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Gary Marchant of Arizona State University on Toxic-Tort Genomics

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At A Glance

Gary Marchant, professor of law and executive director, Center for Law, Science & Technology,

Arizona State University College of Law, Tempe Ariz.

Education: 1990 — JD, Harvard Law School

1990 — Master of Public Policy, John F. Kennedy School of Government, Harvard University.

1986 — PhD, genetics, University of British Columbia.

1980 — BSc, University of British Columbia.

Experience: 2000-Present — Faculty, Arizona State University College of Law

1990-1999 — Attorney, Kirkland & Ellis (Washington, DC)

 

In 1990, the top student coming out of Harvard Law School was a PhD geneticist with a desire to combine his scientific education with his legal skills. While his magna cum laude credentials opened many doors, his options were limited as not many law firms offered that type of practice.

Today, Gary Marchant, 46, is a tenured professor at the Arizona State University College of Law, teaching Environmental Law, Law Science and Technology, and Genetics and the Law, while heading up the school’s program in science and technology. The school has 27 faculty members specializing in law, science and technology as of the fall, and 85 law students specializing in this area. Marchant is teaching in the dynamic genomics environment of Phoenix,where the Translational Genomics Institute has raised over $100 million to kick off its research efforts; where Arizona State University is preparing to open the first 250,000 square feet of a planned 1 million square feet of advanced research space for its AZ Biodesign Institute; and where Amersham’s CodeLink line of microarrays is beginning a transition to new owner General Electric. following that company’s $10.3 billion acquisition.

Before coming to ASU, Marchant worked at the Washington offices of the law firm of Kirkland & Ellis, rising to partner in 1995, while conducting a practice in environmental law, occupational safety & health law, and administrative law, and making appearances before the US Supreme Court and five different circuits of the US Court of Appeals.

Recently, BioArray News caught up with Marchant to speak about the role that genomics and toxicogenomics might play in environmental law and policy.

The FDA is not alone in looking to regulate this emerging field, is it?

Last summer, the EPA put out an interim genomics policy that said, ‘starting now, the agency will include genomic data in making regulatory decisions but will not base regulatory decisions solely on genomic decisions.’ That [policy] gave a green light, saying ‘Okay, we are open for business on this. If you, as a company, want to submit genomic data, you can, and we will consider it; and it can go into our decision making but we are not going to base our decision solely on genomic data.’

Also, the US Environmental Protection Agency and Europe’s [environmental regulatory agency] have come to an agreement that they are going to start using genomic data in screening chemicals. They are going to use genomics in SIDS, a basic dataset that regulators put together about chemicals. That is a real project.

So far, pharma seems hesitant to submit genomic data. Will chemical companies follow suit?

I think the same thing is happening. Although in a draft white paper on genomics that came out 10 months after the interim policy paper, [EPA] made reference to one company that has submitted genomic data, although they won’t say whom, I think very much the same thing is happening: Chemical companies are holding back a little bit. The chemical industry had a conference on this about two years ago in Orlando about how they were going to deal with genomic data. They put out a summary that was published in Environmental Health Perspectives, which is an NIEHS journal, and they were talking about the issues as they saw them. They were clearly scared.

What would they be scared about?

The big thing would be chemical A causes a change in gene expression at some level below where it is regulated. And so now is this an adverse affect? The way a lot of environmental regulation is based is that you find the lowest concentration of the chemical where you get any kind of adverse toxicological affect and that triggers all kinds of regulatory things. It triggers reporting requirements. The regulations are based on applying some safety factors — 10-fold or 100-fold — and then that’s your regulatory level. That affects big-buck decisions, like how you have to clean up a site, or how much you have to reduce emissions from your stack. So their big concern is this gene expression. They are concerned that they’ll see a change at a concentration below those that cause normal toxicity. and that is now going to trigger reporting requirements at much lower levels, regulatory requirements, PR and bad press, and environmentalists saying this is causing harm at this level. In their article you can see that they are saying that this has to be tied to a real toxicological end-point before it can really count.

I think the microarray industry is beginning to show some awareness of environmental regulation.

I think the FDA, which has been getting most of the attention, has overshadowed [EPA]. But it’s definitely coming to this [environmental] area as well, and all of the players see it. I’ve given some talks at the EPA and they recognize the FDA as being ahead on this, but I think they are trying to catch up.

But there are differences between [regulating] chemicals and drugs. One of the key things is that drugs have a benefit. From a health perspective, you are weighing a therapeutic benefit versus toxicological side effect. Whereas with chemicals, there is no upside, so there is much more pressure. If you see an adverse affect, you would want to regulate it if you think it is truly hazardous because there is no benefit to that chemical other than economic.

The pharmaceutical industry has horizons of 10 or 15 years, but the chemical industry doesn’t.

Correct. [And], exposure to pharmaceuticals is highly regulated; you can control how much of a dose you get. Whereas environmental [chemicals] are all over the place. Everybody is exposed to different amounts depending on what they do, where they live.

Are there any legal precedents to look at?

There are a lot of related ones, but none right on point. I spoke at the American Bar Association litigation section in Boston two years ago on use of toxicogenomics data and none of lawyers in the audience had a clue of what this was. They all ran up to the mike afterwards. The first response was: ‘I’m salivating about this technology.’ I tell that to some scientists and tell them: ‘Watch what you write because there are a lot of trial lawyers looking at this.’ I think it is only a matter of time before lawyers start using this in litigation.

How are judges preparing to take on the new responsiblities that this science brings?

