Tagged: Whistleblower

In an interview, whistleblower Peter Wilmshurst discusses how pressure from Big Pharma corrupts research….


Fascinating interview from DER SPIEGEL 2015..

 


 

http://www.spiegel.de/international/zeitgeist/spiegel-interview-with-whistleblower-doctor-peter-wilmshurst-a-1052159.html

 

Whistleblower on Medical Research Fraud: ‘Positive Results Are Better for Your Career’

By Rafaela von Bredow and

Andrew Fox/ DER SPIEGEL

 

Cardiologist Peter Wilmshurst at his home in Atcham, Britain. He blew the whistle on malpractice by US pharmaceutical company NMT Medical.

In an interview, whistleblower Peter Wilmshurst discusses how pressure from Big Pharma corrupts research into new medicines and leads companies to cover up fraudulent data. He says he has no regrets about taking on an entire industry.

Semi-retired British cardiologist Peter Wilmshurst — described in 2012 by the British Medical Journal as a “successful and cheerful whistleblower” — began his crusade against dishonesty in medical research in 1986. In the course of the 66-year-old’s career, he conducted studies for pharmaceutical and medical devices companies, and unlike many of his colleagues, never hesitated to publish negative results. He’s been the subject of multiple cases of legal action and risked bankruptcy and his reputation to expose misconduct in the pharmaceutical industry. Today he advises and supports other whistleblowers with the organization “Patients First.”

He sat down with SPIEGEL to discuss mistruths and fraud in medical research and why he decided to challenge the pharmaceutical industry.


SPIEGEL: In your early years as a researcher, a pharmaceutical company offered you a bribe equivalent to two years of your salary: They wanted to prevent you from publishing negative study results. Were you disappointed that you weren’t worth more?

Peter Wilmshurst: (laughs) I was just a bit surprised to be offered any money, really. I was a very junior researcher and doctor, only 33 years old, so I didn’t know that sort of thing happened. I didn’t know that you could be offered money to conceal data.

SPIEGEL: How exactly did they offer it to you? They probably didn’t say: “Here’s a bribe for you.”

Wilmshurst: No, of course not! Initially we were talking about the results that I’d obtained: That the drug that I had been testing for them did not work and had dangerous side effects. Then the company representatives asked me to leave some of the patients out of the data analysis. Without these patients, the study result would have been positive. When I said I couldn’t do that, they asked me not to publish the data. And to compensate me for the work I had done in vain, they said, they would offer me this amount of money.

SPIEGEL: What went through your head at that moment?

Wilmshurst: Well, I thought it was wrong. If you’ve got the data, you have got to publish it. That’s the imperative. I mean, that’s one of the big issues in pharmaceutical research, that the data we’re basing our treatments on are actually only part of the data, because industry conceals the unfavorable bits.

SPIEGEL: So it didn’t take you long to make up your mind?

Wilmshurst: No. Also because the patients that took part in our research did this on the expectation that their data would be used. In this study the participants had had cardiac catheterization. They had risked their lives for the study! So you cannot hush up the results!

SPIEGEL: How did the company react?

Wilmshurst: They terminated the trial prematurely, and to prevent us from doing more research with the drug, a representative from the pharmaceutical company came to the hospital pharmacy and asked for the stocks. The pharmacist noticed that something was wrong and tried to call me. While he was on the phone the drug rep picked up the box with the drug in it and left.

SPIEGEL: They stole the drug?

Wilmshurst: Well, it was theirs, so they didn’t really steal it. But it was very unorthodox. Later other scientists who were associated with the company attempted to publicly discredit our results. And then we learned that three other groups that had tested the drug had also had negative results. But they had been persuaded not to publish them. Each of them had been told that they were the only ones with negative results and that their reputation would suffer if they published.

SPIEGEL: Is research fraud like this widespread?

Wilmshurst: I can’t tell you exactly what percentage of the trials are flawed. But I think the problem is far bigger than you imagine. And it is getting worse.

SPIEGEL: Why?

Wilmshurst: Because research is getting more important for a doctor’s career, and it is so easy to manipulate data, conceal it or fabricate it. Or make unimportant research look like a huge success.

Graphic: The Trillion Dollar Pharmaceuticals Industry Zoom

DER SPIEGEL

Graphic: The Trillion Dollar Pharmaceuticals Industry

SPIEGEL: Are studies about drugs with dangerous side effects also systematically hushed up?

Wilmshurst: Yes, absolutely. And often the scientists don’t even have to be offered bribes or threatened to conceal data. Some do it without any industry pressure. It is much better for a researcher’s career to publish positive results. And that is what it’s about: to climb up the ladder a bit more.

SPIEGEL: How exactly do the strategy managers of big pharmaceutical companies go about bringing a drug to the market? You know the tricks …

Wilmshurst: Indeed. I could probably advise aspiring managers in the pharmaceutical industry (laughs).

SPIEGEL: Okay, let’s play a little game. Let’s pretend to be these managers. What would you advise us to do?

Wilmshurst: Well, I think the way you should do it is to get eminent doctors on your side by paying them a lot of money. Officially they are still independent consultants or university professors, but the truth is, they lose their independence the moment they are on your payroll. What these opinion-leaders say has a lot of weight among other doctors.

SPIEGEL: Is money enough?

Wilmshurst: I think for many of them enough money is all they need, really. I mean, most people have a price. But of course you have to be very friendly with them, you have to go and talk to them, have lunch with them, discuss the research. They have to forget that it is your aim to make the maximum amount of money.

SPIEGEL: And what if the professor produces results in a trial that we don’t like?

Wilmshurst: You have made the principal investigator sign a confidentiality agreement beforehand, so that you have control over the data. And you may put into the contract arrangements for a bonus in case of a positive result. (grins) This may help the researcher interpret the data in a more favorable way for you.

SPIEGEL: But there’s one obstinate researcher who keeps insisting on publishing negative results. And he doesn’t accept the bribe that we offer him. What now?

Wilmshurst: Well, you can try and discredit him, you can try to ruin his reputation and cast doubts on his results. That’s what was done with me. And then in the end you can sue him. The threat is often enough to keep him quiet.

SPIEGEL: Later, long after the first attempt at bribery, you also declined a £50,000 (€69,000) consultancy fee that was offered to you by another company. Are you a hero?

Wilmshurst: (laughs) I don’t know. I’m not actually the only doctor who doesn’t take bribes! And why is this seen as a heroic deed? Nobody says: Great, that you didn’t rob this bank! I see it the other way around: How can anyone accept this money?

SPIEGEL: Most young people start medical school with very high ideals …

Wilmshurst: … yes, at the beginning they all want to work for Doctors without Borders. Then, five or six years later when they leave medical school, they want to be a cosmetic surgeon.

SPIEGEL: And how are they pulled into the system?

Wilmshurst: I think it starts in a very innocent way. You go to a lecture and the pharmaceutical industry provides sandwiches for lunch. You don’t think of a sandwich as a bribe, do you? And then you see other people taking more — money for lectures, tickets to conferences. Gradually you accept bigger and bigger bribes.

SPIEGEL: So many senior doctors are not very good role models?

Wilmshurst: Unfortunately not. As a junior doctor what you see is that money is very, very important. Many doctors judge their value to society by how much they earn. Like bankers. If they haven’t got enough to drive a Porsche, then they’re not a very good doctor.

SPIEGEL: Ambition and envy must play a role, too. Why do so few doctors speak up when they notice one of their colleagues is manipulating data?

