IMA White Paper on Stent Controversy

IMA White Paper on Stent Controversy Report of the Core-Committee for Revision of National List of Essential Medicines November 2015 A Core-Committee was constituted by the Ministry of Health & Family Welfare (MOHFW), Government of India, under the chairmanship of Dr VM Katoch, the then Secretary, Department of Health Research (DHR) and Director General, Indian Council of Medical Research (ICMR), and Dr YK Gupta, Professor and Head, Department of Pharmacology, All India Institute of Medical Sciences (AIIMS) as the Vice Chairman. The Core-Committee in its initial meetings deliberated and decided on the criteria for inclusion and deletion of medicines in National List of Essential Medicines (NLEM). The criteria for inclusion of a medicine in NLEM are as follows: 1. The medicine should be approved/licensed in India 2. The medicine should be useful in a disease, which is a public health problem in India. 3. The medicine should have proven efficacy and safety profile based on valid scientific evidence. 4. The medicine should be cost effective. 5. The medicine should be aligned with the current treatment guidelines for the disease. 6. The medicine should be stable under the storage conditions in India. 7. When more than one medicines are available from the same therapeutic class, preferably one prototype/ medically best suited medicine of that class to be included after due deliberation and careful evaluation of their relative safety, efficacy and cost-effectiveness. 8. Price of total treatment to be considered and not the unit price of a medicine. 9. Fixed Dose Combinations (FDCs) are generally not included unless the combination has unequivocally proven advantage over individual ingredients administered separately, in terms of increasing efficacy, reducing adverse effects and/or improving compliance. 10. The listing of medicine in NLEM is based according to the level of health care, i.e. Primary (P), Secondary (S) and Tertiary (T) because the treatment facilities, training, experience and availability of health care personnel differ at these levels. The criteria for deletion of a medicine from NLEM are as follows 1. The medicine has been banned in India. 2. There are reports of concerns on the safety profile of a medicine. 3. A medicine with better efficacy or favorable safety profiles and better cost-effectiveness is now available. 4. The disease burden for which a medicine is indicated is no longer a national health concern in India. 5. In case of antimicrobials, if the resistance pattern has rendered a medicine ineffective in Indian context. The Core-Committee in its first two meetings, discussed in detail the modalities to be followed for revision of NLEM and prepared guiding principles and criteria for the revision of NLEM 2011 as under Criteria for Inclusion of a Medicine into NLEM 2015: For inclusion of a medicine into NLEM, the medicine should: 1. Be licensed/ approved in the country by Drugs Controller General (India) 2. Be useful in a disease, which is a public health problem in India 3. Have proven efficacy and safety profile based on valid scientific evidence 4. Be comparatively cost effective 5. Be aligned with the current treatment guidelines for the disease 6. Be stable under the storage conditions in India Medicines recommended under National Health Programmes of India are considered for inclusion in NLEM. In addition, the following criteria were also considered: 1. When more than one medicine are available from the same therapeutic class, preferably one prototype/ medically best suited medicine of that class to be included after due deliberation and careful evaluation of their relative safety, efficacy, cost effectiveness. 2. Price of total treatment to be considered and not the unit price of a medicine 3. FDC are not included unless the combination has unequivocally proven advantage over single compounds administered separately, in terms of increasing efficacy, reducing adverse effects and/or improving compliance 4. The medicine in NLEM will be based at P/S/T level of health care according to treatment facilities and training, experience and availability of health care personnel at these levels Criteria for Deletion of a Medicine A medicine will be deleted from NLEM 2011 in the following conditions 1. The medicine has been banned in India. 