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Today, Washington based, Nobel Peace Prize winning, non-profit, non-sectarian organisation Physicians for Human Rights released the latest in a series of white papers and reports documenting and evidencing the advanced, elaborate, large-scale use of torture by the US intelligence and military during the 21st century. The latest report, Experiments in Torture, describes "evidence indicating that CIA medical personnel allegedly engaged in the crime of illegal experimentation after 9/11, in addition to the previously disclosed crime of torture. In their attempt to justify the war crime of torture, the CIA appears to have committed another alleged war crime—illegal experimentation on prisoners". As PHR states in its press release, the allegations are not to be taken lightly even discounting their massive moral weight. The activities described clearly violate the Nuremberg Code – the most basic of formal legal documents underlying research ethical standards applied and accepted throughout the world since at least 40 years.
The Nuremberg Code equals the principles applied by the judges of the part of the Nuremberg Trials where the infamous "Nazi-Doctors", were convicted for crimes against humanity. The incomparable weight and standing of the code as a basis for world-wide research ethical regulation means that even if it has not been literally incorporated into national legislation, its principles are to be found in many parts of the legal system of most countries – also the USA. Thus, even if the US is not a member of the International Criminal Court (thus shielding its citizens against prosecution for crimes against humanity), as PHR notes in its press release, the report opens the door for legal action within the US against medical staff participating in the described activities. Especially so, since an act enabling US federal prosecutors to move on human rights crimes committed by US citizens within the US legal system is well under way, according to the organisation Human Rights First.
Post script: when having finished this piece, I found this article in The New York Times reporting and commenting on the PHR report. The news has also been reported in Swedish media, here and here.
Monday, 7 June 2010
Saturday, 5 June 2010
Will the Synthetic Genome Breakthrough Be Any Good? - Reasons for Doubt
Just a short while after private genetic research entrepreneur Craig Venter announced the successful creation of a functioning synthetic genome, and thus opening the door to the feasibility of creating life-forms functionally governed by DNA never before present in nature, debate is heating up over what the consequences will be of this scientific breakthrough. On May 25, John Sulston – genetics professor at the University of Manchester – went public at a speech to the Royal Society in London with worries about Venter's and associates' ambitions to screen off public access to the new technology through patents and other legal commercial protection mechanisms. The comment from the Venter side so far is merely that they are not alone in doing their best to squeeze some dough out of this branch of science. However, this can hardly be seen as a valid defense if Sulston's main point is correct; rather, it would just make things worse.
In my initial comment on Venter's and colleagues' breakthrough, I devoted some space to demonstrate that the sort of utility applications boasted about by Venter and some of the initial commentators (e.g. pollution eating or biofuel-producing bacteria) are in fact very, very far from what is achievable today or even in the foreseeable future. Even more so if we add the sensible conditions that such applications need to be introduced in an ethically responsible way. However, as I emphasised, this reason for playing down the expectations leaves one area of application that is of particular importance: that of using Venter's new technology (or some of the procedures involved) as a tool in basic science. However, if Sulston is right, also this prospect of the new discovery to have a practical impact fades in front of the eyes of a careful investigator.
In his speech, Sulston reminded about the fights around the Human Genome Project, where Venter's commercially funded side-show initially wanted to have the basic genetic blueprint of humanity as much as possible hidden behind the shields of commercial secrecy and application protection. As it turned out, the side (to which Sulston belonged) that advocated the submission of all acquired information to the public domain won that battle. Had they not, chances are that the genomics research that is now gradually producing actual knowledge and applications of use to people suffering from disease or impairment, would have been stalled considerably. For instance, we would presumably have seen much more of the sort of tricks that some US genetics companies have tried to pull on the basis of a temporary situation in the application of US patent legislation, that is now hopefully being disbanded thanks to a recent legal ruling. That is, the holders of patents and other legal commercial protection mechanisms would have demanded of researchers working for the public good that they pay for the mere use of the knowledge about the basic structure of the human genome and the connected technological processes.
