The Ethics of Pharmaceutical Pricing

I don't think I'm alone in having noticed in my own country – as well as throughout that part of the developed world where states run reasonably expansive publicly financed health service schemes – an increased political and general societal problematisation of the costs of new pharmaceuticals.* The background to this increased focus is doubtlessly complex, but four aspects stand out as especially relevant explanatory factors. First, there is the generally splendid public health situation in these countries, with ever increasing average life expectancy and declining morbidity rates at the population level,** but with the side-effect of more and more of this increase being effected by reparative treatment of chronic, aging-related health problems, rather than primary prevention of basic health problems. Second, there is the next step in pharmacological development strategy, whith drugs targeting more and more specific and limited groups of patients and conditions, as a side-effect also providing treatment for extremely rare and serious diseases which have before been a dire fate to bear, with very limited treatment opportunities (many of these monogenic diseases which have been virtually untreatable). Third, there is the increased focus on rationality and ethics of public spending and the organisation of health services, effecting a greater transparency, control and regulation of the assessment, introduction and prioritarisation of new treatments. Fourth, there is the pricing policies of pharmaceutical companies, in extension reflecting the chosen expectations of return on investments of their owners. This post is about the fourth of these factors.

In most discussions of public policy in this area, this fourth factor is and has for a long time been treated as an immovable state of nature. There are three basic reasons usually presented in favour of that stance: First, commercial businesses have to be assumed to act as commercial businesses and strive to maximise profit for their owners, and are – in fact – in most jurisdictions required by law to do so. Second, if pharmaceutical companies would not be allowed to act in this way, they would soon be deprived of investor capital (as this would move to more profitable areas), and this would cripple the development of new drugs. Third, states are not capable of taking on the task performed by pharmaceutical businesses today; if they would, the result would soon be either an even worse cost crisis, or declining development and production. I think that the third argument is worth some critical discussion, especially in some areas of particular societal importance – such as vaccines – but in the present context, I will let it stand unquestioned for the sake of discussion. That is, I assume in the following that states are indeed dependent on private business solutions to have an effective development and production of pharmaceuticals.

But what about the other two arguments? Lately, these have been questioned in the context of debates in several countries about the pricing of a drug called Soliris by its manufacturer Alexion, targetting the rare and very serious hereditary disease Atypical hemolytic-uremic syndrome, or aHUS. In several countries, agencies responsible for assessing the evidence base, cost-efficiency and priority of new drugs have expressed serious complaints about the high price (here, here, here, here). In several of these cases, the national health services have eventually chosen to introduce this drug any way, in order not to have heavily burdened patients caught in the fight between health institutions and drug companies. But the change of tune with regard to pharmacological companies is notable, and raises the more general question of the plausibility and validity of the two arguments above.

I will claim that, given that the thesis supposed to be backed up by the arguments is that national health services, governments and related agencies have no reason to apply normative (ethical or political) judgement regarding the pricing of pharmaceuticals, my assessment is that while both arguments are plausible (as in likely to be true), they are invalid (as in not supporting the conclusion). I will support that claim with two arguments, one ethical and one political, and then sign off by pointing to some complicating factors that I think are mostly overlooked in health policy debates.

1. Even if commercial companies lack moral obligations, their owners don't
It may be debated to what extent commercial companies have moral obligations and, if so, which these are. Most countries have set up a system where, in Milton Friedman's famed words, 'the business of business is business' – that is, beyond keeping to the limits of criminal and necessary civil, and administrative law, commercial companies are not to mind about anything else than meeting the profit expectations of its owners. Based on this, a company may, of course, chose to abide by one or the other moral judgement, but only to the extent that it is thought to be a sound commercial strategy as defined above. Also, while thus using business only for its expected good outcomes of business (usually increased productivity of goods and services), a state may take political action to compensate for its bad side-effects, e.g., with regard to public health. In recent decades, this 'separation thesis' regarding the obligation of commercial companies (to maximise profits for its owners inside the realm of the law) has been questioned as both increasingly irrelevant (due to globalisation, which enables companies to move freely between jurisdictions in an amoral manner, thus emptying the content of the requirement to abide by the law) and for its inability to reply to increased arguments coming from the area of business ethics, corporate social responsibility and political philosophical observations that the separation thesis assumes a demarcation between the realms of business and that of basic public concerns which is simply not to be had.