Most Federal agency documents used in private litigation say [the documents] are a stamp of approval for this technology. They tell us how this should be done, and as long as we follow the method that the FDA or the EPA has adopted, this is good science. In tort cases, there is this scientific rule of evidence, called Daubert. It’s a decision in 1993 by the Supreme Court that changed the [rules for] admission of scientific testimony. That has really had a major impact. In essence, it is a four-part test for scientific evidence to come into a court case. It requires judges to be gatekeepers of science. They used to all let it go to juries, basically. But now the judges have to be a gatekeeper to determine whether something is good science using this four-part test — Is it testable? What is its rate of error? Is it peer-reviewed [and] published? And, is it generally accepted in the scientific community? The annual meeting of judges is now almost all remedial science courses for judges who have to determine whether what someone with a PhD — who is telling them, ‘this is science,’ — to know if that is indeed science. This has had a revolutionary impact on court cases.

The judges are going to look a lot at what the agencies do. When I go to talk to judges about this, that’s what they ask: ‘What do the agencies say?’ Whatever FDA or EPA says is going to have a whole second impact on the court system.

How did you get involved in this area?

When I got out of law school in 1990, I wanted to do biotech and law. I went and interviewed [at] all of the top law firms in Washington, DC, and none of them had a practice in that area. All of them saw it as something for the future but nobody did any of that in private law firms. Now there is a book published by Legal Times, an annual directory of biotech lawyers. In a short period of time it has gone from zero to several hundred lawyers in this area.

I teach a course, ‘Law of Genetics,’ and we are in the final stages of approval for an advanced law degree, what we call an LLM, the first one in genomics and the law. It’s not specifically for students in our law school, but for students from around the world who are interested in specializing in genomics and the law.

Are there any students who are PhDs like you?

Yes. I tell them they are hitting it at a good time. The ones who are graduating this year are having a tougher time. They want to get into it right away, but there aren’t a lot of jobs. Some are getting jobs, but not all of them. I think in three or four years from now, it’s going to be a great climate. In our incoming class, we have a student who is a tenured biology professor who is giving up his position and his tenure to come to law school. That’s rolling the dice, he’s making quite the gamble. But, I think it’s a prudent move.

Do you think young lawyers might be able to make a difference in the development of this field?

I do. In law firms, you have these entrenched practice groups. The older, more senior lawyers get all the interesting stuff. But when you have something brand new, they don’t know anything about this so the new lawyers, the young lawyers, are going to have tremendous opportunities because they are the only ones who understand this stuff.

Where do you think we will have an intersection between the courts and genomics?

There are all kind of liability issues. I think the driver for pharmacogenomics will be medical malpractice. I think doctors who are not using microarrays when they should be — to determine how people are responding, or who is going to be responding, or who is not responding to a particular therapy, or who has a genetic susceptibility to the toxicity of a particular drug — are going to find themselves facing medical malpractice. I think the standard of medical care is going to turn very quickly and these poor docs are going to get left behind, and some of them are going to get lawsuits. That’s going to light a fire under them and change the practice of medicine. Lawyers are going to be very involved in that too.

No doubt.

Chemical companies are also concerned. What if such and such person is genetically susceptible to chlorinated bleach? Are we supposed to be monitoring that? Are we supposed to do something about that? Are we supposed to be monitoring people who use our products and see if they are having gene expression changes? They are concerned about the liability implications.

Genomics is going to become an increasingly important thing in environmental regulation. It’s a new set of skills. It’s going to be important to set up very flexible laws so that instead of putting it in statutes by Congress, or even regulations by an agency, maybe it’s best to put it in the form of guidance documents that are constantly being updated and revised to keep up with the technology. A lot of these types of rule-making take two or three years, minimum, just to get through the process. That is just too slow to move. The term that comes to mind is called ossification, which is often used in administrative law to describe a regulatory process that becomes so bogged down with all the things you have to consider and all the analyses you have to do that just conducting a rule-making is a huge undertaking. So. if you adopt something, the only way that you can change it is another regulation. You shoot yourself in the foot.

What kind of regulatory teeth do these flexible guidance documents have?

That’s one of the flaws. A regulatory agency can’t enforce them against private parties; they have to go through the regulatory process to be enforceable. It’s a tradeoff for sure. I think companies will generally try to respond to regulatory guidance, although there has been a lot of cases where companies have successfully sued EPA saying: ‘You can’t enforce that against us; that is a guidance, not a regulation.’

Now, with the emergence of systems biology, how do you see this affecting policy and the courts?

In both the regulatory arena and in litigation there are going to be issues. Such as: When you see any kind of biological change, what is the implication of that? Is it something that is enough to take regulatory action against? Is it an adverse affect that we want to try and control? Is it something that people can collect damages for? There is a huge set of cases called latent risk cases, where people bring cases saying they have an increased risk of disease and should they be compensated for that? Or they have a fear of disease because of their increased risk, or they should get medical monitoring because they are at an increased risk. Often, they are losing because they can’t prove biologically that they are at an increased risk. They can say, statistically, I might be, but the courts say you have to prove that you, John Smith, are at an increased risk. Sometimes they say ‘it has to be that my chromosomes have been damaged because I got dosed to this radiation or whatever,’ and a few times they have succeeded, but generally these cases are getting thrown out because they can’t objectively and scientifically both demonstrate and quantify their increased risk. If they can now start using these kind of molecular changes, whether they are genetic or proteomic, or whatever, they may be able to objectively prove that they are in fact at increased risk, or they are not at an increased risk, and that may satisfy [the courts] and may basically open the flood gates to a lot more of these cases. I think it has huge implications because there has never before been this ability to take a single individual and prove that they are, in fact, at an increased risk and be able to quantify that. It has been done previously with epidemiological studies, which are population studies, but not individual.

I think I’ll refer to it as legalomics.

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