November 14, 2013

Study: Lower Your Cholesterol and Raise Your Risk of Death Following Mainstream Diet Advice

You've been hearing for decades about how a healthy diet is one that lowers your intake of saturated fats and replaces them with "healthy" unsaturated oils. This, you have been told, will lower your cholesterol and your risk of having a heart attack.

What you probably didn't hear is that a study published in the British Medical Journal (BMJ) February of this past year found that though the first claim is true--swapping out saturated fats for vegetable oils will lower your cholesterol--if the oil you use instead of saturated fat is full of omega-6 fatty acid, like safflower oil or corn oil, the second claim is completely false.

The study found that when men who had already had a heart attack replaced saturated fats with safflower oil and ate margarine made with safflower oil they significantly raised the risk that they would die of a heart attack, stroke or, in fact, any cause of death, over the next five years.

How significantly was that risk raised? The study states: "Among the control and intervention groups combined, an increase of 5% of food energy from unspecified PUFA [polyunsaturated fatty acids] predicted about 30% higher risk of cardiovascular death and all cause mortality.

A reduction in SFA [saturated fat] and increase in the PUFA:SFA ratio were also associated with increased risks of all cause and cardiovascular mortality." In short, the more they replaced saturated fat with "healthy" polyunsaturated oil the more likely they were to die.

I was only made aware of this study last week, when the Canadian Medical Association Journal (CMAJ) published an opinion piece questioning whether the government should be putting "heart healthy" labels on corn oil and other polyunsaturated fats. (Details HERE.) They cited the February BMJ study in their write-up.

What doesn't come across in the small amount of press the CMAJ article got is something that makes the BMJ study even more significant:  The data that this finding was based on was 40 years old. It was collected during the Sydney Diet Heart Study, a  randomized controlled trial conducted in 1966-73.

This was one of the many landmark interventional studies whose result was used to convince doctors that replacing saturated fats with polyunsaturated fats would lower cholesterol and, by implication, prevent heart disease.

But while the authors of the original study published the finding that the polyunsaturated fats would lower both cholesterol and triglycerides, they did not look to see whether lowering cholesterol with this intervention actually helped prevent heart-related deaths.

They eventually admitted in a study published in 1978--a full 5 years after they began to publish their results--that there was a higher "all cause mortality" in the group eating the safflower oil, but they did not look at whether these deaths were from cardiovascular-related causes. This was a surprising omission, given the point of the dietary intervention--to lower cholesterol in order to prevent heart attacks.

So it was only in the last few years that a new group of researchers were able to go back to the original study's raw data and take another look at it. When they did so, they discovered what they term "previously missing data."  This "missing data" was the data that led to the conclusion that there was a 30% greater risk of cardiovascular death among the people in the study who ate the cholesterol-lowering oil.

Getting at this missing  data was not a trivial process. The original study data had been stored on 9-track tape--the kind you can see at left--which used to be used by IBM 360 series mainframe computers. There are only a very few data recovery specialists around who can still read these kinds of tapes.

Once they recovered the data, the researchers did a very careful analysis, teasing out other factors that might have affected the death rate and, most significantly, analyzing whether the transfat associated with the margarine the test subjects ate might have explained the higher death rate. They conclude it did not.

They also point out that this re-analysis of the data echoes what was found in two other re-analyses of 1960-70s era cholesterol/heart diet trials: Linoleic acid, with its high proportion of Omega-6 fatty acid and complete lack of Omega-3 fatty acid is really toxic stuff.

You can read the whole BMJ study here:

Use of dietary linoleic acid for secondary prevention of coronary heart disease and death: evaluation of recovered data from the Sydney Diet Heart Study and updated meta-analysis.

Omega-6 Fatty Acids Promote Inflammation

The researchers believe that the reason that the polyunsaturated oils used in these cholesterol-lowering diets were so toxic was because the vegetable oils used were very high in Linoleic Acid, an Omega-6 fatty acid, and devoid of the  countervailing Omega-3 fatty acids you need to consume to keep Omega-6 fatty acids from promoting inflammation.

