Philosophy, Ethics, and Humanities in Medicine - Latest Comments

Prudent medicine in imprudent times

Miguel Kottow — 2011-01-25T10:49:40Z

Hardly anyone could fail to honor Edmund Pellegrino as an erudite, prolific and grand initiator of bioethical thought, persistently stressing the importance of ¿preserving the humanity of medicine¿ as recalled in Foni phronimos. Professor Pellegrino has repeatedly emphasized the distinction between philosophy of medicine and philosophy in medicine. Of the latter, he has insisted that the ¿dominant focus of philosophy in medicine has been on medical ethics and bioethics.¿ His contributions to medical ethics centered on ¿beneficence-in-trust¿ and the virtuous commitment to the common good are well known and firmly enmeshed in contemporary bioethics. As for philosophy of medicine, Pellegrino has set the scenario and invited thorough and on-going debate on such issues as health, illness, suffering, pain, the physician-patient relationship, the nature of medical knowledge and many other themes. In doing so, he may have induced a convergence of philosophy in and of medicine, perhaps even an inextricable compound.
As medicine enters a new millennium, these questions have become crucial and deliberation is urgently needed, whereupon J. Giordano`s interview appears as interesting as it is disquieting. Pellegrino repeatedly speaks of ¿moral truths¿, moral realism, and his confidence that ¿there will always be those that believe that one can apprehend moral reality, and find out about moral truth by study of the real world¿. Such trust is unsettling and, according to J. Dewey, R. Rorty, H. Putnam and others, perhaps even misguided and anachronistic.
It is equally surprising to read that E. Pellegrino should express his personal inclination towards ¿bench science¿, even though he is quite aware that more science may lead to less ethical certainty. As empirical knowledge increases, we become more irresolute about how we ought to deal with it. Even sharing Pellegrino`s emphasis on knowledge tempered by medical prudence, one misses the archaeology of a bridge between both realms. Consequently, it is hard to share Giordano`s optimism that Snow`s two cultures show a tendency to converge and become less ¿dissonant¿; it may well be that science and the humanities are more estranged than ever, and that medical education, steeped in molecular insights and evidence-based data, pays mere lip-service to the humanities. Pellegrino`s concern with the impact of the biotechnologies is but one of many new challenges that philosophy and the ethics of life must face without delay.
If medicine`s basic vocation is to care for the sick, how come it is deviating ever scarce human and material resources to super-healing the healthy by providing ever increasing temptations of enhancement ¿pharmaceutical, surgical, genetic-? How are we to deal with so-called ¿new public health¿ moving from traditional preventive public policies to a clinical realm infatuated with individual risk factors, the obsessive unveiling of lanthanic disorders, the exacting detection of predispositions, genetic markers, statistic probabilities and laboratory findings, all of which correlate rather poorly with overt disease conditions, still less with the phenomenology of illness?
And, of course, philosophy of medicine must deal with medical practice as a market value, the physician-patient relationship as a contract, and the experience of patients as litigious customers whose care is fragmented by sub-specialists, diagnostic gadgets, and telecare. Should health, disease, care, and therapy be redefined by insisting that they are culturally and contextually determined and on the move, or are organismic derangements and restorative efforts to be understood and salvaged as anthropological realities that ought to be approached with prudence in the wake of an utterly imprudent and explosive technoscientific evolution? In view of these pressing issues, it becomes questionable how relevant and timely Pellegrino`s quest to understand ¿what it is to be human¿ might be for present-day medicine and its philosophy. Is medicine really to be concerned whether it is dealing with atheists who believe humanity to be but a transitory link in the evolutionary chain, agnostics who avoid metaphysical questions, or convinced believers in transcendence? These queries distract from the specific concerns of philosophy of medicine; if transdisciplinary migration is needed, it should most probably involve medical sociology and anthropology.
In spite of his avowed realism, which has not lived up to the expectation of providing some solid and universal certainties, it is to the credit of Edmund Pellegrino that he should prefer to challenge by posing questions rather than offering unconvincing answers, thus reminding us of urgently pending homework.
Miguel Kottow
Universidad de Chile

Reponse by OP Wiggins and MA Schwartz to Schlimme, Bonnemann and Mishara

Michael Schwartz — 2010-11-01T10:46:33Z

Response to "No departure to Pandora: Using critical phenomenology to differentiate 'naive' from 'reflective'experience in psychiatry and psychosomatic medicine (A comment on Schwartz and Wiggins, 2010).

Osborne P Wiggins and Michael A Schwartz

Schlimme, Bonnemann, and Mishara develop several criticisms of our article, “Psychosomatic Medicine and the Philosophy of Life” [1]. We shall not address all of their criticisms here, however. We shall rather attempt to show how their main ones are misdirected.

Schlimme et al draw a phenomenological distinction between “naïve” and “reflective” experience which they think carries numerous methodological implications and which they see us as failing to respect. This methodological failure on our part, according to them, vitiates our entire attempt to sketch a non-dualistic understanding of mind and body. The methodological distinction in their eyes is closely tied to the various “reductions” that Edmund Husserl repeatedly urged. Rather than enter into this argument with them, we wish to point out that we are doing something else, something quite different from the set of problems which they think germane here.

We are assuming a number of phenomenological findings regarding the mind that Husserl, Merleau-Ponty, Heidegger, Jaspers, and others developed and adopting these findings for use in a non-phenomenological manner. We shall not list all of these findings here. Central among them are intentionality (with its cognitive, affective, and conative dimensions) and time consciousness (Zeitbewusstsein). We are then extrapolating from the properly phenomenological descriptions of these findings and pointing to analogous (although certainly not identical) features in other living beings. Our central aim is not a phenomenology of mind. It is rather a philosophy of life [2]. We suppose that our method can be termed “metaphysical” in the sense that we trying to conceptualize some of the essential structures of all living beings. But our own method is definitely not phenomenological. We are presupposing as given and taking over the findings of others who have employed the phenomenological method, and we are, in a non-phenomenological manner, transferring these notions beyond their human forms to non-human forms of life. There is certainly a speculative element in what we are doing. But we minimize this element by basing our claims in the work done by biologists and phenomenologists. In other words, we think our claims justified because they are based on claims found in biology and phenomenology. We are generalizing at a higher theoretical level than the levels at which biologists and phenomenologists proceed. In this manner we are seeking a theory of organism to unify these. It is precisely because we share Schlimme et al’s high regard for the intellectual rigor of phenomenological reflection that we choose this discipline as the best available characterization of the human mind on which to base our extrapolations. But since mind is not our target concept, we are moving beyond these to basic features of life.

Approaches such as ours are usually criticized as “anthropomorphism.” The charge that imputing human characteristics to non-human reality is a mistake is an old one. It was made at the beginning of the Modern epoch just before Rene Descartes (1595-1650) divided mind and body through developing his novel metaphysical dualism. Francis Bacon (1561-1626) insisted that imputing “final causes” to nature was a mistake issuing from anthropomorphism [3]. Final causes, according to Bacon, “are plainly derived from the nature of man rather than the universe, and from this origin have wonderfully corrupted philosophy” (Bacon, p. 44). This charge was, of course, part of the critique of Aristotelianism in general that cleared the ground for the construction of the new picture of the universe advanced by Copernicus, Galileo, Kepler, and subsequently Newton. At the very outset, then, the banning of “final causes” – or more generally, teleology – from nature became a methodological stricture for engaging in scientific investigation. In other words, the scientist must, even at the beginning, to commit himself to abstracting from and disregarding any aspect of teleology, even in living beings (Jonas, 2001, 33-37).

Not long after Bacon, Descartes solidified this banishment of teleology from nature by providing a proper place for teleology, namely, in the res cogitans that humans alone possessed. Since there was a separate metaphysical domain within which teleology could find a home, there was no puzzle in its constant appearance. And teleology was excluded from “nature” since this nature was defined as exclusively res extensa. Cartesian metaphysical dualism thus shows both why anthropomorphizing nature is possible and why it is a mistake (Jonas, 2001, 33-37).

This, however, is precisely the logical move that we wish to challenge. By asking why the evidence from human life is excluded from the understanding of non-human life, we seek to assert that it need not be. This is why we appealed to Darwin. One of the main thrusts of the theory of evolution is to argue that human life must be conceived in the same terms in which non-human life is understood. Human life is thus reintegrated back into the general realm of living beings. With this reintegration anthropomorphism appears as no longer such an egregious mistake. Attempting to conceive features of non-human life in terms of human life seems to be needed if we are to develop an inclusive comprehension of this reintegration. We can now legitimately ask how far the characteristics of human life, such as teleology, extend into the region of life in general (Jonas, 2001, 38-63).

More particularly, we can inquire into the features of human life because we are ourselves alive and thus have constant and direct experience of what living is like. We have privileged access to life through our own immediate experience of being alive. Granted, this is a “pre-reflective” experience of ourselves. But we human beings, as many philosophers have maintained, are capable of reflecting on our own experience and thereby uncovering its main characteristics. We think phenomenology has most successfully carried out this reflective enterprise and thus furnished us with numerous findings about the life process, at least insofar as that living is experienced by the living subject. Biology and related sciences have, of course, provided us with other evidence. Hence we think it possible to consider both this “inner” and “outer” understanding of life and attempt to delineate features they share.

As any reading of our article will make plain, we are not seeking to solve the “hard problem” of the link between brain events and mental events in the specific sense in which some cognitive neuroscientists and philosophers are. Our concern is not with mind/brain, but rather with the more encompassing reality of life. The concept of life subsumes those of mind and brain. Mind and brain must exhibit the features we attribute to life, but we have not resolved the more specific question of mind/brain interaction by describing the living organism within which, at least in higher forms of life, mind and brain function.

We are not herein expressing a wish to “depart to Pandora” – wherever or whatever that may be. Nor to restore “animism” – except to those animate beings which are self-evidently animate despite generations of thinkers who have sought some way around this fact.

References

1. Schwartz MA, Wiggins OP. Psychosomatic medicine and the philosophy of life. Philosophy Ethics and Humanities in Medicine 2010, 5:2 doi:10.1186/1747-5341-5-2

2. Jonas H. The Phenomenon of Life: Toward a Philosophical Biology, New York: Dell Publishing Co., Inc; 1966.

3. Bacon F. The New Organon. (Eds. L Jardine, M Silverthorne) Cambridge: Cambridge University Press; 2009.

Surmounting dualism

Fernando Ruiz — 2010-11-01T10:45:59Z

Surmounting dualism

The theory of polarities presented by Schwartz and Wiggins seems to be basically a description of the totality of living organisms according basic biological characteristics that unify them. Naturally, this totality includes human beings, in consonance with the theory of evolution. This theory is an ‘external’ vision of the organisms; therefore the mind in human beings is only an inference of subjectivity. The conscience and its intentionality is an internal phenomenon, a phenomenon that appears in the private interiority; in the subjective space of man. Science is not able to gain direct access to human subjectivity. The third person world of science can only infer it
However, the authors claim: “The “polarities” which we discuss are, we contend, ones that can be found as central to both the lived body and the physical organism. Hence they express precisely the unity that we unearth when we seek what is common to or the same in the two ways of conceptualizing living beings. Far from introducing a new dualism, the polarities permeating and sustaining both lived body and physical organism demonstrate their fundamental sameness.” With the acceptance of the ‘lived body’, the authors bring up the ‘mental’ side of the traditional dualism, and contend that this ‘lived body’ shares the same basic characteristic of polarities extracted from scientific observation and analysis. Moreover, they claim we have here a fundamental sameness of these bodies. This seems to me a quite strong and overenthusiastic statement considering ‘lived body’ referrers primarily to subjective corporeal experiences including feelings, and sense of communication and usefulness. Any further conceptual elaboration on this ‘lived body’ (‘personal body image’) will utilize ideas from the surrounding culture, and physical body concepts begging the purpose of the theory. The important point to underscore and keep in mind is that ‘lived body’ is fundamentally a state of conscience occurring in the privacy of the person, not in the objective, external and interpersonal world of science; they are two worlds apart.
Only when man starts reflecting on his basic living experiences do the concepts of “body” and “mind” arise. These concepts, and epistemological perspectives, emerge from the living experiences and are developed in order to gain access to the diverse aspects of the primary living experience. They are an effort to understand human existence in the “circumstances” or “world” in which life itself is immerse. In basic spontaneous living –the radical reality—the indissoluble unity of living man appears. Only after reflecting and studding this primary experience do mind and matter emerge as spaces of exploration to understand and to explain the original experience of ‘existing-in-the-world’.
The philosophy of life and polarities might be pragmatically useful to remind us the wholeness of spontaneous living of organisms, and most importantly of the living man. This is particularly relevant to physicians so they do not forget to inquire about the inner world of patients --the world of feelings and existential meanings. However, it seems the theory of philosophy of life gets around the philosophical problem of mind/body. It is my impression that the theory, as far it is developed, fails to unify coherently the ‘outside’ with the ‘inside’ of the human experience. The theory seems to mix up two perspectives of the human being, --the scientific and the phenomenological--, and does not reach an intelligible surmounting of dualism, neither at the metaphysical, nor epistemological level.
Thanks for this thoughts provoking paper.

Appreciation for review

Ray Greek — 2010-09-02T13:31:55Z

We thank Dr Wolpert for taking his time and applying his considerable intellect to review our book Animal Models in Light of Evolution. We are honored that Dr Wolpert reviewed our book.

We wrote the book in order to prove one point: that animals cannot predict human response to drugs and disease. We state:

"The purpose of this book is to address the ability, or lack thereof, of animals to predict human response and to see what other roles they may have in research and testing. We will argue that claims concerning the great utility of animals as predictive models of human biomedical phenomena are unsupported by evidence and are compromised by both methodological issues and issues arising from basic biological theory." p24

Therefore we are very happy that Dr Wolpert thinks the book:

". . . provides persuasive evidence that animal models should be used with great caution when applying the results to human diseases. Mice and other model animals are both similar and different, in their biology, to humans."

That is exactly what the book was about.

We actually agree, in part, with Dr Wolpert when he points out that we ignored similarities among species and breakthroughs that involved animals. We acknowledged many times in the book that animals and humans have traits in common and that past breakthroughs used animals. For example:

"We are about to begin a detailed analysis of the roles played by animals in biomedical research. This is a good place to make clear, once again, what we are interested in, and what we are not. There can be no doubt whatsoever that if you wish to make discoveries about rats and mice you will be forced of methodological necessity to perform careful scientific studies of R. rattus and M. musculus respectively. In fact, in writing this book, we are the beneficiaries of the results of careful scientific studies of animals. There is no doubt that careful biological studies of rats and mice can help clarify the general contours of mammalian biology. Such studies can also play a valuable heuristic role by prompting new ways of thinking about human biological problems of interest. The issue we are concerned with is this: notwithstanding these cautions, are animal models predictive of human outcomes in, say, toxicology, drug discovery, and the study of the causes and cures of human diseases? . . . This book is not intended to be a criticism of the use of animals in the context of basic biological research. There can be no doubt that careful studies of animals have prompted important hypotheses about basic biological principles, and there can be no doubt that studies of animals have contributed greatly to our scientific understanding of life, and there is little doubt that these studies will continue to illuminate these matters in the future (items (7) and (9) above)." p28-30

And:

"We remind the reader once again that the target of our criticism of animal-based research is restricted to the practice of predictive modeling. We do not dispute that there are legitimate roles for animal test subjects in other kinds of experimental investigation—for example basic biological research aimed at increasing the sum total of human knowledge. Animal experiments in the context of basic research may enrich our knowledge of specific phenomena in mice, and, if painting is permitted with a broad enough brush, they may help delineate some of the important contours of mammalian biology, from which lessons about the Eukaryotes and even life itself might be forthcoming". p351

However, the issue of prediction, which we go to great lengths to define for medical science, does not hinge on past discoveries or phylogenetic similarities. Our purpose in ignoring examples of trans-species similarities or past discoveries was not to slight animal use per se, but rather to avoid what would have been a protracted debate on a topic that was of peripheral interest. (For example, using heart-valve replacement, coronary artery bypass, and open-heart surgery as examples of animal model success stories is very contentious. Animal models both misled and were heuristic in those cases. To really analyze which was more important is work for another book.) By focusing on one and only one facet of using animals in science we were able to go into the depth demanded by such a contentious topic.

Regardless, even the examples that Dr Wolpert cites—Harvey’s use of animals to determine the circulation of blood, Koch and germs, and the work of Pasteur—support our point in that these example occurred at a time when science knew very little and the easily observed similarities among species outweighed the differences. Animal Models in Light of Evolution discusses the use of animals as predictive models for today’s problems of complex diseases like cancer and AIDS and responses to drugs where interspecies differences, and even intraspecies differences, have proven important.

We do think Dr Wolpert misses the mark when he states real progress toward curing Huntington’s has come from studying mice. The study of mice may indeed, when viewed through the lens of history, be seen to play an important role in the eventual prevention and or cure of this disease, but claiming such at this point relies on the assumption that animal models are predictive.

We thank the editors of Philosophy, Ethics, and Humanities in Medicine for publishing Dr Wolpert’s review and again thank Dr Wolpert for his interest.

Ray Greek
Niall Shanks

Bottom Line: Patient Choice is Paramount

Phyllis Mervine — 2010-07-17T22:18:29Z

The Infectious Diseases Society of America (IDSA) Lyme guidelines place commercial interests above quality of patient care, leaving seriously ill patients without effective treatment options. The narrow IDSA diagnostic criteria miss half the cases of Lyme disease, and up to half or more of the patients treated according to these guidelines remain ill. This is not acceptable.

The IDSA guidelines understate the seriousness of chronic Lyme disease, comparing ongoing Lyme symptoms to the "aches and pains of daily living." In contrast, peer-reviewed published studies show that people with chronic Lyme disease have disability and pain comparable to that of people with congestive heart failure and post-surgical pain, respectively. Schoolchildren with Lyme disease are classified as disabled and qualify for accommodations under Section 504 of the Americans with Disabilities Act. Deaths related to Lyme disease have also been reported.

The IDSA guidelines overstate the risks of long-term antibiotic treatment. Long-term treatment under the care of a qualified health care professional has been found to be safe and effective for a number of infectious diseases. The guidelines limit clinical judgment and hold physicians to arbitrary and unproven formulas. The IDSA-endorsed practice of terminating treatment despite persisting symptoms may result in advanced neurological injury, disability and death and constitutes medical negligence.

The California Lyme Disease Association (CALDA) recommends that patients with Lyme disease see a doctor affiliated with the International Lyme and Associated Diseases Society, who will individualize their treatment plan and consider patient preferences. Patients have the right to make informed choices based on their own personal values, just like patients with cancer or other diseases. In our opinion anything less is immoral, illegal, and inhumane.

Phyllis Mervine, EdM
President, CALDA
Editor-in-Chief, Lyme Times

Insufficient Evidence and Poor Outcomes: IDSA Treatment Recommendations Rightly Ignored

Elizabeth Maloney — 2010-07-10T18:18:03Z

Comments from IDSA president, Dr. Richard J. Whitley, suggest that he fully believes that “the best defense is a good offense”. Instead of addressing the shortcomings of the IDSA guidelines on Lyme disease, of which there are many, he assails Dr. Stricker and Ms. Johnson for not providing evidence that long-term treatments are valid.[1] He also tries to distract readers from considering the weak scientific underpinnings of the IDSA guidelines by raising the specter of unending courses of IV antibiotics and “life-threatening drug-resistant superbugs”; readers should not be fooled by such tactics.

Organizations which create treatment guidelines are obligated to prove the validity of their recommendations. This requires them to disclose the strength of their evidence so clinicians can use this information to judge the merits of the treatment recommendations. Because the IDSA Lyme guidelines issued 72 graded recommendations, it is easy for clinicians to lose sight of the fact that 54% of these, including 17 strong recommendations, were based on panel opinion.[2] Other guidelines developers, such as the American Academy of Pediatrics, require that the strength of a recommendation be matched to the strength of the underlying evidence;[3] unlike the IDSA, AAP would not restrict treatment options, via strong recommendations, purely on the basis of panel opinion.

The evidence strength ratings assigned by guidelines panels must be justifiable; even the pedestrian, IDSA-chosen review panel recognized that the strength of the supporting evidence had been stretched to reach the single-dose doxycycline prophylaxis recommendation.[4] And, evaluating the strength of an individual study requires more than a casual glance at the abstract and conclusion. When the article in question is written by a panelist on the 2006 guidelines, the examination should be especially vigorous so as to withstand charges of professional cronyism. This is also true when recommendations are issued to address areas of medical controversy.

This clearly did not happen with the IDSA guidelines. Consider the issue of treatment duration for erythema migrans, a contentious topic. The IDSA guidelines panel cited 8 prospective studies to support its recommendation; of these, only 2 investigated doxycycline regimens employing brief, 10 day treatment durations. In the study by Mazzarotti et al, the authors claimed the 10-day doxycycline arm had a 95% success rate.[5] However, of the 22 patients randomized to and completing this treatment, 7 were immediately retreated with doxycycline or amoxicillin and another patient later required IV ceftriaxone. Thus, 10 days of doxycycline failed to cure 36% of the patients, not 5%. One would think that such a gross overstatement of treatment success would have been caught by a diligent guideline panel; panelist Steere, as one of Mazzarotti’s co-authors, may have been best positioned to prevent the inclusion of this study in the guidelines. The other study, by guidelines panelist Wormser, had excessive drop-out rates.[6] At the study’s completion 49% of the subjects were “unevaluable”; at the earlier 12 month evaluation, 29% of the patients were already “unevaluable.” Biostatisticians warn against drawing outcome conclusions when drop-out rates exceed 20%;[7] thus, the panel also erred in citing the study by Wormser as supportive. If these studies are representative of what the IDSA considers “sound scientific evidence”, perhaps it is premature to be making recommendations in the first place.

After discovering a lack of support for the 10 day doxycycline regimen, I re-evaluated the data from the other 6 trials cited as supportive evidence for the early Lyme disease treatment recommendations.[8-13] During that process, I reanalyzed the outcome data using intent-to-treat methodology (ITT) as opposed to the complete-case(cc) or last-observation-carried-forward (LOCF) methods used in the original papers. ITT is the method preferred because CC and LOCF overstate treatment outcomes.[14] Differences in study designs and in the definitions of treatment success, improvement and failure make direct comparisons difficult but if success is defined as a return to the pre-morbid baseline without relapse during the observation period, then the overall success rates for doxycycline, amoxicillin and cefuroxime are roughly 65%. While this may seem incredulous to many, the review panel, which received my analysis in the course of its deliberations, suggested that future guidelines describe the first-line agents as “effective” rather than “highly effective”.[4]

Dr. Whitley expressed concerns regarding the use of long-term antibiotics in patients with persistent symptoms. There can be no doubt that such approaches carry risks but those risks must be weighed in light of the situation for which they are employed; this is not a case of using sledgehammer to swat a fly. The disease burden in this group is quite high, as the retreatment trials demonstrated.[15-17]

The IDSA guidelines also prohibit retreatment for patients with late neurologic Lyme disease who remain symptomatic following 30 days of ceftriaxone. This restriction is based on scant evidence. The guidelines cite only 4 trials, with a total of 96 patients representing a limited disease spectrum, which can be analyzed in terms of neurologic outcomes.[18-21] In this very small cohort, treatment successfully restored health in only 7 – 35% of the patients. Such a poor outcome is unacceptable for a patient group burdened with a disease causing a profoundly negative impact on the quality of their lives.

While physicians are cautioned to do no harm, it is clear that for the majority of patients with late neurologic Lyme disease, doing nothing more is harmful. To appease those looking for a scientific basis for additional antibiotic therapy, I suggest they read the 1999 study by Logigian et al.[21] In that open label trial using 30 days of ceftriaxone, one patient (who was well at the 6 month evaluation) reported a relapse, supported by a deterioration in his verbal and visual memory, 2 months later. Based on that information, the authors retreated him with 30 additional days of ceftriaxone and he demonstrated sustained improvement. Given that Steere served on the original guidelines panel and co-authored this paper, it is curious that the IDSA recommends against retreatment. Given the poor outcomes to shorter treatment durations and the disease burden, it is unconscionable.

Similarly detailed critiques can be made for the other major recommendations. Rather than shoot the messengers (Dr. Stricker and Ms. Johnson), Dr. Whitley should heed the message: the IDSA failed, in its initial and review efforts, to create impartial, conflict-free, evidence-based guidelines. Moreover, the errors of the guidelines panel were compounded by the review panel, which had an obligation to provide an unbiased review and right these transparent errors. Those of us who understand the situation lack mechanisms to resolve it. The duty remains with the IDSA members; physicians, heal thyselves.

References
1. Whitley RJ. IDSA Response to Stricker and Johnson. http://www.peh-med.com/content/5/1/9/comments
2. Wormser GP, Dattwyler RJ, Shapiro ED, Halperin JJ, Steere AC, Klempner MS, Krause PJ, Bakken JS, Strle F, Stanek G, Bockenstedt L, Fish D, Dumler JS, Nadelman RB. The clinical Assessment, Treatment, and Prevention of Lyme Disease, Human Granulocytic Anaplasmosis, and Babesiosis: Clinical Practice Guidelines by the Infectious Diseases Society of America. Clin Infect Dis 2006;43(9):1089-134.
3. American Academy of Pediatrics: Steering Committee on Quality Improvement and Management. Classifying Recommendations for Clinical Practice Guidelines. Pediatrics 2004;114;874-877.
4. Infectious Diseases Society of America: Final Report of the Lyme Disease Review Panel of the Infectious Diseases Society of America. April 22, 2010. http://www.idsociety.org/Content.aspx?id=16499
5. Massarotti EM, Luger SW, Rahn DW, et al.. Treatment of early Lyme disease. Am J Med 1992; 92:396–403.
6. Wormser GP, Ramanathan R, Nowakowski J, et al.. Duration of antibiotic therapy for early Lyme disease: a randomized, double-blind, placebo-controlled trial. Ann Intern Med 2003; 138:697–704.
7. Schulz K, Grimes D. Sample size slippages in randomised trials: exclusions and the lost and wayward. Lancet 2002; 359: 781–85.
8. Luft BJ, Dattwyler RJ, Johnson RC, et al.. Azithromycin compared with amoxicillin in the treatment of erythema migrans: a double blind, randomized, controlled trial. Ann Intern Med 1996; 124:785–91.
9. Dattwyler RJ, Volkman DJ, Conaty SM, Platkin SP, Luft BJ. Amoxicillin plus probenecid versus doxycycline for treatment of erythema migrans borreliosis. Lancet 1990; 336:1404–6.
10. Eppes SC, Childs JA. Comparative study of cefuroxime axetil versus amoxicillin in children with early Lyme disease. Pediatrics 2002; 109:1173–7.
11. Nadelman RB, Luger SW, Frank E, et al.. Comparison of cefuroxime axetil and doxycycline in the treatment of early Lyme disease. Ann Intern Med 1992; 117:273–80.
12. Luger SW, Paparone P, Wormser GP, et al.. Comparison of cefuroxime axetil and doxycycline in treatment of patients with early Lyme disease associated with erythema migrans. Antimicrob Agents Chemother 1995; 39:661–7.
13. Dattwyler RJ, Luft BJ, Kunkel M, et al.. Ceftriaxone compared with doxycycline for the treatment of acute disseminated Lyme disease. N Engl J Med 1997; 337:289–94.
14. Fitzmaurice GM, Laird NM, Ware JH. Applied Longitudinal Analysis. Hoboken, N.J. Wiley-Interscience, ©2004; pp 391-4.
15. Klempner MS, Hu LT, Evans J, et al. Two controlled trials of antibiotic treatment in patients with persistent symptoms and a history of Lyme disease. N Engl J Med 2001;345(2):85–92.
16. Krupp LB, Hyman LG, Grimson R, et al. Study and treatment of post Lyme disease (STOP-LD): a randomized double masked clinical trial. Neurology 2003;60(12):1923–30.
17. Fallon BA, Keilp JG, Corbera KM, Petkova E, Britton CB, Dwyer E, Slavov I, Cheng J, Dobkin J, Nelson DR, Sackeim HA. A randomized, placebo-controlled trial of repeated IV antibiotic therapy for Lyme encephalopathy. Neurology 2008;70:992-1003.
18. Dattwyler RJ, Halperin JJ, Pass H, Luft BJ. Ceftriaxone as effective therapy for refractory Lyme disease. J Infect Dis 1987;155:1322–5.
19. Dattwyler RJ, Halperin JJ, Volkman DJ, Luft BJ. Treatment of late Lyme borreliosis—randomized comparison of ceftriaxone and penicillin. Lancet 1988; 1:1191–4.
20. Logigian EL, Kaplan RF, Steere AC. Chronic neurologic manifestations of Lyme disease. N Engl J Med 1990; 323:1438–44.
21. Logigian EL, Kaplan RF, Steere AC. Successful treatment of Lyme encephalopathy with intravenous ceftriaxone. J Infect Dis 1999;180:377–83.

IDSA Response to Stricker and Johnson

Diana Olson — 2010-07-01T17:20:08Z

The Infectious Diseases Society of America's primary concern is to enhance the care of children and adults based on sound scientific evidence. IDSA develops treatment guidelines through an extensive, thoughtful review of all of the evidence of a disease or condition, and its treatment options. We have published more than 60 practice guidelines for a range of infectious diseases, and our guidelines for Lyme disease are the only ones that have been challenged. Those guidelines were found to be valid by an extraordinary independent review, the results of which were made public in April 2010.

It is notable that Dr. Stricker and Ms. Johnson choose to criticize IDSA and its Lyme disease guidelines, rather than provide solid, scientific evidence that the treatments they espouse are valid. The reasons are clear. As yet, there is no scientific evidence that long-term antibiotics, often delivered intravenously for months or years, are beneficial for patients with “chronic” Lyme disease. There is, however, solid and abundant evidence that these treatments can be harmful, potentially leading to fatal infections, serious drug reactions, and the fostering of the development of life-threatening drug-resistant superbugs.

The IDSA’s full response to Johnson and Stricker is in process and a further comment will be uploaded giving the article details in due course.

Richard J. Whitley, MD, FIDSA
President, Infectious Diseases Society of America

Clinical practice guidelines need to be the best medicine

lou overman — 2010-06-14T17:11:35Z

If professional societies like the IDSA can continue to use flawed guidelines, even when presented with irrefutable evidence that the guidelines are not good medicine, then this will result in a decline in public confidence in medicine as a whole. The public expects and deserves high standards.

No profession is above question, and bad behavior by some needs some outside enforcement action. Where is that action going to come from? Do we have to have class action lawsuits to get honest medicine?

