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How sad it is that inventors cannot control the eventual application of their work: The flipside of innovations in diagnostic and therapeutic technologies in medicine. Japheth Mati MD

It is fair to conclude that the technological revolution of the twentieth century was unprecedented in human history. Medicine was one area of tremendous progress, especially considering that at the dawn of that century Surgery, in particular, was a dicey procedure to undergo. It was before the arrival of safe anaesthesia, blood transfusion, antibiotics, and other life support paraphernalia we often take for granted. Admittedly, a lot of today’s surgical procedures predate the 20th century, but they were far from being safe. Take Caesarean section, for example, around 1860s the mortality rate associated with the operation in Great Britain and Ireland, was 85%[i]. Major strides in mortality reduction had to await advances, especially in three key areas: Anesthesia, Blood transfusion and Antibiotics.

Anesthesia: In the 20th century, the safety and efficacy of general anaesthesia was improved by the routine use of endotracheal intubation, advanced airway management techniques, and better anaesthetic agents that made “bite the bullet” become obsolete!  Blood transfusion: The discoveries by Karl Landsteiner, of human blood groups (1901) and the Rhesus factor (1937), markedly improved the safety of blood transfusion. Antibiotics: Antibiotics are a creation of the 20th century, starting with the sulpha drug Prontosil in1935; Penicillin[ii] (1942), Streptomycin (1943); Tetracycline (1955); Nystatin (1957); to be followed by others, including the semi-synthetic antibiotic Amoxicillin (1981).

As I marvelled over these and other 20th century great medical scientific and technological feats, one question kept nagging me: does the way we mainly use these inventions today conform to the original purpose of their creators?

Thinking slightly outside of medicine, one can for example compare the opposites in the employment of nuclear technology: on the one hand, its value as a source of efficient energy to drive industry, and on the other its use as a weapon of  mass destruction. Though not to the same degree of departure, in medicine, a considerable number of today’s most celebrated technologies are used in manner that is at variance with the inventor’s original intentions, to the extent that some inventors have had occasion to publicly express regret over the ‘misuse’ of their work.

It’s the intention in this post to review briefly selected diagnostic and therapeutic innovations that have exerted great impact on medicine in general, and the practice of obstetrics and gynaecology in particular, especially beginning the second half of the 20th century.

The review covers the following diagnostic and therapeutic techniques: amniocentesis and amniotic fluid sampling, prenatal cytological sex determination, prenatal blood DNA sex determination, obstetric ultrasound, and in-vitro fertilisation technique. Each one of the above innovations has performed beyond expectation, finding greater utilisation for purposes far removed from the original intention at the time of their discovery. These “other” uses are examples of what can be referred to as ‘the flipside of scientific and technological innovations in medicine’. In sympathy with their cause, we are left to wonder: “If only inventors were endowed with wisdom to foresee the ends to which their creation might end up being applied!”

 Amniocentesis

Amniocentesis is the process of removing a sample of amniotic fluid – the medium in which the fetus floats in the mother’s uterus, to be analysed for markers of certain disorders of the fetus. This procedure is credited to the work of Douglas Bevis, a British obstetrician and gynaecologist at St. Mary’s Hospital in Manchester in early 1950s. Later, following the discovery of ultrasound (see below) it became possible to undertake ultrasound-guided amniocentesis with greater accuracy and safety.

Amniocentesis ultrasound guided image

Ultrasound guided amniocentesis

Amniocentesis and amniotic fluid sampling (AFS) permits the monitoring of fetal wellbeing in utero, especially in the management of Rh-isoimmunisation. It is frequently used in the estimation of fetal lung maturation, and in the diagnosis of genetic disorders such as Down’s syndrome (mongolism) and sex-linked diseases such as haemophilia.

In 1949 Canadians Murray Barr and Ewart Bartram had discovered sex chromatin (a mass of chromosomes, also called “Barr Body”), which is found only in female cells. Thus, finding the sex chromatin in fetal cells obtained through AFS permitted identification of a female child. Later through tissue culture techniques it was possible to identify the actual male and female sex chromosomes in cells, thereby improving accuracy of sex determination using cytogenetic technique, which remains the gold standard. There are now over 500 hereditary diseases that can be diagnosed through amniocentesis and other diagnostic techniques[i].

