Downloaded from journal.pda.org on June 27, 2015
Mens Sana in Corpore Sano Govind Rao
PDA J Pharm Sci and Tech 2013, 67 568 Access the most recent version at doi:10.5731/pdajpst.2013.00956
Downloaded from journal.pda.org on June 27, 2015
EDITORIAL
Mens Sana in Corpore Sano The above Latin quote is widely attributed to the Roman poet Juvenal—interestingly, the original quote says “orandum est ut sit mens sana in corpore sano”. This translates into “You should pray for a healthy mind in a healthy body”—indeed something that few can argue with. It has generally been used as a proverb to promote physical fitness and good health and thereby a healthy mind. However, how much attention have we paid to the reverse—that is, can a healthy mind lead to a healthy body? Our business is all about restoring health through the life saving drugs that most of our members discover, manufacture, regulate, and use. Indeed, in one way or another, as PDA members we are all dependent on the fortunes of the pharmaceutical industry. Much effort is spent into generating the next blockbuster drug and pivotal clinical trials are the key to demonstrating the drug’s safety and efficacy, typically in a double-blind study that uses a representative population and the drug is compared to a placebo. The fortunes of a company can swing greatly depending on the market’s perception of its blockbuster pipeline. Interestingly, it turns out that large numbers of physicians have prescribed placebos and believe that patients have benefited from them (1, 2). Clearly, the effect of the mind is enormous, but it is something that we have not yet harnessed in the development of therapies. One bold avenue suggested by some might be to develop drugs for certain types of conditions based on a reasonable scientific hypothesis, but only (stringently) regulate the safety of the drug. The efficacy question would be left open and developed over time with a crowd-sourcing approach, where users
doi: 10.5731/pdajpst.2013.00956
568
report on its efficacy. With sufficiently large user numbers, it could lead to novel approaches to develop safe and effective drugs but at a much lower cost. A side benefit of such reporting would also allow data mining techniques to be used to look for potential side effects and/or other benefits of the therapeutic. Could such a bold approach shorten development times and allow for unconventional hypotheses to be tested? Clearly, great care would be needed to ensure that safety is not compromised, but the efficacy might be greatly boosted by harnessing the power of the mind that believes that the drug is helping. It would require a major shift in the drug laws of many nations and our regulatory paradigm, and a change in the mindset of the medical and patient community. To best try out such a concept, a case study in a non–life threatening condition should be identified and tested. Perhaps a drug could be developed based on a reasonable hypothesis and given at a very low dose where there are no side effects (i.e., very low risk)—would the mind then take over and boost the therapeutic punch? References 1. Sherman, R. Academic physicians use placebos in clinical practice and believe in the mind– body connection. J. Gen. Int. Med. 2008, 23 (1), 7–10. 2. Tilburt, J. C.; Emanuel, E. J.; Kaptchuk, T. J.; Curlin, F. A.; Miller, F. G. Prescribing “placebo treatments”: results of national survey of US internists and rheumatologists. BMJ 2008, 337, a1938. Govind Rao UMBC, 1000 Hilltop Circle, Baltimore, MD 21250
PDA Journal of Pharmaceutical Science and Technology
Downloaded from journal.pda.org on June 27, 2015
An Authorized User of the electronic PDA Journal of Pharmaceutical Science and Technology (the PDA Journal) is a PDA Member in good standing. Authorized Users are permitted to do the following: ·Search and view the content of the PDA Journal ·Download a single article for the individual use of an Authorized User ·Assemble and distribute links that point to the PDA Journal ·Print individual articles from the PDA Journal for the individual use of an Authorized User ·Make a reasonable number of photocopies of a printed article for the individual use of an Authorized User or for the use by or distribution to other Authorized Users Authorized Users are not permitted to do the following: ·Except as mentioned above, allow anyone other than an Authorized User to use or access the PDA Journal · Display or otherwise make any information from the PDA Journal available to anyone other than an Authorized User ·Post articles from the PDA Journal on Web sites, either available on the Internet or an Intranet, or in any form of online publications ·Transmit electronically, via e-mail or any other file transfer protocols, any portion of the PDA Journal ·Create a searchable archive of any portion of the PDA Journal ·Use robots or intelligent agents to access, search and/or systematically download any portion of the PDA Journal ·Sell, re-sell, rent, lease, license, sublicense, assign or otherwise transfer the use of the PDA Journal or its content ·Use or copy the PDA Journal for document delivery, fee-for-service use, or bulk reproduction or distribution of materials in any form, or any substantially similar commercial purpose ·Alter, modify, repackage or adapt any portion of the PDA Journal ·Make any edits or derivative works with respect to any portion of the PDA Journal including any text or graphics ·Delete or remove in any form or format, including on a printed article or photocopy, any copyright information or notice contained in the PDA Journal
Mens Sana in Corpore Sano Govind Rao
PDA J Pharm Sci and Tech 2013, 67 568 Access the most recent version at doi:10.5731/pdajpst.2013.00956
Downloaded from journal.pda.org on June 27, 2015
EDITORIAL
Mens Sana in Corpore Sano The above Latin quote is widely attributed to the Roman poet Juvenal—interestingly, the original quote says “orandum est ut sit mens sana in corpore sano”. This translates into “You should pray for a healthy mind in a healthy body”—indeed something that few can argue with. It has generally been used as a proverb to promote physical fitness and good health and thereby a healthy mind. However, how much attention have we paid to the reverse—that is, can a healthy mind lead to a healthy body? Our business is all about restoring health through the life saving drugs that most of our members discover, manufacture, regulate, and use. Indeed, in one way or another, as PDA members we are all dependent on the fortunes of the pharmaceutical industry. Much effort is spent into generating the next blockbuster drug and pivotal clinical trials are the key to demonstrating the drug’s safety and efficacy, typically in a double-blind study that uses a representative population and the drug is compared to a placebo. The fortunes of a company can swing greatly depending on the market’s perception of its blockbuster pipeline. Interestingly, it turns out that large numbers of physicians have prescribed placebos and believe that patients have benefited from them (1, 2). Clearly, the effect of the mind is enormous, but it is something that we have not yet harnessed in the development of therapies. One bold avenue suggested by some might be to develop drugs for certain types of conditions based on a reasonable scientific hypothesis, but only (stringently) regulate the safety of the drug. The efficacy question would be left open and developed over time with a crowd-sourcing approach, where users
doi: 10.5731/pdajpst.2013.00956
568
report on its efficacy. With sufficiently large user numbers, it could lead to novel approaches to develop safe and effective drugs but at a much lower cost. A side benefit of such reporting would also allow data mining techniques to be used to look for potential side effects and/or other benefits of the therapeutic. Could such a bold approach shorten development times and allow for unconventional hypotheses to be tested? Clearly, great care would be needed to ensure that safety is not compromised, but the efficacy might be greatly boosted by harnessing the power of the mind that believes that the drug is helping. It would require a major shift in the drug laws of many nations and our regulatory paradigm, and a change in the mindset of the medical and patient community. To best try out such a concept, a case study in a non–life threatening condition should be identified and tested. Perhaps a drug could be developed based on a reasonable hypothesis and given at a very low dose where there are no side effects (i.e., very low risk)—would the mind then take over and boost the therapeutic punch? References 1. Sherman, R. Academic physicians use placebos in clinical practice and believe in the mind– body connection. J. Gen. Int. Med. 2008, 23 (1), 7–10. 2. Tilburt, J. C.; Emanuel, E. J.; Kaptchuk, T. J.; Curlin, F. A.; Miller, F. G. Prescribing “placebo treatments”: results of national survey of US internists and rheumatologists. BMJ 2008, 337, a1938. Govind Rao UMBC, 1000 Hilltop Circle, Baltimore, MD 21250
PDA Journal of Pharmaceutical Science and Technology
Downloaded from journal.pda.org on June 27, 2015
An Authorized User of the electronic PDA Journal of Pharmaceutical Science and Technology (the PDA Journal) is a PDA Member in good standing. Authorized Users are permitted to do the following: ·Search and view the content of the PDA Journal ·Download a single article for the individual use of an Authorized User ·Assemble and distribute links that point to the PDA Journal ·Print individual articles from the PDA Journal for the individual use of an Authorized User ·Make a reasonable number of photocopies of a printed article for the individual use of an Authorized User or for the use by or distribution to other Authorized Users Authorized Users are not permitted to do the following: ·Except as mentioned above, allow anyone other than an Authorized User to use or access the PDA Journal · Display or otherwise make any information from the PDA Journal available to anyone other than an Authorized User ·Post articles from the PDA Journal on Web sites, either available on the Internet or an Intranet, or in any form of online publications ·Transmit electronically, via e-mail or any other file transfer protocols, any portion of the PDA Journal ·Create a searchable archive of any portion of the PDA Journal ·Use robots or intelligent agents to access, search and/or systematically download any portion of the PDA Journal ·Sell, re-sell, rent, lease, license, sublicense, assign or otherwise transfer the use of the PDA Journal or its content ·Use or copy the PDA Journal for document delivery, fee-for-service use, or bulk reproduction or distribution of materials in any form, or any substantially similar commercial purpose ·Alter, modify, repackage or adapt any portion of the PDA Journal ·Make any edits or derivative works with respect to any portion of the PDA Journal including any text or graphics ·Delete or remove in any form or format, including on a printed article or photocopy, any copyright information or notice contained in the PDA Journal