Such prospects are bad news for science, since science works best when tools and information are shared as freely as can be. Patents and other commercial legal protection mechanisms become desirable only when science is ready and done, and the stage of developing actual commercial products is entered. One should not let oneself be fooled by the fact that in this particular case, a commercial research institution succeeded, since it did so by acting within the public domain context of science, thus profiting from the publicised results of all other researchers that have been working in synthetic biology according to these basic scientific principles. The move towards patents by Venter & Co. is, in this light, a disturbing case of parasitical piggybacking, where the Venter research team effectively says to the scientific community: we played you for suckers! now that, thanks to all our combined efforts, we have reaped our harvest, we'll not only bake our own bread, but we'll refuse you to use our recipe - unless, of course, you pay up.
Now, Venter himself may of course claim that he has nothing like that in mind. But how much say in such matters will Venter have in the end? Being an entrepreneur, Venter is caught in the claws of his financial backers, and his scientific empire is in all practical respects run no different from any commercial company. There are shareholders who expect a swift return on their investment, there are company boards and managements who have to comply with the standard legal requirements of setting the economic interests of the company and the shareholders before anything else. In that light, Sulston's worries are highly realistic; what initially looked as a fantastic scientific breakthrough is highly likely to turn into a serious inhibitor of basic scientific research in synthetic as well as general biology.
In my initial comment on Venter's and colleagues' breakthrough, I devoted some space to demonstrate that the sort of utility applications boasted about by Venter and some of the initial commentators (e.g. pollution eating or biofuel-producing bacteria) are in fact very, very far from what is achievable today or even in the foreseeable future. Even more so if we add the sensible conditions that such applications need to be introduced in an ethically responsible way. However, as I emphasised, this reason for playing down the expectations leaves one area of application that is of particular importance: that of using Venter's new technology (or some of the procedures involved) as a tool in basic science. However, if Sulston is right, also this prospect of the new discovery to have a practical impact fades in front of the eyes of a careful investigator.
In his speech, Sulston reminded about the fights around the Human Genome Project, where Venter's commercially funded side-show initially wanted to have the basic genetic blueprint of humanity as much as possible hidden behind the shields of commercial secrecy and application protection. As it turned out, the side (to which Sulston belonged) that advocated the submission of all acquired information to the public domain won that battle. Had they not, chances are that the genomics research that is now gradually producing actual knowledge and applications of use to people suffering from disease or impairment, would have been stalled considerably. For instance, we would presumably have seen much more of the sort of tricks that some US genetics companies have tried to pull on the basis of a temporary situation in the application of US patent legislation, that is now hopefully being disbanded thanks to a recent legal ruling. That is, the holders of patents and other legal commercial protection mechanisms would have demanded of researchers working for the public good that they pay for the mere use of the knowledge about the basic structure of the human genome and the connected technological processes.
Such prospects are bad news for science, since science works best when tools and information are shared as freely as can be. Patents and other commercial legal protection mechanisms become desirable only when science is ready and done, and the stage of developing actual commercial products is entered. One should not let oneself be fooled by the fact that in this particular case, a commercial research institution succeeded, since it did so by acting within the public domain context of science, thus profiting from the publicised results of all other researchers that have been working in synthetic biology according to these basic scientific principles. The move towards patents by Venter & Co. is, in this light, a disturbing case of parasitical piggybacking, where the Venter research team effectively says to the scientific community: we played you for suckers! now that, thanks to all our combined efforts, we have reaped our harvest, we'll not only bake our own bread, but we'll refuse you to use our recipe - unless, of course, you pay up.
Now, Venter himself may of course claim that he has nothing like that in mind. But how much say in such matters will Venter have in the end? Being an entrepreneur, Venter is caught in the claws of his financial backers, and his scientific empire is in all practical respects run no different from any commercial company. There are shareholders who expect a swift return on their investment, there are company boards and managements who have to comply with the standard legal requirements of setting the economic interests of the company and the shareholders before anything else. In that light, Sulston's worries are highly realistic; what initially looked as a fantastic scientific breakthrough is highly likely to turn into a serious inhibitor of basic scientific research in synthetic as well as general biology.
