In today’s article, Joseph Fitchett from the London School of Hygiene & Tropical Medicine writes about Medicine during the Second World War.

“For ever let this place be a cry of despair and a warning to humanity where the Nazis murdered about one and a half million men, women and children, mainly Jews from various countries of Europe.”
Memorial Tablet at Birkenau Concentration Camp

Historical Background
Following defeat of the First World War in 1918, the recently united Germany was left isolated and facing severe sanctions. Germany signed the Treaty of Versailles and, as a consequence, lost over 10 percent of its territory and all its overseas colonies, in addition to which it was set to pay crippling sanctions, prohibited to annex neighbouring states and it had the size of its army greatly capped.

The Weimar Republic, a liberal democracy, was instilled in 1919 to govern Germany. It was difficult, however, to reach a single party majority with its system of proportional representation, resulting in coalition governments that found it near impossible in its early years to control left and right wing extremism, attempted coup d’états, rampant inflation and economic meltdown.

Despite the “Golden Era” from the mid-1920s, political instability within Germany and the crisis of the Great Depression worldwide contributed to the strengthening of popularity of the National Socialist German Worker’s Party (the Nazi Party) with many Germans still humiliated by the terms of the Treaty of Versailles.

The Nazi Party, promoting German nationalism, was racist, anti-communist and anti-capitalist, with its leader Adolf Hitler aspiring to establish a “New Order” of Aryan supremacy in Europe. In 1933, president Paul von Hindenburg appointed the increasingly popular Adolf Hitler as Chancellor for another coalition government in an attempt to keep him under close control.

Ultimately, following more turmoil including a devastating fire at the Reichstag (German Parliament building) blamed as a communist plot, Hitler swiftly began dismantling restrictions of power and expanding his command and German territory, eventually leading to the Second World War.

The Eugenics Movement
The eugenics movement of the early 20th Century was not a phenomenon exclusive to Nazi Germany. The aim was to improve the human species by controlling birth and offspring. Compulsory sterilization was a key mechanism to reach this end.
Eugenics inevitably raises concerns violating human rights, namely the right to life, privacy and freedom from discrimination. However, it was at the time justified in both utilitarian and Darwinian terms.

Controversy over eugenics and the Nazi desire for “racial hygiene” and extermination of certain distinct population groups is highlighted by the fact that other countries applied eugenic policies to differing degrees. The United States of America, Britain, Sweden, Belgium, Canada, Australia and others enforced, in different degrees, compulsory sterilization based on criteria such as mental health, social class, sexuality, and crime.

It was in this controversial climate that the Nazi Party began outlining its increasingly severe interpretations of the eugenic movement of the 1930s and applying it to an unparalleled scale for “Volkwerdung”, or becoming a master race. Hitler increasingly began to see society as a “biological organism” and became fixated on promoting what he believed to be healthier elements. [1]

The “common good” began to carry more importance than the “individual benefit” and economic justification was increasingly used. A slippery slope towards fulfilment of “Volkwerdung” led to an expansion in involuntary euthanasia. Inspired by a 1920s treatise entitled “Release through the Annihilation of Life Unworthy of Living”, involuntary euthanasia was initially confined to the asylums but soon expanded into hospital practice.

The next step, genocide, is extreme but was central to the “racial hygiene” sought by the Nazi Party. [2] The spectrum from compulsory sterilization to involuntary euthanasia and to genocide is broad and chronologically apparent in the Third Reich. Supervised by doctors, they are a chilling reminder to those in the healthcare profession of the importance of a patient-centred relationship for the protection of those most vulnerable.

Nazi Human Experimentation
Enforced scientific experimentation by the Nazis is shocking simply in its nature and compounded by the fact that doctors, respected as protectors of life, carried out the research in labour and concentration camps. Experiments included genetics, experiments on twins, exposure to extreme conditions (including freezing temperatures and high altitudes), infectious diseases and pharmacology.

Many experiments were done in the aim of understanding the conditions a soldier might encounter during the Second World War. Freezing experiments for the Luftwaffe (Nazi air force) would therefore involve a simulation of harsh conditions followed by an attempt at resuscitation. The experimental subjects would then be subjected to very hot temperatures, such as in a bath, which they could succumb to.

Further experiments for pilot survival included analysing the effects of drinking seawater. Some prisoners were subjected to mustard gas in an effort to investigate treatment of their wounds. Other prisoners were deliberately infected with malaria.