However, even if we would grant the idea that companies have no other moral obligations than meeting the profit expectations of their owners inside the realm of the law, it doesn't follow that national health services, governments and related agencies have no reason to apply normative (ethical or political) judgement regarding the pricing of pharmaceuticals. This since the separation thesis does not in any way undermine the claim that owners of businesses have moral obligations and ethical reasons to behave considerate towards other people beyond what the law may require. Or, it may do so in the first instance, as many owner's are institutional business parties (banks, funds, and so on), but at the end of the day, there will be actual and quite ordinary people, and these have the same moral obligations as anyone else. In fact, it would seem that the whole idea of the separation thesis rests on the assumption of a well-functioning society within which businesses may operate, and a core part of such a society is that people act decently towards one another. This implies, e.g., the recognition  of basic and reciprocal civic obligations of due diligence, duty of care and general consideration to other people – all stretching beyond what is strictly required by law. Just start to imagine what walking along a street in a city would be like absent such basic cultural arrangements in place. Likewise, imagine a society were no individual assisted another in need according to such principles. I take it that no one would disagree that we hold these sort of moral obligations to one another. However, if we do, these don't just magically disappear if we happen to open a shop or purchase some company stock. Even if not required by law, as owners of businesses, we are still bounded by ethical considerations to other people, e.g., to care for those in dire and undeserved circumstances.***

So how does one discharge these moral obligations in the role as owner of commercial enterprise? Well, since the enterprise itself – a company – works according to the main principle of realising the profit expectations of the owners, the lever available to an owner seems to be exactly these expectations. That is, the material outcome of the duty of the company towards its owners being discharged can be manipulated by the owners' communication into the company structure of what level and rate of return on invested capital is being expected. This creates ample room for an owner to have ethical reasons to adjust such expectations in view of reasons beyond those of "pure business". Transferred to the case of pharmaceuticals, this line of reasoning results in the conclusion that, to the extent that this is required by our normal set of ethical reasons to be considerate towards each other, an owner of such a company has a reason to decrease his or her expectation of return on invested capital, whether in terms of level or rate. In both cases, such an adjustment will enable the company to adjust its pricing downwards without defaulting what it owes its owners. To be true, such a reason need not always be available, but in the case of drugs for very serious diseases, it seems quite reasonable to claim that it does. Note also, that the reasoning can be applied also to argue against withdrawing investment, thus diffusing the argument that reducing profit margins to enable lower pricing would effect investment flight. Maybe it would, but it still holds that investors should not thus flee a slightly less profitable investment that would mean meeting one's general moral obligations to other people. I made this argument myself, in the Swedish debate around Soliris.

In conclusion, the idea that there are sound and valid normative (ethical) claims to make with regard to the pricing of effective drugs for very serious diseases holds up to scrutiny. The (assumed) facts that "the business of business is business" and that (potential and actual) owners of pharmaceutical companies do as a matter of fact not currently seem to act in accordance with their moral obligations (maybe partly because these have not been recognised) do nothing to undermine this claim. Owners of pharmaceutical companies owe it to very sick people to adjust their profit expectations to enable more modest pricing, and potential owners owe the same people not to withdraw from investment due to this obligation.  

2. States owe their citizens not to be money pumps
The second argument does not target individual people in their role as (potential) owners and investors, but rather state institutions in their roles as counterparties in business negotiations. This argument is entirely independent of the first one, and will hold up even if the former would be shown to be somehow faulty. The argument does, however, assume that pharmaceutical companies are behaving more or less according to "the business of business is business" pattern, with owners who as a matter of fact do not moderate their expectations on return on invested capital as they should. Should owners start to behave more in line with their moral obligations, the validity of the present argument will be undermined (although it is still sound).

