Medicines regulators “putting drug company profits first”

Medicines regulators are protecting the profits of drug companies rather than the lives and welfare of patients by withholding unpublished trial data, two Danish researchers argue.

Writing in the British Medical Journal (BMJ) Professor Peter Gøtzsche and PhD student Anders Jørgensen call for access to unpublished scientific reports “to allow the true benefits of treatments to be independently assessed by the scientific community”.]

The researchers say that because of “selective reporting” of trial results by drugs companies, doctors cannot choose the best treatments for their patients, despite the existence of hundreds of thousands of randomised trials.

They add 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, while anti-arrhythmic drugs have probably caused the premature death of about 50,000 Americans each year in the 1980s.

The researchers go on to say that unpublished reports are “virtually impossible” to access, and describe their struggle to persuade the European Medical Council (EMA) to disclose unpublished trial reports for two anti-obesity drugs in 2007.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.

“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.