Reinhard Merkel

Misuse Of The FDA’s Humanitarian Device Exemption In Deep Brain Stimulation For Obsessive-Compulsive Disorder

Deep brain stimulation-a novel surgical procedure-is emerging as a treatment of last resort for people diagnosed with neuropsychiatric disorders such as severe obsessive-compulsive disorder. The US Food and Drug Administration granted a so-called humanitarian device exemption to allow patients to access this intervention, thereby removing the requirement for a clinical trial of the appropriate size and statistical power. Bypassing the rigors of such trials puts patients at risk, limits opportunities for scientific discovery, and gives device manufacturers unique marketing opportunities. We argue that Congress and federal regulators should revisit the humanitarian device exemption to ensure that it is not used to sidestep careful research that can offer valuable data with appropriate patient safeguards.

Consensus on guidelines for stereotactic neurosurgery for psychiatric disorders

Background For patients with psychiatric illnesses remaining refractory to ‘standard’ therapies, neurosurgical procedures may be considered. Guidelines for safe and ethical conduct of such procedures have previously and independently been proposed by various local and regional expert groups. Methods To expand on these earlier documents, representative members of continental and international psychiatric and neurosurgical societies, joined efforts to further elaborate and adopt a pragmatic worldwide set of guidelines. These are intended to address a broad range of neuropsychiatric disorders, brain targets and neurosurgical techniques, taking into account cultural and social heterogeneities of healthcare environments. Findings The proposed consensus document highlights that, while stereotactic ablative procedures such as cingulotomy and capsulotomy for depression and obsessive-compulsive disorder are considered ‘established’ in some countries, they still lack level I evidence. Further, it is noted that deep brain stimulation in any brain target hitherto tried, and for any psychiatric or behavioural disorder, still remains at an investigational stage. Researchers are encouraged to design randomised controlled trials, based on scientific and data-driven rationales for disease and brain target selection. Experienced multidisciplinary teams are a mandatory requirement for the safe and ethical conduct of any psychiatric neurosurgery, ensuring documented refractoriness of patients, proper consent procedures that respect patients capacity and autonomy, multifaceted preoperative as well as postoperative long-term follow-up evaluation, and reporting of effects and side effects for all patients. Interpretation This consensus document on ethical and scientific conduct of psychiatric surgery worldwide is designed to enhance patient safety.

Autonomy and Authenticity of Enhanced Personality Traits

There is concern that the use of neuroenhancements to alter character traits undermines consumers authenticity. But the meaning, scope and value of authenticity remain vague. However, the majority of contemporary autonomy accounts ground individual autonomy on a notion of authenticity. So if neuroenhancements diminish an agents authenticity, they may undermine his autonomy. This paper clarifies the relation between autonomy, authenticity and possible threats by neuroenhancements. We present six neuroenhancement scenarios and analyse how autonomy accounts evaluate them. Some cases are considered differently by criminal courts; we demonstrate where academic autonomy theories and legal reasoning diverge and ascertain whether courts should reconsider their concept of autonomy. We argue that authenticity is not an appropriate condition for autonomy and that new enhancement technologies pose no unique threats to personal autonomy.

After Cologne: male circumcision and the law. Parental right, religious liberty or criminal assault?

Non-therapeutic circumcision violates boys’ right to bodily integrity as well as to self-determination. There is neither any verifiable medical advantage connected with the intervention nor is it painless nor without significant risks. Possible negative consequences for the psychosexual development of circumcised boys (due to substantial loss of highly erogenous tissue) have not yet been sufficiently explored, but appear to ensue in a significant number of cases. According to standard legal criteria, these considerations would normally entail that the operation be deemed an ‘impermissible risk’—neither justifiable on grounds of parental rights nor of religious liberty: as with any other freedom right, these end where another persons body begins. Nevertheless, after a resounding decision by a Cologne district court that non-therapeutic circumcision constitutes bodily assault, the German legislature responded by enacting a new statute expressly designed to permit male circumcision even outside of medical settings. We first criticise the normative foundations upon which such a legal concession seems to rest, and then analyse two major flaws in the new German law which we consider emblematic of the difficulty that any legal attempt to protect medically irrelevant genital cutting is bound to face.

