Overselling Science, Halting Progress, Killing Opportunities: Gene Therapy, Cloning, Stem Cell Medicine & Synthetic Biology

Here's a note, slightly provoked by a pretty ridiculous piece posted at the webpage of the Institute for Ethics and Emerging Technologies. In this piece, a self-proclaimed, so-called "positive futurist" named Dick Pelletier delivers a sales-pitch for the program of synthetic biology much as envisioned by Craig Venter when holding his regular presentations aimed at potential funders, investors and customers in order to raise the value of his services, products and patents. Right off the bat, I want to underscore that what I mean to be saying here is not against Venter's scientific aims or, for that matter, his visions of what his science might eventually be good for. Not at all. What I want to point to, however, is the sort of overselling of scientific areas which are, frankly, in rather early stages of development that is going on in Pelletier's piece and that Venter himself is a bit guilty of as well, but that does not in any way limit itself to this particular field. Rather, I will here use similar patterns from the areas of human genome and associated gene therapy research, research on cloning and stem cell medicine to illustrate what this sort of overselling actually achieves, and why people and organisations (such as the IEET) seriously committed to using science and technology for the good should be wary of of this type of rhetoric.

So, what is it that Pelletier says? Well, a lot of unsubstantiated stuff, mostly, besides a lot about what synthetic biology "might" or "may" lead to, such as all of that which Craig Venter said when presenting his institute's breakthrough a while back. Very nice. I can see why Venter wants to attract investors and raise the share price of the company holding his patents, as well as the prices of the latter, and I suppose that Pelletier has some personal reasons, unknown to me, to help him doing that. What boggles my mind, however is the lack of complications, risks and the pretty optimistic (or is it infantile?) time-scale applied:

...they will produce a complete cellular system by 2015. Once this happens [...] Darwinian evolution will take over. This knowledge will help scientists understand how humans evolved in the past, and provide guidance towards a future human evolution driven, not by nature, but by tomorrow’s synthetic life technologies. We will see tiny self-reproducing factories, disease-killing machines, and exotic creations performing many useful functions.

 Nice. Getting help from something that certifiably works to understand nature better with the help of some technological innovation. Sound scientific strategy, right? But, who would have thought that....

....by 2020, synthetic life creations could eliminate, or make manageable, nearly all human sicknesses, including most of today’s dreaded age-related diseases.
 

Hmmm? And that is not the end, for in fact....

...by 2030 or before, human-made life forms could provide everyone with an affordable, ageless and forever healthy body fashioned from newly-created ‘designer genes.’

Right. Fantastic. Here's my life savings, then - no questions asked.

Not a word about risk, failure, misuse, limitations or the wicked ways of the world that most likely will see to it that this, just as any other piece of technology, no matter how well it works, will certainly not provide "everyone" with anything worth having. In particular if guys like Pelletier (as well as Venter) continues to cry wolf long, long before there is anything even close to worth having in those areas where imminent delivery is ambitiously promised. Perhaps this is what it means to be a positive futurist? Well, in that case we don't really need them do we? We already have them, just they are known under other names (take your pick) when calling us up at the least suitable hours, or filling our email inboxes, with one senseless business scam after another.

Ok, ok, so calm down. So far, this is just another of these naïve grown-up school boys and useful idiots letting some steam off. Admittedly, there is also a wider organisation with academic ambitions that for some reason is publishing the rant, which is perhaps a bit more of a reason to get worked up. But, hey, that's nothing new, is it? So what is the problem? To get to that, I need to widen the lens a bit, in order to describe how this is just one of many examples of how – indeed! – exciting and promising scientific and technology areas are ridiculously oversold, to the possible financial gain of a few of the involved experts, but to the detriment of those people that could in fact have reaped substantial benefits from the field, had it not been for the fact that once that stage is near, everyone with a buck to spare to make it happen has lost interest and, frankly, faith. So here's my cases:

1. Gene therapy. This baby has in fact been pitched as being right around the corner since the 1950's (and through the 60's and 70's), believe it or not (just pick up some of the scientific articles in the field and look for the little motivator sentence at the end). It is a wonder that James Watson was able to reuse it to attract funding for the HUGO project (although he had to switch to the wider concept of genomics half-way, when the prospect revealed itself to be much less practical than what had been thought at the outset). However, now when at last some of the first really promising clinical applications are indeed surfacing, investors have lost interest and so would I, had I been in their midst. The example of a fully developed, initially tested and very promising gene therapy for cancer sitting in the freezer due to lack of funding to do the larger sort of trials needed to have good evidence for safety and effectiveness is telling. I mean, who would believe anyone claiming to have a "promising" gene therapy that just needs some testing when that song and dance has been performed a million times before with the same depressing aftermath?

