Monday, March 05, 2012

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]

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18 comments:

  1. Anonymous6:46 am

    Isn't Qnexa just Topamax with the "good half" of fenphen? I know for some, the mental side effects of Topamax were tough to take, and it got the reputation for being a "Barbie Doll" drug, which made you skinny but stupid.

    I'm still not convinced there have been any weight loss drugs approved that are any better than the old Ephedrine/Caffeine stack that got taken off the market, because some fools decided to use thermogenics in heat stroke weather.

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  2. It's interesting-- we often hear people tout that there's no "magic bullet" for weight loss, as thought someone battling obesity is just looking for an easy out by choosing medication, surgery, etc. The pronouncement seems like another example of our culture's general weight bias, presuming that someone who hasn't lost weight just hasn't tried hard enough to fix his or her lifestyle, that they just want to live a lazy, easy life, as thought they're trying to take a shortcut around the rest of our hard work. And perhaps there are a few looking for a shortcut; but it amazes me how little people are willing to empathize with what it's like to have a life-threatening condition, try to control it on your own with little effect, be discrimanated against for having said condition and not controlling it, and then, finally, wanting to try the one option that may make the difference in your past efforts. (http://whenwetalkabouthealth.wordpress.com/2012/02/23/qnexa-and-magic-bullet-syndrome/)

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    1. Anonymous9:02 am

      YES, exactly. It's the pervasive stereotype that obese people are lazy and just not trying hard enough that fuels the argument that weight loss drugs are a "shortcut" or "the easy way out." If any of these doctors quoted had ever been overweight, tried unsuccessfully for DECADES to lose weight and keep it off all while watching their health decline I don't think they'd make these statements.

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  3. Anonymous7:27 am

    This really isn't a new drug though. Both phentermine (approved in US in 1959 and available since 70s) and topiramate (generics available in Canada and approved by FDA in 2006) have been out for awhile, and some doctors have experience prescribing the combination. Qnexa really isn't any thing new, just a repackaging of existing drugs.

    Commenting on this by some doctors isn't like commenting on a completely new and untested drug, and isn't necessarily blindly bashing.

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  4. Too bad doctors hadn't been more vocal about "blindly bashing" new drugs like Vioxx and other "approved" pharmaceuticals before these deadly drugs were discredited.

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    1. Anonymous9:02 am

      I guess reading comprehension's not exactly your strong suit.

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  6. Given the rush to approve and use weight loss drugs in the past that turned out deadly for so many people (fen-phen comes to mind), I'm ecstatic that some doctors are exercising skepticism when presented with a new one. We're not talking about curing cancer here, we're talking about a tiny amount of weight loss over an extended period of time that may or may not have an effect on a person's overall health. It makes sense to weigh the potential detriment to health that may come from prolonged use of a drug before giving it to someone who may not be helped all that much by it.

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    1. Kelly-Anne H11:41 am

      15% of presenting weight isn't a tiny amount of weight loss, though. I lost 15% of my start weight of 303# and got a life. I went from trapped in a lazyboy, with a handicapped tag on my car to riding a bike, swimming and travelling on a regular basis. I still can't stand or walk for as long as I'd like, but my life is SO much better than it was.
      15% off my current weight(another 39#) would still not make me a so-called "healthy weight" but would have a huge impact on the quality of my life. I'll definitely be talking to my doctor when this drug is available here.
      Sometimes it isn't about getting to a perfect weight and ideal health. Sometimes it's about losing enough to have a life.

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    2. But my point (and the point of Dr. Cohen, above) still stands. We've seen diet drugs come and go, some of which did more harm than good, as in deadly harm. Sure, it's possible there are fat people out there with a less than desirable quality of life, but that doesn't mean we should rush to prescribe a drug combo just because it may make that person's life a little better. We already know that adopting healthy behaviors has a positive effect on people's overall health, so why not continue recommending behavioral changes and wait and see what happens with Qnexa? I don't see a need for widespread prescription before we can be sure there will be no undue ill effects of prolonged use.

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  7. Thanks for being specific about what is in QNexa. I have been hearing about this drug in the news for a couple of weeks now and wondered what was new about it. After reading this, I'm thinking nothing much is new at all. I've heard of doctors prescribing these 2 drugs for people before to lose weight. It sounds like they decided to mix them together in one pill which in a way is kind of great if the combination has been effective. But I wonder why Phen Fen was discontinued? If Phentermine is being used in this wouldn't that be just as bad? I can say I have used every diet pill made including Phen Fen back in 1997 or so when it first came out. No drug was ever strong enough for me though. I ended up having a vertical sleeve and I've lost 133 pounds so far. It really helped me so much. But if I was still struggling like I was before I would probably be the first one in line to try this.

