Posts Tagged ‘3 billion’

Natural News: GlaxoSmithKline Bribery Admissions

Monday, July 16th, 2012

(NaturalNews) Radio personality Dr. Drew Pinsky once touted GlaxoSmithKline PLC’s antidepressant Wellbutrin as one of a few such medications he prescribed to patients suffering from depression because it “may enhance or at least not suppress sexual arousal” as much as other antidepressants.

What he didn’t tell listeners during that 1999 endorsement; however, was that two months earlier Dr. Pinsky – who rose to fame as “Dr. Drew,” co-hosting a popular radio sex-advice show, “Loveline” – received the second of two payments from GSK for a total of $275,000 for “services for Wellbutrin,” The Wall Street Journal reported.

The paper said the payments were made to Pinsky via a communications firm that worked for GSK, according to revelations in an attachment to a complaint filed by the U.S. government in October 2011 in a Massachusetts federal court. The documents were disclosed in early July after the Justice Department announced a $3 billion criminal and civil settlement with GSK over illegal medication marketing, among other things.

In an email response to an inquiry about the payments by the Journal, Pinsky said: “In the late ’90s I was hired to participate in a two-year initiative discussing intimacy and depression which was funded by an educational grant by Glaxo Wellcome,” one of the pharmaceutical firms that eventually merged into GlaxoSmithKline.

Pinsky added that the campaign he was involved with “included town hall meetings, writings and multimedia activities in conjunction with [a] patient advocacy group.”

“My comments were consistent with my clinical experience,” he concluded, according to the paper.

Revelations stem from Big Pharma fraud settlement

According to published reports, GSK pleaded guilty to promoting popular antidepressants Paxil and Wellbutrin for uses that had not been approved by U.S. drug licensing officials at the Food and Drug Administration.

In its original complaint, the federal government said GSK improperly promoted Paxil as safe for children and adolescents, though the FDA had never given its okay for such patients, and the company’s own clinical trials raised red flags over increased suicide risk concerns.

Federal prosecutors alleged that GSK promoted Wellbutrin for improper uses as well, which included treatment of attention deficit disorder, bipolar disorder, obesity, sexual dysfunction and anxiety, though it was never shown to have been safe or effective for such uses, The Associated Press reported.

The government’s complaint came on the heels of a nine-year investigation of GSK’s marketing practices, which led to the huge settlement.

As the Journal noted, physicians can prescribe medications as they deem appropriate, but it’s illegal for companies to promote a drug for any uses not approved by the Food and Drug Administration - a practice that’s known as “off-label” marketing.

In the case of Dr. Drew and Wellbutrin, the drug’s prescribing label says nothing about it being “less inhibiting of sexual libido than other antidepressants,” WSJ reported.

In an email to the paper earlier this month, GSK refused to answer questions about the company’s financial ties to Pinsky or any other physicians.

Taken out of context?

“The complaint to which you refer concerns events in 1999, 13 years ago. It does not reflect what would be allowed in GSK today,” a company spokesperson told the paper.

“The government has made many allegations and legal conclusions concerning Wellbutrin that GSK disputes,” the spokesperson continued. “GSK admits; however, that during the period from January 1999 to December 2003, there were some occasions in which certain GSK sales representatives, speakers, and consultants promoted its antidepressant Wellbutrin to physicians for uses which were not FDA-approved in violation of federal law.”

Pinsky, the paper said, is only one doctor mentioned in the government’s complaint. It also accuses other doctors of taking payments from GSK and improperly endorsing the company’s drugs. One doctor received $2 million from GSK between 2001 and 2003.

That physician, James Pradko, “gave hundreds of talks to doctors and Glaxo sales reps about depression and frequently made ‘off-label claims’ about Wellbutrin’s effectiveness against a number of conditions for which it isn’t FDA-approved, including weight loss, chronic fatigue syndrome, erectile dysfunction and chemical dependencies,” said WSJ.

In an telephone interview with the paper, Pradko said the U.S. government complaint takes the speeches he gave “very much out of context,” adding he only ever spoke about treating depression and that his speeches “weren’t meant to sell drugs, ever.”

Sources:

http://online.wsj.com

www.naturalnews.com/GSK.html

http://www.naturalnews.com

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How To Sell Drugs to Children — GlaxoSmithKline & Shrinks for Sale

Friday, July 6th, 2012
Fox Business
by Al Lewis – July 5, 2012

The international pharmaceutical giant took top-prescribing psychiatrists to pricey resorts in Bermuda, Jamaica, Hawaii and other exotic locales where, in between spa services, they could hear speeches from fellow shrinks that the company paid to dither on about how kids should pop its pills.

