Largest Ever Clinical Study on Vitamin D Shows We’re Wrong About a Crucial Benefit


We are still in love with vitamins a century after they were discovered, with half the US and UK population taking a supplement.

Vitamin D – the sunshine vitamin – is the favourite and is believed to have the most proven benefits.

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Governments, including the UK government, have said that the evidence for vitamin D’s health benefits is so overwhelming that every adult should take it as a supplement for at least six months of the year.

It was first used to cure rickets in Victorian children living in urban poverty and is now routinely given to prevent and treat brittle bone disease (osteoporosis) and fractures.

It has been associated with a reduced risk of over a hundred common diseases in observational studies, ranging from depression to cancer.

The largest ever clinical study on the benefits of vitamin D in preventing fractures has been reported in the BMJ, with over 500,000 people and around 188,000 fractures from 23 cohorts from many countries.

As vitamin D levels are strongly influenced by genes, the researchers used genetic markers for vitamin D blood levels (called Mendelian randomisation or MR) to avoid the normal biases of observational studies, such as confusing cause and consequence of disease and the effects of other related health behaviours (so-called “confounders”).

 

The results showed no association between vitamin D levels over a lifetime and the risk of fracture. This latest study contradicts the UK government’s recent view, but not a host of earlier clinical trials.

In 2014, a review and meta-analysis of 31 vitamin D supplement trials found no effect on all fractures. Much of our strong belief in the benefits of vitamin D came from studies of supplements in care homes in the 1980s, which were never replicated and were probably flawed.

In a more recent meta-analysis of 33 randomised trials of over 50,000 older adults, supplementation with calcium or vitamin D had no effect on the incidence of fractures. There were also no clear benefits on muscle strength or mobility.

So, if all the data points to vitamin D failing to prevent fractures, why worry about all the people with low blood levels of the vitamin? Vitamin D deficiency has become a modern epidemic with a fifth of the UK and US populations reported to have low levels. Will they be more susceptible to other diseases and cancer?

No consensus on deficiency

There is little agreement on what vitamin D deficiency is. Deficiency levels are arbitrary with no international consensus and confusion caused by different units in the US. A “normal” level can vary from 50 to 80 nanomole per litre of blood, but recent studies suggest 30nmol is quite enough.

While clinical deficiency (<10nmol) is often clear cut, wrongly labelling millions of people as vitamin D deficient causes stress and over-medicalisation. Most people assume calcium and vitamin D are safe, and the more you take the better. My clinical practice changed when studies showed calcium supplements, as well as being ineffective against fractures, may cause heart disease. Prescriptions are now dropping.

Vitamin D is fat soluble, so high levels can build up in the body. While recommendations for supplements are usually with modest doses (10 micrograms or 400 international units (IU)), these will inevitably be overdone by some people taking other sources in cod liver oil tablets or in fortified milk, orange juice or bread. More worrying, people increasingly buy high-dose supplements of 4,000-20,000IU on the internet.

Patients with very high vitamin D blood levels (over 100nmol) are becoming routine in my clinic and elsewhere, and toxic overdoses are increasingly being reported. Several randomised trials have shown that patients with high blood levels or taking large doses of vitamin D (above 800IU) had an unexpected increased risk of falls and fractures. Vitamin D is far from safe.

It can no longer be recommended for use in other conditions; the vast majority of the positive published studies in 137 diseases were reviewed as spurious. It was widely believed that vitamin D supplements prevented cardiovascular disease, but meta-analyses and large-scale genetic MR studies have ruled this out.

Pseudo-disease

We have created another pseudo-disease that is encouraged by vitamin companies, patient groups, food manufacturers public health departments and charities. Everyone likes to believe in a miracle vitamin pill and feels “they are doing something”.

Vitamin D, despite its star status, would not be called a vitamin today, as the doses needed are too large, the body can synthesise it from skin, and it is a steroid precursor. Instead of relying on this impostor, healthy people should get vitamin D from small doses of sunshine every day as well as from food, such as fish, oil, mushrooms and dairy products.

