Tag Archives: genetic research

A Minimal Genome, A Giant Step? Research Ethics in the News

In late May the J. Craig Venter Institute (JCVI) announced the creation of the “First Self-Replicating, Synthetic Bacterial Cell.” (The research team’s report was published simultaneously: Gibson DG, …, Venter JC. Creation of a Bacterial Cell Controlled by a Chemically Synthesized Genome. Science. 2010 May 20. PubMed PMID: 20488990.) With $40 million and over a decade of work, the team produced the synthetic cell by piecing together a replica of a bacterial genome (Mycoplasma mycoides) and transplanting this DNA “software” into a cell from a related bacteria (Mycoplasma capricolum). When the cell began to replicate the information from its “synthetic genome,” the JCVI declared success.

What will be the scientific and social impact of this research? Both researchers and ethicists appear to be of two minds: the synthetic cell is big news, but maybe not worth the “hype” everyone is more than willing to supply. For example, while announcing JCVI’s discovery with great fanfare (suggesting solutions for the flu vaccine, greenhouse gas, and even the BP oil spill), Venter insists in The Wall Street Journal that this is not the creation of life ex nihilo. In fact, he refers us to Arthur Kornberg’s work in 1967 to make a copy of a virus. Perhaps the history lesson is meant to reassure the public; although considered by President Johnson to be “a very spectacular breakthrough,” Kornberg’s work was completed over forty years ago and, while the effort did have a scientific impact, we’re not overrun with zombies … yet.

Ethicists responded similarly: part “hype”, part reassurance. Arthur Caplan (in January 2009) reminded us that ethicists have been thinking and writing about the risks and benefits of synthetic biology for a long time. In fact, Caplan was one of the authors on paper published in 1999: Cho MK, Magnus D, Caplan AL, McGee D. Policy forum: genetics. Ethical considerations in synthesizing a minimal genome. Science. 1999 Dec 10;286(5447):2087, 2089-90. PubMed PMID: 10617419. Caplan echoes these reassuring sentiments in his recent Breaking Bioethics commentary: “The regulatory, social and legal challenges can be solved.” He, nevertheless, insists that grander issues might now be at stake:  “The real fallout from the Venter group’s achievement is subtle but more powerful. The scientists are chipping away at the view that there is something unique and unknowable about life itself. From this day forward, we know that the right chemical messages, presented in the right order and put in the right chemical context, can produce life.”

Julian Savulescu, quoted at BBC News, also looked at both sides of the coin. According to Savulescu the risks and benefits of synthetic biology are “in the far future,” but also “unparalleled”: “If this research goes in one direction Dr Venter may get the Nobel prize, but if it goes in another direction there will be no Nobel prizes to give because there will be no people to give them.”

On the very day of Venter’s press release, President Obama sent a letter to Amy Gutmann, the director of the recently formed Presidential Commission for the Study of Bioethical Issues. The Commission now has six months to complete “a study of the implications of this scientific milestone.” Reporting to the Science and Technology Advisor, Dr. John P. Holdren, the Commission will also develop recommendations for how the Federal government should anticipate and respond to similar scientific developments. Erik Parens, writing for the Hastings Center’s Bioethics Forum wonders if the new commission’s focus on “practical” questions will limit its ability to address the larger philosophical implications of synthetic biology. Although not responding directly to Parens, Jonathan Moreno takes a quick look at one of these big philosophical questions at Science Progress. Not unlike Venter’s reference to Kornberg, Moreno remembers early investigations of the idea that scientists are overstepping natural boundaries and “playing God.” By producing “an organic substance from non-organic matter,” chemist Friedrich Wohler crossed a “natural” boundary in 1828. This was a big deal for chemistry and for the philosophy of science. While Moreno, it seems, believes the ethical issues and philosophical questions are not insurmountable, he graciously opens the debate to a variety of voices: “Whatever challenge it may pose to our contemporary assumptions, it would be foolish to reject wisdom from any source in helping us decide where the path should lead, divine ones included.”

Readers looking for a thorough introduction to ethical issues of synthetic biology may wish to begin with:

Michele S. Garfinkel, Drew Endy, Gerald L. Epstein, and Robert M. Friedman, “Synthetic Biology,” in From Birth to Death and Bench to Clinic: The Hastings Center Bioethics Briefing Book for Journalists, Policymakers, and Campaigns, ed. Mary Crowley (Garrison, NY: The Hastings Center, 2008), 163-168.

The Synthetic Biology Project, established at the Woodrow Wilson International Center for Scholars and partnering with both The Hastings Center and the JCVI, also provides many resources on the subject, including:

Erik Parens, Josephine Johnston, and Jacob Moses. Ethical issues in synthetic biology: an overview of the debates. Synbio 3; 2009 June. [PDF – 585 KB]

For an international perspective, visit SYNBIOSAFE, a project funded by a grant from the European Commission. Browse four years of related links and publications on the site, or begin with this review, commissioned by the Biotechnology and Biological Sciences Research Council:

Andrew Balmer and Paul Martin. Synthetic biology: social and ethical challenges. May 2008. [PDF – 493 KB]

Related News Links

Sharon Schmickle. Genetic research: What are the risks of terrorism or accidents? MinnPost. June 1, 2010.
Natalie Angier. Peering over the fortress that is the mighty cell. The New York Times. May 31, 2010.
Scientist: ‘We didn’t create life from scratch’. CNN Health. May 21, 2010.
Life after the synthetic cell. Nature. 2010 May 27;465(7297):422-4. [PDF – 220 KB]
Michele Norris and David Rejeski. The ethics of creating synthetic life. All Things Considered. NPR. May 20, 2010.
Jonathan D. Moreno. Synthetic Biology Grows Up. Science Progress. May 20, 2010.

