A nanoparticle destroys cancer with heat. Is it a drug, or is it a device? As nanomedicine therapies leave the animal lab and head for human clinical trials, it is an important distinction for regulation.
A Royal Society appeal to the nanotechnology industry to disclose its safety testing procedures has fallen on essentially deaf ears at the industry’s European trade association, which unconvincingly responded that everything is just fine and dandy. |
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Poised for Takeoff
Source: Stephen Heuser: “In medicine, small is about to become big.” Boston Globe, May 8, 2006 Nanotechnology is “poised to make huge leaps in medical treatment,” says a Boston Globe article reporting on the annual Nano Science and Technology Institute conference. Although the meeting “covers all aspects of the field, from national security to ‘functional food design’ — healthcare [in Digest terminology, nanomedicine or nanomed for short] is the fastest-growing topic,” said an NSTI leader. Nanomed products already on the market include Nucryst Pharmaceuticals’ bandages for skin ulcers and burns infused with nano-particles of silver, whose natural antibiotic properties become more pronounced as the particles become smaller and can react more readily with the body. Products not yet on the market include Triton BioSystems’ nanoparticles that attach to any cancer cells they come across. In the presence of a strong magnetic field, the nanoparticles heat up and destroy the cancer cell. Despite being “poised to make huge leaps,” the Triton case illustrates not only that more nanomedicine sits on the lab bench than on the pharmacy shelf, but more interestingly that the US Food and Drug Administration is being forced to decide whether nanoparticles engineered like Triton’s, which do not carry any drug payload, should be regulated as a device, or as a drug. In light of uncertainties about the safety of nanotechnology and the absence of a coherent regulatory framework, Britain’s most prestigious scientific body, the Royal Society, has called upon the industry to disclose how it tests products containing nanoparticles. The European Nanotechnology Trade Alliance (ENTA) has responded that safety mechanisms are already in place. “There are strict regulations to check that products are safe and suitable for the public to use and our members follow these,” ENTA’s chief executive told the BBC, adding that its members “are committed to developing new nanotechnologies in a safe and responsible manner and are working closely with the Government to ensure this.” |