2. Cloning. Well, this story is in fact a part of that of gene therapy, as well as the next one of stem cell medicine. Here, the overselling has been mainly in the form apparent mavericks claiming to be planing very shortly or to actually have done human cloning, as well as to claim human cloning to be a help for a large number of problems that may engage people. I won't supply any link here, since this is fraud and tinfoil-hat territory, but if you're curious, just google "human cloning" and surf away. In any case, human cloning comes in two basic varieties. One is what is also known as "therapeutic cloning" or, better, somatic cell nuclear transfer, as used in a process to produce pluripotent embryonic stem cells. Another one is what is sometimes referred to as "reproductive cloning", meaning that SCNT is used to produce a human embryo, which is then transferred into a woman's uterus and allowed to be carried to term. This latter technique is interesting mostly as the most realistic prospect for having a gene therapy procedure that could in fact work for some of the major and most serious genetic diseases. However, the prospect of having anyone allow that to happen, even less to provide funding for it has been substantially crippled by the actions of the mentioned mavericks. In effect, while gene therapy for mitochondrial genetic disease might slip through the net raised in response to the proof of the apparently obvious irresponsibility of scientists provided by said mavericks, the dream of of this sort of powerful gene therapy has otherwise been effectively bumped off.  

 3. Stem cell medicine. This is a very much alive area, and in recent years there has been a stream of news about fraudulent or highly questionable operations (other examples are here and here, and these are just a few, among the ones popping up through a simple search). Hurrying to promise this or that on the basis of a scientific basis that is still pretty frail and full of gaps, and clinical experience is effectively nil. All of these operations, of course, grossly oversell the potential of whatever stem-cell based service they are offering and, of course, they do that to attract paying customers and investors. A step away from that regarding fraudulent behaviour, but still related when it comes to vested interests playing a part, we have the recent European case of the failed attempt to have embryonic stem cell lines patented. While the reasoning of the court may be discussed, it is clear to me that the case for a patent at this early stage will have to contain pretty obvious misleading parts, lest the condition of usefulness present in all patent laws would be difficult to meet. Furthermore, said sort of overselling would have had to continue when making use of the patent. Stem cell scientists and supporters enraged over the ruling were all pretty open about that the idea of the patent was to sell it to big pharma in order to have them fund clinical development, research, large trials, and so on. Well, that's fine, but would at this early stage seem to imply promising said corporate actors enough to have them open the purse. So, one may justifiably wonder what was indeed happening in the case of professor Brüstle, who was denied a patent by the European Court of Justice – was it just a loss of clinical prospect or was it his personal financial exit strategy that disappeared in a cloud of mist, or was it a bit of both? Probably the last, so we may be certain that he would have just as good a reason to oversell as in the other cases I have mentioned, had he instead been allowed his patent. And I'm pretty sure that this would have backfired, just as the other examples I have been given above, all while the rights of the patents would have blocked the scientific progress that might one day have made the sales-pitch honest and fair. Or, it that would have proven to be overly pessimistic, to discourage any potential funder or investor, just as in the case of gene therapy.

And backfire it will also in the synthetic biology case if people like Pelletier continue to rant and do Craig Venter's marketting work for him, albeit the latter – I'm sure – will laugh all the way to the bank.

Dodgy Stem-Cell Firm CellTex tries to Bully Critical Bioethicist into Silence

Just a short note on this, because it is important. Otherwise, I'm on sick-leave and will post sparsely for a while.

Texas based adult stem cell company CellTex tries to bully bioethics professor Leigh Turner into retracting a letter that he sent to FDA, urging the authority to look into if not the operations of CellTex violate federal US regulation on the licensing of pharmaceuticals and equivalent products (such as stem cells for clinical use). The letter is now streamed online for easy inspection.

CellTex was recently in focus in Nature due to alleged unethical use of unlicensed stem-cell treatments, and its recruitment and  almost as quick loss of prominent bioethics professor Glenn McGee as its own in-house consultant, a process in turn provoking waves due to McGee's ties to the management of a leading ethics journal (see my last post of the latter affair here).

