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The Deceptive Nature Of Averages In Obesity Management

averageImagine there was a safe and effective treatment that worked great for 10% of people living with obesity.

While there would be no discernible benefit (or say even a small risk) for 90% of people with this chronic disease, the remaining 10% would not only experience a substantial weight loss (say 20% of their initial weight) but would also reap the benefits of the concomitant improvements in health and well-being.

Now imagine that in clinical practice, finding out for whom this treatment works and for whom it doesn’t is simply a matter of trying the treatment for a few weeks – if it works, great – if it doesn’t, well then you’re probably among the 90% for whom the treatment does not work – you simply discontinue the treatment.

The problem is, that even if such a treatment were to be developed, it would never find its way to market or into guideline recommendations.

The math is simple.

If you take 100 people each weighing 100 kg of whom only 10 will experience a 20 kg weight loss, the average weight loss for the group would be a rather modest -2 kg. No regulator would approve such a treatment.

Health economists will happily calculate that the benefits of a 2 kg weight loss do not warrant the cost.

Others may point to the side-effects (experienced even by many of the 90% who do not lose weight) and argue that the “risk/benefit” ratio for this treatment would speak against its use.

Payers would use these arguments to deny payment (even if the treatment does somehow find its way to market).

The only people who stand to lose are the 10% for whom this may well be the treatment that they’ve waited for all their life – a treatment that can reduce their morbidity and greatly improve their quality of life.

While 10% may not sound like a big number, applied to Canadians living with obesity, there would in fact be 700,000 Canadians who would potentially stand to benefit from this treatment (in the US the number would be around 8 million).

Unfortunately, these 700,000 Canadians will probably never see this treatment.

Imagine any other situation, where you potentially had a treatment that would significantly reduce the pain and suffering for 700,000 Canadians.

Now, imagine if this treatment were denied to them simply because the treatment does not work for “everyone” (or even “most”) people living with this condition.

I do fully appreciate the statistical and methodological issues with “responder analyses” – the loss of statistical power, the challenges for trial design, the non-randomized nature of the response, regression to the mean, arbitrary definition of “response” (especially for continuous variables), and more.

These are problems that are recognized and discussed – but so far, this discussion has not led to practical solutions in the clinical trial world (which is often remarkably different from what happens in actual clinical practice).

A logical approach would be to first to screen people for response to enrich the final study population with people for whom the treatment may actually work.

Additional trial design elements could include cross over designs, starting and stopping the treatment (in a blinded fashion if possible).

But the most important step is one of ideology – trialists (and regulators) must ask the question, how do we bring a treatment that only works for 10% of people with the disease (and we don’t know who these are without trying) to the 700,000 Canadians who stand to benefit.

Currently, the ideology appears to be focussed on keeping treatments that don’t work for 90% of patients off the market.

I could say the same for “experts” who belittle the potential benefits of current obesity treatments – by averaging the benefits across all participants (including everyone for whom the treatment does not work), we can ensure that no effective treatments will ever find their way to market.

Incidentally, this issue applies to all types of treatment.

Take for example exercise for weight loss – the overwhelming evidence is that average sustained weight loss with exercise is perhaps 1 or 2 kg at best. Yet, there are 1,000s of patients who will attest to the fact that exercise is what helped them lose weight and keep it off.

However, if anyone tried to get regulatory approval for exercise as a treatment for obesity, regulators would probably simply laugh them out of the room – that’s how ineffective exercise is ON AVERAGE! (the same could be said for most dietary treatments for obesity)

The notion that we will one day find a single treatment that works for every (or even most) patients with obesity is perhaps far too optimistic.

On the other hand, the notion that certain subsets of patients with obesity will benefit from some treatments (while others won’t) only reflects the complex and heterogenous nature of this condition.

@DrSharma
Edmonton, AB

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Will Low Oil Prices Lead To An Obesity Spike In Alberta?

Oil-Barrels-with-Red-Arrow-740There is no doubt that the low oil price is pummelling the Alberta economy.

According to the Alberta economic dashboard, in October 2015, Alberta’s seasonally adjusted unemployment rate was 6.6%, up from the 4.4% rate a year earlier and from last month’s 6.5% rate. The youth unemployment rate was 11.6%, up from last year’s 9.0% rate, while male unemployment increased precipitously from 3.6% last October to 7.3% this year.

As no one seems to be expecting a rosier future for this industry, it may well be that many who lost their jobs in the wake of mass oil patch layoffs, will find the coming months (not to mention the festive season) both economically and emotionally challenging.

According to this report, suicide rates from January to June in Alberta this year are up 30% compared to the same period in 2014.

One challenge that may escape notice is the fact that this situation may also lead to significant weight gain in those affected.

