SPEECHES
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A Talk to Legislative Staffers
Washington, DC
September 14, 2006

While writing Next, Michael concluded that laws covering genetic research desperately needed to be revised, and spoke to Congressional staff members about problems ahead.



What will happen next in genetics? After a year of inquiry, I’ve concluded that most of the discussion swirling around this field is pure fantasy. I think we should address realities, and legislation to deal with those realities.

The idea that we may create a race of ultra-smart people, that we can make designer babies, that we will live forever, or that we’ll have little Hitlers running around, is pure fantasy. To worry about such ideas is like worrying about an alien invasion. Conceivably we might one day face alien invasion, but it doesn't belong on our to do list now.

And the same with all the heavy pronouncements. In reality, I don't believe our humanity is at risk, I don't think we are playing God, I don't think any of the fears that we hear are justified in terms of what we is actually possible. And I think many of these hopes and fears about the genome will ultimately prove to be impossible.

As for legislation, I suggest we stick to the present. We laugh at the parent who frets over college applications right after the baby is born. There is a time to worry about college, but not while still changing diapers. And by the time the child is old enough for college, many things will have changed. And many fears just don’t come true.

What legislation is needed now? I identify four areas in need.

1. Stop gene patenting. Gene patents might have looked reasonable 20 years ago but the field has changed since in ways nobody could have predicted. And we have plenty of evidence that today, gene patents are bad practice, harmful and dangerous. End the practice now.

In saying this, I remind you that I am an intellectual property veteran. For forty years I have made my living from IP—selling it, licensing it, litigating it, negotiating it. I've lived through generations of change in IP agreements caused by changing technology in my particular areas. I've been to court over IP more than once (and I always win.) But I viscerally understand that IP creators need to protect their work and to make a profit.

But let me report the single deep truth about intellectual property that I learned in my life working in this area. The single truth is this---an IP worker will take possession of everything he can get. Everything.

Of course I copyright Jurassic Park. But if I could copyright all dinosaur stories on an island, I would. If I could copyright all rampaging animal stories, I would. I will take everything I can get. It’s just common sense.

However, my copyright protection is narrowly limited to specific expression. After Jurassic Park, somebody made a game called Jurassic Island, or Dino Island, I forget. Nothing I could do about it. This annoys me, but it is in the public interest because more products are available. And in fact it is in my interest, because it means that after dozens of medical TV shows, I can still do ER.

And it is this lifelong experience in IP that leads me to see so clearly gene patenting is against both public and private interest. Gene patenting breaks all sorts of long-standing rules about what is protectable, and it does so with no countervailing benefit.

1. Genes are facts of nature. Like gravity, sunlight, leaves on trees, and wind, genes exist in the natural world. They 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 rule.

Of course you can argue about what's a fact of nature, and there are people paid to do that. Here's a simple test. If something exists before homo sapiens arrived on the planet, it's a fact of nature. If I can have a child and it's in that child's body at birth, it's a fact of nature. Cut the sophistry and legalisms. Genes are our common heritate. Most of them are millions of years old. They are not human inventions and cannot be owned.

2. Gene patents are imprecise and debatable. Hoffman-LaRoche and Chiron litigated the Hepatitis C patents for ten years. We now know that gene sequences may perform different functions at different times. Or different parts of the sequence may be activated. So what is being patented? Or has been patented? Vague patents are bad patents, because they discourage others from working in the area. Gene patents discourage research. The recent NAS study of gene patents found that, too.

3. A gene patent is an undeserved monopoly. Once again, trouble arises because the patent is not for an invention, but a fact of nature. 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 your mp3 player, too. My patented mousetrap is wood, but your titanium mousetrap is allowed.

This is not what happens in 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. This makes the patent an overbroad monopoly, and bad public policy. That alone should be the end of the argument.

4. We have ample evidence they're bad policy, that gene patents 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 of creating a gene test is nothing like the cost to develop a drug. Not surprisingly the European patent office revoked that patent. The Canadian government announced it would test 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 and cooperated to get the gene identified. Too bad.