The technique of amniocentesis reigned supreme till the tail-end of the 20th century when in 1997 Dennis Lo and colleagues (both in Oxford UK and Hong Kong, China) published their seminal paper[ii] reporting the presence of fetal DNA in maternal blood, thereby opening the door to a new non-invasive technique that avoided the risk (albeit very small) of abortion following amniocentesis. The new DNA test, which employs the more advanced Polymerase Chain Reaction (PCR), has the added advantage of being performed at an earlier gestational age- as early as 7 weeks, much earlier than was possible with ultrasound scan (see below) which could only demonstrate male fetus at 11 weeks earliest, and not so reliably. An important downside of DNA PCR test is the cost involved.

The potential to determine fetal sex has opened the door to abuse of these tests. The ‘flipside’ of prenatal sex diagnosis has been its utilization in selective abortion of female fetuses, to the extent sometimes, of posing demographic imbalance as has been feared for India[iii] and China[iv]. In this regard the test changes from enhancing the wellbeing of the fetus to selecting it for destruction. A complete turnaround!

Ultrasound scanning

Prof Ian Donald[v] (1910-1987), the Regius Professor of Midwifery at the University of Glasgow (1954 -1976), and a tough Scot who endured three open-heart valve-replacement operations, is the celebrated Father of Medical Ultrasound, a technology he pioneered beginning the late 1950s. His first major publication on the subject appeared in the Lancet in 1958, which contained the first ultrasound images of the fetus ever published[vi].

The potential to reveal information on the growing fetus in the womb was soon realised and the use of ultrasound spread quickly, improving the safety of pregnancy and childbirth, and allowing for the much more effective detection and treatment of fetal abnormalities. Since the 1970s ultrasound scanning has become a routine part of antenatal care. And as the science of ultrasound developed, so did its applications. Ultrasound scanning is now used in numerous other areas of medicine, with recent advances in technology enabling three-dimensional images to be produced.

Ian Donald hommedia

Professor Ian Donald

A less discussed dimension of Ian Donald’s work is what fundamentally may have driven him to develop the technology. In this regard, he seems to have considered obstetric ultrasound to be more than simply a means to visualise the fetus in utero; instead, he saw the technology as providing a chance to ‘individualise’ the fetus. The technology made it possible for the fetus to be recognised, or at least spoken of as, an individual, a reality. This view comes out clearly from the description he uses in the following 1978 presentation to a lay audience[i]:

Here’s the baby see how he jumps … This baby is about a 12 week pregnancy … She [the mother] certainly cannot feel these movements but there is no doubt about the reality, … now you see it move its hand up to its face you see his head is up here and his chest is down here then he throws his legs out and his arms … You see his hands come up like that. And you see his face here, the back of his head … It is rather like a child on a trampoline, tremendous strength, energy and vitality.)

Perhaps because of these experiences, Ian Donald came to hold quite strong views against abortion, being a lead campaigner against the 1967 Abortion Act in the UK. He is known to have employed the ultrasound imagery as a powerful persuasive resource in urging women to continue with their pregnancies. In his view the only indication for abortion was a very grossly deformed fetus; no consideration in cases of mild or moderate handicap. Indeed Ian Donald even went to the length of attempting to save a fetus in an ectopic pregnancy – a heroic surgical endeavour which failed miserably, but which nevertheless, justified an audience with Pope John Paul II, an occasion he described as ‘the crowning event of my life’[ii].

Personal idiosyncrasies apart, there is absolutely no argument that Ian Donald’s work has contributed immensely to better outcomes in many medical disciplines, away from his own field of obstetrics and gynaecology. However, in a rather ironical way, ultrasound scan happens to be the most reliable way of diagnosing not only early pregnancy, but also of ensuring the uterus has been completely evacuated, following both spontaneous abortion and induced abortion (especially medical termination of pregnancy).

By the 1970’s, Ian Donald had become aware of the truth, that the ends to which technology is put cannot be determined by its originators. He somewhat despairingly wrote, “My own personal fears are that my researches into early intrauterine life may yet be misused towards its more accurate destruction”[iii]. Indeed, Ian Donald had come face to face with the flipside of his own scientific and technological innovation in medicine!

 In vitro fertilization

Patrick Christopher Steptoe (1913 – 1988), a British obstetrician and gynaecologist, along with biologist/ physiologist Robert Edwards, were the pioneers of the technique of in vitro fertilization for infertility treatment. Louise Joy Brown, their first ‘test-tube baby’, was born on 25 July 1978, the product of great perseverance- it took them 10 years before they had their first successful birth. Edwards was awarded the 2010 Nobel Prize in Physiology or Medicine for this work, however because the Prize is not awarded posthumously, Steptoe was not eligible for consideration.

