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ccp
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« Reply #250 on: November 15, 2010, 03:09:52 PM »

Gupta I guess goes to number 1 with the experts here.   He thinks it is a simple choice.
And number four (me) is not a hypothesis as much as a conclusion.
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JDN
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« Reply #251 on: November 15, 2010, 04:20:53 PM »

Gupta I guess goes to number 1 with the experts here.   He thinks it is a simple choice.
And number four (me) is not a hypothesis as much as a conclusion.


Yep, CCP you are right, Gupta goes with nearly all the medical/scientific experts (no reason to count
best seller authors trying to sell weight loss books), it's a simple choice, i.e.

1.) obesity is a behavioral choice.

Now, how to convince people to make the appropriate behavioral choice is still a mystery to me!   smiley
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ccp
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« Reply #252 on: November 15, 2010, 05:51:12 PM »

JDN,

Did you see the video?

It is 70 minutes long.

The speaker goes into great depth explaining why it is not simple choice.

He also theorizes that it is not a matter of eating too much or excercising too little.  He makes a good case that these behaviors are symptoms and not the cause of a disorder. 

His way of looking at the problem does make a lot of sense.  But I don't think he explains what happens to cause this.  He goes into carbs and insulin and glucose uptake needed to convert fatty acids to storage with trigylcerides in the fat cell which is an endocrine organ and not simply a  storage bin.  But it is unclear to me and I think him as well (if I understand him right) as to what goes haywire in affecting this pathway leading to lipohypertrophy.

My thinking is this is only one piece of the puzzle.

I am not a fan of Gupta.  I like you far more.  Yet this video points out the  strategy of consciously  eating less and moving  more is only marginally helpful and almost always doomed to fail.

Doug,

As for cigarettes your uncle's story is a good one.  I have examples from that extreme (pt quits simply because he is asked) to those that cannot or will not quit no matter what I or anyone says or tries to do.

In my experience getting people to quit cigarettes is far easier than getting people to lose and keep off large amounts of weight.  Even people who do  treat weight loss for a living and are far better than me at it will tell you it is quite a challenge at best (if they are honest; surely there are a lot of huskers out there).

Doug, do you have relative who was obese and lost mega amounts of weight simply because he/she decided he/she was too fat?  And kept it off for many years?

My guess (based on probability) is you don't.  Neither do I.  Except for one who had to have bariatric surgery.
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5RingsFitness
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« Reply #253 on: November 15, 2010, 06:30:26 PM »

Taube is a cool bit as he mostly concerns himself with investigating whether science is actually science or not

and in the clip he goes over some of the studies showing decreased caloric intake and obesity being concomittant

and

in a couple cases obesity on the bottom and
emaciation on the top

did those folks starve their faces and feed their butts?

south park it's not Wink

interesting eh?

choices are not all made at the conscious level
some are made at the genetic level

then ther is the enteric nervous system
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"Nations have passed away and left no traces, And history gives the naked cause of it - One single simple reason in all cases; They fell because their peoples were not fit."-Rudyard Kipling
DougMacG
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« Reply #254 on: November 15, 2010, 10:38:52 PM »

CCP, You are exactly right.  In the one example I would cite, the weight came off seemingly easily to a very healthy level but did not stay off, nor did he ever repeat the weight loss - ever.  For most that I know, the excess weight seems stable, just not near levels considered healthy.

One thing I have learned in this discussion is to make a distinction between the obese with the difficulty in losing weight compared with the fit with their challenge of staying fit.  In this forum, most people likely range from extremely fit to fanatically fit.  The self discipline referred to by the fit is to keep doing what has always worked, where life is centered around awareness, health and fitness.  The obesity problem is a wholly different challenge - to change everything about a person whose lifestyle and history is very much the opposite.  I have not watched the video yet but what 5rings says make sense to me.  Conscious choice is only a part of behavioral choice.  I assume the conscious part of the brain and nervous system is a small part (1%?) of all that is going on.  The martial artist likely is unusually proficient at controlling the rest of the system, with mind very in tune with and in control of body, extremes in awareness and self control.  The obese patient is, I assume, very much the opposite.  Innate within us, someone else mentioned, is the subconscious survival urge to eat all that you can, when you can, because it might not be there tomorrow. 

Anther observation is that with a smoker, an alcoholic, a coke, meth or heroin addict after withdrawal and treatment, if successful, would hopefully never try it or use again.  With food, it is necessary and keeps getting reintroduced.  It would be like training an alcoholic or addict to get high in moderation 3 times a day with complete self control instead of quitting.
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5RingsFitness
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« Reply #255 on: November 16, 2010, 07:12:42 AM »

roflol
wow that last bit is spot on about training an addict to partake three times a day
that is priceless
yoink!

lifestyle
education
attitude
reason
need

or
learn

a model I have seen used for body comp

what is funny is in all honesty, the majority of the folks I deal with or have contact with I try to impress on them that if they stop focusing on weight, and rather focus in moving well and moving often, getting rid of the compensations physical or otherwise that are there to overcome the lack of mobility at some part of their body, and become as strong as they can, that by just eating whole and as close to original state foods they will be changed

my question everytime is
"if you could feel good all the time, move like an athlete, eat what you like and weigh the same would that be ok?"
common answer is yes

but people have to apply to work with me, and I charge a lot Wink so the level of commitment tends to be high
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"Nations have passed away and left no traces, And history gives the naked cause of it - One single simple reason in all cases; They fell because their peoples were not fit."-Rudyard Kipling
ccp
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« Reply #256 on: November 16, 2010, 09:38:26 AM »

*In this forum, most people likely range from extremely fit to fanatically fit*

I used to work out like a madman on a stairmaster.  Burned 2000 to over 4000 calories a workout couple of times a week.  And did weight machines and free weights.
My weight was 15 pounds lighter than now. 

Why because I can't overwhelm my appetite with extreme excersice anymore.  I am too old.

Even when I worked out say 2000 calories a day and you add that to the say 1800 a day that I was burning at rest I could easily eat 3800 calories and still be very hungry.
Why, because excercise is an appetite stimulant.   But for me that worked overall.  I would earn a negative caloric balance of, say 3800 calories, so I could eatmore yet still control myself so I could lose and keep the weight off.

And that is just me.   Everyone is different.  Would worked for me might not work for another.  Or they wouldn't or couldn't work out as hard as I did.  Or wouldn't want to.
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JDN
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« Reply #257 on: November 16, 2010, 09:43:04 AM »


my question everytime is
"if you could feel good all the time, move like an athlete, eat what you like and weigh the same would that be ok?"
common answer is yes

but people have to apply to work with me, and I charge a lot Wink so the level of commitment tends to be high

With no offense meant, I am sure you are a good personal trainer, but if if an obese person came to you, then truly "weighed the
same" after being with you (no weight loss?), but was able to "feel good all the time" and "move like an athlete" and "eat what you like"
the customers would be lined up at your door regardless of your hourly training price.  But then I have a bridge to sell.   shocked

CCP

I did watch the video; it's good.  I guess my cynicism is caused because he is an author, not a scientist or physician.  His objective
is to sell his book.  Nothing wrong with that, but...  And the overwhelming scientific and medical community says it's a "choice".

Genetics, enteric nervous system etc. do affect weight; but then why only Americans?  As I travel the world I marvel at the physique
of most of the citizens compared to Americans.  Or do they have a different enteric nervous system?   grin

But I do agree with you that once a person is obese, truly obese it is very difficult to lose the weight and keep it off.  For everyone one I see
lose the weight, I will see 10 maybe 20+ either not lose the weight after beginning a diet, or lose some weight only to gain it back
in the near future.

Probably you are right; surgery may be the only answer.  For example my wife (she was never fat) after her pancreaticoduodenectomy (Whipple
Procedure) is able to eat anything and any amount and not gain weight.  While she is the envy of her girlfriends, I think given a choice
my wife would rather exercise more and eat less than having needed surgery.  Surgery should be last resort.  

The key I think is to challenge them to lose weight before they become obese.  For example, I'm cheap; I simply won't buy new pants for example.  I don't need a scale to tell me I've gained a few pounds.  And I also agree, while I do think it's just calories, counting those calories is a major lifestyle change requiring education, attitude, reason and need.  
« Last Edit: November 16, 2010, 09:55:45 AM by JDN » Logged
ccp
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« Reply #258 on: November 16, 2010, 11:13:17 AM »

"And the overwhelming scientific and medical community says it's a "choice".

I don't know that people in the scientific and medical community who really treat weight loss would agree with that at all!

Gupta is a neurosurgeon.  Frankly, he doesn't know what he is talking about when he speaks of obesity.

Most of us in medicine do not get real training when we are dealing with the treatment of overweight people.  That is a gigantic void in our education.

All doctors tell their patients to eat less and excerise.  It almost never works.  And if it does only for short periods and only becasue the pt. was able to find some way to do it.  Just telling patients to eat less and move more is essentially the dumbest thing we do.

Why do we than tell people this when we know it doesn't work?  Because most doctors don't know anything else. Also it takes a lot of time which we don't have or get reimbursed to do.   Most experts who treat obesity will tell you a 15% maintained weight loss over years in a average population of motivated patients who can stay with a program is a remarkable achievement.

To me Gupta is just as much a quack as the snake oil salesman down the corner push cart.

He may be a good neurosurgeon, or was.  He couldnt be now at the same time he is a talking head.  But he is not a leading expert on many subjects he talks about.
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DougMacG
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« Reply #259 on: November 16, 2010, 12:02:30 PM »

I like the focus on movement the positive instead of weight the negative, also to changing the types of foods.  Carrots and spinach are not as addicting as MSG loaded potato chips dripping in salt and fat.  You can't quit eating but it seems to me you would have to commit to quitting forever certain named junk foods that are causing you the most problem (or resign to living a shortened and immobile life).  For example, if you are 100 pounds long term overweight and serious about improving your health, and french fries, glazed donuts and all you can eat buffets are your 3 worst violators, you need to make a conscious yes-no list for all the foods you have been eating and commit to never again eat certain named worst violators, as serious as drug addiction withdrawal, and add an equal number of new, healthy choices for sustenance to your list that don't sound as good right now to replace them.  And then stick with it, everyday, like a recovering alcoholic refusing to have one beer.

Regarding mobility, I'm no expert but there are forms of swimming and water exercise that might be lower impact on the joints than even going for a walk.

Other helpful hints: Scale down to one small refrigerator and one small television and put them in opposite corners of the house.  The conscious brain can limit some choices of the subconscious brain.  Instead of a midnight snack, go to bed earlier.  You will be more tired if you worked on mobility during the day.
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ccp
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« Reply #260 on: November 16, 2010, 12:28:04 PM »

Now that we are going to have pictures of death and disease on cigarette packages.

How about pictures like this being required on all Big Macs wrappers:

http://images.search.yahoo.com/images/view?back=http%3A%2F%2Fsearch.yahoo.com%2Fsearch%3Fei%3DUTF-8%26p%3Djon%2Bbrower%2Bminnoch%2Bphoto&w=160&h=109&imgurl=www.bing.com%2Fimages%2Fsearch%3Fq%3Djon%2Bbrower%2Bminnoch%2Bphoto%23focal%3D1d93e2af336b9a18bc2a244c10e49213%26furl%3Dhttp%253a%252f%252fwww.weightlossdietwatch.com%252fwp-content%252fuploads%252f2009%252f07%252fjon-brower-minnoch.jpg&size=&name=search&rcurl=http%3A%2F%2Fwww.bing.com%2Fimages%2Fsearch%3Fq%3Djon%2Bbrower%2Bminnoch%2Bphoto%23focal%3D1d93e2af336b9a18bc2a244c10e49213%26furl%3Dhttp%253a%252f%252fwww.weightlossdietwatch.com%252fwp-content%252fuploads%252f2009%252f07%252fjon-brower-minnoch.jpg&rurl=http%3A%2F%2Fwww.bing.com%2Fimages%2Fsearch%3Fq%3Djon%2Bbrower%2Bminnoch%2Bphoto%23focal%3D1d93e2af336b9a18bc2a244c10e49213%26furl%3Dhttp%253a%252f%252fwww.weightlossdietwatch.com%252fwp-content%252fuploads%252f2009%252f07%252fjon-brower-minnoch.jpg&p=jon+brower+minnoch&type=&no=2&tt=108&oid=http%3A%2F%2Fts2.mm.bing.net%2Fimages%2Fthumbnail.aspx%3Fq%3D318756296117%26id%3D2d582f77c482fd04496fef3a30897221&tit=Name%3A+Jon+Brower+Minnoch&sigr=16dbhq8nl&sigi=166mgvsjb&sigb=122ci9j2g&fr=yfp-t-892#FCar=f61a987420285132e11db896cbdef033

For all beer and alcohol a simple picture of Charlie Sheen should scare the begeebies out of anyone into sobriety.
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JDN
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« Reply #261 on: November 16, 2010, 12:33:55 PM »

CCP
While i am not in particular a fan of Gupta, I don't agree that he is "just as much a quack as the snake oil salesman down the corner push cart."
http://www.cnn.com/CNN/anchors_reporters/gupta.sanjay.html?iref=allsearch

I guess it comes back to Marc's question/comment; how are people in other countries able to avoid obesity and we are not?

