Tag Archives: FDA

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.

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Protecting your Heart from new Weight Loss Drugs

Well it’s that time of year again.  The time of year that we talk about cupids and Valentines and love and stuff.  And, as a good friend of mine on facebook pointed out, we’ve also reached the golden moment where post-Valentine’s day chocolate is 50% off.  It’s the time of year when we think about our hearts.

So in this spirit, I thought I’d write about a new controversy brewing over two new weight loss drugs/combinations that have recently been approved by the FDA.  In 2012, the Food and Drug Administration approved two new sets of magic beans, I mean “weight loss drugs” lolorcaserin hydrochloride (brand name Belviq, manufactured by Eisai Inc.) and phentermine-topiramate (brand name Qsymia, manufactured by Vivus, Inc.).

People have been pretty excited about these coming out, especially since a number of other “weight-loss” drugs have been taken off the market due to concerns over cardiac side-effects.  Now one might think, in light of the fact that we put thousands of people at risk with the previous round of “weight loss” drugs, that the FDA might be extra careful not to release a new round of weight loss drugs with the same problems.

Not so fast, say a pair of doctors in an editorial recently published in the February 10, edition of JAMA.  In this article, Steven Woloshin, MD, and Lisa M. Schwartz, MD, point out that these drugs were approved by the FDA despite an alarming number of side effects.   In the abstract for the piece the doctors state:

The drugs have been associated with serious harms: Both drugs’ labels include warnings about memory, attention, or language problems and depression; for lorcaserin, the label also warns of valvular heart disease and euphoria; and for phentermine-topiramate, the label warns of metabolic acidosis, increased heart rate, anxiety, insomnia, and elevated creatinine levels. Neither medication is marketed in Europe because of safety concerns.

And as I read these words, all I can think is, “Here we go again!”  The drugs were approved under the condition that the drug manufacturers would conduct studies looking into the drugs’ heart risks.   According to the FDA, waiting until such studies were completed to approve the drugs would “delay effective therapy” for obesity.  The post marketing trials that were required to begin 16 months ago, do not appear to have begun.  And even once those trials begin, those studies are not scheduled to be finished for another four or five years.  And in the meantime we’re prescribing drugs known to potentially cause memory, language, attention, mood and serious vascular and inflammatory problems because some trials have shown short-term weight loss improvements of 3 to 7 percent over placebo.  There are no studies indicating long-term weight loss improvements in those who take these medications.  Nor, as Doctors Woloshin and Schwartz point out, is there any proof that these medications prevent disease or help us live any longer.

In the meantime we play with people’s hearts both literally and figuratively.  In a culture and a society where many of us are taught that being overweight is the worst possible situation, doctors are peddling hope in the form of these pills.  And rather than rule out potential cardiac and other serious heart attacks before the drugs are prescribed, doctors prescribe these pills to hundreds of people and “expose a lot of people to it while sorting it out,” said Woloshin.

So we can hope that the “post marketing studies” will actually begin and show no serious, long-term side effects like the permanent heart-valve damage we’ve seen from similar drugs in the past.  We can hope that we won’t market these drugs as the next great hope for people hoping to escape the pain of weight stigma in our society just to have to pull them off the market a short time later.

But I fear this is yet another page in the weight-loss-fantasy playbook likely to leave a string of broken hearts.

Love, Jeanette (AKA The Fat Chick)

Trigger Warning: Why an At Home Stomach Pump Might Not be Such a Good Idea

happytummyOkay, what I’m going to talk about today amounts to potential corporate backed, government sanctioned bulimia.  And it has a pretty major “ick” factor as well.  So if either of these things are triggering to you, you might wish to go back to Thursday’s post with the dancing bird.  I’m totally cool with that.

But there has been a flurry of articles and emails flying around about a firm that wants to tackle obesity by offering what amounts to an at-home stomach pump.  I know.  It sounds like an article from The Onion.  It sounds like a really badly thought out skit on Saturday Night Live.  I even checked Snopes.com  But unfortunately, it appears that this is real.

Wired magazine recently published the article, “US firm wants to tackle obesity with at-home stomach pump.”  In the story, they explain that a US company (ASPIRE BARIATRICS LLC) has filed for a US patent for “Apiration Therapy” which is intended to be “a non-invasive alternative to gastric bypass.”  Basically what happens is the patient has outpatient endoscopic surgery in which a tube is installed in their stomach that pokes out a very small incision in the center of the abdomen.  Once the incision heals, the tube is trimmed flush with the patient’s body and a “skin port” is installed.

The patient is then encouraged to regularly pump the contents directly out of their stomach.  Let me explain exactly what this means.  (And I’m offering an additional trigger warning right here.  Thursday’s dancing bird was super cute…)  Here’s a quote from the “study”

She “aspirated” after every meal: “the patient uncapped [her] tube, connected a 60 cc syringe and extracted food from her stomach twice. This resulted in a siphon effect, which permitted the subject to freely drain the stomach by allowing the open tube to empty into a bucket. The patient squeezed the tube to enhance propulsion and to break up large food.”

 

Okay.  So you eat a meal.  And then you connect a syringe to your “skin port” and create a “siphon effect” which “freely drains” your undigested stomach contents into a bucket. Apparently by doing this and drinking water between each aspiration, the dieter was able to evacuate between 2 and 3 liters of fluid after each meal.

Let’s just stop right there, shall we?  Just HOW can anybody think that this is okay?  How, exactly are you supposed to have anything approaching a normal life with this treatment?  After each meal, you have to attach a syringe and engage in a multi-stage process, during which you drink several liters of water and dump your raw stomach contents into a bucket.  How can THIS be a good idea?

The reason I am telling you this decidedly disturbing story is not simply to gross you out or titillate you with gory details.  (Although I have no doubt that both of these play a part in why the story was originally published).  No, I want to use this story to illustrate a few very important points.

1.  Our society makes people desperate to lose weight.  Fat people face constant messages that they are sick, lazy, gross, unworthy and useless.  Many are harassed by strangers in pubic places, derided by doctors, passed over by potential employers and face daily abuse by strangers and loved ones alike.  Fat people who have internalized these messages or are worn down by the constant abuse may become desperate.  They are desperate enough to have irreversible surgery done to alter the functioning of healthy organs.  They may even be desperate enough to siphon their stomach contents into a bucket.  But is the real problem here the fat, or the desperation that our world inflicts on fat people?

2. This patent application was filed based on a single study of 24 patients who, best I can tell, have been followed for less than two years.  Now it’s important to note that this invention has NOT been approved by the US Food and Drug Administration.  But given some of the folks involved in this project (including Segway creator Dean Kamen who co-invented the prototype) it is likely to move rapidly in that direction.  Can we just note the situation here where we had a guy who invented a product that keeps people from having to walk anywhere also inventing a bariatric product?  Anybody else see a contradiction here?  And while many weight loss schemes and products seem to work well in the first year or two, they all seem to have considerably less success at the 3-5 year stage.  What reason do we have to believe that this process would be any different?

3.  The purpose for the product as stated in the patent application is “The present invention is less invasive than current surgical procedures for reducing weight and allows patients to live a normal and active lifestyle without experiencing adverse side effects.”  Just exactly how normal is it to spend more than 20 minutes several times per day emptying food out of your gut into a bucket?  It is interesting however that the patent application does not cite any potential health benefits of the product outside of the “normal and active lifestyle”.  This may be because with their extremely limited sample size and study duration they weren’t able to record any.  Or maybe they just feel the health benefits of weight loss are something that “everybody knows” about.  Or maybe it’s because we’re finally realizing that the health problems associated with overweight and obesity may have been blown out of proportion.

4.  How is this not medically induced bulimia?  Whether you regurgitate your stomach contents or squeeze them out of a tube, it basically amounts to the same thing.  Sure, you may have less damage to tooth enamel and esophagus from the tube method, but it seems likely that many of the problems of malnutrition as well as the damage of the binge/purge cycle would apply here.  Maybe dealing with fat by creating a systemic, medicalized eatiing disorder is not the way to go here.

5.  It’s about money.  The prototypes were created, the medical trials were completed all at what had to be enormous expense, because there is a tremendously huge amount of money at stake here.  Gastric bypass surgeries seem to be waning in this down economy as stories of corruption, and more and more information about long term side effects and reductions in efficacy come to light.  Bariatric medicine is looking for the next “big” thing that will allow them to make a lot of money.  You can bet this project will be fast-tracked.

Okay, this post has already reached epic length and I should probably wrap this up here.  So here’s the bottom line.  Do we want to live in a world that is so emotionally toxic to fat people that they will do anything to lose weight?  Do we want to live in a world where the health benefits of intuitive eating and regular moderate exercise are pushed aside in a mad dash to create stunning “before” and “after” pictures and to line the pockets of bariatric medical establishments?  Or do we want to choose something better for ourselves and for all of our brothers and sisters of all sizes?

I don’t know when or if this product will ever come before the FDA.  I do know that in the mean time, I will continue to work towards a HAES (R) approach to wellness.  I know that I will work for health and well being for people of all sizes that is based on sound science, dignity and self-respect.

Love,

The Fat Chick