What on Earth Can I Eat? - The Book

Life is full of unexpected surprises. There is no way in the world I could have envisaged ten years ago that one day I would publish a book. Even less credible was the possibility that it would be a book to help people with type 2 diabetes find a way of eating to assist in individually managing their condition.

But that is exactly what I have done today. If you look at the side-bar, there it is. I can hardly believe it myself. How on earth did that happen?

A little over eight years ago I was just like many of the people who are reading this right now. I had just left the doctor's surgery with a handful of diet brochures, a new blood glucose test meter and a new diagnosis of type 2 diabetes to add to my various afflictions. But, unlike many newly diagnosed people, I was determined to conquer this one. I hit the ground running. I started seeking information and I haven't stopped since.

In the eight years since then I have learned from every source I could, commencing with my doctors, dieticians and educators but not limited to those and continuing with usenet and the web. I turned my affliction into my hobby. I learned to use the various medical search engines on the web and subscribed to email alerts from sites such as the New England Journal of Medicine, the American Diabetes Association, Journal of the American Medical Association, Heart, Endocrine Today, Diabetes in Control and many others. I read everything I could find. I learned to understand “Medi-speak” and how to pick a valid research paper from a poor one; and believe me, there are far too many poor ones.

I started on usenet's misc.health.diabetes, back when it was very active (usenet is fading these days), and later added more diabetes groups and web forums. I learned a lot from many good people who helped me. Over time I started trying to help others as they arrived, shocked and scared, on those forums. If their situation sounded like mine and I felt I could suggest a way to help, I did. And slowly, over time, I found that many people started to experiment for themselves using my suggestions and they worked for them too. Often we both learned from the mutual feedback of advice and experiment.

Over time I found that I am a good coach. Like many coaches, I found that some of those I helped achieved better results than the coach. I respect them but I do not envy them, because we each have to choose the right balance for ourselves. I could work harder and achieve tighter goals, but I balance that with my enjoyment of life. My signature on the web is “Everything in Moderation – Except Laughter”. I keep that in mind when making lifestyle decisions. But I never forget that the laughter may become a bit strained if the terrible diabetes complications start to appear in my life. So I try to make sure I work just hard enough to ensure they do not. That can never be guaranteed but after more than eight years they have not arrived yet.

After a while I added other forums and groups to my morning and the number of new arrivals I responded to started to grow, especially on the American Diabetes Association Forum. I found that I was repeating myself daily. So I looked for a way to store the “standard” suggestions and discovered blogging. This blog started in 2006 as a type of archive; a way to give a new person a link to more information without typing it several times daily. Then it started to grow, as I answered more questions and posted some of those answers to the blog.

The book I have published today grew out of that experience, partly to help those who are more comfortable with a book than a computer screen. I finally made the decision to write the book when many of those who had followed my suggestions over the years urged me to write it for their relatives and friends.

That is the story behind the book. I'm a good coach, but not much of a salesman because I tend to be too honest and "tell it like it is".

I do not promise a cure. I don't have a magic bullet. I don't sell herbal mixtures, special potions or promise reversal of your diabetes in 30 days. After buying the book you don't get follow-up mail to buy anything or join a program or start a business. All you get is a book that is easy to read, easy to understand and offers clear and simple ideas to help you take control of your diabetes.

What I can promise is that following the suggestions in my book will help you understand much more clearly the relationship between the foods you eat and the consequences for your long term health. I can teach you a way to find an enjoyable way of eating that suits you. My hope is that this information may help you take control of your own diabetes management, just like many others who have reported back to me, and may help you delay the progression of your diabetes towards those terrible complications.

If you're really quick - you might even get delivery before Christmas :)

Seasons greetings to all. I just received my Christmas present; I hope you receive what you wish for.

Cheers, Alan, Australia

Low Carb Crustless Quiche

I experimented for a while with various quiche recipes, but almost all included either flour or milk leading to carbohydrate content higher than my goal .

Eventually I made this simple version myself tonight from basic ingredients. It was intended to be the next in a series of new experiments. I was quite surprised to find that it set well and tasted delicious. Even better, my spouse, who will not eat eggs in any other form, loved it.

Ingredients.

4 whole eggs, free range if possible
200ml reduced cream
¼ tsp baking powder
2 rashers bacon, chopped (one rasher is 3 or 4 American strips)
1 medium onion, sliced
1 cup sliced swiss chard or spinach (1/4 cup if frozen)
30gm (1oz) of grated or sliced cheddar cheese
¼ tsp cayenne pepper
A grating of black pepper
Salt to taste – remember that the bacon will add salt too.

Method.

Four eggs and 200ml cream was the right quantity for my quiche dish, but if you have a larger dish add an extra egg and cream in proportion. Beat the eggs with a whisk until smooth. Add the cream, cayenne and baking powder and beat again until smooth. Set aside.