2. If there are reports of concerns on the safety profile of a medicine 3. If medicine with better efficacy or favorable safety profile and better cost-effectiveness is now available 4. The disease burden for which a medicine is indicated is no longer a national health concern 5. In case of antimicrobials, if the resistance pattern has rendered a medicine ineffective Stent Position • Stents and other devices are medicines and included in the Drugs and Cosmetics Act. • Stents have been put under NLEM and hence are an essential item and underprice capping. • Stents use drugs like sirolimus, everolimus, paclitaxel and zotarolimus • Each drug is different • Therefore, one category of each drug stent has to be in NLEM the one which is best suited • Only non-inferior latest stents of the same company with one best suited NLEM stent can be in non NLEM category • Most stents are built on a stainless-steel platform, the least-expensive stent material available. Unfortunately, stainless steel is not fully compatible with the human body and implantation usually is followed closely by restenosis and thrombosis. In addition, stainless steel can pose difficulties related to some types of imaging, such as magnetic resonance. Now alternative platform materials such as gold, titanium, cobalt-chromium alloy, tantalum alloy, nitinol and several types of polymers (Silicone, polyethylene and polyurethane) are available. • Some polymers are biodegradable, bio-absorbable, or bio-erodible. Biodegradable or bio-absorbable stents contain a major component (such as an enzyme or microbe) that degrades quickly enough to make them appropriate for short-term uses. A bio-erodible polymer is a water-insoluble polymer that has been converted into a water-soluble material. Biodegradable materials can form an effective stent coating because they can be mixed with an anti-re-stenotic drug and will degrade within a few weeks, thus releasing the drug into the surrounding tissue and reducing the risk of restenosis. • Examples of biodegradable polymers are: polyesters, polyorthoesters and polyanhydrides. Collagen is also very biocompatible and reduces the rate of restenosis and thrombosis. In addition, anticoagulants and fibrinolytic agents bound to the collagen can aid in drug delivery. How to choose a stent • Stents are characterized according to material composition, thickness of struts, and whether or not they are capable of eluting drugs for local delivery • Stent design may also be specific for certain indications such as small (<2.5 mm diameter) vessels or lesions involving a bifurcation of a main vessel and side branch. Vessels smaller than 2 mm are not suitable for stenting. • Tortuous, angulated, and calcified arterial segments pose challenges for even the newest stent designs because of difficulty delivering the stent to the target lesion. • The first two DES, called first generation stents, approved were sirolimus -eluting stent (SES) in 2003 and paclitaxel -eluting stent (PES) in 2004. • In 2008, the zotarolimus-eluting stent (ZES) and the everolimus-eluting stent (EES), called second generation stents, were approved. • EES and Resolute zotarolimus-eluting stent (R-ZES) are comparable in terms of efficacy and safety • Use newer generation DES in almost all cases, and either EES or R-ZES are preferred choices. For patients undergoing intracoronary stenting with a DES, IMA recommends an EES, either with a durable or bioresorbable polymer or R-ZES rather than a PES. • The choice between EES or R-ZES should be guided by issues such as cost, practitioner familiarity, and availability. • There have been two iterations of the ZES (Endeavor and Resolute); manufacturing of the older Endeavor-ZES has stopped internationally. • EES may have the lowest rate of stent thrombosis than all other DES, but one cannot make a recommendation to prefer EES to R-ZES based on this factor alone. • The results of the multicenter randomized ABSORB II study by Patrick Serruys and colleagues1published in The Lancet (Nov 19, p 2479) did not show non-inferiority in terms of late luminal loss (restenosis) or superiority in vasomotor reactivity of the bioresorbable vascular scaffolds compared with the drug-eluting stents. • Earlier this year, the multicenter randomized NORSTENT elective percutaneous coronary intervention trial showed no significant differences between participants receiving drug-eluting stents and those receiving bare-metal stents in the composite outcome of death from any cause and non-fatal myocardial infarctions. • The bare-metal stent technology has evolved into the drug-eluting stent technology that has produced a marked reduction in restenosis, at a cost of longer term dual antiplatelet therapy. Clinicians are trying to achieve the utopian 0% restenosis with more expensive technologies that present new problems such as thrombosis, neoatherosclerosis, stent recoil, and much stronger medications for longer durations. The ABSORB II and NORSTENT studies challenge the typical trend of showing the new thing to be shinier and the old thing dustier than they really