Monday, 11 August 2008

 Princess Health and Letter to the Editor.Princessiccia

Princess Health and Letter to the Editor.Princessiccia

I wrote a letter to the New York Times about their recent article "The Overflowing American Dinnerplate", which I reviewed here. The letter didn't get accepted, so I will publish it here:


In the article "The Overflowing American Dinner Plate", Bill Marsh cites USDA data showing a 59% increase in fat consumption from 1970 to 2006, coinciding with the doubling of the obesity rate in America. However, according to Centers for Disease Control NHANES nutrition survey data, total fat intake in the US has remained relatively constant since 1971, and has actually decreased as a percentage of calories. The apparent discrepancy disappears when we understand that the USDA data Marsh cites are not comprehensive. They do not include the fat contained in milk and meat, which have been steadily decreasing since 1970.

The change Marsh reported refers primarily to the increasing use of industrially processed vegetable oils such as soybean oil. These have gradually replaced animal fats in our diet over the last 30 years. Since overall fat intake has changed little since the 1970s, it cannot be blamed for rising obesity.

Sunday, 10 August 2008

 Princess Health and Rats on Junk Food.Princessiccia

Princess Health and Rats on Junk Food.Princessiccia

If diet composition causes hyperphagia, we should be able to see it in animals. I just came across a great study from the lab of Dr. Neil Stickland that explored this in rats. They took two groups of pregnant rats and fed them two different diets ad libitum, meaning the rats could eat as much as they wanted. Here's what the diets looked like:
The animals were fed two types of diet throughout the study. They were fed either RM3 rodent chow alone ad libitum (SDS Ltd, Betchworth, Surrey, UK) or with a junk food diet, also known as cafeteria diet, which consisted of eight different types of palatable foods, purchased from a British supermarket. The palatable food included biscuits, marshmallows, cheese, jam doughnuts, chocolate chip muffins, butter flapjacks, potato crisps and caramel/chocolate bars.
It's important to note that the junk food-fed rats had access to rat chow as well. Now here's where it gets interesting. Rats with access to junk food in addition to rat chow ate 56% more calories than the chow-only group! Here's what they had to say about it:
These results clearly show that pregnant rats, given ad libitum access to junk food, exhibited hyperphagia characterised by a marked preference for foods rich in fat, sucrose and salt at the expense of protein-rich foods, when compared with rats that only had access to rodent chow. Although the body mass of dams was comparable among all groups at the start of the experiment, the increased energy intake in the junk food group throughout gestation was accompanied by an increase in body mass at G20 [gestational day 20] with the junk food-fed dams being 13 % heavier than those fed chow alone.
Hmm, this is remarkably reminiscent of what's happening to a certain group of humans in North America right now: give them access to food made mostly of refined grains, sugar, and industrially processed vegetable oil. They will prefer it to healthier food, to the point of overeating. The junk food then drives hyperphagia by interfering with the body's feedback loops that normally keep feeding behaviors and body fat within the optimal range. These data support the hypothesis that metabolic damage is the cause of, not the result of, "super-sized" food portions and other similar cultural phenomena.

The rest of the paper is interesting as well. Pups born to mothers who ate junk food while pregnant and lactating had a greater tendency to eat junk than pups born to mothers who ate rat chow during the same period. This underscores the idea that poor nutrition can set a child up for a lifetime of problems.

Saturday, 9 August 2008

 Princess Health and Hyperphagia.Princessiccia

Princess Health and Hyperphagia.Princessiccia

One of the things I didn't mention in the last post is that Americans are eating more calories than ever before. According to Centers for Disease Control NHANES data, in 2000, men ate about 160 more calories per day, and women ate about 340 more than in 1971. That's a change of 7% and 22%, respectively. The extra calories come almost exclusively from refined grains, with the largest single contribution coming from white wheat flour (correction: the largest single contribution comes from corn sweeteners, followed by white wheat flour).

Some people will see those data and decide the increase in calories is the explanation for the expanding American waistline. I don't think that's incorrect, but I do think it misses the point. The relevant question is "why are we eating more calories now than we were in 1971?"

We weren't exactly starving in 1971. And average energy expenditure, if anything, has actually increased. So why are we eating more? I believe that our increased food intake, or hyperphagia, is the result of metabolic disturbances, rather than the cause of them.

Humans, like all animals, have a sophisticated system of hormones and brain regions whose function is to maintain a proper energy balance. Part of the system's job is to keep fat mass at an appropriate level. With a properly functioning system, feedback loops inhibit hunger once fat mass has reached a certain level, and also increase resting metabolic rate to burn excess calories. If the system is working properly, it's very difficult to gain weight. There have been a number of overfeeding studies in which subjects have consumed huge amounts of excess calories. Some people gain weight, many don't.

The fact that fat mass is hormonally regulated can be easily seen in other mammals. When was the last time you saw a fat squirrel in the springtime? When was the last time you saw a thin squirrel in the fall? These events are regulated by hormones. A squirrel in captivity will put on weight in the fall, even if its daily food intake is not changed.

A key hormone in this process is leptin. Leptin levels are proportional to fat mass, and serve to inhibit hunger and eating behaviors. Under normal conditions, the more fat tissue a person has, the more leptin they will produce, and the less they will eat until the fat mass has reached the body's preferred 'set-point'. The problem is that overweight Westerners are almost invariably leptin-resistant, meaning their body doesn't respond to the signal to stop eating!

Leptin resistance leads to hyperphagia, overweight and the metabolic syndrome (a common cluster of symptoms that implies profound metabolic disturbance). It typically precedes insulin resistance during the downward slide towards metabolic syndrome.

I suspect that wheat, sugar and perhaps other processed foods cause hyperphagia. I believe hyperphagia is at least partially secondary to a disturbed metabolism. There's something about industrial foods that reached a critical mass in the mid-70s. The shift in diet sent us into a tailspin of excessive eating and unprecedented weight gain.

Thursday, 7 August 2008

 Princess Health and Media Misinterpretations.Princessiccia

Princess Health and Media Misinterpretations.Princessiccia

The New York Times just published an article called "The Overflowing American Dinner Plate", in which they describe changes in the American diet since 1970, the period during which the obesity rate doubled. Bill Marsh used USDA estimates of food consumption from 1970 to 2006. Predictably, he focuses on fat consumption, and writes that it has increased by 59% in the same time period.

The problem is, we aren't eating any more fat than we were in 1970. The US Centers for Disease Control NHANES surveys show that total fat consumption has remained the same since 1971, and has decreased as a percentage of calories. I've been playing around with the USDA data for months now, and I can tell you that Marsh misinterpreted it in a bad way. Here are the raw data, for anyone who's interested. They're in easy-to-use Excel spreadsheets. I highly recommend poking around them if you're interested.