Further comments on CellTex's move on Turner can be found here and here. A general comment on the bully tactics of dodgy stem cell firms in the US can be found here. For my own part, I must confess myself amazed at how perfectly CellTex conforms to the analogy to the quackery Burzynzki Clinic that I made in my first posting. This - trying to intimidate bloggers and critics by threatening lawsuits - is exactly what the people behind the Burzynski scam uses as last resort when criticism becomes too hot to handle (see here and here and here). But in the CellTex case, there is a further twist. For what Turner has done is simply his job as bioethics scholar and citizen: He has contacted the appropriate state authority in light of worries over the legality of a commercial operation coming out of him analysing the practice of CellTex as a bioethicist. He has not declared the operation of CellTex illegal, he has simply asked FDA to look closely into the matter and mentioned a few reason for initiating such a probe. So no way that this will ever reach a court of law, and almost as unlikely that charges will actually be filed against Turner. This is pure bullying and harassment tactics meant to awake fear and create silence.

But, hey, CellTex, you know what?! This backfires badly and does nothing else than expose your own fear! The response to Turner's criticism is clear evidence that leading people inside CellTex are seriously scared of what an FDA probe would demonstrate. The more the reason for FDA to make a move, don't you think?

Confidence Lost: The McGee's, Celltex and the American Journal of Bioethics

The past week or so, a new controversy related to the vastly successful journal The American Journal of Bioethics and its management has been a growing buzz in my field of research speciality. I have reported before about such a controversy (here, here and here), which in that case rather quickly deteriorated into a storm of more and more personal accusations between what at the time looked to me as a bunch of rather overinflated egos, of less and less interest from a bioethics point of view. There was also a very strange former questioning of AJOB's fine impact factor, which I will not even link to here, since it was obviously based on lies about it being based on high degree of internal citations. In fact, AJOB has less degrees of internal citations than most other ethics journals tracked by Thomson Reuter. The journal AJOB is a success, and it is a real success especially in terms of making bioethics publication have a real impact on medicine and medical science – hence the fine citation record, which anyone can use their university's Web of Science subscription to check. 'Nuff said on that.

This latest scandal, however, seems to me to be more of a real deal. This since there are a number of principal matters of publication ethics and bioethics implied, rather than just controversy over singular editorial policy decisions and insubstantiated slander. The matters are:

1. Glenn McGee's handling of his shift from editor in chief of AJOB to President of Ethics and Strategic Initiatives of the private stem cell business CellTex. The verdict has to be: not very nicely done at all. See: Leigh Turner's blog for more.

2. The attempt to resolve the obvious conflict of interest created by that shift by appointing McGee's wife, Summer Johnson McGee as the new EIC and for Glenn McGee to keep some managerial (rather than just ceremonial in terms of founder, full stop) ties to AJOB. See the previous link and this one for more. The vested interests of Glenn McGee in terms of his financial ties to CellTex cannot, in my view, be separated from those of Summer Johnson McGee for the very reason that they are married and thereby under default arrangement share private economic interests and resources.

3. The issue of the ethics of a bioethics scholar to assist a firm that offers non-FDA approved stem cell therapies in a manner that very much resembles the activities of the Burzynski clinic that I have been posting about. Read more about this here.

4. The implied result of having Glenn McGee more or less indirectly in a position of power in relation to an FDA-connected editor of a journal in the AJOB family, where publications may influence whether or not CellTex products will eventually receive FDA clearance. (see previous links).

I personally like AJOB and its special editorial idea very much and I also have the highest regard for its contribution to the positioning of bioethics as a research speciality, but the combination of the above four matters  taken together cannot but leave an ugly stain on its record of credibility. By themselves, they also each stain the credibility of both Glenn McGee and Summer Johnson McGee as bioethics scholars. By implication, this taints also other people involved in the managerial and editorial operation around AJOB. But the root of all this is the ruined credibility of Glenn McGee as bioethics scholar.

Simply put, Glenn: how can I from this day know what master you speak for when you make decisions, assessments, arguments, and so on? As a bioethics colleague: why isn't your first action re. CellTex the obvious one of refusing to be affiliated with it before they either close down their questionable operations or obtain proper approval for their activities?? None of the answers to the latter question that I can imagine inspire confidence, I'm afraid. In light of this, how could you ever imagine that the moves made regarding the management of AJOB would get the journal off the hook in terms of conflicts of interests and reduced credibility. AJOB is your child, I can see that, and I can also see that you care very much for this child of yours to do well in your absense. However, the path entered by the decisions made in recent times is not promoting that end, quite the opposite. 

