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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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Scalability of Obesity Treatments: Need To Target

bariatric patient in bedYesterday, I discussed the desperate need for scalable obesity treatments.

I pointed out that neither behavioural nor surgical interventions are readily scalable to provide long-term obesity treatments to the over 7,000,000 Canadians currently considered to have obesity.

I also noted that, like for other chronic diseases, only medical treatments with anti-obesity medications have the potential for scalability in the millions – we do this regularly for the millions of people living with diabetes, hypertension, heart disease, or any of the other common chronic diseases affecting Canadians.

Nevertheless, before we discuss what it would take to scale up medical treatments, let us take a look at whether all 7,000,000 affected Canadians really need obesity treatment.

Let us first note that the number 7,000,000 refers to Canadians with a BMI over 30. This may well overestimate the problem – as not everyone will actually need or likely benefit from anti-obesity treatments (BMI measures size – not health!).

In fact, if we apply the actual WHO definition of obesity, namely the presence of abnormal or excess body fat that impairs health, we can perhaps readily reduce this number by about 5-10% (anyone with Edmonton Obesity Stage 0) obesity, as these individuals are pretty healthy despite their excess weight. As there is no evidence that these rather healthy individuals would experience any long-term benefits from anti-obesity treatments, it would be entirely reasonable to take a “watch and wait” approach.

The 7,000,000 also includes an additional 15-20% of people, who would have rather mild impairments in health (Edmonton Obesity Stage 1), associated with a very low long-term risk – for these there is also no proven long-term benefit of obesity treatment.

Thus, we can readily exclude about 20 to 30% of individuals for whom the risk-benefit ratio (and thus, the cost-benefit relationship) would hardly justify the use of prescription medications.

This would reduce the number needed to treat by as many as 2 million – leaving us with about 5,000,000 left to treat.

Of these (by definition), all would have Edmonton Obesity Stage 2 or higher, meaning that they will all have some obesity related health impairments.

However, many of these individuals will have obesity related health risks (e.g. hypertension, diabetes, sleep apnea) that are currently well managed with other available treatments (e.g. anti-hypertensive or anti-diabetic medications, CPAP, etc.). For these well-managed patients, it is not clear what additional value anti-obesity medications would offer.

Let us assume that this number of well managed patients is about 50% of the remaining 5,000,000 – this leaves us with only 2,500,000 individuals with obesity related health problems that are not well managed with the available treatments for their comorbidities. It is probably only in these individuals that medical obesity treatment would make sense – both in terms of cost and benefit.

Let us further assume that for another 50% of the remaining for various reasons (e.g. too sick, too old, no ready access to medically supervised care, not interested in obesity treatment, etc.) medical treatment for obesity is not feasible.

This would leave us with only about 1,250,000 patients where medical treatment with prescription drugs would be both practical and likely cost-effective.

This is now a much more manageable problem. In fact, this is only about half the number of Canadians currently living with diabetes, a problem that is routinely managed with medical treatments.

So where are the anti-obesity treatments for these patients?

That will be the topic of tomorrow’s post.

@DrSharma
Edmonton, AB

 

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Dr. Ryan’s 10 Commandments of Obesity Management

Dr. Donna Ryan, Pennington Biomedical Research Centre, Baton Rouge, LA

Dr. Donna Ryan, Pennington Biomedical Research Centre, Baton Rouge, LA

These are the 10 Commandments of Obesity Management for health professionals presented by the Pennington Biomedical Research Centre’s Dr. Donna Ryan, who also happens to be the President Elect of the World Obesity Federation:

  1. Thou shalt use BMI as part of the electronic health record, but thou shalt not use it as a diagnosis that directs treatment;
  2. Thou shalt consider the patients’ genetic/ethnic background as part of the BMI and waist circumference risk assessment;
  3. Thou shalt not treat on BMI alone. Thou shalt remember that waist circumference is a risk factor and use it and other health risks to direct treatment;
  4. Thou shalt not worship at the shrine of ideal weight, but rather extoll the virtue of good health and set a weight goal based on a health target;
  5. Nor shalt thou worship at the shrine of any one diet;
  6. It is your job to teach the skills training in behaviors to produce weight loss or to refer the patient to someone who can;
  7. Thou shalt not impugn thy patient’s willpower, but rather prescribe aids to help thy patient adhere to the diet and exercise plan;
  8. Thou shalt prescribe medications according to the label, and if the patients lose 5% or more, thou shalt continue those medications.
  9. Thou shalt refer patients for bariatric surgery, especially if they suffer metabolic complications of obesity;
  10. Thou shalt expect a relapse if treatments are stopped.

@DrSharma
New Orleans, LA

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Does Testosterone Treatment Help Conserve Lean Body Mass in Dieting Men?

sharma-obesity-dexa-scan1Screen Shot 2016-05-29 at 9.03.11 PMLoss of muscle is an almost obligatory consequence of losing weight. This is particularly true during very restrictive diets resulting in rapid weight loss.

Now, a randomised controlled study by Mark Ng Tang Ful and colleagues, published in BMC Medicine, suggests that treatment with testosterone may help promote diet-induced loss of fat mass and limit loss of muscle mass.

The study included 100 middle-aged men with obesity, who had a total testosterone level of or below 12 nmol/L, the lower limit reported for healthy young men.

Subjects received 10 weeks of a very low energy diet (VLED) followed by 46 weeks of weight maintenance during which they were randomly assigned to 56 weeks of 10-weekly intramuscular testosterone undecanoate or placebo.

Of the 82 men, who completed the study, participants treated with testosterone had an about 3 Kg greater reduction in fat mass with a greater reduction in visceral fat.

While both groups lost the same amount of lean mass during the VLED, participants treated with testosterone, quickly regained the lean mass so that they had about 3.4 more lean mass than the controls at the end of the study, so that virtually all of the greater weigh loss by these participants over the course of the trial was attributable to fat loss.

These findings are consistent with what is known about testosterone function in men with obesity.

Thus, as the authors remind us,

“Experimental studies in humans suggest that fat-derived adipokines and pro-inflammatory mediators may play a role in central gonadal axis suppression. In addition, preclinical evidence has shown that testosterone deficiency promotes adipose tissue accumulation but reduces myogenesis via an androgen receptor mediated pathway.”

Thus, these findings suggest that dieting men may benefit from adjunct treatment with testosterone to promote fat loss and conserve muscle mass.

@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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