Liberation Biology & Bioindustry Ethics (BOOK REVIEW FROM 2005) PUBLISHED IN BIOTECH LAW REPORTS

BioIndustry Ethics (2005); Liberation Biology (2005): BOOK REVIEW(S) By Dr. Arthur Kyriazis, molecular biologist Biotech Law Committee, AIPLA For Biotech Law Reports April 1, 2008 BioIndustry Ethics. David L. Finegold, C.M. Bensimon, A.S. Daar, M.L. Eaton, B. Godard, B.M. Knoppers, J.E. Mackie & P.A. Singer. (Available from and published by Elsevier Academic Press, 30 Corporate Drive, Suite 400, Burlington, MA 01803, USA, 2005). Liberation Biology: The Scientific and Moral Case for the Biotech Revolution. Ronald Bailey. (Available from and published by Prometheus Books, 59 John Glenn Drive, Amherst, NY 14228-2197). (Review copy available in hardcover, 332 pages, ISBN 1-59102-227-4, $28.00, Publication Date July 19, 2005). Reviewed by Dr. Arthur Kyriazis, molecular biologist. These two volumes are both indexed as “bioethics” volumes, yet two more different volumes could not be imagined. BioIndustry Ethics is a balanced, impartial study which deserves a place either on the professor’s reading list or on the shelf of in-house counsel at any biotech company, or on the shelf of outside counsel to a biotech company. The same cannot be said for Liberation Biology, which while admirable in scope and effort, fails at times on various accounts to be a fully academic study of the topics concerned, although suitable for a more general audience. I. BioIndustry Ethics – Book Review BioIndustry Ethics is a study of thirteen different biotech and pharmaceutical companies’ efforts to cope with a growing thicket of biotechnology ethics and regulatory environments by self-regulating. These companies in the main do so by delegating the job to Ethics Advisory Boards (“EABs”), which in turn draft model standards of ethical conduct for the companies to follow, et seq. Each chapter of BioIndustry Ethics is devoted to a solitary case study of a single company’s responses in the ethics realm. The specific companies studied in this volume are, seriatim, Merck, Genzyme, Millenium Pharmaceuticals, Maxim Pharmaceuticals, Diversa Inc., Pipeline Biotech A/S, TGN Biotech, the Partnership of Interleukin Genetics & Alticor, Sciona Ltd., Affymetrix, Inc., PharmaSNPs, Inc., Monsanto (during their bio-agriculture phase), and finally, Novo-Nordisk. The authors of the research, who have reported on their results and assembled these valuable case studies in BioIndustry Ethics are all university affiliated professors and scholars, who appear to be independent and impartial. The result is a rather dry, impartial and professorial study. At the inception of the study, the preface of BioIndustry Ethics states that “this book is the end product of a study that examined how bioscience companies are incorporating ethics into their decision-making….the book contains detailed case-study descriptions of how thirteen bioscience companies are approaching ethical concerns, primarily from the viewpoints of the executives and employees within the firms.” In summary, BioIndustry Ethics is a useful and functional volume. For those who teach, this volume would serve as an ideal addition to the reading list of a course or seminar for the week or unit on ethics and regulatory matters. Specifically, this volume shows how startups all the way through large pharmaceutical companies can self-police ethics issues and thus avoid potential problems down the road. Let us discuss the case of Merck. In Merck’s case, the fact that Merck has always had a clear mission statement and a public policy and image associated with serving the public first and profits second, has always served it well in terms of ethics and in terms of public image. The well-known Merck Manuals and other Merck publications distributed to the medical and nursing professionals and to the public, which have added to the cache of the Merck name. These are all matters raised in the Merck case study in BioIndustry Ethics. Many additional points are raised about Merck. Despite recent reverses, over the course of the last fifty years, Merck has been a model company with regards to ethics and public health issues. Merck early recognized that pharmaceutical companies bear a special responsibility in the greater fabric of society and the health professions, and that they have ethical duties and responsibilities. Consequently this may be viewed as one of the pivotal case studies in BioIndustry Ethics. The other case studies in BioIndustry Ethics are just as vibrant and important as the Merck case study. They demonstrate that the use of in-house EABs, mission statements, policy statements and commitments to being ethical in the development and deployment of pharmaceutical and medical device products is the wisest course in avoiding conflict with government regulatory agencies in the bioethics