European Court Rules Against (almost all) Patenting of Embryonic Stem Cells

Yesterday, the European Court publicized its ruling on the controversial case of the patentability of human emryonic stem cell lines (hESC) in European law. I have discussed this issue in two former posts: here and here. The complete ruling can be found here and is quite long, but the conclusions are clear:

On those grounds, the Court (Grand Chamber) hereby rules:

1.      Article 6(2)(c) of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions must be interpreted as meaning that:

–        any human ovum after fertilisation, any non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted, and any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute a ‘human embryo’;

–        it is for the referring court to ascertain, in the light of scientific developments, whether a stem cell obtained from a human embryo at the blastocyst stage constitutes a ‘human embryo’ within the meaning of Article 6(2)(c) of Directive 98/44.

2.      The exclusion from patentability concerning the use of human embryos for industrial or commercial purposes set out in Article 6(2)(c) of Directive 98/44 also covers the use of human embryos for purposes of scientific research, only use for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it being patentable.

3.      Article 6(2)(c) of Directive 98/44 excludes an invention from patentability where the technical teaching which is the subject-matter of the patent application requires the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place and even if the description of the technical teaching claimed does not refer to the use of human embryos.

In short, hESC lines can indeed be patented, but as part of a procedure for "for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it". In other words, patenting of hESC lines for the purpose of regenerative medical purposes or research is ruled out within the jurisdiction of European patent law.

Bad Arguments on All Sides in the European Embryonic Stem Cells Legal Circus, part 2

So, this is the second part of a post begun a few days ago. I'll repeat the bare bones of what it's all about:

In March, Nature News reported, a judge at the European Court of Justice (the decisions of which are binding for all EU member countries) named Bot (forename unknown) brought forth the proposal that patenting embryonic stem cell lines would be unlawful, since they have been produced through a process involving the destruction of embryos. Thus, the judge argued, (as reported by Nature News) "they are tantamount to making industrial use of human embryos", which (quoting the judge) would be contrary to "ordre public and morality". The proposal follows a motion made by Greenpeace to repeal a patent application made by German researcher Oliver Brüstle. The European court is expected to make a ruling "in a couple of months".

In my former post, I analysed the proposal of ECJ judge Bot in quite negative terms – concluding it to be a covert attempt to smuggle into European case law legally unsupported and controversial views on the moral status of embryos. However, I also stressed that the many faults of that proposal did not imply that the idea of patenting embryonic stem cell lines is a very good one. To get to the reasons why that is so, I'll now have a look at the response to Bot's proposal from the embryonic stem cell research crowd.

April 27, BBC reported that leading European researchers in the embryonic stem cell field have protested against judge Bot's proposal in a letter to Nature. According to this report, the researchers make three arguments against the proposal – two of a pragmatic nature, and one factual. The pragmatic arguments are that a patent ban on the basis suggested by the judge would imply a disparaging moral message about embryonic stem cell researchers and their activities, and that the ban would undercut investor interest in research on stem cell based therapies, which is now entering the stage of clinical trials. I'll get back to these arguments in a moment.

 The factual argument is that, contrary to what the judge seems to assume, therapeutic procedures involving the use of embryonic stem cell lines would in fact not imply any "industrial use of human embryos". This since the lines are already in existence and that, therefore, all that is needed for the continued use of them is the proliferation of the cell lines themselves. For sure, once upon a time, a number of embryos were destroyed to create these lines, but once that was done any further destruction of embryos is unnecessary. Now, while this argument seems to be sound and valid as regard the particular patent application of Brüstle, it is limited as a response to the principled claims made by judge Bot in his proposal. What the factual argument implies is that this proposal may not apply to Brüstle's application and possible other applications for about 100 cell lines already in existence. However, if the proposal was to pass the ECJ, it would seem to apply to all future attempts to secure patent protection in conjunction with the launching of attempts to produce new embryonic stem cell lines. That is, the factual argument may perhaps get Brüstle and a number of other potential patent applicants in the stem cell field off the hook, but it would allow judge Bot's main idea that producing stem cell lines through the destruction of embryos equals the exploitation of mass murder for organ trafficking purposes to pass into European case law. So, let's move over to the two pragmatic arguments.

Both these arguments seem to me rather weak as they stand. First, if the judge were right about the moral status of embryos according to European law (which he is not, see part 1, but that is not argued by the researchers), sending a disparaging moral message about embryonic stem cell researchers would not seem misplaced. In other words, this argument presumes an argument to the effect that Bot's claim regarding the moral and legal status of embryos is mistaken, but no such argument is given by the researchers.

