Science Policy For All

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Gene Patenting: Ethical and Legal Issues

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By:  Jessica Scherrer Lamb

The role of intellectual property in the health care sphere can be controversial.  In a society where health care costs are a significant issue, it is easy to question whether the contributions companies make in research, development, and manufacturing justify the price protection and licensing fees patents enable.  Many scientists worry that patents hinder research, either by patent holders’ direct interference or because competing companies will not invest in developing products that might infringe on existing patents.  Furthermore, products derived from human tissue introduce problems of donor consent and ownership.  While these issues are important in all areas of biomedical research, the idea of “gene patents” seems to raise eyebrows the highest.  Read the rest of this entry »

Written by sciencepolicyforall

July 13, 2012 at 11:49 am

Posted in Uncategorized

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The Potential and Pitfalls of Direct to Consumer Genetic Tests

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By:  Danielle Daee

At the genomic level approximately 0.1% of our genomic sequence differs from person to person.  Some of these subtle genetic variations have important physiological consequences, which are reflected in our risk for developing diseases and our overall health.  In recent years genome-wide association studies have sifted through individuals’ entire genomic sequences to try and identify genetic variants that are associated with increased disease risk.  While these studies are highly informative, they often lack the functional studies required to close the gap between correlation and causation.  After all, without knowing what the changes in a particular gene do, there is no way to understand whether that change is actually the cause of a particular disease.

Despite the caveats to interpreting correlative association studies, several biotech companies have developed direct to consumer (DTC) genomic tests to help consumers identify their personal risk for various diseases.  These tests present a variety of public health policy concerns.  Foremost is whether or not companies are overstating the usefulness and understating the caveats of genetic information to their consumers.  Furthermore, are consumers adequately equipped to interpret the results of genomic tests without a trained professional?

In May 2010, Pathway Genomics announced a plan to offer their genetic testing services at Walgreens pharmacies.  This plan marked the transition of DTC genetic testing sales from a less-accessible, internet commerce model to an over-the-counter sales model that would dramatically increase accessibility.  This increased reach sparked a firestorm of public concern and triggered an investigation by the General Accounting Office, a Congressional Committee hearing, and a Federal Drug Administration (FDA) panel discussion to determine how regulation of DTC tests should proceed. Read the rest of this entry »

Written by danidaee

June 5, 2012 at 11:53 am