So, okay. Safflower oil is now out of your diet. But it turns out that safflower oil is not the only common vegetable oil that is rich in linoleic oil.  Corn oil  is very high in it, too. You can see a complete list of oils sorted by their percentage of Linoleic acid HERE.

Finally, though health nuts who still fear that eating saturated fat will kill them will tell you that canola oil and flaxseed oil are healthier alternatives, neither of these oils has been a part of the human diet for any significant period of time the way animal and dairy fats have been.

Canola oil does contain Omega-3 fatty acids, but the process used to take away its rank smell and keep it from going rancid is likely to damage them. Damaged Omega-3 oils is not healthy. Flaxseed oil is the recently renamed stuff we used to call linseed oil and use for mixing up oil based paint--which it often tastes like.  It's safe to eat if you keep it refrigerated and don't let it go rancid, but since it is not a traditional food, I would suggest eating it in small quantities.

Palm oil is another fat that has recently made its way into our food system, as manufacturers are using it as a replacement for the hydrogenated oils full of transfat. But while there may be health benefits from consuming the palm oil eaten in traditional societies, the industrially processed palm oil that is appearing on supermarket shelves is very different stuff and may very well be harboring transfat-like molecules that escape the FDA labeling requirements. And besides that, it often tastes--and refuses to melt--suspiciously like lipgloss. Treat it with caution.

Stick to the traditional healthy vegetable oils and fats like olive, coconut , and melted butter, and you are more likely to actually improve your health.





October 1, 2013

Study Quantifies Whether Weight Loss Surgery Cures Diabetes

A study recently published in the Annals of Surgery gives much more insight into oft-repeated claims that weight loss surgery cures diabetes.

The study can be found here:

Can Diabetes Be Surgically Cured? Long-Term Metabolic Effects of Bariatric Surgery in Obese Patients with Type 2 Diabetes Mellitus.   Brethauer, Stacy A. et al. Annals of Sugery, 10/13/2013. doi: 10.1097/SLA.0b013e3182a5034b

The study followed  217 people with Type 2 Diabetes who had had weight loss surgery for a period lasting between 5 and 9 years. One hundred and sixty-two had the radical Roux-en-Y gastric bypass operation, which irreversibly reroutes the path of food through the stomach and small intestine. Thirty-two had the potentially reversible gastric banding procedure where a band limits the site of the stomach, and 23 had the irreversible amputation of part of the stomach sleeve known as sleeve gastrectomy.

Complete remission--i.e. a cure--was defined as the patient having an A1C less than 6% and a fasting blood glucose less than 100 mg/dL while taking no diabetic medications.

It is worth noting that many people with Type 2 are able to achieve these same numbers by cutting down their carbohydrate intake, without exposing themselves to any of the significant long-term risks that come with these major surgical interventions.

The Long Term Results

Only 24% of those who had these surgeries met the definition of "complete remission." This, of course, means that 76% still had abnormal blood sugars.

Thirty-four percent were described as having "improved." The study defined "improvemetn" as meaning that the subjects experienced a drop in A1c greater than 1%. Since the starting A1cs of the subjects in this study ranged up to 8.5%, a person could be considered "improved" if their A1c six years after surgery was still 7.25%--a level corresponding to an average blood sugar of 162 mg/dl (9 mmol/L). That is a level high enough to cause all the classic diabetic complications and it correlates with a greatly increased risk of heart attack.

But it gets worse. A full 16% of those who had these major surgeries--one out of 6--saw no improvement at all in their blood sugars.

And even more depressing for people who had these expensive, dangerous surgeries, of those whose blood sugars normalized right after surgery, 19% saw their blood sugars go back up into the diabetic range.

The authors of the study describe these results as being wonderful news showing that "Bariatric surgery can induce a significant and sustainable remission" in people with Type 2 Diabetes.

The statistics above suggest that the improvements caused by these surgeries are almost entirely due to the fact that they make it impossible--at least for a short time after surgery--for people who have rearranged their stomaches to eat any significant amount of the carbohydrate-rich foods that raise the blood sugar of people with diabetes.

