A1c is an unreliable diagnostic test for diabetes

Using the hemoglobin A1c to diagnose diabetes tends to underestimate the prevalence of the disease, suggests a study presented at ENDO 2019, the Endocrine Society’s annual meeting in New Orleans, Louisiana.

In the study, 9,000 adults without a diabetes diagnosis were randomized to an A1c test and an oral glucose tolerance test (OGTT). Comparison of the results showed that using A1c as a diagnostic test missed about 73% cases of diabetes that were detected by OGTT. Race and ethnicity were found to have a significant impact on the accuracy of the test. A1c was more likely to detect abnormal glucose levels in non-Hispanic whites than in non-Hispanic blacks or Hispanics.

As per the authors of the study, A1c, when used solely to define diabetes is a highly unreliable test and significantly underestimates the prevalence of diabetes. A1c should be used along with OGTT for improved accuracy of detection.

The American Diabetes Association recommends measuring HbA1c to diagnose prediabetes and diabetes due to its “greater convenience (fasting not required), greater preanalytical stability and less day-to-day perturbations during stress and illness.” HbA1c value of ≥6.5% has been established as the diagnostic figure associated with diabetes.

However, A1c has lower sensitivity to diagnose diabetes. A1c can give false results in some people.

·         People of African, Mediterranean, or Southeast Asian descent, or people with family members with sickle cell anemia or a thalassemia are particularly at risk of interference. People in these groups may have a less common type of hemoglobin, known as a hemoglobin variant that can interfere with some A1c tests.

·         A falsely low A1c result may be seen in people with anemia, heavy bleeding.

·         A falsely high A1c result is seen in individuals who are very low in iron, e.g., those with iron deficiency anemia.

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

Hon’ble Supreme Court: Death due to mosquito bite is not an accident under insurance policy

Dr KK Aggarwal &d Advocate Ira Gupta

On Tuesday i.e. 26^th March, 2019, the Hon’ble Supreme Court in the matter titled as “The Branch Manager, National Insurance Co. versus Smt. Mousmi Bhattacharjee & Others, Civil Appeal No. 2614 of 2019 has held that in a policy of insurance which covers death due to accident, the peril insured against is an accident: an untoward happening or occurrence which is unforeseen and unexpected in the normal course of human events. The death of the insured in the present case was caused by encephalitis malaria and insured was based in Mozambique which malaria prone area as per WHO.  Thus, the illness of encephalitis malaria through a mosquito bite cannot be considered as an accident. It was neither unexpected nor unforeseen. It was not a peril insured against in the policy of accident insurance.

A person who suffers from flu or a viral fever cannot say that it is an accident. Of course, there is an element of chance or probability in contracting any illness. Even when viral disease has proliferated in an area, every individual may not suffer from it. Getting a bout of flu or a viral illness may be a matter of chance. But a person who gets the flu cannot be described as having suffered an accident: the flu was transmitted in the natural course of things. To be bitten by a mosquito and be imbued with a malarial parasite does involve an element of chance. But the disease which is caused as a result of the insect bite in the natural course of events cannot be regarded as an accident. Particularly, when the disease is caused in an area which is malaria prone.

Facts of the case

·         The insured was working as a Manager of a Tea Estate in Assam.

·         He thereafter took up employment in 2012 as a Manager of a Tea Factory at 

Cha-DeMagoma, District Gurue, Province-Zambezia, Republic of Mozambique.

·         During his stay in Mozambique, the insured was admitted to the hospital on 

14 November 2012. He was diagnosed with encephalitis malaria and died on 

22 November 2012 due to multi-organ failure.

·         His death certificate issued by the Republic of Mozambique spelt out the conditions and causes of death thus:

“VII. Conditions and causes of death

56. Causes of the Death                   WRITE ONE DIAGNOSIS PER LINE

Direct cause                                    a) Multi organ failure

Intermediary cause                          b) Encephalitis Malaria

Basic Cause                                    c) Pnasituria – Malaria.”

·         The heirs of the deceased filed a complaint under the Consumer Protection Act 1986 before the District Consumer Disputes Redressal Forum alleging that the insurer had committed a deficiency of service in not settling the claim under the insurance cover.

