Lilian Joensen - GRR

 A new genomic bubble in construction in the Faroe Islands?

November 2011 (Actualized April 2013)

 

 

In a world that has fallen in the deepest financial crisis, some are still being creative in order to subsist for a while recycling ideas that have been tried other places with not much success. It gets much more worrying when these projects are proposed in such a small Nation like the Faroe Island, where the people and the economy are so much more vulnerable to risky ideas that sound very interesting to the inexpert, at the same time that experts caution seriously against such proposals.

 

Science and business are a dangerous mix that makes scientific research risky and not reliable. One should be suspicious of the motives behind, when business comes to a little country asking for the possibility to let their citizens be donors in a joint venture with arguments that sound altruistic, though are not based on facts but on promises of immediate benefits of a scientific research the results of which might be decades away.

 

The markets were told some weeks ago, that the Faroe Islands would be the first to sequence an entire Nation[1] , [2]. The population is genetically fairly homogenous. Data from the project, known as FarGen, will support research and personalised medicine. The project will start with 100 people selected at random, and should cover the entire population in around five years2.1.·It has been said that the Faroese people finally are ready to give their DNA to this genome sequencing project unlike in 1999. From speeches and interviews one can read: Like our Minister of Health I find the FarGen project very promising. I was Minister of Health in 1999 when there was an effort to start genetic research in the Faroes, at that time we and the Faroese people certainly were not ready[3] , when the Icelandic company DeCode approached us to use us as a check population to their own projects.. but the Faroese political system backed out of the process. The Faroese population at that time was probably not ready for a process like that…[4]

 

Some are very confident that the Faroese population knows about the project, but I have asked all the people I have been meeting at primary, secondary and tertiary schools, in the supermarket, at family and friends reunions, ever since I got a massage where I was told of this project by a Canadian friend, and I have still not met anybody who knows anything. I have asked teachers, some of them even biologists, I have asked nurses, I have asked bank employees, I have asked factory workers and fishers, and I have asked my pupils. I have even asked newly elected politicians and political active citizens of the Faroe Islands. Why are the Ministers and proponents of the project so sure that the people agree with the idea? And why does people not know what is being projected with their own genomes though the news is all over the internet? What are they waiting for? I don’t agree if they think that because the Faroese people have heard a lot about the CTD problem, and they wish that this and other genetic diseases that are more common among our population were subjected to public research funding, they automatically agree with having their genomes sequenced and attached to their health files. It might be significant to point out that, though some genetic diseases are more frequent here than in other countries, life expectancy is even higher than in Denmark[5]. Sharing half of my genome with the rest of the people of this country, I don’t like the way we are presented to the world by the scientific community. We seem to be in the focus only when it comes to bad genes or poisoning from PCBs, DDT and mercury in our traditional food. That is the way we are presented all too often. Our biological and psychological samples have given material to many scientific articles and authorships, and now they are coming for more.

 

The Minister of Trade and Industry showed his fascination to this project on the 17 February 2011 during the FarGen workshop when he welcomed the participants calling the meeting as a certainly special occasion to be given the opportunity to entertain so many high profiled international researchers, who have spent the whole day debating research opportunities based on the genes of the Faroese population. He said that he was confident that given the potential hidden in our most personal and precious resource (meaning our genome), in the years to come, genetic and biotechnological events will be part of everyday business in the Faroe Islands. His thoughts went from the genome of the Faroese almost immediately to the other less personal and precious resources, fish and farmed salmon. The Minister described the Faroe Islands as: a biological and social laboratory inhabited by 50000 people and the place to make small-but-full-scale experiments all this in order to create business opportunities within genetics and biotech nurturing entrepreneurship within the knowledge industries. He mentioned a law in the making to enable us to build a science and innovation park in a public-private joint effort. The facilities will be open to both public and private research institutions and also to start-up entrepreneurs working in the fields of biotech, genetics, bioinformatics, etc[6]. Being a scientist that has worked in public health for several years, as a molecular biologist in one of the countries that has embraced  biotechnology with the same fanaticism shown in this speech, I really find this statements quite disturbing and worrying.

