ENVIRONMENTAL AND EPIGENETIC IMPACTS | “BIOPIRACY” AND PATENTS ON: “INDIVIDUAL HUMAN” GENOMES, MICROBIOME ORGANISMS’ GENOMES | PLANT GENOMES | ANIMAL GENOMES | AS OF 1994-2024 AND “GENE DRIVES” by Jeffrey Thayer (September 2024).

Of all the articles written by Change the Thoughts, this one well be the most important Nd relevant for all readers and the most disturbing. The mere thought that one’s genome, or portions it, is patented and owned by a third party(ies) may raise more than a few eyebrows. Readers of the FULL article will learn the technology to patent human genomes, DNA sequences and processes … has existed for over 30 years or more. Patent applications began to flood the US Patent Office in the 1990’s, with little, if any public disclosure, and ever less oversight. The FULL article addresses the history and many of the players, euphemistically called “stakeholders”; and one of many being revealed in this article, is discussed in greater detail below. Consider as one:

“DRIVEN TO EXTERMINATE: HOW BILL GATES BROUGHT GENE DRIVE EXTINCTION TECHNOLOGY INTO THE WORLD”. https://www.etcgroup.org/content/driven-extinction

Why are patents granted on human genomes, microbiomes, plants animals and “gene drives” important in 2024 to readers of this FULL ARTICLE? I cannot and will not answer that question. Readers’ due diligence and critical thinking with independent VERIFICATION is required. NOW … more than ever in human history. A good place to first start may be a thorough etymological study of the words “novel” and “virus”; as used and codified in the phrase “novel virus” repeated ad nauseum over the past 10 years. In part 4 of our article we return to author Michael Crichton, whose novel “Next” (2006) was his last work published before his death.

“Next” by Michael Crichton PDF. Contains the novel ONLY without the ADDITIONAL MATERIALS in the hard copy book itself, but contained in the TXT file below. PDF (Open Source). https://archive.org/details/MichaelCrichton-Next

TXT File (Open Source) Recommended. Contains eAudio Interview, NY Times Op Ed by Michael on the book, Author Notes and complete Bibliography and research Michael used to write the book. https://archive.org/stream/MichaelCrichton-Next/MichaelCrichton_next_djvu.txt

Introduction. This FULL article is divided into three short parts:

Biopiracy of the Genomes and Patenting of Human Genomes;
The Current Applications of “Gene Drives” Before, During and After COVID.
Summaries of Court Decisions on Patenting “Life”
An Open Source presentation of author Michael Crichton’s work product research, Author Note’s, from his novel “Next” (2006)

“History doesn’t just repeat itself. It rhymes”. — Mark Twain.

“The only thing new in the world is the history you do not know”. — Harry Truman

“It was passing through the air, and I was passing through my life, so we met in the street of the sky, and the bird passed, and I passed”. — Pablo Neruda

https://youtu.be/KgvhUPiDdq8?feature=shared

https://youtu.be/6tw_JVz_IEc?feature=shared

Biopiracy of the Genomes and Patenting of Human Genomes;

“… In the case of gene drives, while most international debate has focused on their application in malaria and conservation, the industrial farm is where gene drives may first make their impact; the very foundational patents for gene drives have been written with agricultural applications in mind. In 2017, a secretive group of military advisors known as the JASON Group produced a classified study on gene drives commissioned by the US government which was tasked to address “what might be realizable in the next 3-10 years, especially with regard to agricultural applications.” The JASON Group was also informed by gene drive researchers who were present during a presentation on crop science and gene drives delivered by someone from Bayer-Monsanto. Other groups involved in gene drive discussions behind the scene include Cibus, an agricultural biotech firm, as well as agribusiness majors including Syngenta and Corteva Agriscience. The startup Agragene, whose co-founders are none other than the gene drive researchers Ethan Bier and Valentino Gantz of University of California at San Diego, “intends to alter plants and insects” using gene drives. The JASON Group and others have also raised the flag that gene drives have biowarfare potential—in part explaining the strong interest of US and other militaries in the technology”.

“Zahra Moloo and Jim Thomas, ETC Group in 2016, at the Forbes 400 Summit on Philanthropy in New York, Bill Gates was asked to give his opinion on gene drives, a risky and controversial new technology that could—by design—lead to the complete extermination of the malaria-carrying mosquito species, Anopheles gambiae. If it were his decision to wipe out this mosquito once and for all, given the risks and benefits being considered, would he be ready to do it? “I would deploy it two years from now,” he replied confidently. However, he added, “How we get approval is pretty open ended.”. Gates’s ‘let’s deploy it’ response may not seem out of character, but it was an unusually gung-ho response given how risky the technology is widely acknowledged to be. Gene drives have been dubbed an “extinction technology” and with good reason: gene drive organisms are created by genetically engineering a living organism with a particular trait, and then modifying the organism’s reproductive system in order to always force the modified gene onto future generations, spreading the trait throughout the entire population. …”

https://www.etcgroup.org/content/driven-extinction

“Biopiracy, a term originally coined by ETC Group, refers to the appropriation of the knowledge and genetic resources of farming and indigenous communities by individuals or institutions that seek exclusive monopoly control (patents or intellectual property) over these resources and knowledge. ETC Group believes that intellectual property is predatory on the rights and knowledge of farming communities and indigenous peoples. Through nanotechnology- and synthetic biology-related patents, intellectual property claims are now being extended to elements of the periodic table and to key metabolic pathways involved in cellular functioning (and resulting in natural products with high commercial value).”. https://www.etcgroup.org/issues/patents-biopiracy

https://www.etcgroup.org/content/gene-boutiques-stake-claim-human-genome

The Current Applications of “Gene Drives” Before, During and After COVID.

NOTICE: A reading of the FULL ARTICLE is required for complete context.

Gene Boutiques Stake Claim to Human Genome | ETC Group

The article discusses the controversy surrounding the patenting of human genes by U.S.-based genomic companies in collaboration with major pharmaceutical corporations. These companies are actively filing patents for human gene sequences, raising ethical, social, and economic concerns about the commercialization of human genetic material and the potential consequences for innovation and global healthcare.

Overall

Despite widespread international debate, U.S. genomic companies are moving rapidly to patent human genes and related genomic technologies. These patents are seen as a way for corporations to control future healthcare developments by monopolizing genetic discoveries. However, concerns abound over the implications this will have on public access to life-saving medical treatments, innovation in research, and the balance of power between private companies and public institutions. The article emphasizes the importance of protecting human subjects from unjust patent claims and calls for global regulations to safeguard genetic resources. Meanwhile, the commercial potential of these genetic technologies remains untested.

Highlights

💡 Gene patenting: U.S. companies seek exclusive rights over human gene sequences.
⚖️ Controversy: Ethical concerns over ownership and control of genetic material.
🧬 Genomic companies: Focus on discovering genes for drug development.
🔍 Human Genome Project: Public research differs in its non-commercial approach.
🏢 Corporate investments: Major pharmaceutical firms are investing heavily in genomic companies.
💸 Patent race: The biotech industry views gene patenting as the future of pharmaceuticals.
💊 Healthcare impact: Patents could increase drug prices and limit accessibility.
🌍 Global concern: Debate over North-South equity in genetic research and benefit-sharing.
📉 Innovation at risk: Exclusive control may hinder scientific collaboration.
🚨 Need for regulations: Calls for international protocols to protect against commercial exploitation.