It's all a mess. And it's a dangerous mess. When you hear that SARS (severe acute respiratory syndrome) research was inhibited by concerns about who owned the genome, with three simultaneous patent claims going on...so research wasn't vigorous...that's scary. We're talking about a contagious disease with a 10% death rate that spread to two dozen countries around the world. And scientists wouldn't do research? Because of patent fears? You have to be out of your minds to allow this to continue.

At the moment, Hepatitis C, HIV, hemophilus influenza, various diabetes genes, are all owned by somebody. They shouldn't be. Nobody should own a disease. The idea is so ridiculous I can hardly bring myself to discuss it.

Finally, you should end gene patents because there is no other solution to the public policy mess they have created. Back in 2000, the AMA said that patent licenses should be inexpensive, so that research and patient care is not affected. That's a nice idea, but how do you ensure it happens? What's the definition of inexpensive? Who will determine that? Who will keep track? A new bureaucracy? A new wave of patent lawsuits?

This is all nonsense. Stop gene patents and move on. There will be screams, because as I said, everybody in IP tries to grab as much as they can. There will be cries that business will end, and companies will go bankrupt. But in reality there will not be serious interference with business or profits or research. On the contrary, my prediction is that ending gene patents will be phenomenally liberating and will usher in a golden age of biogenetic therapy.

2. We need added legislation to clarify a legal conception of human tissues and how they are used. Federal rules already exist, but the courts are ignoring those rules, and are confused because they are trying to reason based on prior property law. But people will always have a sense of personal ownership about their bodies and parts of their bodies, and that sense will never be abrogated by any contractual technicality or legal trickery. We need clear laws.

You may know about the recent Catalona case, in which an eminent prostate cancer physician assembled a large collection of tissues samples from his patients so he could work on the disease. When the doctor went to another university, he tried to take his tissues with him. Washington University refused, saying they owned the tissues; the case was litigated, and the judge upheld the university, in part because of such trivial facts as some of the releases were printed on Washington University stationery. Patients are understandably outraged, they thought they were giving their tissues to the beloved doctor, not the shadowy university; they thought they were giving tissues specifically to research a disease, not for any use, which the University now claims the right to do.

Where does that leave us? Under present law, if somebody takes my picture, I have rights forever in the use of that picture. Thirty years later, somebody publishes it or puts it in an ad, I still have rights. But if somebody takes my tissue, part of my body, I have no rights. I have more rights over my image than I have over the physical tissues of my body. That’s just plain absurd.

Universities are being very foolish. Patients will figure this one out. Let me give you a futuristic scenario. I have to go to the hospital for a blood test. Right now, I pay for the test. But I will soon go to priceline.com to get a bid for which hospital will pay me the most for the privilege of doing my test, and keeping my blood. So if you think that current rulings about tissues protect medical research, think again. If my tissues are valuable but you give me no rights once they leave my body, then my whole focus will be to control the point of departure. Fleets of lawyers will converge on this point. What happens next will be brutal, and expensive.

So: how can we really assist medical research? By giving patients appropriate control. I donate my tissues for a purpose, and that purpose only. You want to use them for something else, you need my permission again. You can't get my permission, you can't use the tissues. Simple. Two reasons for this: first, it gives me that emotional sense so important to me because it makes explicit the tie to the tissue even if it has left my body. Second, it acknowledges there may be significant legal and religious reasons why I do not want the tissue used for another purpose. Third, because that’s already the federal guidelines. The NIH seems to be able to do research, therefore other institutions can, too, thus proving their whines to be a legal fiction. But as I said, IP workers take all they can get.

3. We need laws to reveal information about gene testing. My understanding is that legislation is needed if the FDA is to publish adverse results from gene therapy trials. Pass such legislation. Make sure information gets out.

