Why Are Some Physicians Bashing a Weight Loss Drug Before it's Even Out?

I've been practicing in obesity medicine exclusively since 2004, have worked with literally thousands of patients and would guess that I've prescribed medication in roughly 0.5% of cases.

So why don't I prescribe meds? Is it because I think people should "Do it the right way", the "old-fashioned way", the "diet and exercise" way? Good god no! It's just that to date the medications that we've had available to us haven't been particularly impressive, where for the most part their side effects weren't worth most people's whiles given the only very modest improvements they provided to weight.

But what if there were a medication that was well tolerated and actually helped the average person taking it lose a medically significant amount of weight? While I'm quite certain I wouldn't use it with each and every patient, certainly if I had a patient who wanted to try it, or a patient where their best efforts weren't affording them further weight loss and the risk or impact of their weight was still significantly greater than the risk or negative impact of the medication, damn right I'd suggest it. Why wouldn't I? That's what doctors do - if there's a therapy where the risks of inaction outweigh the risks of treatment, we discuss treatment.

Now there's something to be said about not trying brand spanking new drugs. Many doctors, myself included, often like to wait for a while once a drug's been released so that if there was a risk or a side effect that the limited sample sizes of Phase 3 clinical trials weren't powerful enough to reveal, we'd learn about it. That caution isn't what I want to chat with you about today. But first, some brief background.

Qnexa is a new weight loss drug that an FDA advisory committee has recently overwhelmingly recommended be approved for use. It's a combination drug that combines a known weight loss medication (phentermine), with a known anti-seizure medication (topiramate). The doses of the drugs used in Qnexa are relatively low compared to their regular usages separately, and perhaps that's why only 16% of the folks prescribed the top dose of Qnexa withdrew from the more than year long study due to adverse effects. As far as weight loss goes, the drug's impressive with an average weight loss of 14.4% of presenting body weight lost by week 56 in one study and 16% in another.

Yes, weight can and does respond to lifestyle changes, but statistically speaking, usually only temporarily. And really, so what? Pretty much everything responds to lifestyle changes including hypertension, diabetes, depression, osteoarthritis, osteoporosis, hyperlipidemia, esophageal reflux, etc., and yet I've never heard a physician suggest it'd be unfortunate if the FDA would approve a new blood pressure medication because upping exercise, losing weight and reducing sodium might do the trick, or because we don't yet know what the impact might be of taking it for a lifetime. And yet that's exactly what Harvard's Dr. Pieter Cohen said about Qnexa,

"It's likely that the FDA will soon approve Qnexa for weight loss. This is unfortunate. Qnexa does help some people lose a modest amount of weight, but to keep the weight off, one has to take Qnexa for a lifetime. But we have no idea if Qnexa is safe to use for a lifetime."

"Assuming Qnexa is approved, what do I recommend? It will be very tempting to try a new diet pill once the FDA gives it their blessing, but in the case of Qnexa: just say no. Stick with the hard work of increasing exercise, modestly decreasing calories and selecting healthy foods"

And Yale's Dr. David Katz, a man I greatly respect and admire, in that same piece had this to say,

"Yes, Qnexa can help you lose weight. But that doesn't mean it will, or even that it should.

Qnexa combines a stimulant drug with an anti-epilepsy drug. The first can drive up blood pressure, and can [cause] jitteriness. The second can cause fatigue, nausea and brain fog. It's not a great drug by any means, and likely only works as long as people keep taking it.

For those facing bariatric surgery, it is an option worth considering, although not as effective. For most others, better use of feet and forks is the far better option."

Honestly, I don't get it. Blindly bashing a drug that's not yet been released because in some cases lifestyle changes might treat the condition, and in other cases because there's the potential for side effects seems insane to me - lifestyle likely has a positive impact on pretty much every condition out there, and every drug ever made has the potential for side effects, and who am I or any doctor to say what each individual's "better" option is?

I'm no pill pusher, and yes, it'd be wonderful if everyone lived incredibly healthy lifestyles, but I think my job as a physician is to ensure people are equipped to make informed decisions, not to make their decisions for them, or to judge the ones that they make. If Qnexa's approved I'll be happy to discuss the medication's pros and cons with each and every suitable patient. I'll also discuss with them the options of forgoing medication in favour of lifestyle changes, of bariatric surgery, and heck, I'll even discuss the option of doing absolutely nothing with them. I'll do it all in a nonjudgmental manner too - because my job is to ensure my patients are aware of the risks and benefits of all of their treatment options, including watchful waiting, and then to support them in whatever informed decision they make. To do otherwise in my mind is contrary to the spirit of medicine and I think, when it comes to Qnexa specifically, it's suggestive of an unfair weight bias that clings to the belief that unless a person is willing to make formative lifestyle changes, they're not worthy of being helped and that if only patients wanted it badly enough, they'd just fix themselves.

