Jessica Flanigan, Pharmaceutical freedom, Oxford University Press, 2017

Most academic philosophers live in a world of pharmaceutical paternalism: new treatments are subject to premarket approval by State regulatory agencies, and patients will only be able to access them through medical prescription. Outside academic philosophy, there has been a long tradition of pharmaceutical libertarianism, advocating for allowing patients to take their risks with experimental treatments without State or medical interference. Precisely because this tradition has had almost no philosophical echo, Jessica Flanigan’s Pharmaceutical Freedom was a necessary book. Its broad claims and intuitions are not new. The real originality lies in the thorough examination and defence of the right to self-medicate from the standpoint of contemporary moral philosophy.
Flanigan grounds her arguments on the patient’s authority in knowing what will promote her overall well-being and in deciding what to do, with an original twist: she shows that supporters of informed consent should also endorse self-medication, as it is based on the same foundations. She criticizes regulatory paternalism for failing to adequately protect public health: informed self-medication could do better. Moreover, pharmaceutical regulators “wrongfully kill patients by withholding access to investigational drugs”, until they are approved. Drug prescription is equally objectionable for restricting the right to die, the right to use recreational drugs, the right to self-enhancement and the right to use pharmaceuticals for non-medical reasons. Flanigan defends that patients should “develop drugs outside the formal mechanisms of the approval process, disobey pharmaceutical regulations, and protest existing policies” (p. 165), even if they do not have the support of a majority of voters (“biased against rights of self-medication”). If, at this point, you are wondering whether pharmaceutical companies do have any particular moral obligation towards patients, Flanigan defends that it is an industry like any other: there is no reason to expect that they provide affordable products. Pharmaceutical marketing (e.g., direct to consumer advertising) should be deregulated, such as any other instance of paternalistic health regulation. Tort law provides enough defence for pharmaceutical consumers to stand against any industry misdeed.

These are the claims that Flanigan makes in her book, and I think the author deserves all the praise to make them as boldly and straightforwardly as possible. Most of these claims, although with different justifications, have been around since the passage of the 1962 Food and Drug Administration Act. It established a pre-market approval system for drugs on the basis of the safety and efficacy they showed in randomized clinical trials. Flanigan surely draws on these libertarian/pro-industry sources (e.g., W. Wardell and L. Lasagna are cited; T. Stossel is mentioned in the acknowledgements), but she constructs arguments that rely, to an unprecedented scale, on principled philosophical considerations (after the steps of Allen Buchanan, Robert Veatch, etc.). Nonetheless, Flanigan has also a policy proposal: a supervision system for pharmaceutical markets. Instead of pure market control (customers select the good treatments buying them), in the best libertarian tradition, or ex post withdrawal of the dangerous compounds (Wardell and Lasagna’s approach), Flanigan defends a certification system, in which a public agency tests the treatments already sold in the market and assesses their safety without gatekeeping powers.

I leave to moral philosophers the discussion of her more principled arguments and, as a philosopher of science, let me take issue instead with this latest proposal. My general contention is that Flanigan tends to overstate her moral claims at the expenses of every other consideration. A case in point is precisely the certification of drug safety.  For Flanigan,  “Drug safety is a normative judgment that requires knowledge about how the risks and side effects of a drug fit into a patient’s life as a whole” (p.10). The 1962 FDA Act definition of safety linked it to efficacy as shown in one particular experimental design: randomized clinical trials should establish whether a treatment for a given condition would reliably have certain effects. This is the positive concept of safety: the choice of a treatment outcome might be normative, but regulators care about it being predictable. Flanigan claims there is something more to safety: a drug may be unsafe for the FDA (e.g., having known adverse effects) and yet a patient may think it is safe for her to take it and, according to Flanigan, she should have the last word about it.  Flanigan provides three arguments about why people can consent to drugs that carry known (and unknown) risks (p.24), showing how consent to risky alternatives (rejecting treatments, participation in phase I trials) is considered acceptable, and yet it seems unjustified to consent to risk thresholds below FDA-safety. So why not leave the ultimate assessment of safety up to the patients?