 

A day after the Faroese Minister expressed his excitement towards the promising opportunities he could envisage from putting the sequence of the Faroese most personal and precious resource in the hands of entrepreneurial businesses within the knowledge industries, more cautious and truly expert voices expressed their concern in an article published in Science Magazine warning against the new genomic bubble on the 10th anniversary of the Human Genome Project[7]. Evans et al. say:

Unrealistic expectations and uncritical translation of genetic discoveries may undermine other promising approaches to preventing disease and improving health….

…But claims of near-term applications are too often unrealistic and ultimately counterproductive. From the South Sea and dot-com “bubbles” to the ongoing housing market crisis, the world has seen its share of inflated expectations and attendant dangers. (Here I would refer to cases nearer the Faroe Islands, such as Stein Bagger[8] and the Iceland’s business Vikings[9]) Science is immune to neither. (Fx the Milena Penkowa case[10]). If we fail to evaluate the considerable promise of genomics through a realistic lens, exaggerated expectations will undermine its legitimacy, threaten its sustainability, and result in misallocation of resources. Fueling unrealistic expectations for predictive genetic testing and uncritical translation of discoveries may also distract our gaze from other promising approaches to preventing disease and improving health.

Their applicability to patient care shows little promise; studies demonstrate that even combining dozens of risk (genetic) markers provides little clinically meaningful information. In the public health realm, the prospect of effectively stratifying populations as high or low risk, thereby guiding screening, is equally dismal. Given the multifactorial nature of common diseases and the weak predictive properties of genetic-risk alleles, the probability of misclassifying individuals as high or low risk is likely too great to make such an approach feasible in the general population for guiding such things as mammography or colorectal cancer screening.

…The public, researchers, and clinicians frequently fail to appreciate that the history of medicine is strewn with ideas once thought promising that did not pan out when scrutinized through the lens of evidence based medicine). Hormone replacement therapy, prostate-specific antigen screening, peri–myocardial infarction lidocaine, and many other good ideas, when prematurely implemented, created bubbles of expectation and investment

 

Nevertheless, the discourse promises that the genome database will enable doctors to look up the patient’s genetic material and e.g. check whether a certain drug will have side effects, or whether it is right to provide preventive treatment for a hereditary disease[11], as if it was a fact, and this is deceiving. This is contended by professor of medical ethics and health policy at Penn's Perelman School of Medicine, Dr. Ezekiel J. Emanuel who predicts that the challenges are very great from the economic and efficiency point of views also:

 

Before we buy into this, we need to remember that almost every evaluation of what drives health care costs up points to new technologies… We need to be skeptical. We need to see the data before people buy into the idea that personalized medicine is going to produce cost savings and be so much better for the system… Using genetics is just one more way of subdividing patients. It's not 'personalized' in that way. You still have a group of people who are going to be treated in the same way. And for some people, the treatment will work. For [others], it will not work…You have to look at the cost of a screening test over a large group of people. Then you need doctors to actually adhere to the test results. Then, when you identify a smaller group of patients to treat, the pivotal question is, how expensive is the new treatment? You need to add up what you're saving and what you're spending…You're going to use the drug on ever fewer people, but then [companies] have to recoup the development costs and [see] corporate profits. The idea that this is going to be cheap is a myth. It's going to be very expensive." Professor of Medicine Jason Karlawish argues furthermore: "As a society, we're going to need to start to think about the ethical, legal and social implications of this. Frankly, this is numbers-driven medicine, and there are a lot of for-profit and proprietary interests at hand in owning the numbers. It's a new model that presents novel challenges." [12]

 

Therefore, the idea of sequencing the whole population of the Faroe Islands as a way of providing a better service can be seen more as a misleading illusion that will add costs to a vulnerable economy rather than as a vision of a way to improve healthcare and business opportunities.

 

Evans et al., Emanuel and Karlawish are warning against exactly what is being proposed in the Faroe Islands. After all, why did the Icelandic and the Estonian genomic projects, which were not much different from the one proposed in the Faroe Islands, fail to deliver the big businesses they were supposed to be?[13] , [14]

 

Besides the promises of a better health care system, the discourse from the speech provided by the Minister of Trade and Industry addressed to the scientific community, offering the population of his Islands for research, has now been taken by some scientists interested in building a resource for research and exploration of social challenges and even study social implications, as also Bogi Eliasen, the Faroese FarGen main lobbyist argues:

”All 50.000 of the islands inhabitants are to be invites to have their genomes sequenced and linked to their medical records, to tailor health care to individuals’ DNA and build a resource for research…The ambitious FarGen project will examine how doctors can use individual patients’ DNA to select the best therapy and to predict and reduce their risk of developing certain diseases. It will also explore the social challenges of mass genome sequencing. These include the logistics of collecting, storing and interpreting DNA data from a whole population, the consequences for privacy and insurance, the ethics of sequencing children, and confidential access for medical research. Bogi Eliasen, the program manager of the Faroes’ Department of health is in charge and he said that Faroes’ small population make it ideal to pioneer comprehensive genomic health care and study its social implications. The movement is accompanied by school lectures on genomics so that people would understand what it means, its benefits and its risks…The isolated population of Faroe Islands will serve as an excellent research material for testing the implications of the introduction of ‘personalized medicine’ into the health care system and will indicate the additional knowledge and skills needed for the medical personnel to meet the new demands[15].

 

The contradictions in the arguments are also worrying from the ethical point of view. In order to do the research that might some day make this hypothetical probability true, the genomic data of each Faroese citizen should be available for those who might want to do research on it. And since the idea is to make genetic research, the data should not be kept so anonymous, that scientists cannot use it. To do genetic and environmental research you need to get information about family, age, place, nutrition, psychology, etc. How can you achieve anonymity in a country of 50000 people, while providing other data?  But it must be anonymous due to ethical reasons. So I cannot see how the information contained in the Faroese genomes can be useful to research in order to be able to design drugs some day or other scientific aims. It does not make sense. If the sequence is hidden from everybody in a personal health file it will be meaningless data because today there is no way you can use this information to cure diseases you have not researched. And if the sequence is offered to the scientific community in open databases as the genomes of T. cruzi, E. coli, M. tuberculosis, Plasmodium spp. or the universal human genome, or otherwise, there is a high risk and even a certainty that employers, insurance companies or even a political system that might criminalize democratic activities in a future might get these data somehow, and use this against the person that owns the genome or even their progeny. We must remember that half of each of our genomes is passed to our children and so on. Neither can I imagine how the project can be interesting to businesses if it is kept protected in the patients file. The law does not address such issues[16] and even if it did, there is no way to guarantee what politicians might rule in the future, once the genomes are out there. Very probably, if a person regrets and wants to retrieve the genome information from her or his own personal file, there is no guarantee that this might be possible once it has been digitalized.

 

What worries me also is that all this excitement from those who, out of misinformed ignorance, believe that knowing the sequence of the four letters is a miracle solution in itself. What about gene regulation or epigenetics, which are heritable modifications in gene expression not encoded by the DNA sequence. The epigenetic landscape has grown increasingly complicated in the past decade[17], for instance.

 

 Therefore the arguments lack any sense of reality and criticism. The more we know about the molecular biology of complex organisms as us, the more complex it becomes. I cannot see how one can offer people to design personalised medicine at this stage. Right now, it is only at the hypothetical level. Years of research must be performed. We can offer our selves as guinea pigs, but then the people must know the risks of having their genomic information offered to private or public research. Politician and lobbyists that might see the project as job opportunity to themselves and friends or family are blinded by marketing arguments that have no hold in reality as it is today. And teaching how the four letters become an amino acid sequence in the biology class to primary school or high school children will not bring more knowledge, since molecular biology is not so simple. And simplifying the knowledge to these levels will only misconstrue biological true knowledge even more.

 

 Not least worrying is the fact that Illumina, which is a US company that is part of the Advisory Board of the FarGen project[18], 12.1* and is supposed to perform the sequencing, is apparently not in a good financial shape according the information available in different sites[19] , [20]. The US government has put this company in a rough patch reducing the funding to academic and research institutes that are a major part of Illumina’s customer base. And the downward trends seem to continue for several years and funding restrictions are limiting the number of new contracts awarded to gene sequencers[21]. And it is not only the US that is not providing funding to support the economy of the company. The EU is not getting better as a source of funding[22]. Illumina has announced that it will have to cut 200 jobs to reduce costs[23]., [24]  Furthermore, Illumina’s genotyping platform 610 Quad array produced errors in the identification of the SNPs genetic markers and was, in part, responsible for the retracting of a high profile study on genetic patterns tied to old age from not less than the scientific magazine Science. The article had erroneously reported 150 genetic variations that could be used to predict whether the person was genetically inclined to see their 100th birthday. Soon after the paper was published by Science, the researchers learned that the Illumina chip had been shown in unpublished studies by other investigators to produce incorrect results[25] , [26].