As for "Also it takes a lot of time which we don't have or get reimbursed to do." I agree.  One of the advantages of a National Health Care Plan
(there are many disadvantages too; I am not looking to debate that subject here) is that doctors get reimbursed for visits, often for minor
ailments.  My point is that in Japan for example doctors will frequently see patients for the common cold.  Not much they can truly do,
BUT seeing and being reimbursed to see a patient on a frequent basis before something serious i.e. obesity develops problem presents itself
offers an opportunity to address the issue before it's too late.  I agree, once a patient is truly obese, the options are limited and the success
ratio of doing something about it is low.  It's probably is too late simply to say eat less and move more...

Doug just posted; he too is identifying "choice" i.e. "focus on movement".  I agree.  The few successes I have seen combined
"movement" with diet.

As for your pictures on Big Mac's, well, why not?  Obesity kills, and costs a lot more than cigarettes.

As for alcohol I kind of like Charlie Sheen's show so his picture might not do it for me...    grin

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ccp
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« Reply #262 on: November 16, 2010, 08:44:24 PM »

***I guess it comes back to Marc's question/comment; how are people in other countries able to avoid obesity and we are not?***

JDN and Crafty,

Well this  IS a great question.  I was speaking to one of the dieticians I refer patients to and the book "why are french women so thin?" came up. 
I just looked it up on line and there are multiple links to discussions that came out in 2005.  This one seems to sum it up:

http://www.medicinenet.com/script/main/art.asp?articlekey=62088

Yet when I read the explanations as to how French babes stay so hot it comes down to different behavior.  More walking, smaller portion size, being aware of internal satiety cues.
This is not different from what we try to teach people who are overweight here.  Eat smaller portions, stop eating when you feel full, don't finish everything on your plate, eat more slowly, drink more water and on and on.  This is cognitive behavior therapy.

I've tried it.  But it only works marginally well.  Indeed, I can't even follow my own advice.  Food is just too good!  And old habits are hard to change.
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Crafty_Dog
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« Reply #263 on: November 17, 2010, 12:59:41 AM »

The French women article's reference to yogurt prompts me to proffer a pet theory of mine:

We are continuously dosed by antibiotics via our consumption of industrial poultry and beef.  The results is our natural intestinal flora is disrupted and diminished.  This I think has consequences-- one of which may be to increase digestive disorders and susceptibility to weight gain.


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ccp
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« Reply #264 on: November 17, 2010, 12:17:59 PM »

There may be something to the intestinal flora thing yet my understanding is the research is mixed.

Though that doesn't stop the army of sales people hawking everything from capsule with bacteria to yogurt to Lord knows what else.

Some doctors also Rx it too.  Even in the hospital.  Yet when I read up on reviews the data is contradictory.

If it was a drug company seeking approval from the FDA they would be shot down.  As long it is "natural" then anyone can say and sell whatever anyone is willing to listen to and buy into.

I don't write it off at all.  Just that I think it all is murky.
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Crafty_Dog
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« Reply #265 on: November 18, 2010, 08:36:04 AM »

Fair enough. 

I would also add the question of what are the cumulative consequences of taking antibiotic medicines various times in one's life?  How does the flora re-establish itself?  Is the mix the same? Or do other less positive bacterias increase their place in the mix?
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Crafty_Dog
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« Reply #266 on: November 19, 2010, 12:14:41 AM »

A couple of random thoughts:

a) One way of thinking about things is that our sweet tooth is nature's way of cluing us to eat certain things that are sweet e.g. fruit.  Instead we eat sugar and our body is confused.  Its near for carbo fuel is sated, but it remains hungry for the nutrition which it was intended to receive by eating the fruit.

b) Muscles consume calories, even at rest.  Part of healthy living is to realize the natural potential for muscle mass.  Genetic disposition to eat (appetite) has a tendency to be suitable for the intended muscle mass of the human in question.   If natural muscle mass is not achieved, there will be an inherent contradiction between the disposition to eat and the disposition to eat a certain amount.

Just rambling here , , ,
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ccp
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« Reply #267 on: November 30, 2010, 09:38:08 AM »

Vitamin D levels that are consdiered deficient or insufficient in the blood is quite prevalent.  It seems half of all of us are in that range.  What is the optimal level of blood Vitamin D?  No one is certain.  I shoot for 40 because I've read that lower levels are associated with osteoporotic bone fractures.  Some experts are advocating massive Vit D dosing in order to get people's levels up.  I did this for some months till I read that there is an association of massive dosing and cardiovascular events like heart attacks.  Is it possible that too much can contribute to heart attacks?  No one is quite sure.  However, coronary artery CT scans are actually looking for calcium in the coronaries arteries that is associated with plaque.  Therefore one could question if the high doses of Vit D can increase plaque buildup.

In any case, the cost of measuring Vitamin D is around $200 or 250.  Medicare will only pay for one measurement per year.  Don't think they aren't pissed off about doctors who are ordering a lot of these.  While nothing I read about the below article is wrong per se, don't forget the hidden agenda about the dollars and cents behind this from our government who is going to tell us what we can and cannot have paid for.  This is a good example of what we are in store for:

Google NewsReport: A bit more vitamin D is good, not too much
(AP) – 10 hours ago

WASHINGTON (AP) — Got milk? You may need a couple cups more than today's food labels say to get enough vitamin D for strong bones. But don't go overboard: Long-awaited new dietary guidelines say there's no proof that megadoses prevent cancer or other ailments — sure to frustrate backers of the so-called sunshine vitamin.

The decision by the prestigious Institute of Medicine, the health arm of the National Academy of Sciences, could put some brakes on the nation's vitamin D craze, warning that super-high levels could be risky.

"More is not necessarily better," cautioned Dr. Joann Manson of Harvard Medical School, who co-authored the Institute of Medicine's report being released Tuesday.

Most people in the U.S. and Canada — from age 1 to age 70 — need to consume no more than 600 international units of vitamin D a day to maintain health, the report found. People in their 70s and older need as much as 800 IUs. The report set those levels as the "recommended dietary allowance" for vitamin D.

That's a bit higher than the target of 400 IUs set by today's government-mandated food labels, and higher than 1997 recommendations by the Institute of Medicine that ranged from 200 to 600 IUs, depending on age.

But it's far below the 2,000 IUs a day that some scientists recommend, pointing to studies that suggest people with low levels of vitamin D are at increased risk of certain cancers or heart disease.

"This is a stunning disappointment," said Dr. Cedric Garland of the University of California, San Diego, who wasn't part of the institute's study and says the risk of colon cancer in particular could be slashed if people consumed enough vitamin D.

"Have they gone far enough? In my opinion probably not, but it's a step in the right direction," added prominent vitamin D researcher Dr. Michael Holick of Boston University Medical Center, who said the new levels draw needed attention to the vitamin D debate and encourage more food fortification.

Vitamin D and calcium go hand in hand, and you need a lifetime of both to build and maintain strong bones. But the two-year study by the Institute of Medicine's panel of experts concluded research into vitamin's D possible roles in other diseases is conflicting. Some studies show no effect, or even signs of harm.

A National Cancer Institute study last summer was the latest to report no cancer protection from vitamin D and the possibility of an increased risk of pancreatic cancer in people with the very highest D levels. Super-high doses — above 10,000 IUs a day — are known to cause kidney damage, and Tuesday's report sets 4,000 IUs as an upper daily limit — but not the amount people should strive for.

And Manson pointed to history's cautionary tales: A list of other supplements — vitamins C and E and beta carotene — plus menopause hormone pills that once were believed to prevent cancer or heart disease didn't pan out, and sometimes caused harm, when put to rigorous testing.

Stay tuned: To help settle the issue, Manson is heading a government-funded study that's recruiting 20,000 healthy older Americans to test whether taking 2,000 IUs of vitamin D really will lower their risk for heart disease, a stroke or certain cancers.

In the meantime, it's hard to consume 600 IUs of vitamin D from food alone. A cup of D-fortified milk or orange juice has about 100 IUs. The best sources may be fatty fish — some servings of salmon can provide about a day's supply. Other good sources are D-fortified cereals.

But here's the report's big surprise: While some people truly are seriously deficient in vitamin D, the average American in fact already has enough circulating in his or her blood — because we also make vitamin D from sun exposure, and because many people already take multivitamins or other D-containing dietary supplements.

Wait a minute: Headlines in recent years have insisted the opposite, that a majority of people don't get enough vitamin D, especially during the winter. What explains the contradiction?

Most testing laboratories are using a too-high cutoff for those blood levels, said report co-author Dr. Clifford Rosen of the Maine Medical Center. The report says at least 20 nanograms is adequate for bone health, while many labs instead list people as low if their blood levels are below 30 ng. Serious vitamin D deficiencies are diagnosed when levels dip well below 20, something that hasn't changed.

Rosen called the state of vitamin D testing "the wild, wild West," and said he hoped that "with this report, we can at least temper people's enthusiasm for just taking tons of supplements."

As for calcium, the report recommended already accepted levels to go along with your daily D — about 1,000 milligrams of calcium a day for most adults, 700 to 1,000 mg for young children, and 1,300 mg for teenagers and menopausal women. Too much can cause kidney stones; the report said that risk increases once people pass 2,000 mg a day.

It's true that most studies link poor health to vitamin D levels that are below 20 ng, said preventive cardiologist Dr. Erin Michos, a Johns Hopkins University School of Medicine professor who wasn't part of the study.

But, "I'm not sure I'm going to dramatically change my practice," said Michos, who pushes her patients to boost their levels until they're between 30 and 50 ng.

EDITOR'S NOTE — Lauran Neergaard covers health and medical issues for The Associated Press in Washington.

Copyright © 2010 The Associated Press. All rights reserved.
« Last Edit: November 30, 2010, 02:11:34 PM by Crafty_Dog » Logged
ccp
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« Reply #268 on: December 04, 2010, 11:42:01 AM »

I am shocked by this rec. by an FDA panel of experts.  Lap bands have a failure rate of 80% over a couple of years.  To think that the FDA approves doing this for people who are only class 1 obese is wrong.  It is a very costly procedure with not great results.  The surgeons will get rich though.  As well as the hospitals that do this.  WE will go broke paying for these through skyrocketing insurance costs.  I don't get it.

While obesity is hard to treat this ain't the answer.   Someone was bribed or owns stock options.

****By MATTHEW PERRONE, Associated Press Matthew Perrone, Associated Press – Sat Dec 4, 1:18 am ET
WASHINGTON – About 12 million more obese Americans could soon qualify for surgery to implant a small, flexible stomach band designed to help them lose weight by dramatically limiting their food intake. The Food and Drug Administration will make a final decision on the Lap-Band in the coming months.

The device from Allergan Inc. is currently implanted in roughly 100,000 people each year and usually helps patients lose 50 pounds or more. Under federal guidelines, it has been limited to patients who are morbidly obese.

On Friday, a panel of FDA advisers recommended expanding use of the device to include patients who are less obese. The panel voted 8-2 that the benefits of broader approval outweighed the risks.

If approved for wider use, the Lap-Band could be available to patients like Angela Denson, a 37-year-old Indianapolis woman who wants to lose 80 or 85 pounds. She said she has struggled with obesity since she started having children 20 years ago.

"I've tried diet pills. I've tried Weight Watchers ... all different types of diet plans," she said.

Denson is not quite obese enough for the surgery under the current standards, but she still wants to pursue the procedure to ward off future health problems and feel better.

But experts stress that the Lap-Band cannot stop deeply ingrained behavior that drives people to overeat. And the high cost of the procedure will remain a barrier for many potential patients.

More than a third of all American adults are obese. About 15 million of them meet criteria for gastric banding surgery under existing guidelines, which say a person should have a body mass index of 40 or higher, or a BMI of 35 or higher if the person suffers from a weight-related medical problem such as diabetes or high blood pressure.

If adopted, the proposal would lower the Lap-Band requirement to a BMI of 35 or higher, or as low as 30 with one related health problem.

Doing so would increase the number of eligible patients to 27 million, according to federal health data.