·         By an order dated 28 February 2014, the District Forum allowed the claim.

·         The State Commission by its order dated 2 February 2016 affirmed the order of the District Forum, holding that a “sudden death due to mosquito bite in a foreign land” was an accident; it would be rather silly to say that it was a natural death.

·         The order of the State Commission was assailed in revision before the National Commission which also allowed the claim of the complainant.

Question to be decided by Hon’ble Apex Court

Whether a death due to malaria occasioned by a mosquito bite in Mozambique, constituted a death due to accident?

Judgment of the Hon’ble Supreme Court

14. In order to constitute an accident, the event must be in the nature of an occurrence which is unnatural, unforeseen or unexpected. The present case concerns death caused due to a disease being contracted. Section II of the insurance policy covers death caused by accident. Death or injury from accident caused by insanity or venereal disease has been specifically excluded and not covered under the policy. The issue is whether death caused by any other disease not specifically excluded under the policy, is be covered.

18. As the law of insurance has developed, there has been a nuanced understanding of the distinction between an accident and a disease which is contracted in the natural course of human events in determining whether a policy of accident insurance would cover a disease. At one end of the spectrum is the theory that an accident postulates a mishap or an untoward happening, something which is unexpected and unforeseen. This understanding of what is an accident indicates that something which arises in the natural course of things is not an accident. This is the basis for holding that a disease may not fall for classification as an accident, when it is caused by a bodily infirmity or a condition. A person who suffers from flu or a viral fever cannot say that it is an accident. Of course, there is an element of chance or probability in contracting any illness. Even when viral disease has proliferated in an area, every individual may not suffer from it. Getting a bout of flu or a viral illness may be a matter of chance. But a person who gets the flu cannot be described as having suffered an accident: the flu was transmitted in the natural course of things. To be bitten by a mosquito and be imbued with a malarial parasite does involve an element of chance. But the disease which is caused as a result of the insect bite in the natural course of events cannot be regarded as an accident. Particularly, when the disease is caused in an area which is malaria prone. 

On the other hand, there may well be instances where a bodily condition from which an individual suffers may be the direct consequence of an accident. A motor car accident may, for instance, result in bodily injuries, the consequence of which is death or disability which may fall within the cover of a policy of accident insurance. Hence, it has been postulated that where a disease is caused or transmitted in the natural course of events, it would not be covered by the definition of an accident. However, in a given case or circumstance, the affliction or bodily condition may be regarded as an accident where its cause or course of transmission is unexpected and unforeseen.

20. In a policy of insurance which covers death due to accident, the peril insured against is an accident: an untoward happening or occurrence which is unforeseen and unexpected in the normal course of human events. The death of the insured in the present case was caused by encephalitis malaria. The claim under the policy is founded on the hypothesis that there is an element of uncertainty about whether or when a person would be the victim of a mosquito bite which is a carrier of a vectorborne disease. The submission is that being bitten by a mosquito is an unforeseen eventuality and should be regarded as an accident. We do not agree with this submission. The insured was based in Mozambique. According to the World Health Organization’s World Malaria Report 2018, Mozambique, with a population of 29.6 million people, accounts for 5% of cases of malaria globally. It is also on record that one out of three people in Mozambique is afflicted with malaria. In light of these statistics, the illness of encephalitis malaria through a mosquito bite cannot be considered as an accident. It was neither unexpected nor unforeseen. It was not a peril insured against in the policy of accident insurance.

21. We are hence of the view that the interpretation placed on the terms of the insurance policy was manifestly incorrect and that the impugned order of the National Commission is unsustainable.”

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

Postmenopausal women at high risk of fractures should be treated for osteoporosis

Osteoporosis is often a silent disease and is responsible for minimal trauma fractures in the hip, spine and ribs later in life.

In contrast to senile osteoporosis, osteoporosis occurs much more in the spine in postmenopausal osteoporosis, which is a cancellous bone.  In senile osteoporosis, bones are 50-50, cancellous as well as cortical.  Osteoporosis occurs both in the spine and hip. The commonest fractures in osteoporosis are spine fractures in postmenopausal women followed by fractures in hip and wrist.