We should also trust that thousands of years of evolution would cope with a natural drop in vitamin D levels in winter without us snapping our limbs. About half the population take vitamins daily, despite zero benefits, with increasing evidence of harm. The worldwide trend of adding unregulated vitamins to processed food has now to be seriously questioned.

While vitamin D treatment still has a rare medical role in severe deficiency, or those bed bound, the rest of us should avoid being “treated” with this steroid for this pseudo-disease and focus on having a healthy lifestyle, sunshine and importantly save your money and energy on eating a rich diversity of real food.

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Antibiotic and acid-suppression medications during early childhood are associated with obesity


Abstract

Objective Gut microbiota alterations are associated with obesity. Early exposure to medications, including acid suppressants and antibiotics, can alter gut biota and may increase the likelihood of developing obesity. We investigated the association of antibiotic, histamine-2 receptor antagonist (H2RA) and proton pump inhibitor (PPI) prescriptions during early childhood with a diagnosis of obesity.

Design We performed a cohort study of US Department of Defense TRICARE beneficiaries born from October 2006 to September 2013. Exposures were defined as having any dispensed prescription for antibiotic, H2RA or PPI medications in the first 2 years of life. A single event analysis of obesity was performed using Cox proportional hazards regression.

Results 333 353 children met inclusion criteria, with 241 502 (72.4%) children prescribed an antibiotic, 39 488 (11.8%) an H2RA and 11 089 (3.3%) a PPI. Antibiotic prescriptions were associated with obesity (HR 1.26; 95% CI 1.23 to 1.28). This association persisted regardless of antibiotic class and strengthened with each additional class of antibiotic prescribed. H2RA and PPI prescriptions were also associated with obesity, with a stronger association for each 30-day supply prescribed. The HR increased commensurately with exposure to each additional medication group prescribed.

Conclusions Antibiotics, acid suppressants and the combination of multiple medications in the first 2 years of life are associated with a diagnosis of childhood obesity. Microbiota-altering medications administered in early childhood may influence weight gain.

Crash dieting highly effective for losing weight – BMJ


https://speciality.medicaldialogues.in/crash-dieting-highly-effective-for-losing-weight-bmj/

Corticosteroid therapy for sepsis: a clinical practice guideline


https://www.bmj.com/content/362/bmj.k3284

Functional Testing Best for Detecting Coronary Artery Disease


Functional testing outperforms anatomical testing for detecting coronary artery disease (CAD) in low-risk patients, according to a new network meta-analysis.

“Currently available evidence indicates that both anatomical- and functional-based diagnostic strategies have no differential effect on the subsequent risk of myocardial infarction, but considerable differences exist in the need for further investigations and revascularizations,” said Dr. George C. M. Siontis from Bern University Hospital in Switzerland.

“Physicians should make their decision following appropriate risk stratification of their patients, based on local constraints for each diagnostic strategy and patients’ preferences,” he told Reuters Health by email.

Both functional and anatomical noninvasive tests are widely available and used according to locally available resources and expertise, Dr. Siontis and his colleagues write in The BMJ, online February 20. Randomized controlled trials have not provided conclusive evidence as to which strategy gives the best results for subsequent downstream testing or clinical outcomes.

To investigate, Dr. Siontis and colleagues used a network meta-analysis of 30 diagnostic randomized controlled trials, including more than 33,000 patients and six different imaging modalities.

Among patients with low-risk acute coronary syndrome, evaluation by stress echocardiography, cardiovascular magnetic resonance, or exercise electrocardiogram was significantly less likely to trigger referral to invasive coronary angiography than was coronary CT angiography.

Similarly, patients evaluated by cardiovascular magnetic resonance and stress echocardiography less frequently underwent subsequent revascularization than did those evaluated by coronary CT angiography.

Overall, a functional-testing strategy and cardiovascular magnetic resonance were significantly less likely than an anatomical-testing strategy to lead to referrals for invasive coronary angiography.

None of the strategies affected the rate of subsequent myocardial infarction.

For patients with suspected stable CAD, there was no clear discrimination between diagnostic strategies regarding the subsequent need for invasive coronary angiography, but differences between the strategies in the risk of myocardial infarction could not be ruled out.