The behaviour of pharmaceutical companies with regard to pricing of drugs as just sketched means that they try in every instance to find an optimal equilibrium between the price per sold item and the number of items sold. This is the reasons why the so-called "list price" of new drugs is in most cases much higher than the price eventually paid by public health services; the company sets an exaggerated price as it expects a negotiation where the price will be decreased in light of consumer demand, as expressed by the public agencies doing the state's bidding. In my own country, where up till recently, this bargaining has been undertaken by each single county government (responsibly for its health care service region), companies have thus been very savvy at, insisting on commercial secrecy around the agreed price, play all these counties against the middle to maximise bargaining outcome. From a political ethical standpoint, to have state or county agencies – and ultimately tax payers – thus being allowed to be played for suckers is simply unacceptable. For what it means is that the state – in view of the never ever ending demand for health care – allows commercial parties to milk its treasure chest dry. In more technical sense, the state thus allows itself to be what experts on economic bargaining rationality and game theory call a money pump – someone who applies a bargaining or game theoretical choice strategy that systematically leads to a losing position, albeit each single move may appear winning, given the circumstances.**** The argument that one should avoid such strategies (technically, to avoid dutch book strategies) has given raise to the discipline of dynamic choice theory, and is a standard motivation, e.g., for why it is irrational to apply decision strategies that make one succumb to blackmail – as each concession of a black mailer's demands (no matter of well motivated in the single instance) makes it rational for the blackmailer to continue the blackmail and increase the demands. In the case of negotiations about the price of pharmaceuticals, the state or responsible public agency becomes a money pump by being overwhelmed by the reason to accept the offered price presented by needs of single patients, and thus not considering the option of declining the offered product as a live option. Just as the blackmailer in the analogous situation receives increased reasons to continue the blackmail and up the stakes, the pharmaceutical companies are thereby reinforced in their reasons in terms of business logic to increase prices even more, and thus increasingly bleed the public health services budget.

I take it that everyone agrees that a state and its agencies owe it to their people to avoid such positions. As a matter of fact, since the rationality of avoiding being a money pump is so basic, this would seem to hold even on the super-thin libertarian idea of the state as a security business enterprise of its citizens (which I take most people would want to go beyond). But to do that, the state has to create a bargaining situation where the counterparty counts a declining of its offer as a live option to be calculated with. And to create that situation, the state needs to actually decline offered services also when they are necessary to meet important needs.If they don't, the companies will not view such a declining as a live option, and will thus be motivated to increase the stakes. Now, this does not necessarily mean that it is in case of effective orphan disease products such as Soliris, where the most urgent need for such demonstration of actual bargaining power is called for. Rather, one would find it more acceptable to decline state subsidising of treatments for far less serious, albeit more widespread conditons, although that may not harvest much of political popularity. But if the state never says "no" to anything, the money pumping result will eventually affect the entire public health service supply, and it is not unlikely that before long the willingness of citizens to fund very expensive treatments for conditions that strike only very few will falter as a result. Moreover, as more and more drugs for all sorts of condition (many of which will not be as extreme as aHUS) can be expected to become "orphan" in the sense of targeting only very specific patient groups, or add only very minor therapeutic effects (and often considerable side-effects) to serious conditions which are inevitably killing patients very shortly (as is the case with many new cancer medications), the fact that the targeted condition is either rare or very serious cannot by itself be a disclaimer from applying a rational bargaining strategy that also takes into consideration therapeutic effect, cost and opportunity costs in terms of what other treatments to other conditions may may be funded by the same money.

In any case, however, the many difficult priority setting issues which follow from the state and responsible agencies thus taking its responsibility to citizens are handled, the fact remains that the state does have such responsibilities. As much as society has reasons to allocate resources to be able to offer its members publicly available health care services, it has strong obligations to the very same members not to unnecessarily waste these resources. Avoiding the money pump position in relation to pharmaceutical companies seems like an elementary part of performing that duty.