are. • Clinicians should reflect and use cost-effective technologies that have stood the test of time before adopting newer technologies on a large scale. Durable Polymer • Xience (V, Prime, Xpedition): Abbott Vascular: Cobalt chromium: Everolimus • Promus (Element, Premier): Boston Scientific: Platinum chromium: Everolimus • Resolute: Medtronic: Cobalt chromium: Zotarolimus Bioabsorbable polymer: SYNERGY: Boston Scientific: Platinum chromium: Everolimus Older Cypher Cordis/J&J Stainless Steel Sirolimus Taxus Boston Scientific Stainless Steel Paclitaxel Promus Boston Scientific Cobalt chromium Everolimus Bare Metal Vision Abbott Vascular Cobalt chromium VeriFLEX Boston Scientific Stainless steel REBEL Boston Scientific Platinum chromium Integrity Medtronic Cobalt chromium Issues Can all stents be under NLEM? No. As per NLEM guidelines, when more than one medicine is available from the same therapeutic class, preferably one prototype/ medically best suited medicine of that class should be included after due deliberation and careful evaluation of their relative safety, efficacy, cost-effectiveness. Stents need to be classified in different groups; in each group, one of them must be in NLEM and the rest in non NLEM. Will the cost of the procedure increase to compensate for the loss of profit in selling stents? No. As per NLEM guidelines, the price of total treatment to be considered and not the unit price of a medicine. Are non-NLEM stents superior to NLEM stents? No. As per NLEM guidelines, a drug will be deleted from NLEM if there are reports of concerns on the safety profile of a medicine and if a drug with better efficacy or favorable safety profile and better cost-effectiveness is now available. All NLEM drugs have to be efficacious or proven safety and quality. Non-NLEM drugs should be non-inferior to the NLEM drugs. If a non-NLEM drug is superior to NLRM drug, it is likely to enter into NLEM category. Does costly means better? NLEM drugs will be cheaper and non-NLEM though costly, will be non-inferior to NLEM drugs. What do you mean by high end stents? Low end or high end stents, each will be a class. And, from each class, one drug must be in NLEM. Can hospital make profits from stents? As per NPPA clarification (20.2.2017), NPPA did not take price to hospitals (PTH) as price to retailers (PTR) & considered hospitals out of stents 'trade channel' for price fixing. That means there will be margins for the distributors but not for the hospitals. As per AIMED, the hospitals need to make income from procedure and compete with other hospitals and not from medical devices used in the procedure. Once hospitals won't make profits on Stents, their procurement will shift back to the buying price of product and quality. Can hospitals compel a patient to buy a drug only from hospital inventory? No. There are many state government, NCDRC and court decisions against it. If stent companies do not sponsor conferences, then who will? Why should drugs or stent companies sponsor conferences? Either doctors must pay for the learning and contribute or the hospitals should sponsor out of their profits. The delegation fee in any specialty conference nowadays is not less than Rs 10,000/-. How does we ensure that Indian stents are good? It is not our job to decide good or bad. Any stent approved by DCGI is good. The responsibility lies with the DCGI and the expert committee under Technical Drug Advisory Board (DTAB). In the Anuradha Saha case, the apex court said one needs to follow the label cleared by the DCGI. The DCGI also has a PvPi program (9717776514 phone number). If the department receives any report of side effects of any device, the device can be immediately taken off the market. Till today, the very fact that Indian stents can be marketed means no adverse effects have been notified to PvPI so far. What is IMA’s stand on routine pharma drugs? Write NLEM drugs and inform the patient about the reason, if prescribing non NLEM drugs. IMA campaign is “Write CAPITAL, Write NLEM”. A large segment of the society will thus be covered with affordable health care. Those who can afford can go for newer non-superior drugs with some special advantages for example longer-acting, mouth dissolvable, nanotechnology, more tasty formulations etc. How much can a cardiologist charge for the implantation? As per MCI, the only requirement is transparency and pre-procedure declaration. As per CEA, rates will be defined by the state government in consultation with organisations including the IMA. How should a prescription for a stent be written? Example: Advised Everolimus Drug Eluting stent with stable polymer. Avoid writing simply ‘advised stent’. Dr KK Aggarwal National President IMA & HCFI