“Appropriate risk stratification of each patient before the application of any diagnostic strategy is the key element for a successful diagnostic approach,” Dr. Siontis said. “Hybrid strategies (which have not been tested in clinical trials so far) may be useful in selected cases, whereas ongoing trials of other emerging technologies that noninvasively evaluate anatomical and functional lesion hemodynamics or myocardial perfusion may be proven useful.”

“Nevertheless,” he said, “any additional diagnostic test should be carefully evaluated in the context of its risk. Finally, it is of high importance for the physicians to identify those patients who require directly invasive assessment (high pre-test probability).”

Source: BMJ

More Than Half of UK Docs Support Assisted Dying


Assisted dying is not legal in the United Kingdom, but debate over the issue continues, most recently in a series of articles published online February 7 in the BMJ.

The organization that represents physicians — the British Medical Association (BMA) — does not accurately represent their views on the issue, argues Dr Jacky Davis, consultant radiologist at the Whittington Hospital in London, in a personal view article.

The BMA has long been opposedto assisted dying, and its view is often quoted in parliamentary debate as representing that of physicians, she comments.

But a recent opinion poll of physicians (conducted in October 2017 by doctors.net) found that 55% agreed or strongly agreed that assisted dying should be made legal in defined circumstances; 43% disagreed, and 2% had no opinion.

Hence, the BMA should change its policy and adopt a neutral position — “a stance that would allow for constructive engagement while acknowledging the range of views of the membership,” she argues.

Dr Davis, who is also a member of BMA Council, a board member of Dignity in Dying, and chair of Healthcare Professionals for Assisted Dying, argues that the current disconnect between BMA policy and the views of physicians and patients “undermines the BMA’s credibility, and its continuing opposition excludes it from the public debate.”

Assisted dying does not represent a leap into a dangerous unknown. Dr Jacky Davis

“Assisted dying does not represent a leap into a dangerous unknown,” Dr Davis writes. “Other jurisdictions have proved that it is possible to change the law, and doctors have shown that such laws can work hand in hand with excellent palliative care.”

Public Morality Shift?

“It feels as if we are experiencing a rare example of public morality shifting ahead of legislative change,” writes Dr Bobbie Farsides, professor of clinical and biomedical ethics at the University of Sussex, in a commentary.

Prof Farsides acted as adviser to the House of Lords committee that considered the Assisted Dying Bill in 2015. At that time, very strong views were expressed both for and against the legislation, as previously reported by Medscape Medical News.

But the polarization of past parliamentary debates is “no longer reflected in society, given recent opinion polls,” she comments.

She was referring to a poll of the general public conducted in 2015 that found that 82% supported legislation for assisted dying.

“Given this is so, the law may well change soon,” Prof Farsides comments.

She has been involved in the debate about assisted dying for the past 20 years, after she wrote an editorial for the Journal of Medical Ethics (1998;24:149-50). “I argued that it was logically consistent to be a good palliative care doctor and to think that for some patients the best option would be a managed death,” Prof Farsides writes.

“I have never campaigned for or against legal assisted dying,” she states. Instead, she presents evidence from countries where assisted dying is legal and invites colleagues to draw their own conclusions.

“Patients are more aware than ever of what is, and is not, possible for them as they approach the end of their lives, and practitioners need to be prepared and able to respond compassionately,” she comments.

“Surely we have come to understand that there need be no contradiction between being a good palliative care doctor and respecting a patient’s wish to die and their request for assistance,” she concludes.

“Not a Proper Role for Doctors”

Arguing the case against passage of legislation in a “head-to-head” article is Dr Bernard Ribeiro, former president of Royal College of Surgeons and a member of the House of Lords. In 2015, when the Assisted Dying Bill was rejected in the United Kingdom, he argued that “assisting patient suicides was not a proper role for doctors.

“I hold to that view and I make no apology for using the term assisting suicide,” he writes. “In law, supplying terminally ill patients with lethal drugs with which to end their lives constitutes assisting suicide.”