In my mind those attitudes are far more toxic than any drug could ever be.

[Full disclosure: I am not a shareholder of Qnexa's parent company Vivus nor am I their paid consultant]

R.I.P. Marijuana Receptor Weight Loss Drugs

Not sure if you've heard of them since they never really hit North American shores.

They were a class of drugs that worked on the endocannabinoid receptors and multiple drugs companies were working on obesity drugs based on blocking CB-1 receptors and in so doing, decrease caloric intake.

The drugs were actually fairly effective, one of them had even been released, but unfortunately there was an unacceptably high incidence of adverse psychiatric affects including suicidal ideation and less than 2 years after their much bally-hoo'ed launch, they've been permanently pulled from the market and the drug companies have all quashed their development.

Could someone please invent a safe and efficacious medication for weight management?

Please?

Which "Natural" Weight Loss Supplements Really Work?

Simple.

The ones laced with prescription weight loss drugs.

You see the thing is, there is far less regulation with nutraceuticals than pharmaceuticals.

With real drugs potency and ingredients are tested, studies are conducted to determine efficacy and safety and mandatory reporting of serious adverse effects exists.

The same can't be said about "natural" products.

Perhaps this is why on a weekly basis I get a report from Health Canada detailing the week's latest recalls.

This week?

This week's lineup includes:

Dan Bai Shou Shen Su (Found to contain undeclared thyroid hormones and sibutramine)

Karntien (Found to contain undeclared sibutramine and N-desmethylsibutramine)

Karntien Easy to Slim (Found to contain undeclared sibutramine and N-desmethylsibutramine)

More Slim (Found to contain undeclared sibutramine)

Soloslim (Found to contain undeclared sibutramine and illegal in Canada synephrine)

Honestly, if there really was a natural product that was both effective and safe for weight loss, do you think it'd be a secret? Of course not, quite the opposite as the company that made it would ensure that a copy of the studies proving the product's safety and efficacy were on every single physician's and reporter's desk in the world.

Bottom line?

When it comes to "natural" weight loss products. If your doctor doesn't recommend a particular weight loss aid it's safe to assume that to date it hasn't been proven to be safe and effective and therefore also safe to assume it's probably a waste of your money and potentially a risk to your health.

Oh, and if you think that doctors don't recommend "natural" products because of a global conspiracy to keep people ill, may I suggest you go to see the new X-Files movie.

Should 8 Year Olds be on Cholesterol Lowering Medication?

In case you hadn't heard, last week the American Academy of Pediatrics recommended that kids between the ages of 2 and 10 be screened for cholesterol problems if they have risk factors for problems therein.

Risk factors would include strong family histories, obesity, high blood pressure or diabetes.

The Academy goes on to recommend that for kids over 8 with high cholesterol, medications be considered.

On the one hand, perhaps that makes sense. We know high cholesterol to be a risk factor for heart disease and these kids therefore have at least two risk factors. Presumably lowering cholesterol will therefore reduce long term cardiac risk in these children.

The problem is, given that generally we haven't been treating 8 year olds with cholesterol lowering medications, we actually don't know that there will be a long term benefit, we just assume there will be one and that there won't be any surprising long term complications from starting these drugs during years that their bodies and brains are developing.

On the other hand, by giving these kids drugs, at least in kids whose secondary risk factor is not a strong family history (in which case they may well have genetically high cholesterol levels), we're not addressing the root cause of their effectively middle-aged bodies - lifestyle.

Given that 8 year old kids don't cook for themselves, don't shop for food for themselves, don't pack their own lunches for themselves and all in all live the way their parents have taught and allowed them to live, I think it's a crying shame that there's no pill that we can prescribe to their parents to help them learn, set, live and lead better examples.

Are Antioxidants Dangerous?

Since the late 1980s antioxidants have been heralded as molecules that are dramatically important to our health. Multivitamins shout their antioxidant concentrations on their labels and food and beverages are promoted based on their antioxidant properties.

Antioxidants work by neutralizing free radicals, the byproducts of oxidative stress in the body - put simply, they are supposed to be working to protect us by neutralizing dangerous and damaging molecules that have been touted as being theoretical culprits in a myriad of disease processes.

This week a study was pre-released by the Annals of Internal Medicine that looked at the long term effects of selenium supplementation on the risk of developing diabetes. The reason researchers chose selenium is because it's a potent antioxidant and oxidative stress has been proposed as an important mechanism in the development of insulin resistance and diabetes and therefore researchers postulated that if they provided folks with more protection against oxidative stress, it might translate into protection against diabetes.