This is Flanigan’s certification proposal: let regulatory agencies certify the predictable risks of a treatment and leave to patients the informed decision to take them. On purely normative grounds, I think this is a very persuasive idea for anyone with even a minimal anti-paternalist inclination. The problem is, of course, the positive implementation, about which Flanigan provides almost no detail. Her intuition is that for the majority of patients who value their health, not much would change: they will rely on certification, while the most desperate/daring patients will trust their own judgment (p. 62). But I disagree here: the devil is in the details. Randomized clinical trials are long and complicated experiments, often involving thousands of patients, and completing them usually takes years. Assuming that Flanigan’s system adopts the current evidential yardstick, certification will be equally slow. There will be many non-certified systems in the market for which patients will only have the non-certified information provided by the manufacturer. Patients in need of these treatments will have to trust the honesty of the manufacturing company in reporting risks (p.26), and litigate if, after trying the drug, she feels cheated: according to Flanigan, tort law provides a better protection for her rights than any pharmaceutical regulator (p. 221).

I doubt it. For a start, there is an extensive academic literature on the misdeeds of pharmaceutical marketing that should give us some pause about its honesty. This literature is simply absent from the two sections in which Flanigan discusses the topic (pp. 209-217). Instead, pro-industry views are presented on a positive note, giving them, I fear, more epistemic weight than they deserve. E.g., I was intrigued by an unusual reference on the positive effects of direct-to-consumer advertising (p. 211, footnote 13) for which just the title was given and a long Proquest link. Searching on Proquest, I found that the paper was published in the “Web Exclusives” supplement of a journal, with some very serious scholars as lead authors and some co-authors from a marketing agency. After reading Sergio Sismondo’s work on pharmaceutical publication planning, I would have expected Flanigan to add some caveats on the reliability of such a source (and contrast it with more standard sources on the topic).

But even if the libertarian pharmaceutical consumer cannot trust the manufacturer, if she feels cheated after receiving the non-certified treatment, she can always sue for dishonest reporting about risk. My question is: on what grounds can she contest the honesty of the non-certified brochure? On the one hand, there are many evidential standards that can be used to argue that a drug is safe/effective, ranging from clinical trials with different designs to observational studies or simple expert judgment. If the industry is self-serving in choosing the evidence reported in the brochure, how can a court adjudicate whether the information was accurate? On the other hand, given that testing treatments involve long and expensive studies, how can the dissatisfied libertarian patient ground her legal claims? Judges and patients may both defer, of course, on the certification agency test as a benchmark, but then we would be almost back at the status quo: which company will dare to launch a product without conducting long clinical trials, for fear of litigation? 

This are not mere counterfactual scenarios: this is the history of pharmaceutical markets. For example, legitimate British manufacturers in the 1930s were demanding a regulatory intervention in order to protect themselves against the rogue competitors who sold fake drugs based on pretence tests, undermining their own sales. Fraud prosecution offered little protection (against Flanigan’s optimism), because it was difficult to prove fraud in court without an evidential benchmark for authenticity. Again, I cannot help feeling that Flanigan cherry-picks the evidence that supports her case. She cites uncritically the usual bunch of old econometric studies that provide ammunition against our current regulatory system (Peltzman, Temin, etc). Yet, the key concept of Dan Carpenter’s landmark monograph on the FDA, a thick volume of analytical social science published less than a decade ago, is dispatched in just one sentence (p.127).

Summing up, there is a significant gap to bridge between Flanigan’s normative understanding of drug safety and the practical implementation of a certification system for “positive” safety. Flanigan is at her best in the discussion of moral principles (which is 2/3 of her book), but really does a poor job when it comes to policy recommendations (the reminding 1/3). I have been clearly unfair to her work in focusing on this latter aspect, but, I think, it is for a good reason. If I were a libertarian patient willing to dismantle the FDA, I would want some reassurance that we won’t see a regression to the world of unpunished pharmaceutical frauds of the early twentieth century. Moral argument, in other words, is not enough for policy action. But we should be grateful to Flanigan for articulating the libertarian case so well and making it part of our philosophical conversation on the pharmaceutical world.