If you do not have reduced cream use your local equivalent. The cream I used is 35% milk fat, which is a little less than UK double cream or US heavy cream. I will try it with fresh cream next, which is a little lower in fat but I see no reason why that should not work OK. The fat content will be slightly lower and the carb content slightly higher.

Turn the oven on to let it heat up to 170C (340F) . In a suitable pan or skillet cook the bacon and onion until the onion is starting to caramelise. Add the chard or spinach, remove from the heat and set aside for a moment for the chard to wilt while you prepare the dish.

Use olive oil or butter to grease a suitable quiche baking dish well. Place it in a larger baking tray and add enough water to that tray to surround the quiche dish without causing it to float. Drain any excess liquid from the vegetable mix then spread the vegetables over the base of the quiche dish. Pour the egg and cream mix over the vegetables and spread the cheese over the top. I pressed the cheese down, but if you prefer a crusty top leave it on the surface.

Bake for about 30 minutes, but test with a skewer in the centre at 25 minutes in case your oven cooks more quickly than mine. When it is almost, but not quite, set in the centre it is time to remove it from the oven; it will finish cooking from residual heat.

Let it sit for a few minutes after you remove it from the oven. Don’t be disappointed if it goes flat – that is normal, it is a quiche, not a souffle.

We cut it into four serves, but double that would still be a very low carb meal. This is not a low fat meal. We had a simple lettuce, cherry tomato and onion salad with it. Delicious.

Nutrition Table
for one serve:

Energy 340 kcal
Protein 11 gm
Carbs 5.5 gm
Fat 31 gm

Bon Appetit

Up-date added 14th January 2011. I now use 5 eggs and cook it a little longer, about 40 minutes. It provides four substantial main meal serves.

Cheers, Alan, T2, Australia.
Everything in Moderation - Except Laughter

To Medicate - Or Not?

Quite often type 2 diabetics appear on forums that I read announcing that their goal is to become medication-free or to avoid needing insulin.

Although that sounds like a good goal, and for some individuals it may be, I think they may be confused about the true goal. To me the true goal is to delay or defer the terrible complications of diabetes for as long as possible; preferably to a date about ten years after I die in my sleep as a very old man.

I do not fear medications. If medications are needed to achieve my true goal I will take them. I added metformin a few years back for that reason. However, and it is a very important however, I will use them if, and only if, reasonable application of diet and exercise cannot achieve the desired result. There is an enormous difference between fearing medications and having a healthy and informed respect for the full implications of adding drugs to our bodies.

In my opinion medications should be used to complement a healthy lifestyle, not to attempt to compensate for an unhealthy lifestyle. If the diabetic's circumstances are such that further changes in lifestyle are unreasonable, impossible or not capable of producing the same benefits as medication, then medications are appropriate and valuable. But, if that is not the case, medications may be adding to their problems instead of solving them. Nor am I in favour of prophylactic medication, prescribed because some study somewhere showed a statistical benefit for some people. I'm interested in the effects on me as an individual, not a percentage of a study group who may or may not represent me.

There are no side-effects-free medications. As with all things in life a risks-benefit analysis is needed when considering adding medications or insulin.

I am unapologetically selfish about testing of new drugs. When new medications appear, often with lots of fanfare and research papers supported by the manufacturer of the new wonder drug, I have decided to wait for a decade or two of human experience before I will add that to my regimen. I will let others be the human guinea pigs over that period unless there is an urgent need that no other course of action can meet. Selfish? True. But sensible.

The history of many drugs makes salutary reading. First the euphoria, then the glowing reports, then the doubts, then the reaction. Some recent relevant cases for the drugs commonly prescribed for type 2s include the statins, Byetta, Avandia, Actos and even insulin. All may be beneficial to a large number but have significant risks for minority. The difficulty is knowing whether you are in the majority or the minority in advance. Nothing is risk-free.

Medications should not be feared. They are a valuable tool for us - but they should be respected and used only when needed.

Cheers, Alan, T2, Australia.
Everything in Moderation - Except Laughter

Privacy On Forums And The Web

I've been wandering around the internet since Netscape and Internet Explorer first appeared. I've seen it grow and change. Lately it has changed again with the dramatic increase of activity by multitudes of people posting overwhelming volumes of their most intimate personal details on places like MySpace, Facebook, Twitter and the constantly expanding range of other social net-working sites.

That trend is now reaching older sites such as the diabetes web forums I have been reading and posting on for a few years. The ADA Forum was re-vamped last November to add social networking and dLife added it a couple of years earlier.