Denson said her insurer denied her doctor's request for a band procedure because her BMI was 39.3, and she had no serious conditions.

Dr. Jack Ditslear said broader approval could help people with lower BMIs avoid dangerous complications down the road.

"We know that being overweight increases the risk of diabetes, high blood pressure and heart disease," said Ditslear, a surgeon at Clarian Bariatrics in Indianapolis. "Ideally you want to lose the weight before you have the onset of those diseases."

The adjustable band has been available in the U.S. since 2001 but far longer in Europe and Australia, where it is dominant. A ring is placed over the top of the stomach and inflated with saline to tighten it and restrict how much food can enter and pass through the stomach.

The device was developed as an alternative to gastric bypass surgery, a permanent procedure in which food is rerouted from a pouch in the stomach to the small intestine.

There were about 220,000 gastric surgeries last year, with banding accounting for an estimated 40 percent. Surgeons say the fact that the procedure is reversible and relatively low-risk accounts for its growing popularity.

"As a clinician, it's pretty common for patients to come in because they've heard about banding," said Dr. Eric DeMaria, a surgeon at Durham Regional Hospital. "It's probably the lowest-risk surgical procedure available for morbid obesity."

But there are hurdles to wider use of the procedure, particularly its cost, which can range from $14,000 to $20,000. The device itself costs $3,000.

Susquehanna International analyst Gary Nachman says both insurers and patients are often reluctant to pay.

"It's a very expensive procedure and even if someone has coverage, they may have to pay a copay of a few thousand dollars," Nachman said. "And that's why in a tough economy, we've seen this franchise struggle more than you would normally."

According to Nachman, the payment issues for Lap-Band will only increase if it is approved for patients with less severe obesity. He projects a modest 8 percent rise in Allergan's business through 2014 to about $258 million.

Susan Pisano, a spokeswoman for the industry trade group America's Health Insurance Plans, said she believes a majority of insurers now cover bariatric surgeries.

"They may approach this surgery in a cautious way, but I think there is a broad acknowledgment that there is a place for surgery in the treatment of morbidly obese people," she said, noting that some employers who provide group health coverage choose not cover the procedure in their plans.

The FDA's consideration of the Lap-Band comes as rising health care costs threaten to consume nearly a fifth of the U.S. economy. Obesity-related health care spending is estimated at $147 billion, double the level of a decade ago.

While experts say the Lap-Band can help patients control their weight, it cannot replace healthy lifestyle choices.

"It is a tool to make the lifestyle easier, but not easy. It doesn't help people exercise more or resolve their behavioral issues," said Madelyn Fernstrom, director of the University of Pittsburgh's weight management center. "It's most important for people to understand what it can and can't do."

To change eating behavior, the drug industry has invested billions of dollars to develop weight-loss medications, most of which have not proven effective.

The FDA has rejected two such medications this year alone because of safety concerns.

On Friday the agency issued a lackluster review of a third drug called Contrave, which combines an antidepressant with an anti-addiction drug used to treat alcoholism.

Experts say such drugs have been largely unsuccessful at addressing the main obstacle to weight loss: the brain's fundamental drive to eat enough food to maintain current weight.

Dr. Derek Lowe, a pharmaceutical researcher and blogger, says unless medicine finds a way to address that issue, devices like the Lap-Band will have mixed effectiveness.

"There are certainly people who've had gastric bypass surgery and managed to turn themselves back into their original size by sipping on milkshakes all day," he said.****

___
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G M
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« Reply #269 on: December 05, 2010, 08:44:49 PM »

http://www.tobiasbuckell.com/2010/12/04/how-i-lost-30-pounds-while-eating-a-donut-every-day/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+TobiasBuckell+%28Tobias+S.+Buckell+Online%29&utm_content=FaceBook

How I lost 30 pounds while eating a donut every day

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ccp
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« Reply #270 on: December 06, 2010, 09:33:20 AM »

The procedure, particularly its cost, which can range from $14,000 to $20,000. The device itself costs $3,000.

Now based on FDA experts 100,000,000 people total will qulify for the procedure.  That's right 100 million.

Using the above numbers that means we could spend 1.5 TRILLION for the people who qualify.

It should NOT be covered by insurance or Medicare for people who are with BMI 30 to 35.  If they choose to pay out of pocket - be my guest.

I do not want to subsidize this.

Why is everything ass backwards with the government?Huh
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ccp
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« Reply #271 on: December 06, 2010, 09:43:38 AM »

I don't recall where I read it but the longer term results of lap band are not very good.  Most people will gain most of the weight back.
That is not true for the gastric bypass which does work much better.

When I do a search all I see are advertisements from surgeons telling you how wonderful the procedure is and how state of the art they are.

But then again most diet business will not tell you that almost all fail after five years 95% of people.

GM,
I cannot pull up the link in your post.

I heard something about the donut man's diet.  Isn't he some guy at Rutgers?

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G M
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« Reply #272 on: December 06, 2010, 09:50:45 AM »

CCP,

That's a different guy with the same basic idea. Burn more calories than you consume and you lose weight. Even if some of your food choices are less than ideal.
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ccp
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« Reply #273 on: December 08, 2010, 12:03:46 PM »

Update from CDC on influenza.

One can go back in time to see how it is spreading throughout the US over the past month up to 11/27:

http://www.cdc.gov/flu/weekly/WeeklyFluActivityMap.htm
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JDN
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« Reply #274 on: December 08, 2010, 03:54:27 PM »

the simplest explanation is often the right one. And the simplest explanation for the dramatic rise in obesity rates — roughly doubling as a percentage of the total population in just a quarter-century — is the surge in our daily caloric intake. Excess food now, excess weight later.

http://www.latimes.com/news/opinion/commentary/la-oe-gratzer-obesity-20101208,0,7040118.story
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ccp
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« Reply #275 on: December 16, 2010, 04:34:34 PM »

My quote from Dec. 4:

"someone was bribed or owns stock options"

Well here it is,

http://www.cnn.com/video/#/video/health/2010/12/16/ac.weight.loss.surgery.questions.cnn?iref=allsearch

Gee I wonder who were the ones to vote for enlarging the population of people elligible for the lap band.   They don't give the stats here but the evidence is the lap band fails for more than it succeeds over a couple of years.
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Crafty_Dog
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« Reply #276 on: December 21, 2010, 11:31:05 AM »

http://www.ncbi.nlm.nih.gov/pubmed/20054459 The full text article is free.
 
Int J Environ Res Public Health. 2009 Oct;6(10):2626-38. Epub 2009 Oct 12.

Food choices and coronary heart disease: a population based cohort study of rural Swedish men with 12 years of follow-up.
Holmberg S, Thelin A, Stiernström EL.

Research and Development Centre, Kronoberg County Council, Box 1223, SE-351 12 Växjö, Sweden. sara.holmberg@ltkronoberg.se

Abstract
Coronary heart disease is associated with diet. Nutritional recommendations are frequently provided, but few long term studies on the effect of food choices on heart disease are available. We followed coronary heart disease morbidity and mortality in a cohort of rural men (N = 1,752) participating in a prospective observational study. Dietary choices were assessed at baseline with a 15-item food questionnaire. 138 men were hospitalized or deceased owing to coronary heart disease during the 12 year follow-up. Daily intake of fruit and vegetables was associated with a lower risk of coronary heart disease when combined with a high dairy fat consumption (odds ratio 0.39, 95% CI 0.21-0.73), but not when combined with a low dairy fat consumption (odds ratio 1.70, 95% CI 0.97-2.98). Choosing wholemeal bread or eating fish at least twice a week showed no association with the outcome.

PMID: 20054459 [PubMed - in process]PMCID: PMC2790097Free PMC Article


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Crafty_Dog
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« Reply #277 on: December 24, 2010, 12:20:31 PM »

The Claim: Humming Can Ease Sinus Problems
By ANAHAD O’CONNOR
Published: December 20, 2010
NYTimes
THE FACTS

Dealing with a cold is bad enough, but when it leads to a sinus infection, the misery can double. Some researchers have proposed a surprising remedy: channeling your inner Sinatra.
Sinus infections — which afflict more than 37 million Americans every year — generally occur when the lining of the sinuses becomes inflamed, trapping air and pus and other secretions, and leading to pain, headaches and congestion. Because the inflammation is often caused by upper-respiratory infections, people with asthma and allergies are more vulnerable than others to chronic sinusitis.

Keeping the sinuses healthy and infection-free requires ventilation — keeping air flowing smoothly between the sinus and nasal cavities. And what better way to keep air moving through the sinuses and nasal cavity than by humming a tune?

In a study in The American Journal of Respiratory and Critical Care Medicine, researchers examined this by comparing airflow in people when they hummed and when they quietly exhaled. Specifically, they looked to see if humming led to greater levels of exhaled nitric oxide, a gas produced in the sinuses. Ultimately, nitric oxides during humming rose 15-fold.

Another study a year later in The European Respiratory Journal found a similar effect: humming resulted in a large increase in nasal nitric oxide, “caused by a rapid gas exchange in the paranasal sinuses.” Since reduced airflow plays a major role in sinus infections, the researchers suggested that daily periods of humming might help people lower their risk of chronic problems. But further study is needed, they said.

THE BOTTOM LINE

Studies show that humming helps increase airflow between the sinus and nasal cavities, which could potentially help protect against sinus infections.

ANAHAD O’CONNOR scitimes@nytimes.com
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ccp
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« Reply #278 on: December 24, 2010, 03:14:52 PM »

Next step.

Get a Federal grant to study this.  (tax payers would never know)

It must be for a university from a Democratic district.

One study group must hum a total of two hours a day.  Another study group three hours a day.

A control group with no humming allowed.  The groups would  be monitored for a year.  at the end of the year compare sinus trouble rates between the groups.

Think of the jobs created with this money.  A professor who does nothing but put his name on the paper at the end and take credit even though he/she did nothing.   A phD candidate or medical fellow who does ALL the work, and one nurse (who is already employed by the univeristy ENT department).  Eventually a statistician could be consulted, a secretary to type it up, the study sent in to the NEJM for publication.   

This would undoubetdly get money for a professor who has to get government grants to keep his post at the university, the phD candidate works for free, or for little pay, or even pays into his training, and the secretary and statistian could continue to get minimum wage.

And like ALMOST ALL studies in medicine the results whether positive or negative in their findings of a link between humming and "sinus health" the conclusion WILL BE more study is needed to investigate this further!

Sinus health, prostate health, breast health, colon health, healthy heart.....well at least Americans do have healthy appetites.

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ccp
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« Reply #279 on: December 30, 2010, 07:49:17 PM »

http://www.cdc.gov/flu/weekly/usmap.htm
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Crafty_Dog
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« Reply #280 on: January 17, 2011, 12:51:19 AM »

Comments?
===============================

An easy-to-follow 5-step plan to make yourself diabetic in as short a time as possible...

1) Cut your fat and eat healthy, whole grains: Yes, reduce satiety-inducing foods and replace the calories with appetite-increasing foods, such as whole grain bread, that skyrocket blood sugar higher than a candy bar.

2) Consume one or more servings of juice or soda per day: The fructose from the sucrose or high-fructose corn syrup will grow visceral fat and cultivate resistance to insulin.

3) Follow the Institute of Medicine's advice on vitamin D: Take no more than 600 units vitamin D per day, which will allow abnormal levels of insulin resistance to persist, driving up blood sugar, grow visceral fat, and allow abnormal inflammatory phenomena to persist.

4) Have a bowl of oatmeal or oat cereal every morning: Because oat products skyrocket blood sugar, the repeated high sugars will damage the pancreatic beta cells ("glucose toxicity"), eventually impairing pancreatic insulin production. (Add insult to injury by adding a little honey with your oatmeal.) To make your diabetes-creating breakfast concoction even more effective, make the oatmeal using bottled water. Many popular bottled waters, like Coca Cola's Dasani or Pepsi's Aquafina, are filtered waters. This means they are devoid of magnesium, a mineral important for regulating insulin responses.

5) Take a diuretic (like hydrochlorothiazide, or HCTZ) or beta blocker (like metoprolol or atenolol) for blood pressure: Likelihood of diabetes increases 30% with these common blood pressure agents.

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5RingsFitness
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« Reply #281 on: January 17, 2011, 07:43:03 AM »

yep

diet of fat, protein, veggies and leafy greens= less chance
diet prescribed by big Agra and big pharma= customer for life, even though the quality and span will be reduced
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"Nations have passed away and left no traces, And history gives the naked cause of it - One single simple reason in all cases; They fell because their peoples were not fit."-Rudyard Kipling
Crafty_Dog
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« Reply #282 on: January 26, 2011, 11:08:34 AM »

Each year, federal inspectors find illegal levels of antibiotics in hundreds of older dairy cows bound for the slaughterhouse. Concerned that those antibiotics might also be contaminating the milk Americans drink, the Food and Drug Administration intended to begin tests this month on the milk from farms that had repeatedly sold cows tainted by drug residue.