The reason Marsh was confused by the USDA data is that he confused "added fats" with "total fat".  While total fat intake has remained stable over this time period, added fats have increased by 59%. The increase is almost exclusively due to industrially processed seed oils (butter and lard have decreased). Total fat has remained the same because we now eat low-fat cuts of meat and low-fat dairy products to make up for it!

Another problem with the article is it only shows percent changes in consumption of different foods, rather than absolute amounts. This obscures some really meaningful information. For example, grain consumption is up a whopping 42%. That is the largest single food group change if you exclude the misinterpreted fat data. Corn is up 188%, rice 170%, wheat 21%. But in absolute amounts, the increase in wheat consumption is larger than corn or rice! That's because baseline wheat consumption dwarfed corn and rice. We don't get that information from the data presented in the article, due to the format.

So now that I've deconstructed the data, let's see what the three biggest changes in the American diet from 1970 to 2006 actually are:
  • We're eating more grains, especially white wheat flour

  • We're eating more added sweeteners, especially high-fructose corn syrup

  • Animal fats from milk and meat have been replaced by processed seed oils

Wheat + sugar + processed vegetable oil = fat and unhealthy. Sounds familiar, doesn't it?

Tuesday, 5 August 2008

 Princess Health and Life Expectancy and Growth of Paleolithic vs. Neolithic Humans.Princessiccia

Princess Health and Life Expectancy and Growth of Paleolithic vs. Neolithic Humans.Princessiccia

If paleolithic people were healthier than us due to their hunter-gatherer lifestyle, why did they have a shorter life expectancy than we do today? I was just reminded by Scott over at Modern Forager about some data on paleolithic (pre-agriculture) vs. neolithic (post-agriculture) life expectancy and growth characteristics. Here's a link to the table, which is derived from an article in the text Paleopathology at the Origins of Agriculture.

The reason the table is so interesting is it allows us to ask the right question. Instead of "why did paleolithic people have a shorter life expectancy than we do today?", we should ask "how did the life expectancy of paleolithic people compare to that of pre-industrial neolithic people?" That's what will allow us to tease the effects of lifestyle apart from the effects of modern medicine.

The data come from age estimates of skeletons from various archaeological sites representing a variety of time periods in the Mediterranean region. Paleolithic skeletons indicated a life expectancy of 35.4 years for men and 30.0 years for women, which includes a high rate of infant mortality. This is consistent with data from the Inuit that I posted a while back (life expectancy excluding infant mortality = 43.5 years). With modest fluctuations, the life expectancy of humans in this Mediterranean region remained similar from paleolithic times until the last century. I suspect the paleolithic people died most often from warfare, accidents and infectious disease, while the neolithic people died mostly from chronic disease, and infectious diseases that evolved along with the domestication of animals (zoonotic diseases). But I'm just speculating based on what I know about modern populations, so you can take that at face value.

The most interesting part of the table is actually not the life expectancy data. It also contains numbers for average stature and pelvic inlet depth. These are both markers of nutritional status during development. Pelvic inlet depth is a measure of the size of the pelvic canal through which a baby would pass during birth. It can be measured in men and women, but obviously its implications for birth only apply to women. As you can see in the table, stature and pelvic inlet depth declined quite a bit with the adoption of agriculture, and still have not reached paleolithic levels to this day.

The idea that a grain-based diet interferes with normal skeletal development isn't new. It's well-accepted in the field of archaeology that the adoption of grains coincided with a shortening of stature, thinner bones and crooked, cavity-ridden teeth. This fact is so well accepted that these sorts of skeletal changes are sometimes used as evidence that grains were adopted in a particular region historically. Weston Price saw similar changes in the populations he studied, as they transitioned from traditional diets to processed-food diets rich in white wheat flour, sweets and other processed foods.

The change in pelvic inlet depth is also very telling. Modern childbirth is so difficult, it makes you wonder why our bodies have evolved to make it so drawn-out and lethal. Without the aid of modern medicine, many of the women who now get C-sections and other birth interventions would not make it. My feeling is that we didn't evolve to make childbirth so lethal. It's more difficult in modern times, at least partially because we have a narrower pelvic inlet than our ancestors. Another thing Weston Price commented on was the relative ease of childbirth in many of the traditional societies he visited. Here's an exerpt from Nutrition and Physical Degeneration:
A similar impressive comment was made to me by Dr. Romig, the superintendent of the government hospital for Eskimos and Indians at Anchorage, Alaska. He stated that in his thirty-six years among the Eskimos, he had never been able to arrive in time to see a normal birth by a primitive Eskimo woman. But conditions have changed materially with the new generation of Eskimo girls, born after their parents began to use foods of modern civilization. Many of them are carried to his hospital after they had been in labor for several days. One Eskimo woman who had married twice, her last husband being a white man, reported to Dr. Romig and myself that she had given birth to twenty-six children and that several of them had been born during the night and that she had not bothered to waken her husband, but had introduced him to the new baby in the morning.
Now that's what I call fertility!

Sunday, 3 August 2008

Princess Health and Hunting.Princessiccia

Like 99.9% of the world's population, I am mostly dependent on agriculture for my food. It's fun to pretend sometimes though. I enjoy foraging for berries, mushrooms and nuts.

Last week, I went crabbing in the San Juan islands. We caught our limit of meaty dungeness crabs every day we put the pots out. If we had been working harder at it (and it was legal), we could easily have caught enough crabs to feed ourselves completely. We cooked them fresh and ate some the same day. We extracted the meat from the rest, and made an amazing crab bisque using a stock made from the shells, and lots of cream.

Here's a "hunting photo". No smiling allowed; I had to look tough...


Friday, 1 August 2008

 Princess Health and Composition of the Hunter-Gatherer Diet.Princessiccia

Princess Health and Composition of the Hunter-Gatherer Diet.Princessiccia

I bumped into a fascinating paper today by Dr. Loren Cordain titled "Plant-Animal Subsistence Ratios and Macronutrient Estimations in Worldwide Hunter-Gatherer Diets." Published in 2000 in the American Journal of Clinical Nutrition, the paper estimates the food sources and macronutrient intakes of historical hunter-gatherers based on data from 229 different groups. Based on the available data, these groups did not suffer from the diseases of civilization. This is typical of hunter-gatherers.

Initial data came from the massive Ethnographic Atlas by Dr. George P. Murdock, and was analyzed further by Cordain and his collaborators. Cordain is a professor at Colorado State University, and a longtime proponent of paleolithic diets for health. He has written extensively about the detrimental effects of grains and other modern foods. Here's his website.

