Featured Research

from universities, journals, and other organizations

Call for full access to Tamiflu trial data to allow for independent scrutiny, researchers urge

Date:
January 11, 2011
Source:
BMJ-British Medical Journal
Summary:
Leading researchers today call for access to all clinical trial data (published and unpublished) to allow drugs to be independently assessed by the scientific community.

Tom Jefferson and colleagues from the Cochrane Group argue that the current system for assessing the safety and effectiveness of drugs, based on published trial data only, is "wholly inadequate" and "ethically dubious."

They propose a new approach that would allow in-depth scrutiny of the complete set of trial data for a new drug.

Their call comes after they reviewed the evidence for the antiviral drug oseltamivir (Tamiflu), and were unable to find sufficient published data to support the conclusion that oseltamivir reduces complications in healthy adults.

As a result, Roche (oseltamivir's manufacturer) publicly pledged to make full results for ten unpublished clinical trials available for scrutiny. Yet, to date, they have failed to fulfil this promise.

The Cochrane team's concern deepened after finding reports of ten serious adverse events in patients enrolled in two key manufacturer-funded trials that were not reported in journal publications arising from those trials.

Other recent cases, where the "true" effects of drugs have emerged only after all the evidence (including unpublished data) has been analysed, have further highlighted the importance of independent evaluation.

"The answer is to make the data freely available: we should accept nothing less than a full dataset," say the authors. "Before licensing a drug -- and certainly before large purchase decisions are made -- our governments and policy makers should ensure that all researchers can access data in sufficient detail to allow for the independent exploration and re-analysis of trials," they add.

Their proposed new approach involves compiling a complete list of drug trials (published and unpublished) and requesting full clinical study reports.

They urge researchers, the public, and the media to work together to put pressure on industry to embrace the ethical responsibility to release data in the public interest. They also call on medical journals to require submission of the most detailed report available.

They conclude: "It is time the media, the Cochrane Collaboration, and any reader interested in knowing what they are prescribing or are being prescribed increase the pressure on policy makers. If you swallow a medication, you need to know how it works -- for real."


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. Tom Jefferson, Mark A Jones, Peter Doshi, Chris B Del Mar, Carl J Heneghan, Rokuro Hama, Matthew J Thompson, Tom Jefferson. Neuraminidase inhibitors for preventing and treating influenza in healthy adults and children - a review of unpublished data. Cochrane Database, DOI: 10.1002/14651858.CD008965

Cite This Page:

BMJ-British Medical Journal. "Call for full access to Tamiflu trial data to allow for independent scrutiny, researchers urge." ScienceDaily. ScienceDaily, 11 January 2011. <www.sciencedaily.com/releases/2011/01/110111184138.htm>.
BMJ-British Medical Journal. (2011, January 11). Call for full access to Tamiflu trial data to allow for independent scrutiny, researchers urge. ScienceDaily. Retrieved September 30, 2014 from www.sciencedaily.com/releases/2011/01/110111184138.htm
BMJ-British Medical Journal. "Call for full access to Tamiflu trial data to allow for independent scrutiny, researchers urge." ScienceDaily. www.sciencedaily.com/releases/2011/01/110111184138.htm (accessed September 30, 2014).

Share This



More Health & Medicine News

Tuesday, September 30, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

How 'Yes Means Yes' Defines Sexual Assault

How 'Yes Means Yes' Defines Sexual Assault

Newsy (Sep. 29, 2014) Aimed at reducing sexual assaults on college campuses, California has adopted a new law changing the standard of consent for sexual activity. Video provided by Newsy
Powered by NewsLook.com
Scientists May Have Found An Early Sign Of Pancreatic Cancer

Scientists May Have Found An Early Sign Of Pancreatic Cancer

Newsy (Sep. 29, 2014) Researchers looked at 1,500 blood samples and determined people who developed pancreatic cancer had more branched chain amino acids. Video provided by Newsy
Powered by NewsLook.com
Colo. Doctors See Cluster of Enterovirus Cases

Colo. Doctors See Cluster of Enterovirus Cases

AP (Sep. 29, 2014) Doctors at the Children's Hospital of Colorado say they have treated over 4,000 children with serious respiratory illnesses since August. Nine of the patients have shown distinct neurological symptoms, including limb weakness. (Sept. 29) Video provided by AP
Powered by NewsLook.com
Dr.'s Unsure of Cause of Fast-Spreading Virus

Dr.'s Unsure of Cause of Fast-Spreading Virus

AP (Sep. 29, 2014) Doctors at the Children's Hospital of Colorado say they have treated over 4,000 children with serious respiratory illnesses since August. Nine of the patients have shown distinct neurological symptoms, including limb weakness. (Sept. 29) Video provided by AP
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:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

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