Summary

U.S. genomic companies are patenting human genes despite ethical and social concerns.
These companies believe that gene discoveries will lead to major breakthroughs in drug development.
Concerns include potential restrictions on scientific research and increased healthcare costs.
The Human Genome Project, publicly funded, differs by focusing on mapping the entire genome for public use.
Large investments from pharmaceutical companies are fueling the gene patent race.
Some argue that patents on genetic material could stifle innovation and prevent open scientific exchange.
There are fears that monopoly control over human genes will lead to inequitable healthcare access.
Global debate focuses on the need for regulations to protect genetic resources and human rights.
Many diseases involve complex genetic interactions, raising questions about the utility of single-gene patents.
The future of gene patenting remains uncertain, but it is shaping up to be a major issue in 21st-century healthcare

https://youtu.be/23AjcB48x3A?feature=shared

NOTICE: A reading of the FULL ARTICLE is required for complete context.

https://www.etcgroup.org/content/driven-extinction

Driven to Extinction | ETC Group

This article discusses how the Bill and Melinda Gates Foundation (BMGF) has been a major force behind gene drive technology, an experimental method to alter or eradicate entire species. While promoted for its potential to combat diseases like malaria, the technology raises significant ethical, ecological, and socio-political concerns. BMGF's involvement includes not only funding research but also shaping public narratives, policy, and regulation in favor of gene drives, often in collaboration with military and agribusiness interests.

Overall

The Gates Foundation, alongside DARPA (a U.S. military organization), has been funding research and advocacy for gene drive technologies, particularly targeting malaria-carrying mosquitoes. This technology works by genetically engineering organisms to spread a modified gene through a population, which could lead to species extinction. Though it holds promise for eradicating diseases, gene drives are controversial due to their potential environmental risks and ethical implications, especially as they are tested in Africa. Civil society groups and ecologists are calling for a moratorium due to fears of irreversible ecological damage and the exploitation of vulnerable populations for experimentation.

Highlights

💡 Gene drives: A technology designed to genetically modify entire species.
💰 Gates Foundation: One of the largest funders of gene drive research.
🦟 Target Malaria: A Gates-funded project aimed at eradicating malaria-carrying mosquitoes.
🌍 Global concerns: The technology raises fears about ecological impacts and biowarfare.
🧬 Synthetic biology: Part of a broader field of radical genetic engineering.
⚖️ Ethical issues: Critics warn of the risks of manipulating entire ecosystems.
📊 Influencing policy: BMGF has funded lobbyists to shape global gene drive regulations.
🌱 Agricultural interest: Gene drives may soon be applied in industrial farming.
💼 Military involvement: DARPA's funding indicates interest in gene drives for biowarfare.
🚨 Moratorium call: Civil society is pushing for a halt on the technology’s deployment.

Summary

The Gates Foundation is a major player in pushing gene drive technology forward.
Gene drives are designed to spread modified genes throughout a population, potentially eradicating species.
The technology is being tested to combat diseases like malaria, but it raises ecological concerns.
Many fear that the technology could be misused or lead to irreversible damage to ecosystems.
DARPA’s involvement highlights potential military applications of gene drives.
BMGF has used its resources to influence regulations and public perception in favor of gene drives.
The technology is part of the larger synthetic biology field, with applications beyond malaria.
Critics worry about the ethical implications of using African ecosystems and populations for testing.
Proponents argue that gene drives are necessary to eliminate deadly diseases like malaria.
Civil society groups continue to call for a global moratorium on the use of gene drives.

3. Summaries of Court Decisions on Patenting “Life”

IS THIS PATENTING OF HUMAN GENOMES etc. LEGALLY SUPPORTED?

Forty Years Since Diamond v. Chakrabarty: Legal Underpinnings and its Impact on the Biotechnology Industry and Society. Matthew Jordan, Neil Davey, Maheshkumar P. Joshi, & Raj Davé. JANUARY 2021

LINKS to Significant cases summarized below:

Diamond v. Chakrabarty, 447 U.S. 303, 306 (1980). https://supreme.justia.com/cases/federal/us/447/303/

Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012). https://supreme.justia.com/cases/federal/us/566/66/

Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013). https://supreme.justia.com/cases/federal/us/569/576/

NOTICE: Review article summarized below. Please read FULL article cor context.

https://cip2.gmu.edu/wp-content/uploads/sites/31/2021/01/Forty-Years-Since-Diamond-v-Chakrabarty.pdf

SUMMARY:

Forty Years Since Diamond v. Chakrabarty

This document explores the legacy and implications of the Supreme Court case Diamond v. Chakrabarty (1980), which allowed for the patenting of genetically modified organisms. The decision played a significant role in advancing the biotechnology industry.

Overall

In Diamond v. Chakrabarty, the U.S. Supreme Court ruled that genetically engineered bacteria were patentable, sparking a transformation in the biotechnology industry. Dr. Ananda Chakrabarty's work on oil-decomposing bacteria led to this landmark case. The Supreme Court determined that living organisms, when modified by human intervention, could be considered patentable. This decision set the stage for many advances, including genetically modified seeds and therapies like monoclonal antibodies. However, recent cases, such as Myriad, have complicated the patenting of natural phenomena. As biotechnology continues to evolve, legal uncertainties surrounding patent eligibility persist, prompting calls for legislative clarity.

Highlights

🔬 Biotechnology revolution: Chakrabarty's bacteria patent laid the foundation for advancements in biotech.
🧬 Patentable organisms: The ruling allowed man-made, genetically modified organisms to be patented.
⚖️ Legal foundation: The Court's decision was grounded in Section 101 of the U.S. Patent Act.
🌍 Impact on society: This decision shaped the biotech industry's contributions to agriculture, medicine, and more.
🌱 Genetically modified seeds: One of the major outcomes was the patenting of GMO seeds, crucial in modern agriculture.
💉 Medical breakthroughs: Technologies like DNA amplification and monoclonal antibody therapy also stemmed from this decision.
📜 Legal complexities: Recent cases like Myriad have added confusion over what constitutes patentable subject matter.
🏛 Calls for clarity: Legal experts argue that Congress should clarify patent laws in light of current confusion.
🦠 COVID-19 relevance: Amidst the pandemic, the importance of clear biotech patent laws is emphasized.
📉 U.S. competitiveness: The U.S. risks falling behind in biotech innovation without legislative reforms.

Summary

Diamond v. Chakrabarty marked a turning point by making genetically modified organisms patentable, transforming biotech.
Dr. Ananda Chakrabarty's invention of oil-degrading bacteria was at the center of this decision.
The Supreme Court ruled 5-4 in favor of Chakrabarty, basing their decision on the Patent Act's "composition of matter" clause.
This case paved the way for patents in GMOs, DNA technologies, and medical treatments like monoclonal antibodies.
The case’s broader impact includes the rapid development of the U.S. biotech industry, with applications in agriculture and healthcare.
Recent cases such as Myriad have restricted patent eligibility for natural products like isolated DNA, creating legal ambiguity.
Legal scholars argue that Congress needs to clarify what is patentable to avoid stifling innovation.
Biotechnology’s importance has only increased, especially during the COVID-19 pandemic, where patents could influence vaccine development.
Despite the success in the past, the U.S. faces challenges in maintaining its lead in biotech due to unclear patent laws.
The decision remains a cornerstone of patent law, but the evolving legal landscape demands new solutions.

Law Review Article

RESTORING THE GENETIC COMMONS: A “COMMON SENSE” APPROACH TO BIOTECHNOLOGY PATENTS IN THE WAKE OF KSR V. TELEFLEX

Anna Bartow Laakmann*

Cite as: Anna Bartow Laakmann, Restoring the Genetic Commons: A “Common Sense” Approach to Biotechnology Patents in the Wake of KSR v. Teleflex 14 Mich. Telecomm. Tech. L. Rev. 43 (2007),

https://mttlr.org/wp-content/journal/volfourteen/laakmann.pdf

The proper scope of patent protection for biotechnology discoveries has been the source of longstanding debate among legal scholars, re- search scientists, and industry executives. The debate can be traced back to the 1980 Diamond v. Chakrabarty decision, in which the Supreme Court held that a bacterium genetically modified to dissolve crude oil was a patentable invention.1 The Court noted Congress’s intention to allow the patenting of “anything under the sun that is made by man”2 and concluded that non-naturally occurring, living things produced by human ingenuity are patentable.3 Shortly after the Chakrabarty decision, the Patent and Trademark Office (PTO) “began issuing patents on human genes and gene fragments, transgenic bacteria that express human genes, and human cell lines that express DNA sequences producing pharmaco- logically important proteins.”4.

