Policy & Strategy

Building consensus and developing adequate policies requires attention to two problems

I. Partisan and Professional Politics in Bioethics

Nearly 8 years as member of President's Council on Bioethics gave me an education in bioethics & politics

In retrospect, before I joined the Council I was an innocent – quite naïve about what happens when bioethics is conducted in the national spotlight, particularly when the deliberations address controversial issues that have become part of partisan political debates

A. I learned some quite valuable things

I learned that people of good will with different values and positions can join together in civil debate over many of the bioethical issues that divide people in this country.

I learned that thoughtful scholars with diverse disciplinary backgrounds and moral commitments who haven't focused their work on bioethics bring new insights to the bioethics tabl

B. I also learned some more painful lessons

Lobbyists and advocates with a stake in government's resolution of a controversial ethical problem want you on their side.

If you acknowledge merits of a range of ethical views, you will be attacked by individuals and interest groups with a single agenda.

People also won't like it if you deviate from what Jon Moreno calls "the Great Bioethics Compromise."

This is a "consensus philosophy and social role" for people working in the field: "Keep a close eye on scientific innovation for its societal implications, apply the brakes now and then as needed through regulations or guidelines or just the glare of public discussion, and let the bioethicists be the ones to analyze how all this is going." [1]

Bioethicists comfortable with the Great Bioethics Compromise were vocal critics of a politically diverse Council that dared to depart from this accepted approach to bioethics.

As a liberal Democrat from "mainstream" bioethics, I was disheartened at the narrow-mindedness characterizing some – not all -- of the criticism.

Although there were important exceptions, critics often preferred to rely on media reports and unfounded assertions about the Council rather than the transcripts and reports that constitute its actual work.

Some showed little tolerance for including people outside the field in bioethics deliberations.

Some indulged in petty personal attacks rather than critiques of the Council's substantive work.

C. What's needed to address bioethics politics

• Practice humility - Don't get carried away with your own importance.
• Recognize that you can learn from those having different ethical positions and politics – we live in nation that is pluralistic & people have diverse views on biotechnologies – we have to talk with each other.
• Exercise Due Diligence – This always applies, but it's especially important when addressing politically controversial topics.
• Don't engage in soundbite ethics or simply ridicule or dismiss opposing views.
• Don't cut corners on research or fact-finding if you want to speak out.
• Basic teaching of our legal system is that there is usually more than one side to a story.
• Avoid Guild Mentality – only certain people are "allowed" to participate in public bioethics.
• "Outsiders" with different backgrounds and political views have fresh insights.
• Seek them out in your work, invite them to conferences and welcome their participation.

These are ways to avoid the pitfalls of bioethics politics.

II. Regulatory Gaps

Many of most concerning biotechnologies involve reproduction and enhancement.

Existing oversight system poorly designed to address these areas.

A. Federal government exercises oversight over medical practice primarily through putting conditions on federal funding, eg, research support by NIH, medical care paid for by Medicare/Medicaid.

Innovations in reproduction generally fall outside these areas so there is no regulatory "hook."

FDA regulates products, drugs and devices, not procedures, which reproductive innovations like implantation of multiple embryos tend to be.

States regulate most medical care & few have expertise or political will to regulate reproductive innovations.

Self-regulation is ineffective – ASRM & other professional groups don't even require members to sign pledge to adhere to recommendations.

B. Off-label prescribing allows relatively uncontrolled use of FDA-approved drugs and devices for enhancement purposes.

Once drug approved for any use, eg, Provigil for narcolepsy, doctors are free to prescribe for any use they see fit.

Can do so in absence of good research demonstrating safety & effectiveness, which creates risks to users.

Neither FDA nor any other group engages in systematic look at nature & value of benefit enhancement provides.

Should pure consumer preference define benefit?

Should societal interests be considered, eg, effects on education, creation of pressure to use enhancements, economic costs?

Need to develop some mechanism to consider and regulate reproductive innovations and enhancement uses of new medical products.