But the testing plan met with fierce protest from the dairy industry, which said that it could force farmers to needlessly dump millions of gallons of milk while they waited for test results. Industry officials and state regulators said the testing program was poorly conceived and could lead to costly recalls that could be avoided with a better plan for testing.

In response, the F.D.A. postponed the testing, and now the two sides are sparring over how much danger the antibiotics pose and the best way to ensure that the drugs do not end up in the milk supply.

“What has been served up, up to this point, by Food and Drug has been potentially very damaging to innocent dairy farmers,” said John J. Wilson, a senior vice president for Dairy Farmers of America, the nation’s largest dairy cooperative. He said that that the nation’s milk was safe and that there was little reason to think that the slaughterhouse findings would be replicated in tests of the milk supply.

But food safety advocates said that the F.D.A.’s preliminary findings raised issues about the possible overuse of antibiotics in livestock, which many fear could undermine the effectiveness of drugs to combat human illnesses.

“Consumers certainly don’t want to be taking small amounts of drugs every time they drink milk,” said Caroline Smith DeWaal, food safety director of the Center for Science in the Public Interest, an advocacy group. “They want products that are appropriately managed to ensure those drug residues aren’t there, and the dairy farmer is the one who can control that.”

The F.D.A. said that it would confer with the industry before deciding how to proceed. “The agency remains committed to gathering the information necessary to address its concern with respect to this important potential public health issue,” it said in a statement.

The concerns of federal regulators stem from tests done by the Department of Agriculture on dairy cows sent to be slaughtered at meat plants. For years, those tests have found a small but persistent number of animals with drug residues, mostly antibiotics, that violate legal limits.

The tests found 788 dairy cows with residue violations in 2008, the most recent year for which data was available. That was a tiny fraction of the 2.6 million dairy cows slaughtered that year, but regulators say the violations are warning signs because the problem persists from year to year and some of the drugs detected are not approved for use in dairy cows.

The question for the F.D.A. is whether cows that are producing milk also have improper levels of such drugs in their bodies and whether traces of those drugs are getting into the milk.

Regulators and veterinarians say that high levels of drugs can persist in an animal’s system because of misuse of medicines on the farm.

That can include exceeding the prescribed dose or injecting a drug into muscle instead of a vein. Problems can also occur if farmers do not follow rules that require them to wait for a specified number of days after administering medication before sending an animal to slaughter or putting it into milk production.

“F.D.A. is concerned that the same poor management practices which led to the meat residues may also result in drug residues in milk,” the agency said in a document explaining its plan to the industry. In the same document, the F.D.A. said it believed that the nation’s milk supply was safe.

Today, every truckload of milk is tested for four to six antibiotics that are commonly used on dairy farms. The list includes drugs like penicillin and ampicillin, which are also prescribed for people. Each year, only a small number of truckloads are found to be “hot milk,” containing trace amounts of antibiotics. In those cases, the milk is destroyed.

But dairy farmers use many more drugs that are not regularly tested for in milk. Regulators are concerned because some of those other drugs have been showing up in the slaughterhouse testing.

Federal officials have discussed expanded testing for years. But industry executives said that it was not until last month that the F.D.A. told them it was finally going to begin.

The agency said that it planned to test milk from about 900 dairy farms that had repeatedly been caught sending cows to slaughter with illegal levels of drugs in their systems.

It said it would test for about two dozen antibiotics beyond the six that are typically tested for. The testing would also look for a painkiller and anti-inflammatory drug popular on dairy farms, called flunixin, which often shows up in the slaughterhouse testing.

The problem, from the industry’s point of view, is the lengthy time it takes for test results.

The tests currently done for antibiotics in milk take just minutes to complete. But the new tests could take a week or more to determine if the drugs were present in the milk.

Milk moves quickly onto store shelves or to factories where it is made into cheese or other products. The industry worried that, under the F.D.A. plan, by the time a load of milk was found to be contaminated, it could already be in consumers’ refrigerators, and that could lead to recalls.

One Northeast cooperative, Agri-Mark, sent a letter to its members last month instructing them to dump milk if it had been tested by the F.D.A. “Agri-Mark must ensure that all of our milk sales, cheese, butter and other products are in no danger of recall,” the letter said.

Other industry executives said that processing plants would refuse to take any milk from a farm that had been tested until the results showed it was drug-free, meaning farmers could end up dumping milk for a week or more while waiting.

The F.D.A. plan was also criticized by state officials that regulate the dairy industry.

In a sharply worded Dec. 29 letter, the top agriculture officials of 10 Northeastern states, including New York and Pennsylvania, which are both leading dairy producers, told the F.D.A. that its plan was badly flawed. Among other problems, the letter said, forcing farmers to dump large quantities of milk could create environmental problems.

The F.D.A. said it would consider the regulators’ comments as it reviewed its testing plan.

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bigdog
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« Reply #283 on: February 19, 2011, 08:38:01 AM »

http://sports.yahoo.com/mma/news?slug=dm-mmavegetarians021711
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Body-by-Guinness
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« Reply #284 on: March 29, 2011, 09:58:28 AM »

Lotta folks I respect use chiropractors, though the stuff has always looked too poorly documented for me to check it out. Ran into a piece that explains what to look for in a good one:

The Image of Chiropractic: Consensus Based on Belief
from Science-Based Medicine by Sam Homola


As a chiropractor, I am often asked why the image of chiropractic is so bad. “Why is chiropractic so often ignored by the media and ridiculed by physicians?” Journalists and health professionals tend to judge chiropractic by the worst of what they see, and what they see is often bad. This March 15, 2011, post from a chiropractic group asking for money to provide chiropractic services for earthquake and tsunami victims in Japan is a good example of why chiropractic has a bad image:

Please consider donating whatever you can to the SOTO-I/PAAC [Sacro Occipital Teaching Organization International-Pacific Asian Association of Chiropractic] Japan Relief Fund. 100% of your donation will go directly to helping the needy Japanese people through SOT Chiropractic treatments and services.

Please consider this avenue of donation rather than the Red Cross etc. While they are worthy organizations, we have ZERO overhead to administration and the funds will provide CHIROPRACTIC services to the needy. Please recommend this avenue of aid to your patients and friends also. Any and everything will help!

Practitioners of Sacro Occipital Technic (SOT) and SOT Craniopathy claim to restore innate healing capacity by removing neurological interference and improving the flow of cerebrospinal fluid (“craniosacral respiration”). Vertebral subluxations affecting certain organs are found by palpating tendon insertions at the base of the skull. Craniosacral respiration is improved by adjusting the bones of the skull and the sacroiliac joint.

There are dozens of such nonsensical chiropractic treatment methods foisted on the public through “press releases” and junk-science journals. NUCCA (upper cervical technique), which identifies slight misalignment of the atlas as a major cause of human ailments, is a commonly-promoted technique based on chiropractic vertebral subluxation theory.

This press release further illustrates the reason for chiropractic’s bad image:

A revolutionary neuro relief technique is being used by chiropractors across the United States and Canada to treat a wide-array of Symptoms and Chronic Disorders they were never before able to handle. This technique, when applied correctly performs absolute miracles for patients who have been suffering for an extensive period in their lives. Thus patients are happier and chiropractors are increasing their visibility and incomes!

Online PR News – 12-March-2011

An article titled “Second Opinion: Of Chiropractors & Christians,” published in a Baptist news magazine, describes an “inherently unbelievable” chiropractic message:

My back hurt, so I went to a chiropractor. He is helping my back pain. That’s a good thing.

But that is not what this article is about.

My chiropractor is an evangelist for his particular brand of chiropractic. Literally, he and his staff are religious about it. They preach the word. They offer written materials. They make promises of a greater life. I am unmoved. I just want him to make my back feel better.

I have a better understanding now of how nonbelievers may react to Christian witness. My reactions to the “message” I get at my chiropractor’s office could also be the reactions of someone you know to church, Christianity or the gospel message of Christ:

These folks are extremely nice, and I appreciate that, but that does not mean I am going to believe what they believe or what they tell me to believe.
They sincerely believe what they say. I do not doubt that. Their sincerity does not persuade me to change my mind.
They walk the walk. They cleanse their toxins, go to burst training, take supplements and get regular adjustments. As far as I can tell, they are not hypocrites. But I am not moved.
They go out of their way to educate me. They offer written information. They invite me to seminars, dinners and meetings. I do not have the excuse that “I don’t understand.”
These folks care about me. I believe that.
So, why am I not fully sold? Why won’t I buy into the full program instead of just “settling” with having them make my back feel better?

Their message is inherently unbelievable.
Their message runs counter to what I know and to what I read and hear everywhere else.
Their message is too demanding of my time, energies and commitments.
Sound familiar? Those are reasons why people routinely reject our Christian witness…

Published: March 11, 2011 (The Baptist Standard)

Sorting out a Few Good Apples

As illustrated by the above clips, it’s not hard to understand why chiropractic has such a bad image. If the chiropractic profession does not take steps to eliminate the nonsense in chiropractic, it may be difficult for ethical, science-based chiropractors to separate themselves from questionable treatment methods that have been traditionally supported by chiropractic subluxation theory. The practice-centered approach of chiropractors who disseminate misinformation, whether they are true believers or not, hurts the public as well as the profession. It is unlikely that unethical chiropractors will voluntarily give-up a faith-based or money-based approach they are using to make a living. Ethical chiropractors, many of whom are well-meaning but misinformed, struggle while pitch masters thrive. Guardians of public health feel compelled to issue warnings about chiropractic. Science-based chiropractors, as individuals, are forced to distance themselves from misguided colleagues and from purveyors of bogus methods based on the tenets of chiropractic. My heart goes out to those well-meaning chiropractors whose education left them totally dependent upon belief-based self-employment. Few of them have the faculties or the means needed to take a different path.

While it would be painful for chiropractors to point out and renounce obviously worthless diagnostic and treatment methods used by some of their colleagues, it might be prudent for chiropractic associations to do so to establish credibility in the eyes of the public. No other health profession has such a negative image. Good chiropractors are mixed in with bad chiropractors, like a crate of partially spoiled fruit that still contains a few good apples but is often discarded.

The chiropractic profession has to face the reality that chiropractic as a method of treating human ailments by adjusting vertebral subluxations is not acceptable in the scientific community and is unrelated to the generic spinal manipulation now being used by physical therapists and science-based chiropractors. A look at chiropractic journals, advertisements, and office procedures, however, reveals that a large number of chiropractors still cling to Palmer’s subluxation theory, some combining science with pseudoscience. I suspect that chiropractic has survived primarily because its use of manipulation in the treatment of back pain has provided a service not readily available in medical care, that is, symptomatic relief for mechanical-type neck and back pain or a good back-cracking back rub for providing pleasure and relieving tension. I believe the chiropractic profession today would be better off if it renounced the subluxation theory that gave it birth and concentrated on caring for back pain. So far, there is no indication that this will happen any time soon. Until the chiropractic profession does discard the vertebral subluxation theory, it will be difficult for the profession to condemn a multitude of popular, wacky chiropractic techniques based on a theory that defines the profession.

Entrenched Subluxation Theory

When the Council on Chiropractic Education (CCE) proposed new accreditation standards for chiropractic colleges, subject to take effect in January of 2012, all reference to “subluxation” was omitted. (“The CCE does not define or support any specific philosophy regarding the principles and practice of chiropractic, nor do the CCE Standards support or accommodate any specific or political position. The Standards do not establish the scope of chiropractic practice. They specify core educational requirements but do not otherwise limit the educational process, program curricular content, or topics of study.”) The American Chiropractic Association (ACA), the largest association in America representing the chiropractic profession, responded, in part, with this comment regarding the subluxation:

The document removes all references to the term “subluxation” – a core element of the practice of chiropractic that has been integral since the profession’s beginnings over 100 years ago. While the term “subluxation” and its role in the practice of chiropractic is sometimes misunderstood or not fully appreciated by all parties involved in medical related research and the delivery of health care, the term is one which is explicitly recognized in federal law (Section 1861(r) of the Social Security Act) and has been widely recognized by the courts, state legislative bodies and licensing authorities. The elimination of any reference to this term in the proposed standards will be viewed by many within the profession as a counter-productive action that will, in the long-term, likely weaken the profession’s collaborative strength and historic identity. We would propose placing “subluxation theory” back into Section 2, H. Educational Program for the Doctor of Chiropractic Degree and Vertebral Subluxation Complex into Section 3 Initial assessment and diagnosis as a required component.