In the 1990s, the commencement of the Human Genome Project, and the subsequent flood of patent filings claiming DNA sequences, fueled the controversy over the patenting of biological discoveries.5 The National Institutes of Health (NIH) received sharp criticism from the medical research community after filing two patent applications for over 2000 partial gene sequences identified by one of the Human Genome Project researchers, Dr. Craig Venter.6 Critics argued that patents over partial gene sequences would distort the conduct of basic biomedical research and ultimately impede commercial development.7 The NIH responded to the criticism by reversing its gene patenting policy and electing not to pursue patents for gene sequences.8 Participants in the Human Genome Project, as well as members of the pharmaceutical in- dustry and certain DNA chip9 makers acted to render raw sequence data unpatentable by implementing strategies to release genome data into the public domain.10 Such initiatives spurred the PTO to revise its utility guidelines in 2001 to require “specific, substantial, and credible utility” in order to satisfy section 101 of the U.S. Patent Code,11 thus excluding from patentability DNA sequences of unknown function.12. The debate over biotechnology patents continues to simmer today. In February 2007, Congressmen Xavier Becerra and Dave Weldon intro- duced the Genomic Research and Accessibilty Act, which would amend the U.S. Patent Code to prohibit patents for “a nucleotide sequence, or its functions and correlations, or the naturally occurring products it specifies.”13 The bill may have been prompted in part by best-selling author Michael Crichton’s invective against gene patents in a recent novel14 and a related editorial in the New York Times which began: “YOU, or someone you love, may die because of a gene patent that should never have been granted in the first place.”15

KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007)

https://supreme.justia.com/cases/federal/us/550/398/

Summary:

Approach to Biotechnology Patents in the Wake of KSR v. Teleflex

This article by Anna Bartow Laakmann explores the ongoing debate surrounding the scope of biotechnology patents, particularly focusing on gene patenting, in light of the KSR v. Teleflex case. It argues for a more flexible, "common sense" approach to evaluating biotechnology patents, aimed at fostering innovation while preventing the over-restriction of genetic discoveries.

Overall Summary

The article outlines the history and policy behind gene patenting, particularly how landmark legal decisions have shaped the landscape of biotechnology innovation. It discusses the tension between patent protection, which can drive commercial investment, and the risk of stifling scientific progress due to overly broad patents on gene sequences. The author advocates for aligning patent law with the rapid advancements in biotechnology, suggesting that patents should be granted based on practical application and contribution to innovation rather than on rigid legal frameworks. A key part of the discussion focuses on the "person having ordinary skill in the art" (PHOSITA) standard in patent law and how it fails to accurately reflect the modern state of biotechnology.

Key Highlights

Historical Context: The article traces back the debate to the 1980 Diamond v. Chakrabarty case, where genetically modified organisms were deemed patentable.
Patent Law Development: The role of the Bayh-Dole Act, the Federal Circuit’s stance on patents, and its influence on biopharmaceutical R&D.
PHOSITA Critique: The current legal framework’s misalignment with scientific advances, especially in determining the skill level required for patent obviousness.
ENCODE Findings: Discussion on the 2007 ENCODE project, which challenges the long-held belief that "junk DNA" is non-functional, emphasizing the need for open collaboration in genomics.
Policy Proposals: Calls for a shift from rigid patent interpretations to more flexible ones that prioritize innovation over legal formalities.
"Tragedy of the Anticommons": How fragmented gene patents may stifle downstream research and technological advancements.
Supreme Court's Impact: How the KSR v. Teleflex decision encourages the use of "common sense" in patent evaluations and could reshape the biotechnology patent landscape.
Biopharmaceutical Industry: Discussion on the heavy reliance of pharmaceutical companies on biotechnology innovations and patents for new drug development.
Technological Progress: The increasing automation in gene sequencing and its implications for patent law.
Impact on Research: The article warns that excessive gene patenting could impede both basic and applied research.

Summary of 10 Key Points

Gene Patents History: The Diamond v. Chakrabarty case opened the door for patenting genetically engineered organisms, influencing the rise of gene patents.
Bayh-Dole Act's Role: This act allowed universities and small businesses to retain patent rights on government-funded research, pushing biotechnology innovation forward.
Federal Circuit's Missteps: The Federal Circuit has applied outdated standards to biotechnology patents, particularly the PHOSITA concept, which does not match the modern capabilities of researchers.
Challenges with DNA Patents: The broad issuance of DNA sequence patents has been criticized for limiting future research and innovation in the biopharmaceutical industry.
KSR v. Teleflex Ruling: This ruling introduced a "common sense" standard in determining patent obviousness, offering a chance to reassess how biotechnology patents are evaluated.
Tragedy of the Anticommons: The article discusses the risks of over-patenting in biotechnology, where too many fragmented rights could stifle research and development efforts.
ENCODE Findings: The discovery that much of what was considered "junk DNA" is functional suggests the need for open sharing of genomic information, rather than restrictive patents.
Policy Recommendations: Laakmann suggests a balanced approach that protects genuine innovation while avoiding monopolies on basic scientific discoveries.
Impact on Innovation: Broad gene patents risk slowing down biopharmaceutical progress by making it difficult and expensive for companies to access the necessary research tools.
Future Directions: The article calls for legal reform that takes into account the fast-paced evolution of biotechnology and its unique challenges compared to other fields.

https://youtu.be/4pcjBxNBmKA?feature=shared

An Open Source presentation (uploaded 2012, last accessed September 10, 2024) of author Michael Crichton’s work product research, Author Note’s, from his eBook novel “Next” (2006)

E-BOOK EXTRAS: A Conversation with Michael Crichton, Author of NEXT

Ql: NEXT challenges the reader's sense of what is happening, what is true and what is invented. How much of what's in the book has already taken place?

It's odd but nearly everything in the book has already happened, or is about to happen. The book does look to the future a bit, particularly with regard to some transgenic animals that become

important characters. But for the most part NEXT is not really speculative fiction at all.

Q2: What scaresyou the most about NEXT? And conversely, which possibilities do you find the most encouraging?

I'm not really scared about anything in the genetic realm. My research actually reassured me, obecause I concluded that many of the things people discuss with great fear or great longing — such as designer babies, or extended longevity — are probably not going to happen.

I think that we'll have some remarkable new therapies from this area, and we will also find that the genome is vastly more complicated than we anticipated. In that sense, the genome is a bit like the human brain — much harder to understand than we once imagined.

Q3: What first sparked your interest in genetics?

It's a longstanding interest for me. I studied genetics and evolution in college, and of course as a

medical student. Genetics has been one of the most exciting areas of scientific research in my lifetime. It's hard to remember that when I was born in the 1940s, people weren't really sure what a "gene" consisted of. And they thought human beings had 24 chromosomes, instead of 23! And they had no idea at all how an embryo grew and differentiated into a live birth.

Q4: In the past you've said that you usually do research to answer a question of your own that interests you. What was the origin of NEXT? (possibly for Powell's)

This novel began when I attended a genetics conference at the Salk Institute in La Jolla. I learned just how fast the field was progressing, and how inappropriate certain legal positions were. The field obviously needed some broader attention from the public.

In terms of the novel, the question I asked was: what's the current view of how the genome operates — how you get from genotype to phenotype? Because such ideas have changed hugely in the last decades. Of course, this question is ultimately the old nature/nurture issue, and so it is politically charged. How much of our behavior is ruled by genes, and how much by upbringing and experience? I ultimately concluded I couldn't really address this question in the book, because it is so complex. But I arrived at answers for myself that surprised and satisfied me.

My answer is that genes are an integral part of our adaptive apparatus as organisms in an environment. So we find both heightened importance for nature and also for nurture. But the whole interaction is far more complicated than people thought fifty years ago. And it continues to change.

Q5: NEXT poses many complex questions and presents the audience with many moral gray areas. Where do you stand on the ethics of genetic engineering, stem cell research, genetic therapy and gene patents?

I oppose patenting genes, and argue such patents should never have been granted in the first place. The genome is our common heritage, going back millions of years, and it is absurd that anyone should own any part of it. I hope this book helps undo gene patents. The practice is obstructive and even dangerous.

