barbara osimani
I am Associate Professor of Logic and Philosophy of Science at the Polytechnic University of the Marche and I am currently heading an ERC project, which also runs at the Munich Center for Mathematical Philosophy, LMU: "Philosophy of Pharmacology: Safety, Statistical Standards, and Evidence Amalgamation".
I am interested in scientific inference in research contexts characterised by strategic behaviour and I am developing a "Formal Epistemology of Medicine" in order to analyse issues arising in medical research, with a special focus on the complex interaction of methodological, social and regulatory as well as ethical dimensions in medicine.
I worked on the precautionary principle, evidence hierarchies, causal assessment of pharmaceutical harm, and statistical inference. My recent papers analyse issues around philosophy of evidence (reliability, bias, reproducibility, coherence) from a Bayesian perspective.
In collaboration with drug agencies across Europe I developed a Bayesian framework for the integration of heterogenous items of evidence for the purpose of causal assessment of drug-induced harm ("E-Synthesis").
Phone: +39 3492103427
Address: barbaraosimani@gmail.com
I am interested in scientific inference in research contexts characterised by strategic behaviour and I am developing a "Formal Epistemology of Medicine" in order to analyse issues arising in medical research, with a special focus on the complex interaction of methodological, social and regulatory as well as ethical dimensions in medicine.
I worked on the precautionary principle, evidence hierarchies, causal assessment of pharmaceutical harm, and statistical inference. My recent papers analyse issues around philosophy of evidence (reliability, bias, reproducibility, coherence) from a Bayesian perspective.
In collaboration with drug agencies across Europe I developed a Bayesian framework for the integration of heterogenous items of evidence for the purpose of causal assessment of drug-induced harm ("E-Synthesis").
Phone: +39 3492103427
Address: barbaraosimani@gmail.com
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Medical decisions are paradigmatically uncertain. Awareness of this uncertainty at the policy level has produced a strict regulation of the information exchange related to medical issues, e.g. by means of the institute of the informed consent or through tight administrative norms regulating the pharmaceutical communication towards the public.
As a special support of such sort of information, also the drug package leaflet has been object of thorough legal regulation, especially developed in the European and German legislation.
However, precisely in Germany, recent court decisions concerning damage compensation for information faults have delivered contradictory judgments in relation to package leaflet information and the patient’s contributory negligence.
Court argumentations in these cases range from the appeal to the patient’s duty of taking notice of the PL’s content to general observations concerning the irreplaceable role of doctor’s information.
These observations are also backed by considerations regarding PLs’ information design and layout, which, in despite of great changes in the course of their history, are still object of improvement efforts (see also the recent conferences at the German Federal Institute for Drugs and Medical Devices – BfArM – devoted to the analysis and testing of PL readability: 15th February 2006 and 5th September 2007).
Moreover PL information is blamed by health professionals of hindering compliance. Indeed, empirical findings emerging from psycho-sociological literature hint at contradictory attitudes in relation to health risk information in general: desire for this sort of information is not monotonically dependent on perceived uncertainty and present research falls short of providing coherent models of health information seeking behavior, which is expected to influence information processing and eventually lead to a decision change (e.g. therapy interruption).
Research purpose
The present dissertation aims to examine the adequacy of package leaflet information to the institutional tasks which it is supposed to accomplish, not ultimately in order to establish whether it can legitimately function as a liability disclaimer and on what grounds. The scope of research is limited to the European and especially to the German legal setting.
State of the art
Critics to the PL as a valid form of patient information have been long raised by linguistic scholars on the grounds of lexical, syntactical and pragmatic analyses of PL corpora: Bock 1994; Dontscheva 1990; Ehlich 1994; Ehlich/Noack/Scheiter 1994; Eckkrammer 1995, 1998, 1999, 2002, 2002b; Fickermann 1994; Grosse/Mentrup 1982; Hensel 1989; Hoffmann, 1983; Hoffmann et al. 1998, 1999; Langer 1995; Mentrup 1982, 1988; Mohn 1991; Nickl 2001; Pander Maat, 1997; Pander Maat and Klaassen, 1994; Saile 1984; Schuldt, 1992, 1998, Völzing, 1976, Werner/Heyne 1989; Zacharias, 1986. In these contributions PL texts are blamed to increase the user’s uncertainty because of their scarce readability and reader-friendliness. These studies highlight the uncertainty derived from cognitive perplexity and incomprehension of information, but they fail to recognize the unavoidable uncertainty affecting any (medical) choice.
