EU drugs regulator accused of being too cozy with Big Pharma
11.05.11 @ 13:09
BRUSSELS - The European Parliament has refused to sign off on the accounts of the EU agency responsible for making sure all medicines in Europe are safe and effective for its citizens to use, accusing the body of being too close to Big Pharma.
The European Medicines Agency's reputation was further bludgeoned on Tuesday when the parliament ordered a special investigation of the regulator over its funding sources, which overwhelmingly come from the pharmaceutical industry and its hiring practices.
Completing the bad news for the agency whose claims of objectivity now lie in tatters were accusations from doctors from the Nordic Cochrane Centre, an independent Denmark-based network that publishes systematic reviews of drug efficacy, that the EMA withholds drug trial evidence due for fear of hurting the profits of drug companies.
On Tuesday, a crushing majority of MEPs in a 637-to-four vote refused to sign off on the accounts of the EMA.
There is "no proper guarantee of the independence of experts hired to carry out scientific evaluations of human medicines and some experts had conflicting interests," according to a statement issued by the chamber that described its concerns about the agency as "grave".
A report backed by the deputies that deploys the term "unacceptable" no fewer than five times and describes its concerns as "grave", describes how at the agency, "there is no guarantee that the evaluation of human medicines is performed by independent experts."
According to the MEPs, the alarm is being raised as a result of both hiring practices that do not pay attention to potential staff and expert conflicts of interest and the source of the bulk of the agency's funding, the pharmaceutical industry itself.
The report goes on to warn of "potential risks to the independence of experts/staff involved in the evaluation of medicinal products, which could have not only detrimental consequences to the agency's reputation should the evaluation of products be formally questioned, but also might have negative effects on public health."
The report mentions the case of the EMA's former executive director, Thomas Lonngren, who in December last year, resigned his post announcing that the next month, he was to take up another job for a private consultancy advising the pharmaceutical industry on the development of new medicines and reducing how long it takes to bring a product to market.
The MEPs' report "stresses that this move casts some doubt on the actual independence of the agency."
Within days of Lonngren's announcement, the EMA management board gave this case of ‘revolving doors' a green light, declaring that there was no conflict of interest and wishing him "all success in your future endeavours".
The parliament argued that the board was within its rights to forbid this type of employment, but did not and has demanded that the EMA deliver a list of all comparable cases that have occurred since the creation of the agency and "explain thoroughly the management board's decision in each case."
The case of the slimming pill
The MEPs in particular highlighted the case of the "very late withdrawal from the market" of a so-called slimming pill, benflourex, which was sold under the brand name ‘Mediator', and also demanded "a full and extensive report" from the agency explaining why it took 10 years from the date when the first warning of possible dangerous side effects of this drug was communicated to the agency, before the final decision was taken to withdraw the drug in 2009.
The EMA may yet get into more hot water over this case, as the chamber has asked the agency to detail how any experts and staff involved with the Mediator case were screened for their independence and verified that there was no conflict of interest.
The same day as the vote, the British Medical Journal published an article by two Danish doctors, Peter Gøtzsche and Anders Jørgensen, of the Nordic Cochrane Centre, detailing their struggle to get the EMA to release the results of clinical trials performed on another pair of slimming pills the agency had given the all-clear to.
The one drug, rimonabant from Sanofi-Aventis, traded under brand names such as Slimona and Monaslim until it was taken off the market last year as a result of side effects, notably severe depression and suicidal thoughts. The second, orlistat, is marketed as a prescription under the name Xenical, from Roche, or over the counter as Alli, from GlaxoSmithKline. Public Citizen, a consumer advocacy group has criticised the weight-loss drug's approval questioning its efficacy and raising concerns about side-effects including precancerous lesions of the colon.
"The effect on weight loss in the published trials is small, and the harms are substantial," the doctors wrote in their article. "People have died from cardiac and pulmonary complications or have experienced psychiatric disturbances, including suicidal events, and most of the drugs have been deregistered for safety reasons."
But the EMA refused to release the clinical trial data for three years, arguing that to do so "would undermine commercial interests."
Commercial interests versus patient welfare
Only after a ruling in June 2010 by the European ombudsman ordering the agency to cough up the information, accusing it of maladministration, did the EMA acquiesce, and it still took the body until February this year to do so.
"The EMA put protecting the profits of the drug companies ahead of protecting the lives and welfare of patients," said the doctors.
The agency's clinical trials database, Eudract, is kept hived off from public scrutiny, despite regular promises to make the information available.
The parliament on Tuesday formally called for a special investigation of conflict of interest at the agency. The chamber at the same time asked for a similar investigation of the European Police College and refused to sign off the accounts for the EU Council of Ministers, although it approved most of the EU's 2009 spending.
After the vote, Green MEP and deputy chair of the parliament's budgetary control committee, Bart Staes, said simply: "The EMA is a mess."