Since Louise Brown, there have been over 4 million babies worldwide conceived through IVF. Despite a steady stream of ethical and moral questions arising from IVF, to date, the lives of many women and couples across the globe have been enriched by a child conceived through one or other of the various modifications of the original IVF technique introduced by Steptoe and Edwards. This reproductive technology has made and continues to make tremendous advancements in basic reproductive biology and embryology. It has enabled us to understand the human reproductive processes and especially fetal development, in a way that has never been possible in the past[iv].

At the same time, the world of IVF almost everywhere has become a very competitive market-place, resulting in many treatment centres going to great lengths to ensure a pregnancy is achieved. The temptation is high to transfer large numbers of embryos to the uterus, which results in pregnancies of high multiples, some of which may be lost through spontaneous abortion, or subjected to ‘fetal reduction’ procedures (euphemism for abortion).

The technique of IVF has become an essential source of ‘spare embryo’ for stem-cell research, which gives hope to many people dying from today’s incurable diseases. But, still, this is far beyond Patrick Steptoe’s imagined application of their technique.


[i] I. Donald (undated but after 1978) ‘Predicting ovulation’, unpublished lecture, tape-recording in BMUS Archive).

[ii] Malcolm Nicolson, Ian Donald – Diagnostician and Moralist http://www.rcpe.ac.uk/library/read/people/donald/donald.php

[iii] I. Donald (1972) ‘Naught for your comfort’, Journal of the Irish Medical Association, 65, 279-89.


[ii] Lo YMD, Corbetta N, Chamberlain PF, Rai V, Sargent IL, Redman CW, et al. Presence of fetal DNA in maternal plasma and serum.Lancet1997;350:485-7.

[iv] en.wikipedia.org/wiki/Abortion_in_China

[v] Prof Ian Donald was my supervisor at the Queen Mother’s Hospital in Glasgow in 1969.

[vi] I. Donald, J. MacVicar, T. G. Brown (1958) ‘Investigation of abdominal masses by pulsed ultrasound’, The Lancet, 1, 1188-95.


[ii] Fleming, Florey, and Chain shared the 1945 Nobel Prize for medicine for their work on penicillin.

 

 

Human Rights Issues in maternal health care in Kenya: Do Kenyan women enjoy the right to maternal health?

The findings of a recent Public Inquiry into violations of sexual and reproductive health (SRH) rights in Kenya highlight several factors which underlie the high and increasing rates of maternal mortality in Kenya. This inquiry undertaken by the Kenya National Commission on Human Rights (KNCHR) during 2011 had the overall aim to establish the extent and nature of violation of sexual and reproductive health (including maternal health) rights and to recommend appropriate redress measures.

‘The Public Inquiry Panel receiving evidence from a witness in Kitale’ 12-13 July 2011’

Source: knhcr.org

Maternal health’ refers to the health of women during pregnancy, childbirth and the postpartum period (usually up to 42 days). As such, the right to maternal health should encompass access to antenatal care services; delivery services, including delivery by caesarean section where necessary; essential newborn care services and postpartum care services especially during the first 48 hours of delivery. Provision of these services requires availability of trained service providers (midwives, nurses, doctors and clinical officers) at all times and the capacity of facilities to respond to emergency cases, adequate physical facilities, and adequate equipment and supplies including essential medicines and vaccines.

Improving maternal health is the fifth Millennium Development Goal (MDG5). It has two targets: 5.A: Reduce by three quarters between 1990 and 2015, the maternal mortality rate; and 5.B: Achieve, by 2015, universal access to reproductive health. The indicators to show attainment of these targets are as follows: 5A- Maternal Mortality Ratio (MMR) and Proportion of births attended by skilled health personnel; and 5B- Contraceptive prevalence rate (CPR); Adolescent birth rate; Antenatal care coverage; and Unmet need for family planning. Analysis of the latest available data on Target 5A shows that MMR in Kenya remains high and has not started showing any downward trend, nor has there been an increase in the proportion of births attended by skilled health personnel. In the case of Target 5B, on the other hand, it is encouraging to note the recent rising trend in CPR which, if sustained, may get close to the figure projected for 2015.

The factors behind the high and increasing levels of maternal mortality in Kenya fall in the following broad categories: widespread poverty; limited access to health care services; limited availability of skilled attendance at childbirth including inadequate referral systems; and high prevalence of negative socio-cultural practices such as early marriage and FGM. A key cross-cutting factor is inadequacy of funding to the health sector, and disproportionate allocation for reproductive health services within the health budget.

