Professor Peter Gøtzsche and Anders Jørgensen have reported on the problems they encountered obtaining data from the European Medicines Agency.
Doctors cannot choose the best treatments for their patients
despite the existence of hundreds of thousands of randomised
trials. The main reason is that research results are being reported
selectively. Comparisons of published drug trials with
unpublished data available at drug regulatory agencies have
shown that the benefits of drugs have been much over-rated
and the harms under-rated. Comparisons of trial protocols with
published papers have also shown widespread selective reporting
of favourable results.
Selective reporting can have disastrous consequences. Rofecoxib
(Vioxx) has probably caused about 100 000 unnecessary heart
attacks in the United States alone, and class 1 antiarrhythmic
drugs probably caused the premature death of about 50 000
Americans each year in the 1980s. 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
Accreditation is an expensive treatment similar to a drug or other intervention. Its effects and side-effects are relevant to both patients and staff. Why should its performance be accepted without disclosure of similarly rigorous trials? However, unlike drug trials, there is no body of evidence to hide since accreditation is never assessed for effectiveness.
Allowing researchers access to unpublished trial reports
submitted to drug regulatory agencies is important for public
health. Such reports are very detailed and provide more reliable
data than published papers, but it has been virtually impossible
to get access to them.
Because openness is not what regulators like.
We eventually succeeded in getting access
to reports held by the European Medicines Agency (EMA) after
three years of trying. Our case has set an important precedent,
and we summarise here the process and the arguments….
Without any comment on our arguments, the EMA replied that
the documents could not be released because it would undermine
commercial interests. We appealed to the EMA’s executive
director, Thomas Lönngren, and asked him to explain why the
EMA considered that the commercial interests of the drug
industry should over-ride the welfare of patients….
…after the ombudsman accused
the EMA of maladministration in a press release on 7 June
2010,15 three years after our request, the EMA reversed its
stance. The EMA now gave the impression that it had favoured
disclosure all the time…
Our case sets an important precedent. On 30 November 2010
the EMA declared it would widen public access to documents,
including trial reports and protocols.
Some government embarrassment is going to be needed before the accreditation cartel’s commercial position comes under threat.