{March, 2018}


Gustavo Bueno (1924-2016), el gran clasificador

“Crítica es clasificación”, decía Gustavo Bueno, el gran clasificador. Abra cualquiera de sus obras y lo más probable es que se encuentre una “teoría de teorías”, en la que sus propias ideas se oponen sistemáticamente a cualquier alternativa. Sólo un genio de la clasificación puede permitirse desafiar así las intuiciones de sus lectores. Bueno era materialista, pero, a diferencia de los materialistas vulgares, defendía la realidad de las ideas (un “género de materialidad”). El de Bueno era un ateísmo católico, en el que la tradición escolástica contaba tanto como la filosofía moderna (y bastante más que la contemporánea). A Bueno algunos le conocieron como falangista (en los 1940) y otros como marxista (en los 1970). De cualquier proyecto político a él le interesaba su implantación efectiva, y la universalidad de su alcance. Lo mejor: un Imperio. “De no ser por la Iglesia católica, el cristianismo habría sido una secta judía más”, decía. Caídas la Alemania nazi y la URSS, Bueno se las ingenió para argumentar que, en el siglo XXI, España es lo más parecido a un proyecto imperial que les quedaba a los filósofos sistemáticos-materialistas-ateos-católicos.

Nuestro gran clasificador era, por supuesto, inclasificable. Nadie se atrevió a mezclar tantas ideas como Bueno a propósito de tantos temas como tocó en su extensísima obra. Él se presentaba como un “compositor” en un medio académico de “intérpretes y arreglistas”, como el español. Suya fue la reivindicación de la Symploké ontológica (“No todo está relacionado con todo”), el cierre categorial (la verdad de la ciencia no es la correspondencia entre teoría y mundo: es una forma de organización del propio mundo a través de las operaciones del científico), el animal divino (el terror prehistórico ante el animal sin domesticar es el origen del sentimiento religioso), y un largo etc. Aunque Bueno no fue nunca demasiado cuidadoso al citar sus fuentes, muchos lectores adivinaban de dónde bebía. Pero eso no disminuye su mérito componiendo: ni en su generación ni en las siguientes encontramos semejante fusión de estructuralismo y escolástica, análisis lógico y fenomenología. Pretendiendo ser, todo el tiempo, más consistente que cualquiera de sus interlocutores, pues para eso –decía– sirve un sistema.

“Pensar es pensar contra alguien”, sostenía una y otra vez Bueno. Contra el propio Bueno, sin embargo, no ha pensado todavía nadie. Como sucede en cualquier escuela, los estudiosos de su materialismo filosófico suelen ser más arreglistas e intérpretes que compositores. Fuera de su escuela, nadie se ha tomado la molestia por ahora. Lo cual no dice mucho de sus méritos intelectuales. Así somos en España: ¿quién piensa hoy contra Zubiri, García Bacca, Amor Ruibal o García Calvo? Dice bastante, en cambio, de su implantación mundana. Como demuestran los obituarios publicados estos días, Bueno fue muy generoso con quienes se interesaban por su obra. Pero tenía también un talento enorme para excluirlos, si se distraían. Como a menudo le oí repetir a su hijo Gustavo, gestor de tantas de sus empresas académicas, al final “vale quien sirve”. Tan divertido como hiriente en el insulto, arbitrario en sus decisiones, atrabiliario en sus formas, muchos de sus colegas dejaron de tratar a Bueno (y de leerle) simplemente para evitarse disgustos. Yo entre ellos: duré dos números en el consejo editorial de su revista (El Basilisco), sin haber pedido ni entrar ni salir. “No se enfade usted, señor Bueno”, le rogaba el presentador en una de sus incendiarias intervenciones televisivas. “No me haga usted enfadar, que es muy distinto”, le respondía él, airado.

Gustavo Bueno podía enfadarse fácilmente y mucho. Lo cual, de nuevo, no prejuzga nada sobre el valor de sus ideas. El suyo no ha sido el único carácter difícil de la Historia de la filosofía y sus vaivenes políticos no son mayores que los de otras ilustres luminarias del XX. Bueno se quejaba de que él leía a todos sus colegas, pero ninguno le correspondía. Quizá les intimidase intelectualmente. Quizá temiesen su reacción si se atrevían a opinar. O quizá, simplemente, les aburriese. De lo que no se daba cuenta era de que no le pasaba sólo a él. Javier Muguerza, paradigma de la cortesía académica, decía a menudo eso de que “de los libros de los amigos no sólo hay que hablar bien; hay que leerlos”. Yo leí mucho a Bueno cuando era estudiante y sus tesis me parecieron siempre más interesantes que los de cualquier otro de sus coetáneos españoles, aunque sólo sea por menos aburridas/predecibles. Para una generación como la mía, que habla inglés y accede a Internet antes de salir de la Facultad, resultó fácil encontrar por ahí versiones mejores de casi cualquier argumento escrito en español en los últimos cincuenta años. Por una parte, porque somos muchos ya los filósofos de lengua española que usamos directamente el inglés para publicar. Por otro, porque al inglés se traduce más filosofía que a cualquier otra lengua. Entre todo lo que yo he leído, Bueno destacó siempre por la originalidad de sus argumentos.

