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The Warsaw Voice » Other » July 1, 2009
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Genetic Tests and Biobanking
July 1, 2009   
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Prof. Michał Witt, from the International Institute of Molecular and Cell Biology in Warsaw and the Institute of Human Genetics of the Polish Academy of Sciences in Poznań, talks to Piotr Bartosz.

You came up with the idea for the Polish-British Molecular Genetics Forum, which was held in Warsaw in early June by the Ministry of Science and Higher Education and the British embassy. Why do genetic issues require such an extensive debate?

I have been dealing with genetic tests for some time as Poland's representative in the EuroGentests Network of Excellence, an extensive program coordinated by Prof. Jean-Jacques Cassiman. This aspect of genetics as a range of services provided to the population is close to my heart. It involves tests that make it possible to diagnose genetic diseases, check whether a certain disease, caused by the damage or changed structure of a gene, is present or not. There are also predictive tests that enable doctors to say whether it is highly probable that a given person could have a particular disease in future. These exist in neurogenetics, for example, with respect to Huntington's disease, a serious neurodegenerative illness. Though it manifests itself at a later age, it is genetically determined and its high risk can be discovered much earlier than the first symptoms occur. That means certain steps can be taken well in advance. It is an incurable disease, and its treatment is a separate problem, but genetic tests offer great possibilities to help patients. The only thing is that too many centers offer such tests.

What is the danger in that?

This area of medical intervention is completely unregulated in legal terms, which has far-reaching implications. Many things can sometimes get out of control. This is the weakness of the system.

One would think such a system has nothing but advantages. I want to know the risk or have a disease diagnosed, so I go to someone who performs tests that are just as good, for a comparable price...

That's the question-are they just as good? In Poland, all you have to do is register a business to perform genetic tests. Small and medium-sized enterprises of this kind are established in various places, not only at universities. If such companies only operated out of universities, it wouldn't be so bad, because that would mean they would probably hire people who knew what they were doing. In many cases, though, companies collect biological samples and then send them to another country to a center that performs tests cheaply, quickly and without any guarantees. The result, though it looks very professional, is sent to the patient without any interpretation or advice. At present such companies are mushrooming in Poland. They are a serious threat to the maintenance of proper standards. They are not monitored in any way, have no specialist supervision, and operate simply as businesses. They can practically do whatever they want.

What steps are geneticists taking to regulate this field?

The Bioethics Convention, the fundamental legal instrument obligating the government to take certain action, has been awaiting ratification since 1997. Any recommendations or guidelines constitute "soft law" that can, but does not have to, be followed. A convention is a harder form of law. We have had quite a broad discussion on the additional protocol to the convention that very precisely covers issues of companies' operations involving genetic tests. Of course, this mustn't be viewed in the wrong proportions. Ratification as such will not solve the problem, but it would set a starting point toward regulating the market.

What does ratification of the documents you mentioned mean for such companies?

The additional protocol clearly shows what marketing tricks may not be used with respect to medical genetics. For example, you are not allowed to say you will detect a disease without listing the test's limitations. Genetic tests usually refer to statistical risk; this is what the result often represents. They don't offer certainty.

Another matter is the test result, often issued in a form completely incomprehensible to the average person. Some companies add no comment at all. If the regulations say you may not hand over the results without a genetic consultation, the company will have to hire a professional geneticist or establish contact with a center that has the necessary expertise.

You shouldn't use mutation panels that are not adapted to a given population. One example given at the conference was that some tests sold commercially, also in Poland, use a panel with mutations characteristic of Ashkenazi Jews. Of course, you can sell something like that, but don't be surprised that the detectability of mutations using such a test is very low. I'm not saying it's zero-level, but it is low and does not show the actual incidence of a mutation in our population.

Another example concerned a laboratory that detects a mutation of the lung cancer gene-a gene that doesn't exist.

Why can't this be regulated on the national level, but only as part of a pan-European network?

European conventions obligate the government to regulate these things. Otherwise there is no compulsion to stimulate this type of activity. The government itself isn't really interested. Genetic tests are a marginal operation. How can the incidence of genetic diseases compare with the effects of traffic accidents, or infectious diseases? These are completely different orders of magnitude. There are relatively few patients of genetic clinics, and there's always something more important to get done.

You also discussed biobanks at the congress. Why would the average Pole deposit their genetic material there?

Biobanks are an excellent tool created some time ago in wealthy countries-building a full-fledged biobank is very expensive. They allow scientists to obtain an extremely important comparative tool, for example to look into the genetic profile of the population-when you have a large number of samples that are hard to collect through any other mechanism. That requires cooperation from the public.

You can't force anyone to donate blood for biobanking, but I wouldn't worry about this, because I can see a growing awareness of the importance of genetics, as proved by the growing demand for genetic tests in Poland. People have some knowledge of the issue and want to do the tests. It's no longer just doctors who are saying that a given test should be performed; people often want this too-for themselves and their families.

On the other hand, fears are voiced that if anyone unauthorized gets hold of the results of such tests, it could make someone's life miserable in terms of loans, insurance and employment, for example. Isn't this a reason why the average person may never want to take part in this kind of study?

This is where the huge role of legal regulations comes in, specifying what information may not be disclosed. Of course, employers and insurers would love to have this kind of information helping them develop their employment policies and invent new insurance packages. One absolutely fundamental principle, however, is confidentiality of information and increased security.

Why did congress participants stress the importance of setting up genetic centers in Poland?

Genetic centers are a follow-up to an idea that emerged in several European countries, to concentrate competencies in specified places, usually linked to strong academic communities. The centers bring together both government institutions and private businesses-there's no reason to separate the two. The only criterion is the standard of competence and the quality of genetic testing services offered. Poland should probably have several to a dozen such centers, in large cities.

But nothing has actually been set up yet, has it?
No, what we have are strong academic communities, but in general no official genetic centers have been organized there, though the city of Poznań seems to be a precursor in this field-the first such center has been established there. The centers would be tasked with dealing with genetics not as a science but as providers of services-tests and consultations that should absolutely go together. An organization that is working very well in the Netherlands, Belgium and Britain will also work well in Poland. The establishment of such centers could be facilitated by having them financed by the National Health Fund (NFZ). Whether the NFZ is interested I don't know.

Wouldn't the centers be profitable?

I was thinking more of financing the services. When will people go there? When the service is cheap, or even better-free, reimbursed by the NFZ. If such centers have priority in signing good contracts with the NFZ, allowing their operations to be financed from taxpayers' money, that's a good direction.

Won't it cause a typical problem for this kind of financing-many months of waiting for a test?

It depends on the capacity of the centers and what kind of contracts they have signed [...]

If there's no regulation, we will continue to have a "wild black market." Take any newspaper and see what some gynecologists offer in their ads. Such stupid things are written there, you could split your sides laughing if it weren't sad, because people fall for it. In particular, there are ads targeted at pregnant women, an extremely sensitive group susceptible to activities fueling their fear of genetic diseases. You don't need to argue for long to achieve an effect, which is understandable. If the Convention and the additional protocol were ratified, these kinds of tricks would be not just reprehensible but illegal.

What can we learn from Britain in terms of legal regulations?

The British presented their model, one we can only dream of-and one that we should follow. Like us, they don't have specific regulations covering genetic tests. They have, however, done a very clever thing: they have gathered together bits of legislation from other fields of medicine wherever these refer to genetics and have brought together the professional community of doctors-geneticists. In Poland, we should wish that we have such a well-functioning organizational and legal system for genetic tests in 10 years' time.

"The Bioethics Convention, the fundamental legal instrument obligating the
government to take certain action, has been awaiting ratification since 1997."
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