Posts Tagged ‘bribery’

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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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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Drug Firms Face Bribery Probe from US Department of Justice

Tuesday, October 5th, 2010

Justice Department, SEC Seek Information From Companies on Payments to Overseas Officials

Wall Street Journal, October 5, 2010

by Michael Rothfeld

Federal investigators are looking at ways that drug makers could be paying bribes overseas to boost sales and speed approvals, according to letters sent to the companies and people close to the matter.

Big companies—including Merck & Co., AstraZeneca PLC, Bristol-Myers Squibb Co. and GlaxoSmithKline PLC—in recent months have disclosed they are being investigated for possible violations of a 1977 law that makes it illegal for companies whose stock is traded in the U.S. to bribe government officials in other countries to get business.

[PHARMA]

The companies said they are cooperating with the government, with several adding that the investigation is industry-wide and broader than their companies specifically. Many said they have policies meant to ensure compliance with the Foreign Corrupt Practices Act.

So far, none of the companies has been accused of wrongdoing, and the investigation ultimately may not result in charges.

The Justice Department and the Securities and Exchange Commission requested that companies voluntarily report any violations of the FCPA. Some companies, including SciClone Pharmaceuticals Inc. and Eli Lilly & Co., disclosed receiving subpoenas from the SEC. Baxter International Inc. also has said it is being investigated.

The investigation is targeting transactions in Brazil, China, Germany, Italy, Poland, Russia and Saudi Arabia, people familiar with the matter said.

The Justice Department and the SEC declined to comment.

Such requests from the government typically kick off internal investigations at companies, which generally comply with the requests in order to win leniency from the government if a violation is found.

A lawyer for one drug company said the industry has been vexed because the recent requests were so broad and because the investigations, across operations in several countries, can cost millions of dollars.

“If you don’t have any specifics, a lot of this is just guesswork,” the lawyer said. “Everyone was running around to get in the door to meet with the government so they can better understand what the issues are.”

Letters from the government to one of the companies, which were reviewed by The Wall Street Journal, identified four types of possible violations: bribing government-employed doctors to purchase drugs; paying company sales agents commissions that are passed along to government doctors; paying hospital committees to approve drug purchases; and paying regulators to win drug approvals.

People familiar with the situation said the other companies received similar letters.

The requests are similar to the government’s actions in an older bribery probe involving medical devices. In that investigation, settlement talks are ongoing with several companies, according to a person familiar with the matter.

Representatives for Merck, AstraZeneca, Bristol-Myers, Glaxo and Baxter declined to comment on the probe beyond saying they were cooperating fully with the government.

A SciClone spokeswoman declined to comment beyond the company’s SEC filings, in which it said it was subpoenaed for documents relating to its practices in China. A Lilly spokesman referred to an SEC filing in which the company said the U.S. government expanded to other countries an investigation of its Polish subsidiaries that began in 2003.

U.S. officials and European regulators have become increasingly aggressive in investigating foreign bribery cases in recent years. U.S. officials recently have threatened to file charges against executives and not just their companies.

The pharmaceutical industry is particularly vulnerable because government plays a bigger role in administering medicine in many foreign countries than it does in the U.S. and drugs are highly regulated, which creates contact with public officials. Doctors and hospital administrators often are government employees overseas.

Some of the alleged bribes could involve payments to doctors to influence drug trials, people familiar with the situation said. Justice Department officials have said publicly that drug companies also could face charges if they bribe government officials in the guise of payment for travel, meals, entertainment or speaking fees.

Read the rest of this article here: http://online.wsj.com/article/SB10001424052748704847104575532091781199092.html

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NY Times—U.S. Broadens Bribery Inquiry Into Drug Makers—Federal Prosecutors Investigating Payments Made to Doctors

Tuesday, August 17th, 2010

The New York Times
By Gardiner Harris and Natasha Singer
August 13, 2010

At least a dozen major drug and device makers are under investigation by federal prosecutors and securities regulators in a broadening bribery inquiry into whether the companies made illegal payments to doctors and health officials in foreign countries.

In previous investigations, federal officials have charged that some companies made these kinds of payments to encourage doctors abroad to order or prescribe their products. In the United States, companies routinely hire doctors as consultants to market drugs and devices to their colleagues and other health professionals at medical conventions and small gatherings. Such consulting arrangements are legal in the United States as long as the companies do not pay doctors directly to write prescriptions for their products.

But in much of the rest of the world, doctors are government employees. And even consulting arrangements that would be considered routine in the United States might violate the Foreign Corrupt Practices Act, particularly if the payments are outsize or the arrangements are not disclosed to the governments.

Of even greater concern to prosecutors in the United States are unusually large payments made to foreign doctors who oversee the growing number of clinical trials that drug and device makers conduct abroad, according to Kirk Ogrosky, a former top federal prosecutor who now represents drug and device makers at a Washington law firm.

More than 80 percent of the drugs approved for sale in 2008 involved trials in foreign countries, and 78 percent of all people who participated in clinical trials were enrolled at foreign sites, according to a recent investigation by Daniel R. Levinson, the inspector general of the Department of Health and Human Services. Medical ethicists have long worried that many of these trials are conducted in countries that federal auditors rarely visit and where research controls may be scant.

Now, prosecutors are investigating whether the payments made to doctors who conducted these studies abroad were appropriate. If evidence shows that such payments have influenced the results of some clinical trials, prosecutors will be inspecting the trials closely, Mr. Ogrosky said. An article about the inquiry appeared Friday in The Financial Times.

Last month, a federal drug official reported that he found repeated instances in a landmark clinical trial of Avandia, a controversial diabetes medicine, in which patients taking Avandia appeared to suffer serious heart problems that were not counted in the study’s crucial tally of adverse events. Many of the study’s trial sites were in foreign countries, and the study is a main reason that Avandia remains on the market in the United States. Government officials have not accused GlaxoSmithKline, the trial’s sponsor, of fraud.

“At the Justice Department, investigations that involve allegations of patient harm rise straight to the top and will attract the immediate attention of the F.B.I.,” Mr. Ogrosky said.

Read entire article here:  http://www.nytimes.com/2010/08/14/health/policy/14drug.html?_r=2&hp

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GSK & AstraZeneca face corruption investigation—hospitality lavished on those who prescribe drugs could constitute bribery

Monday, August 16th, 2010

Market Watch
By London Bureau
August 14, 2010

U.K. pharmaceutical firms GlaxoSmithKline PLC (GSK 38.15, +0.01, +0.03%) and AstraZeneca PLC (AZN 51.88, +0.49, +0.95%) are facing a corruption investigation in the U.S. over claims that the hospitality lavished on those who prescribe their treatments could constitute bribery, The Independent newspaper in London reported Saturday, without citing sources.

The newspaper said the two firms are among those facing the investigation being carried out by the Department of Justice and Securities and Exchange Commission.

The investigation is thought to center around allegations that drug companies might have contravened the Foreign Corrupt Practices Act, which limits their ability to spend on such things as hospitality, charitable donations and other non-business activities, the newspaper said.

Read entire article here:  http://www.marketwatch.com/story/gsk-astrazeneca-facing-us-probe-report-2010-08-14

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