3. Where we are in all of this
In conclusion, there are two separate arguments for the existence of valid and sound normative reasons to apply to the pricing of pharmaceuticals by commercial companies. Both assume only a very minimal idea of ethical and political reasons, which should be acceptable across most otherwise competing ethical and political positions and ideologies. However, there is an interesting dialectic between the arguments, hinted at when I wrote above that the second argument gains in validity to the extent that the first argument is ignored by the acting parties – owners of and investors in pharmaceutical companies. But who are these owners? As pointed out, in the first instance they are probably mostly banks, investment and holding companies, funds and so on, but at the end of the line there will of course be actual people (who hold the ethical obligations claimed in section 1 above). Some of these will, of course, belong to the fabled 1% of repugnantly rich, but most of them won't. In fact, most of them will be like you and me, people who has a bit of insurance, a bank account, a small slice of a pension fund (no matter how modest), loans, maybe even some stock. And even if our possessions of this sort are very modest, we are benefiting from a public health services system, which include funds where the capital to pay for and subsidise pharmaceuticals and public health care investments is stored and managed, and we may even be due for a bit of minimal public pension from funds equally so taken care of to be able to deliver what was originally promised. In other words, we who gasp at the indecent pricing of pharmaceutical companies are the very same people who in section 1 above were claimed to have moral obligations to lower their expectations of return on invested capital. In view of the apparent fact that this seems to imply that most people have to lower their pension-, insurance, savings- and welfare demands, one may quite plausibly doubt our collective capacity to effect such an adjustment, no matter how persuaded we are of its rationale on a theoretical level.

Therefore, as in so many other cases, the most rational solution would seem to be the second one: to press the reasons for the state and involved public agencies to apply effective and rational bargaining strategies against the pharmaceutical companies. Of course, to have effective such systems, it is rational to abandon the subsidiarity system, where each county government make their own bargain, and centralise the process nationally. But that's only the first step, of course, as the same logic tells us to accept multinational bargaining cartels, possibly across the entire EU. That will probably have quite a bit of bite, although it will also necessitate difficult issues of health care policy priorities, due to the need of sometimes actually saying no to the offered goods. Moreover, it will, as in so many other cases where we are unable to do collectively what we should be doing together, force us to accept the concessions (in terms a lowered returns on investments, savings, pension fund, insurance benefits, what have you) we were obliged to accept by ourselves, but failed to do.
  

*) There is, of course, a comparably much more pressing issue about the cost of and access to pharmaceuticals in developing and/or economically deprived settings. This issue has attracted the attention of ethical reflection for a long time, and there is a rich debate addressing its many levels to dip into for whoever feels like it – just make some searches using "orphan drugs", "orphan disease", "ethics" and "access to healthcare in developing countries", and you're set.

**) Granted, there is also in many of these countries stark health inequalities. However, if we plot the curves from the start of these modern health policies at the beginning of the 20th century, even the worst of worst-off groups of today come out considerably better. This is not to say that inequalities of the present are unimportant or that it shouldn't be a priority to decrease them, and to lift the worst off even higher (it should!). But the point remains that also the worst off of today cannot be made much better by primary prevention, but will also need the same shift to expensive reparative treatment of basically incurable conditions and mere aging. 

***) The qualification of "undeserved" is inserted merely to silence objections based on considerations of desert.

****) The classic "money pump argument" regards only the case when such a strategy is the result of a choosing party entertaining intransitive or "cyclical" preferences, and used to motivate why a rational actor must avoid such preference structures. However, the argument apparently rests on the assumption that being "pumped of one's money", as may result in this instance, is a general fault to be avoided by a rational actor, no matter the explanation.

Could and Should Rivers have Rights? Yes, of Course!

This little news item, spurred some slightly uneasy reactions when I forwarded it on Twitter today. It's about New Zealand granting a particular river "legal personhood", implying it to have legitimate interests and rights, just like other legal persons.

Must be crazy, right? Or at least appalling and misguided, given all the instances globally where actual people are not being granted such standing? Or, at least, I – in light of philosophical views I hold in other areas – should be against anything in this direction. I mean, if I'm hesitant to award human embryos or fetuses moral status of the sort claimed by pro-life ethics advocates, why should I be prepared to grant rights to a river??

