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GSK to stop doctor incentive schemes

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GSK to stop paying doctors to make speeches

Editor of the British Medical Journal Fiona Godlee: “Doctors need independent, unbiased information about drugs”

GlaxoSmithKline (GSK) is making major changes to its incentive schemes following a damaging corruption scandal in China.

The pharmaceuticals firm will stop paying doctors to promote its products through speaking engagements.

Members of its sales force will also no longer have individual sales targets.

Earlier this year, Chinese police said GSK had transferred 3bn yuan ($489m; £321m) to travel agencies and consultancies to help bribe doctors.

But the company says the latest measures are not related to that continuing investigation. Instead, it says, they are part of a wider effort to improve transparency.

‘Greater clarity’

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There is a long way to go if we are truly to extricate medicine from commercial influence”

Fiona Godlee Editor, British Medical Journal

In a statement, Sir Andrew Witty, chief executive of GSK, said: “Today we are outlining a further set of measures to modernise our relationship with healthcare professionals.

“These are designed to bring greater clarity and confidence that whenever we talk to a doctor, nurse or other prescriber, it is patients’ interests that always come first.”

As well as stopping payments to doctors for making speeches, GSK is also ending payments to healthcare professionals for attending medical conferences.

A spokesperson told the BBC that there were “perceived conflicts of interest with that way of working”.

GSK plans a new system under which independent organisations, such as universities, can approach GSK for a grant if they want a particular doctor to attend a medical conference.

Doctors ‘satisfied’

In a statement, Dr Vivienne Nathanson, head of science and ethics at the British Medical Association (BMA), which represents doctors, said: “Whilst we agree that GSK should not directly sponsor doctors going to meetings, we are satisfied that they will continue to financially support education.

“It is pleasing to see a large pharmaceutical company like GlaxoSmithKline recognise that it can reduce the possibility of undue influence by rewarding employees for providing high-quality information and education for doctors, rather than for their sales figures.”

GSK says sales representatives will be rewarded for “technical knowledge” and the “quality of the service they deliver to support improved patient care”. Their compensation will also be linked to the overall performance of GSK.

Salespeople in the US have already been working under those conditions since 2011.

A spokesperson from GSK said: “It was always our intent to roll it out globally.”

Paying doctors to make speeches and attend conferences is common in the pharmaceuticals industry, but there is growing demand for reform.

“Where GSK leads we must hope that other companies will follow,” Fiona Godlee, editor of the British Medical Journal and a campaigner against industry influence in medicine, told the Reuters news agency.

“But there is a long way to go if we are truly to extricate medicine from commercial influence. Doctors and their societies have been too ready to compromise themselves.”

‘Non-trivial’

Ben Goldacre, author of the book Bad Pharma, is concerned about the quality of advice received by doctors.

He told BBC Radio 4: “Doctors get a lot of their education about which treatment works best from the pharmaceutical industry itself – from doctors who have been paid to give lectures about which drug is best.

“This free education has been shown to be be biased in research and it’s non-trivial.”

Andrew Powrie-Smith, director at the Association of the British Pharmaceutical Industry, told BBC Radio 4: “A number of companies I think are looking at this area and different models of education are emerging.”

He stressed that by 2016 companies would have to disclose how much they pay individual doctors.

Doctors and pharma in China.

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Doctor—patient relationships in China are in crisis. Doctors have been injured or even killed by patients at work. One of the major drivers might be the unhealthy and unethical relations between many doctors and some drug companies.

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On July 8, GlaxoSmithKline (GSK) said that they were investigating allegations that its staff had improperly used cash and other incentives to encourage the prescription of onabotulinumtoxin A (Botox) in China. The company added that “inquiries to date have found no evidence of bribery or corruption in relation to our sales and marketing of therapeutic Botox in China.”

The Lancet has no evidence to suggest that the allegations against GSK in China are true. However, some observers claim that bribing doctors to boost drug prescriptions by some drug companies is an open secret, and that this alleged practice has compromised the public’s trust in doctors. The varieties of unethical relationships that exist between some doctors and some of the drug companies in China are said to range from cash kickbacks, lavish gifts or entertainment, ghost writing services, sponsored supplements in journals, and all-expenses-paid trips. There is real concern that doctors’ prescriptions are therefore not based solely on patient need and clinical evidence, but may be biased by commercial interests.

The perceived unethical association between physicians and industry in China is worrying, because it inevitably harms patients as well as doctors. It damages the doctor—patient relationship and, ultimately, China’s whole health system. The GSK China allegations, although unproven, have clearly rung an alarm bell for China’s regulatory authorities to ensure the drug industry promotes products in a responsible, ethical, and professional way. Chinese doctors should rely on evidence-based clinical guidelines to inform their practice, and are in urgent need of guidance on their collaborations with the drug industry in various areas such as patient care, professional education, and research. Furthermore, training for doctors in China on managing their relationships ethically with the drug industry and other organisations should start at medical school and be part of continuing professional education.

Source: Lancet

GlaxoSmithKline accused of paying rivals to delay generic medicine.

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http://m.guardian.co.uk/business/2013/apr/19/glaxosmithkline-gsk-oft-generic-seroxat-paroxetine

GlaxoSmithKline to pay $3bn in US drug fraud scandal.

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(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.

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.”

Source: BBC Heath.

Rosiglitazone: what went wrong?

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Over 10 years after the diabetes drug rosiglitazone was approved by regulators, and despite studies on tens of thousands of people, questions remain about its cardiovascular safety. An investigation by the BMJ looks at why this happened.

It was, as one Food and Drug Administration (FDA) adviser put it, a “perfect regulatory storm”—a combination of problematic data, uncertain clinical need, politics, and poor drug company behaviour.

Now, 10 years after its approval by regulators in the United States and Europe, the widely prescribed blockbuster diabetes drug rosiglitazone may be about to fold. Two months ago, in July 2010, the FDA convened a 33 member expert advisory panel to decide whether it should be withdrawn from the market in the light of evidence that it may increase the risk of myocardial infarction. Earlier this year a US Senate finance committee report had detailed concerns about the paucity of evidence to support the use of rosiglitazone and about the way in which the drug was evaluated and licensed.1

At the advisory meeting, members of the public heard a damning analysis of the RECORD trial, commissioned by the European Medicines Agency (EMA) when it approved the drug in 2000 in order to determine its safety. Millions of prescriptions later and with the drug still on the market around the world, this trial and other post-marketing surveillance have failed to resolve the concerns.

To date, the FDA and the EMA have decided that the drug is safe enough to stay on the market. But the story reflects badly on almost everyone involved: the regulators, the manufacturer, GlaxoSmithKline, and the clinical community. It has also raised a host of questions. Why did the regulators accept such poor evidence on benefit and safety for rosiglitazone? Did GlaxoSmithKline mislead the regulators?

source: BMJ