arena. Self-policing and setting criteria in-house is clearly demonstrated from the case studies to be the best policy for both biotechnology companies and pharmaceutical companies to follow. BioIndustry Ethics also belongs on the shelf of counsel and managerial employees of biotech companies, for the following reasons; (1) So they understand how other small and large companies handle their ethics issues in-house; (2) So they understand how EABs work and are set up; (3) So they understand how mission statements work and are set up; and (4) So they understand the background of ethics and self-policing of ethics in the industry generally. Finally, this volume belongs on the shelve of private law firms representing the emerging or ongoing biotech, and/or ongoing pharmaceutical company, that the firm might accurately counsel their client regarding, and draft and set the client up with EABs, policy statements, mission statements and the like in the event the client company lacks them. II. Liberation Biology Book Review A more vibrant contrast between BioIndustry Ethics and Liberation Biology: The Scientific and Moral Case for the Biotech Revolution (hereinafter, “Liberation Biology”)could not be imagined. BioIndustry Ethics is a scholarly, impartial study which adheres to academic standards. Liberation Biology on the other hand appears to adopt a point of view at various turns, and at various places, the scholarship or warrant for various points is weaker than that which an academic would like to see. The dustcover advises us that the author of Liberation Biology “Ronald Bailey is an award-winning science journalist, the science correspondent for Reason Magazine, a former television producer, and the author of Eco-Scam: The False Prophets of the Apocalypse.” The title of the book itself is a pun on the phrase “liberation theology,” which was noted as a social gospel movement of the 1960s among Latin American catholic priests and nuns who wanted to spread a gospel of “true” Christianity to the poor downtrodden masses of Central and South America, hoping this might stir them to political action. Bailey’s argument from the sixties movement to his book title is somewhat different; In the twentieth century, liberation theology was a spiritual movement aimed at helping humanity to overcome political and economic oppression. In the twenty-first century, liberation biology is the earthly quest to overcome to the physical and mental limitations imposed on us by nature, enabling us to flourish as never before. The claims made for biology generally, and for biotechnology and pharmaceutical science in particular by Bailey, in this sweeping preface, are extraordinarily broad. They are so broad as to suggest that Bailey views biology as a panacea or cure-all for every one of humanity’s ills. This is a claim that no serious scientist would ever make. While it is true that the new biology holds out great promise for the possible cure of several significant diseases such as cancer or Alzheimer’s with which we have been struggling for some time now, no serious medical professional or biologist would claim the new biology will transform all of humanity as Bailey does. But Bailey goes farther. Mr. Bailey labels his preface “Brave New World Reconsidered” and immediately plunges into a complicated argument—that the negative utopian novels of George Orwell and Aldous Huxley, 1984 (written in 1948) and Brave New World (written earlier) had such a negative effect on the 20th century that all biological experimentation was permanently discredited. Bailey calls this a “dystopic” effect of these two novels, and attempts to prove his thesis by quoting “liberal Boston University bioethicist George Annas” and Leon Kass “chairman of the President’s Council on Bioethics in 2001.” Then, a couple of paragraphs later, he relabels Kass and Annas “bioconservatives.” Reply to this flawed argument requires several levels of comment. A. The History of Bioethics and Forced Sterilizations in the United States Pre World War II; Eugenics, Nazi Sympathizers and Official Anti-Semitism As is now well-recognized, prior to World War II, certain members of the United States biology community were engaged for many years in a widespread eugenics campaign and movement. Moreover, eugenics had the widespread support of the entire United States legal, political and academic community; laws were enacted, forced sterilizations were carried out, and the German racial purity laws of the 1930s were based in large part upon similar laws on the books of the various states of the United States of the 1910s and 1920s. Eugenics was not confined to the biology community: virtually every state had by 1930 passed a eugenics-style forced sterilization law; the US Congress passed a racially motivated immigration-restriction bill in 1923-24 to prevent the