The right to maternal health care services is recognized or implied in several international, regional and national instruments, which many African governments including the Government of Kenya have ratified. Among these are: The Covenant on Economic, Social and Cultural Rights (1966); The International Conference on Population Development Programme of Action (1994); The United Nations Millennium Development Goals (2000); The Maputo Plan of Action on Sexual and Reproductive Health and Rights (2006); Campaign on Accelerated Reduction of Maternal Mortality in Africa (CARMMA) (2009); The Constitution of Kenya, 2010 (Article 43 (a); The National Reproductive Health Policy 2007; and The Prohibition of Female Genital Mutilation Act 2011.

In these, the State is obliged to fulfill SRH Rights ‘progressively’, depending on the resources available to them. The state is obliged to show that it is making ‘measurable progresses’ towards the full realization of the SRH Rights and to restrain from adopting ‘regressive measures’. At the same time, there are those rights for which the state is under obligation to effect immediately, for instance, the obligation to respect an individual’s freedom to decide freely if, when and how often to reproduce and the obligation to ensure freedom from discrimination and from degrading treatment.

The core obligations that are relevant to SRH Rights, which states are under obligation to fulfill immediately, include ensuring:

  • Access to health facilities, goods and services on a non-discriminatory basis, especially for vulnerable or marginalized groups;
  • Access to essential drugs, as defined under the WHO Action Programme on Essential Drugs
  • Equitable distribution of health facilities, goods and services including trained health personnel;
  • Availability of reproductive health services including maternal and child healthcare;

A human rights-based approach to reproductive health care recognizes that all human rights are universal, interrelated, indivisible, and interdependent and are inherent in all human beings. It acknowledges that sexual and reproductive rights cannot be realized without the realization of other broader human rights, for example, the right to information, privacy and confidentiality and education.

The status of maternal health rights is determined by the effectiveness maternal health care services at all levels, namely in terms of: accessibility, availability, quality, affordability and acceptability. From the Public Inquiry findings the following conclusions can be made:

  • The physical accessibility of delivery services is an important issue of concern especially in the arid and semi-arid zones where significant percentages of the population must travel long distances to access health facilities.
  • Many facilities lack transportation support for maternity emergencies. There was evidence that most facilities in rural areas were ill equipped to handle emergency deliveries and women who needed C-sections in small facilities often died or lost their babies because they could not be transferred to a higher level in good time.
  • Lack of safe abortion services in Kenya has resulted in those seeking termination of pregnancy to resort to crude and unsafe methods, often with fatal consequences. There is a lack of awareness regarding provisions in the Constitution of Kenya 2010 (Article 26(4)) among healthcare providers and the general public.
  • The quality of maternal health services countrywide remains an issue of serious concern. Some of the key quality issues that have been highlighted are: lack of basic supplies such as cotton wool, pads, gloves, syringes, surgical blades, linen to wrap babies, anaesthesia, disinfectants, medicines, bed sheets, and blankets; dirty and unhygienic conditions; women forced to share beds or sleep on the floor; and the lack of food and hot water for bathing, etc. Overall, the factors that undermine the quality of maternal health services in Kenya were summarized as: (a) Lack of supplies and equipment; (b) Understaffing and lack of training and supervision; (c) Negligence and unethical practices by health providers; and (d) Weak Referral System.
  • Non-affordability of services is a serious impediment to accessing maternal health care throughout the country. Witnesses testified that the high cost of hospital delivery, especially the fees charged at level 4 and 5 facilities, was a key hindrance to accessing skilled maternal health services.
  • Acceptability of maternal health services- evidence from the Inquiry indicated that some communities did not utilize skilled delivery services because of cultural restrictions, mainly taboos regarding attendance by male nurses, which was prevalent among the Muslims in upper Eastern and North Eastern Kenya, as well as among the Sabaot of Western Kenya. These cultural preferences, together with the chronic shortage of skilled professionals in these areas, and the non-affordability of fees for services, come out as the main factors that perpetuate the demand for the Traditional Birth Attendants (TBAs).

Based on its findings the Public Inquiry concluded that women in Kenya continue to die or suffer disability due to preventable causes. The Inquiry notes that the causes of these deaths prevail against the backdrop of the myriad international and regional human rights frameworks and commitments that Kenya is a party to and the national legal, policy and institutional frameworks that are aimed at enhancing maternal health. From the foregoing therefore, the Public Inquiry concluded that Kenya is still far from realizing the maternal health rights and has made a number of recommendations to government and other stakeholders that are essential in working towards the realization of maternal health rights in Kenya, and the achievement of MDG5 and Vision 2030 goal.