Well, it may surprise you all to know that I actually find the New Zealand move perfectly defensible. Be back to explain why in a later post, unless someone presents the right answer here in the comments before ;-)

Court Acquits Swedish Neonatal Doc Charged with Murdering Newborn Baby in Controversial Case

Today, the verdict was announced in a very controversial case in my country regarding a neonatal intensive care doctor, who has been charged with murdering a newborn baby by administrating high doses of sedatives (here, here, here, here, here, here, here, here). The doctor is acquitted of the charges of manslaughter. It remains to be seen if the prosecutor decides to take the case further to appellate court.

The case has sparked heated discussions and not so little confusion in the medical, political and ethics expert community. Leading voices of medicine have somewhat lost their marbles and made megalomaniac claims about doctors being immune from prosecution whatever they do to their patients in the name of best practice. There has also been rather peculiar criticism about the prosecutor taking a long time bringing the case to court, where the unspoken message seems to be that medical doctors should somehow be treated differently than other people in criminal proceedings - reminding a bit about how Julian Assange or Mr. Strauss-Kahn have been reasoning around their own persons in relation to the rape charges they are or have been facing.

All of this has, to my mind, been sheer nonsense. Of course, it is immensely burdensome for anyone to face serious criminal charges. Even more so if your own view is that you have made nothing wrong, but rather the best you can. It is also completely understandable and justifiable that the legal defense and friends of those charged do their best to have the person charged described as innocent in media. However, the principle of equality before the law stands far above any such individual consideration. Take a deep breath and think about for a moment how society would look like if we let that principle slide and this should be crystal clear to anyone.

Now, there have been several attempts to make a spin on the case settled today according to which it is not about a real legal issue, but rather about a more hazy underlying problem of an ethical nature. The idea has been that the critical issue is whether doctors are allowed to take risks in order to achieve effective pain reduction in dying patients. However, albeit indeed being an interesting issue in its own right, that has never been the centre of discussion in the present case. Doctors are allowed to take such risks according to Swedish law, end of story. But they are not allowed to murder people as this is defined in criminal law. It is the latter that has been the base for the prosecutor's claim in the case decided today. 


Instead of making my own explanations of how I read the court's decision, I have made a quick translation of the court's own press summary. The Swedish original is here. Read for yourself and make up your mind!

Solna District Court today acquitted the doctor who was prosecuted for manslaughter or attempted manslaughter of an infant at Astrid Lindgren's hospital in Solna fall of 2008. The district court has not found it proven that a crime has been committed. The district court has not found it proven that the doctor has done something that was not be medically justified.
The district court has not found the evidence sufficient for showing beyond reasonable doubt that a crime has been committed. The prosecutor's claim is based on an analysis of forensic evidence, which has demonstrated an exceptionally high concentration of thiopental in the blood from the deceased child. The district court has not considered this result to be sufficiently reliable to fully serve as the basis of a conviction. The district court does not believe that one can draw any more far-reaching conclusion of the analysis results than the one that thiopental, although observed in a high concentration, it is unclear how high the concentration was. Given this uncertainty about how high the concentration was, it is conceivable that the occurrence can be explained by the fact that the child had received thiopental on previous occasions during hospitalisation. This means that there is no evidence that a crime has been committed and the doctor is already on this ground freed of the charges made.
 The district court has not considered that the prosecutor with sufficient certainty has proven that the doctor has acted in any way that was not medically justified when the child died.
In the debate related to this case, it has been claimed that the case concerns the distinction between what a doctor can and cannot do when it comes to relieving pain and anxiety in end of life care. This is not correct. The prosecutor's contention is rather that the child has been poisoned, that the child has been receiving a very high lethal dose of thiopental administered in order to effect that the child would die, not in order to relieve pain or distress. There is no doubt that such conduct, if it had occurred, is punishable as manslaughter under Swedish law, whether or not it had been prompted by reasons of compassion and whether or not the child would have died anyway within a very short time. As has just been said, however, the district court did not consider it proven that such a criminal act had in fact taken place.

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.

Pharma Corps put Money Before Swedish Women's Health, But Why Be Surprised?