Second, it is highly debatable if it is actually true that patenting of stem cell lines is either a necessary or a sufficient form of commercial protection for private investors to be attracted to funding the development of stem cell based therapies. What these investors need are patents guaranteeing the exclusive commercial rights to the product ensuing from such research and development, that seems to be true. However, while patenting of cell lines might provide such protection in some cases, they need not do so in all cases – it all comes down to what the product turns out to be. If the product involves using said cell lines, there will be protection. However, the product may also turn out to be a procedure not involving the use of any cells at all (rather, these cells have been a research tool for discovering mechanisms which the product – e.g. a drug – is able to manipulate). More important, even when the product in fact would involve using the cell line in question, the cell line is not identical to the product – the product is the entire procedure in which the cell line is used. In other words, what is necessary is to patent that procedure (insofar as it meets the criteria for European patent protection). This, however, is compatible with having the cell lines themselves unprotected, and thus freely available for use by others for other purposes, such as important basic research.

This brings me to why I actually strongly oppose the idea of allowing patents for all stem cell lines – be it embryonic or adult. First, stem cells are not inventions, they are naturally occurring phenomena – just as (non-synthetic) genes are. The mere fact that the cells have been moved from their original location inside an embryo or the body of an adult doesn't change that. If I move a flower found in the forest into my garden, the flower has not thereby been transformed into a human invention. I may claim, of course, that my garden or the entire flowerbed is my invention – but that does not imply anything about the flower itself. Likewise, if I happen to have developed a unique method for moving the flower, that method is my invention, but the flower is not, wherever it happens to be located as a result of using the method. So, once again, in analogy, while it makes sense to allow patents for various procedures involving stem cells, or whereby stem cells may be transformed into useful products, this does not imply that the patenting of the cells themselves is warranted.

In addition, as we have seen, whatever procedures that may be coming out of stem cell research, it can have its (pragmatically) necessary commercial protection without having any cells or cell-lines patented (unless, of course, all processes are already in the public domain). In fact, granting patents for cells or cell-lines would, in fact, be a disservice both to society and to medical research. Just as we have seen so many nasty examples of in the case of patent on genes in the US, awarding commercial exclusivity rights with regard to "stuff" rather than processes and procedures leads to the result where research and innovation is halted rather than stimulated. The only benefit of such patents befall those individual parties owning the patent and while it may be understandable that, as a friend of mine put it, potential landowners endorse the idea that they may bar parts of the commons for their own private enjoyment, it is hard to see why society should allow – let alone assist – them in realising that ambition.

This brings me to my final point, which is connected to the fact that the ones that seem most enthusiastic about the idea of patenting cells and cell-lines are themselves belonging to a group – representing a field – that I just claimed have the most to loose from having such patents granted. It is actually rather strange to have esteemed scientists and research institutions cheering at the notion of making (a) medical research more difficult and expensive, and (b) thus less likely to produce new breakthroughs (using the resource of stem cells and cell lines). Perhaps they have been blinded by the false idea that cell or cell-line patents are a necessary evil if innovative therapies are to ensue? Or is it perhaps, that they happen to be sitting on some of these precious cell-lines and have let the prospect of making a buck shield their mission as scientists? The gene patent morass in the US has for sure exposed enough of the latter, but there is still time for the European stem cell science community to demonstrate that they are, in fact, better in that respect.

Bad Arguments on All Sides in the European Embryonic Stem Cell Legal Patenting Circus, part 1

I have been commenting generously on what I see as the most profound folly of the legal debates and proceedings concerning (a) embryonic stem cell research (here, here, here, here) and (b) patenting of genes and similar things (here, here, here) in the USA. Might be that I have thus come off as a rather smug European and maybe I was – in any case, here's an apparent redeemer for that. I will do this piece in two parts, starting with the chronological beginning of the story.

In March, Nature News reported, a judge at the European Court of Justice (the decisions of which are binding for all EU member countries) named Bot (forename unknown) brought forth the proposal that patenting embryonic stem cell lines would be unlawful, since they have been produced through a process involving the destruction of embryos. Thus, the judge argued, (as reported by Nature News) "they are tantamount to making industrial use of human embryos", which (quoting the judge) would be contrary to "ordre public and morality". The proposal follows a motion made by Greenpeace to repeal a patent application made by German researcher Oliver Brüstle. The European court is expected to make a ruling "in a couple of months".

I read through the proposal of the judge today (you can download it via the link above) and was actually stunned by its content. Seldom have I seen such an ill-conceived, poorly researched and structured chain of reasoning (I'll soon explain why) provided by an esteemed legal official and expert. And, as if that wasn't enough, it turns out that the foundation of the whole argument is – hold your breath! – an analogy between producing pluripotent stem cells through embryo research and the mass murder that took place in former Yugoslavia, where some victims were harvested for organs intended for transplantation. In spite of being a basic (as in unsupported) premise of the argument, the reasoning revealing this assumption is made very late in the text, just before the judge goes on to summarise his conclusions.

