Top News Stories of 2010
The year saw some notable headlines about human biotech issues, controversies both entertaining and tragic, and a number of significant but tentative adjustments to the law. The following, in no particular order, are among those that drew our attention. Some of the topics were mentioned in last year's summary, none is in The Scientist's list of the top 5 academic papers, and all of them are harbingers. Of something. We'll find out what next year, maybe.
Governments and the Courts
In a landmark ruling in March, a New York District Court agreed with the ACLU (et al.) that human genes cannot be patented because they are products of nature, in the ongoing lawsuit challenging Myriad’s breast cancer gene patents. Several medical experts added their affirmations over the summer, while the appeals procedure began. In October, the U.S. Department of Justice jumped in — also on the side of the angels, and against the U.S. Patent Office; the case seems destined for the Supreme Court. Meanwhile, in Australia Myriad actually offered to surrender its patent, shortly before the Australian Senate released a report recommending modifying though not banning gene patents. And the WARF stem cell patents also came under legal challenge.
The criminal justice system continued to expand the use of DNA forensics, with New York (for example) approving the use of partial matches and aggressively pushing for DNA data collection as a condition of plea bargains. Questions about reliability were overshadowed by stories like the arrest of the "Grim Sleeper" in Southern California.
Controversially, a U.S. court briefly enjoined federal funding for embryonic stem cell research, before having the ruling stayed on appeal. This prompted calls for Congress to reconsider the Dickey-Wicker amendment that bans federal funding of embryo research; after November's election, that change seems less likely. However, the first clinical trials of ESC-based therapies (conducted by two private companies) actually started, in a small way.
Direct-to-Consumer Gene Tests in Hot Water
The nascent industry of consumer gene testing had a rocky time convincing medical experts [1, 2, 3, 4] — not to mention consumers — that it was ready for prime time. The FDA leaned on Walgreens not to sell DTC tests, Congress became involved, and the GAO conducted a devastating sting that prompted reactions ranging from applause to pushback.
And then UC Berkeley decided it would be a good idea to offer all incoming freshmen the chance to have a partial gene test. CGS and other public interest groups complained, and it turned out that many of the faculty with expertise on these matters had not been consulted and did not approve. Finally, the California Department of Health stepped in to point out the absence of a certified lab on campus, and the program was drastically scaled back
Clinical Trials Raise Questions
DNA swabs were in evidence in Minnesota, too, where the "Gopher Kids" study was taking samples at the state fair for research purposes that were essentially undefined. The University of Minnesota was also criticized (by some of its own faculty) for a clinical trial that had led to a subject committing suicide.
There was a major international reaction when historian Susan Reverby revealed that in the 1940s US researchers had deliberately infected Guatemalan subjects with syphilis. Carl Elliott and others connected this to a broader, modern search for clinical trials subjects. In better news, a group of Havasupai Indians won a court case against Arizona State University over the question of informed consent, and in so doing raised awareness of the issue within and beyond scientific circles.
Synthetic Biology
Craig Venter hit the headlines despite not actually creating synthetic life. He did, however, attract criticism from public interest organizations, and succeeded in provoking President Obama to set his Commission for the Study of Bioethical Issues on the case. Regrettably, their response was disappointing.
Nobel Prize for IVF Pioneer
The biggest international headlines of the year went to the Nobel Prize awarded to the acknowledged father of the IVF industry: Robert Edwards, largely lauded though with some caveats. The industry that his work sparked became even more institutionalized this year, and even more international, with U.S. entrepreneurs at the heart of it.
Awareness of this issue did seem to be growing, and there were calls for national and international regulation. Nevertheless, the global trade in surrogacy continued to expand, for instance to Guatamela, as well as many Asian and eastern European countries. One prediction: This issue will become even more prominent in 2011.