 While the US and EU are cutting funding the Faroese government might be stepping in to help the financial situation of this company. And it might have helped Illumina in getting Siemens or Roche or other transnational corporations interested in a project, and making the market believe that the company is expanding to the transnational level, since its value in the stock markets were risen on November 4th 2011[27]. But it only helped for a while. Investors are more cautious today than they were during other bubbles.[28][29] I hope the Faroese government is more careful with what they decide to do with the money from the taxes we pay and the planned plea to Denmark to increase the block grant for 2012. This kind of business could most probably not benefit the Faroese people’s health system, but might even impoverish it due to increased debt and misallocation of financial resources, that might be take from other sectors in order to support an illusion.. The project needs about 300.000.000 Faroese Kr. to begin with. And since Illumina needs to work with scientific groups that count on public funding, they will not provide funding to the project but will be paid, in stead, to do their job. The other Institution represented in the Advisory Board, the EMBL-EBI, gets funding itself that is less than the amount needed to start the FarGen project. The EMBL-EBI received  €40 million in internal and external funding for 2010[30]. It is difficult to see any other source of funding than the Faroese state.

 

Anyway, we should be able to get an explanation about how this amount is meant to be used exactly and how they calculate the expenses, etc. The National Institute of Health, in the US, calculate that the fully loaded cost of sequencing a whole genome for 2012 is U$S 15.000.-[31] (in Faroese croner it might be about 83.000). On the other hand, Illumina says that they will lower the price for mapping all the genes in a single human for research to U$S 4000.-[32]. (in Faroese croner about 23000).  If it goes bad, we can add to the important debt we already have, and end like Iceland and Greece for pretty much the same reasons7. And if it is the State that puts the money, neither Illumina nor FarGen would suffer much. Greed and ignorance have proven to be dangerous combinations and good substrate to entrepreneurship that is more based on hope than on reality. We should stop believing in magic solutions to the crisis, selling whatever can come to our minds, just because others are willing to put a price on it. It does not matter if those who want to take advantage of our desperation for money are either North American, European or members of the growing economies of the BRICS countries. These are very difficult times and the belief in bubbles has been the cause of the collapse of the global financial sectors. We cannot go on letting the taxes of people be used as part of fantasies and lobby arguments that only buy entrepreneurs and businesses a little more time to survive until they either find other politicians in other countries who will fall for their stories or will simply collapse by their own weight.

 

Added April 2013 to the original article (from November 2011)

Recently, from the beginning of year 2013, the Fargen/Illumina/personalized-medicin lobby is starting to be publicly contested by Faroese medical doctors such as Shahin Gaini[33], from the Hospital in Torshavn and MD Eivind Warberg[34], as well as the Scientific Committee of the Islands. These are the first critical voices to be heard loudly in the Faroese media informing the population. The Faroese Vísindasiðsemisnevndini (Faroese Scientific Committee that deals with Faroese ethical issues) had already on April 12th 2012 denied FarGen authorization to go on with the project of sequencing the whole population as it was presented[35],[36]. FarGen filed a complaint against the Faroese sovereign decision to the National Scientific Committee in Denmark. But the Danish committee has supported the Faroese ethic authorities. It is symptomatic, that the news of this refusal has not been published worldwide in the Internet and in English, as did the project itself. It might seem like a lobby strategy, which will for sure either ignore or fight desperately against any opposition. One can suppose that such news might hurt business interests of some corporations. How this will affect the FarGen summit planned for September 2013, in Torshavn, remains to be seen. Among the speakers proudly presented at this international meeting[37], are David Bentley from Illumina, UK. Another speaker is DNA pioneer James Watson[38], who has been much criticized for his points of view that have been regarded as racist, sexist and homophobic[39].  Anyway, the lobby is seemingly thick skinned and blinded by its own vision.

Original article from November 2011 can be found in:
http://www.grr.org.ar/articulos/genoma_faroe.htm

Lilian Joensen, biologist, PhD

Grupo de Reflexión Rural

www.grr.org.ar

 

 

[3] From the speach held by Culture and Education Minister of the Faroe
Islands
Helena Dam á Neystabøs
on the 17 February 2011 to the scientists
 attending the FarGen workshop

[6] From the speach held by the Minister of Trade and Industry, Jóhan
Dahl,
on the 17 February 2011 to the scientists attending  the FarGen workshop.