So what, you may wonder, is the judge doing in all those pages before that? Well, actually, mostly irrelevance (a totally misplaced and longwinded discussion about how totipotent cells compare legally to embryos ending with the judge concluding that it has no bearing on the matter at hand) and smashing in doors that have been wide open for at least two decades while holding himself out as some sort of intellectual pioneer; such as "proving" that the term human embryo signifies all stages of the human organism from conception (or the completion of a nuclear transfer – so-called therapeutic cloning) until the implantation is completed. The purpose of these exercises in futility seem to be to "prove" that the production of pluripotent embryonic stem cells involves the destruction of human embryos. Surprise!

So, how does the argument proceed from that stage? To answer this question, we need to backtrack a bit to the many places in the just related discussion where the judge underscores that he will not make any claim on morality that deviates from any law or received public opinion of any of the EU member states. The judge ponders whether the strategy of his argument should....

....be that we ask in what respect the precursor of life deserves less protection than that in which it will naturally result?
82.    Put in this way, the question would then refer to a solution directly inspired by philosophical or religious considerations and would therefore seem impossible to formulate in a way which is acceptable to everyone.
83.    This will not be my approach.

This he must say, since this is how the European legislation regarding embryos is constructed – e.g. in the Council of Europe Convention on Human Rights in Biomedicine: While stating that the human being in all its stages is to be legally protected, it leaves open to member states to legislate on the nature and extent of that legal protection. And since said legislation indeed varies from the very conservative to the very liberal as regards embryo research, the judge rightly draws the conclusion that a valid legal argument on the European level cannot be based on any assumption regarding the legal or moral standing of the human embryo.

So, then what is his basis? This, it turns out, is a clause in European patent law (present in most if not all such laws worldwide) stating that a patent application that otherwise meets all requirements can be denied on the ground that it regards something that is contrary to "ordre public and morality". In layman's tongue: popularly well-established and widely shared custom or moral views. But, of course, it is now that trouble begins for real – for what well-established and widely shared European customs or moral views might he invoke in the case of patenting embryonic stem cell lines? It is at this stage that the judge starts a chant about the wide European consensus on the absolute moral horror of the mentioned events in former Yugoslavia that – to much surprise – is directly turned into a conclusion about embryos:

104. The pluripotent stem cell in the present case is removed from the blastocyst which, as I have previously defined, itself constitutes an embryo, that is to say one of the stages in the formation and development of the human body which the removal will destroy.
105. The argument put forward to the Court at the hearing, that the problem of patentability which hinges on the removed cell, the way in which it has been removed and the consequences of such removal do not have to be taken into account seems unacceptable, in my view, for reasons connected with ordre public and morality. A simple example will illustrate my remarks.
106. The current judicial activity of the International Criminal Tribunal for the former Yugoslavia shows us, obviously subject to the presumption of innocence, that in the course of those events prisoners were killed in order to remove organs for trafficking. If, rather than trafficking, there were experiments which resulted in ‘inventions’ within the meaning of the term in patent law, would they have had to have been recognised as patentable on the ground that the way in which they were obtained was outside the scope of the technical claim in the patent?
107. Such blinkered thinking cannot result in a solution acceptable to the greatest number.
108. Consequently, even though the claims under the patent did not specify that human embryos are used for the exploitation of the invention, when they actually are, the patentability of such an invention must be excluded.

 In other words, the whole argument can be summarised as follows:


1. A European patent application must be denied if it concerns something in opposition to popularly well-established and widely shared custom or moral views throughout Europe.
2. To approve patent for a procedure that involves or presumes actions similar to the killing of prisoners in former Yugoslavia for the purpose of organ trafficking would be in opposition to popularly well-established and widely shared custom or moral views throughout Europe.
3. The removal of pluripotent cells from embryos involves the destruction of said embryos, and thus of human bodies.
4. THEREFORE: The removal of pluripotent cells from embryos involves an action that is in opposition to popularly well-established and widely shared custom or moral views throughout Europe.

But of course, the conclusion does not follow from the premises. Here is the missing premise needed for such an outcome:

The destruction of the human bodies of embryos is morally similar to the killing of prisoners in former Yugoslavia for the purpose of organ trafficking according to popularly well-established and widely shared custom or moral views throughout Europe.