Sedentary time associated with higher waist circumference & increased cardiovascular risk

Sedentary time associated with higher waist circumference & increased cardiovascular risk The negative health effects of a sedentary lifestyle are well known. Yet another study has shown a sedentary lifestyle to be associated with increased risk of heart disease. In a new study from UK published January 31, 2017 in the International Journal of Obesity led by Dr William Tigbe from Warwick Medical School, University of Warwick, workers who had desk jobs were found to have higher waist circumference and increased risk of heart disease. The study included 111 healthy non-smoking postal workers from Glasgow and randomized them into two groups: 55 were office workers and 56 walked/delivered post. The waist circumference was 2 cm higher in those who had desk jobs; 97 cm vs 94 cm, respectively. The risk of heart diseases was also higher in the workers who had desk jobs. 2.2% compared to 1.6% over 10 years. With each extra hour of sitting from five hours a day, the LDL ‘bad’ cholesterol increased and HDL ‘good’ cholesterol reduced. The various health benefits of walking are well recognized. It has been shown in a study published earlier this year in the American Journal of Epidemiology that lack of exercise affects the human body right up to the cellular level. Elderly women who sit for more than 10 hours a day with low physical activity had cells that were biologically older by eight years compared to women who are more active. Hence, physical activity is recommended for all ages. Getting people to move more is a key strategy for reducing the burden of NCDs, as outlined in WHO's Global Action Plan for the Prevention and Control of NCDs 2013-2020. The plan calls for a 10% relative reduction in insufficient physical activity by the year 2025 to achieve the Sustainable Development Goals (SDGs). White collar workers or people who have desk jobs spend most of their working hours sitting in chairs. Interventions that encourage walking and physical activity in the workplace are needed to counter the negative health effects of sedentary behavior. The IMA initiative ‘Move, Move and Move’ is a campaign to increase awareness about the benefits of physical activity and to encourage people to be more active at work and cut down on sedentary time. (Source: Medical News Today) Dr KK Aggarwal National President IMA & HCFI

IMA supports timely notification of notifiable diseases

IMA supports timely notification of notifiable diseases A notifiable disease is any disease that is to be reported to government authorities as required by the law. India has a double burden of NCDs and communicable diseases, despite the disease epidemiology transitioning to noncommunicable diseases because communicable diseases continue to be prevalent in the country and be major public health concerns. Every now and then, dengue makes it appearance, taking on an epidemic form. Last year, the national capital faced an unprecedented high number of Chikungunya cases. Cases of Bird flu have been reported. China is in the midst of an ongoing avian influenza A epidemic. With blurring of international boundaries and increasing travel, there is a threat of global spread of any infectious disease. The recent Zika virus infection outbreak in Mexico was declared a public health emergency of international concern. Zika is still spreading. Doctors alone can no longer be responsible for Public health. Prevention and control of outbreaks also requires commitment on the part of Policy makers, administrators and all stakeholders. Notification of disease is a step in this endeavor. Notification of a disease is an important source of epidemiological information. It allows mapping of affected areas, the epicentre in particular and take preventive steps to control the spread. Notification strengthens public health surveillance systems. Regulation 5.2 of the MCI Code of Ethics Regulations, 2002 require a physician to notify the constituted public health authorities of every case of communicable disease under his care. “5.2 Public and Community Health: Physicians, especially those engaged in public health work, should enlighten the public concerning quarantine regulations and measures for the prevention of epidemic and communicable diseases. At all times the physician should notify the constituted public health authorities of every case of communicable disease under his care, in accordance with the laws, rules and regulations of the health authorities. When an epidemic occurs a physician should not abandon his duty for fear of contracting the disease himself.” Indian Penal Code 269 says “Any negligent act likely to spread infection of disease dangerous to life is punished with imprisonment of either description for a term which may extend to six months, or with fine, or with both” and IPC 270 says “Malignant act likely to spread infection of disease dangerous to life with imprisonment of either description for a term which may extend to two years, or with fine, or with both.” While a doctor is expected to maintain privacy and confidentiality and not disclose the secrets of a patient that have been learnt in the exercise of his / her profession, exceptions to this in a court of law under orders of the Presiding Judge, in circumstances where there is serious and identified risk to a specific person and/or the community and in case of notifiable diseases (Regulation 7.14). In case of communicable / notifiable diseases, concerned public health authorities should be informed immediately. List of Notifiable Diseases 1. Cerebrospinal fever 12. Tuberculosis 2. Chickenpox 13. Infectious Hepatitis (Hepatitis A, B, C, D & E) 3. Diphtheria 14. Epidemic Influenza (Including Swine Flu (H1N1), Bird Flu & Seasonal Influenza) 4. Leprosy 15. Whooping cough 5. Cholera 16. Viral encephalitis 6. Measles 17. Hemorrhagic fever (Including Dengue) 7. Plague 18. Malaria 8. Rabies 19. Tetanus 9. Scarlet fever 20. Poliomyelitis 10. Smallpox* 21. AIDS 11. Typhoid/Enteric fever 22. Chikungunya 23. Any other disease which the Government may from time to time by notification declare to be a notified disease for the purpose of this part either generally throughout the state or in such part or parts thereof as may be specified in the notification. *Small Pox globally eradicated in the year 1980, but continues to be a notifiable disease. Not notifying diseases like TB, dengue or Chikungunya is a violation of the above regulations including local municipal acts. The Indian Medical Association (IMA) supports proper and timely notification of a notifiable disease. But, it also wants cancer, Zika virus disease and microcephaly to be included in the notifiable list. Dr KK Aggarwal National President IMA & HCFI