Neglect of this aspect might be explained by the fact that, by referring to the official purpose of PL information (“Gebrauchsinformation”, product instruction), these scholars have failed to acknowledge the equally important function of PL information as a basis for the consumer’s therapeutic decision.
Apart from few exceptions (Koyuncu, 2005, 2006, Schlund, 1999) also the legal literature on package leaflet fails to adequately address the disclaiming function of package leaflets and their role in the lay therapeutic choice. This may be partly explained by the fact that PLs have been developed within safety regulation, in which PL information is principally called to warrant for correct and safe use (Hart, 2003 a.o.), and also by the fact that liability for adequate information mainly concerns the doctor.
By tacking into account the liability constraints determining the institutional functions of PL information, the present dissertation investigates the role of PL information within the lay therapeutic choice and outlines the articulation of the responsibility spheres among doctor, pharmaceutical firm and patient as far as the therapeutic risk is concerned.
Methodology
The methodological approach adopted for the solution of the legal dilemmas has mainly drawn on categories developed by Bayesian decision theory.
In fact all main components of Bayesian theory (the theory of knowledge updating through “probabilistic induction” – a.k.a. Bayesian theorem – the theory of decision optimization through maximization of the expected utility; and the theory of information value) provide the best adequate means for analyzing PL information,
- as a basis for knowledge updating (probability of side effects occurrence) for a risk/benefit assessment about the drug and an informed choice;
- as a support for decision optimization based on the expected reward of taking the drug vs. not taking it;
and for exploring its perceived value, as a function of its expected contribution to decision optimization.
Results
I. Legal-communicative analysis
The legal function of PL information is not exhausted by safety purposes: as a privileged form of product instruction, it is also subject to liability regulation with a consequent reallocation of damage responsibility through risk disclosure.
Therefore two main legal-communicative functions are identified for PL information:
1. Warning and risk prevention function, in observance of the consumer’s right to safety;
2. Disclosure of residual risk, in observance of the constitutionally protected right to self-determination.
Safety information should prevent avoidable risk to occur; instead self-determination information should declare the unavoidable (residual) risk, so as to insure that the drug user is aware of it when he decides whether to undertake the therapy or not.
The notion of residual risk is fundamental in this setting, because it is the risk which the beneficiary party needs to shoulder unless he has not previously been informed about it by the doctor and/or by the pharmaceutical firm through the PL.
Once it has been established that PL information is not only a means of safety protection, but also part of the therapeutic informed consent, the point is then to evaluate whether PL information can be considered adequate for consent to be “informed”, i.e. valid.
II. Bayesian analysis
The Bayesian analysis splits into two parts: a normative and a descriptive one. The former deals with the requirements that the legislator establishes for consent to be qualified as informed and with the question whether PL information fulfils them.
Because, from a normative perspective, information prior to consent should enable the patient to make an informed choice, the role of PL information has been evaluated on the basis of its contribution to epistemic accuracy within the therapeutic choice. By drawing on Andersson and Littkens’ two components model of individual health decision (2003), consent has been defined to be informed to the extent that it approaches a decision under risk, i.e. to the extent that the decision maker can assign a probability measure to each relevant health state and that he knows whether the act of taking the drug (a) shifts the probabilistic distribution towards stochastic dominance with respect to the act of not taking the drug.
The model represents in fact the health decision as composed both by states over which the agent can assign probabilities and states shrouded by total ignorance. A complementary weight factor allows representing the proportion of ignorance and risk in the choice at hand. Against the framework of this model, PL information seems to provide the drug consumer with data whose personal relevance, and therefore prognostic value for the individual, is difficult to assess. This means that consent on the basis of PL information rather approaches a decision under ignorance than one under risk: as a prognostic device, PL information fundamentally asks more questions than it answers.