immigration of southern Europeans and favoring the immigration of northern Europeans because of concerns over the dilution of the native American stock; and finally the US Supreme Court weighed in the case of Buck v. Bell, 274 U.S. 200 (1927). The situation was summarized by Prof. Jon Beckwith : How Eugenics Ideology Took Hold In the Early Part of the Century It is possible to distinguish several factors that led to a strong eugenics movement with significant social impact in the first twenty-five years of this century. First, there was the rediscovery of Mendel’s laws of inheritance around the turn of the century. Very quickly, scientists in this new field found that they could explain the inheritance of a host of simple traits by mendelian analysis. However, these same geneticists also very quickly began to attempt to extend this analysis to the inheritance of more complex traits, including human behavioral characteristics. In this early stage, between 1900 and 1915, a majority of the leading geneticists in this country supported this approach, which had serious eugenic implications. Among them were Pearl, East, Popenoe, Davenport, Conklin, Morgan, Jennings and Castle….It may be, that in some subtle way, the exciting discovery of the accurate predictive aspects of genetics influenced scientists to make an illogical jump to the much more complex behavioral traits. The new field of genetics thus either led to or reinforced ideas of biological determinism among them. Prof. Beckwith does not stop there, however. He notes that Davenport, one of the leaders of the eugenics movement and founder of the Eugenics Records Office at Cold Spring Harbor Laboratories, made incredible claims for genetics and eugenics to explain human traits, unfounded by any real scientific basis; …Davenport, one of the leaders of this [eugenics] movement, concluded that ‘alcoholism, seafaringness, degeneracy and feeblemindedness were each due to single mendelian factors.’ Davenport and others also claimed that the findings of genetics research demonstrated that mating between two races within a species would have breed inferior stock. For instance, it was suggested that mulattoes would have ‘the long legs of the Negro and the short arms of the white, which would put them at a disadvantage in picking things up off the ground.’ He also goes on to note the involvement of social and political forces at work in the eugenics movement: Another factor at work in the growth of the eugenics movement was the increasing class conflict in this country [the United States] in the latter half of the nineteenth and early part of the twentieth century. There had been growing unrest of working people over industrial working conditions and wages. Labor agitation led to increasingly violent confrontations between workers and industrialists, culminating in the 1886 Haymarket bombing and riots. As part of the counterattack on workers, the industrialists and the newspapers that supported them began to push the idea that a lot of the trouble could be traced to immigrant workers. According to the New York Times ‘labor disturbances are brought about by foreigners’ and ‘demonstrations were always mobs composed of foreign scum, beer-smelling Germans, ignorant Bohemians, uncouth Poles and wild-eyed Russians.” Thus, ideas of eugenics and their supposed new scientific respectability were a godsend for the ruling class. For instance, Albert Wiggam, who along with Madison Grant and Lothrop Stoddard, was a great popularizer of eugenics, stated: ‘Heredity has cost America a large share of its labor troubles, its political chaos, many of its frightful riots and bombing, the doings and undoings of its undesirable citizens. Investigation proves that an enormous proportion of its undesirable citizens are [sic] descended from an undesirable blood overseas. America’s immigration problem is mainly a problem of blood.’ Davenport, speaking before a conference of social workers, stated that ‘social reform is futile and the only way to secure innate capacity is by breeding it.’ [Professor] McDougall, Chairman of the Department of Psychology at Harvard, called for the ‘replacement of democracy by a caste system based upon biological capacity with legal restrictions upon breeding by the lower castes and upon intermarriage between the castes.’ Eugenics took strong enough hold so that even Margaret Sanger, a feminist, socialist and birth control advocate, suggested in 1918 and in 1919 that ‘all our problems are the result of overbreeding among the working class….[m]ore children from the fit, less from the unfit—that is the chief issue of birth control.’ As a consequence of the overwhelming scientific support for the eugenics movement, and its consonance with socio-political movements of the time, Prof. Beckwith notes, “funding was quickly forthcoming from leading industrialists to support the eugenics movement.” Prof. Beckwith goes on to note that “[i]n 1907, the Harrimans, Kelloggs and Carnegies funded the opening of the Eugenics Record Office at Cold Spring Harbor, Long Island.” As the author notes, “the Eugenics Record Office was located at the site now occupied by The Cold Spring Laboratory of Quantitative Biology” and “[t]here still exists at this laboratory an extensive collection of eugenics literature from this [the 1907-1945] period.” This, of course, is the same Cold Spring Laboratory made famous by James Watson and others of note in more recent times. The archives of the Cold Spring Harbor have given rise to one of the most valuable research sources on American eugenics, because their summaries have been carefully and systematically put on line for scholars and laypersons to examine. These can be found at the “Images Archive on the American Eugenics Movement” at www.eugenicsarchive.org/eugenics. The website contains nearly all of the original material on Davenport, who headed up the Cold Spring project for many years, and many others who contributed to the eugenics movements, and contains many academic as well as photographic references, along with an exhaustive look at laws and policies that flowed from the eugenics movement. The overall impact of the eugenics movement in the United States and in other countries was substantial. In the United States along, Prof. Beckwith notes, “[b]etween 1911 and 1930, 33 states passed laws requiring sterilization for a variety of behavioral traits deemed to be genetically determined. These included, depending on the state, such characteristics as criminality, alcoholism, tendency to commit rape, sodomy or bestiality, and feeblemindedness. Many of these laws are still on the books [as of 1976] and have resulted, since that time, in at least 60,000 [forced] sterilizations.” Prof. Beckwith goes on to note that the greatest number of sterilizations were performed on the grounds of feeblemindedness, based on administration of IQ tests administered by the U.S. Public Health Service, then run by a Dr. Goddard; the same IQ tests found feeblemindedness in 83% of Hungarians, 87% of Russians, 83% of Jews and 79% of Italians. Thirty-four states passed miscegenation laws banning marriage between African-Americans and whites, and in many cases between Asian-Americans and whites, and these laws were not declared unconstitutional until the case of Loving v. Virginia in 1967. But long before the Warren Court had its say, the eugenics movement also had its day at the Supreme Court as well, in a now infamous opinion of the Hon. Justice Oliver Wendell Holmes, in the case of Buck v. Bell, 272, U.S. 200 (1927). In the case of Buck v. Bell, Virginia resident Carrie Buck in 1924 was raped. Carrie Buck’s alleged Binet-Simon IQ test purportedly revealed her ‘mental’ age to be nine (9) years old, and her mother, Emma, was also alleged to have had a ‘mental’ age of less than eight (8) years old. As a consequence, Emma Buck, the mother, was confined to the State Colony for Epileptics and the Feeble-Minded at Lynchburg, Virginia. Upon the birth of Carrie Buck’s daughter, Vivian Buck, on March 28, 1924, Virginia authorities brought a test case to authorize the forced sterilization of Carrie Buck. After a trial November 18, 1924, the trial court found that the Buck family was part of the “shiftless, ignorant and worthless class of anti-social class whites” in the south, and that Vivian, the child, “was not quite normal.” Bell appealed to the U.S. Supreme Court through her attorneys. The U.S. Supreme Court, per Oliver Wendell Holmes, ruled against Buck and in favor of the Commonwealth of Virginia in a 7-2 decision on May 2, 1927, following which Carrie Buck was forcibly sterilized due to her legal and medical diagnosis as a “moron” in October 1927. Justice Holmes wrote for the majority as follows; Experience has shown that heredity plays an important part in the transmission of insanity and imbecility. We have seen more than once that the public welfare may call upon the best citizens for their lives. It would be strange if it could not call upon those who already sap the strength of the State for these lesser sacrifices, often not felt to be such by those concerned, in order to prevent our being swamped with incompetence. It is better for all the world, if instead of waiting to execute degenerate offspring for crime, or to let them starve for their imbecility, society can prevent those who are manifestly unfit from continuing their kind. The principle that sustains compulsory vaccination is broad enough to cover cutting the Fallopian tubes. Three generations of imbeciles is enough. According to one source, after Justice Holmes’ ruling in Buck v. Bell in 1927, “numerous states passed similar laws [to Virginia’s forces