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Healthy Skepticism Library item: 20226

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

GlaxoSmithKline to pay $3bn in US drug fraud scandal
BBC News 2012 July 2
http://www.bbc.co.uk/news/world-us-canada-18673220


Full text:

GlaxoSmithKline (GSK) is to pay $3bn (£1.9bn) in the largest healthcare fraud settlement in US history.

The drug giant is to plead guilty to promoting two drugs for unapproved uses and failing to report safety data about a diabetes drug to the Food and Drug Administration (FDA).

The settlement will cover criminal fines as well as civil settlements with the federal and state governments.

The case concerns the drugs Paxil, Wellbutrin and Avandia.

Deputy US Attorney General James Cole told a news conference in Washington DC that the settlement was “unprecedented in both size and scope”.

Doctors bribed
GSK, one of the world’s largest healthcare and pharmaceuticals companies, admitted to promoting antidepressants Paxil and Wellbutrin for unapproved uses, including treatment of children and adolescents.

Continue reading the main story

Start Quote

We have learnt from the mistakes ”

Andrew Witty
GlaxoSmithKline chief executive
The illegal practice is known as off-label marketing.

The company also conceded charges that it held back data and made unsupported safety claims over its diabetes drug Avandia.

In addition, GSK has been found guilty of paying kickbacks to doctors.

“The sales force bribed physicians to prescribe GSK products using every imaginable form of high-priced entertainment, from Hawaiian vacations [and] paying doctors millions of dollars to go on speaking tours, to tickets to Madonna concerts,” said US attorney Carmin Ortiz.

As part of the settlement, GSK agreed to be monitored by government officials for five years.

GSK said in a statement it would pay the fines through existing cash resources.

Andrew Witty, the firm’s chief executive, said procedures for compliance, marketing and selling had been changed at GSK’s US unit.

“We have learnt from the mistakes that were made,” Mr Witty said. “When necessary, we have removed employees who have engaged in misconduct.”

 

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Cases of wilful misrepresentation are a rarity in medical advertising. For every advertisement in which nonexistent doctors are called on to testify or deliberately irrelevant references are bunched up in [fine print], you will find a hundred or more whose greatest offenses are unquestioning enthusiasm and the skill to communicate it.

The best defence the physician can muster against this kind of advertising is a healthy skepticism and a willingness, not always apparent in the past, to do his homework. He must cultivate a flair for spotting the logical loophole, the invalid clinical trial, the unreliable or meaningless testimonial, the unneeded improvement and the unlikely claim. Above all, he must develop greater resistance to the lure of the fashionable and the new.
- Pierre R. Garai (advertising executive) 1963