III. Empirical analysis
A quantitative study (of limited sample size: n = 55) and a qualitative research have been carried out with the aim to provide a descriptive account of PL information as basis for the therapeutic decision.
Bayesian categories such as knowledge updating, expected net value of information and decision sensitivity to further information have been integrated with specific dimensions concerning the therapeutic decision: trust in the doctor, shared decision making, experience with treatments and side effects. The results provided by the survey provide evidence that the therapeutic decision made with the doctor is hardly shaken by PL information, even when this information is declared to have brought a positive contribution in terms of knowledge. The qualitative study shows that doctor’s information also functions as a filtering key for coming to terms with information overload and incomprehensibility.
In the final chapter an integrated model of health risk information seeking behaviour is proposed, where information seeking behavior does not only depend on the level of uncertainty, as normally assumed by cognitive theories of information processing, but also from the decision sensitivity to incoming information.
Papers by barbara osimani
Medical decisions are paradigmatically uncertain. Awareness of this uncertainty at the policy level has produced a strict regulation of the information exchange related to medical issues, e.g. by means of the institute of the informed consent or through tight administrative norms regulating the pharmaceutical communication towards the public.
As a special support of such sort of information, also the drug package leaflet has been object of thorough legal regulation, especially developed in the European and German legislation.
However, precisely in Germany, recent court decisions concerning damage compensation for information faults have delivered contradictory judgments in relation to package leaflet information and the patient’s contributory negligence.
Court argumentations in these cases range from the appeal to the patient’s duty of taking notice of the PL’s content to general observations concerning the irreplaceable role of doctor’s information.
These observations are also backed by considerations regarding PLs’ information design and layout, which, in despite of great changes in the course of their history, are still object of improvement efforts (see also the recent conferences at the German Federal Institute for Drugs and Medical Devices – BfArM – devoted to the analysis and testing of PL readability: 15th February 2006 and 5th September 2007).
Moreover PL information is blamed by health professionals of hindering compliance. Indeed, empirical findings emerging from psycho-sociological literature hint at contradictory attitudes in relation to health risk information in general: desire for this sort of information is not monotonically dependent on perceived uncertainty and present research falls short of providing coherent models of health information seeking behavior, which is expected to influence information processing and eventually lead to a decision change (e.g. therapy interruption).
Research purpose
The present dissertation aims to examine the adequacy of package leaflet information to the institutional tasks which it is supposed to accomplish, not ultimately in order to establish whether it can legitimately function as a liability disclaimer and on what grounds. The scope of research is limited to the European and especially to the German legal setting.
State of the art
Critics to the PL as a valid form of patient information have been long raised by linguistic scholars on the grounds of lexical, syntactical and pragmatic analyses of PL corpora: Bock 1994; Dontscheva 1990; Ehlich 1994; Ehlich/Noack/Scheiter 1994; Eckkrammer 1995, 1998, 1999, 2002, 2002b; Fickermann 1994; Grosse/Mentrup 1982; Hensel 1989; Hoffmann, 1983; Hoffmann et al. 1998, 1999; Langer 1995; Mentrup 1982, 1988; Mohn 1991; Nickl 2001; Pander Maat, 1997; Pander Maat and Klaassen, 1994; Saile 1984; Schuldt, 1992, 1998, Völzing, 1976, Werner/Heyne 1989; Zacharias, 1986. In these contributions PL texts are blamed to increase the user’s uncertainty because of their scarce readability and reader-friendliness. These studies highlight the uncertainty derived from cognitive perplexity and incomprehension of information, but they fail to recognize the unavoidable uncertainty affecting any (medical) choice.
Neglect of this aspect might be explained by the fact that, by referring to the official purpose of PL information (“Gebrauchsinformation”, product instruction), these scholars have failed to acknowledge the equally important function of PL information as a basis for the consumer’s therapeutic decision.
Apart from few exceptions (Koyuncu, 2005, 2006, Schlund, 1999) also the legal literature on package leaflet fails to adequately address the disclaiming function of package leaflets and their role in the lay therapeutic choice. This may be partly explained by the fact that PLs have been developed within safety regulation, in which PL information is principally called to warrant for correct and safe use (Hart, 2003 a.o.), and also by the fact that liability for adequate information mainly concerns the doctor.