As a chiropractor and a critic of chiropractic, I often found common ground with other health-care professionals by noting the value of generic spinal manipulation while providing guidelines to separate science-based chiropractors from subluxation-based chiropractors. Failure to point out obvious chiropractic nonsense may simply allow a believing public to assume that all chiropractors are the same, most of whom do not deserve to feed off the positive image projected by a few ethical, science-based chiropractors. Subluxation-based chiropractors peddle dubious services without opposition from their colleagues or from their associations, alienating chiropractic from the scientific community.

When I published my book Bonesetting, Chiropractic and Cultism in 1963, I renounced the vertebral subluxation theory and recommended that chiropractic be developed as a back specialty. It has always been my hope that chiropractic would become a form of physical medicine, a sub-specialty of medicine offering physical treatment methods for mechanical-type neck and back problems. If chiropractic aspires to become an independent, primary non-surgical specialty capable of accepting full responsibility for treating neck and back pain and related problems, it would have to have access to certain prescription medications and all available rehabilitative and physical treatment methods as well as access to hospital facilities, requiring changes in state laws and chiropractic college curriculum. As a back-pain specialty or sub-specialty, the chiropractic profession could be sustained by referrals from other health-care professionals.

Back Specialists?

In 2005, the World Federation of Chiropractic defined chiropractors as “…spinal health care experts in the health care system…with emphasis on the relationship between the spine and the nervous system…” This ambiguous definition fails to place proper limitations on the practice of chiropractic, leaving the door open for subluxation-based chiropractors who use spinal adjustments to treat general health problems. Such chiropractors, with only a hammer in their tool box, cannot qualify as a legitimate “back specialist” or “spine specialist.”

According to the Agency for Healthcare Policy and Research, low-back trouble is the second most common reason for office visits to primary care physicians and the most common reason for office visits to orthopedic surgeons, neurosurgeons, and occupational medicine physicians. Back problems are the most common cause of disability among persons under the age of 45 (Acute Low Back Problems in Adults, 1994). Despite the fact that back pain is one of this nation’s most common ailments, the niche for a back-pain specialty remains unfilled. With changes, chiropractic could have filled this niche (specializing like optometry or chiropody), but instead chose to be defined as a form of alternative medicine with a limited treatment method and an unlimited scope of practice .

Most people think of a chiropractor as a “back doctor.” And most people who go to a chiropractor go for treatment of a neck or back problem. It is certainly ironic that many chiropractors consider it demeaning to be called a “back specialist,” preferring to “treat human ailments without use of drugs and surgery.” Unfortunately, most state laws define chiropractic in this way, resulting in scientific and societal suspicion that hinders change and keeps utilization of chiropractic low.

Today, 48 years after publication of my Bonesetting book, I am still of the opinion that the chiropractic profession is not properly defined and limited. Chiropractic associations continue to tolerate implausible theories that provide an umbrella for inappropriate use of spinal manipulation and a variety of proprietary treatment methods applied to the gamut of human ailments. Many subluxation-based chiropractors seek support in the camp of alternative medicine where they are more readily accepted and where quackery is rampant. They are not representative of chiropractors who follow the guidelines of science in limiting their scope of practice. The uncontested proclamations of chiropractors who make vague and all-inclusive claims continue to drag the profession down, as indicated by figures showing that the percentage of the population seeing chiropractors annually decreased from 9.9% in 1997 to 7.4% in 2002 (Altern Ther Health Med. 2005;11:42-49), despite increasing popularity of alternative medicine.

Scientific presentations will not eliminate a belief system such as homeopathy or subluxation-based chiropractic, nor will the actions of a few science-based chiropractors. It seems likely that there will always be subluxation-based chiropractors. Until the majority of chiropractors make a clean break from what has traditionally been known as chiropractic (adjusting the spine to restore and maintain health), changes for the better in the profession as a whole will be problematic. Chiropractic associations will tend to represent the views of the majority, even if these views are scientifically indefensible. And the definition of chiropractic will continue to be based upon consensus rather than upon science.

Since physical therapy as a sub-specialty of medicine is now incorporating use of science-based manipulation in an armamentarium designed for treatment of neck and back pain and other musculoskeletal problems, it might be too late for the chiropractic profession to establish itself as a preferred back-pain specialty or sub-specialty. Forty-six states now allow direct access to the services of a physical therapist without physician referral. According to the American Physical Therapy Association, physical therapy, by the year 2020, will be provided by physical therapists who are doctors of physical therapy and who may be board-certified specialists.

The Majority Rules

Chiropractors who use manipulation appropriately may be in the minority, making it necessary for them to seek refuge and camaraderie in small groups of like-minded chiropractors who voluntarily follow the guidelines of science in offering patient-centered care. It would certainly be nice if these chiropractors could be separated from the herd with a special degree in a separate camp until they become a majority and the national associations are forced to follow suit.

Until then, I hope that good chiropractors will offer their patients (and the public) tips on how to recognize questionable claims so that good judgment can be exercised in selecting a chiropractor. It may be necessary for chiropractors themselves to openly criticize esoteric techniques used to locate and correct the mysterious, asymptomatic, and undetectable chiropractic vertebral subluxations alleged to be a cause of disease. Scientifically indefensible theories and treatment methods must be labeled as such to discourage use by the public as well as by chiropractors. As the undesirable aspects of chiropractic (e.g., “killer subluxations”) become less acceptable in the eyes of the public, fewer chiropractors will tout such nonsense. When science-based chiropractors are in the majority, if that ever happens, chiropractic associations might then define chiropractic properly and make appropriate changes in state laws.

Finding a Good Chiropractor

Here are the guidelines I offer patients who might want chiropractic treatment for back pain:

While a good chiropractor can do a good job treating back pain, not all chiropractors are the same; some follow the guidelines of science, some do not.
Look for a chiropractor who limits his/her practice to care of musculoskeletal problems and who uses hands-on generic spinal manipulation in combination with physical therapy modalities. Such a chiropractor can often be found working in a multi-disciplinary back-pain clinic.
Avoid chiropractors who propose to locate and adjust “vertebral subluxations” as a treatment for disease or to “restore and maintain health.”
Avoid chiropractors who ask for payment in advance for a long course of treatment. As a general rule, treatment should be discontinued if symptoms worsen after one week or have not improved after two weeks.
Avoid chiropractors who routinely x-ray new patients or who do full-spine x-rays on every patient. Remember that simple back strain will usually resolve on its own in a few weeks and does not require an x-ray exam.
Do not accept the services of a chiropractor who refuses to share his/her records with your family physician or a medical specialist. An orthopedist who has exchanged office notes with chiropractors can often offer guidance in selecting a chiropractor.
Persons who want manipulative therapy for a back problem but are reluctant to see a chiropractor should ask for a referral to a physiatrist, a physical therapist, or an orthopedic manual therapist who has been trained in the use of spinal manipulation.

http://www.sciencebasedmedicine.org/?p=11757

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« Reply #285 on: March 29, 2011, 12:34:06 PM »

Herbal Remedies, Street Drugs, and Pharmacology
from Science-Based Medicine by Harriet Hall


David Kroll’s recent article on thunder god vine is a great example of what can be learned by using science to study plants identified by herbalists as therapeutic. The herbalists’ arsenal can be a rich source of potential knowledge. But Kroll’s article is also a reminder that blindly trusting herbalists’ recommendations for treatment can be risky.

Herbal medicine has always fascinated me. How did early humans determine which plants worked? They had no record-keeping, no scientific methods, only trial and error and word of mouth. How many intrepid investigators poisoned themselves and died in the quest? Imagine yourself in the jungle: which plants would you be willing to try? How would you decide whether to use the leaf or the root? How would you decide whether to chew the raw leaf or brew an infusion? It is truly remarkable that our forbears were able to identify useful natural medicines and pass the knowledge down to us.

It is equally remarkable that modern humans with all the advantages of science are willing to put useless and potentially dangerous plant products into their bodies based on nothing better than prescientific hearsay.

Ancient Sumerians used willow, a salicylate-rich plant that foreshadowed modern aspirin. Digitalis was used by the ancient Romans long before William Withering wrote about its use for heart failure. South American natives discovered that chinchona bark, a source of quinine, was an effective treatment for malaria. These early herbal remedies pointed the way to modern pharmaceuticals. How many other early remedies fell by the wayside? What else did the Sumerians, the Romans, and the natives use that did more harm than good? If “ancient wisdom” exists, so does “ancient stupidity.”

Plants undeniably produce lots of good stuff. Today researchers are finding useful medicines in plants that have no tradition of use. Taxol, the cancer-fighting product of Pacific yew trees, was discovered by the National Cancer Institute only by screening compounds from thousands of plants.

There is a reason pharmacology abandoned whole plant extracts in favor of isolated active ingredients. The amount of active ingredient in a plant can vary with factors like the variety, the geographic location, the weather, the season, the time of harvest, soil conditions, storage conditions, and the method of preparation. Foxglove contains a mixture of digitalis-type active ingredients but it is difficult to control the dosage. The therapeutic dose of digitalis is very close to the toxic dose. Pharmacologists succeeded in preparing a synthetic version: now the dosage can be controlled, the blood levels can be measured, and an antibody is even available to reverse the drug’s effects if needed.

“Ancient wisdom” argues that if an herbal remedy has been used for centuries, it must be both effective and safe. That’s a fallacy. Bloodletting was used for centuries but it wasn’t effective and it did more harm than good. If a serious side effect occurred in one in a thousand recipients of an herb, or even one in a hundred, no individual herbalist would be likely to detect it. If a patient died, they would be more likely to attribute the cause to other factors than to herbs that they believed were safe. Even with prescription drugs, widespread use regularly uncovers problems that were not detected with pre-marketing studies.

Arguments in favor of herbal remedies include:

They’re natural. (So what? Strychnine is natural.)
They’re safer than prescription drugs. (Maybe some are, some aren’t; how would you know?)
They’re milder than prescription drugs. (That would depend on the dosage of active ingredient.)
They’re less likely to cause side effects. (When they have been as well studied as prescription drugs, they may turn out to have just as many or more side effects. All effective drugs have side effects, and if an herbal medicine has fewer side effects it might have fewer therapeutic effects too. Formal systems for reporting adverse effects have long been in place for prescription drugs; not so for herbal remedies.)
They’re different from prescription drugs. (Some are identical to prescription drugs, like red yeast rice which contains the same ingredient as prescription lovastatin; and some herbal products have been found contaminated with prescription drugs.)
They’re less expensive. (True, but is a cheaper, inferior product a good bargain?)
They’re easier to obtain. (True, you don’t have to make an appointment with a doctor; but that means you don’t get the benefit of a doctor’s knowledge.)
The mixture of ingredients in a plant can have synergistic effects. (This is widely claimed but almost never substantiated. The other ingredients are just as likely to counteract the desired effect or to cause unwanted adverse effects.)
For every disease, God has provided a natural remedy. (Perhaps this is a comforting thought for believers, but it is not based on any evidence and is not convincing to atheists and agnostics. And it doesn’t help us find that natural remedy.)
Even when an herbal remedy works, finding a safe and reliable source is problematic. Horror stories abound:

Contaminants (such as heavy metals, pesticides, carcinogens, toxic herbs, and insect parts).
Wild variation in content (from no active ingredient to many times the amount on the label).
Mislabeled products that contain an entirely different herb.
I won’t list specific examples here; they are easy enough to find. I’ll just say that natural medicines are not regulated the way prescription drugs are, thanks to the infamous Diet Supplement and Health Education Act (DSHEA) of 1994.

When you take an herbal remedy, you are taking

An active ingredient that usually has not been adequately tested,
Other components that have not even been identified, much less tested,
An uncertain amount, and
Possible contaminants.
The term “street drugs” comes to mind: you don’t really know what you’re getting.

http://www.sciencebasedmedicine.org/?p=11595
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« Reply #286 on: April 12, 2011, 09:01:40 PM »

Compare and Contrast
from Science-Based Medicine by Mark Crislip
5 people liked this

I have been in Infectious Diseases for almost 25 years. I have two major jobs: I see inpatient consults and I chair the Infection Control program. I have been involved in quality improvement, especially as it relates to hospital acquired infections, for my entire career. It has been an interesting quarter century. Year after year we have driven down infection rates and other kinds of mortality and morbidity in hospitalized patients. Everyone recognizes that medicine is difficult and dangerous and its biggest problem is medicine is practiced by humans, who, I would venture to observe, are prone to mistakes and any number of cognitive errors.