Genetic therapy is highly experimental. It has great promise and great hazards. Stem cell research is more a political football than a theraputic issue, at this point. Politically it's a continuation of the abortion controversy that has wracked this country for nearly half a century, with no end in sight. What stem cell research will ultimately offer us is wholly unknown. It may be hugely powerful. It may be a dead end. But in any case I oppose bans on research. They don't work and they displace the arguments, which become about the ban and not about the subject of the research itself.

As for the ethics of genetic engineering, most people argue excitedly about what is not possible. If it were possible to pop genes in and out of embryos, to make designer babies, then we would indeed have serious ethical questions to face. At the moment, that is not possible at all. I

therefore don't think that talking about it does a lot of good. On major human life decisions, I don't think there is great value in deciding what you will do until you are actually faced with the issue. For example, I think it is fruitless to speculate what you would do if you had a fatal disease. Eventually we all get one, and our behavior at that point will probably not be what we imagined.

Similarly, I think we don't know in advance how we will respond to opportunities in new technology. We just don't know.

Q6: What is the latest court ruling as to what constitutes cell ownership? Are there any upcoming cases that you're keeping an eye on?

Rules regarding tissues are fragmented. A recent Sixth Circuit decision regarding the tissue collection of Dr. William Catalona has set back the efforts of patients to have some control over what happens to their tissues, once donated to medical research. There are good reasons why patients deserve such control. If you give your tissue for prostate research, you might not want the tissues used for other purposes you disagree with. You might have religious or other objections. You might have legal concerns, because if your genetic information was published your insurance might be cancelled. These are genuine concerns.

Federal guidelines regarding tissues are much more humane. And they don't interfere with research. We need Congress to make these guidelines the law of the land.

Q7: One of your characters warns that science is as corruptible an enterprise as any other, academics and entrepreneurs are way too cozy and data can be massaged to achieve any desired

result. Is this something the American public should be more aware of?

I hope that such unsavory narratives as the Vioxx scandal will convince the public that we need better and more independent sources of information. But it is also true that the British slaughter of livestock at the height of the BSE scare now seems to have been unnecessary, the result of a flawed computer prediction. We are going to see more such errors in many areas of science. I believe we live in the greatest era of snake oil salesmen in the history of mankind. Unless government acts to assure us of independently verified information, we will continue to suffer

bad science policies, and even deaths.

Q8: How do you stay informed about current and cutting-edge science? How much do you read? Are you actively involved in the scientific community?

There is no secret. I just read a lot. I don't talk to a lot of scientists. It's faster to read than talk.

Q9: Many of your previous books have ignited public discussion and debate. Do you think NEXT will provoke a similar response?

I am never sure how the public reaction to my books will be. I'm usually surprised. I won't make any predictions about this book.

Q10: In 2005, you appeared before the United States Senate's Committee on Environment and Public Works to discuss the politicization of scientific research. What was your message? Why is

this such a big problem and what is the solution?

Essentially I argued that what we need is a government policy that assures independently verified information in any area that is important to policy. This is the essence of the scientific method. There are well-established statistical procedures to make sure that the information you get is unbiased. It's simple enough to do, although expensive. But bad information is expensive, and bad policies are very expensive.

I argue that we live in a technological society where science matters, and it is up to the government to make sure that what we're told is accurate.

For this rather ordinary argument I was thoroughly attacked. There are many people out there who don't want their data to be checked!

Ql 1: What's so striking about all your books and now NEXT in particular is your ability to make complicated science comprehensible to a mass audience while also showcasing your tremendous expertise. How do you pull that off time after time?

Again, there's no secret. Making the story clear is accomplished by rewriting and rewriting until the technical passages are understandable. In any book, there are usually a few pages that I end up rewriting about twenty times.

Q12: After the final thrilling page, what would you most like readers to take away from NEXT?

The future is bright and exciting, and it will challenge us to think in fresh ways about our lives. But among our challenges today, we have some legal problems in genetics that need to be fixed. We need some laws passed, and some laws changed.

But I am optimistic about the future. Very optimistic.

_________

Michael Crichton NEXT Audio Interview Transcript

JB: Hi, I'm Jonathan Burnham, publisher of HarperCollins, and I'm here interviewing

bestselling-author Michael Crichton about his new novel, Next .

Michael, as with many of your other novels, Next is a vivid dramatization of what can happen when cutting-edge science goes a little too far. Is Next a cautionary tale?

MC: Well, I think it is, in the sense that many of the books are. But for me what's different about this book is that so much of it is real — or that so much of it is very thinly-disguised versions of actual events that have occurred. Genetics, which is the subject of the book, has advanced extraordinarily rapidly in the last 15 years or so and sometimes in directions that many people are troubled about, or disapprove of, and so it is a very interesting and hot contentious area.

JB: And have you been tracking the science of genetics for the last 15 years, watching it, seeing what's going on, and building a portfolio?

MC: Actually, you know it's odd, I was very interested in it at the time of Jurassic Park which now to my astonishment was 15 years ago, and I lost track of it a bit, so to return is to have this odd sense of coming into a world where so many things that were fictional 15 years ago are now taking place.

JB: You've chosen a very interesting and I think new form for this novel, which is to break down the conventional narrative into many different stories, some of which overlap, some of which are self-contained, and others which move forward and become the principle themes of

the book. How did you conceive of this book, in formal terms?

MC: Well, I think there were two

considerations that I had. One was that I was unable to overlook the structure of the genome as we are now starting to understand it, and how individual

genes interact with other genes, or may seem to be silent, or we don't really know what they do, or sometimes there are repetitions that are not clear to us, and it struck me as an interesting idea

to try to organize the novel in that way, even though it's not what one ordinarily does. The second thing that was driving me was the notion that there are a great many stories of interest in this area, and they're all quite different in terms of the legal and ethical problems that are raised in the field, so I wanted to do a number of different stories.

JB: Next poses a large number of ethical issues to the reader. Do you personally have a strong position on these issues?

MC: Well, I do on some and not on others. The feeling in general that I have is that we have too little information, and the impulse in some quarters to ban things or prevent research or curtail it seems to me ill-advised and also not very practical. Whatever research isn't done in the United States will be done in Shanghai, so what exactly is being accomplished? I do think that there are some things that have been done in a business sense that are tremendously bad and dangerous

and inappropriate, and among those are the patenting of genes. We have within our bodies, for the most part, identical genes, and many of these genes are millions or even billions of years old — they're found in other animals, they're found in microorganisms, and yet they're being

patented now — diseases are being patented: Hepatitis C isowned by somebody, Haemophilus Influenza is owned by somebody, the gene for insulin is owned - this seems to me to be very wrong on a number of levels and I hope that this will be changed and the book will be influential in starting a discussion.

JB: You've written about many frightening areas of science in your novels — how does genetics rate in the large field that you've covered, in terms of the elements of fear connected to reality that are built into it?

MC: As a person, I think I am myself not very fearful, and it may be that I get out all of these fears in my work. The first sort of genetics book that I did that addressed any of these things was Jurassic Park , and that was of course entirely fiction. What's happened at this point is that

many of these possibilities are real, and so you see because of the structure and the way that things are being done, when you hear for example, that scientists were reluctant to study SARS — the severe acute respiratory syndrome that was spreading across the world — a disease

that had a 10% fatality and was suddenly in 24 countries — and scientists hesitated to study it because there was a conflict over who would own the genome — who would get the patent. That's very scary — that business interest might put us all at risk for a pandemic — it's kind of insane.

JB: How do you keep abreast of new developments in science?

MC: For the most part, it's simply reading. I do visit occasionally laboratories, but not very often, and there are sort of two reasons for it: one is that when one goes to an individual laboratory, one spends time with someone who has a particularly strong interested in a very narrow area, which is usually not my area of interest, and the other thing is that to read is the equivalent of talking to people on the telephone — it's just simply much faster, it's a much quicker way, and the journals stack up in my office and I go through them as best I can.

JB: Your first goal as a writer I'm sure is to entertain, and you've done that brilliantly in this book, but in terms of asking readers to think about the issues that you're exploring, what do you want the reader to take away from Next after they've finished it?