Wilmshurst: I absolutely agree that research fraud seldom goes unnoticed. Colleagues know that someone has not used as many animals or as much radioactive isotope as written in a publication. But there is almost a code of silence not to speak about it.

SPIEGEL: But why do the honest doctors keep silent?

Wilmshurst: It could end your career. Maybe your boss knows about it? And condones it?

SPIEGEL: So you better not risk it?

Wilmshurst: Well, maybe I shouldn’t say this, but it’s a bit like speaking up in Nazi Germany, isn’t it? It’s so much in the system, you don’t know who is involved and whom to turn to. Although obviously the consequences of speaking up in medical science are not so extreme — one can end up unemployed rather than dead.

SPIEGEL: But most publications have coauthors. How can someone agree to have his name on a paper if he suspects the research could be fraudulent?

Wilmshurst: You are absolutely right. Take the case of Joachim Boldt, the German anaesthetist from Ludwigshafen Hospital. He published a phenomenal amount of articles until it became known that he didn’t have the consent of the ethical committee and fabricated data in about 90 of them. How could his coauthors not have noticed a fraud of this size? Even if he did not ask them if they wanted their name on the paper, once the paper was published they must have seen it.

SPIEGEL: A few years ago the medical devices company NMT Medical sued you for libel. You had conducted a study for the company and then pointed out some severe problems with the security of a device. There were several legal actions against you. In the end the company went bankrupt, and you lost £25,000. Was it worth it?

Wilmshurst: Oh yes. Yes, of course.

SPIEGEL: Why?

Wilmshurst: Why? Because it has helped to get the true results of the study out: that this medical device did not work and led to some life-threatening complications. The first publication was sugarcoated. After the trial a correction had to be published. And although this correction is still not 100 percent correct, it is better than the first version.

SPIEGEL: During the almost four years of the legal actions you spent almost all your spare time work on your defense. Does your wife agree that it was worth it?

Wilmshurst: Yes, absolutely. And my two daughters, too. Of course, it was a difficult time for me and my family. But that doesn’t mean you can do what’s wrong, does it?

SPIEGEL: Did you celebrate when the legal actions were over?

Wilmshurst: Oh yes! All along we had thought we were going to go bankrupt and lose our house. When we realized, we would only lose £25,000, my wife and I opened a bottle. So losing £25,000 can be a good reason to celebrate! (laughs)

SPIEGEL: Do you know other cases where things ended well for a whistleblower?

Wilmshurst: No, almost none.

SPIEGEL: Why?

Wilmshurst: Colleagues and superiors don’t trust whistleblowers, because they think it could be their turn to be reported next. Also, the reputation of the medical institution they work for is at risk if a whistleblower reports fraud, so loyalty to your employer is valued higher than the truth. But I think as a doctor your loyalty should be primarily to your patients. And as a scientist it should be to the truth of your research. But I think some people have forgotten what it means to be a doctor and a scientist.

SPIEGEL: What in your view are the most important changes that should be made to prevent fraud?

Wilmshurst: I think there should be routine controls in labs and during clinical studies. Research should be independently checked.

SPIEGEL: That’s unlikely to scare the pharmaceutical industry.

Wilmshurst: Yes, so there also have to be more fundamental changes. Since it’s the money of the pharmaceutical companies that controls the researchers, it would be important to put a barrier between the company and the scientific investigators. The company could pay the money that is needed to do a study to an independent body, e.g. the Department of Health. The Department of Health then suggests which researcher could do the study, and when the company agrees, pays out the money. So there is no direct contact between the company and the researcher.

SPIEGEL: Where would you be today, if as a young doctor you had decided to accept the bribe from the pharmaceutical company?

Wilmshurst: I don’t know. Well, you never know, do you? I might be in prison! (laughs)

SPIEGEL: Dr. Wilmshurst, we thank you for this interview.

Whistleblower Lawsuit Filed By Ex-GSK Manager (Pharmalot 2016)


This company is rotten to the core…

Only 8 days in to 2016 and GSK up to no good..

Interesting to see (Saint/Sir/Whiter-than-White/Whatever) Witty mentioned though..

 


 

http://www.statnews.com/pharmalot/2016/01/07/glaxosmithkline-whistleblower/

 

A former GlaxoSmithKline biostatistics manager has filed a whistleblower lawsuit accusing the drug maker of firing him for alleging dodgy study data was used to tout the effectiveness of a smoking-cessation product.

Alexandre Selmani, who worked at Glaxo for nearly a decade, claims his supervisors ignored repeated efforts to alert them to statistical mistakes made in clinical trials for NiQuitin, according to the lawsuit, which was filed in a New Jersey state court. In the United States, Glaxo markets the product as Nicoderm.

As a result, he claims the company engaged in an “illegal, deceptive marketing program” to promote the product “without justification” as a “significant advance” in nicotine treatment. The lawsuit also alleges Glaxo maintained its product was superior to existing nicotine treatments.

Selmani began complaining about the data in mid-2012. But after meeting resistance, he claims to have sent an email to Glaxo Chief Executive Andrew Witty to warn that the mistakes had “the capacity to cause negative consequences and potential health and safety issues for the general public,” the lawsuit argues, although it does not allege any consumers were harmed.

Along with the drug maker, the lawsuit also names Witty and several employees as defendants. A Glaxo spokeswoman declined to comment.

Despite his protests, the company submitted the data for publication and the study was eventually published online in Psychopharmacology in April 2014. The study abstract concluded the product “could be useful to provide quick craving relief for low-dependence smokers.”

In his suit, Selmani maintains that his supervisors retaliated against him by giving him low job performance ratings and reduced raises; sabotaging some of his work; and, ultimately, firing him last October. His lawsuit cites the New Jersey Conscientious Employee Protection Act, which addresses retaliation by employers.

“The company wanted to use flawed data to sell the product to the public,” Rosemarie Arnold, his attorney, told us. “And when he brought that to the attention of his supervisor, he was basically told to shut up. He worked there many years, got great reviews, and did a great job. But they tried to push him out when he complained they used improper data. And consumers paid for something they didn’t get.”

According to the lawsuit, Selmani’s supervisor told him that he was wasting his time to report the mistakes because he would never be able to convince management to fix them. At one point, Selmani was also told that his “future was not with GSK.”

Ed Silverman can be reached at ed.silverman@statnews.com
Follow Ed on Twitter @Pharmalot

Whistleblower Greg Thorpe’s 7th Amended Complaint..


GREGt“..When you look at the detail and accuracy of Greg Thorpe‘s written complaints distributed to the highest levels of Glaxo (See ‘Document Links’ Below) it’s almost surreal that the company took no corrective action. Now more than a decade later, GSK is essentially admitting that Thorpe had been right in 2001″.. Kenney said

“…As a Colorado Springs sales representative for GlaxoSmithKline, Greg Thorpe tried to put a stop to the practice. His manager wrote him up for not being a “team player” after he objected to the free spa treatments and pedicures, hunting trips, tickets to sports games and skiing junkets that his supervisors expected him to give out to doctors and others..”

“The sky was the limit,” said Thorpe, whose whistle-blower lawsuit against his former employer ended with a $3 billion settlement with the federal government. “Those who spent more money got rewarded because they were positioning the company for more business. And it did pay off.”

“How many kids died from Paxil (and WellButrin) being pushed illegally off label?”