This to me is part of a general need to promote sunlight disinfection in federal research: the best way to regulate any technological issue is to ensure accurate information is made available, and that researchers can’t sit on their data, or only partially disclose it. Hiding the facts is not acceptable. And review studies conducted by those who have an interest in the outcome are not acceptable because they are inherently biased. Disinterested review is accomplished by people who don’t know the original workers, had nothing to do with the original study, and who have no stake, financial or otherwise, in the outcome of their evaluation. They are entirely free to speak their minds and tell the truth as they see it. And we all benefit.

But for a variety of reasons and across a number of political administrations, our government has weakened its demand for disinterested and verified information, and the result in many fields is a kind of madness. I’ve been involved in medicine, climate research, and genetics. In each field, the lack of genuine disinterested evaluation has impeded progress, caused needless conflict and expense, and has even caused deaths. There are now 14,000 lawsuits over Vioxx. A lot of people died for lack of information. Didn’t need to happen, if government did its job.

You can’t rely on the scientists. You can’t rely on the drug companies. You can’t rely on the journals. They are each, in their own way, malleable. So in the end, the people turn to government. And at the moment, we can’t rely on government, either.

Fix that. In the long run, there is no constituency for bad information. In the short run, everybody’s got a reason to feather the truth.

5. My final suggestion is—Don't Ban Anything. I'm aware that various groups want to ban something or other. I myself agree that certain research ought not to be pursued, at least not now. But as a strategy, I oppose bans on research and technology.

First, as a practical matter, bans can't be enforced. Why have we not learned that lesson? From prohibition to the war on drugs, we seem to indulge the fantasy that something can be banned. And we always fail.

On principle I oppose laws that can’t be enforced. They make lawmakers look ineffectual. And in a global economy, bans have other meanings: even if you can prevent the research here, it goes on in Shanghai. So what are you accomplishing?

Furthermore, it's human nature that anything banned becomes more attractive. Bans encourage breaking bans. They just do.

In addition, bans provoke extremists on all sides, either in support of, or opposition to the bans. The discussion gets taken over by the extremists, and the great American center, sensible, gracious, loving, and tolerant, is shoved aside.

Bans jump the gun. Often we ban something that hasn't happened yet, like human cloning. This is wrong for the same reason that worrying about the college application for your newborn is wrong. We’re not there yet—and when we get there, the landscape may look quite different.

Finally, and most important, bans interfere with efforts to arrive at consensus where we really need it. In my lifetime, I have seen a fifty-year explosion of technology around life issues. From the artificial respirator in the 1960s to somatic nuclear transfer in the 1990's, we have seen the ground rules for life change. These technologies force us to think and feel differently, about our loved ones, and about ourselves, and about birth and death.

These are among the most intimate, powerful, difficult, heartfelt feelings we have. The decision to let a loved one die—or not—is agonizing, and it is best made by those human beings closest to the person. It is not best made by somebody in Washington. That is actually deeply offensive at a profound human level. Many decisions must be made in uncertainty, or made with an understanding of the person's wishes, that other family members must respect, whether they agree or not. I argue that there a personal private sphere in which people must make technological decisions based on their beliefs, their conceptions of right and wrong, their conceptions of a Creator, and their understanding and love of their closest kin. This is not the business of Washington and you will, individually and collectively, pay a heavy price if you don’t keep out of it. The Schiavo episode produced a vast reservoir of bad feelings toward Washington throughout the country.

But the positive way to look at my argument is this way: I believe there is only one way that bans work, and that is when there is true social consensus. Nobody goes down the street naked, but not because there are laws against it. It's because we all agree it's inappropriate. Most of our behavior is not legally determined, it's socially determined, and it’s the result of a grown consensus. And this organic consensus is particularly important in the most intimate areas where distant government and other people's belief systems do not belong. Keep away from these areas, let people deal with their most heart-rending problems, let them talk among themselves, leave it alone for a generation or two, and you will end up with true social consensus. Force the consensus, and you have a culture war. We’ve done that quite enough. We know where it leads—to endless dispute, never resolved. That’s not in the interests of our country. Let’s take a different approach, and trust the people of this nation to come, collectively, to a wise and humane approach to the new technology we face.

Thank you very much.

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