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The Society for Medicine and Law in Israel Volume No. 40 - June 2009 www.i s m a l . c o . i l English Abstracts To Raise a Healthy Generation in Our Homeland: 60 Years of Public Health Policy in Israel Shifra Shvarts* Abstract Public health policy in Israel was formulated in the 1950s by Dr. Yosef Meir and Dr. Chaim Sheba, the director-generals of the Ministry of Health in the years 1948-1953. They were assisted by international health and welfare organizations such as UNICEF and WHO. This great effort was necessary to adequately address the serious health issues during the mass immigration to Israel which followed the formation of the State of Israel. The achievements were impressive - infectious diseases, rather common among the immigrants, were eradicated were eradicated, and at the same time the state of the health of Israel’s inhabitants has also improved. A remarkable reduction in maternal and infants' mortality was recorded. There was a significant improvement in the life expectancy of the general population. Public health services – based primarily on health education, vaccination and inoculation health practices, through 'mother and child' clinics and health services within the school system, together with special campaigns such as 'the war to eradicate polio and tuberculosis' – proved to be appropriate and sufficiently flexible to be responsive to demographic changes which took place in Israel’s population. The policies proved suitable for dealing with the health needs of the population in Israel under the conditions at those times. This work describes the first steps in formulation of public health policy, while addressing core aspects of this service such as the vaccination policy, epidemics and quarantine, establishment of health services, medical examination of new immigrants, who came to the country under the Law of Return, while comparing public health indexes at the time and at present. * Associate Professor, The Moshe Prywes Center for Medical Education, Ben Gurion University of the Negev and The Gertner Institute for Epidemiology and Medical Policy Research. Key words: public health, Tipat Chalav, UNICEF, World health organization, Law of Return, immigration. 2009 יוני- 40 'גיליון מס רפואה ומשפט ׀iii English Abstracts Information Concerning the Right to Complain: Another Stage on the Way to Patient Empowerment Sharon Bassan* Abstract The revolutionary availability of information has brought about patients' empowerment and increased their autonomy concerning medical treatment. Such empowerment is depends on availability of information intended to assist the patient in the implementation of his healthrekated rights. Studies in Israel and other countries demonstrate the difficulties of supplying sufficient information, in spite of physicians' duties to do so. The Israeli National Health Insurance Act was recently amended in a way which compels the HMO's to distribute information concerning their respective Ombudsmen. The purpose of this amendment is to increase patients' awareness with regard to their right to present their grievances. In addition to its contribution to patients' rights, the impact this amendment may have on doctors must be also considered. It seems likely that with the increased awareness, the number of complaints may rise. Studies show that such complaints have impact on the work place. Without an appropriate support system for the medical team, such change followed by an increase in complaints may cause have a negative reaction of the medical staff. The system needs to take the necessary steps, educational and others, in order to prevent psychological reactions within the staff and to channel the impact of complaints in a positive direction. It is recommended to make ready with the aid of a support system, similar to the risk management system, to help the teams to accept complaints in a positive manner, and learn from the experience. Such a system requires administrative efforts and arrangements in order to both deal with complaints and be able to process their consequences. The system must find the way to translate patients' rights into effective regulations, which eventually will improve the quality of medical treatment. * Sharon Bassan, (LL.B, LL.N) Adv. and bioethicist, International Center for Health, Law and Ethics, sharonbs@ gmail.com. iv ׀ 2009 יוני- 40 'גיליון מס רפואה ומשפט English Abstracts Donors’ Families and Transplant Recipients' Perception of the Transplant Coordinator's Role in Bringing Both Sides into Contact Pazit Azuri*, Nili Tabak** and Shulamit Kreitler*** Abstract This paper examines the factors, and in particular the transplant coordinator's role, which influence organ donors’ families and transplant recipients to contact one another. ‘Contact’ is defined as interaction that brings about a relationship in the form of a letter, a telephone call, or a face-to-face meeting. Studies which demonstrate the advantages of such a contact report also on high motivation among most donor family members towards contact with the recipient, and a sense of satisfaction and gratification on both sides, for information on the subject from transplant staff. Several studies report the parties' concern about the possible failure of high expectations. Ate present, in Israel, as most Western countries, some degree of contact is common, mostly as the result of both sides’ determination to meet. The study is based on the theory of Cognitive Orientation, designed to explain the motivation behind behavior, and the direction and form behavior takes in practice. 