What the researchers found was that the more selenium provided to the study patients, the greater their risk (yes, I did say greater) of developing diabetes.

So what's going on here? I thought it was supposed to lower risk.

What's going on here is further proof that common sense does not dictate treatment response and that our bodies are big black boxes that don't always behave as predicted.

Interestingly that can be said about a few other heavily promoted antioxidants.

Beta-carotene, once expected to be a contender at reducing the risk of cancer development was actually shown to increase the risk and rate of lung cancer growth in Finnish smokers.

Vitamin E, once expected to help reduce the risk of heart disease, Alzheimer's, cancer and more, was shown in fact to be associated with increased rates of all cause mortality and increased risk of congestive heart failure.

At the end of the day, I'm not suggesting you should immediately stop your antioxidant containing multivitamin. The risks we're talking about here are far from astronomical and there may indeed be benefits to other disease processes. I do however think that consumers need to bear in mind that we really don't have nearly the understanding that folks think we have in terms of how individual micronutrients impact on our health and simply because something theoretically sounds healthy, doesn't make it a smart choice.

My recommendation is to remember that while we might still lack data about the individual components of food, where we've got a great deal of data is about food itself. Diets higher in fruits, vegetables, whole grains, nuts and fish and lower in red meats, refined carbohydrates and salts indeed have been shown to reduce the burden of chronic disease.

Focus on your food, not on your vitamins.

Is Avandia Safe?

If you're a diabetic and on a medication called Avandia (Rosiglitazone) and you read the news you're probably pretty scared. A few weeks ago a study came out in the New England Journal of Medicine that concluded, via a meta-analysis of other studies, that taking Avandia increased the risk of severe cardiovascular disease or death from cardiovascular causes by 8%.

I read the meta-analysis and I'll be honest, my knowledge of medical statistics was insufficient to truly decide how scary this all was. I chose to start taking my patients off Avandia and putting them on other medications figuring that until the issue is more firmly established one way or the other, I'd err on the side of caution.

This week the New England Journal of Medicine invited a diabetologist, a cardiovascular epidemiologist, and a drug-safety expert to give their opinions on the study and their views are available on the New England Journal's website for free here (scroll down to the editorial content and click on the free full text links).

Their conclusions?

Same as mine (but with their knowledge of statistics and study design backing them up) - given that there is certainly uncertainty regarding Avandia's safety and that alternative drugs for diabetics are readily available, it would seem prudent to consider switching patients off Avandia.

If you're a patient taking Avandia I would not recommend stopping it on your own. Go and see your physician and discuss it with them. If you were to stop it on your own without an alternative your sugars may climb dramatically high which certainly carries with it far more established and dramatic risks than staying on the Avandia for the extra few days it may take you to set up your appointment with your doctor.

No Marijuana Weight Loss Drug Yet

So last week Sanofi-Aventis pulled their marijuana receptor based drug rimonabant from the FDA's application process.

It seemed that the drug, widely touted as the next great thing in medical weight loss, worked alright as a weight loss aid but had the nasty habit of inducing psychic side effects including suicidal ideation.

Rather than risk getting rejected from the FDA (I imagine that would hurt sales in the EU where the drug is in fact approved), Sanofi pulled the application.

Sanofi had sunk a tremendous amount of money into the research and development of the drug and shares dropped close to 5% on the news.

Sanofi had predicted over $3 billion per year of global sales of the drug and spent tremendous amounts of money marketing it even before its eventual non release in the States. I remember they were the only booth at the last Obesity Society conference with red carpets, plasma screen televisions, slick handouts and for some odd reason, frozen yogurt bars.

Bottom line here, while certainly I'd welcome a weight loss medication that was safe, effective with little in the way of side effects, it doesn't appear that we're too much closer.

Underwear Makers Rejoice!

And rejoice too if you're sick of Food Guide posts because this isn't one of them!

Alli, a half-strength version of the prescription drug Xenical (Orlistat) has been approved for over the counter sales in the US and will become the first over the counter weight loss drug approved by the FDA.

The way Xenical works is pretty straightforward.

In the gut there are enzymes that help the body break down and absorb fat. One of these enzymes is called, "GI Lipase" and what Xenical does is block it from acting.

Consequently roughly 30% of the fat you might consume will be left unabsorbed and able to pass freely from your body.

And I do mean freely.

Side effects of Xenical may well include increase flatulence, oily stools, diarrhea and um, accidents.

Here's the discussion on side effects from Xenical's official website,

"These changes may include gas with oily discharge, an increased number of bowel movements, an urgent need to have them, and an inability to control them, particularly after meals containing higher amounts of fat than are recommended."