MC: What my experience was in working on this was a kind of combination of anxiety and excitement — the possibility of really wonderful things that might happen — the possibility that for example, certain genetic diseases might actually be cured, and people who might previously

either were certain to die or could only be treated in fairly unsatisfactory ways — there now is the likelihood that you will be able to inject the gene and that person is cured — that's quite extraordinary, and there are many other examples of new cancer treatments and other things that

are just amazing. And then on the other side, there is this connection of law and business and academia which is very distressing in the directions that it's going, and it involves a tremendous amount of secrecy and involves a tremendous direction which I think is against the public

interest and which I think really ought to distress and frighten people.

JB: If you were in a position to create legislation, how would you being to reign in the "bad science" — the combination of science, business, and academics moving in the wrong direction as you see it?

MC: I think there are actually three or four things that would really transform the field. The first thing that I would do is I would make the testing of genes for medical diagnoses completely legal, irrespective of patents. I think that would do a great public service and also oblige scientists to start to look at the patenting business in a different way. The second thing I would

do is I would require universities to follow federal guidelines for use of tissues in research. Federal guidelines are excellent — they give people a tremendous amount of control over the tissues that they donate — many universities, institutions of higher learning, are trying to break these rules, trying to go in another direction — they ought not to be allowed to, and I would change that. The third thing I would do is I would make sure people got the information that they needed to make informed decisions. There are some situations now where patients have died

from gene therapy, and the institutions involved have said that they don't want the deaths reported because they're a trade secret. This is so insane <laughs> that the mind boggles — this, whatever legislation is needed to stop that we ought to do. And the final thing is that in 1980 there was a law passed that was called Bahy Dole — bipartisan law that enabled universities to sell their products to industry, and it was well-intentioned, but it has had the effect of creating this gigantic commercial consulation within universities that is very damaging, and so I would reverse that law.

JB: In spite of the serious message of the book and the profound issues you're tackling, there is a lot of fun in this book. There are many jokes, there are many very amusing passages and stories, and there are a number of ideas — concepts — that perhaps are true or perhaps are fictional. Is there anything in the book that you would like to be real, that perhaps isn't real — that would improve your life?

MC: Interesting question. . .1 don't know how to answer that. . .1 guess what I feel is that whatever I might imagine is probably right around the corner anyway. <laughs>

JB: Absolutely.

Thank you so much for this interview, and we are sure that this book is going to be a huge success.

_________

This Essay Breaks the Law

By MICHAEL CRICHTON

The Earth revolves around the Sun.

The speed of light is a constant. Apples fall to earth because of gravity. Elevated blood sugar is linked to diabetes. Elevated uric acid is linked to gout. Elevated homocysteine is linked to heart disease. Elevated homocysteine is linked to B-12 deficiency, so doctors should test homocysteine levels to see whether the patient needs vitamins.

ACTUALLY, I can't make that last statement. A corporation has patented that fact, and demands a royalty for its use. Anyone who makes the fact public and encourages doctors to test for the

condition and treat it can be sued for royalty fees. Any doctor who reads a patient's test results and even thinks of vitamin deficiency infringes the patent. A federal circuit court held that mere

thinking violates the patent.

All this may sound absurd, but it is the heart of a case that will be argued before the Supreme Court on Tuesday. In 1986 researchers filed a patent application for a method of testing the levels of homocysteine, an amino acid, in the blood. They went one step further and asked for a patent on the basic biological relationship between homocysteine and vitamin deficiency. A

patent was granted that covered both the test and the scientific fact. Eventually, a company called Metabolite took over the license for the patent.

Although Metabolite does not have a monopoly on test methods — other companies make homocysteine tests, too — they assert licensing rights on the correlation of elevated homocysteine with vitamin deficiency. A company called LabCorp used a different test but published an article mentioning the patented fact. Metabolite sued on a number of grounds, and has won in court so far.

But what the Supreme Court will focus on is the nature of the claimed correlation. On the one hand, courts have repeatedly held that basic bodily processes and "products of nature" are not patentable. That's why no one owns gravity, or the speed of light. But at the same time, courts

have granted so-called correlation patents for many years. Powerful forces are arrayed on both sides of the issue.

In addition, there is the rather bizarre question of whether simply thinking about a patented fact infringes the patent. The idea smacks of thought control, to say nothing of unenforceability. It seems like something out of a novel by Philip K. Dick — or Kafka. But it highlights the uncomfortable truth that the Patent Office and the courts have in recent decades ruled themselves into a corner from which they must somehow extricate themselves.

For example, the human genome exists in every one of us, and is therefore our shared heritage and an undoubted fact of nature. Nevertheless 20 percent of the genome is now privately owned.

The gene for diabetes is owned, and its owner has something to say about any research you do, and what it will cost you. The entire genome of the hepatitis C virus is owned by a biotech

company. Royalty costs now influence the direction of research in basic diseases, and often even the testing for diseases. Such barriers to medical testing and research are not in the public

interest. Do you want to be told by your doctor, "Oh, nobody studies your disease any more because the owner of the gene/enzyme/correlation has made it too expensive to do research?"

The question of whether basic truths of nature can be owned ought not to be confused with concerns about how we pay for biotech development, whether we will have drugs in the future,

and so on. If you invent a new test, you may patent it and sell it for as much as you can, if that's your goal. Companies can certainly own a test they have invented. But they should not own the disease itself, or the gene that causes the disease, or essential underlying facts about the disease. The distinction is not difficult, even though patent lawyers attempt to blur it. And even if correlation patents have been granted, the overwhelming majority of medical correlations, including those listed above, are not owned. And shouldn't be.

Unfortunately for the public, the Metabolite case is only one example of a much broader patent problem in this country. We grant patents at a level of abstraction that is unwise, and it's gotten us into trouble in the past. Some years back, doctors were allowed to patent surgical procedures

and sue other doctors who used their methods without paying a fee. A blizzard of lawsuits followed. This unhealthy circumstance was halted in 1996 by the American Medical Association and Congress, which decided that doctors couldn't sue other doctors for using patented surgical procedures. But the beat goes on.

Companies have patented their method of hiring, and real estate agents have patented the way they sell houses. Lawyers now advise athletes to patent their sports moves, and screenwriters to

patent their movie plots. (My screenplay for "Jurassic Park" was cited as a good candidate.)

Where does all this lead? It means that if a real estate agent lists a house for sale, he can be sued because an existing patent for selling houses includes item No. 7, "List the house." It means that Kobe Bryant may serve as an inspiration but not a model, because nobody can imitate him without fines. It means nobody can write a dinosaur story because my patent includes 257 items covering all aspects of behavior, like item No. 13, "Dinosaurs attack humans and other dinosaurs."

Such a situation is idiotic, of course. Yet elements of it already exist. And unless we begin to turn this around, there will be worse to come.

I wanted to end this essay by telling a story about how current rulings hurt us, but the patent for "ending an essay with an anecdote" is owned. So I thought to end with a quotation from a famous person, but that strategy is patented, too. I then decided to end abruptly, but "abrupt

ending for dramatic effect" is also patented. Finally, I decided to pay the "end with summary" patent fee, since it was the least expensive.

The Supreme Court should rule against Metabolite, and the Patent Office should begin to reverse its strategy of patenting strategies. Basic truths of nature can't be owned.

Oh, and by the way: I own the patent for "essay or letter criticizing a previous publication." So anyone who criticizes what I have said here had better pay a royalty first, or I'll see you in court.

_________

See also: The New York Times OP-ED Section Sunday, March 19, 2006

Author's Note

At the end of my research for this book, I arrived at the following conclusions:

1. Stop patenting genes. Gene patents might have looked reasonable twenty years ago, but the field has changed in ways nobody could have predicted. Today we have plenty of evidence that gene patents are unnecessary, unwise, and harmful.

There is great confusion about gene patents. Many observers conflate a call to end gene patents with anticapitalist and anti-private property sentiments. It is nothing of the sort. It is perfectly reasonable for industry to seek a mechanism that will ensure a profit on productive investment. Such a mechanism implies a restriction on competition involving a created product. However, such protection does not imply that genes themselves should be patented. On the contrary, gene patents contradict long-established traditions of intellectual property protection.

