Featured Research

from universities, journals, and other organizations

Public disclosure of clinical trial results by Health Canada should be mandatory, expert argues

Date:
August 29, 2011
Source:
Canadian Medical Association Journal
Summary:
Health Canada is not prevented by law from publicly disclosing safety and efficacy data from clinical trials, pharmaceuticals, biologics and medical devices and should be more transparent, states a new analysis.

Health Canada is not prevented by law from publicly disclosing safety and efficacy data from clinical trials, pharmaceuticals, biologics and medical devices and should be more transparent, states an analysis in CMAJ (Canadian Medical Association Journal).

An example of the need for transparency relates to antidepressants known as selective serotonin reuptake inhibitors (SSRIs). These were not authorized for sale to people under the age of 19 because of risks of self-harm associated with SSRIs in that age group. Health Canada did not disclose this evidence based on a legal stipulation that prevents disclosure of information that might be confidential or a "trade secret." Without full information on the risks, physicians were prescribing the drug to teenagers.

A combination of lack of action on the part of Health Canada, a drive to commercialize medical products and the adversarial nature of the legal system has prevented greater openness. Recent attempts by Health Canada to increase transparency during the "technical discussions on regulatory modernization" between October 2010 and January 2011 were countered by opposition from the associations of medical device, biotechnology and pharmaceutical companies.

There is also concern that regulators such as Health Canada are working with the industry, and this close relationship precludes openness.

"The court has noted that Health Canada's role as a regulator reduces manufacturers' expectations of confidentiality, in contrast to other industry-government relations," writes Matthew Herder, Dalhousie University, Halifax, Nova Scotia. "The public interest, in other words, did not favour confidentiality."

To increase transparency, clinical trials should be registered, including design and key findings, although Health Canada has made little progress in this area. It should follow the lead of the US Food and Drug Administration to register clinical trials and disclose findings and make this mandatory under Canada's Food and Drugs Act.

"A lack of openness about designs and results of clinical trials, coupled with inadequate oversight of off-label use of drugs and adverse events, puts consumers of health products at risk," states the author.

"With Canadian Institutes of Health Research's recent misguided decision to withdraw its policy of clinical trials registration, Health Canada cannot continue to pass the buck," concludes Herder. "The law is no reason for further delay."


Story Source:

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


Journal Reference:

  1. M. Herder. Unlocking Health Canada's cache of trade secrets: mandatory disclosure of clinical trial results. Canadian Medical Association Journal, 2011; DOI: 10.1503/cmaj.110721

Cite This Page:

Canadian Medical Association Journal. "Public disclosure of clinical trial results by Health Canada should be mandatory, expert argues." ScienceDaily. ScienceDaily, 29 August 2011. <www.sciencedaily.com/releases/2011/08/110829131302.htm>.
Canadian Medical Association Journal. (2011, August 29). Public disclosure of clinical trial results by Health Canada should be mandatory, expert argues. ScienceDaily. Retrieved October 20, 2014 from www.sciencedaily.com/releases/2011/08/110829131302.htm
Canadian Medical Association Journal. "Public disclosure of clinical trial results by Health Canada should be mandatory, expert argues." ScienceDaily. www.sciencedaily.com/releases/2011/08/110829131302.htm (accessed October 20, 2014).

Share This



More Science & Society News

Monday, October 20, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Facebook Says The DEA's Fake Accounts Go Too Far

Facebook Says The DEA's Fake Accounts Go Too Far

Newsy (Oct. 19, 2014) Facebook says the DEA violated its Terms of Service and that such impersonations damage the integrity of the site. Video provided by Newsy
Powered by NewsLook.com
Court Ruling Means Kids' Online Activity Could Be On Parents

Court Ruling Means Kids' Online Activity Could Be On Parents

Newsy (Oct. 17, 2014) In a ruling attorneys for both sides agreed was a first of its kind, a Georgia appeals court said parents can be held liable for what kids put online. Video provided by Newsy
Powered by NewsLook.com
Raw: Cruise Ship Returns to US Over Ebola Fears

Raw: Cruise Ship Returns to US Over Ebola Fears

AP (Oct. 17, 2014) A Caribbean cruise ship carrying a Dallas health care worker who is being monitored for signs of the Ebola virus is heading back to Texas, US, after being refused permission to dock in Cozumel, Mexico. (Oct. 17) Video provided by AP
Powered by NewsLook.com
Spanish Govt: Four Suspected Ebola Cases in Spain Test Negative

Spanish Govt: Four Suspected Ebola Cases in Spain Test Negative

AFP (Oct. 17, 2014) All four suspected Ebola cases admitted to hospitals in Spain on Thursday have tested negative for the deadly virus in a first round of tests, the government said Friday. Duration: 00:55 Video provided by AFP
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


Science & Society

Business & Industry

Education & Learning

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