The Endocrine Society has published new clinical practice guidelines on the management of osteoporosis in postmenopausal women. The guidelines were presented at ENDO 2019, its annual meeting in New Orleans, La.

Some key recommendations from the guidelines include:

·         Postmenopausal women at high risk of fractures, especially those who have experienced a recent fracture, should receive pharmacological therapies, as the benefits outweigh the risks.

·         Initial treatment with bisphosphonates to reduce fracture risk.

·         Reassess fracture risk after 3-5 years in women taking bisphosphonates.

·         Women who remain at high risk of fractures should continue therapy, while those who are at low-to-moderate risk of fractures should be considered for a “bisphosphonate holiday.”

·         Using denosumab as an alternative to bisphosphonates for the initial treatment of high-risk individuals.

·         Daily calcium and vitamin D supplementation for postmenopausal women at high risk of fracture with osteoporosis who cannot tolerate bisphosphonates, estrogen, selective estrogen response modulators (SERMs), denosumab, tibolone, teriparatide and abaloparatide.

·         Monitor bone mineral density by DEXA spine and hip in postmenopausal women with a low bone mineral density and at high risk of fractures every 1 to 3 years to evaluate response to treatment.

(Source: Endocrine Society News Release, March 25, 2019; J Clin Endocrinol Metab. May 2019;104(5)

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

Screening test for endothelial function

Brachial artery ultrasound is a commonly used and widely accepted method to evaluate the peripheral macrovascular endothelial function.

Inflating the blood pressure cuff at suprasystolic pressures for 5 minutes occludes the upper arm proximal to the ultrasound measurement. When this occlusion is released, endothelial-dependent, nitric oxide NO-driven, flow-mediated dilation (FMD) of the brachial artery occurs due to an increase in shear stress. Both diameter and blood velocity are measured before and after occlusion at the end of the diastole. The results are reported as a percent change from baseline.

The reported vascular response to increased flow has been shown to be a surrogate for measuring coronary endothelial function.

The stimuli for measuring endothelial reactivity include reactive hyperaemia, exercise, mental stress, or sympathetic nervous activation through the cold pressor test.

Peripheral endothelial dysfunction, as measured by FMD of the brachial artery, was shown to be associated with a higher rate of incident adverse cardiovascular disease (CVD) events during a five-year follow-up period in the MESA study.

For the screening test, an ultrasound is not needed. Just inflate the blood pressure cuff at suprasystolic pressures for five minutes and occlude the upper arm. When the occlusion is released, there is an endothelial-dependent, nitric oxide NO-driven, flow-mediated dilation and increased velocity of the brachial artery. Clinically, this presents as a sudden feeling of warmth in the arm, which suggests normal endothelial function.

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

Plazomicin, a new antibiotic for complicated urinary tract infections

Plazomicin was noninferior to meropenem, a carbapenem for the treatment of complicated urinary tract antibiotics (UTIs) and acute pyelonephritis caused by Enterobacteriaceae, including multidrug-resistant strains in a study published February 21, 2019 in the New England Journal of Medicine.

Plazomicin is a new aminoglycoside antibiotic.

In the study, more than 600 patients with complicated UTIs were randomized in a 1:1 ratio to receive intravenous plazomicin (15 mg/kg once daily) or meropenem (1 g every 8 hours), with optional oral step-down therapy after at least 4 days of IV therapy, for 7-10 days. 

Plazomicin was noninferior to meropenem with respect to the primary efficacy end points of the study.

·         Composite cure (clinical cure and microbiologic eradication) at day 5 was observed in 88% of patients in the plazomicin group vs 91.4% in the meropenem group.

·         At the test-of-cure visit (15 to 19 days after initiation of therapy), composite cure was observed in 81.7% and 70.1%, respectively

·         Microbiologic eradication, including eradication of Enterobacteriaceae that were not susceptible to aminoglycosides was higher in the plazomicin group vs meropenem group; 78.8% vs. 68.6%, respectively) and Enterobacteriaceae that produce extended-spectrum β-lactamases (ESBL); 82.4% vs. 75.0%, respectively.

