Greater transparency and regulatory oversight in disclosing gifts and
payments to physicians from drug and medical device companies could well
reduce their influence on a doctor's prescribing habits and medical
management recommendations. The threat of a very public loss of
professional reputation among peers and patients is likely to discourage a
physician accepting drug and medical device company generosity. However, a
m...
Greater transparency and regulatory oversight in disclosing gifts and
payments to physicians from drug and medical device companies could well
reduce their influence on a doctor's prescribing habits and medical
management recommendations. The threat of a very public loss of
professional reputation among peers and patients is likely to discourage a
physician accepting drug and medical device company generosity. However, a
more positive, potentially more effective and formative approach would be
include in medical school ethics curricula the psychology of gifting and
the adverse influence on clinical practice exerted by pharmaceutical
company incentives and honoraria. Instead of policing behavior to stop
physicians raiding Big Pharma's cookie jar, we should intensively caution
our medical students about inappropriate ties with pharmaceutical
industry. The latter could form the basis of a career-long ethical
approach towards refusing undue gifts and payments.
Careful scrutiny of drug-company sponsored clinical trials could lead
doctors to the conclusion that exciting but expensive new treatments are
not superior to reliable old work horses. Sponsored studies may ignore
comparisons with long-established effective drugs (there's little income
in established patent-expired drugs. By aggressively marketing their
newest products, drug companies would have physicians believe otherwise.
If only doctors had the time at work (preferably paid and without
clinical obligation) and the necessary skills to assess the methodological
robustness of a study, decipher its findings and apply its conclusions to
patients. Such favourable conditions are rarely available outside the
journal club, postgraduate training, teaching hospital and medical school.
If health executives really care about research bearing relevance to
patient care in ambulatory and community practice, they need to fund
doctors to train in appraising the quality of what they read and pay them
for the time spent keeping up to date. Better informed doctors are likely
to deliver better care and dividends in improved care will likely outgrow
remuneration to doctors.
Burgeoning health-care evidence needs to be efficiently delivered to
doctors caring for patients in digestible allotments that will not prove
overwhelming. This involves communicating information relevant to their
clinical practice or specialty, in a format and schedule compatible with
achieving balance in a doctor's work and personal life.
Paying doctors for non-clinical time to learn about the latest
evidence is a good start. Even if one has not assessed the original
studies, investigation and treatment summaries updated with newly emerging
clinical research provides a short-hand way for ensuring patients receive
the best of care, but requires commensurate time to absorb.
The argument for substantial benefit conferred by the placebo effect
in treatment trials has been around for a while. Clinical triallists do
not deny that inactive sugar pills and IV medications or sham surgery have
some quantifiable benefit when compared with doing nothing at all.
Patients who consent to participate in treatment studies tend to be more
motivated and confident that they will get better than those who ref...
The argument for substantial benefit conferred by the placebo effect
in treatment trials has been around for a while. Clinical triallists do
not deny that inactive sugar pills and IV medications or sham surgery have
some quantifiable benefit when compared with doing nothing at all.
Patients who consent to participate in treatment studies tend to be more
motivated and confident that they will get better than those who refuse to
be enrolled, despite only having a one in two chance of receiving a
potentially beneficial therapy. Randomised controlled trials attempt to
discern whether new therapies result in a clinically relevant benefit
(improved survival, reduced symptoms) in addition to that conferred by the
human mind's empowerment to enhance immunological and psychological
defences from participation in studies. Furthermore the awareness of being
closely observed and monitored for clinical progress or deterioration is
an incentive for patients to do better (the Hawthorne effect, aiming to
gain approval from investigators and other participants), regardless of
whether a study subject receive the tested or inactive treatment.
Ebola haemorrhagic fever, with its high case fatality risk, has no
reliably proven effective single drug or immune treatment. Although
several repatriated adults in advanced health systems have survived with
novel immune therapy, it could well have been the excellent critical care
and fluid resuscitation that were responsible for their recovery. The
latter would almost certainly not be available on a day to day basis in
the impoverished West African countries where EHF trials would be
conducted. In addition to placebo comparisons, the study of advanced fluid
resuscitation, immunomodulators and vaccines in vulnerable people who
cannot afford such treatments even if they were found to work remains
ethically challenging.
A substantial proportion of medical research funding in advanced
health economies are diverted to the overzealous policing of low risk
observational studies.
As we plea and wait for the resumption of competitive funding to the
research endeavour so necessary to maintaining Australia's global stature
as a science and innovation based economy, the haemorrhage could be
stemmed re- allocati...
A substantial proportion of medical research funding in advanced
health economies are diverted to the overzealous policing of low risk
observational studies.
As we plea and wait for the resumption of competitive funding to the
research endeavour so necessary to maintaining Australia's global stature
as a science and innovation based economy, the haemorrhage could be
stemmed re- allocating scarce resources from the non-productive and
demoralising barrier imposed by the layer of administration and
bureaucracy that sits on top of, and suffocates, original scientific
research.
I faced months of delays to starting low risk studies that aim to
record current clinical care practices to establish a baseline from which
improvements could be identified and assessed further. This included
"behind the scenes" observation of acute pain management and sedation
protocols that aim to calm the acutely agitated. Neither study influenced
clinician behaviour or treatment as would have been occurred during
routine care. Both had already been declared to being above reproach by
reputable regulatory and oversight bodies in Melbourne Australia.
I had to expend numerous hours of tortuous negotiation of a maze of
needlessly imposed complexity mandated by my local hospital ethics and
governance committee. National Ethics Application Forms and numerous other
documents had to be identically filled in with my hospital's mast head and
be re-submitted to await much-delayed adjudication.
Researchers should contest the resource- and labour-intensive
bureaucratisation of research oversight that confers no additional
protection to participants in low risk obervational research in the
advanced economies, including Australia's.
Australia's gutting of science research funding has at least served
to highlight dispiriting barriers posed by administrative processes that
are wasteful withut conferring additional benefit or participant
protection.
A very difficult area indeed. My view is that that, once you have
decided to stop fluids and/or nutrition, then the patient will certainly
die. Whether or not they will suffer whilst starving, or dehydrating, is
unclear. However, prolonging life in such cases extends suffering for
relatives, staff, and possibly/probably the patient.
A lethal injection at this point is surely more humane than extending
life and,...
A very difficult area indeed. My view is that that, once you have
decided to stop fluids and/or nutrition, then the patient will certainly
die. Whether or not they will suffer whilst starving, or dehydrating, is
unclear. However, prolonging life in such cases extends suffering for
relatives, staff, and possibly/probably the patient.
A lethal injection at this point is surely more humane than extending
life and, thus, extending suffering. As a profession doctors should surely
see a 'good' death as a part of the care we should be providing. I can see
nothing good about allowing someone to starve to death, because we feel
that taking an active step, is a step too far. We have already decided
that they are going to die. Why not provide the quickest and most painless
death possible?
Critics of a regulated market in organs have correctly focussed on
its inability to protect the vendor from coercion and exploitation.
However, they have consistently failed to realise that coercion and
exploitation are not immanent in this market. Rather, they are immanent in
the need to even consider selling ones organs (free people do not engage
in such considerations). In other words, the critics have failed to
ackno...
Critics of a regulated market in organs have correctly focussed on
its inability to protect the vendor from coercion and exploitation.
However, they have consistently failed to realise that coercion and
exploitation are not immanent in this market. Rather, they are immanent in
the need to even consider selling ones organs (free people do not engage
in such considerations). In other words, the critics have failed to
acknowledge that a regulated market in organs should, at least
theoretically, be able to protect the vendor from coercion and
exploitation that might occur within the sphere of exchange, but it cannot
protect the vendor, not even theoretically, from coercion and exploitation
that occur universally outside this sphere. Even worse, its ethical guise
would only serve to conceal and reinforce them.
In this light, criticism of any organ market could make sense only if
it were part of the greater struggle against the oppressive social
conditions that have made it a viable option to begin with. This anti-
market argument still awaits refutation.
The article was well read and understood. I would like to draw the
attention of readers to the current reality, of having grant winners who
are not the authors even though their hypothesis and proposal writing has
contributed significantly and scientifically towards achieving the
grant/funds, followed by processing of the entire scientific/social
projects based on the proposed hypothesis. Authorship i...
The article was well read and understood. I would like to draw the
attention of readers to the current reality, of having grant winners who
are not the authors even though their hypothesis and proposal writing has
contributed significantly and scientifically towards achieving the
grant/funds, followed by processing of the entire scientific/social
projects based on the proposed hypothesis. Authorship is considered to be
reserved only for persons who have been receiving primary credit and have
been holding a primary responsibility for published work (experimental
data or data from other means like literature review, meta-analysis etc)
(APA Publication manual, 2001). International Committee of Medical
Journal Editors (ICMJE, 1997) has formulated regulations for scientific
writing and ethical regulations in publishing/ maintaining the quality of
scientific writing globally. These regulations are currently acceptable
all over the world, in its original form or these regulations have been
modified by respective countries, institutes, departments, units and
research groups as per need of the time, space, funding and legislations.
According to the ICMJE, the authorship credit should be defined/
based on meeting all four of the following conditions:
1) Substantial contribution to the study includes: i. Conception and
design, (e.g. Co-investigator, consultant or research support staff who
have intellectually contributed to the grant proposal) OR ii. Clinical or
methodological support throughout the implementation of
the study (generally through participation in regular team meetings) OR
iii. Analysis and interpretation of data
AND
2) Provide important intellectual contribution towards the
conceptualization or writing and reviewing multiple drafts of the article
or abstract in a timely fashion.
AND
3) Final approval of the version to be published (or may waive final
approval at a point where no more substantial changes are to be made).
AND
4) Are prepared to take public responsibility for the paper.
Keeping in view the above mentioned conditions, There are a variety
of formal strategies of weighting the contributions of co-authors
(Digiusto, 1993). For instance, issues where students are considered as co
author or/ and student as grant holders still need a lot of discussion and
regulation as per consensus of the entire group to be agreed upon. Many
countries (for example, Malaysia) now allows a Phd or MSc student to be a
Principle investigator to hold the grant, where supervisors and the
seniors still have the final say as to whether student can be the first
author/ coauthor even though he/she is holding a grant as a grant winner.
Another important issue in this aspect is the biased authorship privilege,
which is abducted from the articles written by the students as main
authors. This is done for the sake of either maintaining the keep
performance index (KPI) of the university or for personal professional
benefits to improve the CV of supervisor or any of the members of the
research group. Still it could be legal though it is not ethical. The
issues regarding the ghost authors taking privilege from the grant winners
is another area to be discussed. I will suggest that there is a need to
compile a meta analysis of all such studies to be discussed strategically
and conclusively with reference to ICMJE and as per my opinion that a
single article can't bring in any necessary change without consulting the
ICMJE.
References:
American Psychological Association. (2001). Publication Manual of the
American Psychological Association (5th ed.). Washington, DC: Author.
Diguiusto, E. (1993). Equity in authorship: A strategy for assigning
credit when publishing. Social Science and Medicine, 38(1), 55-58.
The term 'suicide tourism' was first coined by the media for obvious
reasons. Is it necessary to use such a repugnant term though. When used
to refer to a group collectively this insult can can be glossed over- in a
way it could not without causing anger if referring to an individual who
takes the harrowing decision to go abroad for an assisted death. To refer
to the increased number of people 'from England' (presumably...
The term 'suicide tourism' was first coined by the media for obvious
reasons. Is it necessary to use such a repugnant term though. When used
to refer to a group collectively this insult can can be glossed over- in a
way it could not without causing anger if referring to an individual who
takes the harrowing decision to go abroad for an assisted death. To refer
to the increased number of people 'from England' (presumably Wales is
still included )as being 'outsourced'(ref responses) like a commodity, is
dehumanising. However strong opinions may be the right of people to be
treated with respect and dignity is paramount, not their usefulness to
support an argument.
Conflict of Interest:
I support the right of individuals to decide when to die but have no competing interests
Formulating the desire to consent in advance to research as a
critical interest is a valuable addition to the literature on consent to
research by incapacitated individuals. As Dr. Buller notes, much
attention has been paid to these concerns in the literature and many
states have enacted statutes protecting human research subjects. States
vary in how thoroughly they treat the topic, with some carefully defining
who ma...
Formulating the desire to consent in advance to research as a
critical interest is a valuable addition to the literature on consent to
research by incapacitated individuals. As Dr. Buller notes, much
attention has been paid to these concerns in the literature and many
states have enacted statutes protecting human research subjects. States
vary in how thoroughly they treat the topic, with some carefully defining
who may provide proxy consent to research under what circumstances, while
others provide virtually no guidance on proxy consent. What is
interesting to note given Dr. Buller's article, though, is that proxy-
focused approaches using human subjects research laws fall short of
providing health care recipients the ability to affirmatively assert their
right to consent to research--to express their critical interest in
research participation in a legally binding format.
Dr. Buller notes that advance research directives have not gained
wide support, yet documenting one's consent to research in advance is
arguably the most patient/participant-centered and empowering way to
document one's critical interest in participating in research. A
relatively recent change in Virginia's Health Care Decisions Act warrants
attention on this point. Virginia appears to be the only state that has
codified the possibility of advance consent to research and has included
consent to research explicitly among the powers of a designated health
care agent. Some states, such as California, note in human subjects
research laws that an agent may consent to research if such power has been
granted in an advance directive, but the separate statutory language
concerning advance directives does not make any mention of including
preferences and instructions regarding research in advance directives.
In contrast, Virginia explicitly authorizes consent to research in an
advance directive (Va. Code s 54.1-2983.1. http://leg1.state.va.us/cgi-
bin/legp504.exe?000+cod+54.1-2983.1) and also includes the power to
consent to research among the agent's powers on the model form (Va. Code s
54.1-2984. http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2984;
see also the "Integrated AD Form"
http://www.virginiaadvancedirectives.org/option-1--integrated-ad.html).
Moreover, recognizing that people may feel differently about research
depending on whether it may offer a direct benefit to them or not, the
power to consent is described in two separate provisions so that people
may opt to choose both, one, or neither. As with any other "default
powers" in a Virginia form, the two powers may certainly be struck
through, and users of the form are made aware of this at the beginning of
the list of powers.
Virginia has well-developed human subjects research laws, as well,
which can control when no advance directive is available. Nonetheless,
the right to consent to research as a critical interest can be best
exercised through affirmative documentation in an advance directive,
rather than through a proxy's inferences about a patient's desire to take
part in research after he or she has lost capacity. Virginia has
recognized the importance of providing mechanisms for people to consent in
advance to research and incorporates research provisions directly into its
Health Care Decisions Act.
I have no argument with Charles Foster's tortuously argued claim that
suicide tourism has not led to a change in prosecutorial policy, although
I am far more exercised by the potential for change in the latter
influencing requirement for the former. Nor do I disagree with his
admission that it is intellectually dishonest for us to allow Swiss
clinics to siphon off our sufferings and responsibility, except t...
I have no argument with Charles Foster's tortuously argued claim that
suicide tourism has not led to a change in prosecutorial policy, although
I am far more exercised by the potential for change in the latter
influencing requirement for the former. Nor do I disagree with his
admission that it is intellectually dishonest for us to allow Swiss
clinics to siphon off our sufferings and responsibility, except to add
that it's also immoral of us to do so.
Where I take issue with him is with his blithe statement that
allowing the status quo to continue "is likely to do less harm overall
than introducing
any conceivable assisted suicide law into England."
The conceivable law now in question is Lord Falconer's Assisted Dying
Bill and this provides for safeguards and transparency that have been long
and carefully considered, are modelled on laws in Oregon operating
successfully for seventeen years, are certainly more comprehensive than
those pertaining in Switzerland; and are our own.
As such, they aim to address
the unnecessary, inevitable suffering resulting from the necessity to
travel - and be able to travel - to die in alien surroundings. Yes, Dr.
Foster, this is a
moral as well as an intellectual challenge.
Hallowell et al. advocate an interesting pragmatic approach to the
disclosure of genetic information in research settings. Furthermore, they
present a useful framework which explicitly addresses advantages and
disadvantages linked to different feedback policies researchers could
pursue (Hallowell et al. 2014, table 1).
We agree with the authors that the feedback of findings from whole-
genome sequencing (WGS) o...
Hallowell et al. advocate an interesting pragmatic approach to the
disclosure of genetic information in research settings. Furthermore, they
present a useful framework which explicitly addresses advantages and
disadvantages linked to different feedback policies researchers could
pursue (Hallowell et al. 2014, table 1).
We agree with the authors that the feedback of findings from whole-
genome sequencing (WGS) or whole-exome sequencing (WES) technologies
cannot be considered as automated processes of data disclosure. Since we
have to take into account the research participant's autonomy as well as
the prevention of possible harms related to the disclosure of genetic
information, feedback policies have to be carefully chosen and thought
over.
In its evaluation of feedback policies, the authors state that no
feedback undermines participant autonomy (policy A) and choosing their
feedback option maximizes it (policy E) (Hallowell et al. 2014, table 1).
However, more freedom to choose feedback options is not necessarily
related to a more autonomous choice of the participant. It could be argued
against Hallowell et al. that if in the information platforms suggested by
Kaye et al. (2012) research participants were responsible to select on
their own what level of research participation they consent to and which
results they would access, this would not necessarily represent a more
autonomous decision. This one-dimensional view of autonomy undermines the
importance of intelligible communicative information transmission (Manson
and O'Neill 2007) an essential and ethically demanded dimension of
research participants' autonomous decision making (Eyal 2012).
As an alternative to Hallowell et al. interpretation of autonomy,
Manson and O'Neill (2007) suggest an agency-based approach that is based
on informational and communicative obligations between the parties of
counsellors and patients in a clinical context that could be extended to
the process of information disclosure in genetic research. Assuming that
the researcher's interest does not primarily focus on the information
submission to the participants but on the generation of scientific
knowledge, the agency-based approach between counsellor and participant
could provide a better framework for assuring intelligible communicative
information for the research participant. Autonomy should not refer only
to more options to choose from, but also to an enhanced comprehension of
information on possible harms and benefits of WGS/WES technologies.
Hallowell et al. state that feedback of genetic findings goes hand in
hand with extensive resources consumed due to the information costs
arising in the communication process. Nonetheless, it can be objected that
information costs should not exceed the normal information costs of a
clinical setting. E.g. after receiving the research results and
counselling the participant, the counsellor may initiate a personalized
genetic test in order to correctly approve the general finding in the
participant's personal context. Thus, the counsellor who stays in close
contact with the participant is responsible for the information disclosure
and information revealing is part of the counsellor-participant
relationship. The counsellor therefore can be considered as the link
between research (research results are usually published in journals or
data bases) and the participant.
Furthermore, it would be incorrect to consider researchers and
sponsors as the only responsible agents for the costs of informational and
communicative obligations. As it occurs with other ethical requirements in
research settings such as post-trial obligations of access to beneficial
information and interventions (WMA 2013 paragraphs 26 and 34, Mastroleo
2014), other agents -e.g. host country governments- have interests in and
bear responsibility for the participants' health needs. So, following
commonly held principles for conducting human health research, it could be
argued that in advance of a clinical trial, sponsors, researchers and
governments (among other agents) should make provisions and bear the
economic costs of continuous genetic counselling for participants who may
need it.
Finally, besides discussing obligations of researchers towards
participants and pointing out the numerous problems arising in this case
(information costs, data quality, communication restrictions etc.), we
should also focus on the communication process between counsellor and
research participant as well as the counsellor's obligations towards
potential participants prior to the participation in research projects. If
we are taking seriously ethical obligation of genetic information process
towards research participants, the consequences of data revealing should
be discussed before samples are collected. Moreover, data disclosure
should be a continuous process underlying the "nature" of genetic
information: research on genetic data is an ongoing process; ideally it
should be moderated by a counsellor to grant research participants truly
informed and autonomous decisions.
References
Eyal, N. (2012). "Informed Consent", The Stanford Encyclopedia of
Philosophy (Fall 2012 Edition), Edward N. Zalta (ed.),
http://plato.stanford.edu/entries/informed-consent/#VolCon
Hallowell, N., Hall, A., Alberg, C., Zimmern, R. (2014). "Revealing
the results of whole-genome sequencing and whole-exome sequencing in
research and clinical investigations: some ethical issues". JME; 0:1-5.
WMA Declaration of Helsinki (2013). "Ethical Principles for Medical
Research Involving Human Subjects.",
http://www.wma.net/en/30publications/10policies/b3/
Kaye, J., Curren, L., Anderson, N. (2012). From patients to partners:
participant-centric initiatives in biomedical research. Nat Rev Genet; 3:
371-6.
Manson, N., O'Neill, O. (2007). Rethinking informed consent in
bioethics. Cambridge University Press, New York.
Mastroleo, I. (2014). "Consideraciones sobre las obligaciones
posinvestigaci?n en la Declaraci?n de Helsinki 2013." Revista de bio?tica
y derecho; 31: 51-65,
http://revistes.ub.edu/index.php/RBD/article/view/10438
Acknowledgments
We would like to thank Prof. Mertelsmann for helpful comments on this
letter.
Contributors
Both authors were involved in the drafting and writing of this piece.
Both authors
approved the final version of the manuscript and are accountable for all
aspects included in it.
Greater transparency and regulatory oversight in disclosing gifts and payments to physicians from drug and medical device companies could well reduce their influence on a doctor's prescribing habits and medical management recommendations. The threat of a very public loss of professional reputation among peers and patients is likely to discourage a physician accepting drug and medical device company generosity. However, a m...
The argument for substantial benefit conferred by the placebo effect in treatment trials has been around for a while. Clinical triallists do not deny that inactive sugar pills and IV medications or sham surgery have some quantifiable benefit when compared with doing nothing at all. Patients who consent to participate in treatment studies tend to be more motivated and confident that they will get better than those who ref...
To the Editor:
A substantial proportion of medical research funding in advanced health economies are diverted to the overzealous policing of low risk observational studies.
As we plea and wait for the resumption of competitive funding to the research endeavour so necessary to maintaining Australia's global stature as a science and innovation based economy, the haemorrhage could be stemmed re- allocati...
A very difficult area indeed. My view is that that, once you have decided to stop fluids and/or nutrition, then the patient will certainly die. Whether or not they will suffer whilst starving, or dehydrating, is unclear. However, prolonging life in such cases extends suffering for relatives, staff, and possibly/probably the patient.
A lethal injection at this point is surely more humane than extending life and,...
Critics of a regulated market in organs have correctly focussed on its inability to protect the vendor from coercion and exploitation. However, they have consistently failed to realise that coercion and exploitation are not immanent in this market. Rather, they are immanent in the need to even consider selling ones organs (free people do not engage in such considerations). In other words, the critics have failed to ackno...
Dear Sir,
The article was well read and understood. I would like to draw the attention of readers to the current reality, of having grant winners who are not the authors even though their hypothesis and proposal writing has contributed significantly and scientifically towards achieving the grant/funds, followed by processing of the entire scientific/social projects based on the proposed hypothesis. Authorship i...
The term 'suicide tourism' was first coined by the media for obvious reasons. Is it necessary to use such a repugnant term though. When used to refer to a group collectively this insult can can be glossed over- in a way it could not without causing anger if referring to an individual who takes the harrowing decision to go abroad for an assisted death. To refer to the increased number of people 'from England' (presumably...
Formulating the desire to consent in advance to research as a critical interest is a valuable addition to the literature on consent to research by incapacitated individuals. As Dr. Buller notes, much attention has been paid to these concerns in the literature and many states have enacted statutes protecting human research subjects. States vary in how thoroughly they treat the topic, with some carefully defining who ma...
Sir,
I have no argument with Charles Foster's tortuously argued claim that suicide tourism has not led to a change in prosecutorial policy, although I am far more exercised by the potential for change in the latter influencing requirement for the former. Nor do I disagree with his admission that it is intellectually dishonest for us to allow Swiss clinics to siphon off our sufferings and responsibility, except t...
Hallowell et al. advocate an interesting pragmatic approach to the disclosure of genetic information in research settings. Furthermore, they present a useful framework which explicitly addresses advantages and disadvantages linked to different feedback policies researchers could pursue (Hallowell et al. 2014, table 1).
We agree with the authors that the feedback of findings from whole- genome sequencing (WGS) o...
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