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Scalable Obesity Treatments: Time For Pharma To Step Up

time spiralIn my two previous posts (here and here), I have discussed the urgent need for obesity treatments that are scalable to the size of the problem. I explained why neither “lifestyle” nor surgery are scalable to the millions of Canadians who would stand to benefit from obesity treatments.

No doubt, not everyone with a BMI over 30 needs treatment. As I also discussed, we should target treatments (especially with anti-obesity medications) to those who are actually experiencing an obesity related impairment in health, especially those with comorbidities that are not well controlled and who are otherwise good candidates for treatment.

As I calculated, this reduces the number of Canadians that would really need to be treated for obesity from about 7,000,000 to perhaps 1,250,000 – roughly half the number of Canadians currently living with diabetes, a chronic disease that is routinely managed with medical treatments.

 

Many of these would no doubt stand to benefit from surgical treatments, but at the current rate of about 10,000 surgeries a year (a number that is unlikely to dramatically increase in the foreseeable future), I see no alternative than the use of anti-obesity medications.

This is where we have a real problem.

While for any patient with diabetes or hypertension who walks through my door, I have over 100 possible prescription medications to pick from, including an almost limitless number of possible combinations, for obesity I have almost nothing.

The two only prescription medications for obesity currently approved in Canada are orlistat and liraglutide. The former is moderately effective but is handicapped by unpleasant side effects. The latter, is an injectable hormone-analogue, where access is limited by cost (in Canada about $15 a day).

Obviously, not everyone will tolerate or respond to either of these medications. This is not unexpected. In fact this is the very reason that we have so many different classes of drugs for the treatment of other chronic diseases like hypertension or diabetes – what works for one patient does not work (or is not tolerated) by another.

So why do we not have more therapeutic options for obesity treatment?

The only answer that springs to mind is that Big Pharma is not putting the same dedication and resources behind developing anti-obesity drugs compared to what they are pouring into other indication areas.

Thus, while Big Pharma is busy developing and appears to be launching new drugs for diabetes almost every other month, nothing remotely comparable is happening in the obesity space.

thus, virtually every multinational pharmaceutical company has active development programs for diabetes.

In contrast, almost no multinational pharmaceutical company has an active development program for obesity worth speaking of.

The only reason that I can think of why a Novartis, Pfizer, Roche, Sanofi, Merck or any of the other major pharmaceutical companies are not investing in finding, developing, and bringing new anti-obesity drugs to market to fill this gaping therapeutic gap, is that they do not expect to make money with anti-obesity drugs.

This is largely because, as we have seen with past introductions of anti-obesity drugs, medications for obesity are seldom covered by pharma benefit plans or public formularies, making access to these drugs for a relevant number of patients difficult.

This lack of coverage of obesity drugs has little to do with the actual cost of new medications. In fact, even the currently most expensive anti-obesity drug in Canada works out to only around $5,000 a year – a sum that drug benefit plans routinely spend on managing patients with diabetes year after year after year.

So if it is not the cost of treating obesity that is prohibitive, why do most people who would stand to benefit from obesity treatments (and remember, we are only talking about half as many people who are currently being treated for diabetes) not have access to obesity treatments?

My guess is that this has a lot to do with the fact that obesity (in contrast to hypertension or diabetes), is still not widely seen as a chronic disease requiring treatment in its own right.

For one, most doctors have never prescribed a medication for obesity – they were simply never trained to do so.

In addition, employers (who generally pay for their employee benefit plans) are offered the option of opting out of covering obesity treatments (drugs or otherwise) – unfortunately, most employers do.

Of course, I understand that prescriptions medications (even after their regulatory approval and meeting the relevant efficacy and safety standards) should only be covered if they promise real health benefits, which of course have to be demonstrated in clinical trials.

But we will never have those new medications or the trials that prove their efficacy, if companies believe that despite all efforts, their medications will not recoup the investments or make profits for their shareholders.

This is where policy makers need to step in.

For one, governments could consider providing significant incentives (e.g. tax breaks?) to Big Pharma to devote resources specifically towards developing new medications for obesity.

Secondly, governments must streamline the approval process for new obesity medications in a way that will ensure that these treatments become available to those who stand to benefit (and I don’t mean anyone who is hoping to lose a couple of pounds to fit into their wedding dress – I mean people with at least Edmonton Stage 2 obesity, especially those with poorly controlled obesity related health problems).

Thirdly, employers and benefit plans should no longer have the option of opting out of paying for obesity treatments (in the same manner that they cannot chose to simply not cover diabetes or hypertension or any other chronic disease).

I believe that if these measures were implemented, at least some of the big pharmaceutical companies will reassess their position on developing safe and effective anti-obesity medications.

With more pharmacological options (and more competition in the market place), I see no reason why the standard for obesity care cannot be on par with what is currently routinely offered for patients with diabetes, hypertension or most other chronic diseases.

