Meyer 1 “The Pharmacy of the Future” (1 March 2005) There are a few basics in the world of pharmacology that even the average adult in today’s world would be able to recognize and explain. I don’t mean Prozac, Lipitor, Viagra, or even penicillin. Science has demonstrated that as antibiotics are over-prescribed, original strains of diseases are able to mutate. Some ear infections no longer respond to penicillin-type drugs. Instead, often times cephalosporin-class drugs are used. When these drugs like Kelfex or Omnicef don’t work, some physicians are even resorting to Ciprodex, a product similar in chemical design and structure to it’s parent drug Cipro, or ciprofloxacin, listed in 2001 as one of the drugs to combat anthrax infection, if ever a dose were to be lethally administered by terrorists. Beyond Cipro, our line of defense gets more experimental. Luckily, drug research ensures the progression of pharmacological science with disease mutations. But how much are we willing to invest? In 2003, America spent about $33 billion on drug research1. At what cost must we labor to keep protecting ourselves? Biologically speaking, just as organisms and species tend to follow the “survival of the fittest” rule, so too do many common human diseases. This poses an enormous threat to human kind in general, should some new strain of a disease emerge and strike in epidemic proportions. Another big newsmaker these days is Merck’s blockbuster arthritis drug, Vioxx, which was recalled last fall because people were unexpectedly dying due to heart complications from the Cox-2 inhibitor. This has led to a flurry of activity within the FDA and the subsequent creation of a new government outlet- the Drug Safety Oversight Board, a division of the Dept. of Health and Human Services. On Monday, February 28, 2005, an article appeared in US Today “Drug Stocks that Put Money to the Work.” Yahoo Finance. 7 January 2005. http://biz.yahoo.com/ms/050107/124756_1.html 1 Meyer 2 about the decision of the FDA, under the new leadership of acting commissioner Lester Crawford, to begin evaluating drugs such as Vioxx through a new program called “Critical Path.” This initiative will focus drug development on genetic information about diseases and drug responses. Individuals or populations within the same disease group would be studied and then treatments would target a smaller group of patients.2 So where is the pharmacy of the future headed? It seems, as has been repeatedly discussed in this class and hinted at in the USA Today article, that it will only be sensible to begin tailoring drug therapy to individual patients, based on genetics, a new field known as pharmacogenomics. This is where biocomplexity, DNA sequencing, and protein structure also assume a large role. Nanotechnology will undoubtedly play a part in shaping this new field. Say nanotechnology and we automatically think small. But how small? …Approximately 2-5 atoms across. When nanotechnology is functional, a time frame that is much closer than most of us could probably fathom, so called nano-bots will do most of the work. Nano-bots, simply defined, are robots on the nano-scale. “Nanotechnology will allow us to economically create an extensive range of complex molecular machines (as well as, molecular computers). It will let us build an amount of computer controlled molecular tools much that are smaller than a human cell but built with the accuracy and precision of drug molecules. For the first time, these tools will permit medicine to intervene in an advanced and controlled way at the cellular and molecular level. They could remove obstructions in the circulatory system, kill cancer cells, or take over the 2 “The FDA and Drugmakers Should Think Small.” USA Today. 28 February 2005. 15A. Meyer 3 function of sub cellular organelles. Just as today we have the artificial heart, so in the future we could have the artificial mitochondrion.”3 And where exactly are we headed, nanometrically-speaking, in terms of drug delivery systems? While nano-bots themselves may be several years down the road, a company known as “Nanoceutical Labs” has developed Health Plus - Nanoceutical Spray For Life - B-12 Energy Booster ™ oral delivery system utilizing Nanotechnology. The system is comprised of nanoparticle size droplets derived from HPI's proprietary dispersion process. This may sound a little sketchy, but according to their website, a Nanoparticle acetaminophen, or Tylenol, as well as a natural remedy for Type 2 diabetes, could be on its way.4 You can even buy Nanomist, marketed as “Spray for Life” for $12.95 online. In 2002, PharmaGenomics published an article that challenged drug design and the economics of it. They presented the idea of “rational drug design” which began with the availability of crystallographic structures of target proteins. As the shapes of these proteins were unveiled, the idea was that chemists might be able to produce more efficient drugs. Problems began to emerge with the great amounts of requisite data which was expensive to collect in vitro, often times risky to collect in vivo, but slightly ameliorated with in silico experimentation. Still, researchers have made leaps and bounds in terms of discovering things, but it’s the development that becomes trickier. Another critical factor is that most experiments are completed at a certain point in time, with a certain set of conditions. Biological species age and it would be impossible to collect data at an infinite number of points, so Time-Series methods for modeling data will hopefully lead to a better understanding of biological processes. This moves us forward into network biology in which cellular communication is quantified. Next issue? …How to validate 3 Theory: Nanotechnology. The Thinkquest Group. 28 February 2005. http://library.thinkquest.org/TQ0313009/Theory.htm 4 Nanoceutical Laboratories, Inc. 28 February 2005. http://www.nanolabs-inc.com/products.html Meyer 4 these networks. As professor Barabasi explained, mathematical methods are needed to investigate the robustness of network structures. What a mess pharm. Researchers have on their hands. We pump billions of dollars into rational drug design, and then something like the Vioxx recall happens, sending the industry into a perpetual tailspin. As investigations of these complex systems probes deeper into the mysteries of biochemistry and genetics, the amount of information generated seems to grow at least proportionally. The 2002 PharmaGenomics article suggests that the industry itself might be taking a new shape. With pharmacogenomics comes many enigmas that only science holds the answers to. In the meanwhile, we have our conventional means of the traditional pharmacy, with a chain drug store on every corner in town. Until nano-bots are fully efficient or the field pharmacogenomics has sorted itself out, or the FDA has reached a consensus on Vioxx (which will set the standard for future improvements), we will continue to pump money into the system. And we’ll still have the same old antibiotics. Meyer 5 Meyer 6 Meyer 7 Meyer 8 Meyer 9