When GSK were fined 3 Billion dollars by the US department of Justice in 2012 (for various criminal/fraudulent activities spanning over more than a decade- which resulted in some cases- in deaths of patients/consumers) the media concentrated mainly on the headline grabbing “3 Billion dollar fine” and very little of the exhibits (and the content of the actual legal complaint) were highlighted. This is understandable, considering this was the biggest health care fine in US history, but the fine itself is only a very small part of the overall story. These exhibits reveal a sinister and sociopathic corporate culture at GSK; a culture which indicate (and considering GSK’s recent China bribe scandal– arguably- still display) an utterly callous disregard for patient health, and an insatiable appetite for fraud and corruption in the pursuit of profits.

The main whistle-blower behind this record breaking fine was a previous employee of GSK- Greg Thorpe. Greg spent 23 years with the company, but when they expected him to get involved in prescribing medications such as the anti-depressant Wellbutrin to kids, Greg felt the need to speak out. Typically, GSK responded by vilifying Greg, and making his life hell. Greg’s original mails (to the GSK upper management -about his absolute unwillingness to participate in these nefarious activities) make for sobering reading. I applaud Greg for his actions, he deserves much praise and respect for doing the right thing. He is a hero (in the true meaning of the word), and he is truly brave and courageous; however I wish I could say the same for the media coverage of the fine itself. Very little of these exhibits were printed online or in broadsheets. The coverage of the finer details was paltry. I always wondered though, why did the department of Justice not go back further than 2000 with the Wellbutrin (off label allegations)? It couldn’t be anything to do with the fact that Andrew Witty was head of marketing around 1997/98 and involved in promoting Wellbutrin also could it? surely not…

Aside from that, I was also disappointed to see that there was very little in this legal complaint about Paxil (Seroxat). However, I have since learned (from my source) that this part of the complaint should have been much longer. Again, I wonder why it was cut short? Another aspect of all this that is interesting is- the fact that there were other whistle-blowers: what was their contribution? What did they know about Paxil (Seroxat) withdrawal/suicides/birth defects etc, or other GSK crimes, where are their complaints and exhibits? Why do we see mostly stuff from Greg in the complaint? (with some input from Blair Hamrick), what did the other whistle-blowers reveal? (if anything at all?) Why do the other four whistle-blowers not speak out at all?

If either whistle-blowers Michael Lafauci, Lois Graydon, Thomas Geraghty, or Matthew Burke are reading this and they would like to contact me about anything in this post, please e-mail : truthman30@gmail.com.

Thanks.

Furthermore, it seems to me that this 3 Billion dollar fine was merely a gift to GSK from Eric Holder, he did say, after all- that some companies were ‘too big to fall’ (he later countered this with a remark that ‘there is no such thing as too big to jail’ but it seems in Glaxo’s case, this wasn’t to be). GSK provide massive employment, investment, research to US states as well as donations to US institutions, academia etc, therefore perhaps Holder was correct, shoot down the beast, and the greater good is affected- however does this make it ethically sound to slap them on the wrist for corporate manslaughter of children? Or how about the birth defects from Paxil? what amount of fines can atone that crime?

The full 7th amended complaint can be found here

Personally, I believe, these several hundred pages of exhibits were the tip of the iceberg, who knows how much more could have been unearthed?

There were thousands of reps with access to these kinds of documents, and thousands more in the company would have been aware, to some degree..

If any of them have a conscience, and are reading this, contact me (anonymously if you like) on: truthman30@gmail.com


The following are examples of exhibits (from Greg’s Complaint) detailing how GSK marketed their various products off-label illegally to doctors in the US.

GREGT

GREG2 GREG3 GREG5 GREG6  GREG11GREG3 GREG5 GREGone GREGseven GREGsix GREGten GREGtwo GREHfour

http://www.glaxowhistleblowers.com/settlement-agreement/

Glaxo’s settlement agreement and the government’s charges against Glaxo

The settlement agreement signed by GlaxoSmithKline, the federal government and the whistleblowers describes not only the terms of the settlement of the whistleblower cases but also the whistleblower claims the government supported based on its investigation.

The claims the government stated in the settlement agreement describing Glaxo’s off-label marketing of Wellbutrin, Advair, Lamictal, Zofran, Imitrex and Valtrex and the financial inducements Glaxo gave to doctors to convince them to prescribe those drugs were based largely on the qui tam lawsuit brought by Phillips & Cohen’s whistleblower clients.

For more information about the government’s claims and the settlement amount allocated to each drug, see the Glaxo settlement agreement for the whistleblower cases and the Justice Department fact sheet about Glaxo’s $3 billion settlement.

Below are the claims the government made in the settlement agreement about Glaxo’s off-label marketing of Wellbutrin, Advair, Lamictal, Zofran, Imitrex and Valtrex and financial inducements offered to doctors to prescribe those drugs. The settlement agreement also contains allegations involving Paxil, which were based on a separate whistleblower lawsuit.

  1. Wellbutrin: During the period January 1, 1999 through December 31, 2003, GSK knowingly: (a) promoted the sale and use of Wellbutrin for conditions (including weight loss, the treatment of obesity, sexual dysfunction and in combination with other antidepressants) and at dosages other than those for which its use was approved as safe and effective by the FDA, and some of which were not medically-accepted indications as defined by 42 U.S.C. §1396r-8(k)(6) for which the United States and state Medicaid programs provided coverage for Wellbutrin; (b) made and/or disseminated unsubstantiated and/or false and/or misleading representations or statements about the safety and efficacy of Wellbutrin; and (c) offered and paid illegal remuneration to healthcare professionals to induce them to promote and prescribe Wellbutrin, in violation of the Federal Anti-Kickback Statute, 42 U.S.C. ‘ 1320a-7b(b). As a result of the foregoing conduct, GSK knowingly caused false or fraudulent claims for Wellbutrin to be submitted to, or caused purchases by Medicaid and the other Federal Health Care Programs.
  2. Advair: During the period January 1, 2001 through June 30, 2010, GSK knowingly: (a) promoted the sale and use of Advair for conditions and dosing regimens other than those for which its use was approved as safe and effective by the FDA (including first line use for mild or all asthma, and for asthma previously treated by short-acting inhalers alone), and some of which were not medically-accepted indications as defined by 42 U.S.C. § 1396r-8(k)(6) for which the United States and state Medicaid programs provided coverage for Advair (b) made and/or disseminated unsubstantiated and/or false and/or misleading representations or statements about the safety and efficacy of Advair (including that Advair was superior to the single component, inhaled corticosteroid alone, for patients previously treated by short-acting inhalers alone); and (c) offered and paid illegal remuneration to health care professionals to induce them to promote and prescribe Advair, in violation of the Federal Anti-Kickback Statute, 42 U.S.C. § 1320-7b(b). As a result of the foregoing conduct, GSK knowingly caused false or fraudulent claims for Advair to be submitted to, or caused purchases by Medicaid, Medicare and the other Federal Health Care Programs.
  3. Lamictal: During the period January 1, 1999 through December 31, 2003, GSK knowingly (a) promoted the sale and use of Lamictal for a variety of conditions other than those for which its use was approved as safe and effective by the FDA (including bi-polar depression, neuropathic pain, and various other mental diseases), and some of which were not medically-accepted indications as defined by 42 U.S.C. § 1396r-8(k)(6) for which the United States and state Medicaid programs provided coverage for Lamictal; (b) made and/or disseminated unsubstantiated and/or false and/or misleading representations or statements about the safety and efficacy of Lamictal concerning the uses described in section (a) of this sub–paragraph; and (c) offered and paid illegal remuneration to health care professionals to induce them to promote and prescribe Lamictal, in violation of the Federal Anti-Kickback Statute, 42 U.S.C. §1320-7b(b). As a result of the foregoing conduct, GSK knowingly caused false or fraudulent claims for Lamictal to be submitted to, or caused purchases by Medicaid and the other Federal Health Care Programs.
  4. Zofran: During the period January 1, 2002 through December 31, 2004, GSK knowingly (a) promoted the sale and use of Zofran for a variety of conditions other than those for which its use was approved as safe and effective by the FDA (including hyperemesis or pregnancy-related nausea), and some of which were not medically-accepted indications as defined by 42 U.S.C.  § 1396r-8(k)(6) for which the United States and state Medicaid programs provided coverage for Zofran; (b) made and/or disseminated unsubstantiated and/or false representations or statements about the safety and efficacy of Zofran concerning the uses described in section (a) of this sub-paragraph; and (c) offered and paid illegal remuneration to health care professionals to induce them to promote and prescribe Zofran, in violation of the Federal Anti-Kickback Statute, 42 U.S.C. § 1320-7b(b). As a result of the foregoing conduct, GSK knowingly caused false or fraudulent claims for Zofran to be submitted to, or caused purchases by Medicaid and the other Federal Health Care Programs.
  5. Imitrex, Lotronex, Flovent and Valtrex: From January 1999 through December 2004, GSK paid illegal remuneration for speaker programs, mentorships, preceptorships, journal clubs, advisory boards (including Local and Regional Advisory Boards and Special Issues Boards), Reprint Mastery Trainings, and provided gifts (including entertainment, cash, travel and meals) to health care professionals to induce them to promote and prescribe the drugs Imitrex, Lotronex, Flovent and Valtrex, in violation of the Federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b). As a result of the foregoing conduct, GSK caused false claims to be submitted to Medicaid and certain other Federal Healthcare Programs.