sterilization laws] and Nazi Germany gave the fullest sweep to the movement [of eugenics]. This case provides a strong argument for careful scrutiny, especially at the local level, of ideas ground upon popular notions of science.” According to another source, “[b]y1927, before Carrie Buck lay prostrate beneath Dr. Buck’s surgical blade, almost 8,500 American citizens had been forcibly sterilized. This ‘official’ figure, taken from informal surveys by proponents of the procedure and representing only what surgeons chose to report, would reach well over 65,000 in the decades to come. Ill-educated and poor, these people were operated upon and mostly forgotten.” According to the same source: After Carrie [Buck’s] sterilization [in 1927], there was a renewed push to pass new laws, and institutions in states that had already approved the procedure began sterilizing inmates at a dramatically higher rate. In all, at least thirty states, as well as the territory of Puerto Rico, passed laws to quell the tide of hereditary defectives through forced sterilization. After 1927, this American technique of social engineering became the model for laws in Canada, Denmark, Finland, France and Sweden. In 1933, in one of the first acts of the newly elected government of Reichschancellor Adolf Hitler, the National Socialist Party enacted a comprehensive sterilization law modeled consciously on American legislation. This was not the nadir of pre-world war II American bioethics eugenics activity. As the anti-Jewish activities of the Nazi regime slowly came to light during the 1930s and thereafter, pressure came upon Congress to relax the very strict immigration quota which had been placed upon Jewish immigration under the Immigration Act of 1924. However, repeatedly, when this issue came up, in 1934 and again in 1938, eugenics leaders such as Harry Laughlin testified and wrote to Congress specifically opposing relaxation of the quota for Jewish immigration: There is a movement now to make special legislative provision for the Jews persecuted in Germany,” [Dr.] Laughlin wrote in 1934. As Jewish refugees fled the systematic brutality of Adolf Hitler and the new regime in Germany, a host of New York civic groups and private citizens demanded that the Chamber of Commerce, responsible for processing most immigrants after they had come to the country through Ellis Island, offer asylum to these foreigners driven from their homes. When the chamber’s chairman, John B. Trevor, set up this special commission to study whether its members should grant any emergency exceptions to the Immigration Act of 1924, he asked Laughlin to prepare a scientific report on these questions. ‘Dr. Laughlin is beyond doubt the foremost authority in the United States today on the subject,’ Trevor said, “and his previous researches along similar lines for the Committee on Immigration and Naturalization of the House of Representatives peculiarly fitting him for the task.’ Laughlin presented his report in the first week in May 1934 and his recommendations were unambiguous: political oppression and forced emigration were not valid reasons to ease the nation’s immigration curbs. Complicating the situation was an executive order from President Hoover restricting emigration under the German quota unless the emigrant could prove beyond a reasonable doubt they could not become dependent on government aid. The conclusion: Based on Laughlin’s report, the Committee on Immigration made three terse recommendations: “No exceptional admission for Jews who are refugees from persecution in Germany. No admission for any immigrant unless he has a definite country to which he may be deported, if occasion demands. No immigrant to be admitted whose ancestors were not all members of the white or Caucasian race.” The United States Congress did not alter its stance from 1934 to 1938, and Dr. Laughlin continued to oppose changing the quotas to admit Jews persecuted by the Nazi regime. The situation did not substantially improve during the war, and the failure to admit the Jewish refugees into England or the United States even as the Holocaust was underway remains one of the most shameful chapters in our history. What is not so generally recognized is that the refusal to admit the refugees had its origins, at least in part, based on “scientific” theories of eugenics made popular and politically palatable prior to World War II. B. The Post World War II Era – the Nuremberg War Crimes Trial, the United Nations, the Founding of the Israeli State, Human Rights and Crimes Against Humanity – the Modern Era of Condemning Eugenics Begins The modern era of bioethics really begins with the defeat of Germany, the discovery of the horrors of the Holocaust, and the Nuremberg War Trials. But in order to make its case of war crimes at Nuremberg, Justice Jackson and the prosecution