Are our risk tools sufficiently evolved?
In this new series of articles, Richard Moore looks at some of the key challenges that are facing the emerging new area of medical nanotechnology and examines some of the hurdles that will have to be overcome in order to bring new medical technology products. Incorporating nanotechnology features in some form or other, to the market and into healthcare systems for the benefit of patients.
In this first article, what nanomedicine is and what new challenges it brings in the way of risk governance and management are explored.
What is nanomedicine?
Nanomedicine is defined by the European ‘Technology Platform on Nanomedicine as: ‘The application of nanotechnology in medicine. It exploits the improved and often novel physical, chemical, and biological properties of materials at the nanometric scale. Nanomedicine has potential impact on the prevention, early and reliable diagnosis and treatment of diseases.”
Another useful current definition is as follows: “Nanomedicine is defined as those practices of medicine, including prevention, diagnosis and therapy that are based on interactions between the human body and materials and structures whose properties are defined at or around the nanometre scale.”
According to Robert A Feitas Jr at the Institute for Molecular Manufacturing, Palo Alto, California and a leading researcher in the field of medical applications of nanotechnology, nanomedicine may be defined as: “The monitoring, repair, construction and control of human biological systems at the molecular level, using engineered nanodevices and nanostructures.”
Although subtly different, all of these definitions are useful in helping us understand the potential impact that nanomedicine may have. Common themes between them include:
reference to the properties of materials, or the ability to engineer materials, at the nanoscale level; diagnosis or monitoring of disease or of physiological condition; treatment of disease or repair of tissues or biological systems;
It seems clear that novel medical devices with characteristics at the nano -level will often act with a different range of mechanisms to “classical” devices and will certainly interface with biological systems in a new way.
And new modes of interaction bring new challenges...
New mechanisms…new challenges for risk management
In many cases the application of nanotechnology to a medical device may be an incremental innovation, for example, the use of nano-contoured surfaces on orthopaedic implants to improve cell growth and fixation in the bone and although a risk management procedure needs to be carried out as usual, it is unlikely that such an innovation would mean any change to the principal mode of action, classification or regulatory status of such a device.
In other cases, nanotechnology may have the effect of further blurring traditional demarcation boundaries between, for example, the medical device and pharmaceutical regulatory regimes. Often with innovative devices, such as coated stents, regulatory clarification has been required and the application of nanotechnology may further serve to obscure the key defining factor, that is, what is the principal intended mode of action and what is the ancillary effect? This erosion of the boundary between different regulatory regimes is certainly a challenge, and one that needs to be addressed, but that process should not serve to delay innovative therapies reaching the patient.
The author believes, as do many others, for example, Maynard et al and Renn and Roco, that an effective and systematic risk-based approach is needed if emerging nano-industries are to survive and flourish, whatever the applicable regulatory regime.
The risks posed by the various facets of nanomedicine are so diverse and so specific that a single prescriptive approach is likely to be of little use and, indeed, may be counter-productive. In some cases, such as the nanocontoured implant mentioned above, the risk profile may be relatively easy to characterise. In others, for example those that may involve the release of novel nanoparticles in the body, there may be relatively less information available on the hazards and associated risks posed. Size of nanoparticle, surface area, surface chemistry, solubility and possibly shape may all play a role in determining the risk in such instances. And, as with all, medical therapies, any risks must always be balanced against the benefits to the patient. Again, here, what may be acceptable in one situation, for example, critical surgery to save a life, may not be acceptable in another, elective treatment for a non life- threatening condition.
In their Nature paper Maynard et al also state that ‘Understanding and preventing risk often has a low priority in the competitive world of research funding.” And that, ‘The science community needs to act now if strategic research is to support sustainable nanotechnologies, in which risks are minimized and benefits maximized.”
This is a crucial aspect which was further reinforced in a BBC News report on 28 March 2007 where it was claimed that the UK government was “failing” nanoscience. As a part of that news item Professor Ann Dowling, chair of the working group that produced a government-sponsored report by the Royal Society and Royal Academy of Engineering in 2004 that outlined possible opportunities and risks from developing nanotechnology, agreed that, More targeted research to reduce the uncertainties around the health and environmental effects of nanomaterials must be funded - especially in light of the growing number of products on the market containing these manufactured ultra-small materials. This is a vital step to ensuring that nanotechnologies are well regulated and inspire the confidence of the public and investors.”
Professor Sir John Beringer, who chaired a Council for Science and Technology (CST) review of government commitments made in 2005, in the same news item said, “The government made a very clear commitment that research needed to be done to understand more about the toxicology and possible risks that may arise from some of the nanotechnologies. But there has been virtually nothing done by government to resolve this problem.”
The pace of research in the domain of nanomedicine continues to accelerate and the technology holds great future promise for numerous exciting and improved products and therapies for patients. But the means and tools for adequately assessing the risk and benefit of such technologies must also evolve if that promise is to be realised.
Richard Moore is Manager of Nanomedicine and Life Sciences at the Institute of Nanotechnology
Source: NANO Magazine - Issue 3 /...
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