Nielegalny marketing GlaxoSmithKline

Piioottrr · Dołączył: 29 Mar 2011 Posty: 990

http://biznes.onet.pl/glaxo-zaplaci-3-mi.....news-detal

Cytat:

Brytyjski koncern farmaceutyczny GlaxoSmithKline poinformował w czwartek, że zdecydował się na zapłacenie 3 miliardów dolarów, żeby zamknąć dochodzenia dotyczące reklamowania leków poza wskazaniami i w innych sprawach.

Negocjacje na temat warunków ugody zakończą się w przyszłym roku, napisała firma z siedzibą w Londynie w swoim oświadczeniu. Koszty zostaną pokryte z rezerw pochodzących z zasobów gotówkowych firmy, poinformował koncern.

Ewentualna ugoda przybliży Glaxo do zakończenia wieloletnich dochodzeń. W czwartym kwartale ubiegłego roku koncern odłożył 3,5 miliarda dolarów na wypadek uzyskania ugody w toczących się dochodzeniach. Koncern poinformował też, że z kwoty 4,6 miliardów dolarów całkowitej sumy rezerw pozostanie mu 1,6 miliarda dolarów po uzyskaniu w czwartek porozumienia i nie zdecydował jeszcze, jak wykorzystać te pieniądze.

„Ta informacja wyraźnie kończy 10-letnią historię dochodzeń – napisał w e-mailu Gbola Amusa, analityk UBS w Londynie. – A także usuwa poważne niepewności dotyczące trwających sporów prawnych”.

Kwota ugody Glaxo przebije 2,3 miliardy dolarów, jakie zapłaciła firma Pfizer w 2009 roku za wprowadzenie do sprzedaży środka przeciwbólowego Bexter i innych leków, a także 1,4 miliarda dolarów, jakie zapłaciła firma Eli Lilly w tym samym roku za sprzedaż leku psychotropowego Zyprexa. Kwota ugody w sprawie leku Bextra była największą uzyskaną sumą na rynku farmaceutycznym w historii Stanów Zjednoczonych.

http://www.nytimes.com/2011/11/04/busine.....r=4&hp

Cytat:

Glaxo Settles Cases With U.S. for $3 Billion

The British drug company GlaxoSmithKline said Thursday that it had agreed to pay $3 billion to settle United States government civil and criminal investigations into its sales practices for numerous drugs.

The settlement would be the largest yet in a wave of federal cases against pharmaceutical companies accused of illegal marketing, surpassing the previous record of $2.3 billion paid by Pfizer in 2009. In recent years, drug companies have been prime targets of federal fraud investigations, which have recovered tens of billions of dollars for Medicaid and Medicare.

The cases against GlaxoSmithKline include illegal marketing of Avandia, a diabetes drug that was severely restricted last year after it was linked to heart risks. Federal prosecutors said the company had paid doctors and manipulated medical research to promote the drug.

GlaxoSmithKline had already set aside cash for the settlement, which analysts said would remove legal uncertainty. The company’s stock rose 2.96 percent Thursday, to $44.55, near its 52-week high, amid a broader market advance of about 2 percent.

“This is a significant step toward resolving difficult, long-standing matters which do not reflect the company that we are today,” Andrew Witty, chief executive of GlaxoSmithKline, said in a statement. “In recent years, we have fundamentally changed our procedures for compliance, marketing and selling in the U.S. to ensure that we operate with high standards of integrity and that we conduct our business openly and transparently.”

The agreement to settle its biggest federal cases should be completed next year, the company added in the statement. It said $3 billion would settle not only the Avandia case, but also a Justice Department investigation of its Medicaid pricing practices and a nationwide investigation led by the United States attorneys in Colorado and Massachusetts into the sales and marketing of nine of its drugs from 1997 to 2004.

GlaxoSmithKline did not specify how much money would resolve each case, nor the possibility of criminal findings and fines, saying the final settlement remained under negotiation. A Justice Department spokesman declined to comment.

GlaxoSmithKline, with a market value of more than $110 billion, had net profit of about $5 billion on sales of $43 billion in the year ending Sept. 30.