team had to specifically spell out that the Nazi’s use of race-purification and discrimination against lesser races on the basis of genetics was a crime against humanity as exemplified in Justice Jackson’s opening statement to the tribunal: [The Nazis] took from the German people all those dignities and freedoms that we hold natural and inalienable rights in every human being. The people were compensated by inflaming and gratifying hatreds towards those who were marked as “scapegoats.” Against their opponents, including Jews, Catholics and free labor, the Nazis directed such a campaign of arrogance, brutality and annihilation as the world has not witnessed since the pre-Christian ages. They excited the German ambition to be a “master race,” which of course implies serfdom for others. They led their people on a mad gamble for domination. In the context of the Nuremberg trials, Nazis were put on trial for experimenting on human beings, for systematic programs of genocide and eugenics programs (including the Nazi “lebensborn” program to “breed pure Nordics” and negative eugenics programs to eliminate “non-Germans”—thus giving rise to the world’s first official legal glimpse at what genocide was and how it worked on a statewide scale. The upshot for the eugenics movement in America was all too clear. As one authority puts it: As revelations of the Holocaust stunned the world [during the Nuremberg War Crimes Tribunal Trials], it became impossible for eugenic reformers to carry on their message of racial purity in the United States. Their foremost leaders, Charles Davenport and Harry Laughlin, had passed away [during World War II], and many of their organizations soon folded or simply removed the term “eugenics” from their names. After Ezra Gosney, the founder and president of California’s Human Betterment Foundation, died in 1942, the sterilization program in the most eugenically active state began a precipitous decline…Other eugenics organizations became devoted to a new cause: world population control. With Nuremberg came the United Nations Declaration of Human Rights, the advent of genocide scholarship, the recognition of rights in all minorities in all nations, and a slow but gradual evolution of recognition on the parts of all societies which forcibly discriminated against their minorities (such as apartheid societies like South Africa or the Jim Crow South of the United States) that change must come through lawful means. That this was a worldwide rather than a countrywide movement is a testament to the far-reaching vision of Justice Jackson and the Nuremberg prosecutors and to the founders of the United Nations. Key also was the founding of the Israeli state in 1948, a homeland for the Jewish people. Because the United States became a key backer of its founding, due to Pres. Truman, who also committed to the desegregation of the armed forces and of the federal government during his administration, Israel became a model for human rights early in its history and a place where all citizens of Jewish ancestry could find haven. The notion that all persecuted minorities were entitled to homelands, to dignity and to respect, took on greater emphasis in the post-world war II milieu with the UN and the founding of Israel. This had a profound effect on how biologists and the public generally viewed the claims formerly advanced for eugenics, which was now regarded as something vaguely German or Nazi-like in scope and in thinking. Indeed, the U.S. biology community spent much of its post-world war II time doing all that it could to rid itself of the memory of eugenics and to devote itself to the serious new sciences of DNA and molecular biology and biochemistry which were now rapidly developing and which promised real advances in actual genetics and true genomics. C. The Current Era of BioEthics and the Claims of Liberation Biology Having examined the pre-World War II history of bioethics and eugenics in the United States, we are now in a better position to debunk Bailey’s claims that the negative utopian works of Orwell and Huxley somehow discredited biological experimentation. First, as to Huxley, it is now fairly clear that Huxley’s work, far from being serious, was in fact intended as a parody of the excesses of the eugenicists. The “brave new world” of Huxley, taken almost word for word from almost any of the eugenics enthusiasts such as the psychology professor we encountered at Harvard during the early part of this century, is in fact intended as a gross joke to demonstrate how sickening and disgusting a world without democracy, devoted to eugenics and classification by function and biology, such a world would be. As such, the book has become a classic in dystopianism, or portrayal of negative utopia, especially in light of the disclosures of the Nazi horrors revealed during the