I'm continually fascinated that people who would not tell their most intimate personal secrets to their own family, and certainly not to those who may not be their friends, happily post everything from their sex lives to their bathroom problems on the web. It becomes patently clear that the vast majority are blissfully unaware that not only can almost all of their writing be seen by anyone who cares to but it is being stored for readers decades from now. Many also appear to believe that forums and sites which require registration can only be seen or used by those who are registered.

Some years ago, when I only posted on usenet's alt.support.diabetes and misc.health.diabetes groups I googled my sig "Alan, T2, Australia" and was quite surprised to find that my posts were appearing on over 40 different forums; everything from bicycling to low-carbing. Some of those forums required registration - but my posts still appeared.

For one example of many, I am not a member of MedKB: http://www.medkb.com/Uwe/Forum.aspx/dia ... k-Diabetes

These days I also write on several other forums and my blog. I just googled that sig again and got 237,000 responses. Now, I know I write too much - but not THAT much!

Registration may help - but that depends on the software of the web-site and the integrity of the web-master or group owner. Try an experiment yourself. If you are a member of a group or forum that you need to register for, select a unique part of one of your old messages, place it in quotes and google or bing for it. You may get a rude surprise.

Even if your message does not appear in that sort of simple search, remember that any-one can register on ANY forum and "mine" the forum until the moderator or web-master ejects them. That includes anyone who may have a grudge against you or may be looking for information about you. To be honest, the only thing protecting the vast majority of the personal information posted on the web's social networking sites is the fact that 99.99% of it is utterly and incredibly boring to anyone but the writer.

Long ago I made the decision that I would never write anything on the net or web that I would be embarrassed to find was read by my mother, my wife, my children or my grand-children. Those are the important ones; I couldn't care less what the rest of the world thinks of me. Although I do keep in mind things like copyright law and that not all readers may have my best interests in mind.

I write on the assumption that there is NO privacy on the web regardless of the site I write on. Always write with that in mind and you will make the web a much safer place for yourself.

Cheers, Alan, T2, Australia.
Everything in Moderation - Except Laughter

I'm Type 2! What Should I Eat?

I often see these questions, in one form or another, on the various diabetes forums I read:

"How many carbs can I eat in a day?" or "What ratio of fat to carbs to protein should I eat?".

I think that is the wrong way to approach the subject for us as individual type 2 diabetics. Very few of us will actually sit down and work out the calories and fat:carbohydrates:protein ratios we are eating on a daily basis, nor does a daily limit for carbs work very well when our response to those carbs may be quite different at different times of day.

I do not deliberately plan to consume any particular proportion of daily fats, protein and carbs, nor any set daily carbohydrates level or limit. Instead, when I slowly developed my present way of eating I followed a simple process to work out what suited me.

My logic is fairly basic. I need to get all the appropriate nutrients for good health, but I need to get them in a way that does not jeopardise any of my various afflictions, including diabetes. I learned very soon after diagnosis that eating excessive carbohydrates caused blood glucose spikes, so I used this technique to adjust my carbohydrate levels until that did not happen: Test, Review, Adjust.

But other people, including my doctor, were then concerned that I may be missing out on vital nutrients. So I used a diet analyser to check what I actually ate to see if that was true. This is the most recent analyser I have found for that purpose: CRON-o-meter; there are others on the web if you do some searching. I also have regular blood tests; those can also show if I am deficient in various vitamins and minerals. If analysis or blood tests showed that I was missing something I then used the USDA nutrients guide to see what foods I could use to include those missing nutrients without increasing blood glucose levels.

In general terms, I found that eating a variety of proteins such as meat, fish and eggs in normal serve sizes, and replacing most of my starchy carbs, such as breads, potatoes, corn, pasta and similar with a wide range of colourful vegetables, such as cabbage, spinach, celery, onions, peppers, cauliflower, egg-plant and similar meant that there were very few nutrients I missed out on. In fact the increased variety of foods, especially vegetables, in my diet improved my nutrient intake in several areas.

If, and only if, I could not obtain a nutrient by adding a food to the menu I then added a supplement. At the moment my only supplements are vit D3, fish oil and magnesium.

When I do take the trouble to work out my fat:carbohydrates:protein ratios I find they are usually surprisingly close to those suggested in these interesting papers by researchers Mary C Gannon and Frank Q Nuttal:

Effect of a High-Protein, Low-Carbohydrate Diet on Blood Glucose Control in People With Type 2 Diabetes

Control of blood glucose in type 2 diabetes without weight loss by modification of diet composition

I did not use those as a guide, but it is reassuring to see that there is some science supporting my present way of eating.

Cheers, Alan

Everything in Moderation - Except laughter

Serendipitous Cajun Chicken

Last night I had some chicken pieces to cook but I didn't feel like baking them, so I made the following up as I went along. I'm not sure this could really be called a recipe because the quantities and directions are not exactly quantified or normal, but the result was delicious.

