Featured Research

from universities, journals, and other organizations

Biased evidence? Researchers challenge post-marketing drug trial practices

Date:
May 3, 2012
Source:
Carnegie Mellon University
Summary:
Bioethicists argue that current research ethics frameworks do not flag drug trials that, while not putting patients at risk, produce biased evidence. As an example, they point to phase IV research -- when pharmaceutical companies test drugs and devices that have been approved for marketing.

Current research ethics focuses on protecting study participants, but according to bioethicists from Carnegie Mellon University and McGill University, these efforts fail to prevent problems that undermine the social value of research.

Published in Science, CMU's Alex John London, and McGill's Jonathan Kimmelman and Benjamin Carlisle argue that current research ethics frameworks do not flag drug trials that, while not putting patients at risk, produce biased evidence. As an example, they point to phase IV research -- when pharmaceutical companies test drugs and devices that have been approved for marketing. They insist that without an adequate system of checks in place, phase IV trials will continue to be used by drug companies to market products without generating the information that clinicians and policy makers can use to improve care and maintain a more cost-effective health system.

"Medical care isn't like most consumer products where the consumer can assess the quality of the product from its performance and estimate its value for the money," said London, associate professor of philosophy and director of CMU's Center for Ethics and Policy. "In medicine we are forced to rely on what can at times be complex scientific studies for this information. So it is difficult to overstate the importance of preserving the integrity of this research."

London and Kimmelman point out how some phase IV studies have used questionable designs and have been used by drug companies for producing "brand loyalty" among physicians conducting the study. Some of the practices that result in bias, like selective reporting of data, may be difficult for journal editors or clinicians to detect on their own.

Current review systems at drug regulatory agencies like the Federal Drug Administration (FDA) or at universities have little authority to police post-marketing trials for bias. To correct the problem, London and Kimmelman, who frequently collaborate on ways to improve clinical research, point to several policy options, including expanding the review authority of the FDA, academic medical centers and medical journals.

"Rigorously designed and executed research has a critical role in improving patient care and restraining ballooning health care costs," said Kimmelman, associate professor of biomedical ethics at McGill. "There is currently a push to streamline the ethical review of research. In this process, oversight systems should be empowered to separate scientific wheat from marketing chaff."

The Canadian Institutes of Health Research funded this research.


Story Source:

The above story is based on materials provided by Carnegie Mellon University. Note: Materials may be edited for content and length.


Journal Reference:

  1. A. J. London, J. Kimmelman, B. Carlisle. Rethinking Research Ethics: The Case of Postmarketing Trials. Science, 2012; 336 (6081): 544 DOI: 10.1126/science.1216086

Cite This Page:

Carnegie Mellon University. "Biased evidence? Researchers challenge post-marketing drug trial practices." ScienceDaily. ScienceDaily, 3 May 2012. <www.sciencedaily.com/releases/2012/05/120503142540.htm>.
Carnegie Mellon University. (2012, May 3). Biased evidence? Researchers challenge post-marketing drug trial practices. ScienceDaily. Retrieved April 18, 2014 from www.sciencedaily.com/releases/2012/05/120503142540.htm
Carnegie Mellon University. "Biased evidence? Researchers challenge post-marketing drug trial practices." ScienceDaily. www.sciencedaily.com/releases/2012/05/120503142540.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