Depression, anxiety, food insecurity, insomnia and simply being unable to afford healthy food are all important risk factors for weight gain.

Indeed it is hard to imagine how going from a high-paying job to being unemployed with little immediate hope of recovery will affect families.

Maintaining a positive spirit – necessary for eating healthy, engaging in physical activity and healthy sleep – will clearly be a challenge.

So while it may take some time for “official” statistics regarding overweight and obesity to change, I would not be surprised to see numbers go up.

Unfortunately, when this happens, people putting on the extra pounds will likely face the same blame and shame for “making poor choices” as everyone else who is struggling with this problem faces everyday.

As medical professionals, we need to acknowledge that unemployment and the worries that come with it can make our patients more susceptible to weight gain – let us not miss the opportunity for prevention.

If you’ve been affected by the economic downturn and this is affecting your health, please feel free to leave a comment.

@DrSharma
Edmonton, AB

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Leaders Have To Understand, Accommodate, Embrace & Support Diversity

The Right Honourable Kim Campbell, PC, CC, OBC, QC, with Arya M. Sharma, MD, FRCPC

The Right Honourable Kim Campbell, PC, CC, OBC, QC, with Arya M. Sharma, MD, FRCPC

Earlier this week, I spoke at a leadership lecture series on barriers to participation at the Peter Lougheed Leadership College at the University of Alberta.

The speaker series was hosted by the principal of the college,the Right Honourable Kim Campbell, who served as Canada’s 19th prime minister in 1993.

While I spoke about the particular challenges and barriers faced by Canadians living with obesity and how these can be accommodated and supported in the workplace and society in general, other speakers spoke on the accommodation of individuals living with other challenges.

Thus, Kelly Falardeau, herself a victim and advocate for burn survivors and Deryk Beal, one of Canada’s  leading clinician scientists on stuttering and other speech impediments, joined me in speaking on the importance of diversity and the need to identify obstacles to social inclusion that keep individuals from reaching their full potential.

In my presentation I did my best to portray the biological, physical, emotional and societal challenges that Canadians living with obesity face everyday.

Here is what I asked the students to think about:

“So how can we help people living with such barriers?

For one, let us educate ourselves on the real issues – if there was an easy solution that actually worked, believe me my clinic would be empty.

Secondly, let us show some respect for people who wake up with this barrier every single morning and go through their day – for the most part doing everything everyone else does. 

Thirdly, let us acknowledge that once you have obesity there is no easy way back. I have patients who have lost their entire weight over on diet after diet after diet only to put the weight back again. Diet and exercise is simply not enough for most people – surgery works but is not available and not scalable – we cannot do surgery on 120,000 Albertans. So let us not pretend that there is an easy solution to the problem – we simply don’t have enough treatments that work.

Fourthly, till we do come up with more treatments that actually work or maybe even get our act together on prevention, let us not make life harder for people living with this barrier than it has to be. We can do many things to accommodate people living with obesity – we accommodate people with all kinds of “special needs” at home, in society in the workplace – just not for people living with obesity.

Fifth, let us show our support for people who struggle with their weight by the way we treat them, the way we talk about them, the way we engage with them – they are people like all of us. Just because they carry extra weight does not mean they are second class citizens or people we can simply make fun of or ignore – we are after all talking about 7 million Canadians – men, women and children.

Let us not be the barrier that makes their life even more difficult than it already is.”

Our presentations were followed by an enthusiastic ‘master class’ with students in the inaugural leadership class of the Peter Lougheed Leadership College.

I’d like to thank the organizers for giving me the opportunity to advocate on behalf of Canadians living with obesity.

@DrSharma
Edmonton, AB

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Are Cost-Saving Arguments For Treating Obesity Another Form of Discrimination?

sharma-obesity-australian-moneyYes, health care costs consume an increasing proportion of taxes (in countries with public healthcare systems) or personal income.

Yes, there is also considerable waste in healthcare systems and not every dollar spent is necessary or provides any meaningful benefit.

Indeed, even where health benefits are achieved, these may perhaps be had at a lower cost than in our current systems.

Thus, there is no argument against reducing waste and improving cost-effectiveness of treatments (or for that matter, prevention).

However, arguing in favour of cost-effectiveness should not be confused with arguments for cost-savings, as is often put forward in discussions about obesity treatment.

Indeed, authors often bend over backwards to demonstrate the potential cost-savings that may come from treating obesity.

Case in point is a study by Oleg Borisenko and colleagues, who in a paper published in Obesity Surgery, suggest that (based on the Scandinavian Bariatric Surgery Registry), surgical treatment of severe obesity led to savings of €8408 per patient, which translates into lifetime savings savings of €66 million for the cohort, operated in 2012.

