Gene therapy research in developing world raises ethical red flags: experts

July 9, 2008,

Early stage gene therapy clinical trials are recruiting patients from the developing world, providing medically deprived populations access to interventions that show promise but have largely unknown effects in humans. According to commentary by bioethicists at Carnegie Mellon and McGill universities published in this week's issue of The Lancet, the practice may be inconsistent with international ethics guidelines on justice.

"There are many reasons why researchers might look to the developing world for research subjects," said Alex John London, lead author of "Justice in Translation: From Bench to Bedside in the Developing World" and director of Carnegie Mellon's Center for the Advancement of Applied Ethics and Political Philosophy. "But serious ethical issues can arise when research relies on the deprivations experienced by people living in developing countries to advance research that is not responsive to the urgent health needs of their communities."

London and his co-author, Jonathan Kimmelman, an assistant professor in McGill's Biomedical Ethics Unit, urge organizations that sponsor research in low- and middle-income countries (LMICs) to ensure that they are addressing the most pressing health needs of those nations. The article also notes that any interventions developed as a result of such research should be affordable and easily implemented in those countries' health care systems.

While other authors have explored ethical issues in later stage clinical trials, in which the interventions have already been deemed safe and effective, for the most part, London and Kimmelman are the first to discuss the more complicated considerations surrounding the riskier early-stage research.

"Our report centers on complex agents like gene therapies that are being tested for the very first time in human beings," Kimmelman said.

Researchers have various reasons for turning to developing nations for clinical trial subjects. In some cases, patients are recruited because diseases like malaria were much more common in LMICs. In other cases, diseases are so rare as to necessitate worldwide recruitment. However, some trials also appear to have recruited patients who did not have access to treatments routinely available in developed countries. Such patients provide a pool of "treatment naive" subjects that would not otherwise be available to researchers. Treatment-naïve subjects are particularly valuable, as they offer the opportunity for researchers to observe an intervention's behavior on a blank canvas, of sorts.

Echoing requirements that have been articulated in a range of international ethics documents, such as that of the World Health Organization, London and Kimmelman urge organizations that sponsor research in LMICs to ensure that they are addressing urgent health needs of those nations. Ensuring that research meets this requirement represents an important step toward unlocking the substantial promise of innovative research like gene therapy for populations that often experience staggering health needs.

"Our goal is not to curtail research in low and middle-income countries," said London, who is also an associate professor of philosophy at Carnegie Mellon. "It is to make sure that project sponsors give careful consideration to relationship between a particular research study and the needs of the communities from which study participants are drawn."

Source: McGill University

Explore further: Bringing cheap and accurate tuberculosis tests to Africa

Related Stories

Bringing cheap and accurate tuberculosis tests to Africa

January 17, 2018
Since the 1970s, millions of women have appreciated the ease of a urine-based home pregnancy test to find out if their family is about to grow.

Physical activity impacts child growth, new study finds

January 17, 2018
Scientific Reports has just published an important new study by Hunter post-doctoral research fellow Samuel Urlacher. Funded by the National Science Foundation, Dr. Urlacher is a biological anthropologist whose research seeks ...

Russians cut back on drinking, smoking as fitness trend grows

January 16, 2018
Russians are drinking less than at any point since the fall of the Soviet Union, figures show, as a raft of government measures bear fruit and healthy living becomes ever more fashionable.

Sanofi to reimburse Philippines for unused dengue vaccine (Update)

January 15, 2018
French pharmaceutical giant Sanofi will reimburse the Philippine government for leftover doses of an anti-dengue vaccine whose use was suspended due to health concerns, the two parties said Monday.

Default setting in EM records 'nudged' emergency department physicians to limit opioid prescriptions to 10 tablets

January 17, 2018
For patients who have never been prescribed opioids, larger numbers of tablets given with the initial prescription is associated with long-term use and more tablets leftover that could be diverted for misuse or abuse. Patients ...

Raising awareness of the risks of natural sciences research

January 17, 2018
New research findings from biology and chemistry are a blessing for the world of medicine. However, if they are misused for military purposes, they can reveal a darker side. How to deal with the "dual-use dilemma"? This was ...

Recommended for you

Best of Last Year—The top Medical Xpress articles of 2017

December 20, 2017
It was a good year for medical research as a team at the German center for Neurodegenerative Diseases, Magdeburg, found that dancing can reverse the signs of aging in the brain. Any exercise helps, the team found, but dancing ...

Pickled in 'cognac', Chopin's heart gives up its secrets

November 26, 2017
The heart of Frederic Chopin, among the world's most cherished musical virtuosos, may finally have given up the cause of his untimely death.

Sugar industry withheld evidence of sucrose's health effects nearly 50 years ago

November 21, 2017
A U.S. sugar industry trade group appears to have pulled the plug on a study that was producing animal evidence linking sucrose to disease nearly 50 years ago, researchers argue in a paper publishing on November 21 in the ...

Female researchers pay more attention to sex and gender in medicine

November 7, 2017
When women participate in a medical research paper, that research is more likely to take into account the differences between the way men and women react to diseases and treatments, according to a new study by Stanford researchers.

Drug therapy from lethal bacteria could reduce kidney transplant rejection

August 3, 2017
An experimental treatment derived from a potentially deadly microorganism may provide lifesaving help for kidney transplant patients, according to an international study led by investigators at Cedars-Sinai.

Exploring the potential of human echolocation

June 25, 2017
People who are visually impaired will often use a cane to feel out their surroundings. With training and practice, people can learn to use the pitch, loudness and timbre of echoes from the cane or other sounds to navigate ...

1 comment

Adjust slider to filter visible comments by rank

Display comments: newest first

menkaur
not rated yet Jul 10, 2008
come on... give me a break... if a person wants to use an innovative medicine that is not well tested yet - it's that person's choice ....

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.