The PR people from the Cleveland Clinic sent me a fact sheet about the study that was all over the news yesterday, which is being headlined as if Weight Loss Surgery was a cure for diabetes.
The facts presented in the sheet were slightly different and more informative than the summary presented in the New England Journal of Medicine research report.
Here's the research report: NEJM: Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes.
Here are extracts from the press release sent to me by the Cleveland Clinic's PR team. 150 patients participated in a 1 year-long trial. 50 had gastric bypass surgery, 50 had gastric banding, and 50 got the usual crap treatment from doctors including, undoubtedly, the advice to eat low fat/high carb diets. Here's what they report.
"After 12 months, a normal HbA1c (less than 6.0) was achieved in 42.6 percent of patients who underwent gastric bypass and 36.7 percent of patients who underwent sleeve surgery..."
Translation, 56.4% of those who had chunks of their stomachs amputated still ended up with blood sugar far from "cured" or even normal. The NEJM report says the average A1c for those having bypass was 6.4±0.9% that means, many still had A1cs up to 7.3%.
Those with gastric banding did even more poorly. 63.3% of them had A1cs over 6.0% The NEJM report says that their Average A1c was 6.6±1.0%, meaning that some still had A1cs of 7.6%.
Many of us can get A1cs under 6.0% just by cutting carbs. I have heard from hundreds of people, some of whom started out with A1cs well over 10.0% who did just that.
The study continues:
"The study authors reported some complications of surgery, but most were not serious. However, four patients did require a second operation. The study authors caution that the favorable results were observed after a relatively short follow-up period (12 months) and that long-term studies are needed to determine the durability of the findings."
Translation: 4 out of 100 people who had surgery ended up with a "complication" like their incisions opening internally that required them to be rushed to the hospital. The rest of the complications aren't detailed, but while not disturbing to the doctors, they may have been tough on the patients. Some complications of WLS can be projectile vomiting whenever people eat, severe mineral deficiencies caused by malabsorption syndrome, and surgical site infections that heal poorly.
It's important to note that this study only lasted 1 year and that previous studies of WLS find that the participants uncure themselves pretty quickly as time goes by. I blogged about earlier results claiming similar cure rates. You can read that post HERE.
This study reports, "There were no deaths." The current kill rate for this surgery ranges from 1 to 6 per thousand, so with only 100 people having the surgery, the fact that no one died doesn't mean its safe. If the kill rate is 1 per thousand and 150,000 people have the surgery, that's 150 people dead.
You can see the death rates for the surgery on this surgeon-created site. Bariatric Surgery Source: Gastric Bypass Surgery Deaths Note that surgeons only list the deaths that happen immediately after the surgery. Not those that occur from malnutrition and other longer-term surgically-caused problems.
To read more about the actual death rate associated with WLS when people are tracked more than 1 year, read the post I made two years ago HERE..
WHAT WASN'T MENTIONED IN THE COVERAGE
Here's the kicker, which appeared at the bottom of the press release: "This study was funded by Ethicon Endo-Surgery, Inc., a subsidiary of Johnson & Johnson, which is a company that designs and manufactures medical devices and surgical instruments. Dr. Schauer is a paid advisory board member of Ethicon, and is in complete compliance with all Cleveland Clinic COI policies."
Dr. Shauer is the first author listed on the NEJM paper. The disclosure, which didn't make it into any of the press coverage, makes it clear that he profits from the sale of the devices used for these weight loss surgeries. This is not research folks, this is a business promotion.
Do you really want to risk your life for a surgery that would give you results no better than you could get by getting serious about cutting down on your carbs? The same people who warn you it is "dangerous" to lower your A1c by cutting your carbs urge you to have this potentially fatal surgery to "cure" your diabetes. Shame on them!
If that's a cure, I'll stick to the disease. My A1cs have been far better than that for longer than 5 years, and so have those of many of you. (Post them in the comment section if you're inclined to.)
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26 comments:
Amen! Thank you for pointing out that once again, the assumption that you can be fixed by medication or surgery does not work for type 2 diabetes. What works is a low carb diet, pure and simple.
The sciences of nutrition and obesity are truly in an embryonic state right now, and science is still being practiced the old-fashioned way: some imperfect human publishes an imperfect study touting one thing and another publishes another imperfect study saying exactly the opposite. Wait a hundred years, and the more accurate and helpful information will stick around, and the trash will be thrown out.
I can see the benefit of WLS for individuals who are so obese that they can't get out of bed, or walk across the room. It would give them more independence, and more quality of life, but seems to me that their health and nutritional state would still have to be carefully monitored for the rest of their lives.
For those who are not so disabled by obesity, it makes sense to wait, because, as you say, the jury is still out. It would be nice to know exactly what causes obesity (no, it's not just pigging out on McD's and sugary sodas)(see my comments on a cartoon by Haidee Merritt on my Facebook page), so that treatments could be more precisely targeted. WLS, although it might be pointing the way in some manner, is still targeting too broad a part of the digestive system, throwing the baby out with the bath water, so to speak.
About low-carb, doing the best I can (i.e. less than perfectly), my A1c hovers around 6. And I am a low glycator. My A1c SHOULD be around 5.0 if I were really achieving what would be normal BGs for me. But obesity is not my problem (BMI between 24 and 25), picky eating, poor cooking skills and extreme dislike of exercise are. Plus the difficulty of adjusting insulin to food intake, even when carbs are limited. We imperfect ones need a lot more help than is available, and long-term, in order for low-carb to get us down to truly normal BGs.
Natalie Sera
Thanks for posting this; I get tired of seeing the same headline over and over, only to look at the medical journals and find that that these studies are rather small, did not go beyond 2 years, and have not been widely replicated. Using this logic to "prove" this surgery should automatically be done would also apply to low-carb diets if any researchers ever cared to study it, but no highly-paid associations or well-funded food manufacturers wish to pursue it, so we get a very unbalanced picture.
my A1c has never been over 5.5 since I found out I had diabetes and started low carb. Last one 5.2.
I always assumed WLS was mainly because one was dangerously overweight and dieting didn't work for a variety of reasons. The whole "cures diabetes" thing always seemed to me to be a possible added benefit, not the primary reason. But if it is being pushed for that reason, that would be a problem.
That said, cutting carbs does work on both fronts. I've lost over 100 lbs. and have cut my diagnosis A1c from 8.6 to 4.9 on my recent one. In fact, just watching carbs dropped my A1c to 5.3 three months after diagnosis.
So meticulously watching ones carbs does work.
So my husband said, "What good does this do someone like you who's only 105 lbs? Some cure!"
A family member of mine had this surgery done back in the late 70's-early 80's, when the procedure first became known to the general public. She's now 65 years old, and has had nothing but problems with her health in the last 20 years or so, due to malabsorption issues, and spontaneous fractures (recently, her pelvis). The doctors just tell her that she knows she needs to take her vitamins because of the surgery, and they just keep giving her cortisone shots for the pain (which, I believe, contributes to her already problematic bones.) Needless to say, I was appalled when I saw the news the other day touting this procedure as an effective cure-all for diabetes. Not to mention, that this family member has continued to struggle with her weight all these decades, in spite of the surgery having been positioned originally as a cure-all for her existing weight problem. Yes, let's cut folks open and mutate their bodies as a new stream of revenue. Not only do you get the profit from the medical equipment companies, but also from the life long medical complications and care that will be needed. Definitely a new twist on long-term profit planning.
I've had diabetes for 10 to 15 years depending on the diagnostic criteria and have been on very low carb and insulin for about 9 years. My A1c is under five and has been since starting low carb.
Glad to see this being taken to task. I saw various headlines that didn't even mention that this would only be effective for Type 2s. The conflict of interest is scary as well. Thanks for the detective work here.
Kathy,
It isn't particularly effective for most Type 2s.
If there were no alternatives that could give people A1cs around 6.6% and if those A1cs avoided heart attack it would be one thing. But the risk of heart attack at 6.6% is still twice that of someone whose A1c is 5.5%. And my guess is that once people have the surgery, they'll consider themselves "cured", stop metformin, and end up with much higher mortality long term.
By the way, the death rate for type 1 and type 2 diabetes combined is between 24 and 25 per 100,000 people. Bariatric surgery, in other words, is SIX TIMES more likely to kill you than diabetes is.
I don't think bariatric surgery is appropriate for anyone. If someone is so fat they're bedridden, it should be easy to put them on a diet that will drop the weight--it's not like they can run out to McDonald's and cheat. The only reason anyone's opting for the surgery instead is that too many people hate the obese and are so disgusted by them that they don't want to put in the high-touch time involved in feeding someone better food to nurse them back to health.
Just saying.
Fantastic blog post Jenny.
The profiteering in medicine has become such a problem. We have the "general consensus" that restricting dietary carb is dangerous, but feel free to have your stomach mutilated and go under general anesthesia, and subject yourself to long term malabsorption syndromes. Not to mention surgery is so dangerous for any diabetic person who is poorly controlled in the first place. As a registered nurse, I have encountered countless diabetic after diabetic, who developed severe infections or failure to heal after surgery...surgery is *extremely* dangerous for any diabetic person.
I have observed anecdotally that most bariatric patients suffer a long term consequence. Meaning even if they are the fortunate one who does not die immediately post op.... several years down the road they show signs of something being wrong with health. I will never forget one story of a woman who developed severe neuropathy rendering her a cripple (non-diabetic woman post gastric bypass; probably a complication of severe malabsorption and is noted to occur from time to time).
I know people in my personal life who have had this, done well, and then gradually over years started to show signs of nebulous health problems and regression of well being.
I think the real long term risks of this horrible gastric mutilation surgery are way worse than the statistics lead on. But remember, cutting carbs will kill you!
I am a retired surgeon. Diabetic, what else. A1c from 7.8 to an average of 5.4 in the last three years. All on low-carb (tough at first, easy after that) dieting.
BTW.: i have given Jenny's book to every one of my diabetic friends, with great success stories by those who become believers in low-carbing. Unfortunately, I still have a pot belly, but, happily married for a zillion years, who cares?
TJ,
The pot belly is subcutaneous fat, and appears to be nature's way of keeping us older folk from becoming too vain. I can't budge mine either, but it isn't going to kill me.
Good stuff, Jenny. Thanks.
Obviously Dana Seilhan didn't see the TLC program where a super size guy called for take out and put the money in a bucket he lowered from the window and the delivery guy put the food in a bucket. All while his family were trying to keep him on a diet.
Unknown, When a person has that kind of problem, surgery could be fatal. In fact, reputable surgeons won't do surgery on people who don't first demonstrate that they can lose weight by dieting before surgery. It takes a lot of discipline to cope with the surgery and attempting to overeat can be very dangerous.
But I'd also suggest you don't depend on TLC for your health information,any more than you'd depend on Bravo for psychological counseling.
If A1c of 6% means "cured", I was "cured" of my type 2 diabetes a long time ago :)
But if I start eating like before my diagnosis, I have no doubt that this "cure" will go away. :(
My "cure" happened because I started eating significantly less than what I used to eat before diagnosis. This, I believe, translates to reduced "calorie in". I also began exercising regularly which would translate to increased "calorie out." The exercise also resulted in increased muscle mass (in this middle aged, pot bellied male) which might translate to a little more "burning" of calories. My diet cannot be considered very low carb because I might consume around 180 to 200 grams of carbs on a typical day.
Regards,
Rad
I didn't mean he should have surgery, I meant just because someone is bedridden doesn't mean you can force a diet on them without their cooperation.
Does everyone who posts have to agree with 110% of what the blog author says. It seems like there are no dissenting comments.
I publish all the comments people send except for the ones that spam with links to product pages. If you'd like to disagree, you're welcome to post.
I was appalled at these stories as they hit the paper this week. My A1C has been below 6 since diagnosis 15 months ago, with no meds for 11 months, basically on (now) 225 carbs/day (was 180 when I was losing weight, slightly higher now along with calorie intake) or so (with a highly active lifestyle, now running 25 miles a week or so) - lower than guidelines based on the total caloric intake. Many people are amazed to hear I lost 85+ pounds (to a normal weight) on what I would refer to as a "high fat" diet - calories pretty much only come from three sources - any there's only so many ways to get protein - so if you aren't getting carbs, you probably are getting a little more fat. And thats OK - my triglyceries and cholesterol have never looked better!
And I know if I get down into the 180 carb range, the numbers will only look better - the trick is that I don't want to go lower until the numbers show I have to!
All the readers who worship at the feet of the author don't realize that while this may not be a true cure, it is a major improvement for those with uncontrolled diabetes. That is a major step forward whether you want to admit it or not. Also, the surgeries have been getting safer over the years as well. Don't take everything this blogger says as if it is holy writ. She has some good things to say (low carb is good overall) and some bad things as well (scaring the bejeesus out of everybody by exagerrating). You all realize she is trying to sell her book, right (she's a profiteer just like the medical industry)? In order to sell her books, she has to take a big alarmist position in order to get attention.
To dd1029
And your professional expertise is what? Do tell
And a name, perhaps?
Helen Howes
Jenny's book is free on the Blood sugar 101 web site. If that is profiteering I guess I don't understand profit! If you decide to buy the book you get it for a nominal price and it has a great deal of useful information.
Right on, Ms. Ruhl! When this story broke, I immediately thought of your post of a few months ago and what your reaction might be to this crap! It is no surprise either that the purveyors of this baloney have such a blatant conflict of interest.
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