First, genes are facts of nature. Like gravity, sunlight, and leaves on trees, genes exist in the natural world. Facts of nature can't be owned. You can own a test for a gene, or a drug that affects a gene, but not the gene itself. You can own a treatment for a disease, but not the disease itself. Gene patents break that fundamental rule. Of course one can argue about what's a fact of nature, and there are people paid to do that. But here's a simple test. If something exists for

millions of years before the arrival of Homo sapiens on earth, it's a fact of nature. To argue that a gene is in any way a human invention is absurd. To grant a gene patent is like granting a patent

on iron or carbon.

Because it's a patent on a fact of nature, a gene patent becomes an undeserved monopoly. Ordinarily, patent protection enables me to protect my invention but encourages others to make their own versions. My iPod doesn't prevent you from making a digital audio player. My

patented mousetrap is wood, but your titanium mousetrap is allowed.

This is not what happens with gene patents. The patent consists of pure information already existing in nature. Because there has been no invention, no one can innovate any other use of the

patent without violating the patent itself, so further innovation is closed. It's like allowing somebody to patent noses. You couldn't make eyeglasses, Kleenex, nasal sprays, masks, makeup, or perfume because they all rely on some aspect of noses. You could put suntan lotion on your body, but not on your nose, because any modification of your nose would violate the

patent on noses. Chefs could be sued for making fragrant dishes unless they paid the nose royalty. And so on. Of course, we would all agree that a patent on noses is absurd. If everyone has one, how can anyone own it? Gene patents are absurd for the same reason.

It takes little imagination to see that monopolistic patenting inhibits creation and productivity. If the creator of Auguste Dupin could own all fictional detectives, we would never have had Sherlock Holmes, Sam Spade, Philip Marlowe, Miss Marple, Inspector Maigret, Peter Wimsey, Hercule Poirot, Mike Hammer, or J. J. Gittes, to name just a few. This rich heritage of invention would be denied us by a patenting error. Yet that is exactly the error in patenting genes.

Gene patents are bad public policy. We have ample evidence that they hurt patient care and suppress research. When Myriad patented two breast cancer genes, they charged nearly three thousand dollars for the test, even though the cost to create a gene test is nothing like the cost to develop a drug. Not surprisingly, the European patent office revoked that patent on a ptechnicality. The Canadian government announced that it would conduct gene tests without

paying for the patent. Some years ago, the owner of the gene for Canavan disease refused to make the test widely available, even though families who had suffered with the disease had

contributed time, money, and tissues to get the gene identified. Now those same families could not afford the test.

That is an outrage, but it is far from the most dangerous consequence of gene patents. In its heyday, research on SARS (Severe Acute Respiratory Syndrome) was inhibited because

scientists were unsure who owned the genome — three simultaneous patent claims had been filed. As a result, research on SARS wasn't as vigorous as it might have been. That should scare every

sensible person. Here was a contagious disease with a 10 percent death rate that had spread to two dozen countries around the world. Yet scientific research to combat the disease was inhibited — because of patent fears.

At the moment, hepatitis C, HIV, hemophilus influenza, and various diabetes genes are all owned by some entity. They shouldn't be. Nobody should own a disease.

If gene patents are ended, we can expect screams of outrage and threats that business will abandon research, that companies will go bankrupt, that health care will suffer and the public will die. But it is more likely that an end to gene patents will be phenomenally liberating to

everyone, and will result in a burst of new products for the public.

2. Establish clear guidelines for the use of human tissues. Human tissue collections are increasingly important to medical research, and increasingly valuable. Appropriate federal regulations to manage tissue banks already exist, but courts have ignored federal rules. Historically, the courts have decided questions about human tissues based on existing property

law. In general, they have ruled that once your tissue leaves your body, you no longer maintain any rights to it. They analogize tissues to, say, the donation of a book to a library. But people have a strong feeling of ownership about their bodies, and that feeling will never be abrogated by a mere legal technicality. Therefore we need new, clear, emphatic legislation.

Why do we need legislation? Consider a recent court ruling on the case of Dr. William Catalona. This eminent prostate cancer physician assembled a collection of tissue samples from his patients so he could work on the disease. When Dr. Catalona moved to another university, he tried to take the tissues with him. Washington University refused, saying that it owned the tissues; the judge

upheld the university, citing such trivial facts as some of the releases' being printed on Washington University stationery. Patients are now understandably outraged. They believed they were giving their tissues to a beloved doctor, not a shadowy university lurking in the background; they thought they were giving tissues specifically for prostate cancer research, not for any use, which the university now claims the right to do.

The notion that once you part with your tissue you no longer have any rights is absurd. Consider this: Under present law, if somebody takes my picture, I have rights forever in the use of that photo. Twenty years later, if somebody publishes it or puts it in an advertisement, I still have rights. But if somebody takes my tissue — part of my physical body — I have no rights. This means I have more rights over my image than I have over the actual tissues of my body.

The required legislation should ensure that patients have control over their tissues. I donate my tissues for a purpose, and that purpose only. If, later, someone wants to use them for another purpose, they need my permission again. If they can't get permission, they can't use my tissues.

Such a rule fulfills an important emotional need. But it also acknowledges that there may be significant legal and religious reasons why I do not want my tissue used for another purpose.

We should not fear that such regulations will inhibit research. After all, the National Institutes of Health seems to be able to conduct research while following these guidelines. Nor should we accept the argument that these rules impose an onerous burden. If a magazine can notify you that your subscription has run out, a university can notify you if they want to use your tissues for a new purpose.

3. Pass laws to ensure that data about gene testing is made public. New legislation is needed if the FDA is to publish adverse results from gene therapy trials. At the moment, it cannot do so. In the past, some researchers have tried to prevent the reporting of patient deaths, claiming that

such deaths were a trade secret.

The public is increasingly aware of defects in the systems we use to report medical data. Research data has not been made available for other scientists to inspect; full disclosure has not been required; genuinely independent verification of findings is rare. The result is a public exposed to untold unknown hazards. Bias in published studies has become a bad joke. Psychiatrist John Davis looked at the trials funded by pharmaceutical companies in competition for the most effective of five different antipsychotic drugs. He found that 90 percent of the time, the drug manufactured by the company sponsoring (paying for) the study was judged superior to the others. Whoever paid for the study had the best drug.

This should not be news. Review studies conducted by those who have a financial or other interest in the outcome are not reliable because they are inherently biased. That fact should be addressed by an information system that does not permit biased testing, and takes steps to ensure

that it does not occur. Yet gross bias remains far too common in medicine, and in certain other areas of high-stakes science as well.

Government should take action. In the long run there is no constituency for bad information. In the short run, all sorts of groups want to bend the facts their way. And they do not hesitate to call their senators, Democratic or Republican. This will continue until the public demands a change.

4. Avoid bans on research. Various groups of different political persuasions want to ban some aspect of genetic research. I agree that certain research ought not to be pursued, at least not now. But as a practical matter, I oppose bans on research and technology.

Bans can't be enforced. I don't know why we have not learned this lesson. From Prohibition to the war on drugs, we repeatedly indulge the fantasy that behavior can be banned. Invariably we

fail. And in a global economy, bans take on other meanings: even if you stop research in one country, it still goes on in Shanghai. So what have you accomplished?

Of course, hope springs eternal, and fantasies never die: various groups imagine they can negotiate a global ban on certain research. But to the best of my knowledge, there has never been

a successful global ban on anything. Genetic research is unlikely to be the first.

5. Rescind the Bayh-Dole Act. In 1980, Congress decided that the discoveries made within universities were not being made widely available, to benefit the public. To move things along, it

passed a law permitting university researchers to sell their discoveries for their own profit, even when that research had been funded by taxpayer money.

As a result of this legislation, most science professors now have corporate ties — either to companies they have started or to other biotech companies. Thirty years ago, there was a distinct difference in approach between university research and that of private industry. Today the distinction is blurred, or absent. Thirty years ago, disinterested scientists were available to discuss any subject affecting the public. Now, scientists have personal interests that influence their judgment.