As time goes by people who have had some of these procedures will have their stomachs stretch out again and will once again be able to eat the high carbohydrate foods that raise blood sugars, explaining the failure that often occurs in people who at first appeared succesesful.

This is because most people with Type 2, even those with very high A1cs will see dramatic drops in their blood sugars within a week or two if they cut back dramatically on their carbohydrate intake--whether they do this by limiting their stomach size or changing what they keep in the refrigerator.

Those who don't see a drop in their blood sugars after restricting carbohydrates usually turn out to have a problem secreting insulin. If they have this kind of surgery they are likely to end up in that unfortunate 16% who get no benefit from it at all. In fact, what they need is not surgery, it's often an appropriately prescribed insulin regimen.

But sadly, rarely do surgeons or the doctors who refer people for this surgery do the tests that could determine if people are insulin deficient and hence unlikely to benefit from this kind of surgery.

Finally, it is interesting that there is no hint here to confirm the latest, most fashionable explanation for why weight loss surgery works--that rearranging the gut boosts incretin hormones and lowers blood sugar independent of carbohydrate intake.

Why No Mention of the Complication Rate? 

A far worse omission, however, is that this study omits any mention of the surgical complications these people could have suffered as a result of undergoing these major invasive surgeries. Quite a few studies have found that the rate of post-operative complications associated with these surgeries is between 7 and 9%--almost one in ten.

Serious complications--such as incisions opening-occur in roughly 3.5%--one in 29--and one in a hundred patients require additional surgeries.  (Details HERE and HERE) Even more tragic, large epidemiological studies find that something like .18% of patients who have these surgeries die. That is almost two per thousand. Given that it is estimated that 205,000 people a year have weight loss surgery, this works out to about 400 deaths each year due entirly to elective bariatric surgery.

And these complication statistics include only the deaths and complications that occur shortly after surgery. They ignore the ongoing health problems that many people suffer after having supposedly "successful" surgeries.

These problems include permanent malnutrition due to the loss of the gut's ability to absorb vital minerals and mental changes which can lead to fatal anorexia or an increased incidence of suicide. I have heard from several people whose relatives died from the anorexia and malnutrition caused by having had this kind of surgery. It is a real problem which probably has something to do with changes the surgery makes in the gut hormones that regulate appetite and feeding behavior in the brain.

Consider the Alternatives

So before you sign up for this questionable diabetes cure, it's worth checking out the alternatives. Because the surgeons selling these expensive surgeries don't tell you that the majority of people with Type 2 diabetes can achieve the exact same kind long term results as are depicted in this study--or better--without resorting to surgery. They can do it simply by following the technique described here:


How to Lower Your Blood Sugar


It is carbohydrates that raise blood sugar, and cutting back on them will lower the blood sugar of most people with Type 2 Diabetes.

But despite this being true, many people who are told that they can lower their blood sugar permanently by cutting down on their carbohydrate intake dismiss this idea saying, "I could never stop eating the high carb foods I love."

If you fall into that category and would prefer a surgical approach, it's worth considering that any weight loss surgery that lowers your blood sugar will force you to give up those high carb foods forever.  When your stomach is shrunken to where you can only eat 1000 or so calories a day, it is physically impossible to eat a lot of carbohydrates .And in many cases--often those who are most "successful" with both weight loss and blood sugar control, the changes the surgery makes in your digestive tract ensure that high carbohydrate foods will cause projectile vomiting--an experience that will quickly train you to avoid the foods that could raise your blood sugar no matter how you used to feel about them.

Personally, I'd prefer to lower my blood sugar using a technique that doesn't expose me to the risk of death or permanent malnutrition and that allows me an occasional indulgence in ordinary foods. I also prefer an approach that doesn't permanently rearrange my organs and which leaves open the possibility that I might be able to benefit from some less radical future advance in the control of Type 2 diabetes.