Ethical guidance for the management of conflicts of interest for researchers, engineers and clinicians engaged in the development of therapeutic deep brain stimulation

The clinical promise of deep brain stimulation (DBS) for neuropsychiatric conditions is coupled with the potential for ethical conflicts of interest because the work is so heavily reliant upon collaborations between academia, industry and the clinic. To foster transparency and public trust, we offer ethical guidance for the management of conflicts of interest in the conduct of DBS research and practice so that this nascent field can better balance competing goods and engineer new and better strategies for the amelioration of human suffering. We also hope that our ethical analysis will be of relevance to those working with other related neuroprosthetic devices, such brain-computer interfaces and neural arrays, which naturally share many of the same concerns.

Zur Frage der Verbindlichkeit von Patientenverfgungen Eine notwendige Ergnzung der bisher in Deutschland gelufigen Argumente

Zu den meistumstrittenen Problemen sog.Patientenverfgungen (PV) gehrt die Fragenach ihrer rechtlichen Bindungswirkung frden behandelnden Arzt bzw. einen gesetzli-chen oder gewillkrten Vertreter des nichtmehr einwilligungsfhigen Patienten. Vondieser Frage der Verbindlichkeit einer PVsind andere umstrittene Probleme zu un-terscheiden, vor allem die folgenden: erstensdas ihrer Wirksamkeit als Willenserklrung,insbesondere Fragen der Verfgungs- (nm-lich Einwilligungs-)Fhigkeit ihres Verfas-sers, seiner mglicherweise gebotenen rzt-lichen Aufklrung vor Abfassung der PVsowie deren Freiheit von Willensmngeln(Irrtum, Tuschung, Ntigung); zweitensdas ihrer sachlichen Reichweite, vor allemdie Frage, ob die PV in der abstrakten Be-schreibung ihrer Anwendungsbedingungendie jeweils konkrete Situation des Patiententatschlich erfasst, ob also diese unter jeneeindeutig subsumierbar ist; und schlieslich,drittens, das ihrer zeitlichen Reichweite (diefreilich zugleich auch eine sachliche ist),nmlich die Frage, ob die Geltung jedenfallssolcher PVen, die eine lebenserhaltende Be-handlung untersagen, auf Situationen derzeitlichen Nhe zum Tod beschrnkt werdendarf oder sogar sollte.Diese Fragen werden mit der nach derVerbindlichkeit einer PV nicht selten ver-mischt. Der Transparenz des Gesamtpro-blems ist das wenig dienlich. Im Folgendensollen sie nicht weiter behandelt werden.Vielmehr setze ich die Situation einer ein-deutig wirksamen, nach rztlicher Aufkl-rung verfassten, in ihren Anwendungsbe-dingungen die aktuelle Lage des entschei-dungsunfhigen Patienten erfassenden undauf Behandlungsverweigerung gerichtetenPV voraus. Ebenfalls vorausgesetzt und (et-was apodiktisch) behauptet wird die Unzu-lssigkeit einer Wirksamkeitsbeschrnkungauf die Zeit der Todesnhe des Verfassersder PV.

Killing or letting die? Proposal of a (somewhat) new answer to a perennial question.

There is as yet no widely agreed-upon solution to the standard textbook problem whether actively shutting off a life-sustaining medical device, e.g. a respirator, and thus bringing about a patients death amounts to active killing or just to an omission of further treatment. Apart from a range of astutely contrived case examples and respective particular solutions proposed in the literature, there seems to be no consensus on the normative principles such solutions should be grounded in, not even on the need for such principles beyond sheer intuition. The present paper attempts to develop a normative approach based on fundamental principles of law. From this perspective, what is decisive for the question of ‘killing or letting die’ in such cases is not that death ensues from a behaviour that is active and relevantly causative, but rather, whether or not the agent in performing the deadly act transgresses the boundaries of the domain of his or her sole normative authority, and thereby intervenes in the protected sphere of another. Unless he or she does so, their behaviour cannot be classified as active commission regardless of the amount of causal activity it may display and regardless of its potentially harmful consequences. This conception is spelled out in detail and tested in a range of case examples, as are several of its corollaries that deviate from standard type solutions.