Drug regulators accused of risking patient safety

Related; Overseas Clinical Trials; Big Pharma's global guinea pigs-Special Report From Reuters

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Sarah Boseley, health editor

guardian.co.uk, Tuesday 10 May 2011 23.30 BST
Article history

Drug regulators are being accused of being more concerned with protecting the profits of pharmaceutical companies than safeguarding the lives of patients.

The charge comes from doctors who spent three years battling with the European Medicines Agency (EMA) to extract the results of clinical trials carried out by drug companies on anti-obesity pills. The EMA, which gave the drugs a marketing licence, refused the requests.

The doctors, from the well-regarded Cochrane Collaboration which publishes assessments of the safety of drugs, say the EMA and other drug-licensing bodies turn down requests to see the evidence from trials on the basis that they could harm the commercial interests of drug companies.

Yet, they say, there is a strong public interest in the wider availability of drug trials data.
They cite the case of vioxx, also known as rofecoxib, which probably caused 100,000 heart attacks among those with arthritis in the US who were taking it as a painkiller, of which 40% were fatal on average.
It is not the only example. Drugs taken by people in the US with arrhythmia (irregular heartbeat) in the 1980s probably caused the deaths of 50,000 a year.

"An early trial found nine deaths among patients taking the antiarrhythmic drug and only one among those taking placebo, but it was never published because the company abandoned the drug for commercial reasons," Professor Peter Gøtzsche and Dr Anders Jørgensen from the Nordic Cochrane Centre in Denmark say in an online article for the British Medical Journal.

The two doctors describe their long but eventually successful struggle to extract trial data from the EMA on two anti-obesity drug it had licensed: rimonabant – which was withdrawn last year in Europe because of side-effects – and orlistat.

"The information was important for patients because anti-obesity pills are controversial," say the authors. "People have died from cardiac and pulmonary complications or have experienced psychiatric disturbances, including suicidal events, and most of the drugs have been de-registered for safety reasons."
The EMA refused the doctors access to the data, arguing that it could damage the commercial interests of the drug companies and that there was no over-riding public interest in disclosure. It claimed that releasing the data would pose an unacceptably heavy administrative burden and the documents would be useless once the necessary redactions to remove personal identifying details had been carried out.
When the authors appealed to the European ombudsman, the EMA strongly defended its position but was nevertheless accused of maladministration. At that point, three years after the original request, the agency agreed to release the material.

"There is something fundamentally wrong with our priorities in healthcare if commercial success depends on withholding data that are important for rational decision making by doctors and patients," say Gøtzsche and Jørgensen.

They suggest that access to data should be prompt and documents should be provided in a useful format to allow for independent scrutiny. "Drug agencies should get rid of the huge paper mountains and require electronic submissions from the drug companies, including the raw data, which should also be made publicly available," they conclude.

In an accompanying editorial, researcher Andrew Vickers says the system is broken and needs fixing. He describes a new initiative by the Wellcome Trust to tackle the problem by developing principles for funding bodies with regard to data sharing and suggests the medical research community "get used to it".

The article is published as the European parliament orders an audit of the EMA by the European court of auditors, following concerns that the agency's former executive director, Thomas Lonngren, took up paid and unpaid consultancies within the pharmaceutical industry within weeks of leaving his position.

The management board of the EMA fully approved his move into the private sector until public concern was raised by health watchdogs in Europe. The investigation of potential conflicts of interest will last until June.
Health Action International, one of the groups that raised the alarm, said there would continue to be concerns as long as the EMA's revenue came from the drug companies, which pay to have licence applications considered.

"The agency needs to be weaned off the fee-for-service relationship that it currently has with pharmaceutical companies," said Katrina Perehudoff, project officer at HAI Europe.
• This article was amended on 11 May 2011. Originally it stated that the drug "probably caused the deaths of about 100,000 people with arthritis".This has been corrected