martes, octubre 16, 2007



by Gregor Wolbring

October 15, 2007

Nano -- especially in its nanoscale meanings (see my column “From Nanotech to Nanoscale Technology and Sciences”) -- plays an increasingly important role in medicine (see my nanomedicine and nano cancer treatment columns). Pharmaceuticals also play a big role. I will explore nanopharmaceuticals in this column, nano-drug delivery systems in November, and nano-related patent issues in December.

The term “pharmaceutical nanotechnology” first appeared in the National Library of Medicine database PubMed in 1999. The Albany College of Pharmacy has set up a Center for NanoPharmaceuticals. Others will follow, I am sure.

In 2004, the editorial “Pharmaceutical nanotechnology: A new section in IJP," the International Journal of Pharmaceutics highlighted a number of areas in pharmaceutical sciences that use nanotechnology:

  • drug discovery, including combinatorial chemistry and synthesis on the molecular and macromolecular scale;
  • nanoanalysis, including bioanalysis using miniaturized probes, microarrays, and lab-on-a-chip approaches;
  • body fluid approaches;
  • drug delivery systems having sizes in the nanometer range (e.g. liposomes, nanoparticles, microemulsions, dendrimers);
  • implantable devices that can sense blood levels and automatically administer drugs;
  • nanoscale biomaterials including biomimetics;
  • biological macromolecules (e.g. proteins, enzymes, DNA- and RNA-based nanostructures, molecular assemblies, biomolecules, cells, biochips);
  • molecular sensors and biosensors, clinical diagnostic techniques; and gene delivery and expression.

Polymeric nanopharmaceuticals were the topic of a recent Ninth Annual Chinese-American Kavli Frontiers of Science Symposium.

According to the market research portal Infoshop, the market for nanopharmaceuticals will grow from $406 million in 2004 to $3 billion in 2009 and $16.6 billion in 2014. The USA National Science Foundation estimates that half of all drugs will be made with nanotechnology by 2010.

A recent article in Nanotechnology Law and Business highlighted the first three nanodrugs Emend® ,Tricor®, Rapamune®, approved by the FDA. The 2006 report of the Lux consulting firm -- quoted by -- states: “As of mid-2006, 130 nanotech-based drugs and delivery systems and 125 devices or diagnostic tests are in preclinical, clinical or commercial development.” reported in 2005, ”While only two kinds of nanoparticle therapies against cancer are now clinically available in the United States, roughly 150 more lie in various stages of development... The combined market for nanoenabled medicine (drug delivery, therapeutics and diagnostics) will jump from just over $1 billion in 2005 to almost $10 billion in 2010.”

It is less clear what counts as nanodrugs. Some include liposome-based drugs as nanodrugs. (For nanoparticle-related nanodrugs see the pdf here.) Many drugs with a variety of delivery systems are called nanodrugs today. I think this terminology may leave some with the false impression that nanodrugs are nothing new and they are not worth special coverage. Nanodrugs are new, and indeed nanoformulated drugs are seen as having various advantages over existing drugs, such as increased solubility and bioavailability, ability to cross biological barriers such as the blood-brain barrier, better half-life and imaging, and better ways of targeting the drug. These advantages also create the possibility of toxic side-effects, overdosing and other issues that need to be considered. However, safety is only one concern with respect to nanoformulated drugs.

The Choice is Yours

It is clear that a growing number of nanoformulated drugs will appear. However, there is more to the issue than an increase in nanoformulated drugs. Drugs of any kind are big business -- and that’s nothing specific to nanoformulated drugs. In previous columns, I covered the dynamic of medicalization in high-income countries, the consequences of focusing on medical fixes for neglected diseases, and the impact of medicalization in low income countries.

In one of my publications (pdf) I covered a number of issues I think need to be considered in addition to safety issues:

  • Growing use of existing drugs is seen by the health system as the number one cost driver for drug expenditures.
  • In Canada, increased drug spending is a consequence of the volume of drug use and the entry of new drugs that are typically introduced to the market at higher prices.
  • Prescription drug spending can be attributed to increased use of existing drugs (50%), sales of new drugs in their first full year (32%), and price increases of existing drugs (18%).
  • Drugs are both over-utilized and inappropriately used.

A recent Forbes article used data collected by the Agency for Health Care Research and Quality -- a US government organization charged with assessing where Americans' health care dollars are spent -- to conclude: "Of the ten fastest-growing diseases ranked by percentage increase in cost, only one was caused by an increase in the cost of care per patient whereas in the other nine the cost increased because more and more people were diagnosed."

So what to do? The choice is yours.

Gregor Wolbring is a biochemist, bioethicist, disability/vari-ability/ability studies scholar, and health policy and science and technology governance researcher at the University of Calgary. He is a member of the Center for Nanotechnology and Society at Arizona State University; Part Time Professor at Faculty of Law, University of Ottawa, Canada; Member CAC/ISO - Canadian Advisory Committees for the International Organization for Standardization section TC229 Nanotechnologies; Member of the editorial team for the Nanotechnology for Development portal of the Development Gateway Foundation; Chair of the Bioethics Taskforce of Disabled People's International; and former Member of the Executive of the Canadian Commission for UNESCO (2003-2007 maximum terms served). He publishes the Bioethics, Culture and Disability website, moderates a weblog for the International Network for Social Research on Disability, and authors a weblog on NBICS and its social implications.

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