There is a lot of money in selling these surgeries. And as everyone with diabetes knows, it is the money to be made that drives what treatments we are directed to. Surgeons market their surgeries to your family doctors just as much as the drug companies market their latest, most expensive, and most dangerous drugs.  I hear from quite a few people whose family doctors have told them to have these surgeries--without ever suggesting carb restricted diets or doing the tests needed to determine if the person needs insulin.

But armed with the facts like those that came out of this study, you will be better prepared to defend yourself against inappropriate and potentially harmful treatments.

One last note: It continues to amaze me that the same physicians who continue to issue dire warnings about how dangerous low carb diets are to your health are the same people who recommend these far more dangerous surgeries.

When researching my book Diet 101: The Truth about Low Carb Diets I was able to find a grand total of 2 verified reports of deaths that could be linked in any way with low carb dieting--and they were linked with starvation diets that were dangerous not because of their low carbohydrate intake but because of their lack of calories and electrolytes. Compare this with those 400 deaths a year attributable to these surgeries!

September 18, 2013

Generic test strips that work in Ultra meters. Get them before their maker is forced out of business!

UPDATE: May 12, 2014

The FDA issued a warning about Genstrips, telling people not to use them as they are not accurate and the company making them failed quality inspections.  Reviewers on Amazon also report that while the strips they purchased earlier worked well, as did mine, the newer ones did not.


http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm395180.htm 


ORIGINAL POST

I learned about the generic One Touch Ultra strips sold as Genstrips in a tweet from diabetes business analyst Scott Strumello  (@sstrumello).  It turns out that the company that sells them came up with their own strip engineering design that works with the One Touch Ultra meters without violating Johnson & Johnson's patents.

The FDA required rigorous testing before allowing them to be sold, and they passed.

The company then made a deal with Walmart, which would have sold these cheap but effective strips to people all over the world who can't afford the obscene prices Johnson & Johnson charges for them. But Johnson & Johnson hit the company with expensive lawsuits intended to drive them out of business, even though the Patent Bureau has opined that these strips do not violate Johnson & Johnson's patents.

In the face of this legal pressure, Walmart bowed out, so for now the only place you can get them is on Amazon.

You can find the link to buy them here:

Genstrip Test Strips 50ct for Use with Onetouch® Ultra® Meters

Since Johnson & Johnson has vast financial resources they can continue to harass the company that makes Genstrips with lawsuits. The company is financially strapped without significant sales of its strips, and is likely to give up when the money runs out, even if it is in the right, legally. So it may be only a matter of time until the maker of Genstrips goes belly up and Johnson & Johnson is left to enjoy its monopoly.  Stockholders will applaud, and the only people who suffer are the 99% who can't afford to shell out hundreds every month to test their blood sugar, even when they need to.

For Use with Old Minis Only? 

The documentation with these strips says they should only be used with meters sold before 2010.  However, there is a comment on the Amazon page from someone who says this is not true.  My testing suggests they are correct.

Apparently the issue is that your meter has to be able to be set to match the code that comes on the vial of strips. All the brand name Ultra strips sold now are coded 25, so you don't ever have to change the code with a newer One Touch Ultra meters, and it is possible that some of them might not allow you to do this.

My Genstrip strips were coded 13, but both an old  Ultra Mini meter that was sent to me as a freebie when the Ultra Minis first came out and a brand new Ultra Mini I just bought allowed me to change the meter's code to match that of the strips.

If you are using another brand of Ultra meter, before you buy these strips, make sure your meter lets you change the code. And if you have gotten out of the habit of checking the code on your strips, remember to do it with these. If you don't set the code on your meter, the strips will give an inaccurate reading. 


My Tests So Far 
I bought a pack and tested them with both my original Mini, which I was sent as a freebie when the Ultra Minis were first released and with a brand new Mini which I received recently from my insurer.

I was not able to test the two Ultra Mini meters simultaneously as I only had one working battery, so there was a time lapse of about ten minutes between the tests of the two meters as I swapped out the battery from the new one to the old one.