I started with a chicken maryland (drumstick and thigh) and two wings. I jointed all those and ended up with eight small bits of chook, to be cooked for two.

I browned all those in a wok in a decent splash of peanut oil. When they were browned but not fully cooked I removed them to be returned later.

I sliced or chopped one red onion, a stalk of celery and a medium carrot and sautéed those in the chicken-flavoured oil; adding a minced clove of garlic when they were nearly cooked. Then I added a half teaspoon of cayenne, a half-teaspoon of turmeric, a half-teaspoon of paprika, a half-teaspoon of salt and a grating of pepper. The measurements were by calibrated eyeball. I also added just a few flakes of my ultra-hot dried birds-eye chili from the garden and some dried oregano, also from my garden.

I returned the chicken to the veges in the wok, gave it a good stir, then covered it all with chicken stock. I brought that to the boil and then reduced it to simmer and went off to upload some movies to my travel blog. That turned out to be an essential and serendipitous part of the cooking technique.

The up-loading took a little longer than I expected. Some time later (probably about a half-hour) I returned to find the wok had boiled almost dry and the veges on the bottom were starting to stick to the pan and going rather black. On tasting, the flavour had developed a slightly charred characteristic (hence the cajun tag) but still seemed edible.

I added a little water and gave it a good stir to de-glaze the wok and to mix the black flecks into the mass of veges; just enough water to result in a nice gravy consistency. I did not use any thickener in the recipe; no flour or guar gum. Then I returned it to the simmer for about ten minutes; this time under supervision.

I served it with some trepidation. The tasting judge, my better half, thought it was wonderful. She claimed it was the best chicken she had eaten for a long time. Surprisingly, so did I. Of course, she may have just been trying to ensure that the cook continues to cook for her...

I'm not quite sure how to write that down as a recipe technique: "cook until just charred but not burnt".

I haven't worked out a nutrition count but the only significant carbs would have been the carrot. It hardly caused a blip on my peak post-meal BGs.

Bon appetit,

Alan

Everything in Moderation - Except Laughter

Banting's Diet

Just a quick post-script during my travels.

The title does not refer to the Banting who wrote the "Letter on Corpulence" but to the Banting who discovered insulin. Although both Bantings appear to have had some similar dietary views.

I was re-reading the fascinating story of Lois Jovanovic's grand-mother, which I refer to in SMBG - A Doctor Who Understands when something I missed earlier caught my eye.

Read again the letter an 8-year-old girl wrote to Dr Banting.



In addition to marvelling at the courage of that little girl giving herself injections with the size and type of syringe available in 1922, note this section on diet:

"I have been sugar-free for the last five days and getting about 1900 calories consisting of Pro 60 Fat 163 Ch 44."

Those numbers do work out close to 1900 calories. The percentages of calories from macronutriuents are approximately:

Protein 13%
Fat 78%
Carbohydrates 9%

That was the diet Banting, the discoverer of insulin, appears to have prescribed to his patient.

Cheers, Alan, T2, Australia.
Everything in Moderation - Except Laughter

A Brief Interlude

Among my various afflictions I am one of those unfortunates afflicted with wanderlust, a terrible condition (according to SWMBO) that causes me to become increasingly crabby and difficult to be around if I am confined to one locality for any extended period.

For that reason there will be a temporary hiatus on this blog until early May while I wander all over South America seeking a cure for it. If I am lucky, I'll fail in my quest...

In the interim I will post occasional trip reports, subject to the whims of internet cafes, wi-fi availability and upload speed on my travel blog for anyone interested.

I look forward to returning refreshed and relaxed.

Cheers, Alan

SMBG - A Doctor Who Understands

Over time I must admit to developing a certain degree of cynicism about researchers and doctors in the medical research field. I get a little jaded and dispirited about the entrenched attitudes in the fields of diabetes research, especially concerning diet.

Recently, in SMBG Research, Or The Lack Of It, I wrote “There are so many areas of diabetes crying out for research. There are some that have never been studied at all, including those dealing with diet modified by structured testing or similar methods which can lead to minimal medication or insulin needs.”

A friend from the Netherlands has gently chided me by sending me a copy of a paper that shows I may have been a little harsh. Time is the enemy and I only read it in full for the first time today. It's not a research study, more a position or discussion paper, but it is the closest statement from a qualified doctor that I have seen yet to Jennifer's Test, Test, Test advice or my own version of Test, Review, Adjust.

The paper is written by Dr Lois Jovanovic and includes references to other studies in support. Not a lot of other studies, most are small and some are only obliquely relevant, but at least there is some research happening in the field. It is so pleasant, after years of reading so many doctors ignoring so many patients on this subject, to finally read a paper like this one. They can ignore diabetics like me and dismiss us as unqualified; but Lois Jovanovic is someone who may be harder to ignore.

