaningful and effective changes to its business culture.   Glaxo’s piecemeal approach to compliance holds back on clearly needed wholesale changes while the executive suite waits for the next investigation of unethical conduct to crop up.

With Glaxo’s recent history, it is hard to keep a straight face when reading the company’s statement responding to the latest bribery allegations involving Jordan and Lebanon. Glaxo declares: “We are confident in our processes and controls and that we do not have a systemic issue with unethical behavior in GSK.”

If Glaxo truly doesn’t recognize that bribery allegations in multiple countries around the globe add up to a “systemic issue,” then the company has even bigger management problems than it seems. In that case, GSK and Andrew Witty should be prescribed a full dose of reality – with unlimited refills.

 

 

 

 

The Great Glaxo Transparency Swindle… Prof. David Healy says ‘now is the time of greatest peril’…


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http://davidhealy.org/welcome-to-troy/#comments

Trojan Horse

The press coverage of AbbVie’s withdrawn legal action suggests that most major companies have now embraced an option for transparency pioneered by GSK.

All Trials are among those taking credit for pressuring AbbVie into submission. They have aggressively welcomed the offer by GSK to make clinical trial data available with no questioning of the terms on which the data is being produced.

But GSK’s offer is a manoeuvre worthy of Ulysses himself. You’d never guess from company self-congratulation that it was forced on GSK by a New York Court as part of the resolution of a Fraud action. The Fraud Action happened because GSK had written up a positive portrayal of a trial when in fact the company itself thought the trial had shown their antidepressant, Paxil, did not work.

The trial – Study 329 – was test of Paxil in children. As mandated by the Courts in the wake of Study 329, GSK put up company study reports for all of their trials, Paxil and other drugs including the diabetes drug Avandia. These could be downloaded. Steve Nissen of the Cleveland Clinic did just this for the Avandia reports and was able to show that Avandia killed.  A company blockbuster was stopped in its tracks.

Poacher turned Game-Keeper?

Putting study results up on the web must have seemed like a very bad idea to GSK. So why are they now championing data access?

GSK and other companies are reaping kudos for apparent transparency. And they can say with a straight face to any TV anchorman or Congressional committee that they are making data available.

But in fact here is what is happening. Having seen what happened with the Avandia study reports GSK now know what to do when writing a Study Report to avoid a repeat. Suitably Doctored Study Reports for other drugs will go up on their website.

The Study Reports however do not contain the data. A first approximation to the data in the case of Study 329 comes in a series of 7 appendices to the 329 Study Report – something GSK did not put up on the company website until the omission was spotted nearly 10 years later by Peter Doshi and New York State required them to do so.

In the case of Study 329, the ghostwritten article that led to GSK being sued for fraud, is 11 pages. The Study Report is over 700 pages. There are then 7 appendices that between them come close to 5500 pages. Even this however is not the raw data.The raw data lies in Clinical Report Forms.

You can Look but you cannot See

As things stood before GSK’s offer of transparency, the 5,500 page of appendices and 700+ pages of the Study Report could be downloaded and printed off. Finding what went on in a clinical trial from paperwork like this is a bit like playing Memory – where there a bunch of cards with faces or plants or whatever turned face down and if you turn one up you have to remember where the matching face you turned up before is. It can be done with 5,500 pages printed off.

But playing Memory is much harder to do now with the new improved access GSK is offering.

If you apply to access a GSK trial now you are forced to submit an analytic plan which essentially stops an applicant from accessing any adverse events on the drug. Adverse events are the material the company tries hardest to hide.

Should you get access to the full set of appendices that contain company listings of adverse events, there is almost no way to play the Memory Game because access is through a remote desktop. It may be that a younger generation used to playing Digital Memory will be able to work the system, but it’s not easy. It takes multiple passwords to access the desktop. You are logged out regularly. And while on the desktop, GSK can monitor your every keystroke.

Nightmare in Harlow

But here’s the rub. To really nail down what’s going on, you need access to the approximately 70,000 pages of patient level data. Through a remote desktop this becomes a nightmare.

This scheme to deliver frustration cloaked in the appearances of transparency was devised several years ago. 

The history of the idea was outlined two years ago in May Fool’s Day. Last year the details of GSK’s scheme were outlined in April Fool in Harlow.

– See more at: http://davidhealy.org/welcome-to-troy/#comments

Neil1Neil2

 For more on The Ben Goldacre/GSK/Data Debacle See My Previous Posts Here:
https://truthman30.wordpress.com/tag/ben-goldacre/
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