Legislation v. Litigation - Pharmaceutical Technology

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Legislation v. Litigation
Which route will we take to arrive at a national stem-cell policy?

Pharmaceutical Technology
Volume 35, Issue 7, pp. 12

Michelle Hoffman
In the course of every relationship, there arise moments for the "difficult conversation." Usually it's of the "where are we headed with this?" variety. But that's really just part of a larger question: Do we have a shared philosophy, and what is it?

Whether we think of it that way, nations ask themselves this question routinely. Should our nation be guided by a religious philosophy, or not? Should we elect our leader as a group, or should a person ascend to leadership through inheritance? If the times require us to alter our viewpoint, do we decide as a group, or does someone decide for us, and if so, who?

Sometimes the answer is explosive: Whoever we are, it's not working, and we need to change now.

That's the kind of answer that can lead to revolutions. In the US, we've mostly dealt with the question of our national ethic more quietly, starting with the first national conversation, which lay out a basic philosophy in the form of a constitution. Nevertheless, there have been many difficult conversations we've failed to have as a nation. To whom do we accord full citizenship, for example? Not even the Founding Fathers could agree on this one, thereby establishing the alternative to a national conversation: the local conversation. Instead of making a national decision about which people could own land, vote, or intermarry, those questions were left to local governments.

In these cases, challenging and sometimes overturning local philosophies (and sometimes overturning them again) has been, not through legislation, but through the courts, through litigation. That's how we've handled teaching evolution in schools, gay marriage, and abortion—locally and through litigation.

Some conversations, it seems, are just too difficult to have nationwide. I expected the conversation about stem-cell therapies to be one of those too-difficult conversations as well, one that would also be handled case by case and concession by concession—through litigation rather than legislation.

So it came as a surprise to learn that in mid-May, US Representatives Brian Bilbray (R-CA) and Diana DeGett (D-CO) introduced the Regenerative Medicine Act of 2011 (H.R. 1862). The Act notes that, "Regenerative medicine products have already successfully treated numerous health conditions, and have the potential to provide cures, treatments, and diagnostics for a range of diseases and disabilities including diabetes, spinal cord injury, heart disease, stroke, and various forms of cancer."

The proposed legislation goes on to say, "A United States national strategy on regenerative medicine is critical to ensure that this technology fulfills its potential to cure and treat diseases and disabilities, reduce overall health spending, and promote economic growth."

Not once does the Act mention stem cells, embryonic or otherwise, which are among the therapeutic agents used in regenerative medicine. It is the potential use of embryonic stem cells that makes a national conversation difficult, because, like the still-unresolved abortion debate, it pits technology against notions of personhood. Indeed, the stem-cell debate has already been the object of some well-publicized litigation. And it seemed likely that the entire debate would continue that way.

Whatever the fate of the Regenerative Medicine Act of 2011, I hope it sets a precedent for the way we discuss novel, but potentially ethically thorny issues of technology in the future. After living together as a nation for 235 years, shouldn't we at least know how to broach difficult conversations?

Michelle Hoffman is editorial director of Pharmaceutical Technology. Send your thoughts and story ideas to


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