I think two unique factors make this particular doctor more aware of the close relationship between carbohydrate input and post-prandial hyperglycemia than most doctors. First, she has a depth of experience especially in gestational diabetes and pregnancies in patients already diagnosed as type 2. That has led to experience in trying to attain and manage normoglycemia much tighter than the levels usually expected for most type 2s. Her bio, in part reads:

Dr. Jovanovic has authored over 240 articles, including 135 for refereed journals, and 25 books on the topic of diabetes and pregnancy and islet cell transplantation. She serves as an Associated Editor of Diabetes Care and is on the editorial boards of Clinical Pharmacology and Therapeutics and the American Journal of Perinatology and is a contributing editor for the Journal of the American College of Nutrition and special editor for Endocrine Practice, the official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists. In addition, Dr. Jovanovic serves on the national board of directors of the Society for Experimental Biology and Medicine.

Not someone whose opinions on diabetes can be lightly dismissed.

Second, Lois Jovanovic is a type 1 diabetic. Uniquely, she is the grand-daughter of an 8-year-old type 1 girl in the original group treated by Banting when insulin was discovered. I found this fascinating article on her story here: Dr. Lois Jovanovic's Story. The discovery of insulin did not just save her life as a Type 1; she would never have existed at all without it.
The abstract of the paper can be found here: Using Meal-Based Self-Monitoring Blood Glucose (SMBG) Data to Guide Dietary Recommendations in Patients With DiabetesLois Jovanovic, MD, MACE
The Diabetes Educator, Vol. 35, No. 6, 1023-1030 (2009)DOI: 10.1177/0145721709349587

The purpose of this article is to describe how self-monitoring of blood glucose (SMBG) data is a useful tool for identifying and managing postprandial hyperglycemia (PPHG).

PPHG and postprandial glucose excursions occur frequently in patients with diabetes even when hemoglobin A1C is controlled below 7.0%, and convey increased risk of cardiovascular morbidity and mortality. Consequently, effective management of diabetes must include control of postprandial glucose levels. Postprandial plasma glucose (PPG) depends on the composition of meals, specifically the amount of carbohydrates.

Reduced-carbohydrate diets offer short-term improvements in glycemic control and other metabolic parameters, but await the support of long-term efficacy and safety studies. Glucose profiling and paired-meal SMBG are useful tools for detecting PPHG and glucose excursions. They provide immediate feedback to patients on the effect of foods and meals, thereby allowing appropriate food and medication adjustments to improve postprandial glycemic control.

But that abstract does not give an inkling of the specific recommendations in the full text or the pleasant shock I received when I read this marvellous “To Do” list for guiding dietary recommendations that is included as Table 1:

Educate your patients on the risks associated with high peak-postprandial glucose concentrations (≥150 mg/dL)

Ensure patients understand that postprandial glucose concentrations are determined by the total amount of carbohydrates consumed

•• Encourage patients to measure their carbohydrate consumption

•• Recommend that patients keep a food diary

Remind patients of the benefits of monitoring their blood glucose levels with SMBG and construct a testing plan that optimizes these benefits

•• Have patients determine the best time for postprandial SMBG by testing 45, 60, 75, 90, 105, and 120 minutes after a meal to detect their peak postprandial glucose concentration

•• Using preprandial and postprandial SMBG, together with a food diary, patients can understand how certain foods influence their glucose concentrations

•• If preprandial glucose concentrations are already high, there is no room for carbohydrates in the upcoming meal

Review recent SMBG and food diary data with your patients to help them recognize trends in out-of-target readings

•• Use this information to recommend a specific SMBG testing schedule including number of tests per day and appropriate testing times

•• Have patients meet with a nutrition specialist if they are having trouble identifying or controlling their carbohydrate consumption

Personally, I was particularly pleased to read the recommendation to find the post-prandial peak and use that as the best time.

I could hardly have asked for a better list of advisory guidelines from a doctor. I hope her paper is widely distributed among her peers. It should be required reading on the boards of organisations such as the ADA, NHS, CDA and Diabetes Australia.

Cheers, Alan, T2, Australia.
Everything in Moderation - Except Laughter

Should Detectives, Not Just Academics, Review Drug Research?

The different reports I intend to comment on may seem a bit disconnected as you read this; however, I think you will see the common thread.

A little while ago I wrote Money, Medications and Motives, related to this report of a corrupt doctor who strongly promoted prescription of powerful antipsychotic medicines to children while receiving un-declared income of over $1.6 million from drug-makers. That New York Times article goes on to describe other doctors acting similarly and implies a systemic problem in the relationship between practicing physicians, academia and the massive medical industry.