Dr Josef Mengele, a physician and Schutzstaffel (SS) officer, was the notorious medical officer at Auschwitz and chief medical officer at Birkenau. Particularly interested in experimentation on identical twins, Mengele initially treated his subjects well. However, from around 3,000 twins only 52 are known to have survived Auschwitz. [3]

Mengele was even referred to as the “White Angel” as he inspected the new arrivals to Auschwitz and Birkenau concentration camps, directing them either to the right or to the left, indicating their immediate fate: hard labour or the gas chambers.

Nuremberg Trials and the Nuremberg Code
Following the end of the war, the Allied Forces (France, the United States of America, the Soviet Union and the United Kingdom) put on trials for suspected war criminals. Political differences between the Allies at the end of the Second World War resulted in diplomatic difficulties over continuing to use the International Military Tribunal that had operated in 1945-46.

Instead, 12 trials were held before United States military courts in the city of Nuremberg in the American-occupied zone. The Doctors’ Trial, December 1946 to August 1947, brought 23 defendants to trial facing accusations on four charges, namely: conspiracy to commit war crimes and crimes against humanity, war crimes, such as performing medical experiments without the subject’s consent, crimes against humanity, and membership of a criminal organisation, such as the Schutzstaffel.

Prosecutors concentrated on the experimentation within the camps. Seven war criminals were acquitted, seven sentenced to death (including Karl Brandt, Hitler’s personal physician), and the remaining nine received sentences of imprisonment.

The trial led to the Nuremberg Code – a set of biomedical research ethics principles addressing non-therapeutic experimentation on human subjects, with the first principles emphasising that the “voluntary consent of the human subject is absolutely essential”. [4]

The impact of the Nuremberg Code on medical ethics can be felt to this day with subsequent statements such as the 1964 Declaration of Helsinki [5] and 1978 Declaration of Alma Ata [6] emphasising ethical principles for human experimentation and promoting health as a human right, respectively.

Reflections
The Auschwitz camp complex, including the Birkenau extermination centre, stands today as a poignant reminder to prevent exploitation of those most vulnerable. It feels almost impossible to comprehend how such atrocities could have taken place.

The fact that human beings are capable of the most inhumane of thoughts and actions is unsettling. Patients trust their doctors and healthcare professionals often at times of great despair. Accordingly, doctors have an unparalleled responsibility to protect the individuals they treat and care for, and must respect their patients’ autonomy, always seek their consent and do them no harm.

Through experimentation, hard labour and murder, the prisoners in the Nazi concentration camps were dehumanised and subjected to the gravest violations of their human rights. The presence of a medical professional can often be seen to justify a procedure, particularly relevant to this day with accusations of supervised torture.

Acknowledging and protecting an individual’s fundamental rights and never treating them merely as a means to an end are two of the most important principles we must all actively promote throughout our lives to safeguard humanity.

“A destruction, an annihilation that only man can provoke, only man can prevent”
Elie Wiesel, Holocaust survivor and Nobel Laureate

Poem extract from Primo Levi’s If This Is a Man [7]

Consider if this is a man
Who works in mud,
Who knows no peace,
Who fights for a crust of bread,
Who dies by a yes or a no.
Consider if this is a woman
Without hair, without name,
Without the strength to remember,
Empty are her eyes, cold her womb,
Like a frog in winter.

Joseph Fitchett
Joseph.fitchett@doctors.org.uk

Acknowledgments: The author would like to thank Professor Michael Biddiss, FRHistS, for his comments.
For further reading, see references 8, 9, 10 & 11.

1 Biddiss M. Disease and dictatorship: the case of Hitler’s Third Reich. J Royal Soc Med 1997;90:342-6

2 Annas G, Grodin MA. The Nazi Doctors and the Nuremberg Code. Oxford University Press, 1995

3 Lagnado LM, Dekel SC. Children of the Flames. Penguin, 1991

4 The Nuremberg Code. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No.10, Vol.2, pp 181-2. US Government Printing Office. Washington DC, 1949

5 World Medical Association. Declaration of Helsinki – Ethical principles for medical research involving human subjects. Helsinki, 1964

6 World Health Organisation. Declaration of Alma Ata. International Conference on Primary Health Care. Alma Ata, 1978

7 Levi P. If This Is a Man. Abacus (English translation 1958), 1947

8 Caplan A (ed) When Medicine Went Mad. Bioethics and the Holocaust. Totowa, Humana Press, 1992

9 Special Issue on the Nuremberg Doctors’ Trial. BMJ 7 December 1996

10 Proctor RN. Racial Hygiene. Harvard University Press, 1988

11 Weindling P. Health, Race, and German Politics, 1870-1945. Cambridge University Press, 1989

Today’s feature comes to us from Ana Zelić, Kristina Špoljarec and Tin Knežević, who discuss the current and future status of palliative care in Croatia with Professor Anica Jušić.