Academic institutions have changed in unexpected ways: The original Bayh-Dole legislation recognized that universities were not commercial entities, and encouraged them to make their

research available to organizations that were. But today, universities attempt to maximize profits by conducting more and more commercial work themselves, thus making their products more valuable to them when they are finally licensed. For example, if universities think they have a new drug, they will do the FDA testing themselves, and so on. Thus Bayh-Dole has, paradoxically, increased the commercial focus of the university. Many observers judge the effect of this legislation to be corrupting and destructive to universities as institutions of learning.

Bayh-Dole was always of uncertain benefit to the American taxpayers, who became, through their government, uniquely generous investors. Taxpayers finance research, but when it bears fruit, the researchers sell it for their own institutional and personal gain, after which the drug is

sold back to the taxpayers.Consumers thus pay top dollar for a drug they helped finance.

Ordinarily, when a venture capitalist invests in research, he or she expects a significant return on investment. The American taxpayer gets no return at all. The Bayh-Dole legislation anticipated

that the public would receive a flood of marvelous life-saving therapies such that the investment strategy would be justified. But that hasn't happened.

Instead, the drawbacks far outweigh the benefits. Secrecy now pervades research, and hampers medical progress. Universities that once provided a scholarly haven from the world are now commercialized — the haven is gone. Scientists who once felt a humanitarian calling have become businessmen concerned with profit and loss. The life of the mind is a notion as quaint as

the whalebone corset.

All these trends were perfectly clear to observers fifteen years ago; no one paid much attention back then. Now the problems are becoming clear to everyone. A good first step toward restoring

the balance between academia and corporations will be to repeal Bayh-Dole legislation.

________

Bibliography

Excellent books on genetics are available to the general reader, including many written by researchers. This bibliography emphasizes texts I used to research this book. I relied particularly on the work of law professor Lori Andrews, authors Matt Ridley and Ronald Bailey, and

scientists John Avise, Stuart Newman, and Louis-Marie Houdebine.

Andrews, Lori, and Dorothy Nelkin.Body Bazaar: The Market for Human Tissue in the Biotechnology Age. New York: Crown Publishers, 2001.

For many years, Andrews has been the

most wide-ranging and authoritative legal scholar on genetic issues. Dorothy Nelkin is a professor at New York University. Their book is comprehensive.

Andrews, Lori B.The Clone Age: Adventures in the New World of Reproductive Technology. New York: Henry Holt and Company, 1999. If you want to know about the real cases that are

fictionalized here, read her book.

Andrews, Lori B., Maxwell J. Mehlman, and Mark A. Rothstein. Genetics: Ethics, Law and Policy. American Casebook Series. St. Paul, Minn.: West Group, 2002. A legal text on genetic issues.

Avise, John C.The Hope, Hype, and Reality of Genetic Engineering. New York: Oxford University Press, 2003. Despite the awkward title, this is one of the best books on genetic engineering for the general reader. It covers the entire field from crops to pharmaceuticals to human gene therapy; it is admirably clear, and the author explains exactly what procedures are being carried out at the genetic level. Most books do not. If you are asking yourself, "What exactly are they doing?" this is a good place to begin.

Bailey, Ronald. Liberation Biology: The Scientific and Moral Case for the Biotech Revolution. Amherst, NY.: Prometheus, 2005. A scientifically informed critique of bioconservatives — those individuals from both the political left and right who wish to constrain the field. Bailey's counterarguments cite scientific realities; he is respectful of opponents and ultimately entirely persuasive, in my view. I regard his book as the clearest and most complete response to religious

objections to biotechnology.

Buller, David J. Adapting Minds: Evolutionary Psychology and the Persistent Quest for Human Nature. Cambridge, Mass.: MIT Press, 2005. A critique of evolutionary psychology.

Chesterton, G. K. What's Wrong with the World. San Francisco: Ignatius Press, 1910. Bon vivant, wit, and tireless author, Chesterton lost the debate about the future direction of society to his contemporaries H. G. Wells, Bertrand Russell, and George Bernard Shaw. Chesterton saw the implications of their vision of twentieth-century society, and he predicted exactly what would come of it. Chesterton is not a congenial stylist to the modern reader; his witticisms are formal,

his references to contemporaries, lost in time. But his essential points are chillingly clear.

Chesterton, G. K.Eugenics and Other Evils: An Argument Against the Scientifically Organized Society. Edited by Michael W. Perry. Seattle: Inkling Books, 2000. Originally published in 1922,

this astonishingly prescient text has much to say about our understanding of genetics then (and now), and about the mass seduction of pseudoscience. Chesterton's was one of the few voices to oppose eugenics in the early twentieth century. He saw right through it as fraudulent on every

level, and he predicted where it would lead, with great accuracy. His critics were legion; they reviled him as reactionary, ridiculous, ignorant, hysterical, incoherent, and blindly prejudiced, noting with dismay that "his influence in leading people in the wrong direction is considerable."

Yet Chesterton was right, and the consensus of scientists, political leaders, and the intelligentsia was wrong. Chesterton lived to see the horrors of Nazi Germany. This book is worth reading

because, in retrospect, it is clear that Chesterton's arguments were perfectly sensible and deserving of an answer, and yet he was simply shouted down. And because the most repellent ideas of eugenics are being promoted again in the twenty-first century, under various guises. The editor of this edition has included many quotations from eugenicists of the 1920s, which read astonishingly like the words of contemporary prophets of doom. Some things never change — including, unfortunately, the gullibility of press and public. We human beings don't like to look back at our past mistakes. But we should.

Forgacs, Gabor, and Stuart A. Newman.Bio logical Physics of the Developing Embryo. Cambridge, England: Cambridge University Press, 2005. A college-level text on a crucial subject.

Fukuyama, Francis. Our Posthuman Future: Consequences of the Biotechnology Revolution. New York: Farrar, Straus and Giroux, 2002. Critics on both the left and right perceive impending

dehumanization from biotechnology. Fukuyama argues that we can control biotechnology, and should. While I agree that one ought not to assume that technology is uncontrollable, in this case I doubt control is possible.

Hamer, Dean, and Peter Copeland.The Science of Desire: The Search for the Gay Gene and the Biology of Behavior. New York: Simon and Schuster, 1994. A book as curious and oblique as the discovery that prompted it. Rambling, good-natured, informative.

Horgan, John.The End of Science. Reading, Mass.: Addison Wesley, 1996. A remarkable book, willfully misread by most of its attackers.

The Undiscovered Mind: How the Human Brain Defies Replication, Medication, and

Explanation. New York: The Free Press, 1999. Horgan is one of the brightest and most iconoclastic observers of science today. His prose is bracing and his viewpoint subtle.

Houdebine, Louis-Marie. Animal Transgenesis and Cloning. Hoboken, N.J.: John Wiley and Sons, 2003. A clear discussion of transgenesis that is accessible to the interested, not-very-

technical reader. Inserting genes into embryos is immensely complex.

Knight, H. Jackson. Patent Strategy for Researchers and Research Managers. 2d edition. Chichester, England: John Wiley and Sons, 1996.

Krimsky, Sheldon, and Peter Shorett, eds. Rights and Liberties in the Biotech Age: Why We Need a Genetic Bill of Rights. Lanham, Md.: Rowman and Littlefield, 2005. This collection of very brief essays identifies a range of concerns among those who feel that biotechnology must be limited. Some essays address science; others raise philosophical or legal issues.

Krimsky, Sheldon. Science in the Primate Interest: Has the Lure of Profits Corrupted Biomedical Research? Lanham, Md.: Rowman and Littlefield, 2003. Krimsky was one of the earliest, and has been one of the most persistent, critics of the commercialization of biology. A thoughtful,

important book that indicates the complexities within the trend to academic commerce.

Larson, Edward J. Summer for the Gods: The Scopes Trial and America's Continuing Debate over Science and Religion. Cambridge, Mass.: Harvard University Press, 1997. Few events in American history are as misunderstood as the Scopes trial. Today it is emblematic of a war between science and religion. In fact, it was nothing of the sort; the truth is far more amusing, complex, and provocative. A gem of a book.