I did run a test using the same drop of blood to compare the Genstrip in my brand new Mini with my Freestyle Lite. The Genstrip read 93, the Freestyle 95, and the Mini using the brand name strips read 99.  When I got the old Mini working, ten minutes later, it read 99, too.

The Genstrip strip took a fraction of a second longer to fill with blood than the brand name Ultra strip but my meter didn't seem to notice any difference between the two strips.

Given the general unreliability of all meters and strips, I came away feeling confident that the Gentest strips are good enough. I would just as soon buy these strips priced at $18.50 per 50 instead of the obscenely expensive brand name strips.

While they last, these strips might be a better choice than ordering name brand strips from no-name vendors who may sell you heat damaged or out-of-date strips that still cost more than these do.

By the way, if you are wondering what the best way to use your limited supply of any blood sugar test strip might be, please read this page:

How to Lower Your Blood Sugar.

It will teach you how to use the readings you get after meals to tweak your diet until you find one that gives you normal or near normal blood sugars. This approach has worked for thousands of people and it can work for you, too.



September 2, 2013

Onlgyza Appears to Raise Risk of Heart Failure

A two year long study of two DPP-4 inhibitors (one not available in the U.S.) found that these drugs did not, as hoped, lower the risk of heart attack in people with diabetes who took them, and they found a surprising increase in cases of heart failure among people taking Onglyza.

UPDATE 2-Doctors get good and bad safety news on diabetes drugs
http://www.reuters.com/article/2013/09/02/heart-diabetes-idUSL6N0GY0S720130902

The study also claimed to find no sign of pancreatic disease with Onglyza, but there are several reasons to discount this finding:

1.  The study only lasted 2 years, which is far too short a time for the changes in pancreatic architecture discovered by Dr. Butler to result in pancreatitis. (Details HERE)

2. Cancers also take much longer than 2 years to cause symptoms. Pancreatic cancer, in particular, is almost always symptom free until it is too late for any treatment to keep the patient from dying within a few months. The patients in Dr. Butler's study who took Januvia and died with small precancerous tumors in their pancreases and abnormal cells throughout the pancreatic tissue had no symptoms suggesting anything was wrong with them.

The British Medical Journal looked into this issue and found disturbing signs of suppression of evidence suggesting this is a very real problem: Their findings are discussed here: Medcscape: BMJ Digs Deep Into Incretins and Pancreatic Cancer Debate.

The actual BMJ review article is found here:

Has pancreatic damage from glucagon suppressing diabetes drugs been underplayed?

The chances are very good that it will take 10 years or more for the pancreatic tumors these drugs are capable of growing to cause the epidemic of cancer deaths that I fear is coming. By the time the deaths appear, it will be too late to do anything.

Please do not take or let anyone you love take any of the incretin drugs. There is a lot of money going into studies like this that are supposed to reassure patients and keep the money machine cranking for the companies that sell these highly profitable drugs. But there is enough evidence, despite the white washes that these drugs are dangerous that there is no reason to take any of them.

No matter how bad your blood sugar might be, a combination of  lower carb diet and, if needed insulin, properly dosed (which, alas, it often isn't) will lower your blood sugar far more safely.


August 14, 2013

Berberine Works But May Very Well Be Harmful

I have been getting a lot of email of late about the supplement Berberine, which appears to be the latest miracle cure being sold to those people with diabetes who believe that completely unregulated herbs imported from countries with long histories of food and drug adulteration are somehow safer and "more natural" than the tightly regulated pharamceuticals.

Berberine does appear to work to lower blood sugar. The problem is that we really know very little about how it does it or what its long term effects are on the body.  I see many mentions on sites promoting berberine supplements of the fact that berberine has a long history of use in Chinese medicine. However, quite a few of the traditional Chinese herbs have turned out to be highly toxic, and it's worth noting that the incidence of kidney and other urinary tract cancer among Chinese herbalists is far greater than that of the population at large. (Details HERE)

You can lower blood sugar by damaging your liver as happens with severe alcoholism.  You can lower blood sugar with drugs that raise the likelihood of heart attack, as is the case with most sulfonylurea drugs. (Details HERE) You can lower blood sugar with drugs that over time damage the pancreas as is the case with the incretin drugs.(Details HERE)  And you can lower blood sugar by taking drugs that turn bone precursor cells into fat cell, as happens with Avandia and Actos, which, over a decade of use of these drugs can lead to your developing bones so brittle that they are prone to breaking. (Details HERE)

Many of these severe, life-ruining side effects did not show up until people had taken these drugs for five to ten years. So the fact that a drug lowers blood sugar for three months in a small population without major harm tells you nothing about its actual safety.

