Thursday, July 12, 2012

GSK- Nature editorial

Take a stand

Pharmaceutical giant GlaxoSmithKline (GSK) agreed last week to settle criminal and civil claims by paying the US authorities a stunning US$3 billion. It is the largest drug-industry settlement in history; the allegations include that the company ran illegal campaigns to promote the prescription of drugs for unapproved uses in children, and published “false and misleading” accounts of clinical studies.

According to the US complaint, GSK also lavished some doctors and academics with “sham consulting fees” and other payments, as well as gifts and attendance at luxury conferences in venues such as Bermuda and Jamaica — sometimes with sailing or deep-sea fishing thrown in — to encourage them to prescribe drugs for off-label uses (see Speakers could earn $1,000–2,500 per hour to talk at promotional events, with some negotiating 'six packs' of $12,000-worth of talks over two days. One speaker earned about $1.5 million between 2001 and 2003. Nice work if you can get it — and too many could. Andrew Witty, chief executive of GSK, last week apologized for the company's past behaviour, but argued that since he took the helm in 2008, GSK has implemented deep reforms (see

The settlement, which is far from GSK's first, is the latest in a slew of similar payouts by drug companies in the United States over the past few years, with Pfizer, for example, entering into a $2.3-billion settlement in 2009. The pharmaceutical industry as a whole has now overtaken the defence industry's historical lead in penalties paid to the US government.

“Rotten apples who accept kickbacks should be investigated.”

Some parts of the pharmaceutical industry have been revealed to be riddled with huge pressures on staff to make sales, corporate and individual greed, and a disregard for ethics and the law that seems often to put the interests of shareholders and investors above those of the people the companies are intended to serve. Some observers told Nature that drug companies might write down financial penalties as a cost of doing business. If so, nothing short of jail time will be an effective deterrent.

The GSK settlement does demand that the company enter into a stringent five-year Corporate Integrity Agreement with the US Department of Health and Human Services. Experts in health law say that the contract has real teeth: it puts in place extensive reporting requirements and external oversight, with penalties for failures in compliance, including heavy fines and going as far as exclusion from federal health-care programmes. Importantly, the rules also protect whistle-blowers from retaliation. GSK saw this oversight coming, and has already started to implement reforms.

The stream of revelations from the drug industry is a reminder that researchers and institutions must be vigilant to ward off the potentially corrupting influence of industry funding and practices. Given that the most drug-industry settlements have concerned the off-label market, journals and the media should rigorously assess studies claiming new benefits from existing drugs. One lesson from the GSK case is that flawed or small studies can be exploited by the sales force and a well-oiled public-relations machine to advance off-label ambitions.

Pharmaceutical research demands that industry and academia work together, so the temptation to decry all industry involvement as suspicious must also be resisted. At the same time, institutions and researchers must not be naive in their dealings with industry, and must hold themselves and the companies they work with to the highest ethical standards, including full disclosure of links. Rotten apples who accept kickbacks should be investigated and exposed for bringing shame on the research and medical establishments.

The biggest victim of these drug-industry scandals is the public trust that a medicine does what it is claimed to do, and that information on its safety is reliable. Other victims include honest GSK scientists and staff, who were far removed from their company's machinations, and now must feel sick about the pall of suspicion that will inevitably fall over their efforts.

This is unfortunate and unfair. But the US action is essential, one that other countries can follow as a model and a landmark on the road to making corporate responsibility less of a slogan, and more of a reality.

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