By tacking into account the liability constraints determining the institutional functions of PL information, the present dissertation investigates the role of PL information within the lay therapeutic choice and outlines the articulation of the responsibility spheres among doctor, pharmaceutical firm and patient as far as the therapeutic risk is concerned.
Methodology
The methodological approach adopted for the solution of the legal dilemmas has mainly drawn on categories developed by Bayesian decision theory.
In fact all main components of Bayesian theory (the theory of knowledge updating through “probabilistic induction” – a.k.a. Bayesian theorem – the theory of decision optimization through maximization of the expected utility; and the theory of information value) provide the best adequate means for analyzing PL information,
- as a basis for knowledge updating (probability of side effects occurrence) for a risk/benefit assessment about the drug and an informed choice;
- as a support for decision optimization based on the expected reward of taking the drug vs. not taking it;
and for exploring its perceived value, as a function of its expected contribution to decision optimization.
Results
I. Legal-communicative analysis
The legal function of PL information is not exhausted by safety purposes: as a privileged form of product instruction, it is also subject to liability regulation with a consequent reallocation of damage responsibility through risk disclosure.
Therefore two main legal-communicative functions are identified for PL information:
1. Warning and risk prevention function, in observance of the consumer’s right to safety;
2. Disclosure of residual risk, in observance of the constitutionally protected right to self-determination.
Safety information should prevent avoidable risk to occur; instead self-determination information should declare the unavoidable (residual) risk, so as to insure that the drug user is aware of it when he decides whether to undertake the therapy or not.
The notion of residual risk is fundamental in this setting, because it is the risk which the beneficiary party needs to shoulder unless he has not previously been informed about it by the doctor and/or by the pharmaceutical firm through the PL.
Once it has been established that PL information is not only a means of safety protection, but also part of the therapeutic informed consent, the point is then to evaluate whether PL information can be considered adequate for consent to be “informed”, i.e. valid.
II. Bayesian analysis
The Bayesian analysis splits into two parts: a normative and a descriptive one. The former deals with the requirements that the legislator establishes for consent to be qualified as informed and with the question whether PL information fulfils them.
Because, from a normative perspective, information prior to consent should enable the patient to make an informed choice, the role of PL information has been evaluated on the basis of its contribution to epistemic accuracy within the therapeutic choice. By drawing on Andersson and Littkens’ two components model of individual health decision (2003), consent has been defined to be informed to the extent that it approaches a decision under risk, i.e. to the extent that the decision maker can assign a probability measure to each relevant health state and that he knows whether the act of taking the drug (a) shifts the probabilistic distribution towards stochastic dominance with respect to the act of not taking the drug.
The model represents in fact the health decision as composed both by states over which the agent can assign probabilities and states shrouded by total ignorance. A complementary weight factor allows representing the proportion of ignorance and risk in the choice at hand. Against the framework of this model, PL information seems to provide the drug consumer with data whose personal relevance, and therefore prognostic value for the individual, is difficult to assess. This means that consent on the basis of PL information rather approaches a decision under ignorance than one under risk: as a prognostic device, PL information fundamentally asks more questions than it answers.
III. Empirical analysis
A quantitative study (of limited sample size: n = 55) and a qualitative research have been carried out with the aim to provide a descriptive account of PL information as basis for the therapeutic decision.
Bayesian categories such as knowledge updating, expected net value of information and decision sensitivity to further information have been integrated with specific dimensions concerning the therapeutic decision: trust in the doctor, shared decision making, experience with treatments and side effects. The results provided by the survey provide evidence that the therapeutic decision made with the doctor is hardly shaken by PL information, even when this information is declared to have brought a positive contribution in terms of knowledge. The qualitative study shows that doctor’s information also functions as a filtering key for coming to terms with information overload and incomprehensibility.
In the final chapter an integrated model of health risk information seeking behaviour is proposed, where information seeking behavior does not only depend on the level of uncertainty, as normally assumed by cognitive theories of information processing, but also from the decision sensitivity to incoming information.