Midgley, Mary. Evolution as a Religion. London: Methuen and Co., 1985. Our attitude toward genetics is closely tied to our understanding of evolution. A long -simmering philosophical debate concerns the way we think about evolution and what lessons we draw from it. I find this debate more interesting than the debate that gets all the media attention, which has to do with the mechanisms of evolution. Midgley, a British philosopher who has addressed scientific subjects all her life, does not hesitate to take on sacred cows and those leading lights whose thoughts she

regards as uninformed or shallow.

Moore, David S.The Dependent Gene: The Fallacy of "Nature vs. Nurture." New York: Henry Holt and Company, 2001. A psychologist aggressively attacks notions that genes and environment interact in any simple or even measurable way. His assessment of such terms as heritability make this book worth reading. One may conclude that the author protests too

much; nevertheless, he exemplifies the deep passions that characterize the nature/nurture debate.

Morange, Michel.The Misunderstood Gene. Cambridge, Mass.: Harvard University Press, 2001.

Mueller, Janice M.An Introduction to Patent Law. New York: Aspen Publishers, 2003.

National Research Council of the National Academies. Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health. Washington,

D.C.: National Academies Press, 2006. Gene patents endanger future research.

Petryna, Adriana, Andrew Lakoff, and Arthur Kleinman, eds. Global Pharmaceuticals: Ethics, Markets, Practices. Durham, N.C.: Duke University Press, 2005.

Pincus, Jonathan H., and Gary J. Tucker.Behavioral Neurology, 4th edition. New York: Oxford University Press, 1974.

Ridley, Matt. Genome: The Autobiography of a Species in 23 Chapters. New York:

HarperCollins, 1999. Ridley is that rarest of science writers, one who is able to be entertaining and also not simplify the material. An easy and readable style, good humor, rich anecdotes, and a

generally lively mind.

The Agile Gene: How Nature Turns on Nurture. New York: HarperCollins, 2003. How do genes interact with the environment? What constitutes an environmental or a genetic effect?

With brilliant examples, Ridley takes the reader through the intricacies.

Sargent, Michael G. Biomedicine and the Human Condition: Challenges, Risks, and Rewards. New York: Cambridge University Press, 2005.

Shanks, Pete.Human Genetic Engineering: A Guide for Activists, Skeptics, and the Very Perplexed. New York: Nation Books, 2005. Balanced, straightforward, easy to read.

Stock, Gregory. Redesigning Humans: Our Inevitable Genetic Future. New York: Houghton Mifflin, 2002. A UCLA biophysicist embraces this new technology while attempting to clarify the reasons why others oppose or fear it.

Tancredi, Laurence. Hardwired Behavior: What Neuroscience Reveals About Morality. New York: Cambridge University Press, 2005. The author is experienced in both medicine and law, and presents a brisk, engaging overview. He distinguishes clearly between present realities and

future possibilities.

U.S. Department of Commerce. Patents and How to Get One: A Practical Handbook. New York: Dover Publications, 2000.

Wailoo, Keith, and Stephen Pemberton. The Troubled Dream of Genetic Medicine. Baltimore: Johns Hopkins University Press, 2006.

Watson, James D.The Double Helix. New York: Touchstone, 2001. A classic. A memoir as brilliant as the discovery itself.

Weiner, Jonathan.Time, Love, Memory: A Great Biologist and His Quest for the Origins of Behavior. New York: Knopf, 1999. Too many books fail to give any sense of how science is actually done. This delightful book focuses on Seymour Benzer and his work.

West-Eberhard, Mary Jane. Developmental Plasticity and Evolution. New York: Oxford University Press, 2003. The relationship of plasticity to evolution is central to our understanding of how evolution actually occurs. It is a difficult subject here made clear in an excellent text.

ARTICLES, PRESS

Attanasio, John B. "The Constitutionality of Regulating Human Genetic Engineering: Where Procreative Liberty and Equal Opportunity Collide, "The University of Chicago Law Review 53 (1986): 1274-1342. 1 ordinarily dislike far-out speculation, but this essay, now twenty years old, remains remarkable for its detailed and complex presentation.

Charlton, Bruce G. "The rise of the boy-genius: Psychological neoteny, science and modern life,"Medical Hypotheses 67, no. 4 (2006): 679-81.

Dobson, Roger, and Abul Tahar. "Cavegirls Were the First Blondes to Have Fun,"The Sunday Times (U.K.), February 26, 2006.

Marshall, Eliot. "Fraud Strikes Top Genome Lab,"Science 274 (1996): 908-910.

Newman, Stuart A. "Averting the Clone Age: Prospects and Perils of Human Developmental Manipulation,"Journal of Contemporary Health Law and Policy 19, no. 1 (2003): 431-63. A scientist presents the anti-cloning case.

Patterson, N., Daniel J. Richter, Sante Gnerre, Eric S. Lander, and David Reich. "Genetic evidence for complex speciation of humans and chimpanzees, “Nature (advance online publication), DOI: 10.1038/nature 04789.

Rajghatta, Chidanand. "Blondes Extinction Report Is Pigment of Imagination,"Times of India, October 3, 2002.

"Scientist Admits Faking Stem Cell Data,"New York Times, July 5, 2006.

Stern, Andrew. "Artist Seeks to Free His Glowing Creation — Rabbit," Reuters, September 23, 2000, http://www.ekac.org/reuters.html

Wade, Nicholas. "University Panel Faults Cloning Co-Author,"New York Times, February 11, 2006.

“Journal to Examine How It Reviewed Articles,"New York Times, January 11, 2006.

Neng Yu, M.D., Margot S. Kruskall, M.D., Juan J. Yunis, M.D., Joan H.M. Knoll, Ph.D., Lynne Uhl, M.D., Sharon Alosco, M.T., Marina Ohashi, Olga Clavijo, Zaheed Husain, Ph.D., Emilio J. Yunis, M.D., Jorge J. Yunis, M.D., and Edmond J. Yunis, M.D. (2002). "Disputed maternity leading to identification of tetragametic chimerism,"New England Journal of Medicine 346, no. 20: 1545-52.

INTERNET SOURCES

"Berlusconi's Fat Becomes Soap." http://www.ananova.com/news/story/sm_1424471.html

'"Berlusconi's Fat' Moulded to Art." BBC News, June 20, 2005.

https://news.bbc.co.uk/2/hi/entertainment/4110402.html

"Blonde Extinction." http://www.snopes.com/science/stats/blondes.asp

"Blondes to Die Out in 200 Years." BBC News, September 27, 2002.

"Extinction of Blondes Vastly Overreported, Media Fail to Check Root of Study.'" Washington Post, October 2, 2002.

"Genetic Savings & Clone." http://www.savingsandclone.com/

"Marco Evaristti, Polpette al grasso di Marco, 2006 (to fry in his own fat)."

http://www.evaristti.com/news/meatball.htm

"It Really Hauls Ass." Wired, May 2006. http://www.wired.com/wired/archive/14.05/start.html

Marshall, Eliot. "Families Sue Hospital, Scientist for Control of Canavan Gene."

http://www.sciencemag.org/cgi/content/summary/290/5494/1062

"The Cactus Project." http://www.thecactusproject.com/images.asp

"Tissue Engineering: The Beat Goes On: Nature."

www.nature.com/nature/journal/v421/n6926/full/421884a.htm

WHO. "Clarification of erroneous news reports indicating WHO genetic research on hair color." October 1, 2002. http://www.who.int/mediacentre/news/statements/statement05/en/

Tuesday, September 10, 2024

ENVIRONMENTAL AND EPIGENETIC IMPACTS | “BIOPIRACY” AND PATENTS ON: “INDIVIDUAL HUMAN” GENOMES, MICROBIOME ORGANISMS’ GENOMES | PLANT GENOMES | ANIMAL GENOMES | AS OF 1994-2024 AND “GENE DRIVES” by Jeffrey Thayer (September 2024).

KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007)