Hans Keirstead is a professor of anatomy and neurology at the University of California at Irvine who has done something incredible with paralyzed rats. Able
to walk only with their forelegs, the rats dragged their torsos, hind legs, and tails behind them. Keirstead coaxed stem cells derived from human embryos into becoming
oligodendrocytes, cells that help neurons send impulses throughout the body. He then injected the cells into the rats. The result: the rats miraculously could move their hind legs and tails.
In the fall of 2004, Keirstead campaigned for California’s stem cell initiative – Proposition 71 – by showing “before” and “after” videos of his rats to various groups of potential voters.
He and his work have been featured in a segment of the news magazine 60 Minutes and an article in the New Yorker magazine. Keirstead’s primary financial backer, the biotechnology firm
Geron, hopes that the Food and Drug Administration (FDA) will soon make its oligodendrocyte preparation the first product derived from human embryonic stem cells approved for use in human
clinical trials in the United States.
Hwang Mi Soon spent nineteen years in a wheelchair, paralyzed after falling from a bridge at the age of nineteen while running from a would-be attacker. In October 2004, she received a spinal injection of stem cells collected from umbilical cord blood. The next month, with the help of a walker, she stood up and shuffled several steps. Repeating the description used by Soon herself, newspapers around the globe called the results a miracle. The creator of the therapy announced plans for clinical trials and claimed that it would be widely available by 2006.
Within weeks, though, the apparent benefits had completely dissipated. Just months after her first injection, Soon underwent a second stem cell treatment. This one caused an infection and, according to reports, left her in constant pain and unable to sit for more than a couple of hours at a time. “I was like an animal they used for testing,” she said the following year. “I don’t want there to be another victim.” She blamed her condition on “unscrupulous doctors who were more concerned with making their names and earning money by enabling me to walk than the potential risks.”
Over the past decade, there has been no shortage of scientific experts and political leaders predicting that stem cell research will lead to the most important medical care advances in our lifetimes. Former National Institutes of Health (NIH) director Harold Varmus testified before Congress that “There is almost no realm of medicine that might not be touched by this innovation….It is not too unrealistic to say that this research has the potential to revolutionize the practice of medicine and improve the quality and length of life.” The dean of the Harvard University Faculty of Medicine claimed that stem cell therapies “have the potential to do for chronic diseases what antibiotics did for infectious diseases” and hopes that current research will lead to a “penicillin for Parkinson’s.”
Senator Orrin Hatch (R-Utah) called stem cell research “the most promising research in healthcare perhaps in [the] history of the world.” More than two hundred members of Congress signed a letter to President George W. Bush claiming that “stem cells have the potential to be used to treat and better understand deadly and disabling diseases that affect more than 100 million Americans, such as cancer, heart disease, diabetes, Parkinson’s, Alzheimer’s, multiple sclerosis, spinal cord injury, and many others.”
Whether the potential of stem cell research will be achieved, justifying these prophecies, or whether a path strewn with unfulfilled expectations will cause history to regard the stem cell revolution as more hype than substance depends on the intrinsic power of stem cells and the creativity and brilliance of the research scientists who work on the revolution’s front lines. But that is only part of the story. The ability of these scientists to deliver improved treatments and cures for a raft of debilitating diseases depends, in turn, on how our government makes the policy choices, designs the laws, and creates the institutions that surround the stem cell research endeavor. This book is about what the critical choices are, how the law ought to be structured, and how institutions should be designed.
The policy issues raised by stem cell research are wide ranging and varied. As a result, this book has an extremely broad scope. Some of these issues garner a fair bit of attention in the popular press, although the media’s superficial coverage rarely does justice to the complexity of the questions involved. Many of the issues receive little attention at all outside of a very small circle of people who study bioethics and scientific research for a living. Dealing with all of the issues in a thoughtful and prudent manner, however, is critical to ensuring that the stem cell revolution leads to the most far-reaching improvements in the treatment of disease that the underlying science is capable of delivering while at the same time not undermining our society’s moral fabric.
One set of issues that we as a society must confront in the early years of the stem cell century is whether, in spite of its potential health benefits, ethical considerations should lead us to prohibit or refuse to fund certain types of stem cell research. A second set concerns the regulation of the relationship between researchers and the donors of the biological matter that is the raw material for stem cell research. Of course, embryonic stem cell research has attracted enormous interest in the United States and internationally, not only because of its scientific and medical potential, but also because of its commercial promise. Forecasts of the market for stem cell technologies range from a fairly modest $100 million to a more optimistic $10 billion by 2010. Such financial projections raise a third set of important policy concerns: how the law should allocate intellectual property rights to the innovations that result from stem cell research. Rules of property and contract law not only serve to allocate the financial proceeds of research, but they also create incentives for research that are likely to have a significant impact on what research is undertaken, how much private funding it will attract, and how successful the research will be in leading to new and more effective medical treatments.
The following nine chapters engage this broad range of legal issues implicated by stem cell research and the potential of that research to revolutionize the treatment of disease. Each issue-specific chapter attempts to achieve three interrelated but distinct goals: (1) identify the most important, interesting, and salient legal issues raised by stem cell research; (2) for each legal issue raised, describe the current state of the law. In some instances, the law is clear and this task is straightforward; in others, it is quite unsettled, and a large amount of interpretation is required; (3) offer a critical assessment of the law and proposals for optimal policy.
Chapters 2 and 3 concern the legal relationship between the scientists on the front lines of stem cell research controversy that has gained the strongest foothold in the media and the popular imagination: the morality of human embryonic stem cell (husk) research, whether the U.S. government ought to fund such research, and the consequences of the current funding embargo. Chapter 3 considers the subject of therapeutic cloning, including both the policy issues and constitutional concerns implicated by proposed legislation to prohibit this area of research, which has tremendous but uncertain medical potential.
Chapters 4 and 5 turn to issues relating to intellectual property rights in the fruits of stem cell research. Chapter 4 considers patents. Should people be able to own innovations in stem cell technology to the extent that they can prohibit others from using that technology without permission? A negative answer might stifle basic research, but a positive one might stifle applied research, in addition to having the unsettling consequence of making what exists in one person’s body the property of another. Chapter 5 focuses on controversies over whether and how the public ought to benefit from innovations that owe their development to public funding. What payback, if any should we expect from innovations that blossom from our tax dollars?
Chapters 6-8 shift from the scientists upon whom society relies to innovate in the field to the donors of human tissues, the raw materials on which scientists will increasingly need to rely. Chapter 6 examines the autonomy principle and “informed consent” rules that underlie the legal regulation of scientific research involving human subjects and considers complicated questions in this area of law raised by stem cell research. Chapter 7 takes on the controversial question of whether the embryos, ova, and other human tissues needed to fuel stem cell research should be subject to market transactions rather than merely altruistic donations. Chapter 8 grapples with how the law does and ought to deal with tissue donations when compensation is not mentioned at all by either researcher or donor.
Chapter 9 looks ahead to an era of clinical regenerative medicine in which stem cells are routinely conceived of as therapeutic treatments. It addresses three distinct questions: In what circumstances is it appropriate to use one person’s stem cells for the medical benefit of another? To what extent should the origin of stem cells in the human body subject them to different regulatory treatment than other medical products? In what circumstances should the makers of such a new class of products be legally liable for harm that they inadvertently cause? Finally, Chapter 10 concludes with a summary of the book’s findings.
While this book is about public policy and law rather than cell biology or medical research, for nonbiologists a brief description of stem cell science and its potential is nevertheless a necessary prelude to analyzing the social issues that are considered in detail in the chapters that follow. It is at this point that we shall begin.