Class 9-12
Topics: Industrial science: interfaces with government and academia, including ownership and patenting of intellectual property
In the second part of this extended class, we will first discuss how science contributes to the economy, considering some of the conflicts that occur in the transformation of scientific discoveries into practical items of commercial value. We will talk about some articles, legal rulings, and books that illustrate problems about ownership (patents and licensing) and financial returns (to basic scientists and product developers), and we will think about what is in the best interests of the public versus the owners of intellectual property.
To whet your appetite for these topics: assigned reading about current events:
(1) http://www.nytimes.com/2016/12/19/health/harnessing-the-us-taxpayer-to-fight-cancer-and-make-profits.html?smprod=nytcore-ipad&smid=nytcore-ipad-share
Public funding is backing a new immunotherapy treatment, but the bulk of any profits will go to a private company. So are taxpayers getting a good deal?
An academic provides an inside view of the relationships being forged with corporations, and the accompanying expectations.
(3) https://www.nytimes.com/2017/03/10/opinion/bernie-sanders-trump-should-avoid-a-bad-zika-deal.html
Bernie Sanders and a former head of the NIH square off over the development of a vaccine against Zika virus
In considering these three recent conflicts, we will depend on several aspects of patent law.
Article I, section 8, reads, “Congress shall have power… to promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.”
Here are some relevant readings:
(1) Charles R. McManis & Sucheol Noh, “The Impact of the Bayh-Dole Act on Genetic Research and Development: Evaluating the Arguments and Empirical Evidence to Date” (An accessible legal essay that reviews some important aspects of the Bayh-Dole Act of 1980, legislation that strongly influenced how academic institutions pursue ownership of biological findings and products.) A PDF is on the class website.
(2)https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4225052/pdf/40142_2014_Article_55.pdf
An essay by Robert Cook-Deegan, a leading scholar on genetics and the law, about the Supreme Court’s decision on DNA patenting in a case that invalidated the patent held by Myriad Genetics on the BRCA1 gene. Reference #23 has the Court’s decision, an important document (US Supreme Court, American Association of Pathologists v.Myriad )
(3) The latest and most intense patenting fight in recent times has been over the gene-editing method often referred to as CRISPR/Cas9. An account of the ruling can be found in the NY Times by Andrew Pollack: https://www.nytimes.com/2017/02/15/science/broad-institute-harvard-mit-gene-editing-patent.html
Here is one of many articles about the effects of the fight on science: “Pursuit of profit poisons collaboration,” by Jacob S. Sherkow, Nature, April 14, 2016 https://www.ncbi.nlm.nih.gov/pubmed/27075081
(4) Debate about the invention and royalties from the HIV test kit was among my most difficult problems in my first year as NIH Director. One account of the settlement is here: http://articles.latimes.com/1994-07-12/news/mn-14822_1_hiv-test-kit
(Another account can be found in my memoir, The Art and Politics of Science.)
Some interesting, longer, optional readings on these topics
These are not required for class but keep them in mind if you want to read more about ownership of intellectual property, fights over priority in science, and other items related to turning discoveries into fame and profits. All can be found at Amazon.com
Jardine, The Man who Measured London (a lively biography about Robert Hooke, a remarkable scientist and difficult person who played critical roles in English science, the Royal Society, and the plan for London in the late 17th Century)
Skloot, The Immortal Life of Henrietta Lacks (a very popular social history of the origins and politics of the most famous cell line in medical research: HeLa cells)
Hall, Invisible Frontiers (an excellent account of the early days of the recombinant DNA industry by a journalist who met with you in February)
Kornberg, The Golden Helix (a personal story of the founding of the company DNAX by a Nobel Prize-winning biochemist )
Werth, The Billion Dollar Molecule (a highly readable story about the development of a biotech company by superb chemists)
Shreeve, The Genome Wars (one of several good accounts of the race to finish and possibly commercialize the human genome)
Hoffman and C. Djerassi, Oxygen (a play by two distinguished chemists aboutestablishing priority for the discovery of oxygen; another example of representation of science in the arts)
Session 10# April 18th, 2018 Guest lecturer: Jonathan Weiner
“How is writing about science like doing science?”
[Jonathan Weiner is Maxwell M. Geffen Professor of Medical and Scientific Journalism at Columbia Journalism School. His six books about science have won many awards, including a Pulitzer Prize for The Beak of the Finch.]
In some ways, writing nonfiction stories about science can be like doing science itself. With each story, science writers have to ask themselves hard questions about evidence, significance, objectivity. This evening we will explore some parallels between science writing and science, using a few science stories as case studies.