Today, the Swedish branch of the international pharma corporation GlaxoSmithKlein (GSK) announced that it will appeal the decision of the united health care regions of Sweden to use the vaccine product of their competitor Sanofi Pasteur MFD (SP), Gardasil, over GSK's Cervarix. The decision is another stalling maneuver in a longwinded process following the decision of Swedish public health authorities to provide young girls and women with a publicly run vaccination programme against Human Papillomvirus (HPV) – causing both cervix cancer and STD's, such as condyloma. It is unknown how long the processing of the appeal will take, but the financial director of GSK in an interview alludes to an earlier court process (see below) that took about 18 months. Thus, due to GSK's decision today, during this time-period potentially all Swedish young females will be provided with no protection against HPV. Possibly, some of these will buy a vaccination with their own money, but that can hardly be credited  as an upside to GSK's decision, given that they could instead have received it for free.

However, this is not the first appeal in this story. In fact, the decision that GSK is now appealing is the result of a former appeal that SP made against an earlier decision to purchase Cervarix. Also in that case, the material effect of the appeal was endangerment of many, many young women's health. Both companies of course argue that their product is the best, but that's just smoke. What they do is to repeat their sales pitch, but now publicly rather than in the original business bid. In the case of GSK, they even have the poor judgement and tasteless arrogance of trying to present their bid as objective argumentation in a debate article. Come on! The assessment of these bids is the business of the buyer, and if the buyer makes a bad decision, that's where the responsibility is to be placed. However, the buyer of a large public health policy order has many things to balance. Of these the effectiveness of the product is, of course one. But effectiveness is a complex matter and in the case of HPV very much so, since different strands of HPV link to several different health problems. In addition to that, the expected effect has to balanced against the cost. This since, at the end of the day, every Swedish Crown spent unnecessarily is a crown that could instead have been spent on other important public health undertakings. Given this situation and given that all information from the bid-makers have their basis in the self-interest of a business organisation (which in the case of becoming a part of a large public health undertaking is huge), the argumentation like the one presented by GSK today is simply not credible. Of course, they have to say that they believe in their product, just as SP has to. But so what? Regardless of this, the buyer has to make an assessment and a decision. What the appeals create is only that this procedure has to be done all over again, the first time by the buyer (according to procedures prescribed in Swedish administrative law), and this last time by a court of law. In neither of these cases will the repetition of GSK and SP of the claim that their product is the best one mean anything. The whole process is so absurd, that the responsible politician for the process of buying the vaccine, Stig Nyman, today urges the government to change the regulation around purchase of health products by the public sector, so that the armies of lawyers of the pharma corps are barred from obstructing orderly processes of great benefit of the public to proceed. Similarly, in Sweden's foremost politically conservative news paper, Svenska Dagbladet, otherwise notorious for its overly charitable interpretations of the intentions and doings of private enterprises, the deadly outcome of GSK's decision is underscored and the analysis is made that the pharma area of business is in fact nothing but callous, inconsiderate and deceitful.

Now, GSK has realised that the decision to appeal yet another time does not put the company's image in a very good light and therefore tries to give an impression of having taken the decision greatly troubled and burdened by ethical considerations. All pharma corps nowadays do their utmost to project such an image of caring about the health of people and minding about ethics, and GSK is no exception. However, is this more than mere branding (a question that applies to SP  just as much, of course)? One of my department's most successful young researchers, Joakim Sandberg, wrote his PhD dissertation Ethical Investing: Making Money or making a Difference? (and numerous papers) on the issue of how much the projected interest of being "ethical" used as a marketing tool by companies in different branches (using the case of investment funds) is grounded in any substantial ethical commitment. The sign of such a commitment is double: (1) that the company has a clear, publicly accessible and plausible idea of the criteria for acting ethically defensible (most of the book is about what that implies) and (2) that this idea at least sometimes is actually motivating the company to make decisions that are less than optimal in business terms. Simply put, if you are not prepared to sacrifice anything for your ideals, you effectively have no ideals. Not surprisingly, perhaps, it appears that the examples of business operations projecting the image of being especially ethical and at the same time meeting condition (2) is a rare species indeed.

