Industry; Transgenic Monkeys; Offshore Trials: Research Ethics in the News

Industry

Industry Funding of Research: Assessing the Harms. Susan Gilbert, Bioethics Forum. 29 May 2009.
No one argues about the importance of industry funding to medical research. Most clinical trials could not take place without it. The questions are about the effects of this relationship–does it bias researchers and degrade scientific integrity and, if so, in what ways? … A new study goes deeper than previous studies in answering these questions.

Transgenic Monkeys

Monkeying Around With Genetic ‘Enhancement’. Henry I. Miller, Forbes. 29 May 2009.
New experiments reignite old ethics controversies. Scientists have created a line of monkeys carrying a gene that encodes a green fluorescent protein integrated into their DNA and passed on to their offspring. The research, published this week by a group of Japanese and American scientists in the British journal Nature, marks the first such accomplishment in primates and could lead to new models of human diseases. … But this technology could, at least in theory, also be used not to prevent or treat disease but for “enhancement”. If society is to realize the full spectrum of benefits from human gene therapy, it cannot be considered in a philosophical vacuum. It must be judged in the broader context of what people want and what society permits.

Related:

GM monkeys with glowing feet could help research into Parkinson’s. Mark Henderson, The Times. May 28, 2009

Sasaki E, Suemizu H, Shimada A, et al. Generation of transgenic non-human primates with germline transmission. Nature. 2009 May 28;459(7246):523-7. PMID: 19478777.

Offshore Trials

Reliability of offshore clinical-trial results in doubt. Tom Blackwell, National Post. 2 June 2009.
[S]tatistics show increasing numbers of trials are being outsourced to emerging economies like India, China and Eastern Europe to limit expense and avoid what some researchers call stifling red tape in Canada and other jurisdictions with highly sophisticated medical systems. The trend is sparking debate about the quality and applicability of some of the research, and the treatment of vulnerable subjects in poor nations. … Health Canada said recently it had unearthed problems in a number of developing-world trials submitted by companies trying to get drugs approved here. Key information on side effects and other potential shortcomings had been left out, either deliberately or because of misunderstanding.

Related:

Outsourcing clinical trials: further thoughts. Nancy Walton, The Research Ethics Blog. 5 June 2009.

<!–[if !mso]> <! st1\:*{behavior:url(#ieooui) } –>

Monkeying Around With Genetic ‘Enhancement’. Henry I. Miller, Forbes. 29 May 2009.

New experiments reignite old ethics controversies. Scientists have created a line of monkeys carrying a gene that encodes a green fluorescent protein integrated into their DNA and passed on to their offspring. The research, published this week by a group of Japanese and American scientists in the British journal Nature, marks the first such accomplishment in primates and could lead to new models of human diseases. … But this technology could, at least in theory, also be used not to prevent or treat disease but for “enhancement”. If society is to realize the full spectrum of benefits from human gene therapy, it cannot be considered in a philosophical vacuum. It must be judged in the broader context of what people want and what society permits.

Related:

GM monkeys with glowing feet could help research into Parkinson’s. Mark Henderson, The Times. May 28, 2009

http://www.timesonline.co.uk/tol/news/uk/science/article6375145.ece

Sasaki E, Suemizu H, Shimada A, et al. Generation of transgenic non-human primates with germline transmission. Nature. 2009 May 28;459(7246):523-7. PMID: 19478777.

http://pubmed.gov/19478777

http://www.forbes.com/2009/05/28/monkeys-genetic-enhancement-opinions-contributors-ethics.html

Reliability of offshore clinical-trial results in doubt. Tom Blackwell, National Post. 2 June 2009.

[S]tatistics show increasing numbers of trials are being outsourced to emerging economies like India, China and Eastern Europe to limit expense and avoid what some researchers call stifling red tape in Canada and other jurisdictions with highly sophisticated medical systems. The trend is sparking debate about the quality and applicability of some of the research, and the treatment of vulnerable subjects in poor nations. … Health Canada said recently it had unearthed problems in a number of developing-world trials submitted by companies trying to get drugs approved here. Key information on side effects and other potential shortcomings had been left out, either deliberately or because of misunderstanding.

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s