The company set aside $3.4 billion in January — eliminating its fourth-quarter profit — and $2.3 billion in July 2010 to resolve a variety of civil and criminal cases.

Critics of the settlements made with drug companies argued for stiffer penalties, including prison sentences for corporate officials.

Frances H. Miller, a Boston University law professor and health policy expert, said, “Although $3 billion is a very big number in terms of drug industry settlements, it’s not a very big number in relation to almost $50 billion in annual revenue for the world’s fourth-largest pharmaceutical company.”

Patrick Burns, spokesman for Taxpayers Against Fraud, an advocacy group for whistle-blowers, said, “Who at Glaxo is going to jail as a part of this settlement? Who in management is being excluded from doing future business with the U.S. government?”

Last year, the Justice Department accused a former vice president and associate general counsel of GlaxoSmithKline, Lauren C. Stevens, of obstruction of justice and making false statements. But she was acquitted of all six charges in May by a United States District Court judge, Roger W. Titus, in Maryland, who ruled that she had been advising the company in good faith.

Mr. Burns said the health care sector accounted for more than 80 percent of the $4 billion in overpayments recovered by the government in 2010 as a result of whistle-blower lawsuits and resulting fraud investigations by federal and state agencies.

“This is a well-worn path for big pharma,” said Les Funtleyder, health care strategist with the New York brokerage firm Miller Tabak.

“I know $3 billion sounds like an astronomical number,” he added, “but when you live in the world of worst-case scenarios, like investors do, $3 billion is a welcome relief. At least you have certainty.”

Brian Bourdot, an analyst at the investment bank Barclays Capital, called the settlement an important step but also noted that GlaxoSmithKline “remains involved in other legal disputes, including alleged violations of the Foreign Corrupt Practices Act.”

“We regard such disputes as an innate risk for large multinational pharmaceutical companies,” he wrote in a note to investors.

In a separate case last year, GlaxoSmithKline agreed to pay $750 million, including a $150 million criminal penalty, to resolve federal complaints about manufacturing quality at a plant in Cidra, P.R., since closed.

Mary Anne Rhyne, a spokeswoman for the company, said Thursday that it was still negotiating with the government over whether to include a corporate integrity agreement in that deal. The agreement could provide further penalties for other violations, though in manufacturing.

Piioottrr · Dołączył: 29 Mar 2011 Posty: 990

Insight into how pharma manipulates research evidence: a case study

TRANSPARENCY AND MEDICINE – A series examining issues from ethics to the evidence in evidence-based medicine, the influence of medical journals to the role of Big Pharma in our present and future health.

Here Jon Jureidini explains what he encountered while examining internal documents as an expert witness in a case against a pharmaceutical company.

It’s well known that academic literature on medication in psychiatry is distorted by selective publication – failing to publish studies with negative results or selectively publishing only positive results from studies with mixed outcomes.

I had the unusual opportunity to see inside the process of how the marketing department of a pharmaceutical company controls and distorts information in the medical literature. This chance arose when I was provided with access to a huge number of internal documents because I acted as an expert witness for a US law firm.

Between 1993 and 1998, SmithKline Beecham (SKB, subsequently GlaxoSmithKline) provided $5 million to various academic institutions to fund research into paroxetine (also known as Aropax, Paxil (GSK) or Seroxat), led by Martin Keller. Keller was from Brown University and received $800,000 for participation in the project.

The results were published in 2001 by Keller et al. in the journal article, “Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial”, in the Journal of the American Academy of Child & Adolescent Psychiatry (JAACAP). The article concluded that “paroxetine is generally well tolerated and effective for major depression in adolescents”.

This was a serious misrepresentation of both the effectiveness and safety of the drug. In fact, when SKB set out their methodology for their proposed study protocol, they had specified two primary and six secondary outcome measures. All eight proved negative, that is, on none of those measures did children on paroxetine do better than those on placebo.

The published article misrepresented one of the primary outcomes so that it appeared positive, and deleted all six pre-specified secondary outcomes, replacing them with more favourable measures.

Reszta tutaj: http://theconversation.edu.au/insight-in.....study-4071

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