Folks who look to Alli to help them with their weight loss woes but don't also change their lifestyles will be in for a staining disappointment - best case scenario without a lifestyle change behind you, I imagine Alli will lead to a 3-6% weight loss.

The other issue of course is compliance. If you knew you were having a fatty meal (let's say you order in a pizza) - are you going to take a pill that will cause increased flatulence, painful diarrhea and um, accidents?

Lastly, if you think my picture's in poor taste, it's actually not what you might think.

Thanks to the crack research teams over at bookofjoeI bring you the underwear safe.... no burglar's going to look in there

(I'm not making this stuff up - if you want to buy it, click this link).

Stupidest Weight Loss Drug Ever Round II

It's called Slentrol and it's being marketed by Pfizer as a prescription weight loss drug for dogs.

Yes, I did just write a prescription weight loss drug for dogs.

So where does this dramatic rise in canine obesity come from?

It must be the growing prevalence of suburbia where the dogs are much more likely to drive to work than walk. Or perhaps it's all of the commercials that basically brainwash dogs into eating more. Maybe it's the rapid growth of fast dog food restaurants where dogs get to great-dane-ersize all of their portions for just a few pennies. I suppose it's also possible there's a new doggie gut bacteria causing rapid weight gain, or maybe an adenovirus?

Or maybe, just maybe, it's from their owners feeding them too much food and not going out with them for exercise?

If a doggie weight loss drug isn't enough of an example for you of a world gone wrong, how about a doggie gym? Or a doggie treadmill?

Here's a simple rule - you know your lifestyle needs a major makeover if : (a) Your dog is fat, and (b) The best solution you can come up with for helping your dog lose weight is a prescription weight loss drug.

CLA - Far from a Magic Weight Loss Bullet

The media are alive with the sound of CLA!

I can't get over the number of articles I've read, in both mainstream and blogosphere press, about the benefits of supplementation with CLA (conjugated linoleic acid) on body weight and body fat percentage, and all from a very small, limited, and poorly designed study.

The study took 40 (yes, just 40) people and randomly assigned 20 to receive a CLA supplement and 20 to a placebo for a 6 month period. The subjects were exclusively young (between the ages of 18 and 44) and none of them were obese to begin with (BMI between 25 and 30). They were watched to see if there was a difference in weight loss and/or a difference in their body fat percentage.

The study was written in a manner that was supposed to reflect "holiday weight gain" by being conducted over the course of last year's Christmas holiday season. That said, while the study participants were indeed controlled so that the placebo and control groups were roughly the same age and weight, what was not controlled for was lifestyle.

What do I mean by that? Well, there's no note about whether or not the participants used gyms, whether or not they had sedentary or active jobs and importantly, given the aim to discuss "Holiday" weight gain, their religions, whether or not they had large family gatherings over the holiday season and whether or not they themselves celebrated a holiday season were not mentioned in the methodology or controls.

Regardless, even if we ignore the clear lack of appropriate controls, the results were far from spectacular.

With a percentage just barely greater than would happen by chance, the folks in the CLA group lost a grand total of 1.3lbs and their body fat percentage went down by 1%.

So what can we conclude from this paper?

Not too much.

Best case conclusion:

If you're a non-obese, young adult and you want to spend over $20 a month on CLA supplements, you may lose 1.3lbs over a 6 month period.

Woo-hoo?

Wanna know how else you could lose 1.3lbs over a 6 month period?

Burn or not eat 25 calories a day.

Hmmm, let's see, $120 in pills that may have long term risk (in multiple studies CLA has been shown to increase insulin resistance and increase deposition of fat in the liver and spleen) or you could simply walk for an extra 5 minutes every day.

As I tell all my patients, if there was something that I could sell them that would help them lose weight and help me pay the rent, I would.

Guess I'm the scrooge of supplements 'cause I don't sell any!

Merry Christmas to all those celebrating, and a big Bah-Humbug to the neutraceutical corporations and the press who get folks excited about non-exciting stuff!

Unless your doc runs a weight loss program, don't let them give you weight loss drugs

Just a quick post. A study published recently in the New England Journal of Medicine, confirmed something anyone involved in medical weight loss already knows - the drugs aren't so great all by themselves.

If your family doc prescribes you Meridia, Xenical or Phentermine but does not offer you guidance or support in lifestyle change, you're probably wasting a great deal of money. On the other hand, using these drugs in conjunction with a behavioural weight loss program can be quite beneficial.

If it were as simple as, "Here take this pill", over 65% of North America wouldn't be overweight. If it sounds too good to be true, of course it probably is.