This perspective was published in the New England Journal Of Medicine today (Volume 362:669-671 February 25, 2010 Number 8): Serving Two Masters — Conflicts of Interest in Academic Medicine, by Bernard Lo, M.D.

He comments on the recent introduction by Boston-based Partners HealthCare, which includes some of the nation's leading teaching hospitals, of strict limitations on the level of compensation appropriate for their officials for serving on boards of directors of biomedical companies or similar situations. I must admit, from my perspective, a limit of "$5,000 per day for the time spent at board meetings" seems a trifle loose; it certainly causes one to wonder what the unlimited compensation has been. He includes this comment in his conclusions:

The public grants the medical profession considerable discretion in setting its own standards because it trusts that physicians will place patients' interests ahead of their own or those of third parties. To maintain this trust, AHCs (academic health centers ) should take the lead in addressing conflicts of interest in medicine, rather than merely responding to government requirements and adverse publicity about troubling cases. Taking the initiative will promote a culture of accountability and a commitment to professionalism.

I could not agree more. Unfortunately, I think the gate has been left open too long and the horse has well and truly bolted. It is now time for agencies beyond academia and the medical profession to take a keener interest.

A couple of days ago an article was reported in TheHeart.org about an analysis performed by Dr Mohammed Hassan Murad (Mayo Clinic, Rochester, MN) and colleagues of 202 papers or articles authored by medical professionals concerning Avandia. Coincidentally, an article in the UK Guardian newspaper reports that, after a two-year inquiry, the US Senate finance committee concluded that Glaxo Smith Kline knew of the link between Avandia and heart problems in 2004 but intimidated scientists to ensure favourable reports. You might note in that Guardian report "Glaxo firmly rejected the committee's findings, saying that 164 independent clinical trials have failed to find an association between Avandia and heart attacks."

Coincidence is a strange thing. Independently, as far as I can determine, Dr Murad and his colleagues examined the links some authors of papers and reports had with antihyperglycemic agent manufacturers and with rosiglitazone's manufacturer which may have conflicted with an unbiased report on the medication. Please read the full article; I don't wish to infringe copyright so I'll just mention the bare facts.

The analysts found that 107 of 202 papers or reports included a conflict-of-interest statement and 90 (45%) indicated a conflict existed.

Of the authors who concluded that no risk of heart problems are posed by rosiglitazone, 91% had financial relationships with antihyperglycemic agent manufacturers and 86% had relationships with rosiglitazone's manufacturer.

On the other hand, of authors who stated unfavourable opinions, only 25% had financial relationships with antihyperglycemic agent manufacturers and only 18% had relationships with rosiglitazone's manufacturer.

I don't think it takes a statistician to realise those numbers are significant. Who pays the piper calls the tune.

Earlier this month this brief statement appeared in the FDA news Drug Daily BulletinFeb. 2, 2010 Vol. 7 No. 22

Researcher Reaches Plea Agreement on Charge of Fabricating Data

A former influential pain drug researcher has reached a plea agreement with the Justice Department on a charge that he fabricated patient data. Federal prosecutors accused Scott Reuben, former chief of acute pain at Baystate Medical Center in Springfield, Mass., of falsifying patient data in trials of painkillers, including Merck’s Vioxx (rofecoxib) and Pfizer’s Celebrex (celecoxib). Reuben agreed to plead guilty to one count of healthcare fraud.

News reports on that appeared in several places, this is a brief extract from Medpage Today:

A Massachusetts anesthesiologist accused of fabricating data in studies of pain drugs will plead guilty to federal criminal charges under an agreement with prosecutors.

Scott Reuben, MD, a well-known pain researcher at Baystate Medical Center in Springfield, Mass., was charged with one count of healthcare fraud.

Early last year, the hospital announced that an internal audit had revealed that Reuben had made up research data out of whole cloth, affecting at least 21 published studies over a 15-year period. (See Special Report: Few Gaps in Analgesic Practice After Reuben Retractions) The criminal charge arose from one of those studies, funded by Pfizer and published in Anesthesia & Analgesia in 2007.

If you refer back to that article of mine on Money, Medications and Motives you will find that Celebrex was not Pfizer's big money maker. This is from 2007 figures:

"Pharmaceutical revenue from Pfizer’s U.S. operations decreased last year as competition in the cholesterol market contributed to an 8 percent decline in revenues for the firm’s flagship product Lipitor. The company’s $48.6 billion 2007 total revenue was 1 percent better than its 2006 revenue of $48.4 billion.

Overall, the company’s domestic revenue dropped 11 percent to $21.74 billion in 2007. Lipitor (atorvastatin calcium) had revenue of approximately $7.2 billion in the U.S. last year compared with approximately $7.85 billion in 2006. Worldwide Lipitor revenues were approximately $12.7 billion, a 2 percent decrease from 2006."