Pero la originalidad no es todo lo que se debería buscar en un filósofo. Cualquier idea de las que interesaron a Bueno, y en particular todas las que se refieren a las ciencias, están discutidas con infinitamente más información y detalle en el mundo filosófico anglosajón. Tanta información y detalle que difícilmente darán lugar a un sistema tan ambicioso como el que pretendió construir Bueno. Aquí está el reto para su materialismo filosófico: ¿habrá entre sus discípulos algún otro compositor que acierte a ponerlo al día y obtener el eco académico que no obtuvo su fundador? ¿O como en tantos palacios de la antigüedad, los lectores de Bueno irán arrancando piezas de su sistema para levantar sus propios argumentos, ajenos ya a la composición original?

"El universo mudanza, la vida firmeza”, decía Bueno con los estoicos. Quizá algún día una biografía intelectual nos descubra cuánto cambió realmente Bueno en sus seis décadas de escritura académica. Hoy sólo podemos admirarnos de su fecundidad filosófica y recordar los buenos ratos que (a algunos) nos ha hecho pasar con sus diatribas. Si estáis contentos, aplaudid al actor.

{Contextos, agosto de 2016}


David Spiegelhalter, Sex by numbers, London, Profile books, 2015

For many, sex is more about quality than quantity, so David Spiegelhalter’s Sex by numbers may put off many potential readers.  Yet, in sex quantity seems to have a certain quality of its own –or so it claims Brooke Magnanti, invoking the intellectual authority of Stalin. This book has indeed a quality of its own: accuracy. Our folk understanding of sex is full of made up numbers to which we inadvertently stick without further reflection. Checking them out is more complicated that it seems: there are competing sources and we need a certain degree of statistical (and methodological) literacy to assess them properly. Hence, we can only be grateful to have Spiegelhalter, a world-leading statistician, spelling out for us what we really know about the numbers of sex in a clear and accessible manner.

Spiegelhalter is a Bayesian: for him, probabilities measure how strong our beliefs about random events are. This is a technicality that readers may safely ignore, but it explains why the book starts with a credibility ranking of the available figures about sex: numbers we can believe, numbers that are reasonably accurate, numbers that could be out by quite a long way, numbers that are unreliable, and numbers that have just been made up. Evidence in the two first categories will improve our statistical understanding of sex, whereas the remaining three scores will probably mislead us.

Ranking evidence depends crucially on its sources and half of this book is about how social research on sexuality can be properly carried out. Spiegelhalter's paradigm for reliable data is the British National Survey of Sexual Attitudes and Lifestyles (Natsal-3, 2010-2012). This is based on a random sample of face-to-face interviews funded by a private charity, the Wellcome trust -incidentally, the same trust commissioning this book. Spigelhalter spends time discussing the methodology and comparative reliability of his many sources (devoting an entire appendix to Natsal methods) and the crucial choices on which they all depend (e.g., what counts as a sexual partner). He also uses Natsal data in the first few chapters to introduce a number of handy statistical concepts: the mean and the median are important when we wonder about how much sex we are having.

With all these methodological caveats in sight, Spiegelhalter proceeds to inform you about everything you thought you knew about sex, despite not having a reliable source to check. Statistics about partners, heterosexual and homosexual activity, masturbation, reproduction etc. Most of it illustrated with graphics, about which I will make my only formal complaint about the book: in the epub version, sometimes they were not easy to read (despite trying the graphics on various readers). The text instead is delightful to read. Spigelhalter excels at both clarity and wit, both in the best British tradition, even if (or perhaps because) the topic is sex. 