Please read:
“The Really Big One,” by Kathryn Schulz. New Yorker, 2015.
And please read any one of these three:
Chapter One, The Beak of the Finch, by Jonathan Weiner
Excerpt, The Next One Hundred Years, by Jonathan Weiner
“The Tangle,” by Jonathan Weiner. New Yorker, 2005.
April 25 Session #11
Scientific communities: Changes in the demography of science
In this session, we will consider the several factors that determine the vitality of scientific communities. We will view those factors and their consequences from the perspectives of social planners and leaders of science who are thinking about the likelihood of success in scientific careers. Some of the factors include the kinds and numbers of jobs available for the conduct of scientific work; the educational and training mechanisms required to develop the scientific work force; the mechanisms used to support scientific studies (including, especially, grants in the public sector and also allocations for research in the private sector); and government policies and political support for them.
The timing of this session is coincidentally propitious: on April 12th, the National Research Council issued a long-awaited and Congressionally mandated report entitled The Next Generation of Biomedical and Behavioral Sciences Researchers:
Breaking Through. The report was inspired by widespread concerns, during the past decade or more, that newly trained investigators in the biomedical sciences are increasingly at risk of being unable to fulfill their potential because of a paucity of suitable positions and financial support for their scientific work. Such limitations have been viewed as threats to the future of the U.S. scientific enterprise and as perverse conditions fostering an unhealthy, “hyper-competitive” atmosphere in the current world of medical science.
During our class on April 25, we will discuss the causes and consequences of the current state of affairs and some possible remedies. The following questions are among those you should think about:
–What do you see as the major events that have created the current crisis of confidence in our traditionally successful research enterprise?
–Given current conditions and systems for training, research, and funding, what feasible short-term changes would you recommend?
–If you could dictate the availability of talent (the labor force), research positions in academic, government, and commercial sectors, and funds for the support of research, how would you organize the system?
To help you think about these issues, please look at the following materials:
- The new report from the NRC, which is freely available for downloading from the National Academies website (https://www.nap.edu/download/25008)
I would recommend reading the Summary and any additional chapters or appendices that you find especially interesting.
- A short paper that I co-authored with three senior colleagues in 2014 and attracted widespread attention. It seemed to capture current anxieties about how imbalances of the labor force and resources (especially jobs and grants) were affecting the performance of science. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4000813/
- A preprint (!) from a similar group of authors, representing the advocacy group called Rescuing Biomedical Research (RBR), that makes some specific recommendations for improving prospects for NIH grant support for young investigators. https://peerj.com/preprints/26465/ (This article will likely appear in Science magazine soon; it illustrates the utility of posting preprints, a topic we discussed on April 10th.)
Of course, there is a great deal written on these topics, and you can find references to most of that work in the NRC report or in our paper in PNAS. But if you read the PNAS paper and the recommendations in the NRC report summary, we will have the basis for a lively discussion.
For some of you, this topic has important practical consequences; for others, I hope the significance of the issues for the future of medical science will be apparent.
May 2 Session #12 Controversial Science
As you have learned during this course, science is a complex activity with complicated relationships to government, business, the arts, the law, and virtually all other elements in our society.
In this final session before your project presentations, we are going to talk about the ways in which scientific work is treated when it is thought to pose risks to society. When the dangers are obvious and extreme—for example, the design and testing of atomic weapons or the production of biological weapons—we use a variety of legal tools and rigorously monitored precautions, such as bans, international treaties, or the labeling of research as “classified” so that only properly credentialed individuals have access to it. And of course 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 recent report (which I co-chaired) from the National Research Council. The report is attached as a PDF or 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.
Some questions about controversial research:
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? Beliefs? Costs?
Who should set the limits? The executive branch? Law-makers? The scientific community?
What are the dangers of 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?
What has been done in the past? And what has been learned from those experiences?
What shall we do about current uncertainties?
Readings to inform our discussion
- DURC and bioterrorism. 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
- 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:
The National Academies have also weighed in with a report on germ line editing, summarized in this news release:
http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=24623
- Historical examples. Two famous episodes of controversial science give some perspective on the current debates.
The most notable was the controversy in the mid-1970’s about the use of recombinant DNA technologies. There are many places to read about this, but here are a couple:
One reflection by the main organizer, Paul Berg of Stanford:
https://www.nature.com/articles/455290a’
Another by the man who was the head of NIH at the time, Don Fredrickson:
https://www.ncbi.nlm.nih.gov/books/NBK234217/
The other worth mentioning is the long-standing controversy about studies of human embryos and the 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
DURC Report
