Featured Research

from universities, journals, and other organizations

Experts call to end secrecy surrounding approval of new drugs

Date:
March 31, 2010
Source:
BMJ-British Medical Journal
Summary:
Changes are urgently needed to end the secrecy surrounding approval of new drugs in Europe, argue experts.

Changes are urgently needed to end the secrecy surrounding approval of new drugs in Europe, argue experts online in the British Medical Journal.

Questions about the benefits of the flu drug oseltamivir in otherwise healthy people have fuelled debate about the secrecy surrounding the documentation submitted by drug companies to obtain approval of new drugs, write Silvio Garattini and Vittorio Bertele' from the Mario Negri Institute for Pharmacological Research in Italy.

They believe that greater transparency "would open drug dossiers to evaluation by the scientific community and help independent interested parties define the benefit-risk profile of new medicines before they are allowed on to the market."

And they suggest that the recent movement of the European Medicines Agency (EMA) to the Health and Consumer Policy Directorate (DG Sanco) rather than the Enterprise and Industry Directorate "presents an opportunity to introduce more openness."

The industry considers it has the right to secrecy, in order to protect the substantial investments made to develop a new drug. But the authors argue that the public is an "essential partner" in new discoveries and therefore has "the right of access to all relevant information."

Secrecy about clinical data "implies undue exploitation of the rights of doctors and patients participating in the studies," they say.

Transparency of the regulatory system is also required "to overcome several dysfunctions in the drug industry's behaviour" and "cast light on deviations from trial protocols," they add.

The abolition of confidentiality would help make the system more transparent and enable clinicians and patients' representatives to obtain information on which to base constructive criticism, establishing public confidence and improving research in the industry itself, they explain.

Abolition of secrecy by EMA would also boost the regulatory authorities' credibility and show that patients' health has priority over industrial interests, they conclude.


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. Garattini et al. Europe's opportunity to open up drug regulation. BMJ, 2010; 340 (mar30 2): c1578 DOI: 10.1136/bmj.c1578

Cite This Page:

BMJ-British Medical Journal. "Experts call to end secrecy surrounding approval of new drugs." ScienceDaily. ScienceDaily, 31 March 2010. <www.sciencedaily.com/releases/2010/03/100330210951.htm>.
BMJ-British Medical Journal. (2010, March 31). Experts call to end secrecy surrounding approval of new drugs. ScienceDaily. Retrieved July 25, 2014 from www.sciencedaily.com/releases/2010/03/100330210951.htm
BMJ-British Medical Journal. "Experts call to end secrecy surrounding approval of new drugs." ScienceDaily. www.sciencedaily.com/releases/2010/03/100330210951.htm (accessed July 25, 2014).

Share This




More Health & Medicine News

Friday, July 25, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

New Painkiller Designed To Discourage Abuse: Will It Work?

New Painkiller Designed To Discourage Abuse: Will It Work?

Newsy (July 24, 2014) The FDA approved Targiniq ER on Wednesday, a painkiller designed to keep users from abusing it. Like any new medication, however, it has doubters. Video provided by Newsy
Powered by NewsLook.com
Doctor At Forefront Of Fighting Ebola Outbreak Gets Ebola

Doctor At Forefront Of Fighting Ebola Outbreak Gets Ebola

Newsy (July 24, 2014) Sheik Umar Khan has treated many of the people infected in the Ebola outbreak, and now he's become one of them. Video provided by Newsy
Powered by NewsLook.com
Condemned Man's US Execution Takes Nearly Two Hours

Condemned Man's US Execution Takes Nearly Two Hours

AFP (July 24, 2014) America's death penalty debate raged Thursday after it took nearly two hours for Arizona to execute a prisoner who lost a Supreme Court battle challenging the experimental lethal drug cocktail. Duration: 00:55 Video provided by AFP
Powered by NewsLook.com
Can Watching TV Make You Feel Like A Failure?

Can Watching TV Make You Feel Like A Failure?

Newsy (July 24, 2014) A study by German researchers claims watching TV while you're stressed out can make you feel guilty and like a failure. 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