Spigelhalter is cautious, but not shy, in appraising causality through data. Sometimes the evidence makes more likely some explanations of why sex happens the way it does. But often the data are far from conclusive regarding causation and, at best, they just describe what we do (and how often we do it).  Spiegelhalter adopts a good old positivist stance regarding the science of sex and admits at all points what we do not know, keeping it separate from any normative judgment. The most opinionated readers may be displeased by such a sober discourse on sex. The rest of us will be surely enlightened by the quality in the quantity.

{August, 2016}


Paul Erickson, Judy L. Klein, Lorraine Daston, Rebecca Lemov, Thomas Sturm, Michael D. Gordin, How Reason Almost Lost Its Mind. The Strange Career of Cold War Rationality, Chicago (Ill.), University of Chicago Press, 2013

Is rationality as clean and well-defined concept, such as a system of axioms, or rather a sticky syrup, like a “bowl of molasses”? Philosophers, at least within the analytic tradition, usually opt for axiomatic definitions and a paradigmatic illustration is, for instance, expected utility theory (EUT). Established by von Neumann and Morgenstern in 1947, and expanded later by Savage in 1954, it quickly became the paradigm for the analysis of decisions between uncertain alternatives, until the accumulation of experimental anomalies forced economists to search for alternatives –although none has completely displaced it, as of today. The normative appeal of EUT (as a warrant of consistency in our decisions) still captivates philosophers, but all this anomalies have forced us to rethink whether there is some axiomatic unity in our rational choices or whether our decisions are like molasses and EUT is just one bowl containing some.
Herbert Simon made the remark about the bowl of molasses commenting on how “the irrational is the boundary of the rational” (115). As I read it, How reason almost lost its mind(CWR from now on) is a book about such boundaries: the concepts that came to define rationality among the social scientists around the 1950s and 1960s would not have hold together were it not for the context (the bowl) provided by the Cold War.
The ideal type of Cold War Rationality (3-4) would be a formal algorithm providing mechanically the best solution for a given problem. These algorithms would originate in the analytical decomposition of the actions of a person of “seasoned experience and proven judgment” (43), so that anyone could implement such sets of rules and obtain the same success. Human calculators, computing variables for astronomers in many 19th and 20th century observatories, provide a paradigm of the rationality that Cold War would generalize, thanks mostly to the success of algorithms in foundational research on the paradoxes of set theory. Ideas then flew from the more abstract regions of mathematics to the social sciences, in a process accelerated by the II World War and its posterity.
One major issue in the historiography of rational choice theory is to what extent it was shaped by such context: for instance, is it something more than a formal rendition of the neoliberal ideology that emerged after the war? In this case, we may wonder whether the rules defining rationality were somehow tainted by their military uses. The answer of CWR seems mostly negative. For a start, Cold War Rationality is something more than a simple combination of decision and game theory. Bounded rationality was just as much a Cold War product. The organization of the airlift that would provide basic supplies to Berlin during the Soviet blockade started a research agenda on military management that ultimately led Herbert Simon to defend the necessity of non-optimizing decision rules. The limitations of information and computing power that plagued such projects left no alternative.
Even further from rational choice standards, but equally part of Cold War rationality was Charles Osgood’s GRIT, the acronym for “graduated and reciprocated initiatives for tension reduction”. Osgood, a psychologist, studied strategies for de-escalating conflicts –paradigmatically, in the nuclear arms race. Osgood did not establish his decision rules on formal grounds and, as CWR point out, they were difficult to test experimentally. But nonetheless they had the algorithmic form distinctive of the era. And there is even more to Cold War rationality. Rules did not only emerge in theoretical contexts as a solution to a given problem, be it formal or not. There was also empirical research on how rules emerged, via the analysis of “situations”. These were small group interactions placed in a context that could be externally controlled and observed: e.g., a negotiation in a room with microphones and one-way mirrors, as the one used by Robert Bales at the Harvard Laboratory of Social Relations in the 1950s. Decomposing the interaction into its minimal elements and coding how often they featured would allow social scientists to engineer future exchanges so that they yielded the desired outcomes.
If Cold War rationality is so diverse (and showing it is a major contribution of this book), we may well grant that its content was not constrained by one single agenda. But then what brings all these different algorithms together under the umbrella of rationality? The bowl containing this molasses would have been the military demand for procedures that could handle the complexity of Cold War issues –from nuclear strategies to logistics and negotiation processes. Military budgets funded research according to their needs, independently of any disciplinary boundary. The RAND Corporation was probably the most successful hotbed of Cold War rationality, but we can find research programs tied to the military in University departments all over the United States.
