Unlawful drug marketing: GlaxoSmithKline & 4,000 doctors Face Criminal Charges in Italy

Mon, 7 Jun 2004

On March 25, 2004, the US Attorney in Pennsylvania commenced an investigation of Eli Lilly's marketing promotion of Zyprexa (olanzapine), Prozac (fluoxetine) and Evista (raloxifene).

On April 19, a class action lawsuit was filed in federal court against Eli Lilly, accusing the company of heavily promoting Zyprexa as a safe and effective drug for psychotic disorders, while virtually concealing the risks of side effects from doctors and from the patients themselves. Zyprexa has been linked to severe side effects including diabetes, hyperglycemia and pancreatitis. In 2002, both the Japanese Health and Welfare Ministry and the UK Medicines Control Agency issued emergency warnings concerning Zyprexa and diabetes-related complications

On May 13, Pfizer pled guilty to criminal charges and civil liabilities in connection with illegal and fraudulent promotion of unapproved uses of Neurontin and agreed to pay $430 million in penalties.

On May 18, New York City filed a suit against GlaxoSmithKline, charging the company with "anticompetitive, fraudulent, and inequitable conduct," when it acquired patents for its anti-depressant Paxil, and for obtaining "frivolous" patents to unfairly keep cheaper, generic versions of the drug off the market.

On May 26, Italy's finance police ended a two year investigation of GlaxoSMithKline leading to criminal charges against the company and of 4,440 doctors, including more than 2,500 GPs and 1,700 specialists. It is reported that GSK spent $278 million in bribes whose purpose was to influence the doctors' prescribing. The practice, according to British analysts, is common in the pharmaceutical industry. The doctors have been criminally indicted and could face jail sentences. According to the suit "Glaxo employees in Italy in question had offered cash, gifts and prizes to doctors and other healthcare professionals to encourage them to prescribe Glaxo drugs."

On June 2, NYS Attorney General filed a lawsuit against GlaxoSmithKline charging the company with fraudulent marketing of its antidepressant, Paxil / paroxetine and concealment of the drug's hazardous adverse effects from physicians.

Fraudulent pharmaceutical marketing practices affect more than economics, they undermine health and cause preventable deaths. Multi-national pharmaceutical companies that engage in fraudulent marketing cause more harm than illicit drug traffickers. Inasmuch as pharmaceutical companies who engage in fraud have demonstrated that they are not deterred even when fined hundreds of millions of dollars, violators should be jailed, not merely fined. Fraudulent drug marketing practices should, therefore, be criminalized. Pharmaceutical company employees who violate marketing standards should be prosecuted and held liable under the same drug enforcement rules that are applied to those who traffic in illicit drugs.

Over 4,000 doctors face charges in Italian drugs scandal

John Hooper in Rome and Heather Stewart
Thursday May 27, 2004
The Guardian
Contact: Vera Hassner Sharav
Tel: 212-595-8974

One of the biggest inquiries into marketing practices in the drugs industry ended yesterday with Italian police asking for almost 5,000 people to be put on trial, including more than 4,000 doctors and at least 273 employees of the British pharmaceuticals giant, GlaxoSmithKline. Some face up to five years in jail if tried and convicted.

Italy's revenue guard, the Guardia di Finanza, said in a statement that GlaxoSmithKline and its predecessor firm had spent 228m (152m) on "sweeteners" for doctors, chemists and others over four years. The alleged bribes ranged from cameras, computers and holidays to outright cash payments.

The Guardia di Finanza said GlaxoSmithKline "should be held responsible for corporate crime as its managers and other employees acted in the company's interest".

A spokesman for GSK said last night it had been "cooperating closely with the authorities to facilitate their investigations. GSK is committed to ensuring that all its business practices are of the highest standards and any breach of that is unacceptable", the spokesman added.

But a British-based pharmaceuticals analyst said yesterday the type of activity the Italian authorities allege to have uncovered is common practice among global drug companies.

"In parts of Europe, these things are absolutely rife," he said. "For example, doctors may be given 'research grants' - but there are no limits on how they can spend them." He cited cases in which doctors had been offered cars or holidays as inducements to prescribe a particular brand.

Italy's Adnkronos news agency reproduced what it said was a letter written by a GlaxoSmithKline district manager contained in the 10,000 pages of evidence assembled by the Guardia di Finanza.

The letter urged sales representatives to approach specialists directly to get them to prescribe a cancer drug produced by the company. "The initiative can work well with oncologists who have congresses, investments from us ... and who have not given us anything in return," the district manager was quoted as writing. Illicit incentives were said to have been disguised in the firm's accounts under the headings of "field selling", "other promotion" and "medical phase IV".

Of the 4,713 people from all parts of Italy facing charges, 4,440 are doctors. They include more than 2,500 GPs and some 1,700 specialists.

The most serious accusations have been leveled at doctors, pharmacists and sales representatives alleged to have been involved in a programme intended to promote Hycamtin, a drug mainly used in the treatment of lung and ovarian cancers. In some cases, it is claimed, specialists received a pro rata cash payment based on the number of patients treated with the drug.

At a press conference yesterday, a senior revenue guard officer, Giovanni Mainolfi, estimated the investigation was costing GlaxoSmithKline's Italian subsidiary 400m a year in lost sales.

Thousands named in Glaxo incentives probe in Italy

MILAN, May 26 (Reuters) - Italian police said on Wednesday they believed about 4,400 medical professionals and 300 employees in Italy of pharmaceuticals firm GlaxoSmithKline took part in an illegal incentives scheme to boost Glaxo's sales.

Italy's finance police, ending a nearly two-year investigation, said the Glaxo employees in Italy in question had offered cash, gifts and prizes to doctors and other healthcare professionals to encourage them to prescribe Glaxo drugs.

"It is not a new situation. Since February 2003, GSK has been cooperating closely with the authorities to facilitate their investigations. This cooperation has been acknowledged by the investigating authority," said a Glaxo spokesman in London.

"GSK is committed to ensuring all of its business practices are of the highest possible standards and any breach of these is unacceptable," he said.

Italian police said in a statement Glaxo spent 228 million euros ($276 million) between 1999 and 2002 on the incentives and "should be held responsible for corporate crime, as its managers and other employees acted in the company's interest".

Of the 300 Glaxo employees named in the probe, 73 were suspected of corruption and criminal association, it said.

Prosecutors must now decide whether to seek a trial for those named in the probe.

Police said the investigation had helped to save 620 million euros per year in public health spending.


Additional reporting by Mike Elliott in London

http://www.guardian.co.uk/italy/story/0,12576,1225576,00.html

Copyright 2003 The New York Times Company

FAIR USE NOTICE: This may contain copyrighted ( ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a 'fair use' of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit.

Alliance for Human Research Protection (AHRP) is a national network of lay people and professionals dedicated to advancing responsible and ethical medical research practices, to ensure that the human rights, dignity and welfare of human subjects are protected, and to minimize the risks associated with such endeavors.