Thursday, 20 May 2010
From synthetic genome to synthetic life: prospects as well as perils of gene technology exponentially multiplied
In today's issue of Science it is announced that (in)famous private genetics research wizard Craig Venter's team has succeeded in cooking a working genome out of non-living constituents. The popular summary describes the crucial breakthrough as being (1) not only making DNA-strands, but making them properly packed in the form of chromosomes, (2) inserting the synthetic chromosome into bacteria as replacement for its "natural" chromosome, (3) ending up with a living organism (the bacteria) that continued to replicate and produce proteins. Since the technique involves the use of "natural" bacteria as hosts for the synthetic DNA, this is not a case of the creation of synthetic life. Therefore, the suggestion by, e.g., Art Caplan that Venter and colleagues' achievement means that "What does it mean to be alive? /.../ What seemed to be an intractable riddle -- and one with significant religious overtones -- has been solved" is a clear overstatement (and, arguably, partial evidence that bioethics needs to be combined with careful attention to scientific detail). This misreading of what has actually happened is repeated in many newsreports, also in my own country. It still remains to be seen if human engineering is capable of creating a wholly synthetic living organism.
Nevertheless, the news clearly means that Venter and colleagues race to the top of Nobel Prize candidates for the coming decade. The achievement is truly stunning – both as a piece of genetic engineering, and as a source for understanding scientifically what is involved in organic reproduction and many other processes involving the genome. During the last 15 plus years that I have worked as a researcher and a commissioned expert on the ethics of genetics, I have had reason to touch on the possibility of gene technology breaking lose from the bonds of using as building blocks only pieces of DNA already to be found in nature a few times. My message has been, first, that this possibility seems rather remote and, second, that when it is realised, the ethical issues surrounding gene technology will not only multiply, but exponentially so. On the first point I was wrong, wrong, wrong. The second one, however, holds firmer than ever.
The new area of synthetic genomics opened up by Venter's and colleagues' result is of relevance primarily for two areas of genetic research and development: (1) basic science (that gets a new tool to play around with for the attainment of new knowledge), (2) genetic modification and design. However, as far as I can understand, it will not have any significant impact on what is so far the most potent application of gene technology to human beings: genetic testing and analysis. Synthetically made genetic variants never before present in nature will not improve our abilities to detect the genes of cells, humans or other organisms. In that case, the prospects offered by nanotechnological methods for studying the content of cells without destroying them has a greater potential for changing the prerequisites of present-day ethics discussion about genetic testing, prenatal diagnosis and, in particular, preimplantation and preconception genetic diagnosis (the latter being detection of the genome of gametes that allows these to be subsequently used for reproduction).
With regard to genetic modification and design, the last two decades have seen many applications to non-human organisms, primarily crops and animals used for food, pharmaceutical production or medical research. Although the modifications done so far have not been very far-reaching (mostly changes of one or a few features of organisms), the effects are rather unsettling. Biologists and Ecologists warned early on for systemic effects within the DNA, the ability of the modified DNA to spread into the rest of nature and for the modified variant's capability of taking over habitats and thereby eradicate other species and variants through ordinary processes of natural selection. In sum, due to our lack of understanding of the subtleties of the DNA and its adventures in larger biotic complexes, this side of genomics can be likened to a lottery with all our basic living conditions in the pot in order to gain a few bucks here and there. All of these scenarios have proved real enough, albeit commercial interests have so far been powerful enough not to have policy makers react as they should have to begin with. The possibility of beefing up this virtual wild west of in situ technological experimentation with synthetic genomics is hardly appealing.
Moving over to genetic modification applied to human beings, this has been a wet dream of medical researchers for many decades and work on achieving the curing of some of what are doubtlessly the worst diseases we may imagine has been committed. However, what has been achieved so far is two results: prohibition and failure. All around the world, so-called germ-line genetic modification of human beings is legally banned in some way or other (if nothing else through bans on so-called reproductive cloning). The reason for the banned is either mystical ideas about such modification violating religious commands, incomprehensible ideas about the procedure threatening human autonomy, dignity or identity, or the much more sensible claim that such a procedure is much too uncertain to be responsible (i.e. the argument that applies with even greater force to non-human genetic modification). It does not appear overly speculative to suggest that the addition of the possibility of synthetic germ-line genetic modification would mainly change this argumentative and legislative picture to the disadvantage of genetic modification supporters.
