Drug regulators are protecting profits over patients, warn researchers

Medicines regulators are protecting drug company profits rather than the lives and welfare of patients by withholding unpublished trial data, argue researchers in the British Medical Journal today.

They call for full access to full trial reports (published and unpublished) to allow the true benefits and harms of treatments to be independently assessed by the scientific community.

Despite the existence of hundreds of thousands of , are unable to choose the best treatments for their patients because research results are being reported selectively, write Professor Peter Gøtzsche and Dr Anders Jørgensen from the Nordic Cochrane Centre in Denmark.

Selective reporting can have disastrous consequences. For example, Rofecoxib (Vioxx) has probably caused about 100,000 unnecessary heart attacks in the USA alone, while anti-arrhythmic drugs have probably caused the premature death of about 50,000 Americans each year in the 1980s.

This must be remedied, they say, and they describe a three-year struggle to access unpublished trial reports for two anti-obesity drugs, submitted by the manufacturers to the European Medicines Agency (EMA) for marketing approval in the European Union.

"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."

But the EMA refused access, arguing that this would undermine commercial interests and that there was no overriding public interest in disclosure. They also cited the administrative burden involved and the worthlessness of the data after they had edited them.

The authors appealed to the European ombudsman, who criticised the EMA's refusal to grant access. But only after the ombudsman accused EMA of maladministration, did it 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 ," say Gøtzsche and Jørgensen.

add to favorites email to friend print save as pdf

Related Stories

Useful stroke trials left unpublished

Apr 22, 2010

An investigation into unpublished stroke research data has revealed that 19.6% of completed clinical trials, which could potentially influence patient care, are not published in full. Researchers writing in BioMed Central's ...

New strategies to tackle medical ghostwriting are debated

Feb 03, 2009

Better strategies to tackle ghostwriting in the medical literature are the subject of a debate by leading authors in next week's issue of the open-access journal PLoS Medicine. Ghostwriting is scientific misconduct, argues ...

Recommended for you

Supermaterial gives rejected drugs a new chance

14 hours ago

More than 80 percent of all drug candidates in the pharma R&D suffer from poor solubility and are therefore rejected early in the drug discovery process. Now Uppsala University researchers show that the new ...

Risk of antibiotic overuse in aged care settings

Jul 21, 2014

Antibiotics are being overused in residential aged care facilities (RACFs), and more integrated efforts to improve antibiotic prescribing practices need to be introduced, researchers say. 

Ruconest approved for rare genetic disease

Jul 17, 2014

(HealthDay)—Ruconest has been approved by the U.S. Food and Drug Administration to treat hereditary angioedema, a genetic disease that leads to sudden and potentially fatal swelling of the hands, feet, limbs, face, intestinal ...

NIH system to monitor emerging drug trends

Jul 17, 2014

An innovative National Drug Early Warning System (NDEWS) is being developed to monitor emerging trends that will help health experts respond quickly to potential outbreaks of illicit drugs such as heroin and to identify increased ...

User comments

Adjust slider to filter visible comments by rank

Display comments: newest first

NANOBRAIN
not rated yet May 17, 2011
WE WILL SEE ALLOT MORE OF THIS DOWN THE ROAD.MANKIND WILL SEE BIG PROBLEMS BECAUSE OF HIS GREEDYNESS.THERE IS TWO SIDES TO EVERY COIN!

NANOBRAIN