·         Fewer patients in the plazomicin group had microbiologic recurrence (3.7% vs. 8.1%) or clinical relapse (1.6% vs. 7.1%) vs meropenem group. 

Both plazomicin and meropenem were well-tolerated; increase in serum creatinine levels was uncommon but higher with plazomicin.

These findings suggest plazomicin as a short duration intravenous alternative for outpatients who cannot take ertapenem for complicated UTI when there is risk of ESBL-producing organisms

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

Government Doctors’ Exodus: Ill-gotten Gains

The Madras High Court has taken serious note of the growing occurrence of government doctors abandoning their duties to start private practice for “personal enrichment”

By Dr KK Aggarwal

Expressing concern over government doctors who abandon their duties for developing their private practice and “personal enrichment”, the Madras High Court, in a judgment delivered on March 13, 2019, has directed the state government to constitute a monitoring committee to supervise the attendance and assess the performance of government doctors as well as look into the maintenance of government hospitals as per prescribed standards. The Court took serious note of the tendency of government doctors to, after gaining experience and exploiting government resources for acquiring their speciality qualifications and practical experience, leave their job for personal enrichment.

To understand the issue better, it may be pertinent to look at Clause 7.23 of the MCI Code of Ethics Regulations, 2002, which says that “if a physician posted in a rural area is found absent on more than two occasions during inspection by the Head of the District Health Authority or the Chairman, Zila Parishad, the same shall be construed as a misconduct if it is recommended to the Medical Council of India/State Medical Council by the State Government for action under these Regulations”. Further, Clause 7.24 says “if a physician is posted in a medical college/institution both as teaching faculty or otherwise, he shall remain in hospital/college during the assigned duty hours. If they are found absent on more than two occasions during this period, the same shall be construed as a misconduct, if it is certified by the Principal/Medical Superintendent and forwarded through the State Government to Medical Council of India/ State Medical Council for action under these Regulations”.

However, by way of a 2003 notification, these two clauses were conveniently omitted. The notification reads as follows: “In exercise of the powers conferred under section 20A read with section 33(m) of the Indian Medical Council Act, 1956, the Medical Council of India, with the previous approval of the Central Government, hereby makes the following amendments to the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002: The regulations, 7.23 and 7.24 appearing under Chapter 7, shall be omitted.” As a result, doctors posted in rural areas are regulated by their employer under the state service rules but not by the medical council.

In the above case, the Madras High Court said that under Article 21 of the Constitution, the right to life includes availability of decent medical facilities to all citizens and the State is duty-bound to ensure that medical treatments and facilities are provided at par and equally. The Court further stated: “Government hospitals are equipped with advanced medical equipment and infrastructure. But the utilisation of medical equipment and infrastructural facilities is not regulated. The machineries are not maintained properly as per the instructions provided by the manufacturers. Sometimes, medical equipment and facilities are misused by medical practitioners and employees of hospitals by mishandling or not operating as per the instructions.”

The Court further noted that: “Government doctors gain rich experience at the cost of public money….Poor men are being used as guinea pigs for learning. A poor man’s dead body is dissected and provided for learning. The government resources and the life of poor men are under the mercy of these government doctors. If no adequate measures are taken to monitor the quality of treatment and performance, the State is failing in its duty to uphold the right to life ensured to every citizen under Article 21 of the Constitution.” The Court also noted that apart from the prevalence of corrupt practices in government hospitals, doctors are irregular in attending duty, resulting in deaths of several patients, not all of whom are in a position to afford quality treatment in corporate hospitals. The situation results in denial of social justice and equal treatment. The Court went on to say that the economic condition of a citizen cannot be a ground for denial of quality treatment and thus, the government is duty-bound to ensure cleanliness, availability of doctors including speciality treatment, paramedical staff, supporting staff, etc.

