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British Paper to Illustrate Relationship Between PGx and Society

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At A Glance

Name: David Melzer

Title: Clinical research associate, Institute of Public Health at University of Cambridge

 

On July 9, pharmacogenomics will get a brighter spotlight shone on it in the United Kingdom. That day, the Institute of Public Health at the University of Cambridge will publish a paper intended to dissect and explain the role that pharmacogenomics plays in society today.

According to David Melzer, clinical research associate at the institute, the paper will tap into the questions and anxieties swirling around genetic tests, databases, and information.

Melzer, a co-author, interviewed US and European regulators, academics, biopharma, physicians, and patients in the hopes of gaining insight into a technology that baffles most medical professionals and government regulators.

The timing is prescient. Last Tuesday, the British government published a White Paper outlining its plan to define and regulate genetic testing and gene therapy. “There are tremendous opportunities in [genetic-based diagnostics and therapeutics] but there are also some risks,” British Prime Minister Tony Blair was quoted in the Evening Standard as saying.

But the bottom line according to Melzer: Pharmacogenomics is “not there yet.”

SNPtech Reporter caught up with Melzer at IBC’s molecular diagnostics and personalized medicine conference in London last week.

You say that the pubic sector’s knowledge of pharmacogenomics should be stronger, and that it is getting stronger. What do you mean?

I think it ought to get stronger in two ways: You know that the US Food and Drug Administration has already published a proposal to have a data safe haven. This is one way that the public sector can learn a bit more about what’s going on the industry.

The other way is — and I guess this would be more of a European or UK issue — that the pharmacology departments at our [UK] universities are pretty small, and there’s a lot of work to be done to make the larger.

I think there ought to be more independent experts that the government can call on. People have criticized the regulators for being so closely tied to industry. There also needs be greater pharmacogenetics work on existing drugs.

You mean those undergoing post-marketing studies?

No; on drugs that are off patent. Most of medicine uses drugs that are off patent, but half of the drugs that are prescribed in the UK are off patent, many of which are good drugs. For example, [clotting drug] Warfarin has attracted quite a lot of attention for ways you can used a genetic test to identify the early bleeders-the people who get catastrophic bleeds before you can do any clotting tests.

Tony Holtzman, the chair of [Health and Human Services Secretary Tommy Thomson’s] genetic-testing task force, is very down on genetic testing and has published a paper saying that predictive testing is hopeless.

The point is that we live with side effects for a whole lot of existing drugs. The question then becomes, ‘Who is going to study and explain why?’

That’s a good question. Who will? In the United States, is it the FDA’s responsibility, and is it EMEA’s in Europe?

Technically, the FDA has a duty to oversee this. But the FDA, as far as I understand … has not done much in the way of basic research on all drugs. The NIH’s National Institute for General Medical Sciences has got a pharmacogenetics program in the public sector, but it tends to do very basic and fundamental research. So there appears to be a real gap. And that’s one real policy question: ‘Who’s going to fill it? Is it going to get filled?’

Do you think that one component of that gap is the fact that pharmacogenomics technologies are so new and not taught at medical schools?

Some people [in the upcoming report] did voice that concern, and some people were very hot on education. However, other people took the view that doctors will learn what they have to learn when they have to do it. So the important question is, ‘When a test is marketed, will there be enough information for doctors to make a sensible clinical decision?’ And ‘Will the information be available, and will it be timely?’ If these tests are good, doctors will learn about them pretty quick. Obviously, if you take a purely medical-school education approach, it’s going to take a very long time to train most doctors.

It’s very speculative, because there’s nothing on the market. There’s [Genentech’s breast cancer drug] Herceptin and a few others, but they’re all ones that deal with a cancer gene. And these are fundamentally different, because when you’re detecting a somatic risk gene the uncertainties are so much greater.

You also say that current uncertainty about privacy and confidentially safeguards for DNA samples may stifle pharmacogenetics trials.

I’m not the first one to say that (laughs).

Considering the nature of the report that is due out early next month, it seems to me that you’re in a pretty unique position to comment on this topic. What currently is being done, what do you feel ought to be done to counter this phenomenon, and who needs to do it? Or is it still unclear?

Obviously, this is a pretty big question. We know that genetics as a whole — any aspect of genetics — is entrenched in deeply rooted public feelings; the history of eugenics. All this kind of stuff. We did a little editorial in the British Medical Journal a few months ago pointing out that, in the public imagination, those family trees of the major catastrophic … diseases is what the public sees: those family trees with the blacked-out leaves. And the picture is of certainty and of tremendous decision, and of inevitability. In fact, it’s anything but certain.

I think the first battle is to start being honest with the public. Tell them that there are two sets of genetics: Major inherited disorders, and common disease genetics. I think we probably can get this message across — that not all genetics is family trees

The second thing is we need to get this message across to [institutional review boards] and, in [the UK] to ethical committees, because, again, there’s tremendous anxiety on the part of people on those panels. There are people who believe that [family-tree genetics plays a role in every disease], and there are people who believe that this is fundamentally wrong, and that there’s nothing special about genetic tests. If I take an X-ray or ask you how old your parents were when they died, then I already have a lot of genetic information about you [laughs] …

A lot more than if you were just blindly looking at a copy of my genotype …

Exactly. But every new technology gets this: hysteria about how wonderful it is, and tremendous concern about how dangerous it is.

It seems to me that the only way to fix this problem is to take out a full-page ad in USA Today that accurately describes genetics.

I think the market will sort it out. I think people will get this test and realize … [laughs]. One of our pharmacy chains tried to offer genetic tests over the counter. And it was a commercial flop. I think it was partly that people haven’t [been] familiar to it. I mean, the first time you get a [cytochrome P450] 2D6 test your doctor will tell you ‘Well, you likely to metabolize a drug this way, but don’t really know what this means.’ The problem is that we’re not there yet.

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