Featured Research

from universities, journals, and other organizations

Drug regulators are protecting profits over patients, warn researchers

Date:
May 10, 2011
Source:
BMJ-British Medical Journal
Summary:
Medicines regulators are protecting drug company profits rather than the lives and welfare of patients by withholding unpublished trial data, argue researchers.

Medicines regulators are protecting drug company profits rather than the lives and welfare of patients by withholding unpublished trial data, argue researchers on the British Medical Journal website.

They call for full access to full trial reports (published and unpublished) to allow the true benefits and harms of treatments to be independently assessed by the scientific community.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This must be remedied, they say, and they describe a three-year struggle to access unpublished trial reports for two anti-obesity drugs, submitted by the manufacturers to the European Medicines Agency (EMA) for marketing approval in the European Union.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


Story Source:

The above story is based on materials provided by BMJ-British Medical Journal. Note: Materials may be edited for content and length.


Journal Reference:

  1. P. C. Gotzsche, A. W. Jorgensen. Opening up data at the European Medicines Agency. BMJ, 2011; 342 (may10 1): d2686 DOI: 10.1136/bmj.d2686

Cite This Page:

BMJ-British Medical Journal. "Drug regulators are protecting profits over patients, warn researchers." ScienceDaily. ScienceDaily, 10 May 2011. <www.sciencedaily.com/releases/2011/05/110510211607.htm>.
BMJ-British Medical Journal. (2011, May 10). Drug regulators are protecting profits over patients, warn researchers. ScienceDaily. Retrieved April 18, 2014 from www.sciencedaily.com/releases/2011/05/110510211607.htm
BMJ-British Medical Journal. "Drug regulators are protecting profits over patients, warn researchers." ScienceDaily. www.sciencedaily.com/releases/2011/05/110510211607.htm (accessed April 18, 2014).

Share This



More Science & Society News

Friday, April 18, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Drought Concerns May Hurt Lake Tourism

Drought Concerns May Hurt Lake Tourism

AP (Apr. 18, 2014) — Operators of recreational businesses on western reservoirs worry that ongoing drought concerns will keep boaters and other visitors from flocking to the popular summer attractions. (April 18) Video provided by AP
Powered by NewsLook.com
Small Reactors Could Be Future of Nuclear Energy

Small Reactors Could Be Future of Nuclear Energy

AP (Apr. 17, 2014) — After the Fukushima nuclear disaster, the industry fell under intense scrutiny. Now, small underground nuclear power plants are being considered as the possible future of the nuclear energy. (April 17) Video provided by AP
Powered by NewsLook.com
Heartbleed Hack Leads To Arrest

Heartbleed Hack Leads To Arrest

Newsy (Apr. 17, 2014) — A 19-year-old computer science student has been arrested in relation to a data breach of 900 social insurance numbers from Canada's revenue agency. Video provided by Newsy
Powered by NewsLook.com
Scientists Create Stem Cells From Adult Skin Cells

Scientists Create Stem Cells From Adult Skin Cells

Newsy (Apr. 17, 2014) — The breakthrough could mean a cure for some serious diseases and even the possibility of human cloning, but it's all still a way off. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
 
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:  

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:  

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile iPhone Android Web
Follow Facebook Twitter Google+
Subscribe RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins