It is generally agreed in most jurisdictions that all competent patients must be fully informed about any proposed treatment, including medications, and have the absolute right to either consent to or refuse treatment. This introduces the dread word “competent” that is often mistakenly taken as being required as a demonstration of insight. It is also often assumed that a person suffering a condition such as schizophrenia is incapable of insight. The Supreme Court of Canada, in 2003, in Starson v. Swayze laid this one to rest. The appellant knew that he had schizophrenia, its nature and effects, and was appealing a decision of a lower court that he should be forcibly given antipsychotic medication on a continuing basis. He argued that he had the right to decide for himself when he should take the medication and when he could avoid it so that he could work without the thought-numbing effect of the drug. His profession required clear thinking.
The court found for him, noting that he knew the nature of his condition and was capable i.e. competent to make these decisions for himself. He had, in other words, insight.
Nathan Hodson is quite correct in his conclusions that the rulings in the awful situation of Dr Hadiza Bawa-Garba are not good news for doctors, but I am not convinced that the analysis starts in the right place. Most of the focus in the article (and almost everywhere else) is on what the GMC has done following the decision of the MPTS not to strike Dr B-G off the register, and, in general, the opinion is that the body shoud not have done what it did. In my opinion, this is the wrong place to start - questions should be asked about how a relatively routine error led to a conviction at all.
As a lecturer in medical law and ethics, I find it strange in the extreme that a) the police felt that they should forward this to the Crown Prosecution Service (CPS) for prosecution, b) that the CPS went forward with the prosecution, and c) that the jury found Dr B-G guilty given the evidence available. Whilst the final part will remain a complete mystery because the law requires that what happens in the jury room must not be divulged, there is need to examine the decisions that led from a tragic but not remarkable incident in a hospital to a cause-celebre which has ruptured both public and professional trust in the GMC, and the law of gross negligence manslaughter. At the very least, there should be an appeal heard into Dr Bawa-Garba's convictions, but really there needs to a full and frank investigation into how this case ever got through the courtroom door. There was no...
As a lecturer in medical law and ethics, I find it strange in the extreme that a) the police felt that they should forward this to the Crown Prosecution Service (CPS) for prosecution, b) that the CPS went forward with the prosecution, and c) that the jury found Dr B-G guilty given the evidence available. Whilst the final part will remain a complete mystery because the law requires that what happens in the jury room must not be divulged, there is need to examine the decisions that led from a tragic but not remarkable incident in a hospital to a cause-celebre which has ruptured both public and professional trust in the GMC, and the law of gross negligence manslaughter. At the very least, there should be an appeal heard into Dr Bawa-Garba's convictions, but really there needs to a full and frank investigation into how this case ever got through the courtroom door. There was nothing about her conduct that was " ... so bad in all the circumstances as to amount ... to a criminal act or omission" (R v Adomako,  3 WLR 288, per Lord Mackay), which suggests that the chances of a successful prosecution were very small, and so should not have been actively prosecuted. To put it baldly, something smells very unpleasant regarding the whole prosecution.
Given the reality that Dr Bawa-Garba is a doctor convicted of manslaughter, and the MPTS found good reasons not to strike her off the GMC register, the GMC did not have any option but to use the powers it has to question the decision. The GMC's mandate includes "where necessary, tak[ing] action to prevent a doctor from putting the safety of patients, or the public's confidence in doctors, at risk." (https://www.gmc-uk.org/about/what-we-do-and-why/our-mandate). In principle, having a doctor convicted of manslaughter remain on the register would undermine confidence in doctors. The GMC is generally widely regarded by the public as being over-protective of doctors at the expense of others - see, for example, the criticism of the GMC when no doctors were disciplined following the Mid-Staffordshire enquiry. Regardless of whether the GMC agreed with the MPTS decision, they had no option but to appeal. However, it could not have anticipated the huge public interest, and unexpected vitriol levelled at the body, for following its mandate.
On a slightly different note, that the Court of Appeal came to a completely different decision than the High Court in this case, and also in the less-reported case of Raychaudhuri v General Medical Council  EWCA Civ 2027, suggests that there is a problem in the law that needs clarifying. Whilst it is no doubt a relief to the doctors involved that their cases ended there, we need a case to go to the Supreme Court for clarity in this area.
What a self centered world we have become, it is a shame that you cannot see the most basic principals of human life for what they really are. This is beyond the argument of abortion, this is murder. To engage in a sexual act is to take the risk of creating a child, a human, and in every sense of the word, that being is a person. Such a decision is yours to make, but should you procure a child, intended or not, wanted or unwanted, burden or no, that child is placed in your care. You can choose to give that child to another through adoption if you truly are unable, but to resort to such measures to save yourself a little possible remorse is just disgusting. Imagine the remorse knowing that you took your child, whom you will inevitably think of years down the road as the article speculates, and did not even give them the chance for life, instead, you killed them. An irreversible decision that was never yours to make. Life is precious, yet so often in this world where we in the name of "betterment of society" we choose to take advantage of the most innocent of children, and place their needs far below our wants. It is sick and shameful. Each person is of value, it is not something a parent or any other can choose to give or take away, it is inherent and a basic human right. As is life. We can make excuses to justify any action if we are twisted enough, but such things always have been and always will be wrong.
In the footnote to his article Dr Finegan makes reference to the debate in Ireland over conscientious objection in the context of any legislation tabled pursuant to the abortion referendum in 2018. Dr Finegan intended his counter-arguments to apply to GPs and other healthcare professionals who he rightly states are significantly part of a public health service.
As an Irish pharmacist I wish to draw attention to the lack of provision for conscientious objection for pharmacists in the final Health (Termination of Pregnancy) Bill 2018. In Ireland only doctors and nurses have the protection of their right to conscientious objection in the legislation. Pharmacists and other healthcare professionals are excluded.
My human right to freedom of conscience, religion and belief is not provided for or protected in the Health (Regulation of Termination of Pregnancy) Bill 2018. Conscientious objection is a right derived from the right to freedom of conscience, religion and belief.
There was no pre-legislative scrutiny of this Bill and the human rights implications for pharmacists and other healthcare professionals do not appear to have been considered.
Conscientious objection is not provided explicitly in the Pharmaceutical Society of Ireland (PSI) , Code of Conduct for Pharmacists (2009). There is no mention of freedom of conscience, religion and belief and/or conscientious objection. There was no explicit mention of freedom of conscience, religi...
Conscientious objection is not provided explicitly in the Pharmaceutical Society of Ireland (PSI) , Code of Conduct for Pharmacists (2009). There is no mention of freedom of conscience, religion and belief and/or conscientious objection. There was no explicit mention of freedom of conscience, religion and belief and/or conscientious objection in the draft Code of Conduct issued for public consultation by the PSI in July 2018.
The Irish Human Rights and Equality Commission (IHREC) published a commentary on the draft legislation https://www.ihrec.ie/app/uploads/2018/09/Observations-on-General-Scheme-... .
The IHREC recommended that the conscientious objection provisions be made to apply more broadly than currently ,to provide for the possibility of conscientious objection by the broader range of health and social care professionals with whom a pregnant woman or girl may come into contact. This recommendation is IHREC No. 20.
Irish pharmacists have the same human rights as Irish doctors and nurses. However Irish pharmacists are not mentioned in the conscientious objection section of the Bill. Irish pharmacy students will not be protected in the same way as Irish medical students/trainees and nursing students.
This unequal treatment is a very grave matter for many Irish pharmacists.
Pharmacists and other healthcare professionals are now ‘less equal’ than doctors and nurses.
Dear Sir or Madam,
Euthanasia? All life is terminal!
Regarding this controversial topic you may be interested in my, Australian, views on the matter:-
While I appreciate that the Hippocratic Oath in effect stipulates physicians should “do no harm”, this is not the end of the matter.
To only allow (or disallow) a “terminally” ill person to decide when they wish to end their life is looking at this problem from the wrong end. It is not if they are ill, terminally or otherwise, but a person’s quality of life – their perception of that quality, which should be the main issue.
Recall and understand that all life, repeat ALL life, is terminal – we cannot escape the end. It is terminal! Sooner or later we all die – ill or not. Palliative care, however well administered, will not halt this process. Furthermore it is impossible to accurately determine the exact time or date in the future as to when a person may die. So to stipulate a time or date (in Australia six months is suggested), sometime in the future which may determine whether or not a person is “allowed to die” is regrettable, to say the least.
Why should anyone have to “live” according to another person’s expectations? We have no “right” to interfere. It is not our life; it is not our choice.
We, and by “we” I include all humans, were presumably born to live in the world. Now if a human being decides, for whatever reason, that the life he or she is currently experiencing...
We, and by “we” I include all humans, were presumably born to live in the world. Now if a human being decides, for whatever reason, that the life he or she is currently experiencing in the world is not a “quality life”, who is to say they are wrong? We, you or I, cannot experience that person’s view with all the emotional, stressful or painful events they may have suffered or endured during their life to date. How can anyone, other than the person concerned, determine what level of “quality” is acceptable or unacceptable?
We can have no idea how this expression of life plays out; or how life events affect a person’s outlook, towards themselves or others – no one can “know” this except the person concerned. They make a choice based on such experience – good, bad or indifferent - it their decision. You or I are in no position to say they are wrong.
What evidence, what insight do we have such that anyone can proclaim that a particular person’s view or expression of life is wrong and that we (or at least the “experts”) alone know better? We may not like or approve of their view but - so what!
Furthermore, what evidence is there for the “experts” to state that those who wish to end their life may be suffering from a “mental disorder” (hence the requirement – in those Australian States that have passed or are considering passing legislation allowing Euthanasia - for a psychiatric assessment on any person wishing to end their life). Disordered from what? From “normal”? As far as I can discover there is no accepted definition of “normal”. Possibly those considered “mentally disordered” react to life’s trials and tribulations differently from those around them – God knows there are enough “odd-ball” people in the community! Are they “wrong”? Or are those who condemn euthanasia just being intolerant and lacking in understanding or compassion?
Consider what (in Australia) may have a bearing on a person’s perception of a “quality” life; a lack of adequate employment; the current gross inequality in income; inadequate provision of low cost accommodation leading to homelessness; inequality in access to adequate medical intervention; inequality in access to adequate levels of education; widespread condemnation of various religious beliefs and practices (in Australia, principally those that are non-Christian); widespread racism; abuse (abuse in any form – emotional, financial, physical or sexual) and bullying, particularly the use of social media to attack the vulnerable.
Then there is widespread over prescribing of antidepressant and antipsychotic medications (remember that, allegedly, one in five -1 in 5 – will, allegedly, suffer from a “mental illness” in their lifetime). There are many reasons why all concerned should be critical about psycho-pharmaceutical drug treatment, such as uncertain causes, the problematic accuracy of the few diagnostic tests available, commercial conflict of interest, poor understanding regarding the mechanism of drug action and their many side-effects together with the related problem of publication bias [Note: The reanalysis of the – originally ghost written - GlaxoSmithKline Study 329 relating to their antidepressant drug formulation paroxetine, Paxil, (also known as Serotax or Aropax) provides an illuminating, if unfortunate, example of these issues].
And then there is extreme pain. Anything that results in an actual or perceived loss of personal control will (possibly) bring about a loss of dignity and of “hope” - those most subjective attitudes of mind.
Furthermore for some to say that only God can decide when or where any person dies is surely a gross over assumption – how do they know? What special insight do they possess? Is it not possible, because (I assume) God gave us free will that God may have already decided to allow a person who wants to die, to die?
Then what about those who say that the legalization of euthanasia would see the end of compassion? Surely it would be more compassionate to allow someone who wishes to end their life to do so in a private setting of their choice, with (possibly) family and friends in attendance?
Far rather this than, to get their way, forcing a person to take extreme actions – drinking or drugging themselves to death; jumping off a high rise building or cliff; driving at high speed into the support column of a freeway overpass or into a tree on a country road; consume rat poison or drink some corrosive liquid (such as ammonia) and take four days, in agony, to die.
Recall also that the British philosopher David Hume (1711 –1776) said, “I believe that no man ever threw away Life while it was worth keeping.”
Finally I will repeat a quote, from the Indian sage Jiddu Krishnamurti (1895-1986), who said, “It is no measure of health to be well adjusted to a profoundly sick society”.
There we have it – in a nutshell!
What follows below is a “Black Box” warning, relating to anti-depressant medications:-
US Federal Drug Administration Product Information Warning:
Patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Although there has been a long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients, a causal role for antidepressants in inducing such behaviors has not been established. Nevertheless, patients being treated with antidepressants should be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or decreases.
Read into this what you will (particularly with reference to the re-analysis of Paxil – above).
I will be very interested in any response you may offer.
87/2462 Albany Hwy
Western Australia 6110
Phone: +61 413582949
PS. I am a 78 year old retiree who has never had any contact with any euthanasia group. Also for your information, I am twice a widower – my first wife committed suicide and died in agony and the second, after 36 years of a loving relationship, suffered a severe illness and whilst in palliative care was given, at my suggestion – and without any questions being asked – higher and higher doses of morphine (via a syringe driver) until she died.
The family was in attendance at her death, which was quiet, dignified and peaceful.
By Christian Fiala and Joyce H Arthur
Authors Montero and Villarroel discuss problems that might arise from “conscientious objection” (CO) to the new law in Chile that legalized abortion in cases of life endangerment of the woman, fatal fetal abnormality, and rape. (“A critical review of conscientious objection and decriminalisation of abortion in Chile”, Jan 6). The law provides the “right” to exercise CO, with the only caveat that health institutions are required to immediately refer patients to non-objecting practitioners. We share the authors’ concerns that conscientious objection may prove be quite widespread in Chile with the new law. In fact, we argue it will create serious, widespread problems for access to safe and legal abortion, despite the referral requirement.
Of course, in a Catholic-dominated country like Chile with a total abortion ban, the new law represents a major advance, and it will undoubtedly help many women. We appreciate the challenges and hard work to get the law passed and acknowledge it may have been difficult to do so without CO as a political compromise. Unfortunately, last-minute lobbying by Catholic hospitals resulted in a court’s expansion of the CO clause in the law, giving the “right” of CO to not just doctors, but also support workers and even institutions (when only individuals can have a conscience). This law will be very difficult to reverse and women will suffer the consequences.
The authors rightly recogniz...
The authors rightly recognize the difference between conscientious objection in health care, and civil disobedience. Yes, Chilean health care professionals who object to abortion and the new abortion law have been using the conscientious objection debate as a political weapon to undermine and repeal the new democratically-decided law. They are being disobedient, not conscientious, because they are prioritizing their personal religious beliefs over women’s right to heath and life. CO is “dishonourable disobedience.” In contrast, other doctors exercise a conscientious commitment to their patients’ well-being and safety by providing abortion when necessary, especially in a stigmatized or legally restricted environment such as Chile.
However, the authors assert without any justification that if CO involves acting according to conscience, then both CO and conscientious commitment “merit identical regard” and one does not prevail over the other. We strongly disagree. CO in reproductive health care is a misnomer because it is not “conscientious” – it is the unethical abuse and abandonment of medical ethics and the duty of care, while conscientious commitment fully respects medical ethics and patients’ right to health care. CO exploits an imbalance of power between doctor and patient, with doctors enjoying a chosen and privileged position of trust and a state monopoly over health care, while vulnerable patients bear the full burden of CO. This is the opposite of CO in the military, where ordinary citizens are drafted into service against their will and must accept punishment or alternate service if they object.
The authors assume that CO in health care is a right, albeit one that must be limited. However, evidence-based arguments indicate that CO in health care is inappropriate and should be prohibited, in the same way as for refusals based on discriminatory racist or sexist beliefs. Currently, Sweden, Finland, and Iceland do not allow a refusal to treat in reproductive health care, and all countries should follow their example if they take evidence-based medicine and women’s human rights seriously.
It may be difficult to overcome the entrenched tradition of accepting CO, especially in Catholic-dominated countries like Chile, but the answer is not to accommodate CO as a right and regulate it – instead, it should be denounced as a violation of patient rights, with steps taken to reduce it as far as possible until it can be effectively abolished.
Some writers distinguish between what might be called ‘genuine CO’ and ‘obstructionist CO’ – but this distinction is impossible to make in an objective way. In fact, the very nature of CO is to be obstructionist because most of those who invoke it want to stop women from having abortions. As we have concluded elsewhere:
“Personal conscientious objection to a treatment that a patient requests has no valid place in health care. Treatment decisions by HCPs [health care professionals] must be patient-directed, not self-directed, and must be based on evidence, medical ethics, and professional obligations. If the treatment is legal, within the HCP’s qualifications, requested by a mentally healthy patient, and primarily beneficial (which abortion is), there is simply no excuse to refuse.”
Montero and Villarroel recommend that the Chilean government regulate CO to prevent “misuse.” But they offer no recommendations for how to do this. As they acknowledge, a significant number of hospitals and doctors will never obey any law allowing abortion, so we can safely assume that these objectors will never obey any regulations on CO either. It is naïve to call for CO regulation when existing CO regulations around the world are widely ignored and enforcement is almost non-existent. In particular, it is well known that many anti-abortion doctors will refuse to make referrals because they feel this makes them “complicit”. They are rarely if ever held to account for such refusals.
If CO regulations sometimes appear to “work”, it is only in a handful of countries that impose strict limits on it, including Norway, England, and Portugal. But Norway and England both have very low levels of objectors anyway, plus England side-steps the CO problem by shifting most abortion care to private clinics. As for Portugal, no rigorous data exist on the prevalence of objection, few objectors are aware of their legal reporting duties under the law, and it is unknown if hospitals and objectors are obeying the law or what actually happens to women.
The authors point out that the Chilean health care system is beset by major shortcomings, with the public sector experiencing “runaway demand, inadequate outpatient services, and a shortage of facilities and hospital beds.” In such an environment, converting the 100,000 estimated illegal abortions a year into safe, legal procedures will undoubtedly strain resources and run up against significant abortion stigma and widespread denial of services.
Historical experience and evidence from other countries, especially Catholic countries like Italy, shows that allowing CO will seriously undermine Chile’s new abortion law and prevent Chilean women from accessing the service. Because that is the political intent of CO. It is a religiously-motivated boycott of a democratically-decided law. It is a refusal to treat based on personal beliefs, something that should not be allowed in any area of medicine – the fundamental purpose of which is to provide care, not refuse it. Chile will not succeed in regulating CO for the simple reason that you cannot “regulate” the exercise of religious beliefs with rational arguments. Similarly, it is impossible to avoid the “misuse” of CO, as CO is a misuse in itself.
Instead, governments should implement strong educational, enforcement, and disciplinary measures against the exercise of CO. Otherwise, not much will change. If the regulation of CO is to work, it must have as its goal the eventual elimination of CO. Some examples of measures that would reduce and eliminate the exercise of CO include:
• Require all public hospitals to provide abortions (as in Portugal, Norway, and France).
• Inform medical students applying to the Obstetrics/Gynecology specialty that abortion is a mandatory part of the curriculum and an expected part of their practice.
• Provide compulsory training in medical schools in abortion techniques for all Ob/Gyn students, and in contraception provision for all family medicine students.
• Include the requirement to participate in abortion in job descriptions at the point of hiring.
• Require existing objectors to take continuing education courses or values clarification workshops on the need for reproductive health care services, why women request abortions, the negative effects of CO on patients, and their fiduciary duty to patients. Also, expose them to patients needing abortion.
• Assist remaining objectors to move to other disciplines or areas where their objection won’t be a problem.
• Impose disincentives against any remaining objectors, such as: require them to register and file reports for each refusal, monitor and discipline them, hold objectors financially liable for harms done to patients, prohibit existing objectors from working alone, allow employers to prioritize hiring of non-objecting physicians, and pay objecting physicians less.
The point is that CO regulations should be designed to actively discourage and eliminate CO, with the understanding that CO is unethical and inappropriate in health care. Any law or policy that implies or recognizes a right to CO, while assuming that objectors will follow any prescribed limits without oversight, is bound to fail and will hurt women. We hope that steps can be taken in Chile to minimize these inevitable harms to women’s health and violations of their rights – such as encouraging pro-choice doctors to make a conscientious commitment to provide life-saving abortion care to women.
 Fiala C, Arthur JH. Victims of CO. 2017. http://www.conscientious-objection.info/category/victims-of-co/
 Fiala C, Arthur JH. ‘Dishonourable Disobedience’: Why Refusal to Treat in Reproductive Healthcare Is Not Conscientious Objection. Woman – Psychosomatic Gynaecology and Obstetrics 2014; 1:12-23 http://www.sciencedirect.com/science/article/pii/S2213560X14000034
 Fiala C, Gemzell Danielsson K, Heikinheimo O, Guðmundsson JA, and Arthur J. Yes We Can! Successful Examples of Disallowing ‘Conscientious Objection’ in Reproductive Healthcare. European Journal of Contraception and Reproductive Healthcare. 2016 pp 201-206. http://www.conscientious-objection.info/wp-content/uploads/2016/10/Yes-w...
 Fiala C, Arthur JH. There is no defence for ‘Conscientious objection’ in reproductive healthcare. European Journal of Obstetrics & Gynecology and Reproductive Biology. 2017; 216:254-258 http://www.sciencedirect.com/science/article/pii/S0301211517303573
 Loriggio P. Ontario doctors who object to treatment on moral or religious grounds must give referral: court. Canadian Press. Jan 31, 2018. https://www.thestar.com/news/canada/2018/01/31/ontario-doctors-who-objec...
 Fiala C, Arthur JH. Letter to the Editor: Refusal to Treat Patients Does Not Work in Any Country—Even If Misleadingly Labelled “Conscientious Objection”. Sep 6, 2017. Health and Human Rights Journal. https://www.hhrjournal.org/2017/09/letter-to-the-editor-refusal-to-treat...
 Chavkin W, Swerdlow L, Fifield J. Regulation of Conscientious Objection to Abortion: An International Comparative Multiple-Case Study. Health and Human Rights Journal. 2017 Jun;19(1):55-68. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5473038/
 Minerva F. Conscientious objection in Italy. J Med Ethics. 2015 Feb;41(2):170-3. https://www.ncbi.nlm.nih.gov/pubmed/24861043
Before any question about the existence, during the existence, one must ask what is the use of existing, because if it is useless, the debate on the existence itself is only a moral judgment invented by us humans. But I do not see how life will have served me when I was in the grave or reduced to ashes. If I am told that I have served someone else, I say what is the value of existing for the person I served? Have I been made as a therapy for this person? As for society that has a life span just a little longer than mine, I do not see the value of its existence either, since society is not a conscious entity and will end just as my existence will end without interest for me. So if I serve society, have I been made to be a social slave? Once this paradox of existence is solved, what are all the philosophies about existence itself? This is for me only a useless debate, an absurd gloss. And now a question: why do not men prevent women from taking the mortal risk of having a child, since this is indeed a deadly risk? For the sake of this woman, should not a man do everything to prevent him from committing suicide, because the conception is the equivalent of a Russian roulette suicide?
The depth of ethical analysis in this article is stupefyingly superficial, ill informed and immature. The author's "critical reflection"comprises some half guesses and frankly irrelevant conjecture about what the deceased's intentions were before his untimely death. The author apparently can't see any good reasons for a child to have a two parents, despite this being a foundation of western civilisation, recognised as beneficial in the literature, and given effect in our laws. The author sees nothing odd in a woman wanting to have a baby with a dead man. Where do the universities find these people.
Innovation is derived from the Latin innovatus which means “to renew or change”. In the broadest sense of the term, it can be viewed as the stimulus that modifies existing processes. Further, innovation has been one of the driving forces in the evolution of society through various revolutionary periods. This concept incorporates connotations of invention and creativity as impulses in themselves, however has recently been applied to commercialised settings. Hence, despite scientific interests, civic duties and altruism providing motivation for innovation, the strongest motive in recent times seems to be with a view to increasing profit. From a bottom-up level, inexperienced and junior innovators with the former inclinations could be met with resistance from the complexity of deriving economic viability. Furthermore, a central component to successful innovation involves promoting a culture to challenge outdated norms and the status quo. Change cannot occur if it is believed that present methods are infallible, as this removes the impetus for a goal-driven action. Consequently, many ideas may not reach fruition. However, within the medical field, it is wise that innovation occurs with incremental and calculated adjustments by enlarge, rather than with abrupt renovations. Wherever innovation leads to novel technology, the ultimate outcome of such is unforeseeable. The collingridge dilemma highlights an important notion that in early stages a new technology is still open to soc...
Innovation is derived from the Latin innovatus which means “to renew or change”. In the broadest sense of the term, it can be viewed as the stimulus that modifies existing processes. Further, innovation has been one of the driving forces in the evolution of society through various revolutionary periods. This concept incorporates connotations of invention and creativity as impulses in themselves, however has recently been applied to commercialised settings. Hence, despite scientific interests, civic duties and altruism providing motivation for innovation, the strongest motive in recent times seems to be with a view to increasing profit. From a bottom-up level, inexperienced and junior innovators with the former inclinations could be met with resistance from the complexity of deriving economic viability. Furthermore, a central component to successful innovation involves promoting a culture to challenge outdated norms and the status quo. Change cannot occur if it is believed that present methods are infallible, as this removes the impetus for a goal-driven action. Consequently, many ideas may not reach fruition. However, within the medical field, it is wise that innovation occurs with incremental and calculated adjustments by enlarge, rather than with abrupt renovations. Wherever innovation leads to novel technology, the ultimate outcome of such is unforeseeable. The collingridge dilemma highlights an important notion that in early stages a new technology is still open to social manipulation and as this malleability is lessened over time the potential for change is reduced.
The NHS system delivers care based on bioethical principles with emphasis on justice- that is, healthcare is widely accessible and free to all members of society, without discrimination on the grounds of socio-economic status, age and ethnicity. An evidence-based approach to treatment was exemplified with the inception of NICE in 2005. The use of scientific, robust research undoubtedly aids in the service of healthcare and ensures harm is reduced to a minimum. NICE publish updates and review their recommendations to reach this end, and in this way it is a protagonist in medical innovation. However, as the subject of healthcare is the human body, the complexities of such make it difficult to be certain of therapeutic successes being attributed to medical care alone. Other factors such as spontaneous remission, placebo and fundamental attribution error may skew our judgements of efficacy. In this way it is pertinent that we challenge customary management protocols wherever treatment failure occurs. Medical innovation, then, is essential to improve patient care.
However, speculation that financial motivations appear to provide the incentive for developing new therapies has naturally arisen. Authors have suggested this may manifest as delaying research results while researchers ascertain patents; leading to a culture of data distortion and neglect of the primary bioethical principles . As the financial market provides the driving force for medical innovation to reach a profit goal, it follows that limiting product development through sanctioning of financial resources necessarily can limit innovation potential. Is it not then possible to foresee how this can be detrimental to patient care? Provided that political and social commitments i.e. moral, may impact the significance of medical research and its goals, innovation is an ideal. The competitive stimulus to acquire financial gains may drive innovation in other settings as well as medicine. This provides enough force for most individuals irrespective of personal concern for duty.
For medical professionals including medical students, the aim is for the improvement and promotion of care. Beginning with fundamentals; the adage “Primum non nocere”, is known to most students from the onset of medical studies. Medical students devote considerable time to through studying the principles of medical science, that it is often easy to forget the reason and aim of their work. With respect to bioethical principles, medical students ought to be encouraged to further medical progress but with an awareness that their actions are primarily for the benefit of patients. To improve the status quo, it is necessary to promote and implement a change in attitudes predominating medical schools. Naturally, when one devotes time, resources and efforts to achieve an aim, one would like compensation for these efforts. Despite the instrumental improvements that financial incentives influence with positive change, it is necessary that one remains conscious of the holistic approach to the patient.
 Blumenthal D, Causino N, Campbell E, Louis K. Relationships between Academic Institutions and Industry in the Life Sciences — An Industry Survey. New England Journal of Medicine. 1996;334(6):368-374.
Paul et al. (2018) “Implementing post-trial access plans for HIV prevention research” present a much-needed discussion on the implementation of post-trial access plans. Here, I just want to signal a mistake on the conceptual definition of access, to an otherwise flawless paper.
If I am correct, the mistake would be related to the formulation of the following question:
"it the responsibility of researchers and sponsors only to ensure that all participants have access to effective preventive therapies, or does that responsibility extend further, to ensuring that participants actually receive them?" (Paul et al 2018:4)
I believe that "to ensure that participants have access to an intervention" is logically equivalent to "ensuring that participants actually receive an intervention". The MRCT Center's framework on post-trial responsibility defines access as “[…] the ability, right or permission of an individual to use an object or asset, and implies the removal of barriers to allow such use” (MRCT Center 2017:76). If a person does not actually receive an effective preventive therapy, she does not have the ability to use it. Therefor she has no access. Hence, distinguishing between the above expressions is conceptual mistake.
Instead, what I believe that the authors wanted to discuss is how much sponsors and researchers need to do to ensure access to an investigational intervention. In fact, irrespective of the abo...
Instead, what I believe that the authors wanted to discuss is how much sponsors and researchers need to do to ensure access to an investigational intervention. In fact, irrespective of the above formulation of the question, the author’s discussion of this question is about whether "referring participants" to local healthcare is enough to fulfil sponsors and post-trial access obligations or not, especially when "referral alone" is shown not be sufficient in some circumstances described in the paper to guarantee responsible transition to appropriate healthcare. However, “referral alone” is not equivalent to access but just a “post-trial access mechanism” (MRCT Center 2017:78).
Hence, I believe that the authors should reformulate the above question that may induce some conceptual confusion. Inspired by a question at the end of the paper, I suggest the following reformulation:
Is referral [alone] sufficient to fulfil [sponsors and] researchers’ [part of post-trial access] obligations [in all cases], or ought they to go further [sometimes?] [...] (Paul et al 2018:5, edited by Mastroleo)
Finally, what I believe that can be of help clarifying this conceptual mistake is to clearly distinguish between different questions, that is, (1) what would be the obligations entailed by post-trial access responsibility in a particular trial, including post-trial access, if any (Cho et al 2018); (2) what is the appropriate distribution of that responsibility between different responsible agents in a particular situation, and finally (3) what are the appropriate post-trial mechanisms that each agent has to fulfil to comply collectively with their part of the responsibility to (referral alone, improved referral, etc.).
Cho, H. L., Danis, M., & Grady, C. (2018). Post-trial responsibilities beyond post-trial access. The Lancet, 391(10129), 1478-1479. https://doi.org/10.1016/S0140-6736(18)30761-X
Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center). (2017). MRCT Center Post-Trial Responsibilities Framework Continued Access to Investigational Medicines I. Guidance Document [Version 1.2, November 2017]. MRCT Center. Retrieved from http://mrctcenter.org/wp-content/uploads/2017/12/2017-12-07-Post-Trial-R...
Paul, A., Merritt, M. W., & Sugarman, J. (2018). Implementing post-trial access plans for HIV prevention research. Journal of Medical Ethics, medethics-2017-104637. https://doi.org/10.1136/medethics-2017-104637