According to CWR, the threat of a nuclear conflictwas powerful enough to break through the different paradigms then available for the study of decision making and bring them into a real debate. Had it not been for the Cold War, the topic might have been studied along more conventional disciplinary paths, with a different level of mutual engagement.Just as it happened after the end of the Cold War. When the bowl of military demand cracked, the molasses of rationality spilled in a plethora of experiments that showed a plurality of decision rules at work (namely, heuristics and biases), more or less deviant regarding formal standards of rational choice.
CWR shows, in sum, that Cold War rationality was more diverse than rational choice theory and that the one in the many, bringing together all such diversity, was the nuclear threat providing the context. Both points are carefully argued and I have learnt a great deal with this volume. But, of course, it is my task to challenge them –trying to live up, I hope, to the spirit of those foundational Cold War debates.
Starting with diversity, the authors define their ideal type in the most encompassing manner, but they often argue as if the canon within Cold War rationality was rational choice theory. I don’t think, at least, that any other of the approaches discussed in the book exhibits to the same degree the features of the type listed in p.5: formal methods modelling self-interested individuals in conflict, with a radical simplification of the circumstances and a step-by-step impersonal approach to a solution. As the authors acknowledge (p. 94), GRIT rulesfor conflict resolution are not as algorithmic as the identification of Nash equilibria. Even if the setting put individuals in conflict, situation rooms apparently neither sought nor yieldeddecision rules (p. 124). And certainly “the collapse of Cold War rationality” came with experimental tests of rational choice models. The other research agendas sparked by the nuclear threat apparently did not make it that far: whereas Cold War results in, e.g., game theory are still part of the standard curriculum in some social sciences, most other topics addressed in this book only belong in the history of their disciplines.
Why not telling the story of Cold War rationality, in all its diversity, giving its weight to its difference constituents? At this point it wouldn’t seem Whiggish, just an acknowledgment of the longer reach of rational choice theory among Cold War theories. My impression is that the authors do not seem very inclined to make such distinction, because they implicitly disagree with the sort of social science associated with rational choice theory (e.g., “the notoriously mean and lean Homo economicus”, p. 185), and they treat it as if its time was already past. This is how I make sense, at least, of the title of the book: “How Reason Almost Lost its Mind”. The reduction of rationality to formal decision models seems was often achieved “at the expense of reason” (p.2), where this latter is understood as the sort of Enlightened wisdom that an automaton can just poorly imitate. The “almost” in the title seems to suggest that the Cold War is over and there is a chance for reason to regain its grounds. Thereby, perhaps, the surprise at philosophers still spending so much time on rational choice theory as of today (p. 187). But what are the reasonable alternatives that we should be discussing instead?
I would have expected though that a historical analysis of Cold War rationality would have made explicit instances of such alternatives at the point where they were perhaps considered and discarded. Taking up again, by way of instance, EUT, it might have been more fruitfulto discuss how a reasonable decision rule from the Enlightement(Bernoullian utility functions) became the standard of Cold War decision making? After all, choosing between uncertain alternatives according to an average (expected utility maximization) is just an option among others (why not focusing on the variance). What made it so attractivecirca 1940?Can we explain its normative appeal on a priori considerations (such as Savage’s Dutch Book argument) or is it also ideological?After all, the alternatives to EUT now under construction among decision theorists (prospect theory, etc.) are closer to Cold War rationality standards than to any sort of mindful reason. And this was the case already in the 1950s: think of Allais’ arguments about the reasonability of EUT. So what is the reason beyond rationality in CWR?
Alternatively, we may wonder whether the Cold War is really over, as far as the idea of rationality in the social sciences is concerned. The contextual pressure of a nuclear threat may have propelled the deployment of rational choice theory in the social sciences. But probably something else is keeping it in place now, for the right or the wrong reasons.Reading CWR I cannot understand well why such algorithmic standards of rationality still prevail. The answer might not be epistemic at all: since the American military and the policy makers were mostly alone on the demand side for rationality during the Cold War, I can’t help wondering whether they were satisfied with the outcome they funded so generously. Perhaps the survival of Cold War Rationality is, after all, the survival of the intellectual institutions that won such War. Historians are certainly among the few who can answer that.

{September, 2014}