A strong correlation exists between sex and the incidence, prevalence, symptoms, age at onset and severity of disease, as well as the reaction to drugs. Now a team of US authors has set out to explain why sex-based medicine is the next step toward the delivery of true personalized medicine. In a full review published in the July issue of Women’s Health, the authors expand on their recent Opinion article that appeared in Nature (1). The article is freely available and is entitled
Sex and Sensitivity: the Continued Need for Sex-based Biomedical Research and Implementation (2).

Candace Tingen, Alison Kim, Pei-Hsuan Wu and Teresa Woodruff of Chicago’s Northwestern University argue that sex-based medicine is implicitly good for both sexes and that sex-based development of new technologies will improve healthcare and cut costs for all. They believe that sex-based medicine must become a primary consideration for all clinicians in their interactions with and treatment of patients as our understanding of sex differences continues to expand past the reproductive system. Practicing physicians may lack appropriate and up-to-date knowledge of the scientific literature, compromising their ability to accurately diagnose their patients in a sex-based manner. They cite a recent survey that revealed that only one in five physicians were aware that more women then men die from cardiovascular disease each year.

Aside from the biological, sex-based disparities, they also highlight behavioral, gender-based disparities between male and female patients and the way physicians interact with them. For example, among patients with chest pain, female patients tended to describe their emotional state more than their physical suffering when compared with male patients, who directly communicated their illness and their interest in treating it.

The authors contend that a sex-based approach is vital at four separate ‘checkpoints’ in the pipeline of biomedical discovery and dissemination:

1) Biomedical research – biological sex differences come from more than just sex chromosomes and hormones, they also extend to the gene expression patterns across the genome.

2) Medical education & clinical diagnosis – clinicians are not always properly educated regarding differences in the presentation of disease in women. They are also more likely to underestimate the risk of disease and attribute patient-reported symptoms to anxiety or emotion in women as compared with men.

3) Development of therapeutics and diagnostics – the presentation of disease differs based on sex. Pharmacokinetics are also sex-specific owing to differences in body weight, fat distribution and metabolism, but sex-specific drug dosages are often absent from drug labels.

4) Patient access to healthcare – women are the primary users of medical care in the United States. Despite lower incomes, women pay more for medical care, are less likely than men to be covered by their employer’s plan, are more likely than men to have only the unstable coverage of a spouse’s employer, and pay more for private insurance.

Teresa Woodruff, senior author of the article, commented: “Studying similarities and differences in disease diagnosis and treatment in men and women will lead to the best science and medicine for
both sexes.”

In order to address these sex and gender disparities, the authors propose that scientific journals should require sex differences to be analyzed and addressed or for the exclusion to be explained, that funding and regulatory agencies should implement these same requirements for patent or grant proposals, and that researchers and clinicians should make the effort to educate themselves regarding sex differences in biomedicine.

References
1. Alison M. Kim, Candace M. Tingen & Teresa K. Woodruff. Sex bias in trials and treatment must end, Nature 465, 688-689 (10 June 2010)
2. Candace M. Tingen, Alison M. Kim, Pei-Hsuan WU & Teresa K. Woodruff. Sex and sensitivity: the continued need for sex-based biomedical research and implementation, Women’s Health (2010) 6(4), 511-516

For complimentary access to all articles in the launch issue please contact Craig Canham,
+44 (0) 20 8371 6092; c.canham@future-science.com

June 2010

Personalized medicine set to impact justice system

Enabled by pharmacogenomics, molecular imaging and other molecular biomarkers, personalized medicine promises to optimize modern medicine and minimize the potential side effects of therapeutic agents. A leading pathologist has now indicated that it may also dramatically impact the justice system, and in ways that we are only just beginning to understand.

In an extended invited Editorial published in the June issue of Pharmacogenomics, Professor Steven Wong and his colleagues highlight the advent of “Personalized Justice” and how this complements personalized medicine and the overlapping practice of translational medicine, which holds that individual differences are caused primarily by genetic and environmental factors.

Steven Wong is Professor of Pathology, Psychiatry and Behavioral Medicine at the Medical College of Wisconsin, and Toxicology Scientific Director at the Milwaukee County Medical Examiner’s Office.

Prof. Wong and his team provide illustrative cases and scenarios, including issues associated with alcohol, antidepressants and antipsychotics, warfarin, and pain management. For example, if pharmacogenomics retrospectively reveals that a warfarin patient was at high risk and testing was not initially performed, litigation might follow – some lawyers already advertise on the internet for cases involving warfarin-related errors. There could be even more fundamental questions from a Personalized Justice perspective, should courts consider identifiable biological conditions that predispose a person to criminal behavior in weighing moral culpability?

Although personalized medicine is rapidly taking root among the medical sciences, the authors predict a slower, more begrudging adoption by the legal profession. Nevertheless, the law’s incredibly rich experience with DNA developments may facilitate acceptance.

They caution that, in establishing Personalized Justice, a firm foundation should be based on sound legal principles as well as reliable and valid evidence-based studies, not on ‘junk’ science and unsubstantiated case reports. With sound scientific and legal principles and correct interpretation, they argue that a firm and lasting foundation could support the emerging concept of Personalized Justice becoming a reality to enhance patient safety and maintain social justice.

“Personalized Justice and Personalized Medicine may also co-exist as an emerging social balance, providing beneficial impetus for advancing molecular medicine.”
Professor Steven Wong, Medical College of Wisconsin

The article entitled From Personalized Medicine to Personalized Justice: the Promises of Translational Pharmacogenomics in the Justice System appears in Pharmacogenomics (2010) 11(6), 731-737. The article is available at www.futuremedicine.com/toc/pgs/11/6.

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Craig Canham, Corporate Public Relations, Future Science Group
T: +44 (0) 20 8371 6092 F: +44 (0) 20 8343 2313 E: c.canham@futuremedicine.com