BOOKS & MOVIES



Hardcover
Published in 2006
by HarperCollins
Paperback
Published in 2007
by HarperCollins
eBook
Published in 2009
by HarperCollins
Enhanced eBook
Published in 2011
by HarperCollins





As in several previous books, Michael put his own personal conclusions at the end of the book, in a separate section. Here is that section for Next:

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 elements like 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 technicality. 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.




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