http://www.justice.gov/sites/default/files/usao-ma/legacy/2012/10/09/Settlement_Fact_Sheet.pdf

Why so little on Paxil (Seroxat)?

Paxil1 Paxil2 Paxil3


http://www.theguardian.com/business/2012/jul/04/glaxcosmithkline-former-chair-3bn-us

GlaxoSmithKline: former chairman denies knowledge of $3bn US deal
Richard Sykes says pharmacy firm’s issues ‘complicated’, as FairPensions urges pursuit of executive malpractice
Sir Richard Sykes, ex-chairman GlaxoSmithKline
Sir Richard Sykes, former chair of GlaxoSmithKline, which has been criticised for ‘putting profits above ethics’. Photograph: Richard Saker

Terry Macalister

Wednesday 4 July 2012 19.54 BST
Last modified on Wednesday 1 October 2014 12.41 BST

Sir Richard Sykes, the former chairman of GlaxoSmithKline, has refused to criticise actions at the large pharmaceutical company, saying he had “not a clue” about the details of a $3bn settlement with US authorities.

But critics said the case, involving issues dating to 1997, underlined the need for tougher action, which could include certain executives being jailed.

FairPensions, the campaign for responsible investment, linked the GSK scandal to the firestorm that has engulfed Barclays bank in the past week, and said the controversies were costing the City much more than tougher regulation ever could.

Sykes, now chairman of the Royal Institution, and the UK’s largest NHS healthcare trust, said the issues concerning the pharmaceutical group, where he had been chairman, were “complicated” and he was still digesting the case, despite a corporate statement from GSK more than 36 hours earlier.

“I have not had a chance to read the newspapers and have not a clue as to what is going on,” he said, from his home in London. “It is a complicated situation with two different companies [SmithKline Beecham and Glaxo Wellcome] and they did not really start coming together till 2001.”

Sykes was chief executive of Glaxo before the £100bn merger in 2000 but then stood down as chairman of the combined GSK in the middle of 2002.

A whistleblower, Greg Thorpe, first alerted the company to the entertainment offered doctors and the culture that allegedly put profits above ethics in 2001.

Sykes suggested that the problems could have related mainly to SmithKline, prior to its merger with Glaxo.

But GSK insisted that the problem was in the US and in the past: “Since Andrew Witty became chief executive in 2008, GSK has made significant changes at all levels within the company to ensure we act with integrity in everything we do, and these matters do not reflect the company that we are today.”

The company admitted in its settlement with various American authorities that it had been offering lavish holidays and hospitality to targeted doctors and encouraged the prescription of unsuitable anti-depressants to children.

GSK also paid for articles to appear in medical journals lauding its products, and hired “independent” doctors to promote the treatments.

Thorpe raised his concerns with David Stout, who was then head of the US business, and Bob Ingram, GSK’s chief operating officer. When he was forced out of the company he took his case to the regulators, who spent almost 10 years investigating the issues.

Stout became a non-executive director of another London-listed pharmaceutical company, Shire plc, and Ingram is chairman of the biotech firm Elan Corporation.

Louise Rouse, director of engagement at FairPensions, said shareholders should be asking searching questions to ensure there is sufficient oversight of people and practices at the new companies the executives had joined.

“Even though the management has moved on, shareholders at GSK need to ensure that the root and branch reform promised on paper has in fact been carried out,” she said.

Sidney Wolfe, director of the Health Research Group at the Washington-based campaign group Public Citizen, noted that the latest fine on GSK was just the latest in a series dating back to 1991.

He said: “Until more meaningful penalties and the prospect of jail time for company heads who are responsible for such activity become commonplace, companies will continue defrauding the government and putting patients lives in danger.”



https://childhealthsafety.wordpress.com/2012/07/03/gsk-fined-us3-billion-largest-health-fraud-settlement-in-u-s-history/

GSK Fined US$3 BILLION – largest health fraud settlement in U.S. history

So hot on the heals of more fraud by Merck [Merck Vaccine Fraud – 2nd US Court Case Over MMR Vaccine] we now have more fraud by GlaxoSmithKline.  You can read the Associated Press breaking story here:

GlaxoSmithKline to pay $3 billion in fines, the largest health care fraud settlement in U.S. history – THE ASSOCIATED PRESS – Tuesday, July 3, 2012

The Justice Department said that British drugmaker will plead guilty to promoting popular antidepressants Paxil and Wellbutrin for unapproved uses. The company also will plead guilty to failing to report to the government for seven years some safety problems with diabetes drug Avandia, which was restricted in the U.S. and banned in Europe after it was found in 2007 to sharply increase the risks of heart attacks and congestive heart failure.

Instead of repeating the story we are going to set out the names of GSK’s Board and ask what they have done about this and also ask what is the next fraud to come out of the company? This is not the first time GSK has been mired in fraud.  We list below the Board of Directors of GlaxoSmithKline today – so check out who was on the board, read the following facts and then ask yourself “should they still be on GSK’s Board?” 

And don’t forget – what are we supposed to think of people like the GSK Board who hired James Murdoch of News International onto their Board of Directors to protect their reputation and then had to dump him because of all the corruption associated directly with James Murdoch at News Corporation and News International which is being examined publicly in the Leveson Inquiry.

And should British first ministers like Prime Minister David Cameron and Chancellor George Osborne cosy up to a company like GSK?  Should we as the public cross the street to avoid GSK and all who have anything to do with it?

And let us be clear about the dates – PA report:

The case against Glaxo was originally brought in January 2003 by two whistleblowers, former Glaxo sales representatives Greg Thorpe and Blair Hamrick. In January 2011, the federal government joined in the case.