Nuremberg war trials era. What is difficult to see is how this wonderful book has impeded, in any way shape or form, modern biological progress. The alpha-helix was elucidated by Linus Pauling; Watson, Crick & Franklin discovered the structure of DNA; crystallography began to uncover the three dimensional structure of proteins such as carboxypeptidase-A; and the modern eras of molecular biology and biochemistry were begun during the 1940s and 1950s. The new genetics were a far cry from what the eugenicists were doing; serious geneticists were karyotyping chromosomes, searching for physical defects, and looking for the keys to life in the structures of the gene itself. Likewise, it is difficult to see what if any relevance Orwell’s work 1984 has to the subject of biology. Written in 1948, the title is a numerogram of its date of writing, and the book is intended as a dystopic parody of both socialism and totatalitarianism, both of which Orwell was opposed to. Orwell was a champion, as everyone knows, of liberty and freedom. But as to how this book impeded modern biology, other than the assertion of the author, we have little evidence. If anything, generations of students who have studied both Orwell’s and Huxley’s works have grown up legitimately opposed to communism and fascism, and to the misuse of science by any central authority with too much power; and if that is true, that is probably a good thing. Perhaps the defeat of the Soviet Union and the liberation of Eastern Europe have not been in vain. Regarding Bailey’s alleged sources on this assertion, Distinguished Professor’s Annas and Kass, if there is one thing we can be sure of, it’s very likely that these two do not agree on very many points, as Annas is fairly liberal and Kass fairly conservative. While both of them would like to regulate modern biotechnology, Annas would like to do so for the society’s right to regulate from above any scientific activity, which amount to liberal bioethics reasons, while Kass’s concerns derive from his conservative, deeply and well-held concerns for the dignity and morality of the individual, which propel Kass to believe than nearly any interference in the natural conception activities are somehow wrong. However, there is nothing intrinsically wrong with the viewpoints held by either scholar, and secondly, it is impossible to see how these viewpoints support Bailey’s argument that Orwell’s and Huxley’s works have played a role in blocking the past, present or future of biotechnology or of biology. There are other flaws in Bailey’s work, too numerous to comment in so limited a space as this. Suffice it to say that Bailey makes numerous claims in his book, but fails to make the necessary arguments to hold them together; as either his warrants for his claims are deficient, or his evidence is lacking, or his arguments are of a form that do not prove the argument, such as being of an ad hominem nature, attacking a straw man, arguing over irrelevant issues, asserting the existence of a homogenous “bioconservative” monody that does not quite exist, and so forth. One could cite numerous such instances but suffice it to say that the book falls short of academic or even logical standards of reasoning, proof, citation and argument. Moreover, the work is argumentative at nearly every turn and fails to take a balanced or reasoned approach to any of its topics, which mars whatever other value the work might have had as a reference. A work on bioethics can certainly take a point of view, but in doing so must be measured and persuasive if it is to capture the audience to its position. Each chapter of Liberation Biology beats a drum for its various positions, but the chapters fall short of being persuasive arguments or even marshalling evidence for their views. One must assume in writing a book that one is attempting to either persuade one of the opposing view, or further convince the true believer. In either event, every statement made in a book must be calculated towards one end; persuading the reader towards the thesis of the writer. First and foremost, the writing must be logical and persuasive, and secondly, the evidence in support of each and every point must be marshaled at every turn. Consistently, Liberation Biology makes assertions instead of arguments; strings together statements rather than making progressive argumentation; fails to be logical or to follow logical syntax; and at every turn where evidence is demanded, mere assertions or conclusions are offered up. In short, the book’s methods of organization, argument and evidence are disappointingly short of the usual academic and logical standards. Far from adhering to academic standards, Liberation Biology engages in a good deal of invective, characterization, faulty reasoning, logically inconsistent or logically fallacious analysis, and in