Other Research Ethics News

John Fauber. Doctors’ role in drug studies criticized. Journal Sentinel. May 30, 2010.
Harold Varmus. Ten years on–the human genome and medicine. N Engl J Med. 2010 May 27;362(21):2028-9.
Sarah Boseley. Andrew Wakefield case highlights the importance of ethics in science. Guardian. May 24, 2010.
Marie Woolf. NHS uses babies’ blood for secret database. The Times. May 23, 2010.
NIH. Financial Conflict of Interest Notice of Proposed Rule Making. NIH News. May 20, 2010.
Aaron S. Kesselheim, David M. Studdert, Michelle M. Mello. Whistle-blowers’ experiences in fraud litigation against pharmaceutical companies. N Engl J Med. 2010 May 13;362(19):1832-9.
U.S. group urges FDA to halt Glaxo’s Avandia trial. Reuters. May 11, 2010.
Eric M. Meslin. Problem solvers: what to expect from our new bioethics commission. Science Progress. May 7, 2010.
Sean Philpott and Udo Schuklenk. A study that should not have been done. Bioethics Forum. May 5, 2010.
Marcia Angell. Big pharma, bad medicine. Boston Review. May/June 2010.

– J.O.

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Broad Consent Comes Up Short in Arizona: Research Ethics in the News

Members of the Havasupai tribe, a small tribe from the Grand Canyon, were angered to discover that their blood samples were being used for research studies beyond the original scope or perceived intent of the project. In other words, the tribe thought it had consented to diabetes research, but found that researchers were also studying schizophrenia and the tribe’s ethnic origins. Over 200 members of the tribe completed a consent form that included an indication that the blood samples could be used to “study the causes of behavioral/medical disorders.” (See: Amy Harmon. Indian wins fight to limit research of its DNA. The New York Times. April 21, 2010. ) Such a clause is certainly broad enough to include research on schizophrenia; research on genetic origins seems less appropriate.

The dust has settled a bit since the Arizona State University Board of Regents agreed to a legal settlement with the Havasupai tribe. (For an overview of the legal issues, see Katherine Drabiak-Syed’s “Havasupai Tribe and Arizona State University Settlement Agreement: ASU to Return the Blood Samples” at PredictER News.) In hindsight, ASU probably wishes it had implemented a more robust outreach and collaboration effort with the tribe. Including Havasupai representatives on a communications team or community advisory board might have helped. Perhaps the tribe would have cautioned the university against culturally sensitive research, including studies on mental illness and genetic origins. Perhaps the tribe would have agreed to research on topics in addition to diabetes.

In any case, it is probable that ongoing Havasupai participation in the governance of the genetic research on their samples would have preserved the tribe’s trust in the research process. As it turns out, research without community trust can be very expensive. After spending $1.7 million in legal fees on the case, the Board of Regents agreed to settle the dispute by paying $700,000 to the tribe for their troubles. ASU also agreed to return the blood samples and, as Harmon reports, to “provide other forms of assistance.” In the long run, the loss of trust may be the most damaging outcome of this dispute between ASU and the Havasupai tribe. Arizona is the home of 22 tribes and ASU is proud of its partnerships with American Indiana Tribes. Following the dispute with the Havasupai, other tribes may be wary of future research projects. Given that the dispute was reported widely, the loss of tribal trust in researchers may impact the progress of research in other states as well. In fact, Rob Capriccioso of Indian Country Today reported that tribal officials “nationwide” had already condemned the conduct of the principle investigator. With this in mind, Rob Rosette, a lawyer for the Havasupai tribe, comments on the future impact of the settlement:  “A precedent was set. Researchers will now know that if they do this kind of research without informed consent, they are going to get in big trouble for it, costing themselves time and money. Exploiting these people was just not worth it.”

Related:

Rex Dalton. Native American Research Lawsuit Settled. The Great Beyond [Nature blog]. April 22, 2010.
Michael Kiefer. Havasupai Tribe ends regents lawsuit with burial. The Arizona Republic. April 22, 2010.
The Havasupai Case: Research Without Patient Consent. Who Owns Your Body? [2007]

Other Research Ethics News

Derek Parker. His little piggies may save lives: Paul Tan. The Australian. May 1, 2010.

Kounteya Sinha. ‘Cervical cancer vaccine trial guidelines not followed’. The Times of India. April 29, 2010.

Rob Stein. 13 additional stem cell lines eligible for federal funding, NIH says. The Washington Post. April 28, 2010.

Nancy Walton. The Thalidomide tragedy: reminding us why research ethics oversight is here to stay. The Research Ethics Blog. April 27, 2010.

Clinical trials hindered by red tape: MDs. CBC News. April 26, 2010.

Evan Binns. St. Louis doctors get $2.5 million from Pfizer, Lilly, Glaxo, Merck. St. Louis Business Journal. April 23, 2010.

AP. Doctor Groups Set New Policy to Curb Industry Sway. The New York Times. April 21, 2010.

Katherine Hobson. Medical Groups Sign on to Tough Ethics Rules. WSJ Health Blog. April 21, 2010.

Wagdy Sawahel. New centre to document bioethics in the Arab world. SciDevNet. April 9, 2010.

Amy Davis. PRIM&R joins the University of Pittsburgh in “Building Trust Between Minorities and Researchers”. Ampersand. April 6, 2010.

— J.O.