Regarding somatic genetic modification, medical science has indeed seen some daring attempts, but alas with rather depressing outcomes. It seems that, apparently, the theoretically much less complex undertaking of modifying the genome of adult cells in the body, is proved by experience to suffer from uncertainties making it not very controversial to suggest that also such applications are very hard to justify before our understanding of the mechanisms involved have multiplied and deepened considerably. Again, adding synthetic genomics to that calculus seems mostly to worsen the prospects of ethically responsible gene therapy.
None of this will, of course, intimidate those people whose megalomaniac lack of consideration for the collateral damage of their attempts to have their names written into the book of history have already produced a number of scandals and tasteless applications within, e.g., preimplantation genetic diagnosis, reproductive medicine, stem cell science and reproductive cloning. Such people are presumably already drooling over the prospect of cooking some of their own DNA and chromosomes and then lure some desperate people into playing guinea pigs. Similarly, regarding the non-human applications, the large companies presently cashing in handsomely on the risking of all our livelihood can be expected to apply the same wild west mentality to the new possibilities delivered by Venter & Co.
For this reason, the urgent call of Art Caplan for oversight and regulation is well placed to say the least, and the challenge that he highlights of implementing a system for identifying synthetic genomic products is indeed important to take on. However, Caplan seems to me overly optimistic about what sort of applications will in fact see the light of day, and actually naïve regarding the risks involved. His dream about synthetically engineered bacteria that solve our economic, environmental and human problems is, to my mind, just as unrealistic as the dreams of the geneticists of the 1980's that DNA technology would end world hunger. What we got was Roundup Ready. There's simply no big money in that sort of thing, it creates no sustainable markets; for that, what's needed are small improvement opportunities that at the same time sustains the underlying problem (e.g. poverty and dependence). Rather, my reaction is that governments all over the world now have a golden opportunity to put a halt to any further development of the institutionalised irresponsibility that is the business of non-human genetic modification. In the human case, the safeguards are already in place. Let's apply the same common sense reasoning to the non-human case, and thereby create an opportunity for responsible technological progress – at least from this synthetic point and onwards.
Postscript: having finished this piece, a number of my colleagues around the world have made their initial comments. A nice collection is provided by the BBC.
Nevertheless, the news clearly means that Venter and colleagues race to the top of Nobel Prize candidates for the coming decade. The achievement is truly stunning – both as a piece of genetic engineering, and as a source for understanding scientifically what is involved in organic reproduction and many other processes involving the genome. During the last 15 plus years that I have worked as a researcher and a commissioned expert on the ethics of genetics, I have had reason to touch on the possibility of gene technology breaking lose from the bonds of using as building blocks only pieces of DNA already to be found in nature a few times. My message has been, first, that this possibility seems rather remote and, second, that when it is realised, the ethical issues surrounding gene technology will not only multiply, but exponentially so. On the first point I was wrong, wrong, wrong. The second one, however, holds firmer than ever.
The new area of synthetic genomics opened up by Venter's and colleagues' result is of relevance primarily for two areas of genetic research and development: (1) basic science (that gets a new tool to play around with for the attainment of new knowledge), (2) genetic modification and design. However, as far as I can understand, it will not have any significant impact on what is so far the most potent application of gene technology to human beings: genetic testing and analysis. Synthetically made genetic variants never before present in nature will not improve our abilities to detect the genes of cells, humans or other organisms. In that case, the prospects offered by nanotechnological methods for studying the content of cells without destroying them has a greater potential for changing the prerequisites of present-day ethics discussion about genetic testing, prenatal diagnosis and, in particular, preimplantation and preconception genetic diagnosis (the latter being detection of the genome of gametes that allows these to be subsequently used for reproduction).
