Given the sincerity and commitment of all parties in debate it is
important to test the coherence of the principles or arguments guiding any
policy. For example, is medical paternalism or participant autonomy
desirable or even necessary in the development of medical science? Such
questions are considered in the context of palliative medicine to analyse
some moral arguments intended to show how to improve clinical practi...
Given the sincerity and commitment of all parties in debate it is
important to test the coherence of the principles or arguments guiding any
policy. For example, is medical paternalism or participant autonomy
desirable or even necessary in the development of medical science? Such
questions are considered in the context of palliative medicine to analyse
some moral arguments intended to show how to improve clinical practice for
vulnerable patients through research. The ideas of altruism and virtue
ethics are discussed to indicate the medical and moral obligations in the
care of patients and participants in research. It is argued that claims
that knowledge needs to be gained or that treatments need to be made
effective are not sufficient: it is concluded that how knowledge is gained
or how treatments are made more effective are both morally and medically
important.
THE MORAL CONTEXT
Keeley believes it is a moral imperative to improve the evidence base
in palliative medicine [1]; this is for him not just a scientific matter
to increase the efficiency or effectiveness of the treatments: he believes
it is morally required. It is on this basis that he offers a particular
variety of moral arguments to justify the need for ‘undertaking good
quality effectiveness research in palliative medicine’ (p757).
He points out that such research is difficult partly because of ‘the
vulnerability of the palliative-care population’ (p757); and of course, it
is the risk of being physically or mentally harmed which is at the centre
of this [2]. In this circumstance, Keeley holds that ‘the need for
effectiveness research in palliative care should be highlighted ...’
(p757). Now, one can understand this emphasis on effectiveness as a way
of minimising physical or emotional harm, but how does one measure this?
For we are not dealing in this situation merely with a comparison of two
factual methods to achieve a certain end, each of which are equally
morally acceptable. One is actually dealing with potential research
subjects rather than future potential patients requiring palliative care;
in other words a particular method is being morally assessed.
Perhaps as a preliminary, one does need in this context to refer to
the perceived Hippocratic injunction ‘Do no harm’; this is not a command
to increase knowledge: it is a plea for the use of knowledge to improve
actual people’s lives. The restriction on medical practice imposed by the
idea of protecting the patient from iatrogenetic causes is a restriction
on medical personnel: do no harm. The purpose of medical research is to
improve clinical practice, its purpose is not primarily to increase
knowledge, but to improve the lives of the sick. This is what is meant by
‘Do no harm’: the proper search for knowledge is within the acceptable
boundaries of care of people [3]. Where this restriction does not occur
and people are used primarily to increase medical knowledge, as has
happened at certain times in human history, the knowledge is poisoned and
may be unusable by the caring doctor.
It may be helpful at this point to remind ourselves that moral
principles and standards are formed in society and constitute the ideal
that the moral individual is sacrosanct. On this basis then, the active
individual is constrained to do right and to refrain from doing wrong. A
central question in this context is whether we have a moral obligation as
a professional to act professionally. This is sometimes obscured because
individuals belonging to groups understand themselves at least partially
in terms of seeking the aims of the group. Commitment is shown when the
member of the group is required by the group to meet certain standards of
efficiency and effectiveness to gain their particular purposes, as when a
medical charity may wish to save lives in conflict situations.
The soldier and the doctor each have a professional obligation to act
professionally but this constraint is not a moral constraint. The
obligations are concerned with ideas of purpose, of efficiency and
effectiveness to which moral ideals may be applied. The soldier or the
doctor may be criticised for failing to meet the required standards but
these standards themselves may be open to moral criticism. The idea of
the constructed purpose is not present in moral standards for they have no
purpose outside their standards. One may serve moral standards through
professional action but this does not show that the actions qua
professional are moral: professional action may be used for good or ill.
The standards of morality may test any standard of efficiency,
effectiveness or purpose.
MORAL ALTRUISM
Keeley’s first argument to justify an improvement in the evidence
base in palliative medicine rests on ‘evidence of untapped altruism
amongst the population of palliative care patients who would be keen to be
involved in such research’ (p757) but a particular concern here is that
altruism is self generated. The freedom of the individual is a central
conceptual requirement in formulating moral criteria; hence the importance
of fully informed consent. One is aware that there are in human history
examples of noble altruism, but one sees too examples of individual
delusion or incompetence or even wishful thinking. However, in the cases
in which Keeley is concerned these failures should not be taken advantage
of, for in the medical profession there is a tradition of doing no harm.
The doctor cannot escape moral censure either by abjuring this medical
tradition or by relying on the potential participant to make the decision
without the rational judgement required by a principle of informed
consent.
One sees in this context that the participant’s fully informed
consent is a necessary condition for acceptable medical research but it is
not sufficient. The medical practitioner’s role is the care of the
patient; there is a guiding idea of what is in the best interests of the
patient. In calculating medical responses to these interests one is
concerned with matters of efficiency and effectiveness; and these will be
weighed in the coinage of the current medical knowledge, materials and
methods available. In other words, regardless of whether the medical
response concerns clinical treatment or research, it is to be carried out
to the best medical and moral standards available. Keeley believes that
‘the development of a culture of research among palliative physicians is
in and of itself a virtue’ (p759). But this idea of virtue is not
necessarily that of moral virtue, and his evidence is inadequate for he
relies on a tautology; ‘The development of a culture in which research and
enquiry are routine will be self-propagating and hopefully exponential’
(p759).
It is fundamental to note that the injunction to do no harm is not a
medical or technical prohibition, it is a moral requirement to treat from
within the limits of one’s knowledge or power. The idea of doing no harm
is not amenable to measures of efficiency or effectiveness; it is an
appeal for moral standards. The pressure for ‘effectiveness research’
(p757) must come from medical practice, not patients, for effectiveness
research is a technical matter resolved from techniques which are morally
acceptable. What this means is that informed consent is required for both
clinical treatment and participation in research, and that idealism or
altruism is to be guided or constrained by it [4]. Altruism is not to be
conceived as a device to override proper consent or to replace the
rational model of informed consent by psychological theories of mental
states.
INFORMED CONSENT
The appeal to ‘justice and equity’ (p757) for palliative research
does not undermine the necessity for informed consent. In this
connection, his reference to polls on the willingness of palliative-care
patients to join certain research projects does not in fact indicate
wholehearted desire; and also, such polls may not be realistic regarding
likely recruitment for difficult research projects. Keeley thinks that
palliative-care patients are sometimes the subject of a clinical
experiment which does not ‘respect the patients (sic) autonomy’ (p760) for
the patient is not aware it is an experiment. Of course, clinical
situations are different to research situations, eg there is an attempt to
gain the individual patient’s benefit; but for an agreement to participate
in research there needs to be such awareness and a wish to participate
gained from sufficient information. His suggestion that to think that
participating in medical research is an important method of avoiding the
idea of ‘a life poorly lived’ (p760) is rather condescending.
Keeley expresses ‘concern ... (for) the autonomy of the individual
patient .... (but feels the emphasis is wrongly placed on what) is, and is
not, permissible in this area rather than an imperative to undertake
research’ (p757). He believes ‘The autonomy of the patient is paramount
... (but this) can be little respected at present as there is little
evidence ... (available for them)’ (p757). His position is that the
principle of autonomy is devalued because of his perceived medical failing
in providing sufficient evidence for informed consent. This puts the cart
before the horse: the requirement of patient autonomy is a given, it is
not weakened by deciding on a basis of poor evidence. To improve
evidence, the researcher needs to design a research protocol to which the
patient can give informed consent. With this in mind, perhaps recruiting
experienced patients or potential subjects to contribute to the required
patient information sheet would help convince research ethics committees
of the value of a research proposal [5].
The current situation is that Keeley seems to acknowledge that there
is little likelihood of the typical palliative-care patient benefiting
personally from palliative research. This leads him to suggest a
motivation of altruism ‘to do good or benefit others without the prospect
of benefit or reward’ (p758), or at least what ‘is true certainly in the
West’ (p758) to follow the golden rule: ‘All things therefore whatsoever
you would that men should do to you, do you also to them’ (758). An
oddity here, of course, is that the golden rule does rely on a specific
reciprocal benefit. Though the essential matter in this regard is that
the concepts of altruism, duty and benefit are independent, one may or may
not gain or provide benefit from one’s duty or altruistic act [6]. With
this conceptual background one may see that Keeley’s opposition to a gate-
keeping role for the local ethics committee is not justified.
Additionally, his presented evidence is a tautology: ‘When normally
accepted and ethically sound protections for subjects (especially for
those who lack independent decision-making) are in place, exclusion of
patients with far advanced disease from research is in and of itself
unethical’ (p758). This is necessarily true; or in the case where a
number of perceived moral courses of action produce equally unethical
outcomes, it is necessarily false.
VIRTUE AND MORALITY
For the early Greeks the idea of virtue was an idea of excellence in
a social setting, ie it would be something learned. One can see from this
that certain habitual action would be sufficient for moral virtue but it
would not be necessary; for sometimes the practitioner demonstrates non-
moral excellence. Following from this Keeley feels that the intellectual
virtue of clinical research is gained ‘through habit’ (p758), but
unfortunately, his argument as stated is again a mere tautology: ‘Unless
clinicians develop the habit and the practice of research such a virtue
will never flourish in an individual palliative clinician, nor, therefore
in the community of palliative physicians in which he or she practices
(sic)’ (p758). He has not succeeded in showing his required relationship
between moral virtue and thinking; he has not shown the intended
connection between research and moral excellence.
In discussing ‘virtue ethics’ (p759) he refers to Aquinas’s use of
‘practice for the good of others’ (p759) and takes medical knowledge to be
an exemplar of this. But we see from particular examples of uses of
medical knowledge that it is not always done for the good of others. As
the early Greeks set it out the excellence of the virtue would be an
indication of its success, ie the virtue would be a means evaluated as
successful in its context, eg an orator’s swaying of a crowd [7]. We are
familiar with causal connection between an action and an effect being
described in terms of means and ends; and here there may be no evaluative
connotations. But in evaluative language an end in itself indicates
intrinsic value; and this evaluation can be applied to causal means.
Hence moral evaluation can apply to both means and ends connected
causally. When one applies the idea of virtue to moral conduct, ie to
actions considered as ends, eg telling the truth, moral conduct is always
a virtue. It is a logical confusion to attempt necessarily to join the
accolade of moral virtue to actions which are valuable because of their
effects, eg as in medical practice. As is apparent with the utilitarian
measure of value, it takes something, eg pleasure, to assess the value of
what may produce pleasure, eg murder, ie it rather misses the point of
explaining moral value. Incidentally, if one includes reference to a
social majority, eg the greatest happiness of the greatest number, one
sees that the paradigm moral judgement may oppose this in favour of
minorities.
But apart from these considerations Keeley has not really noticed
that for Aquinas, for example, ‘knowledge becomes especially virtuous when
it is ... for the good of others’ (p759) ie his use of the word
‘especially’ indicates that the moral use of knowledge may be different
from the possession and use of knowledge. What Aquinas is doing here is
taking an end, eg possession of knowledge, and fitting it on to the early
Greek use of virtue as a means to indicate an excellent or successful
practice. Keeley goes on prematurely to claim ‘the virtuous acquisition
of skills in research ...’ (p759) and one can see that learning may be a
virtue in the sense of being related to later successful action, but this
does not indicate that it is so in the sense of being itself good: the
good learner may learn bad things. He has not offered a plausible link
between palliative care and what he takes to be appropriate medical
research: he has not shown that informed consent is not really necessary
or that medical researchers are well enough informed and morally guided to
dispense with fully informed consent. Altruism is nothing if not self
created. He sees ‘untapped altruism .... (as) a form of disinterested
charity ... (which allows) those nearing the end of their lives a
continued role in wider society and is a store of social capital’ (p759).
Exactly, and it needs to be accessed in a socially acceptable way.
MORAL EFFECTIVENESS
His reference to research in obstetric practices does not help him:
he correctly sees this as a ‘vulnerable time in a woman or a child’s life’
(p759) and believes that vulnerable palliative-care patients should
similarly be researched on. He does not come to the conclusion that
palliative-care patients should be similarly protected through gaining
information to provide informed consent. Of course, political pressure
may speed up research but it is not only the patients who need to sign up:
research is a social practice and needs to meet all the social
requirements [8]. In this connection one may note Keeley’s humility when
he reports: ‘The agreement of experts has been a traditional source of all
the errors throughout medical history’ (p759). But against this he says
‘it requires a child of spectacular bravery or naivety to ... (show the)
consensus-based emperor has no evidential clothes’ (p759).
This metaphor is cashed in terms of ‘a well-conducted RCT to
puckishly refute such dogma’ (p759), and that, of course, is the point:
the participants in a trial are not trial fodder herded in by altruism;
the well-conducted RCT protects participants. They are to be protected in
the same way as the future recipients of successful research; this is a
non-medical, ongoing feature of medical research. The moral dimension
expressed in the normal requirements, ie the dignity, rights, safety and
well-being conditions, protects research and not merely the participants.
Inadequacies in clinical practices are to be removed through adequate
research. He concludes that ‘Without the foundation of a solid body of
clinical effectiveness research, the edifice of medical ethics comes
tumbling down’ (p759) and one can only respond by saying that without a
foundation of medical ethics the edifice of medical research comes
tumbling down.
Author’s affiliations
C Parker
Leeds (East) Research Ethics Committee, Lay Member.
Clinical Sciences Building, Room 5.2, St James’s University Hospital,
Beckett Street, Leeds LS9 7TF, UK
Competing interests: none
REFERENCES
1. Keeley PW. Improving the evidence base in palliative medicine: a
moral imperative. J Med Ethics 2008; 34:757-760. doi:1136.
2. Casarett D. Ethical considerations in end-of-life care and
research. J Palliat Med 2005; 8 (suppl): 148-60.
3. Cassell EJ. The nature of suffering and the goals of medicine (2nd
Edt). Oxford: Oxford University Press, 2004: 25.
4. Isaacs D, Fitzgerald D. Seven alternatives to evidence-based
medicine: what it is and what it isn’t. BMJ 1996; 312:71-2.
5. Ewing G, Rogers M. Barclay, et al. Recruiting patients into a
primary care based study of palliative care: why is it so difficult?
Palliat Med 2004: 18: 452-9.
6. Warnock GJ. The object of morality. London: Methuen, 1971.
7.MacIntyre A. A short history of ethics. London: Routledge and Kegan
Paul, 1971.
8. Ginsberg M. On the diversity of morals. London: Mercury Books,
1962.
Dr. Morati provides a nice history of the function of the
notion of "futility." But she seems to ignore this very
history when moving from the descriptive to the normative
section of her article.
Looking to the USA, Dr. Morati rightly observes that there has
been a major shift to a "procedural" approach to medical
futility disputes. But she mischaracterizes exactly what that
approach entails. In defining the circumstanc...
Dr. Morati provides a nice history of the function of the
notion of "futility." But she seems to ignore this very
history when moving from the descriptive to the normative
section of her article.
Looking to the USA, Dr. Morati rightly observes that there has
been a major shift to a "procedural" approach to medical
futility disputes. But she mischaracterizes exactly what that
approach entails. In defining the circumstances under which an
"intervention should not be performed," Dr. Morati refers to
"general consensus in the medical community," "professional
standards," and "criteria of appropriateness."
But it is precisely the inability to reach a professional (or
broader social) consensus on such standards or criteria that
motivated the shift to a procedural approach in the first
place. As now employed in the USA, the procedural approach is
one of "pure" process. The validity of the "abstention
decision" is determined by the fairness of the method through
which the decision is reached, without reference to external
substantive standards or criteria. Indeed, without consensus
on fine-grained principles capable of resolving disputes,
resort to pure process is the only workable mechanism.
It is ironic that Dr. Gershon, president of the IDSA, would decree
the article by Johnson and Stricker to be full of “inaccuracies and
misleading information” only to mislead readers using inaccurate
information. A look at the science may be enlightening.
The IDSA holds that Lyme disease is easily cured, yet data from
treatment trials cited in the 2006 IDSA guidelines suggests otherwise.
The issue of persiste...
It is ironic that Dr. Gershon, president of the IDSA, would decree
the article by Johnson and Stricker to be full of “inaccuracies and
misleading information” only to mislead readers using inaccurate
information. A look at the science may be enlightening.
The IDSA holds that Lyme disease is easily cured, yet data from
treatment trials cited in the 2006 IDSA guidelines suggests otherwise.
The issue of persistent symptoms following treatment for Lyme disease is a
particularly vexing one, and the etiology of these symptoms remains
unproven. Animal studies and human case reports suggest that persistent
infection with the Lyme spirochete does occur. To investigate this
further, four separate trials studied the use of additional antibiotics in
patients with persistent symptoms following standard IDSA-sanctioned
therapy for Lyme disease. The patients in the retreatment trials had been
ill for extended periods of time. For example, in one study, patients, on
average, had been symptomatic for roughly 4.5 years despite previous
antibiotic therapy. The response to treatment in these trials was mixed.
While one investigator found no improvement with treatment, two others
found a significant and sustained treatment-related reduction in fatigue.
Debilitating fatigue is a prominent complaint in patients with persistent
symptoms following standard antibiotic therapy for Lyme disease. Thus the
statement by Dr. Gershon, “(b)linded, randomized controlled trials show
that long-term antibiotic treatment is not effective for any condition
described as ‘chronic Lyme’ ” is inaccurate and misleading.
The semantics involved in identifying patients who remain symptomatic
after treatment is important. Dr. Gershon notes that there are no
consistent markers for chronic Lyme disease, implying that there is no
evidence for its existence. Yet the IDSA guidelines create a new
diagnostic category, “post-Lyme syndrome”, with a similar problem: “Post-
Lyme syndrome” implies the existence of definitive evidence that the
initial bacterial infection has been cleared. However, available testing
modalities cannot provide such evidence, nor is there a specific biologic
marker for “post-Lyme syndrome”. Rather, the syndrome seems to be defined
by failure of a restricted course of antibiotics to eliminate Lyme disease
-related symptoms in a given individual. It is more likely that “post-Lyme
syndrome” represents a failure of restricted antibiotic therapy to clear
the infection, as outlined in the animal and human studies mentioned
above, rather than a nebulous entity with no clear definition and no
available treatment.
Dr. Gershon contends that Lyme disease is not a fatal illness. This
statement is incorrect. Lyme disease has been associated with fatal
myocarditis and encephalomyelitis (1,2), as well as intrauterine fetal
death (3). Furthermore, tick-borne coinfections with the agents of
Babesiosis, Anaplasmosis, Ehrlichiosis, Rickettsiosis and Tularemia are
well-known direct causes of mortality, and these coinfections can be
transmitted together with the Lyme spirochete (4-7). Because of clinical
ignorance about these diseases and poor laboratory test sensitivity, it is
likely that fatal cases of tick-borne diseases may go unrecognized and
consequently are under-reported (7,8).
Politicians, including the Attorney General of Connecticut, are drawn
into the Lyme disease arena because IDSA has allowed politics to enter
into the discussion of this illness through its restrictive guidelines
process. Generalizable studies that address the many variables affecting
patients with Lyme disease are desperately needed to improve our
understanding of the illness in order to better guide treatment. Until
that work is completed, minds and options need to remain open. The 2006
IDSA guidelines take the opposite approach, which is why they need to be
substantially revised.
1: Tavora F, Burke A, Li L, Franks TJ, Virmani R. Postmortem
confirmation of Lyme carditis with polymerase chain reaction. Cardiovasc
Pathol. 2008; Mar-Apr;17(2):103-7.
2: van Assen S, Bosma F, Staals LM, Kullberg BJ, Melchers WJ, Lammens M,
Kornips FH,
Vos PE, Fikkers BG. Acute disseminated encephalomyelitis associated with
Borrelia burgdorferi. J Neurol. 2004 May;251(5):626-9.
3: Markowitz LE, Steere AC, Benach JL, Slade JD, Broome CV. Lyme disease
during pregnancy. JAMA. 1986 Jun 27;255(24):3394-6.
4: Javed MZ, Srivastava M, Zhang S, Kandathil M. Concurrent babesiosis and
ehrlichiosis in an elderly host. Mayo Clin Proc. 2001 May;76(5):563-5.
5: Bakken JS, Dumler JS. Clinical diagnosis and treatment of human
granulocytotropic anaplasmosis. Ann N Y Acad Sci. 2006 Oct;1078:236-47.
6: Penn RL, Kinasewitz GT. Factors associated with a poor outcome in
tularemia. Arch Intern Med. 1987 Feb;147(2):265-8.
7: Paddock CD, Holman RC, Krebs JW, Childs JE. Assessing the magnitude of
fatal Rocky Mountain spotted fever in the United States: comparison of two
national data sources. Am J Trop Med Hyg. 2002 Oct;67(4):349-54.
8: Millar BC, Xu J, Moore JE. Molecular diagnostics of medically important
bacterial infections. Curr Issues Mol Biol. 2007 Jan;9(1):21-39.
I am wholeheartedly in agreement with Dr. Stricker's and Ms.
Johnson's response to Dr. Gershon's letter. Lyme Disease and its
associated conditions are extremely complex illnesses, and patients who
are suffering from them have their suffering exacerbated by misguided
attempts to "treat ideologically".
Just last week, a new patient gave me the history that her clotted
'pic' line was ignored for hours by an ER p...
I am wholeheartedly in agreement with Dr. Stricker's and Ms.
Johnson's response to Dr. Gershon's letter. Lyme Disease and its
associated conditions are extremely complex illnesses, and patients who
are suffering from them have their suffering exacerbated by misguided
attempts to "treat ideologically".
Just last week, a new patient gave me the history that her clotted
'pic' line was ignored for hours by an ER physician who said he didn't
"believe" in treating Lyme Disease IV, and who had his working diagnosis
as psychiatric, until the infection became fulminant in the ER!
Such needless risk and suffering would be best avoided if we can at
least "agree to diagree" and carry on with supporting the treatment plan
of the specialist who began the treatment. I find the collaboration of my
local colleagues invaluable, as we cope with the increase in severity and
number of cases of tick-borne illnesses of all types in this area.
Many thanks to Dr. Stricker and his colleagues from around the world
for sharing their experiences in treating these conditions, which appear
to have some regional variations in the types of illnesses presenting, as
well as their frequency and severity. I would encourage all who are
interested in these conditions to attend the excellent LDA/IDSA
conferences which will be held in Bethesda, MD in October this year.
In J Med Ethics 2009 (35) Walter Glannon [i] claims that deep brain
stimulation (DBS) improves symptoms of some conditions, but could also
have impact on thought, personality, and behaviour. His argument –
although rich and in detail – misses three important points:
(1) Why should the disruption of thematic unity of one`s life story
always be a harm? Glannon appeals to our intuitions when he claims that
cohere...
In J Med Ethics 2009 (35) Walter Glannon [i] claims that deep brain
stimulation (DBS) improves symptoms of some conditions, but could also
have impact on thought, personality, and behaviour. His argument –
although rich and in detail – misses three important points:
(1) Why should the disruption of thematic unity of one`s life story
always be a harm? Glannon appeals to our intuitions when he claims that
coherence is one of our aims. But intuitions must not be true. A life can
be worth living and happy, though not being coherent throughout lifetime.
Thus, a more detailed examination of the phenomenon of coherence as an
universal aim would be helpful.
(2) Glannon examines the question of “how much alteration of one`s
thought and personality in treating a neurological or psychiatric disorder
with DBS would be consistent with a patient`s rational choice to undergo
the procedure”[ii]. The answer should include two aspects: first, one
needs to compare personality alterations induced through DBS with
alterations caused by other influences (education, pharmaceuticals, etc.).
Second, one needs to give criteria in order to define the point when an
alteration is no longer a change in degree but in quality, e.g., a total
change of personality. While doing this, one must be aware of not entering
the well-known “sorites-problem” (“heap-paradox”).
(3) DBS can be switched on and off immediately. But it is not, as
Glannon claims, just a kind of “trade-off […] between acceptable quality
of life regarding motor control and alteration of the mind.” (Glannon, p.
289) It might be much more: both states are connected with a specific self
-awareness and self-description as well as with a subjective experience of
one`s own. We therefore need to understand how it feels [iii] for the
patient to be under DBS treatment. Additional research approaches, e.g.
biographical patient stories as well as feedback from the patient`s social
environment (e.g. spouse) may help to explain the Janus-faced character of
DBS.[iv]
REFERENCES:
[i] Glannon, W Stimulating brains, altering minds, J Med Ethics 2009: 35;
289-292.
[ii] Glannon, p. 289
[iii] For the subjective character of experience see Nagel T. (1974) What
Is It Like to Be a Bat? Philos Rev, 83 (4):435-450.
[iv] Following Glannon`s model case, being free to move but manic may be
considered a comfortable state for the patient but a problem for his
spouse, who postoperatively does not find the person restored he has loved
previously.
Authors of the eLetter are:
Uta Bittner & Henriette Krug
This excellent paper should be taken in light of several reports,
conferences and papers that draw attention to guidelines and procedures to
be followed by research ethics committees (RECs).
I wish to suggest five simple prescriptive precepts or commandments that
ought to be institutionalized in RECs, and be part of the values or moral
code of members of such organizations. Most of these are self-explanatory
and are ther...
This excellent paper should be taken in light of several reports,
conferences and papers that draw attention to guidelines and procedures to
be followed by research ethics committees (RECs).
I wish to suggest five simple prescriptive precepts or commandments that
ought to be institutionalized in RECs, and be part of the values or moral
code of members of such organizations. Most of these are self-explanatory
and are therefore elaborated only briefly.
(1) Thou shalt not steal ideas of researchers who submit papers for ethics
reviews. This form of plagiarism is difficult to detect. In case a
reviewer or a member of the REC thinks of an idea based on a paper
submitted for review, the proper process should be to inform the REC,
contact the author and discuss further collaboration or development of the
idea.
(2) Thou shalt not destroy the spirit of the research proposal. Some
reviewers and members of REC take great pleasure in suggesting their ideas
for the proposal often distorting the initial research question. They must
be cognizant that their remit is to approve or disapprove or suggest
changes to proposals. The latter is mainly by improving methodology where
appropriate and helping to resolve ethical issues. Suggestions for
improvement of a study ought to remain suggestions. As for these
suggestions, the researcher should have the option to ignore, include and
re-submit or develop a fresh proposal.
(3) Thou shalt not delay the approval process. ERCs must have a fast-track
process at least for certain studies that do not contain major ethical
issues. Members of the ERC must be held accountable for unnecessary delays
in granting approval to studies and there should always be a fall-back
position (for e.g. in case a reviewer does not meet a time-line).
(4) Thou shalt not be influenced by the personalities who submit the
proposal. It is always possible that doyens in a particular field
(unwittingly)intimidate RECs, while smaller-fry researchers are critiqued
mercilessly on minutiae.
(5) Thou shalt not be influenced by the funds at stake. The refusal to
grant approval may have adverse implications to an institution but that
should not sway decisions of ERCs.
It is not surprising that Anne Gershon, the current president of the
Infectious Diseases Society of America (IDSA), would come to the defense
of her society's beleaguered Lyme guidelines. What is disturbing is that
Dr. Gershon relies on the same specious arguments that were debunked by
the Connecticut Attorney General's investigation of the IDSA Lyme
guidelines proc...
It is not surprising that Anne Gershon, the current president of the
Infectious Diseases Society of America (IDSA), would come to the defense
of her society's beleaguered Lyme guidelines. What is disturbing is that
Dr. Gershon relies on the same specious arguments that were debunked by
the Connecticut Attorney General's investigation of the IDSA Lyme
guidelines process
(<http://www.ct.gov/AG/cwp/view.asp?a=2795&q=414284>) and refuted in
our article. Here is a rebuttal to her views.
As stated in our article, the IDSA Lyme guidelines are not "simply
guidelines", as Dr. Gershon meekly maintains. They are a highly
restrictive set of directives published by the largest group of infectious
disease specialists in the world, and they allow a monopolistic medical
society to set a standard of care that forecloses treatment options for
patients. The IDSA guidelines trivialize Lyme disease, ignoring the
growing number of patients with persistent symptoms of tick-borne illness
leading to significant disability. The guidelines also discount the
importance of clinical judgment and fail to provide treatment options for
Lyme patients. As Dr. Gershon knows, the IDSA Lyme guidelines are treated
as the mandatory standard of care by insurers, government agencies and
medical boards, and they are used to deny patients access to the only
viable treatment option for chronic Lyme disease.
Readers can easily refer to the findings of the Attorney General to
dispel Dr. Gershon's protestations regarding suppression of evidence and
the use of a hand-picked panel with known biases and substantial conflicts
of interest, as the findings on these points are clear. Basically, IDSA
researchers selected their own papers based on their own research bias,
found no faults with their own studies, discounted the studies of others,
and excluded opposing viewpoints in reaching their conclusions. Even the
strongest proponents of evidence-based medicine would cringe at the amount
of bias the panel members brought to the table. As noted in our article,
their conclusions support the interests of vaccine patent holders who
favor a narrow disease definition that increases the efficacy and odds of
approval of a vaccine. Their conclusions also favor diagnostic test
patent holders by mandating a positive test for diagnosis. Their
conclusions put money in the pocket of consultants who help to deny
patient care and reduce costs for insurers. The Attorney General found
that IDSA panel members had conflicts of interest in each of these areas.
Did anyone on this panel represent the interests of patients to gain
access to the only medical option that might improve their quality of
life? The answer is no.
Nor can IDSA shore up its guidelines by asserting that other medical
societies independently corroborate them. First, most of the groups
listed by Dr. Gershon do not endorse IDSA's 2006 guidelines. Second, as
pointed out by the Attorney General in his findings, corroboration of the
IDSA guidelines was anything but independent. Hence, the Attorney General
found that "The IDSA portrayed another medical association's [American
Academy of Neurology] Lyme disease guidelines as corroborating its own
when it knew that the two [guidelines] panels shared several authors,
including the chairmen of both groups, and were working on guidelines at
the same time". The New England Journal of Medicine article cited by Dr.
Gershon also shared authors with the IDSA panel. Both publications
appeared after the Attorney General's investigation was launched, and
there was no disclosure of the rather glaring conflict of interest of
panel members who authored these "independent" attempts to exonerate
themselves in the face of an ongoing investigation.
Dr. Gershon implies that "Lyme-literate" physicians prey upon
misinformed and misguided patients. Nothing could be further from the
truth. In reality, patients by the thousands seek care from "Lyme-
literate" physicians because the IDSA guidelines have failed them and the
IDSA physicians who rely on those guidelines have abandoned them. Dr.
Gershon also derides treating physicians for being paid fees for their
services. However, there is a big difference between being paid to care
for patients and profiting from third-party industry ties that should have
no place in determining patient care. If patients are unhappy with their
treatment, they have the power to leave a treating physician and seek
another, and they also have the ability to express their concerns and
ensure that those concerns are addressed. In short, their physicians are
accountable for their care. Patients have no similar recourse with the
guidelines panel of a dominant medical society that has the authority to
set the rules for patient care but is not accountable to those patients
when care fails.
It is all too easy to turn a blind eye on treatment failures and
patient suffering when one never sees or treats the patient, is not
responsible for the consequences of failure and neglect, and has no
obligation to the individual. IDSA's assertion that this medical
abandonment is necessary to honor its hypocratic oath to "first, do no
harm" could be used to justify the denial of any medical treatment, as all
treatments have the potential to do harm. While this may appeal to
insurers, Lyme patients who are suffering a disability equivalent to
congestive heart failure certainly deserve better.
Lorraine Johnson, JD, MBA,
Chief Executive Officer,
California Lyme Disease Association
<http://www.lymedisease.org>
Raphael B. Stricker, MD,
Past President,
International Lyme & Associated Diseases Society
<http://www.ilads.org>
The article entitled “Attorney General Forces Infectious Disease
Society of America to redo Lyme guidelines due to flawed development
process” that appeared in the Journal of Medical Ethics purporting to
explain the agreement between the Connecticut Attorney General and the
Infectious Diseases Society of America (IDSA) regarding its Lyme disease
guideline was extremely disturbing. This article is riddled with
inaccurac...
The article entitled “Attorney General Forces Infectious Disease
Society of America to redo Lyme guidelines due to flawed development
process” that appeared in the Journal of Medical Ethics purporting to
explain the agreement between the Connecticut Attorney General and the
Infectious Diseases Society of America (IDSA) regarding its Lyme disease
guideline was extremely disturbing. This article is riddled with
inaccuracies and misleading information. The article is the latest salvo
from a small but vocal group of physicians and patients who attribute a
wide range of vague symptoms to what they call “chronic” Lyme disease. To
treat “chronic” Lyme infection, this self-described “Lyme-literate” group
promotes the use of long-term antibiotics – often delivered intravenously
for months or even years. The cost of this treatment must be borne by
patients themselves, leading a discerning person to question the authors’
interest in the real reason why they want the treatment guidelines
changed.
Blinded, randomized controlled trials show that long-term antibiotic
treatment is not effective for any condition described as “chronic Lyme”
– a condition that currently has no consistent diagnostic markers. Far
worse, this treatment has been shown to be extremely risky, potentially
leading to fatal infections, serious drug reactions and fostering
development of life-threatening drug-resistant superbugs. That this group
continues to use its assaults on the IDSA and its Lyme disease guidelines
as a platform to promote a not only unproven but expensive and potentially
dangerous therapy is, we believe, clearly unethical.
Among the many inaccuracies in this article, the most egregious
charge is that the IDSA’s Lyme disease guidelines “excluded most Lyme
patients and denied them treatment for their illness.” It is difficult to
find an accurate sentiment in that statement. To start with, the
guidelines are simply that, guidelines, and by their very nature do not
“exclude” patients, nor “deny” them treatment. Further, the authors seem
intentionally to confuse Lyme disease – a proven and highly treatable
illness – with “chronic” Lyme infection, an unproven condition that a
small group of doctors may provide as a “diagnosis” for patients with
vague but often serious symptoms. There is no solid evidence of the
existence of “chronic” Lyme infection. Although we do not doubt that there
are patients who initially were treated for Lyme disease infection and
subsequently have ongoing, vague symptoms, we are concerned these patients
likely are suffering from a different or new illness and are receiving
potentially dangerous “treatment” rather than being evaluated, properly
diagnosed, and treated appropriately.
Although a comprehensive response to the remaining charges would
require an entire article, following are our comments regarding several of
the most salient.
• Regarding the agreement (not “settlement”) between the IDSA and the
Connecticut Attorney General, the IDSA was not forced to “redo” the Lyme
guidelines and no “antitrust laws” were broken. The Lyme disease
guidelines remain in effect. IDSA voluntarily agreed to a special one-time
review of the Lyme disease guidelines. IDSA paid no fines or penalties and
is not restricted from promulgating guidelines of Lyme disease or other
conditions.
• The statement “at least 21 studies documenting death in patients
with this potentially devastating tick-borne illness” is patently wrong.
Lyme disease is not a life-threatening disease. This statement is
reminiscent of a tabloid headline – the patients may have had Lyme
disease, and may have died, but not of Lyme disease.
• The IDSA Lyme disease guideline panel spent months scouring all of
the Lyme disease research. Specific studies were not “selectively
ignored,” but in fact stringently reviewed along with all of the other
research. Based on widely accepted principles of evidence-based medicine,
some studies were determined to lack scientific rigor, and were therefore
not used as a basis for treatment guidelines.
• The comment that the guidelines are “treated as mandatory” and end
up “denying” treatment to patients is inaccurate. The purpose of the
guidelines is to attempt to guide physicians in providing the highest-
quality treatment that is not harmful to patients. However, they are
guidelines, not mandates.
• IDSA does not have nor seek monopoly power. We do not work with
insurers on any guidelines, nor do we develop our guidelines for the sake
of insurers. We develop guidelines to provide guidance to our members,
with the ultimate goal of ensuring the best quality in patient care and to
protect the public’s health.
• Regarding the makeup of the guidelines panel, the IDSA chose the
panel of experts that we believe is the most knowledgeable for the job.
Further, the panel was not limited to “researchers known to have a bias
against the diagnosis and treatment of Lyme disease.” In fact, the point
of the panel was to guide physicians in treating Lyme disease, a known and
highly treatable disease.
• The remark that some of the panel members were working on the
development of vaccines is irrelevant. There are no Lyme disease vaccines
approved for use in humans and the IDSA has made no recommendations in
that regard. The vaccine mentioned in the article was previously in
development, but the decision not to manufacture it was made before the
guidelines were published.
• Regarding conflicts of interest among panel members, physicians
with expertise in a specialty of medicine are often called upon to serve
as expert witnesses, just as lawyers are often asked to do. This is a
professional activity, and compensation is relatively modest. The same is
true of consultation fees with commercial organizations, as long as
specific guidelines are followed. The physicians on our panel followed
those guidelines. The implication that physicians on the guidelines panel
stand to monetarily gain from their recommendations seems particularly
hypocritical coming from a group of practitioners who stand to gain
financially from treating vulnerable patients with an unproven condition
using an unproven, expensive, invasive and risky long-term therapy.
The IDSA is widely recognized as the pre-eminent authority on the
treatment of infectious disease. We are in good company in our lack of
support of the therapy advocated by the authors of this article, including
the American Academy of Pediatrics, the American College of Physicians,
the Medical Letter, the Centers for Disease Control and Prevention (CDC),
the National Institutes of Health (NIH), and even review articles in major
medical journals such as the New England Journal of Medicine. We take our
responsibility as protectors of the public health seriously, and as
physicians who stand by our Hippocratic Oath to “above all, do no harm,”
we wish there were more evidence that these authors and the groups they
represent did the same.
Given what we know and don't know about the processes from which the
'safe limits' for alcohol consumption in general are derived, would the
author not agree that his criticism applies more generally in this area?
On a somewhat pedantic note it's not establishing a negative correlation
that's difficult, it's establishing a lack of correlation. Absence of
evidence is not evidence of absence.
I read with interest the article by Luty et al. (1) about the
retrospective survey they conducted to determine whether medical specialty
journals were more likely to publish the research of their own editorial
board members or the research of editorial board members of rival
journals. I was surprised about the high degree (i.e., almost three times
more likely) to which these cases occur.
I read with interest the article by Luty et al. (1) about the
retrospective survey they conducted to determine whether medical specialty
journals were more likely to publish the research of their own editorial
board members or the research of editorial board members of rival
journals. I was surprised about the high degree (i.e., almost three times
more likely) to which these cases occur.
Typically, the reviewer evaluates the merit and acceptability of a
submitted manuscript, but the final decision is made by the editor.
Macrina (2) pointed out that "Reviewers [and editors] must be comfortable
with the job of impartially reviewing the work. Their review of the paper
must not constitute a conflict of interest, real or perceived [by
others]." I believe that editorial board members who want to publish in
their own journals should be required to disclose in their manuscripts
this conflict of interest, since all other authors are always required to
do so, be it financial or other substantive conflict of interest. Bosetti
and Toscano (3) suggested in a recent article a standardized and written
code of ethics which governs all stakeholders (authors, editors, members
of the editorial board and reviewers) in the peer review process, which
includes a mandated disclosure of real or perceived conflicts of interest.
Reyes (4) emphasized that "honesty and good faith in all the actors
involved in the process of biomedical publications remain the cornerstone
of scientific good behavior." I believe that if this relationship breaks
down, publications become nothing more than papers manipulated during the
review process. The ultimate outcome is that science will be distorted.
I agree with Luty et al. (1) that there is most likely not a single
factor attributable to this phenomenon of publication bias and
discrimination. In my opinion, more research should be conducted in this
area because of its importance to science and the many stakeholders
involved, last but not least, the reader of scientific articles.
REFERENCES
1. Luty J, Arokiadass SMR, Easow JM, Anapreddy JR. Preferential
publication of editorial board members in medical specialty journals. J
Med Ethics 2009;35:200-2.
2. Macrina FL. Scientific integrity: Text and cases in responsible
conduct of research. Washington, DC: American Society for Microbiology
Press, 2005.
3. Bosetti F, Toscano CD. Is it time to standardize ethics guiding
the peer review process? Lipids 2008;43:107-8.
4. Reyes H. Honesty and good faith: Two cornerstones in the ethics of
biomedical publications. Rev Med Chile 2007;135:415-8.
Given the sincerity and commitment of all parties in debate it is important to test the coherence of the principles or arguments guiding any policy. For example, is medical paternalism or participant autonomy desirable or even necessary in the development of medical science? Such questions are considered in the context of palliative medicine to analyse some moral arguments intended to show how to improve clinical practi...
Dr. Morati provides a nice history of the function of the notion of "futility." But she seems to ignore this very history when moving from the descriptive to the normative section of her article.
Looking to the USA, Dr. Morati rightly observes that there has been a major shift to a "procedural" approach to medical futility disputes. But she mischaracterizes exactly what that approach entails. In defining the circumstanc...
It is ironic that Dr. Gershon, president of the IDSA, would decree the article by Johnson and Stricker to be full of “inaccuracies and misleading information” only to mislead readers using inaccurate information. A look at the science may be enlightening.
The IDSA holds that Lyme disease is easily cured, yet data from treatment trials cited in the 2006 IDSA guidelines suggests otherwise. The issue of persiste...
I am wholeheartedly in agreement with Dr. Stricker's and Ms. Johnson's response to Dr. Gershon's letter. Lyme Disease and its associated conditions are extremely complex illnesses, and patients who are suffering from them have their suffering exacerbated by misguided attempts to "treat ideologically".
Just last week, a new patient gave me the history that her clotted 'pic' line was ignored for hours by an ER p...
In J Med Ethics 2009 (35) Walter Glannon [i] claims that deep brain stimulation (DBS) improves symptoms of some conditions, but could also have impact on thought, personality, and behaviour. His argument – although rich and in detail – misses three important points:
(1) Why should the disruption of thematic unity of one`s life story always be a harm? Glannon appeals to our intuitions when he claims that cohere...
This excellent paper should be taken in light of several reports, conferences and papers that draw attention to guidelines and procedures to be followed by research ethics committees (RECs). I wish to suggest five simple prescriptive precepts or commandments that ought to be institutionalized in RECs, and be part of the values or moral code of members of such organizations. Most of these are self-explanatory and are ther...
IDSA Lyme Guidelines: Response to Dr. Gershon
It is not surprising that Anne Gershon, the current president of the Infectious Diseases Society of America (IDSA), would come to the defense of her society's beleaguered Lyme guidelines. What is disturbing is that Dr. Gershon relies on the same specious arguments that were debunked by the Connecticut Attorney General's investigation of the IDSA Lyme guidelines proc...
The article entitled “Attorney General Forces Infectious Disease Society of America to redo Lyme guidelines due to flawed development process” that appeared in the Journal of Medical Ethics purporting to explain the agreement between the Connecticut Attorney General and the Infectious Diseases Society of America (IDSA) regarding its Lyme disease guideline was extremely disturbing. This article is riddled with inaccurac...
Given what we know and don't know about the processes from which the 'safe limits' for alcohol consumption in general are derived, would the author not agree that his criticism applies more generally in this area? On a somewhat pedantic note it's not establishing a negative correlation that's difficult, it's establishing a lack of correlation. Absence of evidence is not evidence of absence.
Dear Editor,
I read with interest the article by Luty et al. (1) about the retrospective survey they conducted to determine whether medical specialty journals were more likely to publish the research of their own editorial board members or the research of editorial board members of rival journals. I was surprised about the high degree (i.e., almost three times more likely) to which these cases occur.
Typic...
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