We talked to professor Anica Jušić, a neurology specialist, who has been promoting paliative care in Croatia for many years. In 1994 she organized The first Croatian Hospice and paliative care symposium,and is a founder of Croatian hospice friends association. Since then she organized over 40 symposia and wrote over 30 articles. Since 1999 she runs the first home paliative care team. Considering the upcoming congress, we decided to get an insight into this subject.

First we would like to ask you is the development of paliative medicine in proportion to the increasing percentage of the elderly population? Or does it depend on the incidence of malignant diseaeses? How can it be explained?

No! Paliative care began to develop significantly in the 1950’s. The discovery of symptome reducing drugs, such as pain and anxiety (non-steroid antiinflammatory drugs, anxiolytic drugs…) ,and the renewed validation of opiates as powerful analgetics encouraged this to happen. Due to the administration of these drugs, the presence of medical staff, especially doctors, during the period of dying became inevitable. Before that, providing care during the difficult time of dying was assigned to family members, volunteers an sometimes nurses. On the other hand, many intensive care units were established, where patients die surrounded by machines, almost completely dehumanized, and parted from their loved ones. At that time the term ˝good˝ death was often mentioned, which connotes the patients right to choose the location of his/her death, most people choose their own homes. This kind of way to die, in the presence of your loved ones, is a better way to die, because it increases the quality of the remaining time to live. This is also done by drug administration, especially analgetics, to reduce pain. Psycho-social problems also need to be dealt with, since many of such occur in these situations. Finally, it comes down to dealing with existential and spiritual issues. The main goal is the patients acceptance of the inevitable and death fear reduction. This way patients can condone to parting with their loved ones, and even give comfort to their families, give a positive advice instead of despair and disintegration. That is the domain of paliative medicine. An older term is hospice care, but it is no longer suitable.

(more…)

Viktor Koelzer and Sara Brittingham debate the ethics and standards of euthanasia and palliative care

The attending physician remarked “the most difficult lesson you will learn is to stand back and let go.” In her case it meant avoiding another unnecessary procedure. I recall meeting Mrs. M on the morning ward during my oncology rotation a couple of months ago. Mrs. M was still quite young compared to the other patients but this I only found out by going through her chart. Her strikingly yellow skin and the bloated abdomen disclosed her disease. She had end stage pancreatic cancer and was in constant need of pain medication. “She is too weak to receive another bout of chemotherapy, we might lose her this way”, my attending said while we were discussing her case. “But she is still so young”, I thought helplessly, “Is there really nothing positive that we can offer her”?

Studies have shown that misinformation and insecurity exists about providing end-of-life care in the medical profession (1). Especially medical students profit from an open discussion and information about end-of-life care, leading to more security and confidence in their work with terminally ill patients (2,3). Our aim is therefore to provide an overview of historical, ethical and legal aspects of palliative care (PC) and voluntary euthanasia (VE) in Europe. We will thereby focus on common values and current problems of these approaches.

In our opinion providing adequate end-of-life care should include compassion and respect, while at the same time adhering to the law and ethical principles of the society we live in. In this way, PC reaches out to terminally ill patients’ with the WHO defining it as “an approach that improves the quality of life of patients and their families facing the problems associated with life-threatening illness […] through the prevention and relief of […] pain and other problems, physical, psychosocial and spiritual” (4). The concept of VE is defined by the European Association for Palliative Care as a “doctor intentionally killing a person by the administration of drugs, at that person’s voluntary and competent request” (5).

We feel that above all understanding patients’ needs in the last phase of life is a prerequisite for providing adequate care. A cross-sectional study surveying patients, families and physicians considered “pain management, communication, […] and being treated as a whole person” to be among the most important necessities (6). In reference to a recent study by Hurst and Mauron, we want to point out that PC and the movement for legalization of VE attempt to answer to these concerns reflecting common values (7): The focus of both approaches lies primarily in the importance of reducing human suffering. Both movements recognize the concept of “total”, multi-dimensional pain “including […] physical, emotional, social and spiritual suffering”. This state is seen as the “worst evil” that should be averted at all costs. PC attempts to reach patients’ “total suffering” in a holistic approach of “total care” with multidisciplinary teams comprised from all specialties, especially focusing on professional pain management, spiritual and psychological support. Proponents of VE recognize the need for an answer to “existential suffering” as well, but see this as an important reason for patients to request a painless, “good” death. A further value emphasized by both approaches is the common concern that end-of-life care should not reduce the human being to the biological (7). Chronically ill or terminally ill patients usually have multiple medical problems. The highly specialized health care system of today responds primarily to the needs of various organ systems, losing sight of the whole person. Care for the whole human being is realized by PC providers with a focus on “compassion” in the concept of “total care”. Proponents of VE feel that this goal is best met by providing the patient absolute control over their fate “up to and including the choice of seeking assisted death” (7).