Without these policy changes, I fear that we will never have obesity treatments that are scalable to address the size of the problem.

The time for policy makers to act is now!

@DrSharma
Edmonton, AB

Post script: I harbour no illusion that any change in policy in Canada alone will make any difference to Big Pharma – after all, the Canadian pharma sales are only about 2% of the global market. Rather, it would take a consortium of countries, including the biggest markets, to make a joint decision regarding any such policies. Sadly, I believe that the  chances for this in the current political climate are rather remote – but, then again, we can always hope…

 

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We Desperately Need Scalable Treatments For Obesity

NN Benefits White Paper CoverObesity, defined as the presence of abnormal or excess body fat that impairs health, currently affects 100s of millions of people worldwide.

Although “weight-loss” is a booming global multi-billion dollar business, we desperately lack effective long-term treatments for this chronic disease – the vast majority of people who fall prey to the natural supplement, diet, and fitness industry will on occasion manage to lose weight – but few will keep it off.

Thus, there is little evidence that the majority (or even just a significant proportion) of people trying to lose weight with help of the “commercial weight loss industry” will experience long-term health benefits.

When it comes to evidence-based treatments, there is ample evidence that behavioural interventions can help patients achieve and sustain important health benefits, but the magnitude of sustainable weight loss is modest (3-5% of initial weight at best).

Furthermore, although one may think that “behavioural” or “lifestyle” interventions are cost-effective, this is by no means the case. Successful behaviour change requires significant intervention by trained health professionals, a limited and expensive resource to which most patients will never have access. Moreover, there is ample evidence showing maintenance of long-term behaviour change requires significant on-going resources in terms of follow-up visits – thus adding to the cost.

This severely limits the scalability of behavioural treatments for obesity.

If for example, every Canadian with obesity (around 7,000,000) met with a registered dietitian just twice a year on an ongoing basis (which is probably far less than required to sustain ongoing behaviour change), the Canadian Health Care system would need to provide 14,000,000 dietitian consultations for obesity alone.

Given that there are currently fewer than 10,000 registered dietitians in Canada, each dietitian would need to do 14,000 consultations for obesity annually (~ 70 consultations per day) or look after approximately 7,000 clients living with obesity each year. Even if some of these consultations were not done by dietitians but by less-qualified health professionals, it is easy to see how this approach is simply not scalable to the size of the problem.

A similar calculation can be easily made for clinical psychologists or exercise physiologists.

Thus, behavioural interventions for obesity, delivered by trained and licensed  healthcare professionals are simply not a scalable (or cost-effective) option.

At the other extreme, we now have considerable long-term data supporting the morbidity, mortality, and quality of life benefits of bariatric surgery. However, bariatric surgery is also not scalable to the magnitude of the problem

There are currently well over 1,500,000 Canadians living with obesity that is severe enough to warrant the costs and risks of surgery. However, at the current pace of 10,000 surgeries a year (a number that is unlikely to dramatically increase in the near future), it would take over 150 years to operate every Canadian with severe obesity alive today.

This is where we have to look at how Canada has made significant strides in managing the millions of Canadians living with other chronic diseases?

How are we managing the over 5,000,000 Canadians living with hypertension?

How are we managing the over 2.5 million Canadians living with diabetes?

How are we managing the over 1.5 million Canadians living with heart disease?

The answer to all is – with the help of prescription medications.

There are now millions of Canadians who benefit from their daily dose of blood pressure-, glucose-, and cholesterol-lowering medications. The lives saved by the use of these medications in Canada alone is in the 10s of thousands each year.

So, if millions of Canadians take medications for other chronic diseases (clearly a scalable approach), where are the medications for obesity?

Sadly, there are currently only two prescription medications available to Canadians (neither scalable, one due to cost the other due to unacceptable side effects).

So what would it take to find treatments for obesity that are scalable to the magnitude of the problem?

More on that in tomorrow’s post.

@DrSharma
Edmonton, Ab

 

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Will WHO STOPS Childhood Obesity Promote Weight Bias And Unhealthy Body Image?

sharma-obesity-kids-playing-outsideChildhood obesity is a grave concern and so far community based interventions to prevent it have been rare and far between, with little evidence that any changes (however meagre) are in fact sustainable over time and will actually lead to a reduction in adult obesity.

Thus, the Australian team of Steven Allander and colleagues must be commended on embarking on what I believe will be the first cluster randomized trial in ten communities in the Great South Coast Region of Victoria, Australia to test whether it is possible to: (1) strengthen community action for childhood obesity prevention, and (2) measure the impact of increased action on risk factors for childhood obesity.