[7] James P. Evans et al., Deflating the Genomic Bubble. Science 18
February 2011,
Vol.
331
no. 6019 pp. 861-862

[9] Iceland's Vikings face a long winterI. Islanders must
create a new future after economy built on massive debt
 falls apart
( http://www.guardian.co.uk/world/2009/feb/09/
iceland-economy-credit-crisis  )

[10] Fraud investigation rocks Danish University. Nature, January
7th 20 (http://www.nature.com/news/2011/110107/full/news.
2011.703.html)

[15]  Halina Osińska1, *Leo Barić,  ”Personalized medicine. Vision
 and Reality”, 
New Medicine 4/2011, s. 130-137

http://www.czytelniamedyczna.pl/3896,personalized-medicine-vision
-and-reality.html

[17] Bilian Jin, Yajun Li, and Keith D. Robertson, DNA methylation:
Superior or subordinate in the epigenetic hierarchy, Genes Cancer.
2011 June; 2(6): 607–617.

 [18] http://gransking.fo/get.file?ID=7443

12.1* http://aktuelt.fo/grein/nyggjur_partur_til_ilegugransking

[23] http://www.xconomy.com/san-diego/2011/10/25/illumina-
restructuring-coming-after-third-quarter-sales-fall-short/

[26] http://www.nature.com/news/2011/110721/full/news.2011.429.html

7 Iceland's Vikings face a long winterI. Islanders
 must create a new future after economy built on
massive debt falls apart(http://www.guardian.co.uk
/world/2009/feb/09/iceland-economy-credit-crisis)

[36] Eftirsum fleiri skeivir og villleiðandi upplýsingar um leiklut og
støðu Vísindasiðsemisnevndarinnar til FarGen-verkætlanina hava
 verið frammi í fjølmiðlunum, vilja vit hervið upplýsa, at vísindasi
ðsemisnevndin eftir drúgva og holla viðgerð av fráboðaðu verkæ
tlanini hevði so nógv fyrivarni til hesa, at nevndin tann 12. apríl
2012 boðaði verkætlanarleiðaranum frá, at FarGen-verkætlanin
 ikki kundi góðkennast vegna eina røð av óavkláraðum spurningum..
.
 
http://aktuelt.fo/lesarabrov/kunning_fra_
visindasidsemisnevndini_um_fargen_verkatlanina

[37]which will focus on some of the first steps of FarGen, along with
 a look at the science needed to realise The FarGen Vision – a vision
that requires broad and international collaboration”.
 
http://greengate.live4.shift.dk/eng/konferencer/fargen

[38] We proudly present these confirmed speakers: Dr. James Watson,
Gil McVean, University of Oxford, UK,
Maynard Olson, University of
Washington, USA, James Lupski, Baylor College of Medicine, USA, Paul
 Flicek, European Bioinformatic Institute, UK, David Bentley, Illumina,
UK, Ulrike Steurwald, Department of Public Health and University of
Hannover, Faroes/Germany, Pál Weihe, Chair of FarGen Steering
 Committee, Faroes, Guðrið Andorsdóttir, Director of the Faroese
 Genetic Biobank, Faroes, Kári Rubek Nielsen, National Hospital
of the Faroe Islands, Faroes, Bogi Eliasen, Director of FarGen, Faroes:
 http://greengate.live4.shift.dk/eng/konferencer/fargen

 

[39] Nature News blog, James Watson’s Race Row, 17 Oct 2007:
 
It is the race aspect of his comments in interviews that has
so far generated most heat. Regarding Africa he said “all our
social policies are based on the fact that their intelligence is
the same as ours – whereas all the testing says not really”…

Watson has previously courted controversy with his views on
women and his musing on the fact it might be possible to
abort homosexual babies. In a recent interview with the,
where he also makes unflattering remarks about fellow
DNA
-scientist Rosalind Franklin, he said “Unfair discrimi
nation exists whether we like it or not; I wouldn’t have
 married a gum-chewing vegetarian. Ultimately, we’ll
help the people we discriminate against if we try to
understand more about them; genetics will lead to a
world where there is a sympathy for the underdog.”

http://blogs.nature.com/news/2007/10/james_watsons_
race_row_1.html