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Draft guidelines for
nanomedicine unveiled
With hundreds of nanoproducts currently being tested in
humans, recommendations aim to safeguard trial participants.
Nanoparticles are already being used to deliver drugs in the body.
Nanomedicines, advocates say, will one day be commonplace.
Nanoparticles are already being used in bone-replacement composites and
chemotherapy delivery systems, and more sophisticated systems could
eventually carry personalized therapies to the precise site in the body
where they are needed.
But their size — measured in billionths of a metre, on the same scale as
much of our cellular machinery — means that nanoparticles could also have
unexpected effects, such as triggering unwanted immune responses.
Despite this, clinical trials of nanomedicines in humans have so far not been
subject to specialized oversight.
That could be about to change. This week, two years into a project
funded by the US National Institutes of Health, a research team has
proposed what it calls the first comprehensive recommendations for the
oversight of nanomedicine.
The team discussed a draft of its guidelines with an invited panel of
experts, including senior government regulators and policymakers, in a
meeting at the University of Minnesota in Minneapolis on 26 September.
The panel's feedback led to some key conclusions, says the team's leader
Susan Wolf, a law and bioethics expert at the University of Minnesota, who
expects the final recommendations to guide future policy in the area.
Government guidelines
The team suggests creating two new bodies within the US Department of
Health and Human Services. The first would be an interagency working
group, including representatives from five government branches with a
stake in nanomedicine. The group would be tasked with providing a
checklist of key questions for agencies that have to evaluate the risks and
hazards of nanoscale technologies. "The guts of it is to get the people with
the right information talking to each other," says Wolf. "You really need a
science-informed process for answering these questions and making
sophisticated ethical judgements."
The second body would be an advisory committee that includes expert
members of the public, akin to bodies that already exist for research on
human subjects.
The team also decided that clinical-trial participants should, for now, be
told explicitly whether their treatments involve nanoscale products. But it
stopped short of recommending a protocol-by-protocol approval process,
something that the Recombinant DNA Advisory Committee implements for
human gene transfer research. "There's not the heightened hazard or risk
for [nanomedicine] that would warrant that," says Wolf.
Holistic impact
Some bioethicists question how much separate oversight is needed for
nanomedicine. Clinical trials that involve new molecular entities occur all
the time, says R. Alta Charo, a bioethicist at the University of Wisconsin
Law School in Madison and a former policy adviser to the US Food and Drug
Administration. "The topics that we're looking at — how do you protect
human subjects generally, how do you inform them before they volunteer,
how do you estimate the risks — are absolutely standard, traditional
issues," she adds.
But nanotherapies could also affect family members of people who receive
them, people who manufacture the treatments, and health workers who
deliver them. They might also have environmental implications if they make
it through sewage treatment facilities into waterways.
"The one thing that does strike me as being genuinely different in the
discussion here is the focus on occupational health and environmental
issues as an aspect of the risk assessment," Charo told the conference in
Minneapolis. "That is something we don't usually do in human-subjects
research."
Roughly 250 nanomedicine products are already being tested in humans, or
are about to be. Mihail Roco, senior adviser for nanotechnology at the
National Science Foundation in Washington DC, predicts that
nanotechnology products will be in significant mass production by 2020,
with about one-third of patents and start-up companies in the sector
having biomedical applications.
As nanomedicine advances from passive technologies, in which
nanoparticles act as vehicles for drugs, to active treatments that involve
more complex cellular interactions, specialized oversight may become ever
more necessary, says Roco. "This project is an example of anticipatory
governance for nanotechnology that we've tried to promote for some
time," he says.
Draft guidelines for nanomedicine unveiled : Nature News
nanomedicine unveiled
With hundreds of nanoproducts currently being tested in
humans, recommendations aim to safeguard trial participants.
Nanoparticles are already being used to deliver drugs in the body.
Nanomedicines, advocates say, will one day be commonplace.
Nanoparticles are already being used in bone-replacement composites and
chemotherapy delivery systems, and more sophisticated systems could
eventually carry personalized therapies to the precise site in the body
where they are needed.
But their size — measured in billionths of a metre, on the same scale as
much of our cellular machinery — means that nanoparticles could also have
unexpected effects, such as triggering unwanted immune responses.
Despite this, clinical trials of nanomedicines in humans have so far not been
subject to specialized oversight.
That could be about to change. This week, two years into a project
funded by the US National Institutes of Health, a research team has
proposed what it calls the first comprehensive recommendations for the
oversight of nanomedicine.
The team discussed a draft of its guidelines with an invited panel of
experts, including senior government regulators and policymakers, in a
meeting at the University of Minnesota in Minneapolis on 26 September.
The panel's feedback led to some key conclusions, says the team's leader
Susan Wolf, a law and bioethics expert at the University of Minnesota, who
expects the final recommendations to guide future policy in the area.
Government guidelines
The team suggests creating two new bodies within the US Department of
Health and Human Services. The first would be an interagency working
group, including representatives from five government branches with a
stake in nanomedicine. The group would be tasked with providing a
checklist of key questions for agencies that have to evaluate the risks and
hazards of nanoscale technologies. "The guts of it is to get the people with
the right information talking to each other," says Wolf. "You really need a
science-informed process for answering these questions and making
sophisticated ethical judgements."
The second body would be an advisory committee that includes expert
members of the public, akin to bodies that already exist for research on
human subjects.
The team also decided that clinical-trial participants should, for now, be
told explicitly whether their treatments involve nanoscale products. But it
stopped short of recommending a protocol-by-protocol approval process,
something that the Recombinant DNA Advisory Committee implements for
human gene transfer research. "There's not the heightened hazard or risk
for [nanomedicine] that would warrant that," says Wolf.
Holistic impact
Some bioethicists question how much separate oversight is needed for
nanomedicine. Clinical trials that involve new molecular entities occur all
the time, says R. Alta Charo, a bioethicist at the University of Wisconsin
Law School in Madison and a former policy adviser to the US Food and Drug
Administration. "The topics that we're looking at — how do you protect
human subjects generally, how do you inform them before they volunteer,
how do you estimate the risks — are absolutely standard, traditional
issues," she adds.
But nanotherapies could also affect family members of people who receive
them, people who manufacture the treatments, and health workers who
deliver them. They might also have environmental implications if they make
it through sewage treatment facilities into waterways.
"The one thing that does strike me as being genuinely different in the
discussion here is the focus on occupational health and environmental
issues as an aspect of the risk assessment," Charo told the conference in
Minneapolis. "That is something we don't usually do in human-subjects
research."
Roughly 250 nanomedicine products are already being tested in humans, or
are about to be. Mihail Roco, senior adviser for nanotechnology at the
National Science Foundation in Washington DC, predicts that
nanotechnology products will be in significant mass production by 2020,
with about one-third of patents and start-up companies in the sector
having biomedical applications.
As nanomedicine advances from passive technologies, in which
nanoparticles act as vehicles for drugs, to active treatments that involve
more complex cellular interactions, specialized oversight may become ever
more necessary, says Roco. "This project is an example of anticipatory
governance for nanotechnology that we've tried to promote for some
time," he says.
Draft guidelines for nanomedicine unveiled : Nature News