BUT PA also report:

The company also will plead guilty to failing to report to the government for seven years some safety problems with diabetes drug Avandia, which was restricted in the U.S. and banned in Europe after it was found in 2007 to sharply increase the risks of heart attacks and congestive heart failure.

If 2008 is the cut-off date then is it the case that any current GSK Director on the Board prior to 2008 is one of those ultimately responsible for overseeing fraud – yes that’s right – fraud?

We can also justifiably ask, is 2008 the appropriate cut-off date or should it be October 2010 when the European Medicines Agency withdrew the licence for Avandia?  In other words the GSK Board of Directors as it was constituted up to and including October 2010 are all implicated as GSK was still marketing Avandia: European Medicines Agency experts have said Avandia, a leading diabetes drug, should be suspended from the market. BBC Health News 23 September 2010 Last updated at 17:13

As you can see of the 16 current GSK Board members, 10 were on the Board during and/or prior to 2008 and 11 up to October 2010.   So should these people be on the Board of any company?  And if not, what are they still doing there?  These are fair questions to ask.  After all, if they can let their companies get away with fraud then everyone might as well do the same.  And what did they know of these frauds?  And if they claim they knew nothing – then why are they on the Board of the Company in the first place.

PA reports: “Sir Andrew Witty, Glaxo’s CEO, expressed regret Monday and said the company has learned “from the mistakes that were made.”

It needs to learn more – like most of the Board of Directors should go and right now.  Here they are:

Sir Christopher Gent – joined the Board as Deputy Chairman in June 2004.

Sir Andrew Witty – Chief Executive Officer – joined the Board in January 2008.

Professor Sir Roy Anderson – joined the Board in February 2007

Dr Stephanie Burns – Non-Executive Director – joined the Board in February 2007.

Stacey Cartwright – Non-Executive Director joined the Board in April 2011.

Larry Culp – Non-Executive Director joined the Board in July 2003.

Sir Crispin Davis – Non-Executive Director joined the Board in July 2003.

Simon Dingemans – Chief Financial Officer joined the Board in January 2011.

Lynn Elsenhans – Chief Financial Officer joined the Board in July 2012.

Judy Lewent – Non-Executive Director joined the Board in April 2011. BUT She is the former Executive Vice President and Chief Financial Officer of Merck & Co., Inc. which is a corporation which has previously been found guilty of fraud.

Sir Deryck Maughan – Non-Executive Director joined the Board in June 2004.

Dr Daniel Podolsky – Non-Executive Director joined the Board in July 2006.

Dr Moncef Slaoui – Chairman, Research & Development joined the Board in May 2006.

Tom de Swaan – Non-Executive Director joined the Board in January 2006.

Jing Ulrich – Non-Executive Director joined the Board in July 2012.

Sir Robert Wilson – Non-Executive Director joined the Board in November 2003


GSK Corruption Allegations Spreads To Syria


Exclusive – Allegations of GSK corruption spread to Syria

LONDON Thu Jul 24, 2014 6:51pm BST

The GlaxoSmithKline building is pictured in Hounslow, west London June 18, 2013. REUTERS/Luke MacGregor

The GlaxoSmithKline building is pictured in Hounslow, west London June 18, 2013.

GlaxoSmithKline PLC
GSK.L
1,469.50p
-12.00-0.81%
16:06:23 BST

(Reuters) – GlaxoSmithKline (GSK.L) faces new allegations of corruption, this time in Syria, where the drugmaker and its distributor have been accused of paying bribes to secure business, according to a whistleblower’s email reviewed by Reuters.

Britain’s biggest drugmaker said on Thursday it was investigating the latest claims dating back to 2010, which were laid out in the email received by the company on July 18.

The allegations relate to its former consumer healthcare operations in Syria, which were closed down in 2012 due to the worsening civil war in the country.

“We have zero tolerance for any kind of unethical behaviour. We will thoroughly investigate all the claims made in this email,” GSK said in a statement.

GSK has been rocked by corruption allegations since last July, when Chinese authorities accused it of funnelling up to 3 billion yuan (285 million pounds) to doctors and officials to encourage them to use its medicines. The former British boss of the drugmaker’s Chinabusiness was accused in May of being behind those bribes.

Since then, smaller-scale bribery claims have surfaced in other countries and GSK is now investigating possible staff misconduct in Poland, Iraq, Jordan and Lebanon.

Syria is the sixth country to be added to the list. The allegations there centre on the company’s consumer business, including its popular painkiller Panadol and oral care products.

Although rules governing the promotion of non-prescription products are not as strict as for prescription medicines, the email from a person familiar with GSK’s Syrian operations said alleged bribes in the form of cash, speakers’ fees, trips and free samples were in breach of corruption laws.

The detailed 5,000-word document, addressed to Chief Executive Andrew Witty and Judy Lewent, chair of GSK’s audit committee, said incentives were paid to doctors, dentists, pharmacists and government officials to win tenders and to obtain improper business advantages.

“GSK has been engaging in multiple corrupt and illegal practices in Syria and its internal controls for its Syrian operation are virtually non-existent,” the email said.

In addition, the email said GSK had engaged in apparent Syrian export control violations, including an alleged smuggling scheme to ship the drug component pseudoephedrine toIran from Syria via Iraq. Pseudoephedrine is regulated as a precursor for making methamphetamine.

GSK said it would investigate this matter along with the bribery claims.

“We welcome people speaking up if they have concerns about alleged misconduct,” the company said.

“On 18 July 2014, we received an email making claims regarding GSK’s former consumer operations and related distributors in Syria. Our compliance and legal departments were immediately notified and, as is our standard procedure, we immediately responded to the sender to confirm receipt and ask for more information.”

The whistleblower’s email said GSK used its own employees and Syrian distributor Maatouk Group to make illicit payments.

An official at Damascus-based Maatouk had no comment when contacted by telephone and said the company’s top executives were not immediately available.

HOLIDAY RESORT

The email listed a range of alleged improper activities, including payments of $1,500 each to two doctors to promote Panadol. The document also highlighted bribes paid to pharmacists and payments for medics to visit a Mediterranean holiday resort.

Further cash payments were related to the promotion of GSK cold and flu products, as well as its premium toothpaste brand Sensodyne.

Bribery charges around the world have tarnished the reputation of Witty and hit the company’s sales in China, at a time when it is also struggling with sluggish sales growth in the all-important U.S. market.

The allegations also leave it open to legal action – and potentially hefty fines – in Western countries where it is based or has a stock market listing.

Britain’s Serious Fraud Office launched a formal criminal investigation into GSK’s overseas activities in May and the U.S. Department of Justice (DOJ) is investigating it for possible breaches of the Foreign Corrupt Practices Act (FCPA).

In the email sent to GSK concerning Syria, the author said that the information would be passed on to the DOJ and the U.S. Securities and Exchange Commission (SEC).

A recently introduced SEC programme provides cash incentives for whistleblowers to report corporate malpractice, including breaches of the FCPA.

GSK has overhauled its marketing policies in the wake of concerns about possible past misconduct. It aims to become the first company in the industry to stop paying outside doctors to promote its products.

 

GSK Whistleblower Blair Hamrick- ” I have suffered nothing compared to the parent of a child who committed suicide on Paxil”


He continued …

 

“Imagine how horrifying that is” .. “It’s so repulsive”… “You’re just talking about a bad company run by bad people in my opinion”… 

Damn right Blair.

What kind of company encourages the prescription of drugs which they know will harm kids? Many people lost loved ones to Paxil (Seroxat) and many more were damaged from this defective Glaxo pill.