In the pharma area, there are numerous examples of this phenomenon. In fact, the list of cases is becoming so long and depressing that the mechanical repetition of the public relations departments of all of the pharma corps around the world that good ethics is a key endpoint of their enterprise is starting to sound like the gibberish of a mad clown who no one think is funny anymore. Just a few years back (before I started this blog, or you would have read about it here), Astra-Zeneca was exposed in a major research ethics scandal,  where they had deliberatly chosen to conduct a clinical trial of psychiatric drug in a country (Russia) that insisted on a placebo arm of the trial, although an existing efficacious treatment was in place. In effect, half of the participants were left with no rather than some treatment and a number of suicides had to occur before A-Z had the sense to abort. What is more, they did this not in order to have a license for the drug in Russia, but to have it in the EU. I and several bioethics colleagues in my country had no problem in harshly criticising A-Z (here, here) and the lame response from A-Z was that they indeed were an ethical company, since they had abided by Russian research ethical regulation - thus pretending that they carried no responsibility for having chosen (obviously for economical reasons) to house the trial in Russia in the first place. This is just one among many, many cases of what in bioethics circles has become known as clinical trial imperialism. Simply put, Western pharma corps systematically try to place their trials of new drugs in countries where the trial will be most cheaply run while still providing results that may get them a license somewhere in the West. As to upholding minimal standards of human subjects protection, reliable oversight and accountability – sod that!

So, to get back to GSK, SP and the HPV vaccination business. What we see happening in this case is just more of the same. Sweden just like all other Western countries are using tax payers money to provide pharma corps with very privileged positions: patent systems, drug subsidises, seed money to ease the establishment of offices and labs, access to the resources of medical schools, university hospitals and public health care systems, close cooperation to smooth the product development process, and support for a market for non-prescription drugs that in most cases actually is detrimental to the health of the population. They do all that because they see no alternative. The development of new pharmaceuticals for serious and widespread disease is a high risk endeavor and very expensive process, and most countries prefer to have it done with the funding accessible through business transactions. But this is no reason to be seduced by their marketing offices. Pharma corps don't care about anyone's health and even less about public health. In fact, the best business sitiuation for a pharma corp is a permanent health problem that never goes away, but where the company can supply a product that slightly mitigate the symptoms. That's far, far better business than anything that cures people or – to name the nightmare of a pharma – that permanently prevents the onset of the problem. Even less do they care about ethics or upholding minimally decent ethical standards. They demonstrate this convincingly by never ever being prepared to sacrifice a buck for adjusting to ethical considerations of any weight. They do, of course, abide by laws, but prefer to place production in countries where efficient industrial operation is combined with the most allowing rules – unless sale efficiency demands otherwise. They do, on homepages and in company prospects, repeat the words "ethics" and "ethical" (as well as "responsible") so often that the cursory reader might mistake them for something out of the Vatican, but, as the Swedish case of GSK and SP regarding HPV vaccination shows, all of this is smoke and bogus. All. That is not a very comforting thought, and in light of our view of pharma corps as necessary, that discomfort may trick us to believe otherwise. But this is, I claim, the sole truth.

Goverment Decision not to Compensate Abused Swedish Foster Care Children: Hypocritical and Invalid

Early this year, a Swedish government committee revealed a scandalous rate of long-standing and severe abuse of children enrolled in the public foster care system (here, here, here, here, here, here). The deeply repugnant pattern of mistreatment goes way back in time, as far as the 1920's, and is, the committee reported, still ongoing. The committee recommended that the government, besides the obvious task of putting a halt to ongoing abuse and express an official apology to past victims, should offer substantial economic compensation to victims of abuses in the past.

Today, however, Sweden's current minister of children and the elderly, Maria Larsson (Christian Democrat), to big surprise reported that the government will not follow the recommendation of the committee (here, here, here, here, here, here, here, here, here, here, here, here)  The given reason is that a compensation scheme would be impossible to implement in a fair and legally secure way. This reason, however, appears to be completely invalid and, in addition, incoherent with established policy.