According to the trial design published in the International Journal of Environmental Research in Public Health, the WHO STOPS intervention will involve a facilitated community engagement process that: creates an agreed systems map of childhood obesity causes for a community; identifies intervention opportunities through leveraging the dynamic aspects of the system; and, converts these understandings into community-built, systems-oriented action plans.

Ten communities will be randomized (1:1) to intervention or control in year one and all communities will be included by year three.

The primary outcome is childhood obesity prevalence among grade two (ages 7–8 y), grade four (9–10 y) and grade six (11–12 y) students measured using established community-led monitoring system (69% school and 93% student participation rate in government and independent schools).

An additional group of 13 external communities from other regions of Victoria with no specific interventions will provide an external comparison.

All of this makes sense and is highly commendable.

What is shockingly lacking however – at least I see no mention of this in the published study design – is the inclusion of an explicit focus on what such community interventions aimed at reducing childhood obesity, will do to self-esteem and body image of the kids involved and weight bias in the communities overall.

Indeed, I see no mention of anyone with an explicit expertise in weight bias or kids mental health on the panel of researchers involved in this study.

This is concerning, as we now understand well that body image concerns and both implicit and explicit weight bias begin in kindergarten-age kids and must acknowledge that the “moral panic” created around childhood obesity has been accused of further promoting eating disorders, body image issues and weight bias.

Thus, we have here the unique opportunity to study the potential harm that could be done by school “surveillance” programs that assess body weight in kids or by the well-meant education on “healthy activity and healthy eating” that may teach kids that obesity is simply a result of making poor choices and not moving enough (rather than a complex biopsychosocial chronic disease, that is highly resistant to lasting effects of time-limited interventions).

I would sincerely appeal to the researchers involved to amend their study protocol to include changes in weight bias, unhealthy weight obsessions, body image issues, and eating disorders both at the level of the kids and the community overall, to ensure that the well-meant interventions do not inadvertently replace one problem with another – as always, the Devil of public health interventions lies in the unintended consequences.

In fact, if I was on the ethics committee tasked with approving this study, I would insist that an in-depth assessment plan for the potential harm of this intervention be in place before commencement of any study related activities in the relevant communities.

If the overall goal of the WHO STOPS intervention is to have a healthier generation of kids, nothing is more important than fully understanding the potential impact of this intervention on mental health and social attitudes towards kids and adults living with obesity.

@DrSharma
Copenhagen, DK

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5th Canadian Obesity Summit – Four More Days To Submit Your Abstracts!

banff-springs-hotelEvery two years the Canadian Obesity Network holds its National Obesity Summit – the only national obesity meeting in Canada covering all aspects of obesity – from basic and population science to prevention and health promotion to clinical management and health policy.

Anyone who has been to one of the past four Summits has experienced the cross-disciplinary networking and breaking down of silos (the Network takes networking very seriously).

Of all the scientific meetings I go to around the world, none has quite the informal and personal feel of the Canadian Obesity Summit – despite all differences in interests and backgrounds, everyone who attends is part of the same community – working on different pieces of the puzzle that only makes sense when it all fits together in the end.

The 5th Canadian Obesity Summit will be held at the Banff Springs Hotel in Banff National Park, a UNESCO World Heritage Site, located in the heart of the Canadian Rockies (which in itself should make it worth attending the summit), April 25-29, 2017.

Yesterday, the call went out for abstracts and workshops – the latter an opportunity for a wide range of special interest groups to meet and discuss their findings (the last Summit featured over 20 separate workshops – perhaps a tad too many, which is why the program committee will be far more selective this time around).

So here is what the program committee is looking for:

  • Basic science – cellular, molecular, physiological or neuronal related aspects of obesity
  • Epidemiology – epidemiological techniques/methods to address obesity related questions in populations studies
  • Prevention of obesity and health promotion interventions – research targeting different populations, settings, and intervention levels (e.g. community-based, school, workplace, health systems, and policy)
  • Weight bias and weight-based discrimination – including prevalence studies as well as interventions to reduce weight bias and weight-based discrimination; both qualitative and quantitative studies
  • Pregnancy and maternal health – studies across clinical, health services and population health themes
  • Childhood and adolescent obesity – research conducted with children and or adolescents and reports on the correlates, causes and consequences of pediatric obesity as well as interventions for treatment and prevention.
  • Obesity in adults and older adults – prevalence studies and interventions to address obesity in these populations
  • Health services and policy research – reaserch addressing issues related to obesity management services which idenitfy the most effective ways to organize, manage, finance, and deliver high quality are, reduce medical errors or improve patient safety
  • Bariatric surgery – issues that are relevant to metabolic or weight loss surgery
  • Clinical management – clinical management of overweight and obesity across the life span (infants through to older adults) including interventions for prevention and treatment of obesity and weight-related comorbidities
  • Rehabilitation –  investigations that explore opportunities for engagement in meaningful and health-building occupations for people with obesity
  • Diversity – studies that are relevant to diverse or underrepresented populations
  • eHealth/mHealth – research that incorporates social media, internet and/or mobile devices in prevention and treatment
  • Cancer – research relevant to obesity and cancer

…..and of course anything else related to obesity.