However, this claim is false, so even if the premise was to be included in the argument, this argument would be unsound. What is more, the judge cannot include this premise on pains of violating his own earlier statement that his argument will not be based on any particular view of the moral status of embryos not shared throughout Europe. Even worse (for the judge), would he to drop that constraint on his own argument and simply make the claim that the destruction of human bodies in the form of embryos is morally similar to the killing of prisoners in former Yugoslavia for the purpose of organ trafficking, he would make a claim that is invalid in European law, since it assumes a particular view of the moral importance of embryos (they are as important as adult human beings) that member states enjoy the right to deny in their own legislation.

So, in conclusion, behind the carefully constructed smokescreen of page after page of trivialities and irrelevancies, the argument made is a textbook of elementary logical, legal professional and scholarly errors. In totality, though, it is even worse: it is a judge that gives the impression of trying to smuggle into European case law the statement that destroying embryos in research or for medical purposes is morally on a par with murdering adult human beings for the purpose of organ trafficking. And this while he is fully aware that this statement contradicts current European law, since he willingly acknowledges the difference between member states as to embryo and stem cell research legislation. The only alternative explanation I can see is that this judge is extremely bad at his job.

In either case, the esteemed position of the judge as Advocate General at the European Court of Justice is less than well deserved. None of this, however, means that I am in favor of the idea of patenting human embryonic stem cell lines. On the contrary – and in part 2, I will present my case for that view through a critical scrutiny of the reactions of stem cell researchers to the judge's proposal.

Meanwhile, in the real world.....

Today, the second U.S. clinical trial for embryonic stem cell based treatments received clearance from the FDA.

But wait! Wasn't this with embryonic stem cell research banned in the U.S.?? Or wasn't it at least highly contested at the most important legal and political levels? Well.......

More on the US Embryonic Stem Cell Research Policy Turn-around

Having just finished replying to a comment to my blog post yesterday on this topic, the news reached me that the US Department of Justice intends to appeal the injunction of Judge Lamberth. Today, the day after, renowned US bioethics scholar Art Caplan reacts with admirably restrained rage in a comment that fiercely attacks the argument made by Judge Lamberth, as well as giving some additional insight into what sort of gatherings, forces and petty interests are behind the suits leading up to yesterday's ruling.

So my guess was right, we have only seen the first moves in what will presumably be a long legal dance. A dance, I have claimed, that is built on hypocricy and outright foolishness - as so often when dogmatism meets real life.

US Stem Cell Legal Debacle the First Step In a Long Fight Based on Absurdity and Stupidity

Today The New York Times reported that US president Barack Obama's about one and a half year old turnaround of US policy on embryonic stem cell research has been halted by Chief Judge Royce C. Lamberth of the Federal District Court for the District of Columbia. Judge Lambert issued a temporary injunction against Obama's policy change that made federally funded research on embryonic stem cell lines legal regardless of when these lines were created. Before the change, federal funding (i.e. NIH grants) could only be granted to projects utilising cell-lines created prior to 9:00 P.M. EDT on August 9, 2001. The judge's argument for the ruling is that President Obama's policy change violates a 14 year old ban on the use of federal money for stem cell research involving the destruction of embryos. The complete ruling can be found here. US stem cell scientists have reacted with shock and the news have quickly waltzed around the world, giving quick and strong echo also in my own country (here, here, here, here, here, here, here, just to name a few), thus illustrating the importance of US policy in this area for scientists and clinicians all over the world, also in countries like my own, that allows stem cell research on the same conditions of ethical review as other types of human subject research.

Judge Lamberth's ruling is the direct result of a suit against Obama's policy change made by the so-called Alliance Defense Fund, a Christian lobbyist and legal activist organisation that describes itself as "defending the right to hear and speak the Truth". One may justifiably rant about the obvious absurdity of this claim in light of the fact that the suit against embryonic stem cell research is an obvious move to stop stem cell scientists to be able to find and speak the truth about stem cells and their role in the human body and impact on human health. However, at the same time, I was not surprised by this attempt from the world (in)famous US "religious right". After all, the basic ethical stance underlying this particular opposition to embryonic stem cell research is that the destruction of human embryos involved in creating the cell lines in question equals first degree murder. In consequence, using the products of such destruction for research equals a deeply immoral exploitation on the occurrence of what people holding this view logically has to regard as mass murder of the same epic proportions as the Holocaust, Stalin's terror and the "year zero" slaughter of Khmer Rouge Cambodia.

