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]