America’s children were depressed. They needed antidepressants. It was GlaxoSmithKline to the rescue.

Paxil was never approved for use by anyone under 18, but GlaxoSmithKline  had 1,900 sales reps visiting doctor’s offices, and pushing the drug for kids.

The international pharmaceutical giant took top-prescribing psychiatrists to pricey resorts in Bermuda, Jamaica, Hawaii and other exotic locales where, in between spa services, they could hear speeches from fellow shrinks that the company paid to dither on about how kids should pop its pills.

According to a criminal complaint filed in U.S. District Court in Massachusetts, the company “engaged in a fraudulent scheme to deceive and defraud physicians, patients, regulators, and federal health-care programs.” The complaint, alleging the company misbranded drugs and failed to report safety data, was filed under seal in October.

On Monday, the international pharmaceutical giant said it agreed to settle this case as well as a civil case for $3 billion. This the largest health-care fraud settlement in U.S. history, involving Paxil and some of its other drugs.

click image to find out more

GlaxoSmithKline said it will plead guilty to the criminal charges, which are misdemeanors, but it will not admit any wrongdoing on the civil charges, which allege potentially deadly behaviors that I think should be considered felonious.

I guess this is why corporate lawyers make the big bucks: To go to court and say, “Yes, we did it–but not if anyone else is trying to sue us.” It’s also worth noting that no single individual has been named as a defendant in the criminal complaint. It’s just another one of those unfortunate corporate things that nobody ever got caught doing.

The U.S. Justice Department’s complaint said the alleged offenses occurred between 1999 and 2010. The company’s chief executive, Sir Andrew Witty, reiterated that this was the behavior of the old company, not the one he is currently running.

“I want to express our regret and reiterate that we have learnt from the mistakes that were made,” Mr. Witty said in a statement released Monday. “Since I became CEO, we have had a clear priority to ingrain a culture of putting patients first, acting transparently, respecting people inside and outside the organisation and displaying integrity in everything we do.”

Yes, you spotted it. It’s the ol’, “mistakes were made” strategy from the PR playbook. The company’s mantra is “Do more, feel better, live longer.” But it might as well have been, “Prescribe Paxil to children. Win a free trip!”

GlaxoSmithKline’s Paxil push occurred between 1999 and 2003, the government alleged, and soon “Paxil became one of the top-selling drugs in the United States.”

Have you ever sat in doctor’s waiting room when an exceptionally well-dressed woman, looking like she could be a fashion model, struts through the door? That was the pharmaceutical rep. Or sometimes it’s a handsome guy who looks right out of GQ. This is how drugs, including Paxil, are sold. Beautiful people handing out free drug samples so doctors will prescribe them. Just look at me, and never mind all that fine print on the side effects.

GlaxoSmithKline "promoted Paxil for unapproved uses by bringing top-prescribing psychiatrists to lavish resorts.

Central to GlaxoSmithKline’s marketing effort for Paxil was an article published in Journal of the American Academy of Child and Adolescent Psychiatry that the government convincingly argues is “false and misleading.” GlaxoSmithKline reps touted this allegedly bogus research. GlaxoSmithKline also paid shrinks to give speeches in which they referenced it.

Here’s how the government describes these paid-shrink performances in it’s criminal complaint:

GlaxoSmithKline “promoted Paxil for unapproved uses by bringing top-prescribing psychiatrists to lavish resorts.

“The meetings were held at expensive resorts such as the El Conquistador Resort & Golden Door Spa in Puerto Rico, the Rio Mar Beach Resort in Hawaii, and the Renaissance Esmeralda Resort & Spa in Palm Springs, Calif. GSK paid for the psychiatrists’ lodging, air fare, and a $750 honorarium. GSK paid speakers a $2,500 honorarium. GSK also paid spouses’ airfare if two cheaper tickets were available for the cost of one full-coach fare.

“GSK hosted nice dinners…and paid for entertainment, including sailing, snorkeling, tours (e.g. the Bacardi rum distillery), golf, deep sea fishing, rafting, glass-bottomed boat rides, and balloon rides.

“The actor/comedian GSK hired to emcee one of the meetings told the attendees “We have a wonderful and unforgettable night planned. Without giving it all away, I can tell you–you’ll be experiencing a taste of luxury.” “After the May 2000 Forum meeting in Hawaii, one psychiatrist wrote: “A beautiful location, enjoyable and fun-filled activities, an exciting, cutting-edge informative educational program…exhilarating!” Another doctor wrote after the Forum 2001 meeting in Palm Springs: “Both my wife and I enjoyed the extra care our drug rep gave to us all weekend.’”

