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When will targeted drugs reach the consumer market?
Surgical Neurology 64 (2005) 278 www.surgicalneurology-online.com
Editorial
When will targeted drugs reach the consumer market?
In an interview with Robert Goldberg, PhD, Head of the Manhattan Institute’s Center for Medical Progress, Peter Benesh of Investors Business Daily (June 4, 2005) learned that the time for targeted drugs to reach the market on a large scale is 2 to 10 years. Goldberg stated that the present randomized trial system for testing drugs does not make sense. I agree and have stated so for years (Surg Neurol 2001; 56:66). Surgical Neurology published a paper by Jobe et al on that subject 4 years ago (Surg Neurol 2001; 56:3-7). The random trial is based on an all-or-none response. It does not allow for gradations in disease or considerations of other associated problems. So you either have diabetes or not, for example. The EC-IC bypass study is also an example of this deficiency. Large numbers of people were tested, many of whom did not need the procedure. Those who did need it were drowned out in the study by the ones who did not need the operation. Fuzzy logic allows for multiple variables in considering the statistical outcome.
0090-3019/$ – see front matter D 2005 Published by Elsevier Inc. doi:10.1016/j.surneu.2005.06.014
However, we are entering a time in which the molecular basis of disease is being determined. Targeted drugs are and will be designed for these specific molecular sites. We are learning that some patients do not respond to these drugs through genetic testing, and so, it is unnecessary to give them the drug because it will not work. When these targeted drugs are available, and the information that certain people may not respond, there will be no need for large-scale random studies. We will know if people respond to the drug or not with very small studies. So, clinical progress will be faster in bringing drugs to market. Randomized studies will disappear. So, are these advances possible within the next 10 years? One scientist thinks so. What does that mean for neurosurgeons and the various diseases they treat? Maybe the treatment for brain tumors or MS or ALS will be here sooner than we think. What will that do to the practice of neurosurgery and other specialties? Are you ready? James I. Ausman, MD, PhD (Editor)
Editorial
When will targeted drugs reach the consumer market?
In an interview with Robert Goldberg, PhD, Head of the Manhattan Institute’s Center for Medical Progress, Peter Benesh of Investors Business Daily (June 4, 2005) learned that the time for targeted drugs to reach the market on a large scale is 2 to 10 years. Goldberg stated that the present randomized trial system for testing drugs does not make sense. I agree and have stated so for years (Surg Neurol 2001; 56:66). Surgical Neurology published a paper by Jobe et al on that subject 4 years ago (Surg Neurol 2001; 56:3-7). The random trial is based on an all-or-none response. It does not allow for gradations in disease or considerations of other associated problems. So you either have diabetes or not, for example. The EC-IC bypass study is also an example of this deficiency. Large numbers of people were tested, many of whom did not need the procedure. Those who did need it were drowned out in the study by the ones who did not need the operation. Fuzzy logic allows for multiple variables in considering the statistical outcome.
0090-3019/$ – see front matter D 2005 Published by Elsevier Inc. doi:10.1016/j.surneu.2005.06.014
However, we are entering a time in which the molecular basis of disease is being determined. Targeted drugs are and will be designed for these specific molecular sites. We are learning that some patients do not respond to these drugs through genetic testing, and so, it is unnecessary to give them the drug because it will not work. When these targeted drugs are available, and the information that certain people may not respond, there will be no need for large-scale random studies. We will know if people respond to the drug or not with very small studies. So, clinical progress will be faster in bringing drugs to market. Randomized studies will disappear. So, are these advances possible within the next 10 years? One scientist thinks so. What does that mean for neurosurgeons and the various diseases they treat? Maybe the treatment for brain tumors or MS or ALS will be here sooner than we think. What will that do to the practice of neurosurgery and other specialties? Are you ready? James I. Ausman, MD, PhD (Editor)