GLOBAL NEUROLOGY REPORT: WORLD ASSOCIATION FOR MEDICAL LAW MEETING 2018

Topic:  Electronic Fetal Monitoring in Developing Nations – A Public Health Threat

The 24th World Association for Medical Law (WAML) Congress was held in Tel Aviv, Israel on 2-6 September 2018.  Leading international experts discussed topics related to Global Health, Medical Law and Bioethics, with a focus on Public Health concerns.

James C. Johnston, MD, JD, reviewed the use of electronic fetal monitoring (EFM) in Africa, and presented a paper co-authored with pre-eminent medical malpractice attorney Thomas P. Sartwelle, renowned medical ethicist Professor Dr. Berna Arda, and leading neurologist Dr. Mehila Zebenigus from Ethiopia.

Dr. James C. Johnston raised the concern that EFM has no proven efficacy in childbirth yet it is being increasingly employed in sub-Saharan Africa in a misguided approach to reduce perinatal morbidity and mortality.  In fact, EFM has a 99.8% false positive rate, and does not prevent or predict cerebral palsy or any other neonatal neurological disorder.  It does cause significant harm by dramatically increasing the cesarean section rate with all of the attendant risks and complications of that procedure, as well as increasing the risk that babies born in this manner may have a higher incidence of developing chronic diseases such as juvenile arthritis, asthma, inflammatory bowel disease, and neurodevelopmental problems.

After reviewing the overwhelming evidence against EFM, Dr. James Christopher Johnston discussed the recent trend of developed countries to stop this procedure through specific guidelines published by birth-related professional organizations in the United States, United Kingdom, Canada, Australia and New Zealand.  For example, the United Kingdom National Institute for Health and Care Excellence states “Do not offer electronic fetal monitoring to women at low risk.”

Dr. James Christopher Johnston

The 24th World Association for Medical Law (WAML) Congress was held in Tel Aviv, Israel on 2-6 September 2018. Leading international experts discussed topics related to Global Health, Medical Law and Bioethics, with a focus on Public Health concerns.

And yet, EFM is rapidly increasing throughout sub-Saharan Africa due to a combination of intense marketing from the EFM manufacturing companies, and the failure of the medical community to understand that the procedure causes more harm than good to mothers and babies.  Dr. James C. Johnston provided specific examples of the marketing, including the Allied Market Research ‘Global Fetal Monitoring Report’ which concluded that the fetal monitoring market is expected “to reach USD 3.6 Billion by 2022,” that the market in “developing countries is lucrative,” and there is a “perpetual need” for these EFM machines.

Dr. James Christopher Johnston and his colleagues concluded that the WHO should establish guidelines stating that EFM is an experimental procedure that is not scientifically reliable, the standard of care does not warrant EFM in low risk pregnancies, and it should not be performed.  This will allow local health boards in each country to adopt the guidelines, and ensure the medical community stops harming mothers and babies through this procedure.  Then, the resources wasted on EFM can be properly allocated to provide additional training of midwives and healthcare workers, and provide care for children with cerebral palsy and related conditions.

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Global Neurology Report: WHO List of Essential Diagnostic Tests

On 15 May 2018, the World Health Organization (WHO) published the first Essential Diagnostics List, providing a catalogue of tests that are necessary to diagnose many common conditions as well as a number of global priority diseases.

This represents a crucial step to improving global healthcare since many people are unable to access diagnostic services, and others are incorrectly diagnosed due to poor quality or improper testing.  As a result, these people do not receive proper treatment and, in some cases, may actually be given the wrong treatment due to a misdiagnosis of their condition.

The list details 113 tests – 58 for common conditions such as diabetes, and the remaining 55 focus on priority diseases such as malaria, tuberculosis, HIV, hepatitis and syphilis.  Some of the tests are designed for primary health facilities in severely resource limited areas, and do not require electricity or trained laboratory technicians.  Other tests are more sophisticated and will necessarily be used in better equipped medical settings.

This Essential Diagnostics List will serve as a reference for countries to develop or update their own protocols within the context of local conditions, ensure appropriate supplies and equipment, and train personnel for the testing.

WHO intends to expand and update the list to incorporate additional non-communicable diseases, neglected tropical diseases, antimicrobial resistance and emerging conditions.

Drs. Mehila Zebenigus and James C. Johnston serve as Directors of Global NeuroCare®, an NGO accredited by WHO and in Special Consultative Status with the UN ECOSOC, and strongly support this initiative.

The full document may be accessed through the following link:

http://www.who.int/medical_devices/diagnostics/EDL_ExecutiveSummary_15may.pdf

GLOBAL NEUROLOGY REPORT: A CRITIQUE OF ELECTRONIC FETAL MONITORING

 

The Surgery Journal recently published a peer reviewed critique of electronic fetal monitoring (EFM) by neurologist James C. Johnston, MD, JD and leading healthcare attorney Thomas P. Sartwelle.

These authors, Thomas P. Sartwelle and Dr. James C. Johnston, along with pre-eminent medical ethicist Professor Dr. Berna Arda, have repeatedly advised that continuous EFM should not be performed in routine labour due to a 99.8% false positive rate, and the fact it does not predict or prevent cerebral palsy or any other neonatal neurological injury.

EFM does increase the caesarean section rate, with an increase in maternal and newborn deaths and birth complications as well as devastating long term complications. In fact, these very concerns have led Australia, New Zealand and the UK to advise returning to intermittent auscultation (IA) instead of EFM, and in 2017 the American College of Obstetrics and Gynecology finally provided a long overdue recommendation that women be given an informed choice between IA and EFM.