The researchers broke food down into three categories: hunted animal foods, fished animal foods and gathered foods. "Gathered foods" are primarily plants, but include some animal foods as well:
Although in the present analysis we assumed that gathering would only include plant foods, Murdock indicated that gathering activities could also include the collection of small land fauna (insects, invertebrates, small mammals, amphibians, and reptiles); therefore, the compiled data may overestimate the relative contribution of gathered plant foods in the average hunter-gatherer diet.
There are a number of striking things about the data once you sum them up. First of all, diet composition varied widely. Many groups were almost totally carnivorous, with 46 getting over 85% of their calories from hunted foods. However, not a single group out of 229 was vegetarian or vegan. No group got less than 15% of their calories from hunted foods, and only 2 of 229 groups ate 76-85% of their calories from gathered foods (don't forget, "gathered foods" also includes small animals). On average, the hunter-gatherer groups analyzed got about 70% of their calories from hunted foods. This makes the case that meat-heavy omnivory is our preferred ecological niche. However, it also shows that we can thrive on a plant-rich diet containing modest amounts of quality animal foods.

The paper also discusses the nature of the plant foods hunter-gatherers ate. Although they ate a wide variety of plants occasionally, more typically they relied on a small number of staple foods with a high energy density. There's a table in the paper that lists the most commonly eaten plant foods. "Vegetables" are notably underrepresented. The most commonly eaten plant foods are fruit, underground storage organs (tubers, roots, corms, bulbs), nuts and other seeds. Leaves and other low-calorie plant parts were used much less frequently.

The paper also gets into the macronutrient composition of hunter-gatherer diets.  He writes that
...the most plausible... percentages of total energy from the macronutrients would be 19-35% for protein, 22-40% for carbohydrate, and 28-58% for fat.
He derives these numbers from projections based on the average composition of plant foods, and the whole-body composition of representative animal foods (includes organs, marrow, blood etc., which they typically ate). 

However, some groups may have eaten more fat than this.  Natives on the North American Pacific coast rendered fat from fish, seals, bears and whales, using it liberally in their food. Here's an excerpt from The Northwest Coast by James Swan, who spent three years living among the natives of the Washington coast in the 1850s:
About a month after my return from the treaty, a whale was washed ashore on the beach between Toke's Point and Gray's Harbor and all the Indians about the Bay went to get their share... The Indians were camped near by out of the reach of the tide, and were all very busy on my arrival securing the blubber either to carry home to their lodges or boiling it out on the spot, provided they happened to have bladders or barrels to put the oil in. Those who were trying out [rendering] the blubber cut it into strips about two inches wide, one and a half inches thick, and a foot long. These strips were then thrown into a kettle of boiling water, and as the grease tried out it was skimmed off with clam shells and thrown into a tub to cool and settle. It was then carefully skimmed off again and put into the barrels or bladders for use. After the strips of blubber have been boiled, they are hung up in the smoke to dry and are then eaten. I have tried this sort of food but must confess that, like crow meat, "I didn't hanker arter it".
I was very impressed by the paper overall. I think it presents a good, simple model for eating well: eat whole foods that are similar to those that hunter-gatherers would have eaten, including at least 20% of calories from high-quality animal sources. Organs are mandatory, vegetables may not be. Sorry, Grandma.

Monday, 21 July 2008

Princess Health and Book Review: "The Human Diet: Its Origins and Evolution".Princessiccia

I recently read this book after discovering it on another health site. It's a compilation of chapters written by several researchers in the fields of comparative biology, paleontology, archaeology and zoology. It's sometimes used as a textbook.

I've learned some interesting things, but overall it was pretty disappointing. The format is disjointed, with no logical flow between chapters. I also would not call it comprehensive, which is one of the things I look for in a textbook.
Here are some of the interesting points:
  • Humans in industrial societies are the only mammals to commonly develop hypertension, and are the only free-living primates to become overweight.
  • The adoption of grains as a primary source of calories correlated with a major decrease in stature, decrease in oral health, decrease in bone density, and other problems. This is true for wheat, rice, corn and other grains.
  • Cranial capacity has also declined 11% since the late paleolithic, correlating with a decrease in the consumption of animal foods and an increase in grains.
  • According to carbon isotope ratios of teeth, corn did not play a major role in the diet of native Americans until 800 AD. Over 15% of the teeth of post-corn South American cultures showed tooth decay, compared with less than 5% for pre-corn cultures (many of which were already agricultural, just not eating corn).
  • Childhood mortality seems to be similar among hunter-gatherers and non-industrial agriculturists and pastoralists.
  • Women may have played a key role in food procurement through foraging. This is illustrated by a group of modern hunter-gatherers called the Hadza. While men most often hunt, which supplies important nutrients intermittently, women provide a steady stream of calories by foraging for tubers.
  • We have probably been eating starchy tubers for between 1.5 and 2 million years, which precedes our species. Around that time, digging tools, (controversial) evidence of controlled fire and changes in digestive anatomy all point to use of tubers and cooked food in general. Tubers make sense because they are a source of calories that is much more easily exploited than wild grains in most places.
  • Our trajectory as a species has been to consume a diet with more calories per unit fiber. As compared to chimps, who eat leaves and fruit all day and thus eat a lot of fiber to get enough calories, our species and its recent ancestors ate a diet much lower in fiber.
  • Homo sapiens has always eaten meat.
The downside is that some chapters have a distinct low-fat slant. One chapter attempted to determine the optimal diet for humans by comparing ours to the diets of wild chimps and other primates. Of course, we eat more fat than a chimp, but I don't think that gets us anywhere. Especially since one of our closest relatives, the neanderthal, was practically a carnivore.
They consider the diet composition of modern hunter-gatherers that eat low-fat diets, but don't include data on others with high-fat diets like the Inuit.


There's some good information in the book, if you're willing to dig through a lot of esoteric data on the isotope ratios of extinct hominids and that sort of thing.

Wednesday, 16 July 2008

 Princess Health and Sunscreen and Melanoma.Princessiccia

Princess Health and Sunscreen and Melanoma.Princessiccia

Melanoma is the most deadly type of skin cancer, accounting for most skin cancer deaths in the US. As Ross pointed out in the comments section of the last post, there is an association between severe sunburn at a young age and later development of melanoma. Darker-skinned people are also more resistant to melanoma. The association isn't complete, however, since melanoma sometimes occurs on the soles of the feet and even in the intestine. This may be due to the fact that there are several types of melanoma, potentially with different causes.

Another thing that associates with melanoma is the use of sunscreen above a latitude of 40 degrees from the equator. In the Northern hemisphere, 40 degrees draws a line between New York city and Beijing. A recent
meta-analysis found consistently that sunscreen users above 40 degrees are at a higher risk of melanoma than people who don't use sunscreen, even when differences in skin color are taken into account. Wearing sunscreen decreased melanoma risk in studies closer to the equator. It sounds confusing, but it makes sense once you know a little bit more about UV rays, sunscreen and the biology of melanoma.

The UV light that reaches the Earth's surface is composed of UVA (longer) and UVB (shorter) wavelengths. UVB causes sunburn, while they both cause tanning. Sunscreen blocks UVB, preventing burns, but most brands only weakly block UVA. Sunscreen allows a person to spend more time in the sun than they would otherwise, and attenuates tanning. Tanning is a protective response (among several) by the skin that protects it against both UVA and UVB. Burning is a protective response that tells you to get out of the sun. The result of diminishing both is that sunblock tends to increase a person's exposure to UVA rays.


It turns out that UVA rays are more
closely associated with melanoma than UVB rays, and typical sunscreen fails to prevent melanoma in laboratory animals. It's also worth mentioning that sunscreen does prevent more common (and less lethal) types of skin cancer.

Modern tanning beds produce a lot of UVA and not much UVB, in an attempt to deliver the maximum tan without causing a burn. Putting on sunscreen essentially does the same thing: gives you a large dose of UVA without much UVB.


The authors of the meta-analysis suggest an explanation for the fact that the association changes at 40 degrees of latitude: populations further from the equator tend to have lighter skin. Melanin blocks UVA very effectively, and the pre-tan melanin of someone with olive skin is enough to block most of the UVA that sunscreen lets through. The fair-skinned among us don't have that luxury, so our melanocytes get bombarded by UVA, leading to melanoma. This may explain the incredible rise in melanoma incidence in the US in the last 35 years, as people have also increased the use of sunscreen. It may also have to do with tanning beds, since melanoma incidence has risen particularly in women.


In my opinion, the best way to treat your skin is to tan gradually, without burning. Use clothing and a wide-brimmed hat if you think you'll be in the sun past your burn threshold. If you want to use sunscreen, make sure it blocks UVA effectively. Don't rely on the manufacturer's word; look at the ingredients list. It should contain at least one of the following: titanium dioxide, zinc oxide, avobenzone (Parsol 1789), Mexoryl SX (Tinosorb). It's best if it's also paraben-free.


Fortunately, as an external cancer, melanoma is easy to diagnose. If caught early, it can be removed without any trouble. If caught a bit later, surgeons may have to remove lymph nodes, which makes your face look like John McCain's. Later than that and you're probably a goner. If you have any questions about a growth, especially one with irregular borders that's getting larger, ask your doctor about it immediately!

Thursday, 10 July 2008

 Princess Health and Grains and Human Evolution.Princessiccia

Princess Health and Grains and Human Evolution.Princessiccia

[Update 8/2011: as I've learned more about human genetics and evolution, I've come to appreciate that many Europeans actually descend from early adopters of agriculture more than they descend from the hunter-gatherers that previously occupied Europe.  Also, 10,000 years has been long enough for significant genetic adaptation.  Read The 10,000 Year Explosion for more information].

You've heard me say that I believe grains aren't an ideal food for humans. Part of the reason rests on the assertion that we have not been eating grains for long enough to have adapted to them. In this post, I'll go over what I know about the human diet before and after agriculture, and the timeline of our shift to a grain-based diet. I'm not an archaeologist so I won't claim that all these numbers are exact, but I think they are close enough to make my point.

As hunter-gatherers, we ate some combination of the following: land mammals (including organs, fat and marrow), cooked tubers, seafood (fish, mammals, shellfish, seaweed), eggs, nuts, fruit, honey, "vegetables" (stems, leaves, etc.), mushrooms, assorted land animals, birds and insects. The proportion of each food varied widely between groups and even seasons. This is pretty much what we've been living on since we evolved as a species, and even before, for a total of 1.5 million years or so (this number is controversial but is supported by multiple lines of evidence). There are minor exceptions, including the use of wild grains in a few areas, but for the most part, that's it.


The first evidence of a calorically important domesticated crop I'm aware of was about 11,500 years ago in the fertile crescent. They were cultivating an early ancestor of wheat called emmer. Other grains popped up independently in what is now China (rice; ~10,000 years ago), and central America (corn; ~9,000 years ago). That's why people say humans have been eating grains for about 10,000 years.


The story is more complicated than the dates suggest, however. Although wheat had its origin 11,500 years ago, it didn't become widespread in Western Europe for another 4,500 years. So if you're of European descent, your ancestors have been eating grains for roughly 7,000 years. Corn was domesticated 9,000 years ago, but according to the carbon ratios of human teeth, it didn't become a major source of calories until about 1,200 years ago! Many American groups did not adopt a grain-based diet until 100-300 years ago, and in a few cases they still have not. If you are of African descent, your ancestors have been eating grains for 9,000 to 0 years, depending on your heritage. The change to grains was accompanied by a marked decrease in dental health that shows up clearly in the archaeological record.


Practically every plant food contains some kind of toxin, but grains produce a number of nasty ones that humans are not well adapted to. Grains contain a large amount of phytic acid for example, which strongly inhibits the absorption of a number of important minerals. Tubers, which were our main carbohydrate source for about 1.5 million years before agriculture, contain less of it. This may have been a major reason why stature decreased when humans adopted grain-based agriculture. There are a number of toxins that occur in grains but not in tubers, such as certain heat-resistant lectins.

Non-industrial cultures often treated their seeds, including grains, differently than we do today. They used soaking, sprouting and long fermentation to decrease the amount of toxins found in grains, making them more nutritious and digestible. Most grain staples are not treated in this way today, and so we bear the brunt of their toxins even more than our ancestors did.


From an evolutionary standpoint, even 11,500 years is the blink of an eye. Add to that the fact that many people descend from groups that have been eating grains for far less time than that, and you begin to see the problem. There is no doubt that we have begun adapting genetically to grains. All you have to do to understand this is look back at the archaeological record, to see the severe selective pressure (read: disease) that grains placed on its early adopters. But the question is, have we had time to adapt sufficiently to make it a healthy food? I would argue the answer is no.


There are a few genetic adaptations I'm aware of that might pertain to grains: the duplication of the salivary amylase gene, and polymorphisms in the angiotensin-converting enzyme (ACE) and apolipoprotein B genes. Some groups duplicated a gene that secretes the enzyme amylase into the saliva, increasing its production. Amylase breaks down starch, indicating a possible increase in its consumption. The problem is that we were getting starch from tubers before we got it from grains, so it doesn't really argue for either side in my opinion. The ACE and apolipoprotein B genes may be more pertinent, because they relate to blood pressure and LDL cholesterol. Blood pressure and blood cholesterol are both factors that respond well to low-carbohydrate (and thus low-grain) diets, suggesting that the polymorphisms may be a protective adaptation against the cardiovascular effects of grains.


The fact that up to 1% of people of European descent may have full-blown celiac disease attests to the fact that 7,000 years have not been enough time to fully adapt to wheat on a population level. Add to that the fact that nearly half of genetic Europeans carry genes that are associated with celiac, and you can see that we haven't been weeded out thoroughly enough to tolerate wheat, the oldest grain!


Based on my reading, discussions and observations, I believe that rice is the least problematic grain, wheat is the worst, and everything else is somewhere in between. If you want to eat grains, it's best to soak, sprout or ferment them. This activates enzymes that break down most of the toxins. You can soak rice, barley and other grains overnight before cooking them. Sourdough bread is better than normal white bread. Unfermented, unsprouted whole wheat bread may actually be the worst of all. 



Wednesday, 9 July 2008

 Princess Health and Another China Tidbit.Princessiccia

Princess Health and Another China Tidbit.Princessiccia

A final note about the Chinese study in the previous post: the overweight vegetable-eaters (read: wheat eaters) exercised more than their non-vegetable-eating, thin neighbors. So although their average calorie intake was a bit higher, their expenditure was as well. 

Although I speculated in the last post that affluent people might be eating more wheat and fresh vegetables, the data don't support that. Participants with the highest income level actually adhered to the wheat and vegetable-rich pattern the least, while low-income participants were most likely to eat this way.

Interestingly, education showed a (weaker) trend in the opposite direction. More educated participants were more likely to eat the wheat-vegetable pattern, while the opposite was true of less educated participants. Thus, it looks like wheat makes people more educated. Just kidding, that's exactly the logic we have to avoid when interpreting this type of study!

Tuesday, 8 July 2008

 Princess Health and Wheat in China.Princessiccia

Princess Health and Wheat in China.Princessiccia

Dr. Michael Eades linked to an interesting study yesterday on his Health and Nutrition blog. It's entitled "Vegetable-Rich Food Pattern is Related to Obesity in China."

It's one of these epidemiological studies where they try to divide subjects into different categories of eating patterns and see how health problems associate with each one. They identified four patterns: the 'macho' diet high in meat and alcohol; the 'traditional' diet high in rice and vegetables; the 'sweet tooth' pattern high in cake, dairy and various drinks; and the 'vegetable rich' diet high in wheat, vegetables, fruit and tofu. The only pattern that associated with obesity was the vegetable-rich diet. The 25% of people eating closest to the vegetable-rich pattern were more than twice as likely to be obese as the 25% adhering the least.

The authors of the paper try to blame the increased obesity on a higher intake of vegetable oil from stir-frying the vegetables, but that explanation is misleading. A cursory glance at table 3 reveals that the vegetable-eaters weren't eating any more fat than their thinner neighbors. Dr. Eades suggests that their higher carbohydrate intake (+10%) was partially responsible for the weight gain, but I wasn't satisfied with that explanation so I took a closer look.  Dr. Eades also pointed to their higher calorie intake (+120 kcal/day), which makes sense to me.

One of the most striking elements of the 'vegetable-rich' food pattern is its replacement of rice with wheat flour. The 25% of the study population that adhered the least to the vegetable-rich food pattern ate 7.3 times more rice than wheat, whereas the 25% sticking most closely to the vegetable-rich pattern ate 1.2 times more wheat than rice! In other words, wheat flour rather than rice was their single largest source of calories. This association was much stronger than the increase in vegetable consumption itself!

All of a sudden, the data make more sense. Wheat seems to associate with health problems in many contexts. Perhaps the reason we don't see the same type of association in American epidemiological studies is that everyone eats wheat. Only in a culture that has a true diversity of diet can you find a robust association like this. The replacement of rice with wheat may have caused the increase in calorie intake as well. Clinical trials of low-carbohydrate diets as well as 'paleolithic diets' have shown good metabolic outcomes from wheat avoidance, although one can't be sure what role wheat plays from those data.

I don't think the vegetables had anything to do with the weight gain, they were just incidentally associated with wheat consumption. But I do think these data are difficult to reconcile with the idea that vegetables protect against overweight.

Tuesday, 25 March 2008

Princess Health and BLOGSCAN - Continuing Investigation of Orthopods' Financial Relationships with Prosthetic Joint Manufacturers. Princessiccia

Princess Health and BLOGSCAN - Continuing Investigation of Orthopods' Financial Relationships with Prosthetic Joint Manufacturers. Princessiccia

On the Hooked: Ethics, Medicine and Pharma blog, Dr Howard Brody expanded his focus a bit to include medical device companies. He posted about the ongoing investigations of orthopedic surgeons' financial relationships to the manufacturers of prosthetic joints. He cited an unnamed senior general surgeon who "did not think that anywhere near as much real 'consulting' ever got done as cash flowed into docs' pockets." This story keeps bubbling just below the surface. Stay tuned, as I suspect there will be more developments.
Princess Health and BLOGSCAN - Imperial Pharmaceutical CEOs. Princessiccia

Princess Health and BLOGSCAN - Imperial Pharmaceutical CEOs. Princessiccia

On the PharmaLot blog, Ed Silverman has two posts about how pharmaceutical executives continue to rake in humongous compensation whose magnitude seems unrelated to their performance or the performance of their companies. The CEO of Cephalon got more than $15.8 million, including the value of stock options, while the company is dealing with an Federal Trade Commission lawsuit which contends the company blocked sales of a generic competitor, and despite settling a suit about off-label marketing (see post here.) The CEO of Bristol-Myers-Squibb got $13.5 million after the company's stock price fell, the company took a charge for losses on sub-prime mortgages, and several top financial officers left (see post here.) Again, as we noted earlier, imperial CEOs seem rampant in health care organizations.

Friday, 21 March 2008

Princess Health and Who Was Responsible for the Purity of Baxter International's Heparin?. Princessiccia

Princess Health and Who Was Responsible for the Purity of Baxter International's Heparin?. Princessiccia

We have posted several times, most recently here and here, about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late last year, hundreds of such reactions, and now 21 deaths were reported in the US after intravenous heparin infusions.

All the heparin related to these events was made by Baxter International. We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. In fact, the company had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from a US company, Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous small, unidentified "workshops," which seemed to produce the product in often primitive and unsanitary conditions. None of the stops in the Chinese supply chain had apparently been inspected by the US Food and Drug Administration nor its Chinese counterpart. Most recently, we found out that the Baxter International labelled heparin was contaminated with over-sulfated chondroitin sulfate, a substance not found in nature, but which mimics heparin according to the simple laboratory tests used in the Chinese facilities to check incoming heparin. (See post here.)

It is not clear whether Baxter International or Scientific Protein Laboratories had inspected most of the steps in the supply chain, or even knew what went on there. The Baxter and Scientific Protein Laboratories CEOs did not seem aware of where they got the heparin on which the Baxter International label was eventually affixed. But one report in the New York Times alleged that Scientific Protein Laboratories would not pay enough for heparin to satisfy any sources other than the small "workshops."

By the end of this week, it became clear that the counterfeit ingredient was added to the heparin in China. Per Bloomberg,



The contamination was present in the powdered raw heparin purchased by Scientific Protein's plant in China, said Robert Rhoades, a pharmaceutical consultant with Becker & Associates in Washington, speaking for Scientific Protein. The company was unaware of the contamination at the time because it wasn't detected in tests Scientific Protein conducted on the powder provided by suppliers, he said.

Scientific Protein purchased raw heparin from consolidators and refined it further before sending it to Baxter, which uses the ingredient to make the finished drug, Rhoades said. The consolidators obtained the ingredients from workshops in China, he said.

The contaminant 'was very likely introduced at the workshop or consolidator level,' Norbert Riedel, Baxter's corporate vice president and chief scientific officer, has said.


Nonetheless, a number of experts suggested that there was reason not be complacent about drugs made in China. A Washington Post article noted that it was well known that Chinese manufacturers were liable to supply dodgy drugs,



Although the contaminated heparin is the largest and highest-profile instance of tainted prescription drugs made in China, it is not the first. In the late 1990s, a spike in deaths associated with the intravenous antibiotic gentamicin was linked to China-based Long March Pharmaceuticals. Although no definitive link was ever established, tests by German researchers later found a wide range in quality and effectiveness in what were supposed to be uniform dosages of the drug, leading them to write that 'it was assumed' the deaths 'were related to faulty manufacture.'

The Post quoted former US Food and Drug Administration (FDA) official William Hubbard,



The history of some of these developing countries in terms of substituting or counterfeiting concerns is a long and well-documented one....

USA Today quoted former FDA Commissioner David Kessler saying that



the news shouldn't come as a surprise: China is 'as close to an unregulated environment as you can get.' In fact, it's a lot like the USA was in 1906, he says �'that's why we developed an FDA.'

Furthermore, one expert argued that Baxter International was ultimately responsible for the drug that it sold, per the Chicago Tribune,



The presence of a foreign ingredient raises new questions about Baxter's oversight because a lack of record-keeping at the China plant makes it more difficult for Baxter and government inspectors to trace the origin of the raw material for Baxter's product.

'Where are the controls here? What is the process here?' asked Carl Nielsen, who was the FDA's director of import operations and policy before leaving the agency to form a consulting firm in 2005.

'Ultimately, Baxter is the most responsible' for monitoring the quality of products that move through the company's pipeline, Nielsen said.


Yet Baxter International executives have not exactly been jumping forward to claim responsibility. In a letter, again to the Chicago Tribune, Peter J Arduini, President, Medication Delivery, for Baxter International seemed to be deflecting responsibility towards Scientific Protein Laboratories and the FDA, while asserting Baxter did all it could do.

Regarding the issue of active pharmaceutical ingredient that originated in China, Baxter's API supplier for heparin is in fact a Wisconsin-based company, Scientific Protein Laboratories, with whom Baxter and its predecessor in this business has worked for more than 30 years. SPL had been procuring heparin raw material from China for more than 10 years and opened a location in Changzhou, China, in 2004. Baxter worked with the U.S. Food and Drug Administration to obtain the appropriate approvals to work with this facility. For the API we receive from SPL, and for the API we receive from all our suppliers, Baxter performs quality testing of all incoming materials above and beyond what's required, to ensure that incoming API is what our suppliers claim it to be. Unfortunately, as the FDA has said, the problematic heparin API could not have been detected by the testing required of and done by any heparin manufacturer.
Previously Baxter International's CEO, Robert L Parkinson Jr, had dodged responsibility for the supply chain that provided the heparin to Scientific Protein Research's Changzhou facility, as we posted here, and as originally reported in the Chicago Tribune,

Baxter International Inc. does not monitor its supply chain to the extent that it would know that a supplier in China was never inspected before it began shipment of the blood-thinning drug heparin, which is linked to more than 300 illnesses in the U.S., the company's chief executive said Wednesday.

Baxter contracted with a Wisconsin supplier, Scientific Protein Laboratories, and not with that company's Chinese affiliate, Baxter CEO Robert Parkinson said Wednesday in his first interview since the heparin problems surfaced.

'It's not unusual for us not to know that the FDA hasn't inspected a supplier to a supplier,' Parkinson said.


Yet if Baxter International is not responsible for the production of drugs that carry its name, who is? If Baxter International's executives are not responsible for how the drugs it sells are manufactured, who should be?

In an ironic juxtaposition, a small and little noticed news item last week declared that Robert Parkinson received $16,600,000 in compensation in 2007, a 30.5% increase from 2006. In fact, the company's 2008 proxy statement suggests even greater total compensation in 2007, $17,580,718. And Mr Arduini's 2007 compensation was reported to be $2,438,642.

The usual justification for compensation at this level is the brilliance of and great responsibilities borne by the executives who receive it. But, if Baxter International's executives will not take responsibility for their products and how they are made, what again is the justification for paying them the big bucks?

So the case of the contaminated heparin becomes another reason to question the imperial nature of the current leadership of health care organizations.
Princess Health and BLOGSCAN - Labor Union Helps to Market Lipitor. Princessiccia

Princess Health and BLOGSCAN - Labor Union Helps to Market Lipitor. Princessiccia

In the Health Beat Blog, Maggie Mahar discussed how a branch of a labor union, the International Association of EMTS and Paramedics, an affiliate of The National Association of Government Employees (IAEP/SEIU), has been helping to market Lipitor (atorvastatin, by Pfizer Inc). I am not sure I have heard of previous cases of labor unions enlisted in stealth marketing efforts by pharmaceutical companies. Ms Mahar so far has not been able to elicit a coherent explanation from the union. Thanks to Dr Alicia Fernandez for blowing the whistle on this on. This also has been re-posted on the GoozNews blog. Although I have not previously heard of a case in which a labor union was helping to market a drug manufactured by a big pharmaceutical company, this is but one of many, many examples we have seen of reputable organizations taken in directions at odds with their missions by leaders with their own agendas.

Wednesday, 19 March 2008

Princess Health and Fake Heparin, then Sick and Dead Patients. Princessiccia

Princess Health and Fake Heparin, then Sick and Dead Patients. Princessiccia

We have posted several times, most recently here, about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late last year, hundreds of such reactions, and now 21 deaths were reported in the US after intravenous heparin infusions. All the heparin related to these events was made by Baxter International.

We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. In fact, the company had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from a US company, Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous small, unidentified "workshops," which seemed to produce the product in often primitive and unsanitary conditions. None of the stops in the Chinese supply chain had apparently been inspected by the US Food and Drug Administration nor its Chinese counterpart.

It is not clear whether Baxter International or Scientific Protein Laboratories had inspected most of the steps in the supply chain, or even knew what went on there. The Baxter and Scientific Protein Laboratories CEOs did not seem aware of where they got the heparin on which the Baxter International label was eventually affixed. But one report in the New York Times alleged that Scientific Protein Laboratories would not pay enough for heparin to satisfy any sources other than the small "workshops."

Now the US FDA just reported it identified a contaminant in the heparin that may be responsible for the adverse reactions. This has already been reported today by many media outlets, but I will quote Bloomberg since its article makes the main points most concisely,


Baxter International Inc.'s blood thinner heparin, linked to deaths and allergic reactions, was contaminated with a less-expensive ingredient derived from animal cartilage, U.S. regulators said.

The contaminant, over-sulfated chondroitin sulfate, isn't approved for use in medicine, said Janet Woodcock, the head of the Food and Drug Administration's drug division, in a conference call today with reporters. Regulators are investigating whether the substance was intentionally or accidentally added to raw heparin from China.

'It does not appear to have come straight from the pig,' Woodcock said of the contaminant. 'It doesn't appear to be a natural contaminant that got in there. We don't know how it was introduced or why.'

Adding the contaminant to raw heparin, the active ingredient in the finished product, would have been cheaper than using pure raw heparin, according to the FDA. The agency didn't know how much money would be saved by its use, Woodcock said.

Chondroitin sulfate is taken orally as a dietary supplement to treat joint pain. The over-sulfated version found in the heparin was chemically modified to act like heparin, Woodcock said.

Over-sulfated chondroitin sulfate is generated in laboratories for experimental purposes, said Siobhan DeLancey, an FDA spokeswoman, in an interview. It is chemically altered to add additional sulfates, she said.

Two percent to 50 percent of the contaminated raw heparin samples tested by the FDA were made up of over-sulfated chondroitin sulfate, Woodcock said.


So it now appears, although it is not yet proven that the adverse reactions and deaths were caused not by a trace contaminant derived from a sloppy, primitive, and unsanitary manufacturing process, but from a bulk counterfeit ingredient deliberately introduced because it was cheaper than heparin, yet would fool purchasers into thinking it was heparin.

Thus we see what happens when US health care leaders were happy to put their prestigious logo on a drug whose source was unknown to them, presumably just to save some money. By obviously failing to exert rigorous oversight over how the drug which carried their company's name was produced, they not only allowed sloppy, primitive and unsanitary manufacturing practices, but apparently were easily snookered by counterfeiters who substituted a likely toxic ingredient for the real thing.

This was putting profits before patients. And the results were very bad for patients.

Baxter claims to apply
its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.

However, rather than its expertise, its sloppy and uncaring leadership seemed to leave some of its patients' lives meaningfully worse.

This case is a glaring demonstration of why we need a new set of leaders of our health care organizations, and a new corporate culture within these organizations. Otherwise, failing to understand the health care context, and failing to put patients before profits will yield more sick and dead patients.
Princess Health and The wages of complacency in defining "Medical Informatics" as a specialty. Princessiccia

Princess Health and The wages of complacency in defining "Medical Informatics" as a specialty. Princessiccia

Over recent months I�ve been exploring roles back in applied HIT, having been a CMIO (Medical Director of IT, now called "Chief Medical Informatics Officer") in decidedly applied settings in the �olden days� a decade ago.

One common feature of the conversations I�ve had was that I�ve left these interviews with a sense of unease and annoyance, but was unclear why. It is only recently that I�ve been able to identify a common theme.

Imagine a seasoned neurosurgeon, interviewing for department chair, in the following interview scenario:


Candidate: I�m here interviewing for chair of the department of neurosurgery.

CIO: Well, you have an interesting background and have done many varied things. Were you aware that it�s important to be able to bring doctors into consensus? Tell us about how you intend to do that. Have you ever brought doctors into consensus?

IT project leader: How would you deal with pharma detail people? I don�t see that on your resume.

Finance: Billing is important. From your background, I�m not sure you understand billing. Tell us about your experience in that area.

Other doc: How would you go about treating meningitis? Can you actually do that? Have you ever done an LP?



While the scenario is absurdist, in effect I believe it summarizes metaphorically what I�ve been experiencing.

The hospital interviews I�ve been having are unlike anything I experienced in seeking clinical roles. They have even been a significant step down from some of the difficult ones I�ve had in pharma, where at least there is an understanding that holding an MD/Informatics title means the person understands something about biomedical research and computing.

In other words, I find that the designation of having studied Medical Informatics seems to confer no �fides� on a leadership role in applied Health IT (HIT) in hospitals. I�ve found myself interrogated about abilities and accomplishments in HIT as if �Medical Informatics� was being parsed as �Hsfapfwllerw�, i.e., meaningless, and as if past accomplishments were imagined or exaggerated. I find line items on a resume that say �led difficult HIT projects, managed staff, managed budgets� seem to mean little or are negated under the umbrella of the �Medical Informatics� title.

I find myself being asked frivolous questions on fundamental issues to which my reply really should be:

�Have you actually read my resume? Do you know what medical informatics is, and have you bothered to look before this interview?�

I�ve been preached to and patronized about HIT project issues by IT personnel and other non-clinical personnel, based upon what they seem to have read in their throwaway journals (e.g. �Advance for Health Information Executives�), as if I didn�t know anything about the area; as if IT staff were the clinical IT experts and I, an intern.

Another common finding is that materials I provide both pre- and post-interview on Medical Informatics (e.g., web links to my sites) are largely ignored, as I track my web sites by IP and can see from where they�re being read - or not.

Interviews of seasoned professionals in well-understood domains should not be like this. In my role interviewing doctoral-level faculty candidates for my college, we never, for example, asked them or challenged them if they understood basic tenets of information/library science, as if they were undergraduates. To do so would have been both unthinkable and alienating. Instead, we sought to have candidates tell us about their specific areas of expertise and how that could fit our needs. The assumption was that by being invited, we understood they were a competent professional.

Yet in medical informatics I�ve started to dread interviews, due to the absurdist scenario above, the need to present myself as someone who "gets it" regarding HIT, and the need to provide remedial education in an interview setting to confused people.

The weaknesses in societal understanding of the term �Medical Informatics�, therefore, are unhelpful to people who�ve expended the time and treasure acquiring the credentials and who wish to work in applied HIT.

This phenomenon impairs the ability of the Medical Informatics profession to contribute to and steer HIT in the service of medicine, and to help healthcare organizations avoid commonplace, expensive errors regarding clinical IT projects they can ill afford.

I am assuming this phenomenon is not just part of a larger phenomenon of dumbing-down in healthcare, of cost-cutting and institutionalized mediocrity.

This really needs to change.

-- SS

Tuesday, 18 March 2008

Princess Health and The Peril to Leaders "Who Accept Their Own Myth". Princessiccia

Princess Health and The Peril to Leaders "Who Accept Their Own Myth". Princessiccia

In the Washington Post, E J Dionne wrote about the recent collapse of the sub-prime mortgage market, and near collapse of at least one prominent investment banking firm, but what he wrote was also highly relevant to how US health care currently operates (I realize that some of Dionne's opinions may have an ideological slant, but I believe the point goes beyond the usual left/right dichotomy).


Never do I want to hear again from my conservative friends about how brilliant capitalists are, how much they deserve their seven-figure salaries and how government should keep its hands off the private economy.

The Wall Street titans have turned into a bunch of welfare clients. They are desperate to be bailed out by government from their own incompetence, and from the deregulatory regime for which they lobbied so hard. They have lost "confidence" in each other, you see, because none of these oh-so-wise captains of the universe have any idea what kinds of devalued securities sit in one another's portfolios.

