Next: A Novel (48 page)

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 theydoing ?” this is a good place to begin.

Bailey, Ronald.Liberation Biology: The Scientific and Moral Case for the Biotech Revolution.

Amherst, N.Y.: 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.Biological 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.