.

http://fiddaman.blogspot.ie/2014/06/hey-glaxo-guess-whos-been-talking.html

Thursday, June 26, 2014

Hey Glaxo, Guess Who’s Been Talking?

GSK Whistleblower Blair Hamrick & Bob Fiddaman
I started writing this blog back in 2006. I had some issues with the antidepressant drug manufactured and marketed by British pharmaceutical giant GlaxoSmithKline. I also had some issues with the way drugs were regulated in this country by the British drug regulator, the MHRA.

Bob Fiddaman Meets GSK Whistleblower Blair Hamrick


http://fiddaman.blogspot.ie/2014/06/hey-glaxo-guess-whos-been-talking.html

Thursday, June 26, 2014

Hey Glaxo, Guess Who’s Been Talking?

GSK Whistleblower Blair Hamrick & Bob Fiddaman
I started writing this blog back in 2006. I had some issues with the antidepressant drug manufactured and marketed by British pharmaceutical giant GlaxoSmithKline. I also had some issues with the way drugs were regulated in this country by the British drug regulator, the MHRA.
Eight years on and I have learned so much about GlaxoSmithKline… I learned more about them yesterday evening as I sat down to dinner with Blair Hamrick, one of the whistleblowers who blew the lid on Glaxo’s fraud in the US, a blow which, after 11 years of legal wrangle, Glaxo settled for a record breaking $3 billion.
Blair is a very brave soul for going up against the company that he once worked for. His life is now back on track after Glaxo sacked him then muddied the waters so he couldn’t get a job elsewhere in the pharmaceutical field. Yes, he was paid handsomely for his bravery and is now living a life that most could only dream of.
Despite the publicity, fame and riches Blair is one of the most down to earth people you could ever wish to meet, a trait that became evident when he just couldn’t bring himself to promote the antidepressant Wellbutrin off-label to doctor’s.Wellbutrin is an antidepressant and indicated to treat adults that are depressed. Blair, whilst working for GSK, was prompted by senior management to promote it off-label to doctors for treating children. He just couldn’t bring himself to do that. One of the side effects of Wellbutrin is seizures and Blair envisaged kids going into seizure. “It was wrong, it wasn’t indicated for kids and I just couldn’t bring myself to tell doctor’s it was okay for kids to take,” Blair told me over a glass of wine in the plush settings of one of Westminster’s finest hotels in London. “They also tried to market it as the happy-horny-skinny pill because they had learned through post marketing that patients taking it for depression were losing weight and reporting high sex drives.” [increased libido] Wellbutrin was not indicated for this but the Glaxo marketing team came up with the “happy-horny-skinny pill” line so reps could convince doctors to prescribe it to patients who were overweight and also those who were experiencing a low sex drive [decreased libido]
Blair also spoke about the doctors who were paid by GlaxoSmithKline, a staggering 48,000 doctors were paid speaker fees, attendance fees and given lavish gifts, all in an attempt to get them to prescribe more of Glaxo’s drugs.

“We’d pay doctor’s between $2-4000 to give a talk to other doctor’s.

“6 or 7 doctors would be invited out for dinner, sometimes with their spouses in tow, they’d be wined and dined and then the speaker would talk about the wonders of drug a or b, of course these were off-label “wonders” – that’s how Glaxo rolled.

“Our marketing team would send them a slide-show and a carefully scripted narrative so they could convince other doctor’s that it was okay to prescribe a number of drugs off-label.

“Some doctor’s, whose basic annual salary was around $150,000, could give 2 or 3 talks in a week, giving them a potential to earn up to an extra $12,000 per week.

“I was also given luxury private box tickets for sporting events, these would be given to doctors as a ‘thank-you’ or incentive to prescribe more and more of Glaxo’s drugs.”

Glaxo, at some point during these wanton violations, caught wind that their off-label promotion had been leaked and reps were told to be careful what they added to their call-notes.Call-notes are what pharmaceutical reps use to familiarize themselves with a doctor.

“The way it worked was that a doctor would be visited by a rep who would  then add notes to a hand-held device.

“It was useful because we knew what these doctor’s liked, be it a particular football, baseball team or if he had a sweet tooth – on the next visit we would bring in a small token of gesture, be it tickets to the game or sweet tasting delicacies – it was just a way to keep them prescribing more drugs.”

Blair recalled a meeting where reps were told to be careful what they wrote in the call-notes, the crux of the meeting was basically to tell reps to “write right”, in other words write down the legal stuff and not the violations.

I asked Blair about Glaxo’s recent announcement that they are going to be more transparent.

“The whole transparency thing wasn’t a conscious decision by Glaxo, their hand was forced, it was all part of the settlement – it makes me laugh when I now read how they are claiming to offer up the results of their clinical trials, they were told that’s what they had to do as part of the agreement they entered into with the Department of Justice.”

Regular readers of this blog will note the tagline I use, “It’s perverse when GSK claim that they are going to be more transparent when they do not offer transparency when writing about their transparency.”
I could have listened and talked to Blair all night, alas I had a train to catch back home, a train that I almost missed due to losing track of the time.Blair Hamrick, along with the other whistleblowers in this particular case, should be applauded for their efforts. It’s no coincidence that Glaxo are now being investigated for the same type of violations in other countries. 
Blair blew the whistle and it almost took the roof off GSK, for that he deserves a future of happiness. His conscience not to promote a drug that could cause kids to have seizures was frowned upon by senior management at GSK – what kind of human being could promote a drug that could be potentially harmful to children, moreover, what type of human being could sanction such a promotion?On a side note, I wasn’t just in London yesterday to meet Blair. Earlier on I met with a film-maker who is in the process of making a documentary about antidepressants. The film-maker also dined with myself, Blair and his partner. More about the documentary in a future post.I now have something to tell my grandchildren.

I once had dinner with Blair.

Bob Fiddaman

GSK Whistle Blowers? : Contact The Serious Fraud Office Confidentially And Blow That Whistle!


From Bob Fiddaman’s Blog: 

http://fiddaman.blogspot.ie/2014/05/a-message-from-uk-serious-fraud-office.html


http://www.networkedblogs.com/XfZzV

Wednesday, May 28, 2014

A Message From the UK Serious Fraud Office re GSK




GlaxoSmithKline plc investigation

27 May 2014

The Director of the SFO has opened a criminal investigation into the commercial practices of GlaxoSmithKline plc and its subsidiaries.

Whistleblowers are valuable sources of information to the SFO in its cases.  We welcome approaches from anyone with inside information on all our cases including this one – we can be contacted through our secure and confidential reporting channel, which can be accessed via the SFO website.

Notes to editors:

The SFO’s secure reporting channel can be accessed here: https://report.sfo.gov.uk/sfo-confidential—provide-information-in-confidence.aspx or via our website home page, www.sfo.gov.uk

The Serious Fraud Office is an independent government department responsible for investigating and prosecuting serious and complex fraud, bribery and corruption. It is headed by the Director, David Green CB QC, who exercises powers under the superintendence of the Attorney General. These powers are derived from the Criminal Justice Act 1987.

The SFO Press Office can be contacted on press.office@sfo.gsi.gov.uk or 020 7239 7316 / 7004 (out of hours: +44 (0) 7557 009 842)


[Source]

I actually went out and purchased a bottle of wine last night on the strength of this latest news.

