2012-02-23

Qnexa Backed by FDA Panel

The Associated Press has the story. The push to approve a potentially risky diet drug like Qnexa has got me thinking.

First Of All, Access to Medicine Is Important
Faithful Stationary Waves readers know me to be, as a general rule, in favor of all new medications regardless of their comparative safety. My philosophy is, let all drugs come to market and let the consumers decide what works and what doesn't. Every product has a monograph and clinical data and studies are widely available to the general public. For novel drugs, the information is the most widespread because such studies are actually part of the pharmaceutical company's marketing strategy. For non-unique drugs (as I believe Qnexa to be), the risks are perfectly obvious: diet drugs are basically controlled doses of stimulants that burn a lot of fat. These products work for the same reason that smoking tobacco or doing amphetamines results in weight loss. But like all stimulants, the user pays a heavy toll in terms of heart and arterial health. We don't need FDA approvals to know this - we all know this already.

Now, please keep in mind that for some patients the risks are entirely worth it. This is why I think the consumers should decide. For some patients, obesity presents more urgent health risks than the controlled use of stimulants under medical supervision. So, as far as I'm concerned, the decision to use weight-loss drugs is an individual one that should be discussed with your doctor (or, preferably doctors). No one decision is right for everyone, universally.

Second Of All, Why The Double-Standard?
But this is not what I have been thinking about. Instead, the push to introduce a new diet drug "despite safety concerns" has highlighted the big discrepancy in regulatory handling of diet drugs versus painkillers.

In terms of risk-versus-benefit, the two therapeutic classes are actually very similar. Both can be addictive, both can be harmful if used over a long period of time, both have a history of finding their way onto the street and/or being abused "recreationally." Yet, the variety of available painkillers is huge, whereas that of diet drugs is comparatively small. Note also that while diet drugs that are found to be "dangerous" are quickly regulated out of the marketplace, whereas highly destructive pain medications like oxycontin persist despite being some of the most criminally abused products out there.

Hello, Bigotry, My Old Friend
I think one of the most obvious reasons for the double-standard is that our society is bigoted toward the obese. Let me rephrase that in case it isn't clear: Our society hates fat people.

We can argue about the various inputs for this bigotry, the various evolutionary sources of these feelings, the various solutions to how to make us all less bigoted, and whatever else. But, at the end of the day, the fact of the matter is that we as a society look less favorably upon people who require medication to deal with obesity than we do at people who require medication to deal with pain.

Perhaps we should avoid diving into a discussion of the comparative tolerability of pain versus obesity. I presume that different people will have different opinions about that. In truth, it is probably subjective. (Which is another reason why it is best to make these medicines available to all and let them decide.)

What I Think Is Going On
Having said all of that, talk of the so-called "obesity epidemic" is ubiquitous. Interestingly enough (and this goes back to the bigotry concept), what seems to bother people most is the idea that fat people drive up health care costs. This is why people seem to believe nowadays that being fat is immoral and should be made illegal.

In the sphere of public health, there seems to be a prevailing attitude that "disease prevention" starts when people seek out healthy lifestyles. The caricature here is that if you eat salad and exercise 3 times a day for your entire life, then you'll never have to worry about getting cancer.

To a great extent, I think this is misguided. People don't get sick because they're unhealthy; they're unhealthy because they're sick. It's true that eating bad things and being lazy will put you in a position where your body starts to deteriorate. But that is a separate issue than viewing a good diet and regular exercise as some sort of panacea that will prevent all chronic illness.

And yet, the notion persists. So I believe that much of what agencies like the FDA now consider is how to cut long-term systemic health costs. They believe that if they approve inexpensive medicines that "cure" obesity, they will "capture those gains" down-stream when the formerly obese people don't end up developing things like type 2 diabetes.

Time will tell whether the regulators are correct. For now, it is well enough that people are getting better access to medications they might want, irrespective of the reason stated by the FDA.