Shh Shh Shh ... Baat Nahi Karo: Hospitals should be Silence Zones

Shh Shh Shh ... Baat Nahi Karo: Hospitals should be Silence Zones Noise is a well-recognized problem in hospitals. Air-conditioning systems, medical devices, phones, pagers, alarms, people movement, conversations etc. all constitute background noise in hospitals. Adding to this is the traffic-related noise, as many hospitals may be located in congested areas. Noise has been recognized as an environmental stressor, which has both physiological and psychological effects. A growing body of literature has demonstrated the potential negative impact of noise pollution in hospitals on patients as well as doctors. Noise disrupts sleep, both quantity and quality of sleep. Sleeping is one way that the body recuperates and recovers from damage. A well-rested body is up to meeting the challenges and stress of daily life. Hence, sleep is very important for patient recovery. A noisy environment also weakens the immune system, increases BP and heart rate and adversely affects wound healing, pain management. Being exposed to constant noise may cause anxiety, stress and increase blood pressure. All these can delay patient recovery and increase hospital stay. Not only patients, doctors too are not left untouched by the negative impact of noise. Reduced concentration, headache, anxiety, annoyance/irritability resulting in reduced work efficiency are some of the outcomes of noise pollution. Perhaps most importantly, hospital noise interferes with oral communication, causing medical errors; at times with disastrous consequences for patient safety. Sound-alike drugs can cause confusion e.g. Isoprin/Isoptin, Amlopress AT/80mg. Controlling noise pollution is the need of the hour, particularly in relation to hospitals. Hospitals need to be silence zones as also areas up to 100 m around them Permissible noise limits in Silence zone are 50 dB in daytime (6am to 10 pm) and 40 dB in night time (10 pm to 6am). Public awareness is also very important to prevent and control noise pollution in hospitals. The general public needs to be sensitized to the adverse health impact of noise pollution. In an effort to control noise pollution within the hospitals, IMA will launch ‘Silent Hour’ in medical establishments. We will observe silence from 2 pm to 4 pm every day, when everyone should not talk or speak very softly to minimize noise. Shh Shh Shh ... Baat Nahi Karo … Dr KK Aggarwal National President IMA & HCFI

India sees Improved Sex Ratio & Decline in Infant Mortality Rate: National Family Health Survey

India sees Improved Sex Ratio & Decline in Infant Mortality Rate: National Family Health Survey

 

•  A latest survey by the government has shown positive trends in key health indicators, including an improvement in sex ratio at birth and a decline in infant mortality rate during 2015-16.
• The National Family Health Survey-4 (NFHS-4) for 2015-16 unveiled by the Health Ministry was conducted after collecting information from 6 lakh households, 7 lakh women and 1.3 lakh men, and for the first time provide district level estimates.
• "Infant Mortality Rate (IMR) declined from 57 to 41 per 1,000 live births between NFHS-3 (2005-06) and NFHS-4. IMR has declined substantially in almost all the states during the last decade. It dropped by more than 20 percentage points in Tripura, West Bengal, Jharkhand, Arunachal Pradesh, Rajasthan and Odisha.
• Infant Mortality Rate declined from 57 to 41 per 1,000 live births between NFHS 2005-06 and NFHS 2015-16.
• IMR substantially declined over the period from 79 per 1,000 live births in NFHS-1 (1992-93) to 41 per 1,000 live births in NFHS-4.
• Sex ratio at birth (number of females per 1,000 males) improved from 914 to 919 at the national level over the last decade with the highest in Kerala (1,047), followed by Meghalaya (1,009) and Chhattisgarh (977).  Haryana also witnessed a significant increase from 762 to 836.
• Institutional births "dramatically" increased by 40 percentage points from 38.7% in NFHS-3 to 78.9% in NFHS-4.
• There was an increase of 34.1% institutional births in public facility, while the Empowered Action Group (EAG) in Assam experienced more than a 40 percentage point increase.
• The proportion of women who received at least 4 antenatal care visits for their last birth has increased by 14 percentage points from 37% to 51.2% over the decade (2005-15), while there has been a substantial increase of 20 or more percentage points in seven states.
• Total Fertility Rate (TFR) too declined to 2.2 children per woman from 2.7 in NFHS-3 moving closer to target level of 2.1
• There was considerable decline in the TFR in each of the 30 states in India with the maximum decline observed in Uttar Pradesh (1.1 child) followed by Nagaland (1.0 child), Arunachal Pradesh and Sikkim (0.9 child each). Bihar, however, failed to register substantial decline.
• Children within the age of 12-23 months have been fully immunized (BCG, measles and 3 doses each of polio) and DPT increased by 18 percentage points from 44% in NFHS-3 to 62% in NFHS-4
• The survey found that the full immunization coverage increased in Punjab, Bihar and Meghalaya by 29 percentage point each, while in Rajasthan, Uttar Pradesh, Jharkhand and Chhattisgarh it increased by 28 percentage points each. 
• There was a decline in percentage of underweight children by 7 percentage points, a consequence of improved child feeding practices and focus on nutritional aspects of children.
• There was "substantial" decline of anemia among children aged 6-59 months as it declined from 69% in NFHS-3 to 58% in NFHS-4. 
• The maximum decrease was reported in Assam with 34 percentage points followed by Chhattisgarh (30 percentage points), Mizoram (26 percentage points) and Odisha (20 percentage points). 
• In category of children under the age of 3 years, who were breastfed within one hour of birth, there was substantial increase of 19 percentage points between NFHS-3 and NFHS-4.

Dr KK Aggarwal
National President IMA & HCFI

Supreme Court denies nod to woman to terminate her 26-week fetus

Supreme Court denies nod to woman to terminate her 26-week fetus New Delhi, Feb 28 (PTI) The Supreme Court has refused to allow a woman, who is in her 26th week of pregnancy, to abort her foetus on the ground that it suffered from 'down syndrome', saying "we have a life in our hands". The apex court said that as per a report of the medical board constituted to examine the 37-year-old woman, there was no physical risk to the mother in continuation of pregnancy. A bench of Justices S A Bobde and L N Rao observed that though "everybody knows that children with down syndrome are undoubtedly less intelligent, but they are fine people." The bench said as per the report, the foetus is "likely to have mental and physical challenges" but the advice of the doctors does not warrant termination of pregnancy. "With this report, we don't think we are going to allow termination of pregnancy. We have a life in our hands," the bench said. "In these circumstances, as per the present advice, it is not possible to grant permission to terminate the pregnancy," the court said. Down syndrome is a congenital disorder due to a chromosome defect, which causes intellectual impairment and physical abnormalities, which varies from individual to individual. Babies with Down syndrome have an extra copy of chromosome 21. Down syndrome is also referred to as Trisomy 21 (CDC). Down syndrome earlier was a dreaded diagnosis, because of the ensuing difficulties in raising the child. Institutionalization was but an inevitable outcome for such children. But, advances in health care and technology have led to a greater understanding of the condition along with better care facilities for their rehabilitation. As a result, most children with Down syndrome are able to lead healthy ‘normal’ lives and can be integrated into mainstream of society. Over the years, life expectancy for people with Down syndrome has considerably increased, from 25 in 1983 to 60 today. The US National Association for Down Syndrome has this to say, “Most children with Down syndrome have mild to moderate impairments but it is important to note that they are more like other children than they are different.” While children with Down syndrome do experience developmental delays, they possess many skills and abilities, which need nurturing. Parents have the most crucial role in this. They can enlist the help of various Support Groups, organizations such as the “Down Syndrome Federation of India” to bring up their child in a supportive and positive manner where they can make valuable contributions to society. There is a list of people with Down syndrome on Wikipedia (https://en.wikipedia.org/wiki/List_of_people_with_Down_syndrome). They have been actors, singers, writers, disability rights activists. One of the names in the list is Karen Gaffney, from Oregon, USA a woman in her 40s. She also has a science degree, an honorary doctorate, and is a champion swimmer who has crossed the Channel in a team relay event (The Guardian). Prenatal genetic screening raises several ethical dilemmas as the outcome of the test may well be a decision to opt for termination of pregnancy because couples may be overwhelmed by the challenges of raising a child with genetic disorder such as Down syndrome. Health professionals, who handle such cases, should also be educated about how to counsel such parents-to-be as to how they can prepare themselves to raise their child to be a useful member of society. March 21 is observed as World Down Syndrome Day every year to raise public awareness about the condition. Is termination of pregnancy for genetic reasons the answer? No, a diagnosis of a genetic disorders should not automatically be a reason to opt for abortion, though the decision to terminate a pregnancy may be based on the specifics of an individual case. Section 3 of the MTP Act 1971 elaborates the conditions when termination of pregnancy is permitted. “3. When Pregnancies may be terminated by registered medical practitioners.- (1) Notwithstanding anything contained in the Indian Penal Code (45 of 1860), a registered medical practitioner shall not be guilty of any offence under that Code or under any other law for the time being in force, if any pregnancy is terminated by him in accordance with the provisions of this Act (2) Subject to the provisions of sub-section (4), a pregnancy may be terminated by a registered medical practitioner,- (a) where the length of the pregnancy does not exceed twelve weeks if such medical practitioner is, or (b) where the length of the pregnancy exceeds twelve weeks but does not exceed twenty weeks, if not less than two registered medical practitioners are. Of opinion, formed in good faith, that,- (i) the continuance of the pregnancy would involve a risk to the life of the pregnant woman or of grave injury physical or mental health ; or (ii) there is a substantial risk that if the child were born, it would suffer from such physical or mental abnormalities as to be seriously handicapped. Explanation 1.-Where any, pregnancy is alleged by the pregnant woman to have been caused by rape, the anguish caused by such pregnancy shall be presumed to constitute a grave injury to the mental health of the pregnant woman. Explanation 2.-Where any pregnancy occurs as a result of failure of any device or method used by any married woman or her husband for the purpose of limiting the number of children, the anguish caused by such unwanted pregnancy may be presumed to constitute a grave injury to the mental health of the pregnant woman. (3) In determining whether the continuance of pregnancy would involve such risk of injury to the health as is mentioned in sub-section (2), account may be taken of the pregnant woman's actual or reasonable foreseeable environment. (4) (a) No pregnancy of a woman, who has not attained the age of eighteen years, or, who, having attained the age of eighteen years, is a lunatic, shall be terminated except with the consent in writing of her guardian.” The Government of India has drafted the Medical Termination of Pregnancy TP (Amendment) Bill, 2014, which proposes to raise the limit of permitting MTP up to 24 weeks pregnancy from the current limit of 20 weeks. However, currently, the law does not permit termination of pregnancy after 20 weeks.