Be that as it may, I feel that savings cannot be the sole argument in favour of providing treatments for a disease. Given the tremendous impact that obesity has on the health and lives of people living with obesity, I would argue for treatments even if they increase healthcare costs.

Let us remind ourselves that we do not argue about whether or not treating people with heart attacks, osteoarthritis, kidney failure or cancer saves money for the health care system – it rarely does, and is besides the point. The reason we spend money treating these conditions is because the people presenting with these conditions deserve treatment – period!

Thus, I would argue that the primary reason that health care systems should be spending money on treating obesity is because people with obesity deserve treatment – not because it saves money for the system.

Thus, even if there was a net cost to treating obesity, people with obesity deserve treatment as much as people with diabetes, heart disease or chronic kidney disease.

If this means a greater cost to the health care system, so be it – raise taxes or increase payers contributions – don’t try to save money by simply refusing to pay for obesity treatment (or rationing it by making it difficult for patients to access).

Using cost-savings as the prime argument for treating obesity reeks of discrimination.

This is why I refuse to participate in debates about how treating obesity can save health care systems millions of dollars – while this may well be the case, it is not the argument that I am willing to make to justify providing effective medical or surgical care to people living with this condition.

@DrSharma
Edmonton, AB

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Why Treating Severe Obesity Has The Highest Potential For Health Cost Savings

sharma-obesity-dollarsAs the latest HQCA report on obesity in Alberta released this week, the substantial population burden of overweight and obesity (now affecting 6 in 10 Albertans) is a significant driver of health care costs in the province. In the US, this increased health care cost for adult obesity is estimated at around $3,508 per individual with a BMI greater than 30 for a total of well over US$ 300 billion per year.

However, as highlighted in a recent article by John Cawley and colleagues in PharmacoEconomics, health care costs are not equally distributed across all people living with increased body weight – rather, obesity related health care costs rise exponentially with increasing BMI levels (i.e. at the extremes of BMI).

Thus, the greatest health care savings for individual patients can be expected in those living with severe obesity.

To illustrate this, the researchers used data from the US Medical Expenditure Panel Survey from 2000-2010 (n=41,435), to calculate the potential annual savings in health care costs (in US $ in the US health care system), for various reductions in body weight in individuals with BMI levels ranging from 30 kg/m2 to 45 kg/m2.

Thus, for e.g. the annual cost savings with a 5% reduction in body weight for someone with a BMI of 30 kg/m2 amounted to a mere $69 per year.

This figure, however, increased exponentially for people with higher BMIs, increasing to $528, $2,137, and $10,030 in an individual with a BMI of 35, 40, and 45 kg/m2, respectively (these figures were somewhat higher, when the individual also has diabetes).

Thus, while treating obesity to achieve a 5% reduction in body weight in someone with a BMI of 30 kg/m2 may never be “cost-effective”, the same amount of weight loss in someone with more extreme obesity, would likely pay for itself or even lead to significant savings.

Because the impact of obesity on mental and physical health, life-expectancy and quality of life is also greatest at higher levels of BMI, one could also make a strong ethical argument for singling out these individuals for priority treatment in the health care system.

Obviously, as readers should be aware, BMI is at best a crude measure for health – a more precise assessment would have used more sophisticated staging systems like the Edmonton Obesity Staging System to calculate individual risk and benefits. However, we should remember that at a population level BMI does function moderately well as an indicator of obesity related risk (although not in individual patients).

This analysis has important consequences both for population and individuals approaches to obesity.

Although the population burden of obesity lies in the middle of the BMI bell curve, and shifting this ever so slightly can move a substantial number of people living with overweight or obesity to a BMI that lies below the current cut-offs, such a change may have little influence on the overall health care costs of obesity, as these live in the extremes.

Thus, using the above numbers in a crude back-of-the-envelope calculation, to save $1,000,0000 per year in health care costs, one would have to lower BMI by 5% in about 14,500 people living with a BMI of 30 kg/m2 compared to only 100 people with a BMI of 45 kg/m2 – a much more manageable problem.

This is why it is harder to make a cost-savings argument for addressing obesity at a population level rather than focussing on those living with more severe obesity, unless such population measures can also substantially help lower the BMI of the latter.

Unfortunately, current population trends show that while rates of overweight and mild obesity appear to be levelling off (thank perhaps in part to population health measures), severe obesity continues to increase at alarming rates.

This is why a greater focus on finding and delivering better treatments to those living with severe obesity, including those that can only offer modest reductions in BMI, has to be the main priority of any health care system seeking to reduce obesity related health care costs.

@DrSharma
Edmonton, AB

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