The SFO may want to investigate the British drug regulator, The MHRA, too. It was they who, after a four-year investigation of GlaxoSmithKline, decided to let Glaxo off with a warning letter. No criminal charges were brought against GSK…even after the MHRA learned during their investigation that GSK had knowingly withheld safety data regarding children taking the antidepressant Seroxat [Known as Paxil in the US]

The MHRA’s four year investigation into GlaxoSmithKline failed on a catastrophic level.

Alistair Benbow, who was then Head of European Psychiatry at GSK, claimed on National TV that Seroxat could be safe in children even though his company did not have a licence to recommend it to children. [1]

All the SFO need to do is request disclosure from GSK. Emails, documents and, more importantly, the notes taken by GSK’s pharmaceutical reps during their visits to doctors and psychiatrists. Did Glaxo’s UK reps offer the same incentives to British doctors as GSK’s American, Chinese, Polish and Iraqi reps did?

Once they have these in their possession then I’m sure they will be able to retrace who said what and who they said it to.

It is imperative that the SFO obtain these documents.

The MHRA should have requested the same documents but why would they? They rely on pharmaceutical money, in fact, they are fully funded by the pharmaceutical industry.

The SFO are calling on whistleblowers – good luck. The carrot being dangled isn’t really as attractive as the carrot dangled in front of whistleblowers in the US.

I suspect the SFO are merely following up on the alleged bribery in China – they need to do more than follow-up though.

GlaxoSmithKline is infested, it’s driven by a culture where sales mean everything.

I do hope the SFO turn over every item they come across, I do hope this is not just them following up on GSK’s foreign violations.

There are plenty of experts out there who could help the SFO’s investigation, whether they choose to use them is another matter.

No stone unturned is the order of the day here. The SFO will, no doubt, face tough opposition from the current UK government. Deals may be struck given that Glaxo’s chairman, Andrew Witty, and the current Prime Minister, David Cameron, are friends and business acquaintances. [2]

One thing is certain though. The eyes of the world are watching.

 

Bob Fiddaman


[1] Seroxat – The Liars? [Video]

[2] Cronyism, Chinese Style

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.

 

 

 

 

GSK Corruption in Iraq… More Details Emerge… (Wall St Journal)


http://online.wsj.com/news/articles/SB10001424052702303532704579476862300832806?mg=reno64-wsj&url=http%3A%2F%2Fonline.wsj.com%2Farticle%2FSB10001424052702303532704579476862300832806.html

Glaxo Investigates Bribery Accusations in the Mideast

Emails to U.K. Drug Maker Allege Corrupt Practices in Iraq

CONNECT

April 6, 2014 3:48 p.m. ET

Chinese authorities last summer accused GlaxoSmithKline of bribing doctors. Bloomberg News

GlaxoSmithKline GSK.LN -1.51% PLC is investigating allegations of bribery by employees in the Middle East, according to emails reviewed by The Wall Street Journal, opening a new front for the company as it manages a separate corruption probe in China.

A person familiar with Glaxo’s Mideast operations emailed the U.K. drug company late last year and earlier this year to report what the person said were corrupt practices in Iraq, including continuing issues and alleged misconduct dating from last year and 2012.

The emails cite behavior similar to Glaxo’s alleged misconduct in China, including alleged bribery of physicians.

Chinese authorities last summer accused Glaxo of bribing doctors and since have been investigating the company. China said last July that it had detained four of Glaxo’s senior Chinese staff, but none has been charged. Glaxo says it appears that some its senior staff in China may have broken the law and that it is cooperating with the investigation. The company has cut some staff in China in connection with the inquiry, a person familiar with that matter said.

Glaxo said it takes all of the allegations seriously and started investigating the Iraq matters as soon as it became aware of them. The investigations are continuing.

The person familiar with Glaxo’s Mideast operations emailed the company saying, “I believe GSK practices in Iraq violate the FCPA and the U.K. Bribery Act.” The U.S. Foreign Corrupt Practices Act addresses bribery of foreign officials by U.S. businesses or foreign corporations trading securities in the U.S.

In an email, the person said Glaxo hired 16 government-employed physicians and pharmacists in Iraq as paid sales representatives for the company while they continued to work for the government.

A government-employed Iraqi emergency-room physician has prescribed Glaxo products, even when they weren’t in the hospital’s pharmacy and a competitor’s brand was in stock, an email from the person said.

Glaxo has been hiring government-employed Iraqi doctors as medical representatives and paying their expenses to attend international conferences, the person alleged in the emails. Glaxo pays other doctors high fees to give lectures in exchange for promoting and prescribing its drugs, the allegations continued.

After Glaxo won a contract with the Iraqi Ministry of Health in 2012 to supply the company’s Rotarix vaccine, Glaxo paid for a workshop in Lebanon for Iraqi Ministry of Health officials, the email said. That included paying for a doctor’s family to travel to Lebanon “so it would be a family vacation for him at the hotel.”

The emails to Glaxo said that the person planned to share the information with the U.S. Justice Department and the Securities and Exchange Commission. The agencies declined to comment.

A new whistleblower program at the SEC, established in 2010 with the passage of theDodd-Frank financial-reform act, provides cash incentives for employees to report securities violations, including breaches of the FCPA. If the SEC gets involved and finds wrongdoing after a whistleblower complaint, the person stands to gain as much as 30% of any monetary sanction the agency recovers.

Glaxo has disclosed in SEC filings that the Justice Department has been investigating the company since 2011 as part of an industrywide bribery probe into pharmaceutical companies. It was unclear if the Justice Department is investigating the allegations in China or those raised by the person in the Mideast.

Glaxo responded to the emails, saying the allegations were being taken seriously. “Our collection and analysis of data continues and the scope of the investigation now covers several countries and business units” in the Gulf and Near East region, said a March 13 email from Glaxo’s head of compliance investigations to the person. The Glaxo region includes the nine countries of United Arab Emirates, Qatar, Bahrain, Oman, Kuwait, Lebanon, Syria, Jordan and Iraq.

“We have members from Legal (internal & external), Compliance, Corporate Security and ABAC working on this as a team with the full support of the Corporate Executive Team and Board members,” the email from Glaxo’s compliance head said. ABAC stands for antibribery and corruption, according to an earlier email from the same person. “This is a substantial piece of work to undertake both in volume and complexity so it will continue to take some time to complete.”

The drug maker has zero tolerance for unethical or illegal behavior, has strict controls in place globally with regard to compliance matters, bribery and corruption, and takes the allegations seriously, Glaxo said in a statement to the Journal. Glaxo has reinforced governance requirements in Iraq, including those covering payments to doctors and travel agencies, provision of samples and processes around public-tender submissions like the awarding of government vaccine contracts, the statement said.

The company has also put a temporary stop to all interactions between Glaxo and government officials in the region, “to ensure any activity is in compliance with our policies and procedures,” Glaxo said.

Glaxo said in December that it was stopping all payments to doctors to attend conferences or speak about its drugs—a policy it expects to be in place globally by 2016.

Write to Christopher M. Matthews at christopher.matthews@wsj.com and Hester Plumridge at Hester.Plumridge@wsj.com

GlaxoSmithKline and ‘The Erosion of Trust’


http://pharma.flemingeurope.com/webdata/2619/GSK%20Hackett%20slides%20for%20transp%20conf%2021-11-11.pdf

Strategic Priorities

Trust is all about our permission to trade. Over time, the constant erosion of credibility builds up a real threat to the company’s business model… Trust is all about making sure that we face the issue head on, building credibility and being trusted by external stakeholders… it is time for GSK to step out and say ‘we’re going to do things the right way’.” 