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  8. Their free snow blower hasnn't arrived yet?

    (past behaviour a predictor of future behaviour).

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  9. I might be biased, as the first and only article I read about the drug talked about the fact that it had already been up for approval once, and the committee thought the side effects were too dangerous to consider. Apparently, years later, the committee thinks that the "side effects of obesity" are more dangerous than this drug, and are voting to approve it.

    To primate was a drug I considered, and rejected, because I didn't think it fit within my own brand of mental interestingness. I already think psychiatric drugs are overused, and I disliked the idea of using psych drugs fo weight loss. Packaging this with another drug doesn't make that any better.

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  10. Michele7:12 pm

    What I've read about it is less than stellar. The trial subjects lost an average of 10% of their body weights over 12 months. So a 200 lb. pound woman may have gotten down to 180 in a year...not particularly impressive (considering that a 200 lb woman -- ME -- lost 65 lbs in seven months through -- wait for it -- eliminating processed food, sugar and alcohol, eating clean, whole foods and exercising for an hour a day and has kept it off for four years so far by -- wait for it -- eating clean and exercising). And "significant" weight was regained by the trial subjects in the second year of the study. And increased heart rate was reported (losing weight by the training effect results in lower resting heart rate). If I were still my former 200 lb self today and was offered Qnexa I think I'd opt out. Stop sucking Big Pharma's d*** and encourage people to get to the root cause of their overeating and deal with it and then to do a little learning about basic nutrition.

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    1. Michele, medically speaking, a 10% weight loss is pretty fantastic. Although it will not turn you into our society's standard of beauty, it will lower insulin resistance, lower blood pressure, and reduce your risk of myriad chronic diseases.

      Kudos to you for losing a significant amount of weight, but it's certainly not easy for everyone. There is no shame in needing help losing weight, considering the obesogenic environment in which we all live. Indeed, many people know very well how to lose weight... rather, they struggle in keeping it off. Our bodies are designed to hold onto fat stores, and they literally sabotage weight loss efforts as time goes on. 5-10% of your total weight can be kept off for a long period of time without undue suffering, which is another reason why it's considered significant. It's the minimum needed to give you health benefits, yet your body is not fighting you every step of the way to get that weight back.

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    2. I don't think there is shame in needing help to lose weight either. I support the decision to have Weight Loss Surgery when it is a last resort and when the patient takes the requirements post-surgery seriously (far too many of them do not) and when the surgeons insist on proper screening and psych counseling of patients (many do not). Weight loss pills historically and currently have proven to be short term fixes at best, fatal at worst. The results of the trials on Qnexa are FAR from impressive, a 10% loss on an obese person is "better than nothing" but even WITH the drug, regains in the 2nd year were COMMON. It's just a snake eating its tail. Those are my concerns. More false hope...let's all remember Dexedrine in the 70s, phen/fen in the 80s, Meridia in the 90s, Alli in the 2000s....what of them? ALL bad ideas rushed to market delivering empty promises and DANGER to make $$$$ for stockholders.

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    3. Michele9:00 am

      I didn't say my weight loss was easy nor is the maintenance. It takes THOUGHT and EFFORT and far too few people are willing to do that. They want to eat what's easy and cheap and tasty and do it while watching TV. If health means making hard changes, they'd rather shoot insulin in their arms (as if that is easy). There is nothing wrong with getting help when warranted but this pill is just another quick fix that I guarantee you will prove problematic and will be taken off the market like all its predecessors within a decade.

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  11. Far too many people in the medical profession refuse to sit down with their overweight patients and discuss options.

    Many doctors treat the overweight person like a naughty child, and no adult appreciates that attitude.

    I agree with the author and believe that no option should be off the table when dealing with the obese. I’m sure you’ve guessed that I’m overweight, and some doctors have felt free to be incredibly rude.

    The author of this article takes a more realistic position, and is at least willing to listen to all options. Doctors who dismiss the medication option out of hand are letting their prejudices shine through.

    I wish the author lived near me, I’d be happy to talk to a reasonable doctor.

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