This is “a matter for the courts, not for the consulting room,” he argues.

Dr Ribeiro emphasizes the uneveness of the physician-patient relationship. “The doctor holds most of the cards. We have professional expertise that most patients are in no position to challenge.”

He worries about vulnerable patients “who, not unreasonably, could interpret a doctor’s willingness to process a request for ‘something to end it all’ as meaning that in the doctor’s view, ending their lives is a course of action that would be in their ‘best interest.’ ”

Controversy Subsides After Legislation

“Although plans to adopt assisted dying have caused much controversy, most places have found that once the political decision has been made this tends to subside,” writes journalist Bob Roehr in a feature article in the BMJ.

“The pattern has been repeated many times, beginning 20 years ago in the state of Oregon,” he writes. Since that time, the pattern has been followed in five other states, including the most populous state, California. The pattern has also emerged in Canada.

Roehr highlights a disconnect in the United States between physicians and the American Medical Association (AMA) that is similar to the disconnect between physicians and the BMA in the United Kingdom.

The AMA opposes assisted dying, and the American College of Physicians (ACP) and the American Academy of Family Physicians are opposed to physician-assisted suicide.

Yet in a 2016 Medscape poll, 57% of US physicians showed support for assisted dying, and in a 2017 Medpage poll, 61% of healthcare professionals showed support.

The situation was different in Canada, where medical aid in dying was legalized in 2016, Roehr notes.

“The Canadian Medical Association initially resisted assisted dying. But after that country’s high court ruled it to be a fundamental human right, the association embraced the decision and participated in writing the law, provincial regulations, and training its members to implement that ruling,” he writes.

Stefanie Green, MD, president of the Canadian Association of Medical Assistance in Dying Assessors and Providers (CAMAP), says she is seeing a gradual increase in willingness among physicians to learn and participate in assisted dying when their patients express interest, he adds.

BMJ Calls for a Neutral Position

“The BMJ supports the legalisation of assisted dying,” says Dr Fiona Godlee, the BMJ’s editor in chief, in a statement.

“The great majority of the British public are in favour and there is now good evidence that it works well in other parts of the world, as a continuation of care for patients who request it and are in sound mind. We believe that this should be a decision for Society and Parliament, and that medical organisations should adopt at least a neutral position to allow an open and informed public debate.”

Taking an Emotional Toll

Physicians’ experience of how it feels to be involved in assisted dying is detailed in an essay written by Dr Sabine Netters, now a consultant in medical oncology and palliative care at the Isala Oncology Center, Zwolle, the Netherlands.

She describes her first experience of euthanasia, which occurred 10 years ago, when she was a medical trainee. The patient had metastatic cancer with paraplegia caused by spinal metastasis, which left him “paralysed from the waist down, unable to control his bowels, his skeleton ridden with cancers.”

“He makes me see that even when therapy fails, the doctor’s role is far from over,” Dr Netters writes. “Instead it adjusts, because the goal has changed from living longer to dying better.

“But textbooks offer no advice, and years of training have left me totally unprepared for this,” she adds.

She writes that after the patient has died from a lethal injection, surrounded by his family, “I’ve just helped kill someone, but I don’t see it in a negative way. It was beautiful.

“As a doctor I will do anything to save a life, and this evening that meant giving someone a dignified death,” she adds.

She also details the emotional toll that the process takes on the physicians involved.

“I hoped euthanasia would become less of an emotional burden to me as my experience grew,” Dr Netters writes, noting that she has helped five patients to die over the past 10 years.

“But it didn’t, and now I know it never will,” she writes.

“The general population, politicians, and legislators — perhaps even some doctors who have not been involved in the procedure — seem to think that assisted dying or euthanasia is just another medical intervention,” she comments. “It is not.”

Ultra-processed foods linked to cancer : BMJ


https://speciality.medicaldialogues.in/ultra-processed-foods-linked-to-cancer-bmj/

Multivitamins in pregnancy linked to lower autism risk in children : BMJ


https://speciality.medicaldialogues.in/multivitamins-in-pregnancy-linked-to-lower-autism-risk-in-children-bmj/

Diabetes, cardiovascular disease, and chronic kidney disease in South Asia: current status and future directions


South Asians are more susceptible to diabetes and cardiovascular diseases and have worse outcomes than other ethnicities, say Anoop Misra, Tazeen Jafar, and colleagues. They call for urgent action to provide screening and treatment, complemented by population level lifestyle modifications.

All South Asian countries have adopted the World Health Organization’s Global Action Plan for the Prevention and Control of Non-Communicable Diseases, which recommends a 25% relative reduction in the prevalence of raised blood pressure by 2025 and a halt to the rise in diabetes and obesity. Although considerable diversity exists between countries, all South Asians have markedly elevated risks of diabetes and variably elevated risks of cardiovascular disease compared with other ethnicities.12 In this paper, we review the burden of diabetes, cardiovascular disease, and chronic kidney disease in the region and policies to mitigate this burden. We identify key actions for health authorities and governments to attenuate the rise in non-communicable diseases and meaningfully improve outcomes for the millions of people with, or expected to develop, these diseases.

Methods

We gathered data on characteristics of populations and health systems from publicly available World Bank reports and WHO’s country profiles. Information on death and disability from cardiovascular disease, diabetes, and chronic kidney disease and their attributable risk factors came from Health Metrics and Evaluation’s data visualisation tool of the Global Burden of Disease Study 2015. We searched PubMed and Google scholar for relevant literature up to January 2017, using the terms “South Asians”, “diabetes”, “cardiovascular disease”, “myocardial infarction”, “stroke”, “renal”, and “kidney disease”. We formulated this paper by drawing from our collective experience in this field and the available literature.

Current epidemiology and trends

Cardiovascular disease, diabetes, and chronic kidney disease now account for 27%, 4.0%, and 3.0% of deaths, respectively, in South Asia (table 1).3456 Notwithstanding the limited quality and breadth of data, ischaemic heart disease is the leading cause of death in India, Pakistan, Nepal, and Sri Lanka, and stroke is the leading cause in Bangladesh.

The age standardised years of life lost as a result of cardiovascular disease has increased in South Asia in contrast to most other regions, where the reverse is true.5 In part, this is because cardiovascular disease events are more common in South Asia than in high income countries.78 Furthermore, acute myocardial infarction occurs six years earlier in South Asians than in European counterparts, probably owing to earlier onset of risk factors. Case fatality rates are higher in South Asia, especially in younger adults, thereby increasing the years of life lost.78 Stroke and chronic kidney disease may also occur earlier in South Asians.91011 The effect of lives lost due to premature cardiovascular disease is far worse in South Asia than elsewhere, as more than half of the population lives in conditions of poverty.3

Susceptibility to diabetes, cardiovascular diseases, and chronic kidney disease

The region has experienced rapid demographic, epidemiological, environmental, and economic transitions. These, coupled with unhealthy lifestyles of physical inactivity and consumption of a calorie dense diet, have increased the risk of non-communicable diseases. In addition, social disparities, wealth inequalities, and conflicts in the region contribute to high rates of stress associated behaviours including smoking.1112 Evidence from multi-country case-control studies indicates that hypertension, dyslipidaemia, smoking, obesity, diabetes, physical inactivity, low fruit and vegetable intake, and psychosocial stress attribute up to 90% of the population risk of cardiovascular disease in South Asians.1314 Age standardised blood pressure and cholesterol levels and prevalence of diabetes have increased in South Asia over the past decades.151617 High blood pressure and high blood glucose are the leading attributable risk factors for deaths from chronic kidney disease in every South Asian country (table 2).

