Session 12
As you have learned during this course, scientists have complicated relationships to government, business, the arts, the law, and virtually all other elements in our society.
In this final session before you begin to present your projects, we are going to talk about the ways in which scientific work is viewed, conducted, and sometimes regulated when it is thought to pose risks to society or to individuals. When the dangers are obvious and extreme—for example, the design and testing of atomic or biological weapons—we have established a variety of legal tools and rigorously monitored precautions (such as bans, international treaties, the labeling of research as “classified”, or laws enforced by the Department of Commerce to avoid sharing secrets inappropriately with foreign entities). When the use of medical methods could pose serious threats to individuals, we have developed regulatory measures (such as those employed by the Food and Drug Administration to ensure the safety and efficacy of drugs or devices). But there are other forms of science that are not clearly threatening and hence not “classified” or subjected to existing regulatory measures. That is what we’ll focus on.
20th Century Examples
We will begin by talking about two famous episodes of controversial science that provide some perspective on current debates.
- Recombinant DNA research. Perhaps the most notable scientific controversy in the modern era occurred in mid-1970’s when recombinant DNA technologies were under development. There are many places to read about this; here are a couple of good ones:
One reflection by the main organizer, Professor Paul Berg of Stanford: https://www.nature.com/articles/455290a
Another by the man who was the Director of NIH at the time, Donald Fredrickson:
https://www.ncbi.nlm.nih.gov/books/NBK234217/
In retrospect, could this controversy have been handled better? What were the issues, how were they evaluated, and by whom? Did the resolution of the debate provide a useful precedent for dealing with subsequent controversies?
- Human embryo and stem cell research. Another example is the long-standing (and still ongoing) controversy about studies of human embryos and so-called “pluripotent” stem cells derived from them. Some of this is discussed in Chapter 13 from my memoir: https://www.ncbi.nlm.nih.gov/books/NBK190607/
A short recent synopsis outlines the prospects for use of such cells in experimental work and medical treatment:
https://www.nature.com/articles/d41586-018-03268-4
A very new twist to remind us that the debates about embryo research are not over: chimeric human-monkey embryos. https://www.statnews.com/2021/04/15/international-team-creates-first-chimeric-human-monkey-embryos/?utm_source=STAT+Newsletters&utm_campaign=5343aebbab-MR_COPY_14&utm_medium=email&utm_term=0_8cab1d7961-5343aebbab-149562933
More recent and current examples.
We will devote much of our class time to the consideration of two contemporary issues. One gets relatively little airtime: “dual use research of concern” (DURC) and bioterrorism. The other saturated the science press for a few months of 2019 and was featured in Part II of the science documentary, The Gene, (recently released and freely available on PBS): the use of CRISPR technology to modify the human genome in patients or embryos.
(The documentary gives a vivid account of efforts by a scientist in China to use gene editing to change the human germ line. Watch it if you can: https://www.pbs.org/video/part-2-revolution-in-the-treatment-of-disease-z9nxg5/)
Readings to inform the discussion
- DURC and bioterrorism.
The vast majority of scientific work is thought to pose minimal or no risk of harm. But in some instances, scientific work may be viewed as having “dual” potential: the likelihood of producing new knowledge that has beneficial applications but some chance of being used—unwittingly or with malevolent intent—to cause harm. Such research is often called “dual use research of concern” (abbreviated as DURC).
Many features of DURC are summarized in a report (which I co-chaired) from the National Research Council a few years ago. The report can be read online from this link: https://www.nap.edu/read/24761/chapter/1
It will be useful to skim the background information and the recommendations.
Several of the controversies in the world of DURC have involved the study of viruses that could be used as weapons or could initiate epidemics as a result of careless handling of genetically modified agents. Some examples include:
—Work on the horsepox viruses that was too late to be included in the DURC report, here reported on NPR:
—Studies of influenza viruses engineered to be able to be transmitted by the airborne route:http://www.sciencemag.org/news/2011/11/scientists-brace-media-storm-around-controversial-flu-studies
Can you imagine experiments with SARS-CoV-2 that might be called DURC because they pose significant risks, while also providing potentially useful knowledge that could help to end the pandemic? Can you propose ways to make such studies relatively safe and to keep the findings from being used in a malicious fashion?
- Gene editing with CRISPR/Cas9 and other tools.
