Navigation Links
Rethinking Research Ethics: Carnegie Mellon and McGill Researchers Challenge Post-marketing Trial Practices
Date:5/3/2012

PITTSBURGH, May 3, 2012 /PRNewswire/ -- 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.

(Logo:  http://photos.prnewswire.com/prnh/20020422/CMULOGO)

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.

Related Articles:
Ethicists Outline Ways To Improve Risk/Benefit Estimates in New Drug Trials
Ethics Expert Calls For Refocus of Scientific And Ethical Review To Ensure Integrity of Research Process

About Carnegie Mellon University: Carnegie Mellon (www.cmu.edu) is a private, internationally ranked research university with programs in areas ranging from science, technology and business, to public policy, the humanities and the arts. More than 11,000 students in the university's seven schools and colleges benefit from a small student-to-faculty ratio and an education characterized by its focus on creating and implementing solutions for real problems, interdisciplinary collaboration and innovation. A global university, Carnegie Mellon's main campus in the United States is in Pittsburgh, Pa. It has campuses in California's Silicon Valley and Qatar, and programs in Asia, Australia, Europe and Mexico. The university is in the midst of "Inspire Innovation: The Campaign for Carnegie Mellon University," which aims to build its endowment, support faculty, students and innovative research, and enhance the physical campus with equipment and facility improvements.


'/>"/>
SOURCE Carnegie Mellon University
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. The Multiple Myeloma Research Consortium (MMRC) and Proteolix Initiate Phase 2 Clinical Trial Investigating Carfilzomib for the Treatment of Multiple Myeloma
2. Multiple Myeloma Research Consortium (MMRC) Partners with Novartis to Advance Phase II Study of Deacetylase Inhibitor
3. Lexicon to Present Research Results at American Chemical Society Meeting Regarding Target of LX1031 Drug Candidate
4. Researchers at Cleveland Clinic Identify Site of Dysfunction in HDL, Carrier of Good Cholesterol
5. Video: New Research Discovers Independent Brain Networks Control Human Walking
6. Quark Pharmaceuticals Extends Research Agreement with State University of New York for Proprietary siRNA Compounds for Acute Hearing Loss
7. Cleveland Clinic Researchers Identify Mechanism Behind Platelet Function and Potentially Fatal Blood Clot Formation
8. HistoRx and Radiation Therapy Oncology Group Initiate Brain Tumor Biomarker Research Partnership
9. Diabetes Research Institute Invention Promotes Growth of Stem Cells into Insulin-Producing Cells
10. Researchers Identify Virus Possibly Responsible for Declining Honeybee Population Using 454 Sequencing Technology from Roche
11. Peregrine Researchers Report Data Showing Bavituximabs Potential to Shrink Human Prostate Tumors in Model of Relapsed Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/19/2017)... , Jan. 19, 2017 ViewRay, Inc. ... a federal institution supporting research in Germany ... and patient treatments at the University Clinic Heidelberg as ... The MRIdian Linac program will be headed by ... also heads radiation oncology at the German Cancer Research ...
(Date:1/19/2017)... 19, 2017   Science Exchange , the leading ... that the first five replication studies from the ... published in eLife today. Despite intense scrutiny around ... practical evaluation of reproducibility rates that may identify ... other assessments of reproducibility, the results of this ...
(Date:1/19/2017)... , January 19, 2017 ... Option to Address Motor Symptoms and Motor Complications ... ...      (Logo: http://photos.prnewswire.com/prnh/20151014/276718LOGO) ... , European Neurological Review,2016;11(Suppl. 2): 2-15, http://www.touchneurology.com/articles/safinamide-new-therapeutic-option-address-motor-symptoms-and-motor-complications-mid-late ...
Breaking Medicine Technology:
(Date:1/20/2017)... ... 2017 , ... International Protein, a company based out of Australia that focuses ... January ECRM trade show in Hilton Head, SC. , International Protein was founded ... a line of products that would elevate her fitness regime. At this ECRM trade ...
(Date:1/20/2017)... ... January 20, 2017 , ... ... sugar-free alternative VW+ 002. The drinks have been produced in collaboration with Zlatan ... perform during your workout. , After a successful launch in Sweden last year, ...
(Date:1/20/2017)... ... 20, 2017 , ... “Code Word: Chocolate Biscuit”: a biographical account following a man who went ... creation of published author, Marlyn Ivey, born in Lynn Haven, Florida and at the age ... at 19 years of age, he joined the Navy and got married right out of ...
(Date:1/20/2017)... ... ... in Suffolk”: a story of love, secrets, and mystery. “Christmas in Suffolk” is ... works in a daycare and looks for inspiration in the local coffee shop as ... Seymour’s new book is an adventure of love and secrets. , After ...
(Date:1/20/2017)... ... ... “The Land of More and More”: a brilliant story for children and adults ... and achievable answer. “The Land of More and More” is the creation of published ... Indiana where he works with the children’s ministry department. , Michael says that ...
Breaking Medicine News(10 mins):