It has not been a easy journey. People hate change and there has not always been certainty as to the best options to choose to solve a problem, a problem that continues today. For example, how best to treat a patient with potential methicillin resistant Staphylococcus aureus colonization (MRSA). Should we screen everyone? Screen high risk patients? Surgical patients? Do we decolonize, with the long term consequence of accelerating antibiotic resistance? Do we place everyone with MRSA in isolation, with the known decrease in care that patients in isolation may have? Everything we do has potential downsides and unintended consequences. No good deed ever goes unpunished.


When I was a resident every PVC (preventricular contractions) in cardiac patents was suppressed as we thought PVC’s were the sentinel event that led to ventricular tachycardia and death. So patients received IV lidocaine and we often sent patients home on quinidine or other antiarrhythmics. Subsequent studies demonstrated that antiarrhythmics may have killed more people than they saved, and doctors no longer suppress every PVC in the ICU. Medicine changes, one hopes for the better, offering old geezers like me the opportunity to ‘reminisce’ about the old days, when I tied an onion to my belt, which was the style at the time. Now, to take the ferry cost a nickel, and in those days, nickels had pictures of bumblebees on ‘em. Give me five bees for a quarter, you’d say. Now where were we? Oh yeah: the important thing was I had an onion on my belt, which was the style at the time.

Sorry. I digress. A couple of months ago I had a patient with severe malaria that needed IV quinidine (the dextrorotatory diastereoisomer of quinine, but that is obvious) and there was none in the pharmacy; we had to get some shipped in by our dealer, er, distributor. In medicine, if it discovered that what was thought to be a beneficial intervention turns out to cause more harm than good, the intervention is abandoned.

When To Err is Human was published, it caused quite a brouhaha. Depending on whose numbers you want to believe, 44 to 98 thousand Americans died each year from medical errors. I did not have issues with the numbers. There are about 5700 hospitals in the US, so that would be about one death every month and a half. Knowing what I did about infections and other complications in the hospital, that did not seem like an unreasonable estimate. A bit high, perhaps, but in the ballpark of my understanding of reality.

That is old data, and no longer applicable. Due, in part, to To Err is Human, the last decade has led to innumerable studies evaluating the causes of infections and complications in hospitals and the best approaches to decrease them. My institutions have invested huge time and effort to implement these quality improvements with great success.

When I started in Infection Control, the infection data was considered protected. The thought was that institutions would be more likely to collect and evaluate data about infections if there were not discoverable by lawyers. The downside was, as I was informed, if I informed anyone about the data, it would no longer be protected, and the institutions would be open to expensive lawsuits. This century my institutions are much more transparent about disseminating information about our practice. I thought I would have a conniption the first time I saw the infection data for the ICU posted in the ICU for all too see. It turns out, like so many deeply held convictions, that keeping the data protected was a bad idea. Transparency has not led to an increase in lawsuits but it has led to a decline in all manner of hospital associated complications. Our staff takes a great deal of pride in their work. They took the data as a personal affront and worked to improve all aspects of patient care. When they saw harm potentially occurring, practice changed for the better.

So there are three reactions to new data in medicine that demonstrates that a given medical practice may cause harm.

First, the data and the conclusions are challenged, as they should be. All studies are open to analysis and improvement. In medicine we continuously try to improve care, and that requires good information.

Second, further studies are done to confirm and refine the problem and other studies are done to see how practice can be improved.

The third is practice change, which is often slower than we like. But change we do. I am old enough that I often bore the residents with how it used to be in the old days. Medicine today is drastically different than 20 years ago, and many logs better.

The most impressive example of improvement in the last 20 years is hand hygiene. Hand washing adherence 20 years ago was an embarrassment. Part of the problem was the time it took to wash hands; I have heard that if a nurse spent her time appropriately washing her hands, 80% of his shift would be spent at the sink.

Alcohol foam changed that. When we introduced the foam in the hospital, even when compliance was only 20%, we had a 50% drop in hospital infections, and as compliance has increased to 90 to 95%, the infections had a parallel decline. And the effects of alcohol foam improved once I discovered it was not a po agent, to be used like Cheez Whiz. Our biggest problem now is fall prevention. Most falls occur when the patient doesn’t want to bother the nurse and, in the process of moving about the room without help, falls. We are investigating ways to remove gravity from the hospital.

The threshold for changing and abandoning a therapy can be very small. Last century there was a drug called trovafloxacin that caused several hundred cases of hepatitis and a half a dozen deaths when it was being prescribed at a rate of 300,000 new prescriptions a month. Hepatitis was an extremely unusual complication, but the small risk was not worth the potential benefits since there were equally efficacious alternatives.

Compare and contrast medicine and alt med.

Most alt med interventions are, of course, based on eternal truths that cannot be improved or changed. They are often immune to reality induced change. Studies that confirm their eternal truth are always accepted. Studies that show harm or lack of efficacy? Not so much.

Certainly, when complications of alternative medicines are published the data is up for discussion. That is good and as it should be. But that is where the similarities with medicine ends.

There is an ongoing issue of safety in the two most invasive alternative interventions: acupuncture and chiropractic.

There were two reviews concerning chiropractic safety published recently. Safety of chiropractic interventions: a systematic review, which found

A total of 376 potential relevant articles were identified, 330 of which were discarded after abstract or complete article analysis. The search identified 46 articles that included data concerning adverse events: 1 randomized controlled trial, 2 case-control studies, 7 prospective studies, 12 surveys, 3 retrospective studies, and 115 case reports. Most of the adverse events reported were benign and transitory, however, there are reports of complications that were life threatening, such as arterial dissection, myelopathy, vertebral disc extrusion, and epidural hematoma. The frequency of adverse events varied between 33% and 60.9%, and the frequency of serious adverse events varied between 5 strokes/100,000 manipulations to 1.46 serious adverse events/10,000,000 manipulations and 2.68 deaths/10,000,000 manipulations.

CONCLUSION: There is no robust data concerning the incidence or prevalence of adverse reactions after chiropractic. Further investigations are urgently needed to assess definite conclusions regarding this issue.

That is impressive complication rates, although the authors suggest the data to support the rates are not robust, for an intervention that only has at best proven efficacy for low back pain and safer alternatives. Also published recently was Deaths after chiropractic: a review of published cases.

Twenty six fatalities were published in the medical literature and many more might have remained unpublished. The alleged pathology usually was a vascular accident involving the dissection of a vertebral artery.

That is about three times the number of deaths from trovafloxacin, an excellent antibiotic that we abandoned in the U.S. as too dangerous. Of course, we have safer alternatives with equal efficacy.

Also recently published was Acupuncture-related adverse events: a systematic review of the Chinese literature which found

that in total reported on 479 cases of adverse events after acupuncture. Fourteen patients died. Acupuncture-related adverse events were classified into three categories: traumatic, infectious and “other”. The most frequent adverse events were pneumothorax, fainting, subarachnoid haemorrhage and infection, while the most serious ones were cardiovascular injuries, subarachnoid haemorrhage, pneumothorax and recurrent cerebral haemorrhage.

Based on the reported complications of the two interventions, if they were a medical therapy regulated in a manner similar to medications and medical devices, they would certainly have, at a minimum, a black box warning and, in the case of chiropractic, no longer be used. Especially as there are no good indications for chiropractic or acupuncture.

What you do not see in the medical literature or the chiropractic blogs is any concern that harm may be done and investigations into changes in practice that could minimize the morbidity and mortality.

Instead you get The Self Importance of Being Ernst and Death by Chiropractic Another Misbegotten Review

Two essay that show zero interest in considering that chiropractic could potentially cause harm, the latter including the argument that it is real doctors that kill people and in comparison out ‘an order of magnitude greater than the side-effects attributed to spinal manipulation.’ See. If you kill small numbers of people, it is not important. Safety only matters when you kill people in large numbers. In the risk/benefit calculus of medicine, an intervention that has no benefit should cause no harm.

If there are concerns in the chiropractic community expressed about these complications, I can’t find them. If there is to improve chiropractic care, I can’t find it. If there is any quality/safety research being done, please rub my nose in it. I would love to know and those involved or aware of such research should trumpet the results for all to read. All the literature and letters to the editor I can find concerns denying there is a problem at all.

At least I could find concerns in the acupuncture literature : ‘A single injury – let alone a fatality – caused by acupuncture is one too many.” Exactly right. If you are practicing prescientific magic, it should have a mortality and morbidity of zero. Again if there is ongoing research into improving the safety of acupuncture, I cannot find it either.

Both seem far more interested in the messenger (Dr. Ernst) and his malevolent intent rather than the message.

It is, I think, a key difference between medicine and its ‘alternatives’. The former takes safety and quality seriously and strives constantly with research and its application to improve care. The alternatives? Nope. Not yet. And probably never.

Addendum. This may be the last post of 2010. I would like to say on behalf of myself and the other authors of SBM (who can disagree in the comments if they desire): Happy New Year. Enjoy 2011 since the world will end in 2012. With one exception, we have a wonderful group of readers and commenters and at times I learn more from the comments that I do preparing my posts. Stay healthy, my friends.

http://www.sciencebasedmedicine.org/?p=9448
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« Reply #287 on: April 13, 2011, 10:12:46 AM »

INteresting article.  The scrutiny of the pharmaceutical, mainstream medical "industry" if vast. 

Scrutiny of chiropractic, alternative, or natural "medicine" is nill.

We see all day long law firms advertising for anyone injured by any drug whatsover, even if rare, that went through a billion dollars of testing to get approved and get to market.  Yet not a peep about "homeopathic" substances being sold to us by mostly non medical doctors all day long on radio, cable, internet etc.

As for chiropracters once in awhile I have a patient who states they made their pain worse.  I have never heard or seen any serious injury and have read as alluded in this article that serious injuries are guite rare.  More often I do hear patients tell me they feel better after manipulation.  How much is placebo affect and real is often hard to sort out. 

One study years ago comparing treatment from a primary docotr, vs orthopedic doctor, vs a chiropractor doctor for low back pain should no differences in outcomes three months out suggesting that no matter what any of us do the outcomes are the same.  Most times the person simply just gets better.

Indeed, the chiropractic group even did a little better.  At three months out everyone felt about the same level of improvement though earlier on those with manipulation felt better sooner.
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« Reply #288 on: April 14, 2011, 08:20:02 AM »

What does a new drug cost?
from Science-Based Medicine by Scott Gavura

Despite the variety of health systems across hundreds of different countries, one feature is near-universal: We all depend on private industry to commercialize and market drug products. And because drugs are such an integral part of our health care system, that industry is generally heavily regulated. Yet despite this regulation, little is publicly known about drug development costs. But aggregate research and development (R&D) data are available, and the pharmaceutical industry spends billions per year.

A huge challenge facing consumers, insurers, and governments worldwide are the acquisition costs of drugs. On this point, the pharmaceutical industry makes a consistent argument: This is a risky business, and it costs a lot to bring a new drug to market. According to PhRMA, the U.S. pharmaceutical industry’s advocacy group, it cost $1.3 billion (in 2005 dollars) to bring a new drug to market. The industry argues that high acquisition costs are necessary to support the multi-year R&D investment, and considerable risks, in to meet the regulatory requirements demanded for new drugs.

But what goes into this $1.3 billion figure? To understand the cost of a new drug, we need to consider both the cost of drugs that were marketed, but also factor in the costs of the failures – those discontinued during development. While most pharmaceutical companies are publicly held, no company produces detailed breakdowns of “per marketed drug” R&D costs, or the specific amounts spent on drugs that were later abandoned. Yet there have been attempts to estimate these values. The most detailed and perhaps controversial paper is a 2003 paper from DiMasi et al, entitled, The Price of Innovation: New Estimates of Drug Development Costs.[PDF] DiMasi’s estimates has been subject to considerable criticism, most recently in a paper by Light and Warburton, entitled Demythologizing the high costs of pharmaceutical research. They claim the median R&D cost is a fraction of DiMasi’s estimate: Just $43.4 million. “Big Pharma lies about R&D to justify illicit profits” shouted Natural News. Who’s right?

Drug Development
Drugs can be developed in different ways, but the usual model used describes a series of phases. The pre-clinical development stage constitutes preliminary studies of chemicals that have been synthesized or isolated, and are then screened. This process can take years: Identifying promising leads, validating them, tweaking with their chemical structures, and conducting endless in vitro studies. Only a fraction of drugs that show promise in pre-clinical studies will every progress to clinical trials. Clinical trials are generally grouped into three stages, each one representing an important milestone in a drug’s development. Phase I studies are small studies in healthy volunteers designed to help understand the basic pharmacology and pharmacokinetics in humans: how a drug is absorbed, distributed, metabolized, and eliminated. It’s in Phase II that the drug is tested in groups with the condition of interest. These trials are larger, and may be randomized, with multiple arms, possibly evaluating different dosing regimens. Endpoints are usually related to basic efficacy and safety parameters. Phase III studies are the largest studies, that may be randomized and double-blind, in order to establish a drug’s efficacy against a given condition. Regulators like the FDA will usually require one or more Phase III trials to support an approval to market a drug. In cases where real outcomes need to be measured (like mortality or morbidity), phase III studies can be massive. (Like this one, with over 18,000 participants!).