Implementing the Reproductive Health Provisions of the Kenya Constitution

Implementation of RH provisions of Kenya Constitution- KMA conf

Focus on providing safe abortion services, not post-abortion care.

In order to minimize the problem of unsafe abortion and its impacts there is an urgent need for a paradigm shift in strategic planning, from the present focus on ‘post-abortion care’ to provision of ‘safe abortion services’. The present challenge for Kenya under the new constitutional dispensation ought to be ensuring all women who are legally entitled to legal termination of pregnancy do access the services without unnecessary impediments.

Addressing the problem of unsafe abortion in Kenya should significantly contribute to the achievement of Millennium Development Goal 5 on Improving Maternal Health, considering that unsafe abortion is one of the major factors behind the high maternal mortality rates in the country. In addition, complications resulting from unsafe abortion contribute to serious sequelae for women’s reproductive health such as chronic pelvic inflammatory disease (PID) and infertility. The incidence of unsafe abortion generally reflects the magnitude of unwanted (unplanned) pregnancies in a particular community. Hence, the only sure way of effectively minimizing unsafe abortion is to ensure women have easy access to safe, effective and acceptable contraceptive information and services, backed up by policies that promote social justice and equality, enhanced status of women, as well as legislation that decriminalizes abortion.

The single, greatest challenge to addressing unsafe abortion in Africa is the lukewarm commitment on the part of governments to promote, protect and respect women’s reproductive rights, including the right to access safe and legal abortion services. This lack of political will affects the availability, accessibility, and quality of abortion-related care.

For several years there has been a mistaken notion that post-abortion care (PAC) services provide the solution to morbidity and mortality associated with unsafe abortion[i]. Consequently considerable resources have been expended on expansion of these services. Unfortunately, although PAC services can (and do) save lives, in many respects the intervention comes late, at the tail-end of the train of events that precipitated the tragedy in the first place, and as such they cannot be considered an efficient public health strategy for the prevention of abortion-related morbidity and mortality.

Prevention of unsafe abortion requires a paradigm shift in strategic planning, to a focus on provision of ‘safe abortion, not post-abortion care, services’.

‘Safe abortion’ services are those provided by trained health workers, supported by policies, regulations and a functional health infrastructure, including equipment and supplies[ii]. Performance of abortion outside these conditions constitutes ‘unsafe abortion’.

The new Constitution of Kenya, while maintaining the longstanding restrictive stance towards abortion, it nevertheless, does provide opportunities for enhancing the reproductive health and rights of Kenyan women. The Constitution is explicit in the chapter on Bill of Rights regarding circumstances when abortion may be legal. Article 26 (4) states: Abortion is not permitted unless, in the opinion of a trained health professional, there is need for emergency treatment, or the life or health of the mother is in danger, or if permitted by any other written law. Although several questions arise from this statement, for example: Who is a trained health professional? Is there any emergency that does not threaten life or health of the mother? What definition of ‘health’ is implied here? etc., whatever the answers may be the Constitution has entrenched the right for a woman to have a legal abortion, though under certain conditions.  The present challenge for Kenya then is to ensure women who are legally entitled to legal termination of pregnancy can access the services without hindrance or delay.

Experience in other countries where abortion has been legalized shows that women are often denied safe abortion services to which they are legally entitled[iii]. The reasons for this include the following:

  • Provider related factors: lack of knowledge of the law, or failure to apply the law, by providers, negative provider attitudes, biases and conscientious objection, and lack of awareness (or neglect) among providers of their ethical/legal obligations to provide women in need with appropriate information on where safe abortion services can be obtained.
  • Medical policies and bureaucracy: insistence on unnecessary/outdated medical abortion techniques e.g. requirement for hospitalization, use of general anaesthesia, etc.; opposition to task-shifting, and other regulatory bottlenecks.
  • Other factors: lack of public information about the law; lack of awareness about facilities providing safe abortion services; lack of awareness (among women) of need to report early in pregnancy.

[i] Mati JKG J. Adolescent reproductive health in the era of HIV/AIDS: Challenges and Opportunities. Obstet. Gynecol. East Cent. Afr. (2005); 18: 1-18

[ii] World Health Organisation. (2003) Safe Abortion: Technical and Policy Guidance for Health Systems. Geneva, World Health Organisation

[iii] World Health Organisation. (2003) Safe Abortion: Technical and Policy Guidance for Health Systems. Geneva, World Health Organisation

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