Andrew Witty

Global Employee Broadcast September 2008

__________________________________________________________________________________

Drugs Contaminated at GSK Uncovered

Posted by 

politicol

on January 2, 2011

http://www.politicolnews.com/drugs-contaminated-at-gsk-uncovered/

Jan. 2, 2011 Drugs contaminated at GSK prescription factories of the major drug companies reveal that an inspector Cheryl B. Eckard who was interviewed on CBS 60 Minutes found disturbing facts of bacteria and two drugs mixed together in one bottle.

Cheryl Ekard Reduced to Tears on GSK Unethical Drug Production

Photo courtesy of Boston Herald

In one case the drug Paxil which is a powerful anti-depressant was found in a container with

Tagamet

which is used for ulcers and stomach problems.  Two drugs mixed together for two entirely different groups of consumers who were unaware of what they were consuming in one drug bottle.

The outrage is clear and the FDA is again an agency too close to to drug company influence to be an effective stop gap against this type of danger to the consumer.

If a consumer was allergic to the drug Tagamet and was prescribed Paxil the problems appear to be unresolved by the FDA.  As it was revealed the FDA did not demand the shut down of this Glaxosmithkline drug factory.

As the video reveals the mixture of several drugs in one prescription drug bottle, and bacteria found in an ant-bacteria medicine was uncovered in the drug factory in Puerto Rico.  The Puerto Rico factory of GSK also made the diabetes drug Avandamet which was also mixed in with Paxil drugs.

As an employee of GlaxosmithKline Cheryl Eckard would know what she saw and what she documented in her reports which she relayed to the plant’s executives and to her own employer

GlaxoSmithKline’s head offices.

GlaxoSmithKline is the UK’s biggest drug producer hired Eckard to do a job and when she did they ignored the warnings and she wanted to shut the plant down but the higher ups refused.

The 60 Minute Video news story called

Bad Medicine

was aired January 2, 2011 on the CBS show 60 Minutes and the revelations are not only shocking they are disturbing.

It is not likely the head CEO did not know about what was going on at the factory level of his own company and if he did he is ultimately responsible for the damage that could be cause by such low standards. It would be like Toyota denying their products were defective and after all they tried that also. But this is a consumer product taken orally by a person who is assuming the drug is safe. Today, you can assume no drug is safe because they are not even tested anymore by the US government.

A quote from the company’s website regarding their corporate responsibility principals as they call it:

“We are committed to creating a strong ethical culture at GSK.”

They go on to say ” We do this by developing strong policies, recruiting the right people and equipping them with the information they need to make ethical decisions. Putting patients first is the core principle of being an ethical pharmaceutical company. Profit without principle is short lived.”

Failure to uphold high standards of ethical conduct carries significant business risk:

  • Erosion of trust in GSK and our products including among regulators, doctors and patients
  • Fines and litigation resulting in serious financial or legal consequences
  • Damage to GSK’s reputation”  end quote.

Ethics?  GSK claims to have ethics?

Further, Cheryl Ekard was later fired from her job but here is a misleading tidbit from GlaxoSmithKline’s corporate policy on employees:

” Employment practices We will treat our employees with respect and dignity, encourage diversity and ensure fair treatment through all phases of employment. We will provide a safe and healthy working environment, support employees to perform to their full potential and take responsibility for the performance and reputation of the business.”

It certainly sounds good, but they do not really practice fairness and responsibility towards whistleblowers.

On human rights the copy is even more laughable:

Human rights We are committed to upholding the UN Universal Declaration of Human Rights, the OECD guidelines for Multi-National Enterprises and the core labour standards set out by the International Labour Organization. We expect the same standards of our suppliers, contractors and business partners working on GSK’s behalf.”

The standards and ethics at GSK and this statement on their website is simply untrue and a blatant lie:

Standards of ethical conduct We expect employees to meet high ethical standards in all aspects of our business, by conducting our activities with honesty and integrity, adhering to our CR principles, and complying with applicable laws and regulations.”

On how customers are regarded along with the standards of their product production it is hard to believe GSK abides by its own statements:

Products and customers We will promote our products in line with high ethical, medical and scientific standards and will comply with all applicable laws and regulations.”

The lack of standards, ethics and following the law is glaringly lacking at GSK and the FDA has by it’s own failures allowed this corporation to continue operating in this manner.  The FDA claims it has few inspectors however, this is simply not the case.

In 2004, Cheryl Ekard was forced hire a lawyer Leslie Ann Skillen and filed a claim against her former employer in Boston mostly since the FDA did not shut Glaxosmithkline down, or even found the errors and mistakes in their association with the drug company.  The same production lines continued to pump out the wrong medications and Ekard demanded justice.

Again the failures of the FDA are a mile long list of  complete ignorance and incompetence when it comes to keeping American consumers safe from the most basic errors.  Two very different drugs mixed together can be deadly, can harm a person and can cause serious risks even death.

On November 26, 2010  GlaxoSmithKline ended up paying 750 million dollars for selling “adulterated drugs” and pleaded guilty.

The drug giant had to also pay medicaid program of Massachusetts eight million dollars for defrauding the government.

The GSK CEO’ boasts about their vaccine business in their quarterly profit reports -notice no mention of how they will improve their quality controls, how they will not fire whistleblowers and instead take heed that they are producing dangerous drugs.

2010 Report on Profits at GlaxoSmithKline.

This is laughable.

Defrauding the US government and the public is not the way to run a corporation, with such a low standard of ethics, stockholders and the Board of Directors have some say here in how this corporation runs their business.  It appears GSK is more interested in profits than safety and ethics and this is a practice that is allowed by the FDA.

Editors Note:  GlaxoSmithKline like many of the drug giants have a long history of violations, of producing harmful drugs, and of escaping culpability concerning jail time. A US federal habit of small fines is not a deterrent to these criminal acts which continue to endanger the lives of Americans and consumers worldwide.

Peter Neisman

Editor

Source: CBS Evening News-60 Minutes Scott Pelley Report Video

Tags: Drugs contaminated at GSK, Drugs, CBS 60 Minutes -Bad Medicine, Cheryl Ekard, CBS News Reporter Scott Pelley, Glaxosmithkline contaminated drugs, Glaxosmithkline mixed up drugs, paxil, tagament, Glaxosmithkline quarterly profits, Avandamet

Drug Companies in Bed with Government and Judges: On the Avandia lawsuit GlaxoSmithKline only paid $ 46,000.00 per person for endangering their lives with a heart attack from their product Avandia. The lawsuit was a sellout to patients who died, patients who had only diabetes but ended up with heart attacks as a result of taking a drug. The law, the courts, and the judges are all in favor of letting off these billion dollar corporations with small penal fines and settlements are far from punitive.

If you take Fosamax your jaw will be permanently damaged and your teeth will fall out, there is no proof this drug prevented osteoarthritis. Dentists are refusing to treat jaw death by Fosamax.

If you take Fosamax your jaw will be permanently damaged and your teeth will fall out, there is no proof this drug prevented osteoarthritis. Dentists are refusing to treat jaw death by Fosamax.

http://www.cafepharma.com/boards/archive/index.php/t-374365.html

Cafepharma: 

Just a little quote from the below article! Real freaking shocker, GSk saying one thing and doing the opposite!

It didnt take long did it? GSK upper management are idiots. I agree w/ the above post Keep young reps w/ low pay and perhaps it affected your business…..GSK deserves this for being so stupid…

 A bunch of major F’ing assholes running this company.

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