When the issue of certain side effects came up, the programs went something like this: “OK, so some of the kids who took Paxil had suicidal thoughts and killed themselves. Maybe it was an adverse reaction to the drug, or maybe they were just depressed. Depressed kids do depressing things, you know. It’s what we call ‘emotional liability.’ Meantime, please, enjoy the resort, and don’t miss that Bacardi rum tour!”

Maybe the reason kids are depressed is because of the way some of the highest-paid adults in this world behave.

(Al’s Emporium, written by Dow Jones Newswires columnist Al Lewis, offers commentary and analysis on a wide range of business subjects through an unconventional perspective.)
http://co106w.col106.mail.live.com/default.aspx#!/mail/InboxLight.aspx?n=434132513!n=219306126&fid=1&fav=1&mid=3217e4a4-c775-11e1-a160-00215ad9bc86&fv=1

 

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GlaxoSmithKline Admits to Criminal Pharma Fraud in 3 Billion Dollar Case

Thursday, July 5th, 2012

In related news on this case – also read “Has Dr. Drew Been Pimping Wellbutrin to his Listeners for GlaxoSmithKline?” http://goo.gl/uZadq

Natural News – July 4, 2012

by D. Holt

British registered company, GlaxoSmithKline, faces $3 billion in penalties after pleading guilty to the biggest health care fraud case in history. GSK admitted that physicians had been bribed to push potentially dangerous drugs in exchange for Madonna tickets, Hawaiian holidays, cash and lucrative speaking tours. They also admitted distributing misleading information regarding the antidepressant Paxil. The report claimed that it was suitable for children, but failed to acknowledge data from studies proving its ineffectiveness in children and adolescents.

GSK faced charges that they had used the gifts to sell three drugs that were either unsafe, or used for purposes that were not approved. The first drug, Paxil also known as Seroxat, was touted as safe and effective for children and adolescents. The ineffectiveness of Paxil, and the link to suicides, meant that it was banned for kids under 18-years-olds in 2008.

The second drug, Avandia was used in Britain to treat diabetes until it was withdrawn due to safety fears, including increased risk of heart attacks. The US government claimed that GSK had attempted to conceal the data surrounding the dangers.

The third drug, Wellbrutin is used in the UK for treating depression, but it was alleged that GSK had recommended physicians used it for ADHD, lost libido and as a slimming aid. None of which were approved uses for the drug.

The moral code of Big Pharma companies exposed

Sir Andrew Witty, chief executive of GSK said “Whilst these offenses originate in a different era for the company, they cannot and will not be ignored. On behalf of GSK, I want to express our regret and reiterate that we have learned from the mistakes that were made. We are deeply committed to doing everything we can to live up to and exceed the expectations of those we work with and serve. In the US, we have taken action at all levels in the company. We have fundamentally changed our procedures for compliance, marketing and selling.”

US attorney for Massachusetts, Carmen Ortiz said: “The GSK sales force bribed physicians to prescribe GSK products using every imaginable form of high priced entertainment, from Hawaiian vacations to paying doctors millions of dollars to go on speaking tours, to a European pheasant hunt, to tickets to Madonna concerts.”

This is the biggest settlement in the history of drug industries, ahead of the 2009 Pfizer case in which it was fined $2.2 billion for promoting four drugs for unapproved uses. In 2010, GSK paid $96 million to a whistle-blower who exposed contamination problems and a management cover up in Puerto Rico.

The practice of pushing drugs for unapproved uses is endemic within the drug industries. Two of the largest drug companies have been caught and fined huge amounts for chasing sales targets using any means necessary. It proves that the health of customers, even children, ranks lower on the companies’ agenda than profit. Using bribes to get doctors to prescribe drugs shows a complete lack of moral fiber from both sales teams and the doctors. After this case, surely the doctors also need to face the courts for their conduct.

Whilst the amounts of money seem to be a huge punishment for GSK, the settlement is merely a slap on the wrist for a company whose market value is $133 billion. Can we trust another multinational that promises to clean up its act, when others have promised the same, only to behave just as recklessly but much more surreptitiously.

Sources for this article include:

http://www.dailymail.co.uk

http://www.nytimes.com
http://www.cbsnews.com
http://bottomline.msnbc.msn.com

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