Drug regulators are protecting the profits of drug companies rather than the lives and welfare of patients by withholding unpublished trial data, researchers have argued.
Writing in an article published in the British Medical Journal, Danish authors called for access to unpublished reports “to allow the true benefits of treatments to be independently assessed by the scientific community”.
Doctors cannot choose the best treatments for their patients, despite the existence of hundreds of thousands of randomised trials, because results are being selectively reported, writes Professor Peter Gøtzsche and PhD student Anders Jørgensen.
They added that selective reporting can have disastrous consequences. For example, they say Merck’s painkiller Rofecoxib has caused about 100,000 unnecessary heart attacks in the US alone.
The researchers went on to say that unpublished reports are “virtually impossible” to access, and described their struggle persuade the European Medical Council to disclose unpublished trial reports for two anti-obesity drugs in 2007.
The European Medicines Agency argued that releasing the data would undermine the protection of commercial interests.
It also said that the redaction of unspecified data would cause a disproportionate administrative effort that would divert attention from its core business.
The authors appealed to the European ombudsman to access the trial reports, who criticised the European Medicines Agency’s refusal to grant access. But only after the ombudsman accused the agency of maladministration did the regulator agree to widen public access to documents.
“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.