There is now enormous interest in the use of gene editing to treat diseases, make improved agricultural products, and even change the human germ line. Foreign Affairs magazine has devoted most of a recent issue to this topic; see for example the article by Bill Gates:
Or a plea from an ethicist to consider forms of regulation:
Or a 2020 update on a therapeutic approach in somatic cells: https://www.statnews.com/2020/03/04/crispr-first-use-inside-human-body-blindness-therapy/
Or the final few chapters in Walter Isaacson’s currently best-selling book about the discovery of CRISPR, The Code Breakers.
One specific goal is effective treatment of sickle cell disease, and the prospects for doing this are illustrated in Part II of the PBS documentary, The Gene, noted above, and in an excellent film, Human Nature, that was recently released. I have permission from the producer to allow you to see it at: https://vimeo.com/324302262
Password: biu725fdas583 (Please do not forward this link to anyone.)
The National Academies have weighed in with a report on germ line gene editing, summarized in this news release, following a high level meeting in Washington in 2015:
http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=24623
Despite a declared consensus that gene editing of the human genome should not be attempted at this time, a scientist from China (Dr. Jiankui He) described his attempts to perform such editing of human embryos, with the goal of rendering the resulting infants resistant to infection with HIV, at a second high level meeting in Hong Kong a few months ago (http://www.nationalacademies.org/gene-editing/2nd_summit/index.htm). (Part of this talk is shown in The Gene, Part II.)
Here are some accounts of what happened:
— “Shock greets claim of CRISPR-edited babies” Science 362: 978, November 30, 2018. https://www.nytimes.com/2019/01/23/health/gene-editing-babies-crispr.html
And here are some of the many responses to that electrifying news.
— The terse summary from the meeting’s organizers:
http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=11282018b
–An editorial in The New York Times; “Should scientists toy with the secret to life?” January 28, 2019
–Three essays in the New England Journal of Medicine, January 16, 2019:
- A perspective from some of the meeting organizers: “After the storm—a responsible path for genome editing,” by G. Daley, R. Lovell-Badge, and J. Steffann.
- An essay by a well-known ethicist: “Rogues and regulation of germline editing,” by R. Alta Charo.
- A lively journalistic account: “The future of gene editing—towards scientific and social consensus” by L. Rosenbaum.
A few other controversial topics that are worth noting but we probably won’t have time to discuss:
–The use of DNA to track and identify people.
- The dark side: “China uses DNA to track its people with the help of American expertise,” New York Times, Feb.21, 2019.
- A useful application: “She helped crack the Golden State killer case. Here’s what she’s going to do next” in the New York Times, August 29, 2018.
- A method to escape a loophole: “One twin committed the crime—but which one? A new DNA test can finger the culprit” in the New York Times, March 1, 2019. (see Krawczak et al, “Distinguishing genetically between the germlines of male monozygotic twins,” PLOS Genetics, December 20, 2018 (https://doi.org/10.1371/journal.pgen.1007756)
–The Trump administration’s attempt to curtail or terminate the use of human fetal tissue in research.
- “Trump officials move to limit human fetal tissue research,” Science 362: 1223, December 14, 2018;
- “Why we need fetal tissue research” Science 363, p.207, January 18, 2019.
–Efforts to limit the impact of statements by people opposed to vaccination and thereby improve protection against measles, papilloma viruses, etc, and now Covid-19!
- “The law and vaccine resistance”, Science 363: 795, February 22, 2019;
- “Make America measles-free again,” The New York Times, p.A22, March 12, 2019. There are many other articles and we will hear a report from one of you on the difficulties of controlling misinformation spread by social media.
- Many news articles describing vaccine hesitancy during the current pandemic, especially those that propose mandating vaccination, making vaccination a requirement for certain activities (including school attendance), or developing a vaccination “passport”.
Some general questions about controversial research:
Our discussions will be guided by several underlying questions that arise in virtually all of the older and more recent controversies. Think about these while preparing for class:
Should scientists be able to follow their curiosity wherever it leads? Of course not. But what are the limits?
What influences those limits? Danger to health, property, security, environment? Ethics? Religious beliefs? Costs?
Who should set the limits? The executive branch? Lawmakers? States or the federal government? The scientific community? When should decisions be made by the judicial branch of government?
What are the dangers of setting limits on what can be studied? Or of not setting limits?
How should scientists proceed when matters are unresolved by authorities? When should dangers be considered: before starting an experiment or when it is time to publish? In the “information age” is it possible to control the distribution of potentially dangerous information?
What has been done in the past to reduce societal threats posed by science? And what has been learned from those experiences?
What shall we do about current uncertainties? Who should deliberate? Who should decide?