The suggestion to economically compensate victims of past abuse is consistent with the way that Sweden eventually came to handle victims of the compulsory sterilisation policies that were in operation between 1935 and 1975. These were offered economic compensation (besides an official apology) and this was swiftly implemented. So, obviously, it is possible to set up a satisfactory system for compensating victims of mistreatment resulting from official policy. Maria Larsson is simply not telling the truth here. Even worse: since she is well aware of the compensation in the sterilisation case, she is deliberately holding out a pretext as good reason.

To this may be added that the compulsory sterilisation program, when it ran, was part of officially condoned policy, enjoying broad support all across the political and religious board. It was also accepted as a part of acceptable professional practice by medical doctors. The decision to compensate thus was an ethical decision, based on the assessment that although no formal error had occurred, a serious moral mistake had been made. In the case of the abuse of foster children, however, it is obvious that formal errors have been made. Not least, official agencies responsible for the administration of the system have obviously committed serious errors of neglect. So, here we have something which is both a moral and a formal fault, but then the government decides not to compensate. This is official hypocrisy at the highest level.

And allow me to become a bit personal: Maria Larsson is supposed to represent a political party the stronghold of which is held out to be politics on the basis of christian ethics, with the interests of the weakest and most vulnerable at the center of attention. How she manages to look at herself in the mirror with a straight face when making the decision revealed today is beyond me: the hypocrisy apparently goes far beyond just inconsistent and ill-considered official policy making. This shakes the very fundamentals of our country's supposed "ethical" party.

But it doesn't stop there. At the same time as Maria Larsson deliver her deeply unethical, formally erroneous decision under the smokescreen of an obviously bogus reason, she has the extremely bad taste of offering the victims of the abuses for which Swedish public institutions are both morally and formally responsible a "ceremony" where an official apology is extended, to which the victims will be invited. In short: spit in their faces and make a ceremonial bow.
 Shame, shame shame!

Read Entire Chapt. 1 of My New Book Online for Free

Springer, who publish my new book on the ethical basis of the precautionary principle, The Price of Precaution and the Ethics of Risk, has permitted Google books to make the entire first chapter available for online reading. Here it is embedded:




And if you rather prefer that, here's a link to the Google books site. And here's a presentation of the book from a recent post, with links for sampling other chapters and look at the index.

Torture as Treatment?

Despite the ugly track record of treatment of intellectually and cognitively disabled people over the centuries, I was actually quite shocked to learn about this apparently ongoing practice in the USA:

Eight states are sending autistic, mentally retarded, and emotionally troubled kids to a facility that punishes them with painful electric shocks.

Read more here.

My Book on the Ethical Basis of the Precautionary Principle is Out!

So, some shameless self-promotion:

My book on the ethical basis of the precautionary principle, The Price of Precaution and the Ethics of Risk, is now officially released by Springer. To view the table of contents, sample substantial portions of chapters and look up names or subjects in the index, click on the button below:

 Here's the content summary in all of its glory:

Since a couple of decades, the notion of a precautionary principle plays a central and increasingly influential role in international as well as national policy and regulation regarding the environment and the use of technology. Urging society to take action in the face of potential risks of human activities in these areas, the recent focus on climate change has further sharpened the importance of this idea. However, the idea of a precautionary principle has also been problematised and criticised by scientists, scholars and policy activists, and been accused of almost every intellectual sin imaginable: unclarity, impracticality, arbitrariness and moral as well as political unsoundness. In that light, the very idea of precaution as an ideal for policy making rather comes out as a dead end. On the basis of these contrasting starting points, Christian Munthe undertakes an innovative, in-depth philosophical analysis of what the idea of a precautionary principle is and should be about. A novel theory of the ethics of imposing risks is developed and used as a foundation for defending the idea of precaution in environmental and technological policy making against its critics, while at the same time avoiding a number of identified flaws. The theory is shown to have far-reaching consequences for areas such as bio-, information- and nuclear technology, and global environmental policy in areas such as climate change. The author argues that, while the price we pay for precaution must not be too high, we have to be prepared to pay it in order to act ethically defensible. A number of practical suggestions for precautionary regulation and policy making are made on the basis of this, and some challenges to basic ethical theory as well as consumerist societies, the global political order and liberal democracy are identified

Thank you for your kind attention!