Reply to David Kelly’s comment, “On the nature of the good.”

Michael Schwartz — 2010-04-05T21:25:10Z

In his comment on our article, “Pscyhosomatic Medicine and the Philosophy of Life,” David Kelly poses questions about our all-too-brief discussion of some basic values as inherent in life itself. His questions offer us an opportunity to articulate more clearly the point of our remarks and to circumscribe their implications. Our point about value was a metaphysical one. We certainly did not intend there to propound an ethical theory, i.e., a philosophical ethics that would adequately delineate moral duties and obligations. The sort of egoistic ethics to which Kelly suspects we may be committed is far from our purpose. The metaphysical point about values and life that we rather sought to make was related to our opening sketch of the mind/body dualism that historically issued from Descartes’ metaphysics. Cartesian metaphysics, if taken to its logical conclusion, postulates a value-free or value-neutral nature. Later philosophers, convinced that natural science must regard nature as devoid of inherent value in order to consistently apply the scientific method to it, tend to view all value that is attributed to nature as issuing solely from the human subjects that experience it. It was this view of a nature whose value comes exclusively from human subjectivity, whether collective or individual, that we were concerned to oppose. We wanted to make the metaphysical point that value was present in nature itself if living beings are understood as parts of nature. Thus in the section of our essay to which we assume Kelly must be referring we write:

Value is thus built into the reality of organic life: it is organic life itself that places value there. It is not human beings and certainly not human agency that introduces value into an otherwise value-free universe. Living beings themselves, by striving to preserve themselves, already signal that, at least for the being involved, its own life is a good (Schwartz et al, PDF 3).

We certainly believe that there are other goods for livings beings, depending upon which kind of living being one is considering. But the full range of goods or values for organic beings is something that in this article we did not have space to survey. For some remarkable examples illustrative of this range, we direct interested readers to John Tyler Bonner’s recent “The Social Amoebae” Princeton University Press, 2009.

Embodiment, Values, and Dis-ease

Ronald Pies — 2010-03-25T08:11:55Z

I very much enjoyed this paper from Drs. Schwartz and Oz. Their discussion of how "...living beings are both enclosed within themselves...[and also] ceaselessly reaching out to their environment..." reminds me of Merleau-Ponty's concept of "embodiment", as another reader already noted.

In their chapter on this topic, Gallagher & Zahavi write, "The phenomenological emphasis on the body obviously entails a rejection of Cartesian mind-body dualism. But it should be just as obvious that this does not entail an endorsement of some kind of Cartesian materialism." (p. 135, The Phenomenological Mind).

I also liked the discussion of Canguilhem's thesis that "...the positive value of health and negative value of illness" is "...posited by the organism itself and not simply through some external judgment conceived by medical practitioners."

This, in my view, is analogous to the position that several of us have taken, in relation to the construct of "disease"; i.e., that it originated not as an external judgment by "experts", but as an expression of the ordinary person's felt experience of "dis-ease" (suffering and incapacity)when affected by some pathogen, infection, etc.

As Dr. Schwartz and I have discussed (and debated!) many times, the term "disease" has taken on a more technical, "pathology-based" meaning, in the past few centuries; however, I believe that the primordial meaning of the term--which is essentially phenomenological--is the appropriate point of orientation when we consider, for example, whether psychiatric diagnoses are instantiations of disease ("dis-ease").

Furthermore, the late Dr. R.E. Kendell's insistence that "disease" ought to be predicated of persons--not "minds" or "brains"--is consistent with the unified, "psychosomatic" approach taken in the paper by Drs. Schwartz and Oz. In essence, "personhood" is the bridge that over-arches "mind" and "body" duality.

Similarly, when we hear (as psychiatrists) the charge that psychiatric diagnoses are merely "value judgments", we should be reminded by the Schwartz-Oz paper that all judgments about illness and health entail "value judgments"--judgments, for example, that it is better to be able to digest food than not; or that it is better to be able to think clearly than to have one's thoughts interrupted by accusatory "voices" (auditory hallucinations).

In short, I believe the discussion of Canguilhem lays the foundation for acknowledging that in all of medicine, including psychiatry, very basic--indeed primordial--"values" underlie our judgments about health and illness.

--Best regards, Ronald Pies MD

Dr. Pies declares no conflicts of interest.
He is Professor of Psychiatry and Lecturer on Bioethics & Humanities, SUNY Upstate Medical University, Syracuse, NY; and Clinical Professor of Psychiatry, Tufts University School of Medicine, Boston.