Short sleep duration as a risk factor for childhood obesity

Short sleep duration as a risk factor for childhood obesity Childhood obesity is a global public health problem that has increased at an alarming rate, more so in the low- and middle-income countries. According to the WHO, in 2015 the number of overweight children under the age of five globally was estimated to be over 42 million. Almost half of all overweight children under 5 lived in Asia and one quarter lived in Africa. The causes of obesity are variable, genetic, lack of physical activity, unhealthy eating patterns, or a combination of these factors. Addressing obesity assumes importance given that overweight and obese children are likely to be obese adults and more likely to develop noncommunicable diseases (NCDs) like diabetes and cardiovascular diseases at a younger age. Several studies have described short sleep duration as a risk factor for obesity, including childhood obesity. Excess carbohydrate consumption has been suggested as a possible mechanism due to increased hunger through dysregulated hormonal mechanisms that involve decreased leptin (satiety hormone – suppresses appetite) and increased ghrelin (hunger hormone) levels. Lack of sleep disturbs the balance between these hormones. This association between short sleep duration and risk of obesity in children was demonstrated in a study published in the February 2017 issue of the journal Sleep. Researchers examined the association between estimated sleep duration and macronutrient intake as percentages of total energy among Mexican American (MA) 9–11 year old children. The intake of carbohydrates decreased with longer sleep duration. Children who slept for longer duration ate fewer calories from carbohydrates and a higher percentage from fat, especially from PUFAs. This study highlights the role of sleep in the prevention of obesity emphasizes the need to inculcate good sleep hygiene in children. Here are a few tips to do so: • Set a regular and consistent sleep schedule. • Remove TV and computers from the child’s bedroom. • Avoid caffeinated products close to bedtime. • Plan up to 1 hour of quiet time before bed such as reading a book. • Make sure that the child does not go to bed hungry. Dr KK Aggarwal National President IMA & HCFI