PC providers and supporters of VE both focus on the importance of patient autonomy in order to avoid unnecessary suffering, but the implementation of this concept is a controversial issue. For VE legalization advocates empowering the patient means to provide the possibility of freely choosing assisted death (8). PC providers hold “that autonomy cannot include the right to choose assisted death, since death puts an end to autonomy itself” (8,9). They see the stabilization of the remaining capabilities of terminally ill patients in the concept of “total care” as a prerequisite for acting out autonomous decisions (7).

The coexistence of VE and PC does not only pertain to common values but a common history that is evident in the literal translation of the term euthanasia meaning “good death”, derived from the greek words Thanatos (θάνατος, death) and the prefix Eu- (εὔ, good). In our view the aim of providing this last service to patients may be the common root of VE and PC throughout history. In the early stages of medicine, hardly any disease could be cured; instead, the patients were accompanied and comforted, trying to palliate suffering (10). One of the earliest medical codices, the Hippocratic Oath (400 B.C.), stated that doctors must never “give deadly medicine to anyone if asked nor suggest any such counsel”. This definite statement leads us to assume that disagreements about medically assisted death were already a matter of debate during this time. With the rise of Christianity in Europe, arguments against VE were further based on religious beliefs. Thomas von Aquin (approx. 1225-1274), one of the most important Catholic scholars of the middle ages stated in his main work “Summa Theologiae” that not only killing but also suicide was a capital sin, and emphasized the Christian virtues of “caritas” (Lat. benevolence) and “misericordia” (Lat. mercy) in the care of patients. In our opinion these values are still central in PC today, emphasizing the Christian roots of the PC movement.

The co-existence of both approaches is also certainly evident in the recent political developments in Europe. The Netherlands legalized VE as the first European country in April 2002 (11). At the same time, a right for PC to every patient was constitutionally guaranteed, emphasizing the political support for both approaches (11). The legalization of VE is the result of leading Supreme Court decisions from as early as 1984 that lead to a non-prosecution agreement in 1990 between the Dutch Ministry of Justice and the Royal Dutch Medical Association setting out criteria of due care for physicians who actively participated to end the lives of patients with a terminal disease (12). Among the most important are the informed consent of the patient, the prolonged and unbearable suffering, lack of medical alternatives and the retrospective report of any case of VE to ethical control commissions (12). Belgium followed the Dutch initiative for legalization of VE in 2002, and the Luxemburg parliament adopted a similar bill in February of 2008 which is expected to come into force before the end of this year (12).

Figure 1

In the light of these developments the vast majority of medical associations in Europe rejected the concept of VE. A possible erosion of ethical, legal and psychological barriers on a slippery slope towards a practice of killing of underprivileged groups and the possibility of facilitating involuntary euthanasia of incompetent patients were among the most important reasons named for this action (see Fig.1). On the contrary proponents of VE point out that legalization is an important step to facilitate societal control of VE (Fig.2). We feel it is important to analyze central government initiated studies from the Netherlands from the years 1990, 1995, 2001 and 2005 as the only country with a considerable history of legal VE, to seek evidence speaking for or against these concerns. (14-16).

Figure 2

Approximately 40 percent of all annual deaths in the Netherlands (>120,000) were preceded by the intentional life-shortening acts of withholding or withdrawing treatment (15-20%), intensified alleviation of symptoms (18-25%), or VE which accounted for an estimated 8-10.000 deaths a year in all four years of the study period (14,15). Legalization of VE has resulted in several important trends: The rate of euthanasia has stabilized at about 1.7% of all deaths breaking with a consistent upward trend since 1990 (15). At the same time, the reporting rate of euthanasia cases to control commissions has constantly risen from a mere 18.0% before 1990, when the practice of VE was illegal, to 80.2% in 2005 (15). Decisions in earlier study periods had often been made by individual doctors, without consultation of other medical professionals or relatives (16). Today doctors seek open discussion with colleagues in a majority (87.7%) of cases and in 75.5% with relatives of the patient (16). It seems to us that the slippery slope of a slow but steady increase in case numbers of VE, a low reporting rate, and decision making without consultation is beginning to be stabilized by clear legislation and control criteria. However there is still significant room for improvement as every fifth case of VE is enacted without control, and we feel that the decision must urgently be discussed with other caregivers of the patient and relatives in every single case to reach a reliable decision.