With regard to genetic modification and design, the last two decades have seen many applications to non-human organisms, primarily crops and animals used for food, pharmaceutical production or medical research. Although the modifications done so far have not been very far-reaching (mostly changes of one or a few features of organisms), the effects are rather unsettling. Biologists and Ecologists warned early on for systemic effects within the DNA, the ability of the modified DNA to spread into the rest of nature and for the modified variant's capability of taking over habitats and thereby eradicate other species and variants through ordinary processes of natural selection. In sum, due to our lack of understanding of the subtleties of the DNA and its adventures in larger biotic complexes, this side of genomics can be likened to a lottery with all our basic living conditions in the pot in order to gain a few bucks here and there. All of these scenarios have proved real enough, albeit commercial interests have so far been powerful enough not to have policy makers react as they should have to begin with. The possibility of beefing up this virtual wild west of in situ technological experimentation with synthetic genomics is hardly appealing.
Moving over to genetic modification applied to human beings, this has been a wet dream of medical researchers for many decades and work on achieving the curing of some of what are doubtlessly the worst diseases we may imagine has been committed. However, what has been achieved so far is two results: prohibition and failure. All around the world, so-called germ-line genetic modification of human beings is legally banned in some way or other (if nothing else through bans on so-called reproductive cloning). The reason for the banned is either mystical ideas about such modification violating religious commands, incomprehensible ideas about the procedure threatening human autonomy, dignity or identity, or the much more sensible claim that such a procedure is much too uncertain to be responsible (i.e. the argument that applies with even greater force to non-human genetic modification). It does not appear overly speculative to suggest that the addition of the possibility of synthetic germ-line genetic modification would mainly change this argumentative and legislative picture to the disadvantage of genetic modification supporters.
Regarding somatic genetic modification, medical science has indeed seen some daring attempts, but alas with rather depressing outcomes. It seems that, apparently, the theoretically much less complex undertaking of modifying the genome of adult cells in the body, is proved by experience to suffer from uncertainties making it not very controversial to suggest that also such applications are very hard to justify before our understanding of the mechanisms involved have multiplied and deepened considerably. Again, adding synthetic genomics to that calculus seems mostly to worsen the prospects of ethically responsible gene therapy.
None of this will, of course, intimidate those people whose megalomaniac lack of consideration for the collateral damage of their attempts to have their names written into the book of history have already produced a number of scandals and tasteless applications within, e.g., preimplantation genetic diagnosis, reproductive medicine, stem cell science and reproductive cloning. Such people are presumably already drooling over the prospect of cooking some of their own DNA and chromosomes and then lure some desperate people into playing guinea pigs. Similarly, regarding the non-human applications, the large companies presently cashing in handsomely on the risking of all our livelihood can be expected to apply the same wild west mentality to the new possibilities delivered by Venter & Co.
For this reason, the urgent call of Art Caplan for oversight and regulation is well placed to say the least, and the challenge that he highlights of implementing a system for identifying synthetic genomic products is indeed important to take on. However, Caplan seems to me overly optimistic about what sort of applications will in fact see the light of day, and actually naïve regarding the risks involved. His dream about synthetically engineered bacteria that solve our economic, environmental and human problems is, to my mind, just as unrealistic as the dreams of the geneticists of the 1980's that DNA technology would end world hunger. What we got was Roundup Ready. There's simply no big money in that sort of thing, it creates no sustainable markets; for that, what's needed are small improvement opportunities that at the same time sustains the underlying problem (e.g. poverty and dependence). Rather, my reaction is that governments all over the world now have a golden opportunity to put a halt to any further development of the institutionalised irresponsibility that is the business of non-human genetic modification. In the human case, the safeguards are already in place. Let's apply the same common sense reasoning to the non-human case, and thereby create an opportunity for responsible technological progress – at least from this synthetic point and onwards.
Postscript: having finished this piece, a number of my colleagues around the world have made their initial comments. A nice collection is provided by the BBC.
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