general, contains many passages which are difficult to follow. Chapters are poorly written, poorly edited, poorly organized, and some chapters could be better viewed as a rant against the author’s favorite targets than as serious academic writing. Liberation Biology consequently cannot be viewed as a well-written, well-reasoned, well-evidenced and well-argued book on bioethics. The contrast with the companion volume being reviewed here could not be more striking. III. COMPARING AND CONTRASTING THE TWO WORKS TOGETHER To understand these two works together, one must propose a paradigm that envelops the entire body of regulation and ethics in the biotech/pharma sphere. This paradigm is easy enough. If there is an ethics problem, there will be one of three solutions; either private industry will police it themselves; the government will regulate it through the states or federal government; or the government will directly legislate on the matter through the states or federal government. There can also be permutations of the two, such as joint industry-state or industry-federal regulation, as we have with FDA approval. Although Bailey is correct to some extent that bioethics experts such as Distinguished Professor Annas usually call for direct federal legislation to solve specific bioethics problems, this is not true of all bioethics experts in the United States. For an example of a leading bioethics expert who turns to non-governmental organizations (“NGO’s”) for the solution to bioethics problems, we can consider Dr. Andrea Bonnicksen, Ph.D., of the University of Northern Illinois. Dr. Bonnicksen has been in the bioethics field for more than twenty-five years. Her advocated solutions to most bioethics are as follows: (1) Industry should always set up Ethics Advisory Boards (“EABs”) in house; (2) Industry should have ethics advisors and ethics consultants at all stages of startup and operations; (3) Industry should self-police; (4) It’s not a conflict for academics to consult to industry on ethics issues frequently; in fact, it’s a valuable service they render; (5) If the government has to get involved, as much as possible, have the industry self-regulation, or devise a regulatory system which give the industry financial incentives to obey the regulatory scheme. Bonnicksen takes industry ethics seriously, and while she accepts that the federal government can do a good job of regulation and of legislation, she correctly puts the onus for most of that regulation on the companies themselves. Of these two volumes, therefore, the first, BioIndustry Ethics, is by far the more valuable, since it presents us with specific case studies. Chapter One presents us with the case study methodology, which is organized and thorough, and Chapter Two gives us the first, and perhaps most interesting case study—Merck—which since its founding by George W. Merck and a speech he made in 1950, has stood by the Merck credo and Merck Mission Statement for more than fifty years: “We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. The better we have remembered that, the larger they have been.” The case study analyzes this statement and the Merck Mission Statement, set forth at length therein, and concludes that there are two main points; first, that Merck is a long-term player, committed to research and development of long-term drugs; and second, that Merck is devoted to patients’ health and well-being as a whole. The self-regulatory approach—endorsed by Dr. Bonnicksen and other centrist bio-ethicists working in the field—and evidenced to be working by such case study works as BioIndustry Ethics—presenting a model of mission statements, as with Merck, and EABs and internal ethics advising groups, as with many other companies—seems to make a great deal more sense than the panoply of increased governmental regulation and micromanagement advocated by Bailey in Liberation Biology or by governmentally- oriented bioethics professors who almost always suggest the government as the cure to all problems. NGOs or non-governmental organizations have the capacity to fully regulate bioethics, or at least police a good proportion of the known issues. While the captivity of government regulatory agencies is a well-known phenomenon and beyond the scope of this review, clearly government regulation is not the solution to any problem in private industry so long as the regulation consists of an agency that eventually will be co-opted by industry lobbyists and interests. It is surely better to rely on the current environment of letting private industry police itself and let the bioethics professors work directly with industry in these EABs promulgating guidelines as consultants. To this extent, BioIndustry Ethics proposes far the more ethical solution to the bioethical complexities our industry faces in the years ahead. THE END