A trend towards stabilization of VE may also not defer from the fact that the cited government initiated studies uncovered a significant and worrisome number of cases of involuntary euthanasia where mostly incompetent (79%) (14), helpless patients are killed without informed consent (14-16). Several high-impact studies report that an estimated 900 to 1000 patients per year were killed involuntarily from 1990-2001; legalization led to a drop in these numbers to about 500 cases a year (14-16). Another troubling development is the recent proposition of the “Groningen Protocol” in the Netherlands which, if adopted by the government, would allow an extension of the practice of euthanasia to newborns “for whom a very poor quality of life, associated with sustained suffering, is predicted” (17). As we pointed out, the primary justification given for VE in terminally ill patients is respect for patient autonomy. This justification by autonomy is “obviously absent” in the case of incompetent helpless patients and infant euthanasia (18). In our opinion the continued killing of patients without informed consent is a central argument demonstrating the dangerous extension of euthanasia to the dependent and helpless population.

As for the VE legalization movement a heterogeneous development for PC within Europe can be observed. Whereas most Western European countries and the UK have successfully implemented PC programs for terminally ill patients, “in many places (especially in Eastern Europe) PC is not featured in the medical curriculum at all” (19). In recognition of these developments the European Health Committee prepared a set of European guidelines in 2003, calling on all countries to formulate national programs (20). Yet follow up studies almost five years later do not show significant improvement of the situation with a patchwork of services especially in Central and Eastern Europe without central organization and national guidelines in many cases (19, 21). In our view, the data that 12 of the 27 EU member states provide three or less hospice services per one million inhabitants demonstrates that PC is still very much underutilized in large parts of the EU (21). Among these are even well developed countries like Denmark, the Czech Republic, Portugal, Greece, and the Ukraine. In this way we feel that the major problem of PC provision in Europe does not lie as much in controversies over the concept of PC itself, as shown in the agreement over international guidelines but in the lack of a consequent implementation.

In summary we feel that it may be impossible to view PC and VE from a single perspective. Open dialogue between PC providers and VE proponents seems to be essential to promote an understanding of the respective position, and to focus on common ground that will benefit the patient. A basis for this process has been laid in a common history, a common aim, and common values. We recognize that there are important differences and disagreements, yet end-of-life care may not be a black and white issue. In our opinion the best way to clear out misunderstandings and counter insecurity is by promoting an educated discussion, beginning in medical training. To this end, we have analyzed central studies about the implementation of PC in Europe and about the present practice of VE in the Netherlands. For VE we demonstrated that the legalization seems to have broken the trend of continuously rising case numbers, with positive effects on the reporting rates to ethical control commissions, and on communication with other caregivers about individual cases. However, a considerable number of worrisome cases of involuntary euthanasia and a possible extension to vulnerable populations are evident. In our view this malpractice must be stopped immediately. Current studies about the implementation of PC demonstrate a very heterogeneous situation in Europe. We feel that the unified approach towards the implementation of a set of general guidelines as proposed by the European Health Committee may greatly benefit terminally ill patients by providing a reliable framework for care.

Viktor Koelzer and Sara Brittingham are 5th year medical students at the Technical University of Munich.

sara.brittingham[at]gmx.de

vkoelzer[at]googlemail.com

References

(1) N Ahmed, J E Bestall, S H Ahmedzai, S A Payne, D Clark and B Noble. Systematic review of the problems and issues of accessing specialist palliative care by patients, carers. Palliat Med. 2004; 18; 525-42

(2) Buss MK, Marx ES, Sulmasy DP. The preparedness of students to discuss end-of-life issues with patients. Acad Med. 1998; 73: 418–22

(3) Ross DD, Shpritz D, Hull MM, Goloubeva O: Long-term evaluation of required coursework in palliative and end-of-life care for medical students. J Palliat Med. 2005; 8: 962–74

(4) http://www.who.int/cancer/palliative/definition/en WHO Definition of Palliative Care. (Accessed on November 18th, 2008)

(5) Materstvedt LJ, Clark D, Ellershaw J, Førde R, Gravgaard AM, Müller-Busch HC, Porta i Sales J, Rapin CH. Euthanasia and physician-assisted suicide: a view from an EAPC Ethics Task Force. Palliat Med. 2003; 17(2):97-101

(6) Steinhauser KE, Christakis NA, Clipp EC, McNeilly M, McIntyre L, Tulsky JA. Factors considered important at the end of life by patients, family, physicians, and other care providers. JAMA. 2000; 284(19):2476-82

(7) Hurst SA, Mauron A. The ethics of palliative care and euthanasia: exploring common values. Palliat Med. 2006; 20(2):107-12

(8) Roscam Abbing HDC. Dying with dignity, and euthanasia: a view from The Netherlands. J Palliat Care. 1988; 4(4):70–74

(9) Gordijn B, Janssens R. The prevention of euthanasia through palliative care: new developments in The Netherlands. Patient Educ Couns. 2000; 41(1):35-46

(10) Pastrana T, Jünger S, Ostgathe C, Elsner F, Radbruch L. A matter of definition–key elements identified in a discourse analysis of definitions of palliative care. Palliat Med. 2008; 22(3):222-32

(11) http://www.reuters.com/article/worldNews/idUSL2011983320080220 Luxembourg parliament adopts euthanasia law. (Accessed on November 15th, 2008)

(12) Bosshard G, Broeckaert B, Clark D, Materstvedt LJ, Gordijn B, Müller-Busch HC. A role for doctors in assisted dying? An analysis of legal regulations and medical professional positions in six European countries. J Med Ethics. 2008; 34(1):28-32

(13) van der Maas PJ, van der Wal G, Haverkate I, de Graaff CL, Kester JG, Onwuteaka-Philipsen BD, van der Heide A, Bosma JM, Willems DL. Euthanasia, physician-assisted suicide, and other medical practices involving the end of life in the Netherlands, 1990-1995. N Engl J Med. 1996; 335(22):1699-705

(14) Onwuteaka-Philipsen BD, van der Heide A, Koper D, Keij-Deerenberg I, Rietjens JA, Rurup ML, Vrakking AM, Georges JJ, Muller MT, van der Wal G, van der Maas PJ. Euthanasia and other end-of-life decisions in the Netherlands in 1990, 1995, and 2001. Lancet. 2003; 362(9381):395-9

(15) van der Heide A, Onwuteaka-Philipsen BD, Rurup ML, Buiting HM, van Delden JJ, Hanssen-de Wolf JE, Janssen AG, Pasman HR, Rietjens JA, Prins CJ, Deerenberg IM, Gevers JK, van der Maas PJ, van der Wal G. End-of-life practices in the Netherlands under the Euthanasia Act. N Engl J Med. 2007; 356(19):1957-65

(16) van der Heide A, Deliens L, Faisst K, Nilstun T, Norup M, Paci E, van der Wal G, van der Maas PJ; EURELD consortium. End-of-life decision-making in six European countries: descriptive study. Lancet. 2003; 362(9381):345-50

(17) Verhagen E, Sauer PJ. The Groningen protocol–euthanasia in severely ill newborns.N Engl J Med. 2005; 352(10):959-62

(18) Jotkowitz AB, Glick S. The Groningen protocol: another perspective. J Med Ethics. 2006; 32(3):157-8

(19) Martin-Moreno JM, Harris M, Gorgojo L, Clark D, Normand Ch, Genteno C. Policy Department Economic and Scientific Policy. Palliative Care in the European Union. May 2008; www.sfap.org/pdf/0-J7-pdf.pdf (Accessed on December 8, 2008)

(20) The Council of Europe. Recommendation Rec (2003) 24 of the Committee of Ministers to member states on the organisation of palliative care. http://www.coe.int/t/dg3/health/Source/Rec(2003)24_en.pdf (Accessed on December 8, 2008)

(21) Centeno C, Clark D, Lynch T, Racafort J, Praill D, De Lima L, Greenwood A, Flores LA, Brasch S, Giordano A; EAPC Task Force. Facts and indicators on palliative care development in 52 countries of the WHO European region: results of an EAPC Task Force. Palliat Med. 2007; 21(6):463-71

The illegal manufacture and sale of ineffective counterfeit pharmaceuticals deliberately targets the sick and disadvantaged. Despite the inexpressible immorality of this practice, it has been estimated that fake medicines comprise anywhere between 1-50% of total drug sales around the world [1]. Low detection rates, underreporting, and a lack of universally accepted definitions have made accurate estimations difficult, however the ubiquity of pharmaceuticals in both the developing and developed world means even the most conservative approximation of 1% translates into a staggering number of people. The problem is further compounded by the prevalence of substandard or low quality drugs, particularly in nations without effective drug regulatory agencies. The image of patients carefully taking their medication, yet dying from treatable diseases is deeply disturbing. In the face of such an alarming situation, many in the mainstream medical community still do not appreciate the enormity and seriousness of this issue.

Defining the problem

The World Health Organization (WHO) describes counterfeit drugs as medicines that are packaged in such a manner meant to purposefully mislead [1]. A variety of factors have contributed to the global proliferation of fake drugs including escalating prices, demand exceeding the available supply, the absence of established regulations in many countries governing the manufacture or importation/exportation of drugs, and a lack of enforcement of existing regulations. Although the majority of counterfeit drugs originate in Asia (particularly India and China) and are then disseminated to underdeveloped nations [2], the Western world is not exempt from the trend. In 2001, for instance, an American pharmacist confessed to diluting thousands of chemotherapy prescriptions prior to their distribution to cancer patients [3]. While it might be expected that the more expensive “lifestyle” drugs would be the most common victims of counterfeiting, at least 206 counterfeit cases of cheap anti-infective medications have been reported in 38 different countries [4]. Sadly this is a severe underestimation of the problem, as only 5-15% of the 191 WHO member states actively report cases of drug counterfeiting [4].

Substandard drugs are defined broadly as those that do not meet the quality requirements that have been set for them [5]. While the deliberate counterfeiting of drugs may inspire greater outrage, it is accepted that substandard products represent a far larger threat to the population. Many factors can render a drug substandard including sub-optimal or excessive dosage, poor chemical stability, packaging problems, and contamination. The prevalence of low quality drugs can be attributed to the fact that 30% of WHO member states have no functioning drug regulation policies in place [6]. Additionally, the onus of determining efficacy and safety of drugs is placed on the countries where they are to be distributed. The result is that medicine destined for international aid or development programs often faces no regulation at all, as in these locations the infrastructure to implement these types of programs simply does not exist [5].

Consequences of ineffective medicines

The inability to treat diseases is only one complication of counterfeit and substandard medicine. The possibility that drugs containing suboptimal amounts of active ingredients will help to increase the spread of drug resistant pathogens is a very real concern. Examples include South-East Asia, where the prevalence of counterfeit artesunate based anti-malarial medication approaches 50% and is contributing to growing drug resistance [7]. Health risks are also not limited to a lack of effect. The contamination of pharmaceuticals has more than once resulted in mass casualties, as occurred in Haiti in 1995, where nearly 100 Haitian children died of acute renal failure due to diethylene glycol poisoning from contaminated cough syrup [8]. Lastly, the loss of confidence in medicine by practitioners and patients alike is troubling yet difficult to quantify.

Recommendations

A series of recommendations has been proposed to help fight the spread of counterfeit drugs. These include increasing support for countries that do not have functioning drug regulation policies and increasing the availability of cheap, good quality medicines; also legislating mandatory reporting of any substandard or counterfeit drugs to the national regulation agency and establishing severe penalties for those involved in the counterfeit drug trade [4]. The WHO has also formed the International Medical Products Anti-Counterfeiting Taskforce (IMPACT), designed to fight counterfeiting through increased awareness and international collaboration [1].

The problem of substandard medication will be much more difficult to address. Enforcing a drug inspection policy has been shown to substantially improve drug quality; however this requires resources and infrastructure that may not always be available [9]. The WHO also promotes education campaigns recommending purchasing from licensed pharmacies, but their effectiveness remains unknown [10]. The development of functional pharmaco-vigilance systems in all countries is paramount, even if it requires diverting aid funds from other projects. Without a consistent and reliable source of effective medication, the future of healthcare initiatives in any location is in jeopardy.

Progress in the fight against ineffective medication has been slow; however the situation is finally starting to attract the attention it deserves. Student-led initiatives such as Universities Allied for Essential Medicines have done commendable work in raising awareness about the dangers of ineffective medicine- but there is still a long way to go. In the mean time physicians around the world must educate themselves. In an age of escalating drug prices and online pharmacies it is imperative that patients and healthcare providers alike remain informed; to halt the spread of these deadly drugs and ensure that they do not strike close to home.

References

(1) WHO. Combating counterfeit drugs: a concept paper for effective international collaboration. http://www.who.int/medicines/events/FINALBACKPAPER.pdf (accessed November 28, 2008).

(2) OECD. The Economic Impact of Counterfeiting and Piracy. Paris, France: OECD Publishing, 2008.

(3) D Young. Pharmacists work to regain public’s trust after Kansas City scandal. Am J Health Syst Pharm 2002; 59(9): 814, 820.

(4) Newton P, Green MD, Fernández FM, Day NPJ and NJ White. Counterfeit anti-infective drugs. Lancet Infect Dis 2006; 6: 602-13.

(5) Caudron J-M, Ford N, Henkens M, Macé C, Kiddle-Monroe R and J Pinel. Substandard medicines in resource-poor settings: a problem that can no longer be ignored. Trop Med Int Health 2008; 13(8): 1062-72.

(6) WHO Medicines Strategy 2004-2007. http://whqlibdoc.who.int/hq/2004/who_edm_2004.5.pdf (accessed November 28, 2008).

(7) Newton PN, Fernández FM, Plancon A et al. A Collaborative Epidemiological Investigation into the Criminal Fake Artesunate Trade in South East Asia. PLoS Medicine 2008; 5: 209-219.

(8) O’Brien KL, Selanikio JD, Hecdivert C, et al. Epidemic of pediatric deaths from acute diethylene glycol poisoning. Journal of the American Medical Association 1998; 279: 1175-180.

(9) Syhakhang L, Lundborg CS, Lindgren B and G Tomson. The quality of drugs in private pharmacies in Lao PDR: a repeat study in 1997 and 1999. Pharm World Sci 2004; 26: 333-38.

(10) WHO. Counterfeit drugs – guidelines for the development of measures to combat counterfeit drugs. WHO/EDM/QSM/99.1. Geneva: WHO, 1999.

Paxton Bach

University of British Columbia, Experimental Medicine Program

Gurdeep Mannu writes on the philosophy of utilitarianism and how it can be applied to medical ethics. 

Osler famously describes medicine as an art, and we as medical students are future practitioners of this art. Science and art do not mix more so than in the ethics and morals by which we practice. It is essential for medical students worldwide to appreciate the moral implications of the medical decisions they make. This is despite the fact that philosophy and bioethics is a topic which is to a large part neglected in many undergraduate medical curriculums in spite of recent reforms. This article reviews the common philosophical theory of utilitarianism and examines this doctrine in the context of a medical dilemma.

This article first gives a brief account of the theory. It then discusses its various forms and respective strengths and weaknesses. These points will then be explored in the framework of a modern ethical dilemma in healthcare in order to ascertain whether utilitarianism in all its variations, is sufficient to explore all of the ethical dimensions of such a problem a student or doctor may face. (more…)

Ohad Oren, a 3rd year medical student at Bruce Rappaport Faculty of Medicine, in Haifa, Israel considers an ethical dilemma.

A profoundly disabled child whose annual growth rate is subnormal approaches your care. The parents ask you to test growth hormone function and to consider an active intervention to help their child attain a larger stature. How should you proceed? Increased growth will surely not benefit a severely brain impaired child, with no trace of body image whatsoever. A larger stature, moreover, will impose a higher burden on his caregivers, hampering their continuous care of their child.

This paradoxical scenario – whether to use medical treatments to increase the final stature of a developmentally-disabled child – is not uncommonly encountered in pediatric endocrine clinics. Rejecting the GH hormonal therapy may portray abandoning an effective medical therapy on the grounds of little or no benefit to the patient. But, is offering parents of severely disabled children proactive measures to attenuate growth an ethical thing to do? The Ashley X case, presented in this article, sparked an intensive public discussion concerning the ethical justification of irreversibly altering the body of a profoundly disabled and nonconsenting child. (more…)

The pharmaceutical industry and the medical profession are uneasy bedfellows as Tom Jaconelli discusses

It would be hard to imagine a functioning healthcare system without medicines.  Even outside the system many of us frequently take over-the-counter drugs for common ailments: in the USA 50 billion aspirin tablets are consumed each year. (1)  Also, it is difficult to think of any kind of human experience that doesn’t come with a health warning. (2) This medicalisation of society explains why pharmaceutical companies such as GlaxoSmithKline and AstraZeneca rank in the top 10 share prices in the UK economy.  However, the nature of pharmaceutical companies as profit-driven businesses in contrast to their role as health providers heralds a seemingly intrinsic problem: is their priority health or wealth? (more…)

Would you ever blow the whistle? Elizabeth Leyland explains more about this potentially career wrecking activity

From childish taunting in the playground to kiss-and-tell exposés, whistleblowing affects everybody at some stage of their lives. It raises awareness of ‘naughty’ behaviour, but is almost invariably damaging and very difficult to reverse. In healthcare there are particularly high stakes: lives, jobs and money are potentially at risk if inappropriate practice goes unchecked. If whistleblowing is used too freely the repercussions can be especially severe. I want to tune in to some of the difficulties associated with whistleblowing in a healthcare setting. With these in mind, I will consider the balance between moral responsibility and personal cost of ‘whistling while you work’.

(more…)