While the trial pathway is usually illustrated as a straight-line path, that’s a post hoc view: A tree may be a more appropriate model. Clinical trials may be conducted in different doses, treating different patient groups, using different protocols, in order to understand a drug’s effectiveness.

At any one time, multiple drugs may be in development, so only the most promising products may move forward in the development pathway, as subsequent phases of development mean a significant increase in costs. A drug’s development can be discontinued at any point along the path. Developers may identify toxicity issues, or lack of effectiveness issues. Or clinical practice may change, and all of a sudden, the clinical trials are measuring the wrong endpoints in the wrong patients. Decisions are always made in the face of uncertain evidence about efficacy and toxicity, and for every drug that moves forward that is eventually found to fail, it could be that there is an effective drug that didn’t reveal itself as promising, and went back on the shelf.

The development process is laborious and typically takes several years from discovery to clinical trials. The pharmaceutical industry estimates that it takes 10,000 molecules developed to bring a single drug to market. Without validating that number (a whole other post), it’s fair to say that the number of drugs that make it to market is a tiny fraction of the number of products identified or synthesized that enter initial screening. So there will be a substantial investment into drugs that never make it to market. Without including the cost of abandoned drugs into the costs of drugs that are marketed, we’d be underestimating the investment incurred. So any analysis needs to consider this cost, too.

The DiMasi Paper

The DiMasi paper, from the Tufts Center for the Study of Drug Development is the most widely cited paper on drug development costs. While the methodology they use is described in detail, some  essential information is unfortunately (though perhaps understandably) opaque. The authors used a sample of drug costs drawn from ten companies that volunteered (out of 24 that were asked) that were willing to provide R&D data on a per-chemical basis. Data were collected, and stratified by development phase. Only the costs of self-originated drugs (i.e., they developed the drug themselves) were included. In total, data on 68 products were collected, and the sample consisted of mostly small-molecule drugs, but also included four recombinant proteins, two monoclonal antibodies, and one vaccine. No further information is provided, so there’s no way to know just how representative this sample is.

The methodology for the different calculations is fairly well detailed, but as I noted, the underlying data are not provided. Whether this basket of drugs studied represents a fair measure of the market is impossible to determine. The authors compiled actual costs wherever possible, broken down by development phase. A notable exception is the “preclinical” development period where it’s difficult to draw a direct link between expenditures and a specific drug that ends up being commercialized. For this segment, they inferred, using their own database, costs of $121 million per approved new drug.

To account for the costs of drugs that were abandoned (for any reason) during development, the authors used their own database of investigational drugs to estimate the odds any given new drug would reach a particular development milestone. Setting aside a detailed analysis of the methodology, let’s look at the two biggest cost drivers of the final that have been subject to repeated criticism: Tax issues, and the cost of capital.

Tax Issues
A major criticism of the DiMasi paper has been that the preferential taxation provisions for R&D expenses have not been factored into the analysis. Essentially, if R&D costs are given preferential tax treatment, this should reduce the net cost of R&D to the company. I have no particular insight into this issue other than to flag it as one that has caused controversy. Given preferential treatment of R&D expenses isn’t unique to the pharmaceutical sector, the extent to which this biases the validity of this particular analysis isn’t clear to me.  But I’m a pharmacist, not a tax expert.

The Cost of Capital
Probably the biggest criticism of the DiMasi paper is that the authors factor in what’s called the cost of capital into the development cost. Looking at the calculations, DiMasi estimated the out-of-pocket costs per new drug at $403 million (2000 dollars). But this is then capitalized, based on the opportunity cost of that investment – at 11%, bringing the “total” cost up to $802 million. Adjusting this cost to 2005 dollars, and we’re at the $1.3 billion that PhRMA is calling “the average cost to develop one new drug.”

The cost of capital can be a bit baffling to understand. If I’m going to invest my money in something now, with a possible payoff down the road, I need to factor in the opportunity cost of something else I could have invested in – but decided not to. It is a true cost, because by choosing to invest in one thing, you’re forgoing the investment in another.

DiMasi uses a cost of capital of 11% – that is, they assumed that the drug developers, by moving forward with the development of a drug, where forgoing investments which would be expected to yield 11%. Is 11% valid? From a personal investment perspective, 11% seems rich. But the cost of capital that companies use is dependent on the risk involved. Different industries have different business risks.  The DiMasi paper bases the 11% estimate based (in part) on historic returns in the industry. Given that half of the reported “cost” of a new drug is based on the cost of capital, the value we use use has a massive influence on what the final “cost” of a new drug will be.  But is 11% appropriate? Many argue no – that current returns don’t match past returns, and therefore the CoC should be lower. I took a look at a cost of capital table created by Aswath Damodaran, a Professor of Finance at the Stern School of Business at New York University. He calculates that pharma’s cost of capital is 8.59%. But there is no single “right” answer here. It’s an assumption that goes into our calculation.

 

Other Reviews
Other authors have made their own attempt at estimating the cost of a new drug. Paul Adams of the Federal Trade Commission, writing in Health Economics estimates that the DiMasi estimate is low, and the 2003 cost is closer to $1 billion per new drug, but noted there is significant variation between products. A 2006 Congressional Budget Office report on drug development [PDF] largely supports the DiMasi estimates. Most recently, Light and Warburton argued that, “based on independent sources and reasonable arguments, R&D costs companies a median of $43.4 million per new drug, just as company supported analysts can conclude they are over 18 times larger, or $802 million.” This figure seems implausibly small, given a single clinical trial can involve hundreds to thousands of patients. (For a more detailed critique of the Light and Warburton paper, I’ll refer the interested reader to Derek Lowe’s excellent In the Pipeline blog (and its comments) where it was dissected in detail here and here.) One of the best ways to contemplate the costs and calculations is to manipulate the numbers yourself: There’s a model developed by venture capitalist Bruce Booth, where you can enter your own estimates and see what cost it spits out. I tried working with the model for a while, and I couldn’t get it anywhere near $43 million – it was always in the hundreds of millions.

Other considerations
One important factor that isn’t considered in any of these analyses (from what I can see) are the costs of new indications for existing chemical entities. Consider the case of cancer drugs, where drugs are often approved for the treatment of metastatic disease, and only after efficacy is demonstrated, is it studied as a potential “adjuvant” treatment for early stages of disease. Additionally, the DiMasi analysis only looked at drugs developed solely in-house. Given the growing role of smaller biotech companies that develop, and then sell, promising drugs to pharmaceutical companies, the impact on costs isn’t clear. In contrast, the cost of the “me-too” drugs that seem to fill the pharmaceutical marketplace aren’t discussed explicitly, either. When your new drug is a variation on a competitor’s (or your own) product, how does this influence overall R&D expense? Again, it’s not clear.

Conclusion
Is the $1.3 billion new drug a myth? New drugs could be hitting, or even exceeding this mark – it depends on what your assumptions are. When we try to summarize all the variables of drug development into a single number, accounting for the hits and the misses, we can end up with a number that sounds impressive. But is it meaningful? Without transparency, only the manufacturer will know what it cost for their own drugs. It’s probably more important to understand the key drivers of R&D costs, noting that there are a huge number of variables that may influence the final cost of bringing a new drug to market.

http://www.sciencebasedmedicine.org/?p=11948
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ccp
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« Reply #289 on: April 14, 2011, 07:19:55 PM »

Interesting article BBG.  Perhaps it IS an industry generated myth that drugs are 1 billion dollars to get to market.

I agree most "new" drugs are not much more than variations of existing ones and probably do not cost nearly that much to bring to market.

As for truly new advances in drug I guess we really have no clue what it costs:

https://s3.amazonaws.com/s3.documentcloud.org/documents/81465/col-drugcosts-new-study.pdf

It would certainly not be far fetched to hear the drug industry publically inflating the costs.  Not unlike our politicians playing fast and loose with the financial numbers being flung around over trillions of dollars.  Sums so vast no one can really have any idea what is really going on.
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« Reply #290 on: May 25, 2011, 01:29:55 PM »

 DIANE COLE
This is the story of how my husband's circumcision saved my life.

It's a personal story, but let it also serve as a public health rebuttal to the proposed ban on male circumcision that will be on the San Francisco ballot this November.

San Francisco's ballot initiative would prohibit circumcision on all males under the age of 18. It would allow no religious exemptions, and it apparently gives no regard to the numerous studies demonstrating that male circumcision can substantially reduce—by more than 50%—the transmission of the HIV virus during sex.

"Communities, and especially women, may benefit much more from circumcision interventions than had previously been predicted, and these results provide an even greater imperative to increase scale-up of safe male circumcision services," concludes a study published this year in the peer-reviewed journal Sexually Transmitted Infections.

Peter, my husband, was born with hemophilia, best known as the disease of Victorian royals (and for good reason, since the guilty gene passed through the brood of Queen Victoria right down to the doomed young son of Russia's last czar). Those who suffer from hemophilia lack the crucial factor in the blood that makes it clot.

When we are cut, we all bleed—usually, we need only a Band-Aid and some pressure to stem the flow. Except for the most minor injuries, hemophiliacs almost always need more. Specifically, they need a transfusion of the blood factor of which their DNA made them bankrupt.

As a result of one such clotting factor transfusion prior to 1985, Peter became HIV-positive.

 
A baby rests on a pillow sounded by family members, immediately following his Bris, a Jewish circumcision ceremony in San Francisco. San Francisco voters in November will be asked to weigh in on what was until now a private family matter: male circumcision.
.Today, the U.S. blood supply has been cleaned up significantly, reducing the chance of such transmission to almost nil. But before the risk was known and blood screening had been introduced, the risk to hemophiliacs was enormous.

Peter and I had met and fallen in love at college. We married in 1977, and by the 1980s we were getting ready to have children. I had already suffered two lost pregnancies and we were eager to try again.

I remember reading the earliest news stories about AIDS, a mysterious new blood-borne disease, and freezing with the intuitive knowledge that whatever was borne through the blood could be borne into Peter's blood—and, by accident, perhaps mine, too. Since we were trying to get me pregnant, we had stopped using any birth control. How innocent it seems in retrospect that even when I suffered our second lost pregnancy in 1984, Peter had gamely whispered in my ear, "Don't worry. I'll knock you up again."

But we had no chance. Soon thereafter, it was confirmed that the very blood products that had helped save and heal and improve the lives of so many hemophiliacs also had the power to infect them with AIDS. As for sex—as they say in Brooklyn, fuggedaboutit. In politer terms, Peter's hematologists advised us to cease and desist getting pregnant again. Our mutual, sad assumption in the months that ensued: Not only had our love not produced a baby, but it may well have doomed me, too.

And then our very own HIV test results—his and hers—arrived. Peter was positive. I was negative. How had it happened that I never became HIV-positive myself?

It wasn't until recently that we knew: He was circumcised. Actually, I should say, now I know. Peter died in 1999.

But here is the reason I am alive today: In the same way that circumcision vastly diminishes the chance of infecting women with the human papillomavirus that causes cervical cancer, studies suggest that circumcision also helps guard against the transmission of the HIV virus. In both cases, cells on the inside of the male foreskin are implicated in spreading the virus. But if the foreskin is removed, a source of infection is also removed.

So there you have it: My husband's circumcision saved my life.

That reprieve allowed us to make the decision to adopt a child (our son, now 22, who will soon graduate from college). And it impressed on me the importance of public health decisions that unwittingly can save a life—which in this case happened to be mine. If the San Francisco initiative passes, and encourages other communities to do the same, who knows whose lives won't be saved.

Ms. Cole is the author of the memoir "After Great Pain: A New Life Emerges" (Simon & Schuster, 1992) and the book columnist for the Psychotherapy Networker.

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sting
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« Reply #291 on: May 25, 2011, 05:40:31 PM »

The article about circumcision saving a woman's life is the most unsubstantiated piece I've ever read on the topic.
"So there you have it: My husband's circumcision saved my life.  The wife was spared HIV infection because she had a healthy vagina that kills the HIV virus, not circumcision. "  The wife was spared HIV infection because she had a healthy vagina that kills the HIV virus in the semen.  Likewise, her husband may elect to have a circumcision as an adult.    

