Drug regulators are protecting profits over patients, warn researchers

May 11, 2011

Medicines regulators are protecting drug company profits rather than the lives and welfare of patients by withholding unpublished trial data, argue researchers in the British Medical Journal today.

They call for full access to full trial reports (published and unpublished) to allow the true benefits and harms of treatments to be independently assessed by the scientific community.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This must be remedied, they say, and they describe a three-year struggle to access unpublished trial reports for two anti-obesity drugs, submitted by the manufacturers to the European Medicines Agency (EMA) for marketing approval in the European Union.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.

Related Stories

Recommended for you

Why kicking the opioid habit can be so tough

July 20, 2016

(HealthDay)—He was 26, a specialist fifth class with the U.S. Army, and stationed abroad, when an accident on the German autobahn sent him careening through the windshield of his car.

New research shows vaccine protection against Zika virus

June 28, 2016

The rapid development of a safe and effective vaccine to prevent the Zika virus (ZIKV) is a global priority, as infection in pregnant women has been shown to lead to fetal microcephaly and other major birth defects. The World ...

Can exercise be replaced with a pill?

October 2, 2015

Everyone knows that exercise improves health, and ongoing research continues to uncover increasingly detailed information on its benefits for metabolism, circulation, and improved functioning of organs such as the heart, ...

1 comment

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

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.