Unfortunately, there are EFM apologists continuing to defend the procedure, and journal editors suppressing scientific debate on the topic. This most recent Surgery Journal article exposes one example of these harmful practices, and should raise serious questions about those EFM proponents recommending a procedure that causes more harm than good to mothers and babies alike. But perhaps the more disturbing aspect is a medical journal editor determined to stifle scholarly debate.

This open access article is available through the following link:

https://www.thieme-connect.com/products/ejournals/abstract/10.1055/s-0038-1632404

The authors have also published their concerns in the Journal of Child Neurology, Maternal Fetal and Neonatal Medicine, British Medical Journal, Neurologic Clinics, Journal of Pediatric Care, Maternal Health Neonatology and Perinatology, Medical Law International, Surgery Journal and several other journals and books. These articles are available at James C. Johnston’s ResearchGate.net site:

https://www.researchgate.net/profile/James_Johnston6/contributions

Electronic Fetal Monitoring and CP

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Dr. James C. Johnston is the founding partner of Global Neurology and Director of the non-profit organization Global NeuroCare. As a board-certified neurologist with thirty years of experience, Dr. James C. Johnston has authored over one hundred peer reviewed journal articles, papers and book chapters on various topics related to neurology and global health including cerebral palsy (CP).

The high rate of CP in developing nations has led many of these regions to seek electronic fetal monitoring (EFM) as a means of reducing perinatal mortality and morbidity. However, EFM is an ineffective modality with a 99% false positive rate, and does not predict cerebral palsy, acidemia, neonatal neurological injury, stillbirths or neonatal encephalopathy. It does increase the C-section rate and is a significant source of harm to mothers and babies.

Despite 50 years of continuous use of EFM, the cerebral palsy rate and rate of other neurological birth related maladies remains unchanged. Continuous EFM should not be used in normal pregnancies, especially in developing regions where it will waste money that is so desperately needed for prenatal and post-partum care for mothers and babies, and add another layer of undesirable morbidity and mortality to an already critical situation.

Dr. James C. Johnston and his colleagues have published a number of peer reviewed articles concerning EFM and CP. They have discussed CP litigation in the Journal of Child Neurology; ethical concerns related to EFM in Maternal Health, Neonatology and Perinatology; review of the Task Force failure to address this problem in J Maternal Fetal and Neonatal Medicine; the history of EFM and medical training for EFM in separate articles in the Surgery Journal; and some of the legal and ethical concerns in Medical Law International.

J of Child Neurology: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4431995/

Maternal Health, Neonatology and Perinatology: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5697350/

J Maternal, Fetal and Neonatal Medicine: https://www.ncbi.nlm.nih.gov/pubmed/26067269

Surgery Journal: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5530627/

Surgery Journal: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5553489/

Medical Law International: http://journals.sagepub.com/doi/abs/10.1177/0968533217704883

These and related articles are also available through Researchgate.net at https://www.researchgate.net/profile/James_Johnston6.

Global Neurology Report: Neurological Disorders are the Largest Cause of Disability

The Lancet: Life Expectancy

The Lancet: Life Expectancy

Neurological diseases are the main cause of disability worldwide according to a recent analysis of the Global Burden of Disease (GBD) Study. (Global, regional and national burden of neurological disorders during 1990-2015: A systematic analysis for the Global Burden of Disease Study 2015. Lancet Neurology 2017).

The significant increase in the burden from 1990-2015 occurred despite remarkable advances in the prevention and treatment of neurological disorders, and is partially attributable to population growth and aging. Additionally, the World Health Organization recently re-classified stroke as a neurological disease instead of a cardiovascular disorder which provided a more realistic view of the true neurological burden.

Cerebrovascular disease accounts for the largest proportion of disability adjusted life years, and in fact was the leading cause of disability in 18 of the 21 Global Burden of Disease regions including sub-Saharan Africa (SSA). And the study may underestimate the extent of stroke related disease and disability due to the paucity of data in many developing regions. More research is necessary to define the true extent of stroke and formulate effective prevention and treatment protocols that comport with the available resources in specific areas.

The most serious concern is in SSA which harbours the highest burden of disease, with the least resources, and has a population of one billion people that is expected to double in the next generation.

There are serious impediments to neurological care including stroke management in SSA – a dearth of specialists, limited imaging facilities, lack of medications, adherence to traditional beliefs and seemingly insurmountable infrastructural challenges, all superimposed on abject poverty with food and water insecurity. In addition to the high morbidity of stroke related complications, there are limited if any secondary stroke interventions, and an absence of neurorehabilitation. It is not surprising that the rates of stroke mortality and disability are ten-fold higher in SSA than in developed regions.

As a Director of Global NeuroCare, a non-profit organization dedicated to advancing neurological care in SSA and particularly Ethiopia, Dr. Johnston strongly recommends capacity building through sustainable, comprehensive, multimodality programs to address stroke prevention, treatment and rehabilitation, focusing on realistic goals that are commensurate to local resources. But, stroke prevention is of upmost importance, and funding should be allocated accordingly.

The most effective means of advancing neurological care is to form collaborative partnerships between developed countries and the least developed regions, with clearly defined goals, focusing on the needs of the South to establish self-sustaining programs that incorporate physician training, patient care and medical research, provide triangular cooperation and encourage South-South cooperation.

This is the approach Global NeuroCare has adopted with the Addis Ababa University Department of Neurology, which has an expanding, autonomous neurology residency program that has graduated 30 neurologists over the past decade. The program is now training physicians from other African nations and developing South-South ties that will serve to more effectively combat the neurological burden of disease.