Last year, in the matter of State of Uttar Pradesh & Others vs Achal Singh, the Supreme Court had dismissed a plea by a government doctor, Achal Singh, seeking voluntary retirement from government service. The apex court had held that the government may fill the vacancies, if any. But that would not bring doctors of experience at senior level, and exodus of doctors cannot be permitted to weaken the services when public interest requires them to serve for the sake of an efficient medical profession and fulfil the Directive Principles of State Policy. The Court further stated that when services are required, denial of voluntary retirement is permissible under the Medical Council Rules applicable in the state of Uttar Pradesh.

But why are so many government doctors quitting? What are the systemic compulsions and pitfalls that are compelling them to take such a step? Some possible reasons are: (a) Doctors are often not given their due salaries. The pay structure differs from state to state. Most doctors, from day one itself, start looking for jobs in metro cities for better pay; (b) Doctors do not find incentives in rural areas. Thus, rural salaries should be more than or equal to urban salaries as in Gulf countries; (c) The magnitude of care may differ, but the quality of care should be the same pan-India. All similar hospitals should have similar infrastructural facilities; (d) Doctors who are in the prime of their life (immediately after MBBS or MD) should not be posted to areas where they start de-learning their knowledge and experience due to non-availability of drugs, basic machines and other infrastructure; (e) Most doctors also shift for better prospects, like in any other industry, and this is not against the law. Even the Supreme Court, in the 2011 case of Kanwarjit Singh vs State of Punjab,  held that if a medical professional has acted in a manner which is contrary only to government instructions de hors any criminal activity or criminal negligence, the same would constitute an offence neither under the Indian Penal Code nor under the Prevention of Corruption Act.

To remedy the problem of doctors abandoning government services, the following corrective steps can be taken: (a) The MCI must reamend its ethics regulation and re-bring this in their domain; (b) States must ensure proper maintenance of medical infrastructure and equipment; (c) Every hospital must have an internal redressal mechanism to deal with such complaints; (d) The government should ensure a uniform pay structure for government centres pan-India. It must also be borne in mind that when a doctor is transferred from one place to another, often he/she resigns from the post or seeks voluntary retirement as he/she doesn’t want to move out and leave the lucrative private practice, and joins duty only when he/she obtains a posting to a place of his choice. In such a scenario, people should not be deprived of the services of good doctors.

Reproduced from: http://www.indialegallive.com/madras-high-court/government-doctors-exodus-ill-gotten-gains-62255, Published March 23, 2019

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

14th Signal Review Panel Meeting of Pharmacovigilance Programme of India (PvPI) held on 28th February

·         Amikacin-associated blurred vision: Signal Review Panel suggested PvPI to continue the close monitoring for amikacin associated blurred vision.

·         Ofloxacin-associated mouth ulcer: Signal Review Panel suggested PvPI to continue the close monitoring for ofloxacin associated mouth ulcer.

·         Bedaquiline-associated hypokalemia: Signal Review Panel suggested PvPI to continue the close monitoring and collect the baseline value of potassium prior initiation of treatment for all reported cases of bedaquiline-associated hypokalemia in PvPI database.

·         Clobazam-associated alopecia: SRP suggested PvPI to continue the close monitoring for clobazam-associated alopecia.

·         Telmisartan-associated lichenoid keratosis: SRP suggested PvPI to continue the close monitoring for telmisartan-associated lichenoid keratosis.

·         Tramadol-associated hiccups: PvPI to suggest CDSCO to take necessary steps to incorporate hiccups as an adverse drug reaction into the PIL of the tramadol marketed in India.

·         Phenobarbital-associated DRESS syndrome: The SRP recommended PvPI to suggest CDSCO to take necessary steps to incorporate DRESS syndrome as an adverse drug reaction into the PIL of the phenobarbital marketed in India.

·         Cefepime-associated urticaria: The SRP recommended PvPI to suggest CDSCO to take necessary steps to incorporate urticaria as an adverse drug reaction into the PIL of the cefepime marketed in India.

·         Glibenclamide-associated palpitation: The SRP recommended PvPI to suggest CDSCO to take necessary steps to incorporate palpitation as an adverse drug reaction into the PIL of the glibenclamide marketed in India.

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA