Tag Archives: efficacy

The 1% efficacy rate and weight loss as a prescription

Prescription

Talk to nearly any person over a size 12 and chances are, they have run into a doctor or medical professional who recommended that their health would improve if they would only lose weight.  Whether that person went to a podiatrist for help with their feet or a gyno for a pap smear or an optometrist to get an eye exam, chances are at least one of these medical professionals has stated that the solution for these health woes is that the patient simply lose weight.

Let’s take a look at that prescription for just a moment.  Just how likely is it that one of these people is going to lose any kind of significant weight (and keep it off for any period of time)?  A recent study, conducted by a team at King’s College suggests that this prescription is pretty unlikely to be successful.  For moderately fat people (BMI 30-35) the chances of returning to a “normal weight”  (heavy airquotes here) and staying there for a year is one in 124 for women and one in 210 for men.  For very fat people (BMI 40-45), the chances drop to 1 in 677 for women and 1 in 1290 for men.  The chances for losing only 5% of body fat were greater (one in 10 for women and one in 12 for men) however the majority of these folks gained the weight back within 5 years.

Keep in mind that there is no evidence that this very tiny percentage of people who had lost weight lived any longer or healthier than those who had not lost weight.  While there is some correlation of people who have always been thin and certain health benefits, there is virtually no statistical evidence that the microscopically small group of people who manage to maintain a significant amount of weight loss over the long term enjoy any health benefits at all over the people who don’t.

So, can we talk?  Can somebody tell me why, exactly, medical professionals are suggesting a “treatment goal” which in the very, very most optimistic scenarios can be achieved by 10 percent of those who try it and on the low end has a less than 1 in 1200 chance of being achieved?  And can anybody tell me why we recommend this strategy when there is virtually no evidence that in the rare case it will be achieved it will do any good?

Let’s talk about this in terms of a pill.  We tell the patient that they have somewhere between a 10%  and a .1% chance of even being able to ingest the pill.  And in the long term, so few people are able to keep this pill down long enough to test, that we don’t have really any convincing evidence that the pill does any good at all.  The side effects from even trying to take this pill range from frustration to eating disorders to weight gain, to poor nutrition to death.  So what on this God’s green earth is the point?

I think it’s time to recognize that weight loss is not a behavior–it’s a condition.  And that weight loss as a prescription is probably not worth the paper upon which it is printed.

Love,

Jeanette DePatie AKA The Fat Chick

P.S. Want me to come speak at your school, office, organization or group?  Learn more about my speaking at http://www.jeanettedepatie.com.

Advertisements

FDA Approves New (Torture?) Device for Fatties

I guess I should have seen it coming.  We’ve seen forks that talk to you and bracelets that shock you for eating too much.  We’ve seen painful patches you sew on your tongue, balloons you blow up in your guts and dramatic rerouting of your internal plumbing and drugs that cause high blood pressure, irreversible heart damage and death all in the name of weight loss.

Today, the FDA approved a new implanted electronic device for helping fatties lose weight.  Now, we don’t know that this product will fail as so many have before it.  It’s possible that this will be the miracle all the fat-hating world has been seeking.  But I have to say, I has a concerned.

Concerned kitteh is concerned.

First of all, let’s talk about the device.  According to the FDA News Release:

The Maestro Rechargeable System consists of a rechargeable electrical pulse generator, wire leads and electrodes implanted surgically into the abdomen. It works by sending intermittent electrical pulses to the trunks in the abdominal vagus nerve, which is involved in regulating stomach emptying and signaling to the brain that the stomach feels empty or full. Although it is known that the electric stimulation blocks nerve activity between the brain and the stomach, the specific mechanisms for weight loss due to use of the device are unknown.

Okay, first off, this abdominal lobotomy machine somehow uses electricity to block nerve activity between the brain and the stomach.  Is anybody else even a tiny bit uncomfortable about this?  I mean isn’t that connection between your mind and the fuel tank of your body kind of important?  What about cravings for things our bodies need?  We just do away with all of those?  Personally, I think that the link between my stomach is kind of important.

And then we get to the part that says, “the specific mechanisms for weight loss due to use of the device are unknown.”  Um, okay.  So somehow disrupting a key process of your body makes you lose weight, but we aren’t sure why.  It could be that you get the feeling of being full sooner.  It  could be that the tiny device is receiving signals from aliens from another star system that, frustrated with efforts to starve the human race by planting celebrity “fat shots” into the National Enquirer, have turned to more direct methods.  (It does stimulate the “Vagus Nerve” after all.)

It’s how the MIB know what’s what…

Now let’s talk about efficacy.  You know, whether or not it works.  The FDA approved this device despite it’s failure to meet the primary endpoint.  What does this mean?  It means that the device using group would lose at  least 10 percent more excess weight than the control group.  But despite missing this important marker, the device was approved because AAARGH, DEATHFAT, PANIC!  Now let’s look at the statistics.

The release states that a clinical trial was conducted with a whopping 233 patients.  The group with the functional version of the device lost 8.5 percent more weight than those with the non-functional version of the device and kept it off for 18 months.   So far that’s as far out as they have studied.  Despite the fact that most weight loss products, programs and potions work for 18 months.  Despite the fact that virtually every other weight loss product, program, plan or potion starts to fail shortly after that, leading to mass failure and frequently even higher weights within 5 years.

But that’s okay, because the FDA has rules, right.  The press release states:

As part of the approval, the manufacturer must conduct a five year post approval study that will follow at least 100 patients and collect additional safety and effectiveness data including weight loss, adverse events, surgical revisions and explants and changes in obesity-related conditions.

So the manufacturer (which has NO conflict of interest, right?) will conduct an ongoing study on less than half of the original patients to see if this thing works long term and/or causes more problems than it solves.  Uh huh.  In the mean time, the company that has created this thing faces unmitigated joy as their capital and stock prices rise.  By time we figure out that this thing is causing really big problems, or doesn’t work long term or is receiving signals from the Vega system, the guys that created this will be on their second yacht and summer home in Vail.  But that’s okay too, because AAARGH, DEATHFAT, OBESIPANIC!!!!!

I’m sighing deeply right now as I contemplate just how many more folks will sell their cows for this handful of magic beans, and how big and angry the giant will be, and who will be around to slay it.

Don’t mind me.  I’m going to do something I know will improve my health long term.  I’m just gonna shut off the computer and go for a walk.

Love,

Jeanette DePatie (AKA The Fat Chick)

P.S. Want to hear Jeanette speak at your organization about sensible, sustainable, and research-driven ways to improve your health?  Click here.

P.S.S. Wanna buy stuff that will help you start and stay exercising?  Click here.