There are many countries in the UN that don't have a gross revenue like that. In 2007, if Pfizer was a country and not a manufacturer of pharmaceuticals, $48.4 billion would have positioned Pfizer 72nd out of 190 countries on the world rankings, just below Belarus and just above Luxembourg.

Until the FDA, TGA and other regulatory agencies can be absolutely confident that research studies are not only scientifically sound but are also not fraudulent, it appears to me that there is a case for agencies such as the FBI in the USA and equivalents in other countries to be involved in following the money trail during the process of approval of a medication for prescription by physicians.

There is the possibility that drugs like Lipitor and Celebrex save lives. But there is also the possibility that they kill people. All medications have side effects. Medications scientifically and honestly researched and trialled which provide detailed advice to regulators, physicians and patients of both the benefits and the risks can be a boon to mankind. For example, the risk of type 2 diabetes from Prednisone is well known, but the benefits for patients undergoing chemo are also significant. If a phsyician and patient decide to use that medication when fully aware of the risk, that is acceptable.

However, in my opinion, if a person deliberately falsifies or distorts influential reports on medications which lead to killing people who would not otherwise have died, and if others become aware of that consequence but deliberately falsify or suppress that information to profit from the sales of that medication, that person and those people should be charged with homicide, not just fraud.

Big fines will not cause a blip in the balance sheet of companies with resources like Pfizer. However, the possibility of being charged with murder may cause some second thoughts before repeating or facilitating actions such as the Celebrex scandal.

Resources such as the FBI are limited so their allocation needs to be targeted. An obvious starting point, in my opinion, would be to review ALL of the papers used by the FDA when making their decisions on statins, including Lipitor, Crestor, Zocor and all of othes presently approved.

Follow the money trail...

Cheers, Alan

Everything in Moderation - Except Laughter

SMBG Research, Or The Lack Of It

Nearly three years ago I challenged the authors of a particularly poor paper titled "Impact of self monitoring of blood glucose (SMBG) in the management of patients with non-insulin treated diabetes: open parallel group randomised trial" in the British Medical Journal to conduct a study based on Test, Review, Adjust.

When I first read Jennifer's Test, Test, Test I used to wonder why a study of that method had never been performed.

Of course now, with a little more experience, the reasons are fairly obvious to me. To start with, no researchers are even vaguely aware of the technique. That is apart from the fact that the results are unlikely to lead to increases in medication sales. Over five years ago, back when I naively thought someone would listen, I rang the Australian offices of Roche and Lilly to suggest it. They were polite and totally uninterested. I thought that at least the major test-strip manufacturers may have a vested interest. Apparently not.

My response to that paper was another small attempt to interest somebody in the appropriate field in the concept. But I have to be realistic; not many researchers read the "Rapid Responses" and Farmer et al certainly were not going make any attempt to prove themselves wrong.

The idea surfaced again today when Stuart, a Type 1 diabetic on the dLife forum, posted this very interesting question:

"If you wanted someone to explore something, to do a STUDY on a subject(s) about our diabetes, what do you want them to research? What areas do YOU want to know far more about that don't seem to be being done??? "

He had some very interesting replies. You can read them here. I would like to expand slightly on my answer there.

There are so many areas of diabetes crying out for research. There are some that have never been studied at all, including those dealing with diet modified by structured testing or similar methods which can lead to minimal medication or insulin needs. At the moment research tends to be focused on finding new medications or new ways to use old medications. In the real world "who pays the piper calls the tune".

No researchers are asking us, the diabetics, "what should we be researching?"

My own area of interest is just one of many possibilities. Despite understanding the reasons I still find it hard to believe that after more than three decades of home self-testing of blood glucose by diabetics no medical researcher, anywhere, has researched the use of structured self-testing for dietary modification to reduce blood glucose excursions.

Thousands of type 2 diabetics like myself have been "researching" the method personally and reporting their individual successes on many different forums since before I was diagnosed eight years ago, but we don't count in professional medical and research terms. We are diabetics, not scientists and our reports are anecdotes, not data.

I will offer the basic idea. Who knows, maybe there is a bright scientist out there looking for a PhD subject who has the ability to find a grant or research funds.

I propose a study comparing two groups of type 2 diabetics, all within their first 12 months of diagnosis. The only exclusion criteria would be that none should be using insulin or an insulin-stimulating medication such as a sulfonylurea at the commencement of the study.

Group 1, control, would be treated as individuals by their physicians and other specialists in exactly the same way as the present guidelines for their country. For example that would be the ADA or AACE and American Dietetic Association guidelines in the USA, Diabetes Australia here, or the NICE/NHS guidelines in the UK.