Adverse metabolic factors are evident in South Asians at an early age. South Asian children have been shown to have adverse metabolic factors (hyperinsulinaemia, dyslipidaemia) compared with British children of similar age and body mass index and higher blood pressure than white children in the US.1819 Physical inactivity, dietary imbalances, and increasing obesity amplify this (fig 1).2021

 

Fig 1 Interacting risk pathways contributing to higher risks of diabetes and cardiovascular disease (CVD) in South Asians, acting over the life course. This begins with poor maternal nutrition and adverse programming, with neonates born at lower average birth weights yet higher fat to lean mass ratios compared with white children. This phenotype worsens over time, with greater weight gain and lower activity levels in South Asian children and adults, leading, in turn, via greater insulin resistance and CVD risk factors, to higher rates of diabetes and CVD, respectively. The parallel societal, political, and health considerations, as well as life course considerations, are also shown. BMI=body mass index; BP=blood pressure; CKD=chronic kidney disease

“>Figure1

Fig 1

 Interacting risk pathways contributing to higher risks of diabetes and cardiovascular disease (CVD) in South Asians, acting over the life course. This begins with poor maternal nutrition and adverse programming, with neonates born at lower average birth weights yet higher fat to lean mass ratios compared with white children. This phenotype worsens over time, with greater weight gain and lower activity levels in South Asian children and adults, leading, in turn, via greater insulin resistance and CVD risk factors, to higher rates of diabetes and CVD, respectively. The parallel societal, political, and health considerations, as well as life course considerations, are also shown. BMI=body mass index; BP=blood pressure; CKD=chronic kidney disease

 South Asian adults have greater risks of cardiovascular disease and diabetes, both of which tend to manifest around 5-10 years earlier than in white Europeans.10 The risk of cardiovascular disease is independent of that predicted by established risk factors. Possible mechanisms, among others, include an atherogenic dyslipidaemia driven by high concentrations of triglycerides and low concentrations of high density lipoprotein cholesterol, a pro-coagulant tendency, and higher concentrations of inflammatory cytokines.22 Further work is needed to define mechanisms for this excess cardiovascular disease risk. The risk factors vary by socioeconomic strata, geographical region, and migration.

Of particular importance, South Asian adults are more insulin resistant at any given body mass index and may experience more rapid β cell failure.2 They may progress more rapidly from a state of high risk of diabetes to frank diabetes and may have accelerated microvascular damage, with evidence of earlier diabetic nephropathy and retinopathy.2

Effects of poor and inconsistent treatment

Significant treatment gaps exist in South Asian populations. Studies report that less than half of all people with hypertension have received a diagnosis or treatment and less than a third have their blood pressure controlled with drugs.232425 The rates of diabetes awareness (50%), glycaemic control (<30%), and chronic kidney disease awareness (<15%) are suboptimal.24262728

Delay or prevention of diabetes in South Asians will require earlier intervention—that is, at lower levels of glycaemia. This requires wider testing and earlier use of antihyperglycaemic treatment, complemented with population-wide strategies to drive change in dietary habits and physical activity. Although antihypertensive, antidiabetic, and lipid lowering drugs are part of WHO’s list of essential medicines, availability in government primary care facilities is poor and patients must often pay out of pocket for these drugs. Social insurance schemes in countries are not available to the majority of the population,2930 and they tend to cover hospital based treatment and do not provide for standardised screening and medical management of these conditions in primary care.

Under-diagnosis and under-treatment result in higher rates of myocardial infarction and stroke, with adverse outcomes due to poor access to standardised and affordable treatment. Most patients with acute ischaemic heart disease are brought to the hospital too late to qualify for reperfusion therapy.31 Management in primary care is less than satisfactory, and many patients do not receive appropriate drugs owing to gaps in the knowledge and practices of healthcare providers.323334 The situation is much worse in rural areas, where an acute event is more likely to be fatal.3135

Health policies are not geared to respond to the rising challenge

Non-communicable diseases have been a recent addition to the policy agenda in all South Asian countries. Public health expenditure varies across countries, but overall investment is insufficient to support services for the prevention and management of cardiovascular disease, diabetes, and chronic kidney disease (table 3).36Implementation has been slow owing to donor agencies having limited interest in investing in non-communicable diseases and lack of engagement between governments and professional organisations in this field.

Table 3

Characteristics of health systems and policies for management of cardiovascular diseases and diabetes in South Asia

 In India, the National Programme for Prevention and Control of Cancer, Diabetes, CVD and Stroke has piloted opportunistic screening of risk factors for non-communicable diseases for people over 30 years of age. Furthermore, as part of the national health mission, the Indian government has outlined an operational plan for universal screening for hypertension and diabetes.31 A model of opportunistic screening for diabetes in patients with tuberculosis is being evaluated in Sri Lanka.37 Examples of successful public-private partnerships for non-communicable disease healthcare in the region are limited. Pakistan’s National Action Plan for Non-communicable Diseases is one such model,38 which involved a tripartite collaboration with Heartfile, a not for profit organisation, in formulation of policy and implementation in partnership with the government and WHO.

Recommendations

Progress towards the targeted reductions in death and disability from cardiovascular disease, diabetes, and chronic kidney disease would not be possible without concerted, multi-sectoral efforts by various government entities and non-government partners. We recommend the following essential policy and health system interventions.

Implementation of taxes on unhealthy foods

A tax of 20% on sugar sweetened drinks in India is projected to reduce the prevalence of overweight and obesity by 3.0% (95% confidence interval 1.6% to 5.9%) and the incidence of type 2 diabetes by 1.6% (1.2% to 1.9%) over the period 2014-23, assuming that consumption increases in line with current trends.39 In Mexico, an excise tax of 10% on sugar sweetened drinks decreased consumption by an average of 6% over one year.40 The Indian state of Kerala recently announced a “fat tax” on pizzas, burgers, sandwiches, and tacos sold through branded food outlets.41 Such strategies must be adopted in cities of South Asia that experience widespread marketing and consumption of unhealthy fast foods.

Furthermore, a 20% tax on palm oil purchases in India is projected to avert approximately 363 000 (95% confidence interval 247 000 to 479 000) deaths from myocardial infarctions and strokes over the period 2014-23 (1.3% reduction in cardiovascular deaths).42 Palm oil is consumed widely in low and middle income countries. It is high in saturated fat and causes a large increase in cholesterol concentrations. Empirical data from Mauritius show a reduction of 1 mmol/L in cholesterol concentrations through substitution of palm oil with soya oil.43 This reduction in cholesterol and low density lipoprotein cholesterol would equate to a 22% lower risk for cardiovascular disease, a huge effect by any standards.44

Strengthening of health system capacity to deliver care for non-communicable diseases

Strengthening of health systems and a well designed quality of care improvement framework are essential for concerted efforts to manage hypertension and diabetes for prevention of cardiovascular disease and chronic kidney disease. Shifting management of chronic diseases and risk factors from doctors to community healthcare workers holds promise and is being tested in rural areas in South Asia.34 Studies from Pakistan and India have shown that involving trained health workers in home health education on diet and physical activity and training general practitioners led to earlier diagnosis and better management of patients with hypertension or diabetes, and it was also cost effective.454647 Scaling up similar models is likely to offer substantial reductions in cardiovascular disease and chronic kidney disease in the medium to long term.

Screening populations at high risk (such as people who are sedentary, overweight, or smokers; those with hypertension; those with a family history of diabetes or premature cardiovascular disease in first degree relatives; and women with a history of gestational diabetes) is essential for early diagnosis. Low cost strategies such as validated simple screening questionnaires, blood pressure measurement, and, if possible, fasting or random blood glucose measurement, urinary dipstick for protein, and non-fasting cholesterol measurement, may be used. Although the cost effectiveness of opportunistic screening compared with universal screening is likely to vary according to the characteristics of the population, its value cannot be overstated for countries with a high prevalence of diabetes.48

Making antihypertensives, statins, and diabetes drugs available for free or at low cost in primary healthcare centres should be prioritised. This is consistent with achievement of universal health coverage, including access to quality and affordable essential medicines for all, as advocated in the United Nations’ sustainable development goals.49High quality generic drugs produced in the region can help to make this sustainable. Fixed dose drug combinations may improve coverage and long term adherence in people with established disease, but their widespread use in primary prevention is still debated.50 Health insurance reforms must provide for screening and primary care for these conditions to reduce out of pocket expenditure.51

Evidence is growing for m-health (mobile health technologies) interventions in improving adherence to treatment, maintaining appointments, data collection, and supporting health workers.52 More than 80% of the population of South Asia have mobile phones, and a large majority of villages are connected with mobile technology.53 This platform should be strongly considered in risk communication strategies and integration of care delivery for non-communicable diseases where feasible.

Public-private partnerships for non-communicable disease care should be encouraged to provide for unmet needs. Setting standards for long term public sector engagement; having transparent goals, inputs, and expectations; good governance of costs and fair allocation of profits; a shared vision and trust; and agreed processes for negotiation on common interests of partners are crucial to their success. The Sindh Institute of Urology and Transplantation in Karachi, Pakistan, providing dialysis services, and Aravind Eye Care System in India are good examples of successful public-private partnerships in the region.5455

Consideration of population based strategies to promote a healthy lifestyle

Community based interventions to promote a healthy diet and physical activity and reduce smoking and stress will go a long way in delaying the onset of these diseases. The Indian Diabetes Prevention Program, and more recently the D-CLIP study, showed the effectiveness of lifestyle intervention in reducing the development of diabetes in people at high risk, while concurrently tackling problems with community acceptability and long term sustainability.5657

School health programmes, encouraged by WHO to inform children about risk factors for non-communicable diseases and promote physical activity, have been hindered by low education budgets and poor infrastructure. There are no restrictions on advertising unhealthy food to minors.58 Such legislation must be complemented with multi-sectoral action including involvement of schools and workplaces to influence diet and physical activity.

Investment in surveillance and research

Surveillance and monitoring are critical to raise awareness and inform policy and implementation. Although the WHO STEPS instrument (www.who.int/chp/steps/instrument/en/) for collecting data on risk factors for non-communicable diseases has been used in community based studies in South Asia, national implementation is lacking.59 All South Asian countries must institutionalise risk factor surveillance and establish robust cardiovascular disease, diabetes, and chronic kidney disease registries to track trends and monitor progress. Surveillance data must be shared publicly to create awareness.

Evidence on effective interventions to prevent and control non-communicable diseases in the region is very limited. The effect of school, workplace, and community based interventions must be evaluated. Research comparing single versus multiple risk factor screening, as well as opportunistic and targeted screening versus universal screening in all adults, will help to tailor screening strategies. Policy initiatives such as taxes and diet substitution must be rigorously evaluated for their feasibility and impact at a population level.

Conclusion

Capacity building, financing, and a strong quality assurance framework are crucial for the effectiveness, scalability, and long term sustainability of initiatives to curb non-communicable diseases in the South Asia region.

Key messages

  • South Asians are more likely than other ethnicities to develop diabetes, cardiovascular disease, and chronic kidney disease, and these often have an earlier onset and poor outcomes

  • Strategies for early diagnosis and treatment including awareness generation, opportunistic screening, availability of low cost drugs, and task shifting to health workers must be prioritised

  • Countries must consider taxation on unhealthy foods, restrictions on advertising, and appropriate food labelling.

source: BMJ

The FDA just shot down a new rheumatoid arthritis drug.


The FDA just rejected a new daily pill to treat rheumatoid arthritis.

rheumatoid arthritis

Pharmaceutical companies Lilly and Incyte said on Friday that their drug, baricitinib, had been issued a complete response letter , which explains why the drug didn’t get approval.

In its letter, the FDA told Lilly and Incyte that it wanted more data on what the right dose for the drug is. The FDA also wants more data about potential safety issues.

The FDA had previously pushed back its review date of baricitinib by three months. Even so, analysts largely expected the FDA to approve baricitinib, especially after the European Commission approved the drug in February. If approved would have been a competitor to Pfizer’s Xeljanz.

“We are disappointed with this action. We remain confident in the benefit/risk of baricitinib as a new treatment option for adults with moderate-to-severe RA,” Christi Shaw , Lilly Bio-Medicines president said in a news release . The companies plan to resubmit the drug to the FDA.

Rheumatoid arthritis is a common, chronic inflammatory condition that affects the joints. There are a number of ways to treat the disease, such as the chemotherapy drug methotrexate.

Soure: BMJ