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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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Do Summer Vacations Drive Obesity In Kids?

sharma-obesity-kids-playing-outsideOne of the papers presented at Obesity Week 2016 was work Paul von Hippel and Joseph Workman, published in Obesity, suggesting that virtually all of the weight gain in US kids from Kindergarten to Grade 2 happens during Summer vacations.

The researchers looked at data from the Early Childhood Longitudinal Study, Kindergarten Class of 2010–11, a nationally representative complex random sample of 18,170 U.S. children

All of the increase in the prevalence of obesity (which increased from 8.9% to 11.5% during the 2-year observation period), occurred during the two summer vacations.

Thus, the authors conclude that young kids are at greater risk of weight gain when they are out of school than in school.

As for the possible reasons, the researchers have this to offer,

“It is not clear whether children consume more food energy in the summer, but they do sleep less, and they watch more television. In addition, children in hot climates are less physically active during summer, although children in cool climates are more active.”

These findings may have important implications. Currently many health promotion programs focus on school interventions.

However, these data suggest that the time spent in school may not be the problem, which is in fact very much in line with the rather disappointing results from school intervention programs.

Rather, it appears that health behaviours at home may need to be the target of intervention, a much more daunting enterprise with no ready solutions.

Or, as the authors put it,

“Many school-based interventions have had little effect, and effective school-based interventions tend to be those that do not just alter the school environment but also involve parents and try to change out-of-school behaviors such as watching television. There may also be underexploited potential in out-of-school interventions such as summer camps, summer learning programs, parent nutrition education, reductions in screen time, and reductions in child-directed food marketing.”

@DrSharma
Edmonton, AB

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Do Endocrine Disrupters Play A Role in Obesity?

sharma-obesity-universal-theoryThere are now over 1,000 synthesised chemicals that have been characterised as endocrine disrupters – i.e. exogenous chemical entities that interfere with the body’s hormonal function.

Exposure to endocrine disrupters in humans included our diets, personal care products, antimicrobial soaps, household or agricultural pesticides, and cleaning products.

Now, the Endocrine Society has produced its second Scientific Statement on environmental endocrine-disrupting chemicals (EDC-2), published in Endocrine Reviews. (a summary appears in JAMA Internal Medicine)

The major EDC classes reviewed were industrial chemicals (polychlorinated biphenyls [PCBs], dioxins), pesticides, plastics and plasticizers (bisphenol A [BPA] and phthalates), perfluorinated compounds, and flame retardants.

As for the relationship between ECDs and obesity, the authors summarize:

“In animals, several EDCs now referred to as obesogens and diabetogens were associated with obesity and DM2, respectively, with results dependent on the chemical, dosage, and age of exposure. The evidence is strongest for tributyltin, persistent organic pollutants (POPs), pesticides, and BPA. Some EDCs exert actions on adipogenesis, or on pancreatic β- and α-cells. Developmental EDC exposures also led to insulin resistance and hyperinsulinemia and were associated with alterations in serum adiponectin and leptin. Although the mechanisms varied, they included effects mediated via the aryl hydrocarbon receptor, peroxisome proliferator-activated receptor γ (PPARγ), and estrogen receptors (ERs). Furthermore, limited evidence suggests that the hypothalamic control of energy balance may be perturbed. Cross-sectional epidemiological data showed associations between EDCs, obesity, and/or DM2, although causality cannot be inferred. Less is known about EDCs and cardiovascular disease, but emerging work suggests that this merits further research.”

I have little doubt that both exposure and susceptibly varies widely between individuals, however there are currently no tests that would allow us to discern the contribution of ECDs to obesity in a given individual.

Thus, while the magnitude of the contribution of ECDs to any given person’s weight problem may be hard to diagnose and even harder to manage, the findings do remind us that the environmental drivers of obesity may well go beyond just our foodscape and sedentariness.

Free access to the Executive Summary of the Statement is available here

@DrSharma
Edmonton, AB

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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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