On the other side of the hedge, however, are all those people who do not subscribe to this extreme ethical view. Pointing to the enormous potential benefits to life and health of embryonic stem cell research they claim that even if human embryos are not "things" and worth protection (none of these people claim, e.g., that embryonic stem cell research should be unregulated or exempted from the requirement of research ethical review), the research is defensible.

In effect, we may probably look forward to a long legal battle in the US, Judge Lamberth's ruling being but the first step. But in the meantime we may ask about the ethical basis both for the ban on federal funding of embryo research and for Judge lamberth's application of this ban to stem cell research.

I must be honest and declare from the outset that US policy on embryo research has always struck me as part absurd, part plain stupid (no disrespect to US federal politicians intended, the stupidity is structural). This is not because I disagree with the basic ethical view on the moral importance of human embryos described earlier. That is, I do disagree with it, but even if this view is granted as an axiom, one would, I suggest, have to agree that US policy in this area suffers from a complete lack of supporting arguments. Having been involved in the academic ethics debate about embryo research as well as the process of political debate leading to the clear legalisation of embryonic stem cell research in Sweden in the early years of this century, I have had the opportunity to think about this topic once again recently, due to new research on the ethics not of stem cell research but that of regulating stem cell research, undertaken in cooperation with Daniela Cutas, and very recently published in the book Contested Cells - Global Perspectives on the Stem Cell Debate.

So let's start with the absurdity. The idea of the destruction of human embryos being murder, and the systematic such destruction thus being a case of genocide, does not directly imply that it is immoral to use cell lines resulting from such destruction for research or other purposes. For instance, even today, hospitals and doctors all over the world are making use of the results of the Nazi freezing experiments without any representative of the US religious right raising his voice in protest. However, we may also compare to how anyone of us would react if we learned that the hospitals of our country were making use of tissue and organs for transplantation that had been produced by the elaborate murder of people in other countries in order to obtain these organs and tissue. It is, I believe, in this vein that the opposition to embryonic stem cell research has to be understood - again, assuming for the sake of discussion the basic premise regarding the moral importance of embryos. Now, what is the logical conclusion of such a piece of reasoning? Well, I conjecture, it is certainly not that the sort of policy we find in the US is justified.

Consider the Bush policy of banning the funding of research on cell lines produced after August 9, 2001. As I understand it, the result of the ADF suit and Judge Lamberth's subsequent ruling is that this is the policy that is now in effect until further legal notice. However, this policy is not supported by the ethical argument just set out. This argument makes no difference between the destruction of embryos or the use of the cell lines thus produced on the basis of when this destruction and production took place. Murder remains murder even if it occurred before August 9, 2001, and what is, in virtue of the reasoning explained above, an immoral exploitation on the occurrence of murder remains so whenever the murder is supposed to have taken place. In fact, Dr. Cutas and myself conclude, in the chapter mentioned above, the only way to square the Bush policy with the view on the moral importance of embryos entertained by its supporters would be to revise the latter so that strong moral importance is attached only to embryos that exist after August 9, 2001. The absurdity of this sort of standpoint should be obvious even to the most nutty "pro-lifer". That is, had Judge Lamberth been consistent in his ruling, he would have invalidated not only Obama's but also Bush's policy on embryonic stem cell research. His current ruling is, in effect, genuinely paradoxical.

So, over to stupidity. This point regards not only US policy on stem cell research, but its entire legal take on all sorts of embryo research. Again, I'm assuming for the sake of discussion, the validity of the view on the moral importance of embryos already mentioned. Morally speaking, embryo research is in effect genocide. If true, this is excellent reasons indeed to ban embryo research, isn't it?! Indeed it is, however, US policy is not about banning embryo research. You may destroy human embryos by doing research or any other thing, as long as you are not funding your activities through federal taxes. Genocide is OK if you pay for it yourself!! In fact, it is well known among scholars studying the ethical, legal and social implications of genetics and reproductive technology that the chief effect of the US ban on federal funding of embryo research is that all activities where embryos are destroyed are now safely out of reach of any sort of regulation within the confines of the commercial secrecy of corporations and private enterprises. In consequence, embryos are being destroyed at least as much as ever, but due to the ban even farther off from the reach of the long arm of the law than before. This is simply stupid. Especially people who view embryo research as genocide should think so - on this basis, the conclusion has to be that the ban makes a bad thing even worse. And to get away from this stupidity, the only way would seem to lead back to absurdity; claiming that embryo destruction is not murder as long as US federal tax payers don't pay for it. Again, even the nuttiest of pro-lifer should recognise the absurdity of such a claim, and thus oppose and fight the ban regarding embryo research.