I investigate these positions through the lenses of Bayesian epistemology, and in particular of recent results on the Variety of Evidence Thesis. This approach will turn out to be fruitful in investigating the interaction of reliability, independence of evidence, and replication in scientific inference and, more broadly, will cast a new light on the debate between advocates of a pluralist methodology in medical research, who insist on supporting hypotheses through various sources of evidence, and the contending view, represented by the Evidence Based Medicine paradigm, which relies on an “elitist” approach, where “best evidence” is searched for and exact replication is highly welcome.
This paper addressed both challenges in three steps. First of all, the common denominators shared by earlier and more recent defenders of the notion of genetic information are identified. These include: 1) the combinatorial mechanism of the genetic code, 2) code arbitrariness, and 3) causal specificity (the systematic relationship of genetic and phenotypic traits). Genetic information is thus seen as an arbitrary but systematic correspondence between combination of units in one system and units in another system. In a second step, genetic causality is distinguished from other kinds of developmental phenomena by drawing on the analysis of genetic causation developed by Šustar (2007), Waters (2007) and Woodward (2010), following which I define genetic causation as a kind of cause which causes something to be one way rather than another (causal specificity). In a third step, the combinatorial mechanism and code arbitrariness are compared to the linguistic phenomenon of double articulation which points to the relevance of linear order for semantic effects produced at different linguistic levels. This characterizes nucleotide sequences as “information as reality” in that structure and relations among them predominate over other features such as energy and matter, as causal determinants. Furthermore, such “information as reality” is able to produce “information as reality” at higher levels. Hence, genetic causality is defined as a special kind of cause which causes something to be one way rather than another, by combining elementary units one way rather than another. Finally, this definition is tested against the notion of “genetic error” in comparison with other kinds of causal failures in non-genetic phenomena.
Vandenbroucke (2008) has proposed that these should be reversed when dealing with causal assessment of unintended rather than intended outcomes. I suggest instead that “lower level” evidence may be accepted on distinct grounds depending on the epistemology underlying scientific inference and evidence evaluation. Following Cartwright (2007) I distinguish between “clincher” and “voucher” methods, and argue that the purpose of harm assessment is best served by the latter. Finally I present a case study related to the debated causal association between acetaminophen and asthma.
Vandenbroouke presents several arguments in support of such a proposal. One point is methodological, and concerns the idea that selection bias is less likely to affect observational studies with respect to adverse reactions, because unintended effects, qua unintended, are not known by the drug prescriber, who cannot take them into consideration and thus bias treatment allocation. Another point draws on epistemological considerations and regards the distinction between the context of discovery and the context of evaluation.
I flesh out Vandenbroucke’s intuitions in Bayesian terms and contend that rather than a reversal of hierarchies the point at issue is the lexicographic implementation rule which they more or less explicitly endorse. I will illustrate this point through a case study: the recent debate on the causal association between paracetamol and asthma.
Lewis’ notion of “causation as influence” (Lewis, 2000) has been developed in order to solve tricky problems of preemption (i.e. of causal redundancy) affecting the counterfactual analysis of causation. Recently, it has been recently adopted by Kenneth Waters (2007) and by James Woodward (2010) in order to account for the notion of specificity and genetic causality in biology. Also the debate around these two notions has different roots and touches different philosophical questions at diverse levels.
After presenting Lewis’ notion of influence and Woodward’s and Water’s adaptation of this concept to their analysis of genetic causality, the paper examines the different foci of these authors: whereas Lewis’ notion of influence aims to present a sophisticated account of our intuitions underlying the notion of cause tout court, Woodward’s intention is to use different categories, included influence, in order to provide the cues for a typology of causes; finally Waters’ question regards instead whether the selection of a cause among several candidates as “the” cause can be reduced to a pragmatic issue, or whether it can be given an ontological basis. This is especially relevant to the debate around the nature-nurture problem and the related issue of genetic privilege. The paper illustrates how such formalizations of the notion of cause allow to clarify much “informational talk” in philosophy of biology and genetics, without forcing a deflationary account of the notion of information in terms of causation.
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