To get a feel for the quality of the research supporting the claims about berberine, scroll down to the Reference section of this page: http://examine.com/supplements/Berberine/ .

Ignore the enthusiastic editorializing by the editors of the site who don't know very much about diabetes or the drugs that berberine is being compared to and pay attention to the quality of the journals publishing these studies. Most are very obscure. Some sound like they are one of the many  "pay to play" journals beloved by supplement sellers--journals that will publish anything as long as they are paid a hefty fee.

Those studies on berberine published in respected endocrinology journals involve small groups of people taking the drug for very short periods. The only one I could find with a large number of subjects is a meta analysis where data from 14 different very small studies was pooled. Meta analyses are only as good as the quality of the underlying studies, which in this case is not very good.

Some studies published in quality journals suggest that berberine's positive effects may stem from the fact that it activates AMP-Kinase, which is what metformin does. If this is the case, you have to ask yourself, why not just take metformin, a safe, very well understood drug that has been in use since the 1950s and which must meet rigorous manufacturing standards before it is sold.

Several mainstream studies claims to have found that berberine inhibits DPP-4 and raises the concentration of the incretin hormone GLP-1 which is the mechanism used by the incretin drugs Januvia,  Onglyza, and Trajenta. As discussed elsewhere, inhibiting DPP-4 can turn off a mechanism the immune system uses to kill cells that have become cancerous, which may make these a poor choice of drug. In addition, accumulating evidence is pointing to the possibility that artificially raising GLP-1 levels over a long period of time leads to the growth of abnormal cells in the pancreas which may grow into the ducts and cause pancreatitis or turn into precancerous tumors.  (Details HERE)

Mainstream research also finds that berberine has a significant impact on your liver. Repeated use downregulates several important enzymes (P450 cytochromes ) that the body uses to eliminate drugs. You can read about that here: http://www.ncbi.nlm.nih.gov/pubmed/21870106.

This means that if you are taking berberine, other drugs you take may not be eliminated properly if they use those enzymes and may build up to toxic levels, while others, which require those enzymes to be working so that the drug can be broken down into the active form of the chemical they contain may not work as expected.

In particular you should not combine repaglinide (Prandin) with berberine as that combination may produce hypos since repaglinide is eliminated from the body by an enzyme that berberine inhibits. Since metformin also inhibits one of these enzymes to some extent, combining berberine and metformin is probably a bad idea, too. (Note I have blogged about the combined effect of metformin and prandin HERE).

Other drugs affected by berberine include cyclosporin (Neoral, Sandimmune), lovastatin (Mevacor), clarithromycin (Biaxin), indinavir (Crixivan), sildenafil (Viagra), triazolam (Halcion), and many others.

As always, when you buy an unregulated supplement, you have no way of knowing what is actually in the pill. Herbs grown in third world countries often contain toxic herbicides which are prohibited in the U.S.. And supplements manufactured abroad may also contain lead and other toxic heavy metals, as well as other contaminants. As supplements are completely unregulated in the U.S. and receive no scrutiny unless they kill someone, the assurances of the supplement companies that their supplements are "pure" are worthless. When supplements are taken to the lab by consumer groups, they often turn out to contain different dosages thatn what the label claims and to be contaminated.

With all this in mind, it seems prudent if you are going to use a drug to lower your blood sugar, to stick to drugs that are regulated, provided in pills of known dosage, and which have long track records for safety. Currently, the only drugs that fit that description are: metformin, insulin, prandin, gliclazide (not available in the U.S.)  and acarbose.