Group 2 would would also be treated as individuals by their physicians and other specialists in exactly the same way as the present guidelines for their country with the exception of dietary and testing guidelines. Instead, they would be given basic dietary guidelines to understand the differences between carbohydrates, fats and protein and their effect on blood glucose levels, and would also receive training and support in using feedback from peak post-prandial blood glucose testing to modify diet and lifestyle. The method taught would be based on the technique described in Test, Review, Adjust. If that needs clarification I am available as a consultant :)

The period of study would be three months initially, with weekly support and review to record indicators for both groups for the first four weeks, then monthly for the next two months with a preliminary report prepared after three months. Periodic follow-up review and reports would be performed at 12 months, five years and ten years. Indicators recorded would include A1c, fasting and peak post-prandial blood glucose levels, lipids, weight, blood pressure and any others the researchers felt valuable.

The five year and ten year reports would follow up all the earlier results and also include morbidity and mortality and any differences in progression to, or of, diabetes complications.

An inexpensive pilot study would not need very large populations and could be restricted to the first three months. The results of that could support further study over the longer period with a larger population.

I can also see other possible studies. For example, the possibility of combining Gannon and Nuttall's LoBAG20 or LoBAG30 diet with the above study as the starting diet for Group 2 is one that intrigues me. But it may be unwise to put too many variables in the mix. One thing at a time.

My area of interest may be quite different to yours. If you were the person asked by the researchers "what do you want us to study?" what would your answer be?

Cheers, Alan

Everything in Moderation - Except Laughter

Good Targets, Bad Methods

There has been a lot of discussion in the media and the blogosphere about an Early Online Publication in the Lancet on 27 January 2010.

Survival as a function of HbA1c in people with type 2 diabetes: a retrospective cohort study

"Methods
Two cohorts of patients aged 50 years and older with type 2 diabetes were generated from the UK General Practice Research Database from November 1986 to November 2008. We identified 27 965 patients whose treatment had been intensified from oral monotherapy to combination therapy with oral blood-glucose lowering agents, and 20 005 who had changed to regimens that included insulin. Those with diabetes secondary to other causes were excluded. All-cause mortality was the primary outcome. Age, sex, smoking status, cholesterol, cardiovascular risk, and general morbidity were identified as important confounding factors, and Cox survival models were adjusted for these factors accordingly

[snip]

Interpretation

Low and high mean HbA1c values were associated with increased all-cause mortality and cardiac events. If confirmed, diabetes guidelines might need revision to include a minimum HbA1c value."

What has saddened but not surprised me is that the reaction in on-line medical discussions has been much the same as that when the ACCORD and ADVANCE studies appeared. No-one has questioned the methods used to attain targets, all appear to accept that there may be a problem with attempting to aim for tight targets for type 2 diabetics. Thus, the targets are bad and should be eased.

I was not going to write about it because so many others have, but eventually I responded in Present where a doctor posed the following question based on this study: "Are we treating our patients to death?"

This was my response to the doctors.

The answer depends, of course, on the method of treatment and the individual nature of your patient's diabetes.

All of these studies, including ACCORD, ADVANCE and these recent ones have a common thread. They presume that the only way the physician can reach lower A1c and blood glucose goals in a patient is by medication. None of them consider using lifestyle – diet and exercise - changes to complement minimal medication or insulin to achieve those goals.

You all presume that a patient would not use diet and exercise. And, of course, to some degree you are correct, especially when the most generally prescribed diet is directly counter-productive for achieving better A1cs and blood glucose levels.

So you prescribe diet and exercise, the numbers go up, you presume non-compliance and prescribe metformin or a sulf or add insulin, they keep going up so you increase those and add more meds. But you also stress that the patient should eat more carbohydrates – and less fat - to be absolutely sure there are no hypoglycemic episodes as a result of the sulfs or the insulin and so the cycle continues, chasing it's tail.

Lower blood glucose and A1c targets do not cause higher mortality and morbidity. I have read success stories from many thousands of pro-active diabetics of all types on many forums since I was diagnosed eight years ago who have clearly demonstrated the opposite is true.

On the other hand, over-medication to attempt to counter poor dietary advice DOES cause higher mortality and morbidity; that is the consequence these studies are showing.

The solution? First, stop promoting the terrible “heart-healthy” high-carbohydrate AHA diet to your patients, or allowing the dieticians you send your patients to to do so. Instead, suggest that the patient use their meter at their post-prandial peak blood glucose timing to find out what foods are killing them and they will quickly reduce those foods, and their levels, and substitute others. The technique is described here: http://loraldiabetes.blogspot.com/2009/04/test-test-test.html

Some patients will do that and succeed; some will need further medication, but much less than you usually prescribe. And others will be non-compliant whatever you prescribe. They are the ones to prescribe higher medication to – but they are also the ones you should set easier targets for. Because they are the ones dying from over-medication.

Cheers, Alan.

Everything in Moderation - Except Laughter.