Deadline for submission is October 24, 2016

To submit an abstract or workshop – click here

For more information on the 5th Canadian Obesity Summit – click here

For sponsorship opportunities – click here

Looking forward to seeing you in Banff next year!

@DrSharma
Edmonton, AB

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My Critical Review Of Critical Fat Studies: Obesity In Canada

obesity-in-canada-coverA few weeks ago, I was invited by the Editor of The Lancet Diabetes & Endocrinology to review Obesity in Canada, a collection of articles by Canadian and Australian authors, who identify themselves as “fat scholars” engaging in “critical fat studies”. (Edited by Jenny Ellison, Deborah McPhail, and Wendy Mitchinson).

Obviously, I have had multiple interactions with “fat scholars” over the years and have certainly always learnt a lot.

Indeed, I would be the first to admit that many of my own ideas about obesity, including the issue of whether or not obesity is a disease and, if so, how to define the clinical problem of obesity in a manner that does not automatically label a quarter of the population as “diseased”, has been shaped by this discourse.

Similarly, my own notions about obesity management, with a primary goal to improve health and well-being rather than simply moving numbers on the scale, are clearly influenced by ideas that first emerged from the “fat acceptance camp” (not exactly the same, but close enough).

Thus, there was certainly much in this compendium that I was already quite familiar with – which certainly made the reading of this 500 page volume most enjoyable.

Nevertheless, it is important to realise that “fat scholars” do not just see themselves as “scientists” – rather, they see the practice of “fat studies” as a political work, tightly (some might say dogmatically) bound to a frame of reference that is reminiscent of political “activism” rather than “science”.

Fat scholars (at least the ones represented in this volume) are not just critical of, but also appear most happy to discard the entire biomedical and population health discourse around obesity, as nothing more than (I paraphrase), “a thinly-veiled conspiracy by the biomedical establishment to create a moral panic that justifies the reassertion of normative identities pertaining to gender, race, class, and sexuality.

Accordingly, some fat scholars appear to be of the rather strong opinion that there is in fact no “global obesity epidemic” and even if there are perhaps a few more fat people around today than ever before, the health consequences of obesity are vastly overblown, and any recommendations or attempts to lose weight are not only ineffective but actually harmful.

Now, before you simply roll your eyes and decide to file away the whole exercise in the drawer that you reserve for global-warming deniers and anti-vaxxers, let me assure you that there is indeed a lot to be learnt from the discourse (at least I did).

For one, there are absolutely fascinating chapters on the history of fat activism in Canada (which apparently dates back to the early 70s), enlightening perspectives on Indigenous People’s encounters with obesity, the issue of “mother blaming”, and even a chapter on fat authenticity and the pursuit of hetero-romantic love in Vancouver.

There are stories about how kids and families experience childhood obesity intervention programs and how primary school teachers themselves struggle with being thrust into a role of being role models while struggling with their own personal response to the pervasive obesity messages.

Obviously, there are some ideas that may be harder to swallow than others.

Take for e.g, the notion that the “root cause” of fat phobia (at least according to fat scholars who rely on postmodern feminism, psychoanalysis, and queer theories), is simply a reflection of the femininity ascribed to body fat: because women need fat to menstruate, body fat can be seen as female reproductive material that, in patriarchy, must be contained, restrained, and ultimately eliminated.

Personally, I can no doubt think of a wide range of other “root causes” that would result in “fat phobia” and “weight stigma” without having to quite delve into feminism or queer theories – but that’s another story.

Or the notion that there is in fact no link between body fat and diabetes – something that is easily refuted by a host of experimental animal studies and clinical observations  (which, in the world of “fat scholars” do not appear to exist or are for some opaque reason deemed entirely irrelevant for the discourse).

Nevertheless, these “peculiarities” aside, I do admit that I found the book a very timely, relevant and enlightening read for anyone who is seriously interested in the issue of obesity and bold enough to step out beyond the typical biomedical discourse.

I would most certainly recommend this volume to people working in health policy and public health but also to clinicians, who seek to better understand some of the social aspects of the obesity discourse as it relates to their patients.

There is much in the volume that I perhaps disagree with or rather, see from a different perspective (I am after all a clinician) – however, openness to entertaining alternative views and ideas, and willingness to shift your own opinion and beliefs when new evidence emerges, is the defining characteristic of good scholarship – and I certainly remain a lifelong student.

@DrSharma
Edmonton, AB

Disclaimer: I was given a complimentary copy of Obesity in Canada to review by the Lancet Diabetes & Endocrinology

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