135 cases, almost all Jewish-Israelis; 21-76 years old – 75 recipients of transplants from dead donors, between 1998 and 2007 and 60 donor family members were studied. Individual participants were interviewed on the basis of two questionnaires, one for the donor family members and the other for the recipients. Findings: The variable ‘Participant’s perception of the coordinator's role’ was found to influence the association between the intention to make contact and actual behavior. The more a participant perceived the coordinator's role as active, the more inclined he was towards such behavior. The factor found to most influence participants to make contact or avoid it was the information received through the transplant coordinator on the other party's attitude towards the contact. Key words: organ donors’ families, transplant recipients, ‘Contact’, transplant coordinator, intention, actual behavior. * Pazit Azuri – RN,MA. Doctoral Candidate, Tel Aviv University [email protected]. ** Nili Tabak RN, PhD, LL, Associate Professor of Nursing, TAU. *** Shulamit Kreitler PhD, Assoc. Professor, Director, Psycho-Oncology Unit, Sheba Medical Center. 2009 יוני- 40 'גיליון מס רפואה ומשפט ׀v English Abstracts Coping with Errors and Moral Luck Paradox Ella Koren* Abstract Coping with errors demands a careful analysis of the characteristics and causes of mistakes which occur in the caregiver's environment, as well as the examination of her/his attitudes, as well as that of her/his colleagues, towards the phenomenon of errors. In discussing errors, I emphasize the relationship between their occurrence and the way in which errors are being dealt with by the caregiver and her/his colleagues, and the paradox of moral luck which originates from the influence of luck on our moral judgment and evaluation. I focus on three different kinds of luck – resultant, constitutive and circumstantial. The opposing approaches for coping with the problem of luck presented are: A. the anti-luck theory and B. the theory of impure agency. The anti-luck approach deals with the paradox of moral luck, by limiting the caregiver's boundaries of responsibility; the theory of impure agency increases her/his sphere of responsibility. I suggest that each of the approaches provides only a partial solution. The Virtue theory provides for the selective application of both approaches. It grounds the balancing of the two according to the specific circumstances. Key words: Error prone environment, moral judgment, kinds of moral luck – resultant, constitutive and circumstantial, the anti-luck theory, the theory of impure agency, virtue theory, deontological approach. * Ella Koren, RN, PhD, Nursing Division, The Ministry of Health. Drug Regulation in the Post-Vioxx Era Segev Shani*, ** Abstract In September 2004, the pharmaceutical company Merck & Co (MSD) announced a voluntary recall and complete withdrawal of VIOXX (rofecoxib) from the market, due to a safety issue, associated with the use of the drug. This announcement led to series of actions and reactions vi ׀ 2009 יוני- 40 'גיליון מס רפואה ומשפט English Abstracts concerning the data and processing of information, which led to the withdrawal of the drug. These events, which caused a loss of confidence in the FDA, led to the reexamination of the practices of the Food and Drug Administration (the regulatory authority responsible for drugs, devices, biological, food, cosmetics, etc.). The immediate implication of this event was the change of the paradigm from focusing on the assessment of efficacy and the shortening of the time needed for review and processing an application for marketing authorization, to a more conservative approach focusing on the safety profile of the product. The review led to a number of recommendations intended to improve the regulatory process, mainly by focusing on safety reporting and post-marketing surveillance. The recommendations dealt with the basic conflict between the increase in the regulatory requirements and the prolongation of the drug’s development, measures which shorten the product’s effective patent period and consequently lead to an increase in drug prices. * Segev Shani, PhD, MHA, MBA, Department of Health Systems Management, Faculty of Health Sciences, BenGurion University. ** VP Medical & Regulatory Affairs, Neopharm Ltd. Key Words: Regulation, Efficacy, Safety, Public Health. The “Genetic” Group: Elaborating an Ideology of Genetic Inheritance* Commercializing the Genetic Data of Identified Populations: Proprietary, Social and Legal Issues Liat Shechter** Abstract The dizzying pace of genetic research generates numerous legal and ethical problems, and far outpaces the rate of public discussion of these problems. The rapid advancement in human genome mapping has triggered a global debate about the intolerable ease of cracking genetic secrets of individuals. The new genetic era expands issues with ethical ramifications from the individual and family arena, into broader population segments. We are witness to the labeling of ethnic groups, subject to risk of illness, as defective groups. Several programs study the genetics of populations, but the focus on the Jews as a research group, further expands the ethical ramifications. The reason is obvious – the Jewish population is laden by a historical context that cannot be ignored. 2009 יוני- 40 'גיליון מס רפואה ומשפט ׀vii English Abstracts The present article attempts to use the privacy paradigm as an effective way to protect individual and group identities in biotechnology. Protection of the identity interest provides a model against the unlawful use of genetic material, thereby violating our rights to protect our identity. The appropriation of information encrypted in DNA can be construed as the invasion of an individuals' privacy, as an infringement on their personality, their self – their identity. One of the elements of privacy listed in the Privacy Protection Law is the right to prevent the usage of an individual's name, voice, photograph and, in more general terms, image for profit. Since the unauthorized use of voice and image is considered as an infringement upon identity, wouldn't the same hold true for use of the person's DNA? The implications for genetic information, with regards to our inclination to identify ourselves as part of a wider group, and as part of ethnic groups, are tremendous. Other elements which contribute to group identity are social-historical in nature. We believe that the history of persecution of Jews, including the attempt to eliminate them in the Holocaust, strongly affects the formation of Jewish identity at the threshold of the 21st century. The model we propose focuses on expanding the cause listed in Article 2(6) of the Privacy Protection Law to include protection of biological, social and historical elements known as the Jewish identity. The expansion of this cause provides a legal framework to protect group identity as engraved by genetic information as well as by its social history. * The legal arguments presented in this paper and the initial data analysis were part of my PhD work in law with a thesis titled Commercializing the Genetic Data of Identified Populations: Proprietary, Social and Legal Issues and carried out in close collaboration with my supervisor, Prof. Alon Harel (Faculty of Law, the Hebrew University of Jerusalem) and Dr. Otniel E. Dror (Medical Faculty, Hebrew University of Jerusalem). ** The author of this article Is a graduate of Doctoral Studies (L.L.D.) in Law at The Hebrew University of Jerusalem; Graduate Studies (L.L.M) in Law at The Tel Aviv University (Commercial Track); Undergraduate degree in law (L.L.B) at The College of Management: Undergraduate degree (B.A.) in Business Administration at the College of Management (Majoring in Labor Relations and Human Resources). Prenatal Sex Selection Noa Grossman* Abstract The desire to choose our baby’s sex gender has existed for many generations and was also the subject of attention of scientists and other intellectuals, both in its practical and moral aspects. Several non-scientific "methods" for prenatal sex selection have been "recommended". In recent times, modern medical technology enables the prenatal sex selection, based on technology devised for PGD - Pre-Implantation Genetic Diagnosis. viii ׀ 2009 יוני- 40 'גיליון מס רפואה ומשפט English Abstracts This method enables definite certainty in choosing the sex of the future baby. PGD consists of genetic examination of a single cell, obtained from an in-vitro fertilized ovum, at the stage of its third division, and the re-implantation of the embryo into a womb. The elimination of genetic diseases is also determined. PGD may also, or primarily, help bear healthy babies in families who have previously-born ill children, who may benefit from certain cell components of the newborn child (i. e. bone marrow for a child with leukemia). A non-medical indication for the procedure is the desire of the couple to choose the sex of their baby. The ethical, moral, social and economical dilemmas that complicate the use of PGD for such indications is being discussed. The different legal approach to the issue of prenatal sex selection, in different countries, is being described. The Israeli legal attitude and status is presented. * Judge, Magistrates Court, Tel Aviv-Yafo Dissociative States, Murder and Lesser Punishment: A Peer Critique of the Israeli Psychiatric Association's Position Jossef Lereya* and Shmuel Fennig** g Abstract A position paper of the Israeli Psychiatric Association was recently published in this Journal. The paper deals with instructions for expert opinions in cases related to article 300a of the Penal Code, i.e. - the conditions for lesser punishment for murder. The instructions related to dissociative states, emphasize exceptionally severe restrictions as compared to all other psychiatric disorders. It states that the diagnosis of a dissociative disorder may be raised only if it can be proven that the examinee had already experienced dissociative states in the past, and the possibility of a dissociative state occurring de-novo, in the context of murder only, does not exist. The aim of this paper is to question and discuss these statements. We support our argument by the approach accepted by the diagnostic guidelines (ICD and DSM) for the diagnosis of 2009 יוני- 40 'גיליון מס רפואה ומשפט ׀ix English Abstracts the group of dissociative disorders. The relevant professional literature is reviewed, and in our opinion, it reveals a discrepancy between the instructions of the Israeli Psychiatric Association and both the clinical reality and the accepted psychiatric position of present times. It is our assumption that this discrepancy is the result of incertitude with regard to the perception of the forensic psychiatrist and his professional role in court, as opposed to his position and identity as a citizen in society. Such confusion may distort the psychiatrist's expert medical opinion and expose it to irrelevant considerations (judgmental, social, moral, political etc.). We recommend the re-assessment of this section of the position paper, considering the influence of public opinion and social stance on its current phrasing. We further suggest the use of different language, better suited to the medical-psychological set of rules. * J. Lereya, M.D. Director of the emergency Unit, Shalvata Mental Health Center,Hod Hasharon, Instructor, Sackler School of Medicine, Tel Aviv University Ramat Aviv, Israel. ** S . Fennig, M.D Director of outpatient services, Shalvata Mental HealthCenter,Hod Hasharon, Associate Professor, Sackler School of Medicine, Tel Aviv University Ramat Aviv, Israel. Disability due to Bodily Scars Dan Mahler* Abstract The State of Israel has still not enacted a law which defines the handicap levels of various physical disabilities. In the absence of such legislation, the medico-legal authorities uses the Regulations set by The National Insurance Institute of Israel in the year1956. Despite the great developments in medical information in all fields since that time, most regulations remain unaltered. One of the aforementioned regulations is Regulation 75(1), which deals with bodily scars. This regulation is vaguely worded, based on ill-defined terminology, such as the vague definition of the term "scar", which fails to differentiate between various types of scars; makes no room for important physical and functional findings such as itching and impaired heat tolerance; ignores damage such as pigmentation, shape deformities of different forms; and is restricted to only three degrees of disability – 0%, 10% and 20%, thereby severely restricting thecorrect determination of the disability level of many patients. Such lack of exact medical definitions opens a wide range of personal-subjective interpretations and enables manipulation, thereby preventing an accurate assessment of handicap levels, and may bring about unjust and erroneous allocations of compensation funds. x׀ 2009 יוני- 40 'גיליון מס רפואה ומשפט English Abstracts The failings and lacunae of Regulation 75(1), which deals with disabilities due to bodily scars, are presented in this paper. A revision of this Regulation, intended to include various missing elements and criteria, is also put forward, in the hope of prompting a legislative change in this area in Israel. * Professor Emeritus in Plastic Surgery Key words: Bodily Scars; Scars' damages; Disability due to Scars; Heat tolerance; Disability due impaired heat tolerance; Rule of 9; Disability legislation. The Proper Expert 1 Avraham Sahar* Abstract The Patient's Rights Act, 1996, states that 'the patient is entitled to proper (= just) medical care'.2 We here assert that this legal obligation includes equally all activities of the Expert – clinical as well as legal, i.e. when giving evidence in court, since both are within the exclusive prerogative of the Medical Expert. 'The Judge has only what has been put in front of His eyes' – stated the ancients. It stands as true in the modern adversarial legal system, which has no choice but rely on the Medical Experts when dealing with medical malpractice. The other issue raised in the verdict under discussion, concerns the question of "what is the level of expertise required for a given surgical procedure". The case under discussion is that of a 54 years old man, admitted to neurosurgery with organomental symptoms, diagnosed as due to acutely increased intracranial pressure, caused by the obstruction of the third ventricle by a large mass – pituitary apoplexy. An emergency operation was performed, via the pterional approach. The tumor was only partially removed, due to massive bleeding. Postoperatively, the patient is hemiplegic with severe cognitive impairment. 1 This commentary was prompted by the facts, circumstances and evidence as revealed in Civil Case (Jerusalem District Ct. # 8067/06 Z. Mhaber v. Hadassah (not yet published). 2 The Patient's Rights Act, 1996, uses the adjective proper (medical care). The original Hebrew term used – נאות (naoth) – translated into English, means - proper, suitable, seemly, just. The "proximity of meaning" of the two concepts – proper and just – as "applied" to an Expert in Medicine is the subject of this commentary. 2009 יוני- 40 'גיליון מס רפואה ומשפט ׀xi English Abstracts An emergency operation was performed, via the pterional approach. The tumor was only partially removed, due to massive bleeding. Postoperatively, the patient is hemiplegic with severe cognitive impairment. The court held the hospital negligent since the operation was performed by a (sixth year) resident and not by the attending neurosurgeon, whose active participation in performing of the operation was questionable (or questioned). The court's opinion was that the senior surgeon present, should have performed the whole surgical procedure. Neither party brought up the information that despite the undisputed seniority of the senior surgeon, his interests and clinical activities, for many years, had been focused 0n the treatment of pain and spinal problems. The Experts, both that of the claimant as well as that for the defendant, did not even as much as mention that for over 20 years prior to this case, the pterional approach to the pituitary, and especially in caese with apoplexy, had been mostly abandoned, and substituted by the transsphenoidal route, which requires specific technical expertise, but is by far advantageous for the patient. No mention was made of this surgical approach by either Expert Witnesses nor by the surgical team, prior to surgery. Had this approach been taken, by a neurosurgeon familiar and experienced in its performance, most probably that the patient would have made an excellent recovery. The concealment from the court of the full facts pertinent to the case, both by the parties, their representatives and even more so – by the Medical Expert Witnesses, is rather disturbing. It undermines the Court's trust and view of the Expert Witness as an Officer of the Court. It is also contrary to the law. As to the question who should perform which surgical procedure – with all due respect, is not a question to be answered by an Expert Witness (as was the case here) and neither by the court – the classification of surgical procedures, as well as the minimum number of each, mandatory for certification, is by law of this country, the prerogative of the Scientific Council of the Israeli Medical Association. If a (the) procedure is included in the Council's list, and the head of the department, who is responsible for the residents' training, considers the resident capable of performing it, then the resident may perform the surgery, provided he/she is properly supervised. We fully agree with the final outcome, however for different reasons. And… Aharon Barak, (Ret.) President of the Supreme Court of Israel said:3 "The law is set on truth". 3 Spr. Ct. App. 1412/94 Hadassah v. Gilad , P.D. 49 (2): 516, 522. xii ׀ 2009 יוני- 40 'גיליון מס רפואה ומשפט English Abstracts Education for Ethics as a Developmental Process for Mental Health Therapists Yoram Z. Zadik* Abstract Ethical codes represent professional ideals or binding standards of professional conduct. Sensitivity towards and familiarity with ethical issues may prevent behavior potentially damaging for the patient. In the field of mental health, codes of ethics emphasize the principles of professionalism and honesty. Ethics as a subject can be learned, but there is some skepticism as to whether the knowledge gained produces behavior with higher moral value. Professionals must be familiar with ethical principles, codes as well as with the law both legislated and laid out by the courts. They have to be sensitive and aware of ethical problems. This is a lifelong process of learning. All training programs should include courses to be followed by symposia, meetings and specific studies. Staff meetings should include the ethical aspects of real and hypothetical cases. Theoretical discussions of ethical issues is best avoided. Supervision remains an excellent setting for this purpose. Supervisors must be competent both in basic knowledge and in managing the discussion of ethical issues. The readiness of supervisors to discuss ethical conflicts which they have personally experienced may be utilized as models of openness and self-disclosure. Trainees may hesitate to confide about their ethical doubts, since the same supervisors are the ones who evaluate them. The suggested inclusion of ethical issues in the medical file and/or a section of "ethical history" was not implemented largely due to the concern of professionals about possible future legal implications. Ethics committees of professional organizations have four functions: the education of members about ethics; the distribution of the organization's code of ethics to its members as and to the public; the elucidation of ethical issues, including the constant updating of the code ; advising members with regard to ethical conflicts. The internet ethics forum contributes to ethics education by providing information and a medium in which ethical issues and dilemmas can be raised and discussed. * Senior Clinical Psychologist, Rambam Medical Center, Director of The Forum for Professional Ethics, in the Site of "hebpsy.net". [email protected] Key words: mental health, professional ethics, ethical codes, supervision, ethics history taking, ethics committees, internet professional ethics forum. 2009 יוני- 40 'גיליון מס רפואה ומשפט ׀xiii