Also from the article " apparently gives no regard to the numerous studies demonstrating that male circumcision can substantially reduce—by more than 50%—the transmission of the HIV virus during sex"

The African studies are about circumcision reducing HIV transmission from HIV-infected *women* to *men* in sex.  

The two primary HIV transmission paths in the US are 1) anal reception of hiv-infected semen and 2) intravenous reception of HIV-infected blood.  A third, but less common, is vaginal reception of HIV-infected sperm. Largely circumcised US has a higher rate of HIV infection than uncircumcised developed countries such as any European Union nation or Japan/Taiwan, so one may be inclined to conclude the opposite, perhaps that circumcised men shun condoms and engage in riskier sexual activity.

There is always an off laundry list of "health benefits" used to justify circumcision on men, but never on women.  Rarely are the complications of circumcision, which include one US death and a dozen penises rendered useless per year, listed.  Wouldn't female genitalia be cleaner and less prone to disease transmission, general infection or clitoral cancer if, say, the smegma-producing clitoral hood and labia minora were trimmed or amputated?  If mom is circumcised, isn't it important for daughter to look just like mom?   If men learned to prefer the appearance of surgically-altered female genitalia (i.e a hood-free clitoris or shortened/shaped labia minora) isn't that enough of a reason to order the procedure on infant girls ?  I'm not a proponent of circumcision of any kind, but I interchange male and female in the description of circumcision for the sake of argument.

1996 : US federal law bans infant/minor circumcision of any degree on females but not males
201? : US federal law bans infant/minor circumcision of any degree on females and  males

2% of the circumcisions may have a religious justification.  However, the San Francisco circumcision ban proposal will be an interesting bout between freedom of religious expression (on males but not females) and equal protection.
« Last Edit: May 25, 2011, 07:34:55 PM by sting » Logged

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« Reply #292 on: May 25, 2011, 06:24:43 PM »

a) Well, as a first person layman's story, of course it is not sicentific.  smiley

b)  "2) intravenous reception of HIV-infected semen".  Ummm , , , I am almost too afraid to ask, but when I read "intravenous" I think of a needle connected to a tube connected to a bag of some fluid inserted into the forearm of a patient in a hospita.  I hope we are not talking about this with bags of semen?  shocked 

c) "The African studies are about circumcision reducing HIV transmission from HIV-infected *women* to *men* in sex."    I could be wrong, but this is not my understanding.  Do you have a citation? 

d) "The wife was spared HIV infection because she had a healthy vagina that kills the HIV virus in the semen."   I am well aware of the power of the vagina over my mind and body, but did not know that its powers extended to killing HIV.  Any citations?

e) " Likewise, her husband may elect to have a circumcision as an adult." A lot more problematic in adulthood!

f) All procedures have their risks, and accepting your data for this conversation the risks are rather small in contrast to the benefits.

Anyway, sounds like you are against circumcission and that is fine.  The problem is when personal matters are subjected to mob rule.   As for female circumcission, can you really not tell the difference?


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sting
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« Reply #293 on: May 25, 2011, 07:34:27 PM »

I should have written " intravenous reception of HIV-infected blood" as in recreational drug use.  Sorry about my error, and I've corrected it with an edit.  Whew.
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« Reply #294 on: May 25, 2011, 07:49:24 PM »

"intravenous reception of HIV-infected semen". 

Just wait, it'll be in Chuck Palahniuk's next novel
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sting
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« Reply #295 on: May 25, 2011, 08:10:54 PM »

I'll deal with a few points quickly.

"As for female circumcission, can you really not tell the difference?"

There are various types of female circumcision just as there have been various types of male circumcision, according to my research.  Nonetheless, all types of female circumcision, including a ceremonial pin-prick for the purposes of a Covenant with God with a religious or cultural justification, are illegal in the US.  

A "US version" could keep the entire clitoris intact and remove the clitoral hood - the analog of the modern male circumcision.  No parent would accept such a procedure on their daughter.  So why is that procedure accepted on a son?

"a) Well, as a first person layman's story, of course it is not sicentific. "

It was published in the Wall Street Journal, on-line with the title "Circumcision Saved My Life" in the case of a woman married to a hemophiliac.  Well, in the case of women married to hemophiliacs ...

"c) "The African studies are about circumcision reducing HIV transmission from HIV-infected *women* to *men* in sex."    I could be wrong, but this is not my understanding.  Do you have a citation?  "

From the CDC.  Since the study participants were (obviously) men, the reduction rates are comparing uncircumcised to circumcised men for HIV transmission.  In the US, female to male HIV transmission is a minority of the roughly
http://www.cdc.gov/hiv/resources/factsheets/circumcision.htm

Here is a good one on transmission routes.  I need an update.  Current data shows heterosexual sex overtaking drug injection.
http://www.avert.org/usa-transmission-gender.htm

A report from Johns Hopkins University on HIV spread factors:
http://www.measuredhs.com/pubs/pdf/CR22/CR22.pdf
p.109 states that in 18 African countries and India, 10 showed more and 8 showed less HIV infection among circumcised men.

"e) " Likewise, her husband may elect to have a circumcision as an adult." A lot more problematic in adulthood!"

While problematic, why is this more problematic in adulthood?  Days of recovery?  Memory of pain? The infant procedure entails separating skin from flesh as the foreskin is fused to the penis for the first few years of a male's life.  The pain is similar to pulling fingernails or separating less sensitive skin from flesh despite the topical anesthetic that lasts at most an hour or two.  The procedure on an adult is cutting loose but nerve-laden skin.  Infant circumcision takes advantage of an infant's inability to articulate pain.

"f) All procedures have their risks, and accepting your data for this conversation the risks are rather small in contrast to the benefits."

Not a single major US medical association makes this conclusion.  The American Academy of Pediatrics (AAP) has repeatedly issued statements that it can not recommend circumcision even after careful review of the potential medical benefits.  In any case, all Western nations are moving away from the trend of circumcision and their circumcision rate has fallen to the low single digits. The benefits are not obvious to the medical professionals of these countries, either.

http://www.cdc.gov/hiv/resources/factsheets/circumcision.htm

« Last Edit: May 25, 2011, 09:55:42 PM by sting » Logged

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« Reply #296 on: May 26, 2011, 08:18:28 AM »

"There is something I like about the clitoris, but I can't quite put my finger on it". -George Carlin
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« Reply #297 on: June 03, 2011, 10:26:37 AM »

Even though this is a POTH editorial, I concur.  I would add to this editorial that the anti-biotics in the animals are not destroyed by cooking and diminish our own good flora which has negative health consequences.
======================


The High Cost of Cheap MeatPublished: June 2, 2011

The point of factory farming is cheap meat, made possible by confining large numbers of animals in small spaces. Perhaps the greatest hidden cost is its potential effect on human health.

Small doses of antibiotics — too small to kill bacteria — are fed to factory farm animals as part of their regular diet to promote growth and offset the risks of overcrowding. What factory farms are really raising is antibiotic-resistant bacteria, which means that several classes of antibiotics no longer work the way they should in humans. We pay for cheap meat by sacrificing some of the most important drugs ever developed.

Last week, the Natural Resources Defense Council, joined by other advocacy groups, sued the Food and Drug Administration to compel it to end the nontherapeutic use of penicillin and tetracycline in farm animals. Veterinarians would still be able to treat sick animals with these drugs but could not routinely add the drugs to their diets.

For years, the F.D.A. has had the scientific studies and the authority to ban these drugs. But it has always bowed to pressure from the pharmaceutical and farm lobbies, despite the well-founded objections of groups like the American Medical Association and the World Health Organization, which support an antibiotic ban.

It is time for the F.D.A. to stop corporate factory farms from squandering valuable drugs just to promote growth among animals confined in conditions that inherently create the risk of disease. According to recent estimates, 70 percent of the antibiotics sold in this country end up in farm animals. The F.D.A. can change that by honoring its own scientific conclusions and its statutory obligation to end its approval of unsafe drug uses.

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bigdog
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« Reply #298 on: June 03, 2011, 08:06:21 PM »

http://recipe.cicadayear.com/
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« Reply #299 on: June 05, 2011, 10:43:37 AM »



SANTA MONICA, Calif. — When a group of activists proposed banning circumcision in San Francisco last fall, many people simply brushed them aside. Even in that liberal seaside city, it seemed implausible that thousands of people would support an effort to outlaw an ancient ritual that Jews and Muslims believe fulfills a commandment issued by God.

But last month, the group collected the more than 7,100 signatures needed to get a measure on the fall ballot that would make it illegal to snip the foreskin of a minor within city limits. Now a similar effort is under way in Santa Monica to get such a measure on the ballot for November 2012.

If the anticircumcision activists (they prefer the term “intactivists”) have their way, cities across the country may be voting on whether to criminalize a practice that is common in many American hospitals. Activists say the measures would protect children from an unnecessary medical procedure, calling it “male genital mutilation.”

“This is the furthest we’ve gotten, and it is a huge step for us,” said Matthew Hess, an activist based in San Diego who wrote both bills.

Mr. Hess has created similar legislation for states across the country, but those measures never had much traction. Now he is fielding calls from people who want to organize similar movements in their cities.

“This is a conversation we are long overdue to have in this country,” he said. “The end goal for us is making cutting boys’ foreskin a federal crime.”

Jewish groups see the ballot measures as a very real threat, likening them to bans on circumcision that existed in Soviet-era Russia and Eastern Europe and in ancient Roman and Greek times. The circumcision of males is an inviolable requirement of Jewish law that dates back to Abraham’s circumcision of himself in the Book of Genesis.

They say the proposed ban is an assault on religious freedom that could have a widespread impact all over the country. Beyond the biblical, there are emotional connections: checking for circumcision was one of the ways Jewish children could be culled from their peers by Nazis and the czar’s armies.

“People are shocked that it has reached this level because there has never been this kind of a direct assault on a Jewish practice here,” said Marc Stern, associate general counsel for the American Jewish Committee, an advocacy group. “This is something that American Jews have always taken for granted — that something that was so contested elsewhere but here, we’re safe and we’re secure.”

Mr. Hess also writes an online comic book, “Foreskin Man,” with villains like “Monster Mohel.” On Friday, the Anti-Defamation League issued a statement saying the comic employed “grotesque anti-Semitic imagery.”

Jena Troutman, the mother of two young boys who is promoting the ballot measure in Santa Monica, said she did not think of herself as a crusader against religion. Instead, she views her work as a chance to educate would-be parents against a procedure that “can really do serious damage to the child.”

“I am just a mom trying to save the little babies,” Ms. Troutman said. “I’d rather be on the beach, but nobody is talking about this, so I have to.”

Ms. Troutman has run the Web site wholebabyrevolution.com for two years, and she is fond of rattling off sayings like “Your baby is perfect, no snipping required.” Well versed in the stories of circumcisions gone awry, she said the recent death of a New York City toddler who was circumcised at a hospital convinced her that she should push for the ballot measure.

Ms. Troutman, who has worked as a lactation educator and a doula, said she often approached women on the beach to warn them about the dangers of circumcising, but she has declined to answer questions about her own children.

Although precise numbers are not known, several studies have indicated that circumcision rates have been declining in the United States for the past several years and now range from 30 percent to 50 percent of all male infants.

Many medical groups take a neutral approach, saying that the practice is not harmful and that there is not enough scientific evidence to conclude that it is necessary, and leave the decision to parents and their doctor. Several studies have linked circumcision with a reduction in the spread of H.I.V. Roughly half of the 694 baby boys born in the Santa Monica-U.C.L.A. Medical Center and Orthopaedic Hospital in 2010 were circumcised before they left the hospital, officials there said.

Dr. David Baron, a family physician, certified mohel — someone who performs ritual circumcision — and former chief of staff at Santa Monica-U.C.L.A., said that he would not press any parent to circumcise a son but that he viewed the effort to ban the procedure as “ridiculous and dishonest.”

“To say it is mutilation is wrong from the get-go,” Dr. Baron said. “It is a perfectly valid decision to say that it is not what you want for your child. Any doctor who says it is needed is not being honest, but to say that it needs to be banned is shocking.”

If the ballot measure passed, it would certainly face legal challenges. But several legal experts said it was far from certain that it would be struck down in a court. Ms. Troutman said she considered putting religious exemptions in the measure, but then decided, “Why should only some babies be protected?”

Rabbi Yehuda Lebovics, an Orthodox mohel based in Los Angeles who says he has performed some 20,000 circumcisions over several decades, said he often had to soothe nervous mothers.

“I am now doing the sons of the boys I did 30 years ago,” Rabbi Lebovics said. “So I turn to the new mother and ask, ‘Do you have any complaints in the way it turned out?’ ”

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