So they have stopped investing. The biggest, most respected investment firms threaten to come crashing down.

But if this near meltdown of capitalism doesn't encourage a lot of people to question the principles they have carried in their heads for the past three decades or so, nothing will.

We had already learned the hard way -- in the crash of 1929 and the Depression that followed -- that capitalism is quite capable of running off the rails. Franklin Roosevelt's New Deal was a response to the failure of the geniuses of finance (and their defenders in the economics profession) to realize what was happening or to fix it in time.

As the economist John Kenneth Galbraith noted of the era leading up to the Depression, "The threat to men of great dignity, privilege and pretense is not from the radicals they revile; it is from accepting their own myth. Exposure to reality remains the nemesis of the great -- a little understood thing."

But in the enthusiasm for deregulation that took root in the late 1970s, flowered in the Reagan era and reached its apogee in the second Bush years, we forgot the lesson that government needs to keep a careful watch on what capitalists do. Of course, some deregulation can be salutary, and the market system is, on balance, a wondrous instrument -- when it works. But the free market is just that: an instrument, not a principle.


In the last 20 years, for-profit health care corporations seem to have turned their leaders into imperial CEOs. Their organizational cultures have been turned into cults of personality extolling the wisdom of their fearless leaders. Such brilliant leaders of course deserved equally brilliant compensation. So there have been plenty of CEOs of for-profit health care corporations who have had seven-figure-plus compensation. But sometimes, that compensation seemed not very proportional to their competence. (Remember the examples of the "brilliant" former CEO of UnitedHealth, or the former CEO of Pfizer Inc.)

Furthermore, the leaders of not-for-profit health care organizations have also become objects of personality cults, which suggested that they too deserved lavish, often seven-figure salaries and to live the high life at the expense of organizations whose missions are ostensibly to treat disease and reduce suffering, and/or to train students and pursue science. (See our latest example of the leaders of the University of Texas Southwestern Medical Center.)

We have often suggested that leaders who are more focused on their own wealth, power, and privilege may not be good at improving patient care, or advancing academic medicine.

So let us quote Galbraith again, and remember what he said applies well to leaders of health care organizations.

The threat to men of great dignity, privilege and pretense is not from the radicals they revile; it is from accepting their own myth. Exposure to reality remains the nemesis of the great -- a little understood thing.
Far too many leaders of health care have accepted their own myth. Thus it is likely that all too soon, some important part of the health care system will come crashing down like Bear Stearns unless health care professionals and patients can shred these myths in time.

A big hat tip to Dr Peter Rost on the Question Authority Blog.

Monday, 17 March 2008

Princess Health and Living the High Life in Academic Medical Center Leadership. Princessiccia

Princess Health and Living the High Life in Academic Medical Center Leadership. Princessiccia

We had posted awhile back about how a not-for-profit, state supported academic medical center, University of Texas- Southwestern Medical Center, had created an "A list" of local notables who were to be given special treatment, including enhanced access to physicians. This seemed to imply some slippage from the institution's mission (see post here). It turned out that the practice may not be unique, but neither is is universal (see this post).

The local television station that uncovered this practice, "CBS 11," has been keeping an eye on the medical center. Late last year it found out its top officials had quite a taste for expensive wine.


Top state officials at the University of Texas Southwestern Medical Center in Dallas spent tens of thousands of dollars in donations on luxury wines from prestigious New York wine merchants.

A CBS 11 News investigation of charges to the university's credit cards found that President, Dr. Kern Wildenthal, and his right hand assistant, Vice President, Cyndi Bassel, spent more than $125,000 on wine.

A UT Southwestern spokesman says the state healthcare institution purchased the wine with money from unrestricted donations and not tax funds. John Walls explained the wine expenses in a written statement, 'The purchases from New York dealers were for hard-to-find wines not readily available in local retail shops, which were especially appropriate for individual commemorative gifts and special recognition events.'

The TV station's reporters also found that the Medical Center was using restricted donated funds to wine and dine its top executives, although the funds were meant for very different purposes.

Upon his death in 1986, [Jesse] Brittain left his life savings of more than $390,000 to UT Southwestern. Brittain's endowment agreement specified that the money was to be used 'for the sole purpose of enhancing the business operation of UT Southwestern giving priority to the professional development of personnel in the business operation, including training courses, books, seminars, etc.'

Instead,

CBS 11's hidden camera was there to record how the state university has been using money from the Jesse Brittain Memorial Fund.

The family of the late donor says the money was intended to help train employees and not for what CBS 11's investigation found.

The undercover video captured an annual holiday party held for a select group of the university's business administrators.

The state officials gathered in a luxurious penthouse dining room on the University's North Campus. It is a rarified atmosphere with a half million dollar collection of sleek tables designed by the internationally recognized Spanish architect Santiago Calatrava and a breathtaking night vista of twinkling lights on the Dallas skyline.

A white jacketed chef carved slices of herb crusted sirloin from a $450 side of beef. A waiter strolled through the party serving risotto crab cakes that cost $316 and artichoke hearts filled with goat cheese that cost $316.

Tables of silver serving trays filled with specialty appetizers were decorated with large gingerbread houses.

Partygoers bellied up to an open bar where more than $1000 worth of drinks were served.

The party that CBS 11 found in full swing is one of three annual holiday parties that have been paid for with more than $15,000 from the Jesse Brittain Memorial Fund.

In general,


CBS 11's review of financial records obtained under the Public Information Act indicates that more than $40,000 was spent on meals and refreshments which were paid for with money from Brittain's Memorial Fund over the past two years.

Finally, CBS 11 documented how the Medical Center CEO was living high on the hog supported by tax-exempt donations.


Dr. Kern Wildenthal, the President of the University of Texas Southwestern Medical Center in Dallas, spent tens of thousands of donors' dollars on European trips, meals at five star restaurants, parties and expensive gifts, according to CBS 11's review of the state university's records.

CBS 11 uncovered more than $500,000 in expenses charged over the past two years to credit cards issued to Wildenthal and Cynthia Bassel, UTSW's Executive Vice President for External Relations. Financial records obtained under the Public Information Act indicate that most of the expenses were paid for with money that was donated to the medical institution.

The Southwestern Medical Foundation, the university's fundraising arm, paid for the bulk of the credit card expenses including:
--$533 for a donor dinner at a five star restaurant at the Hotel Meurice in Paris, France, for Wildenthal, his wife Margaret, British opera singer Robert Lloyd and his spouse and Andre Dunstetter, a Parisian social figure with ties to Dallas.
--$783 for Wildenthal's two most recent annual memberships in Mosimann's Dining Club, an exclusive restaurant in London.
--$459 for collectible Woodland Eagle dinnerware, including a platter and four mugs from Crow's Nest Trading Company, for two donors in April of 2007.
--$13,000 for tulip arrangements sent to donors for Valentine's Day over the past two years. A note on the 2007 order instructs the florist to deliver a half-dozen of the arrangements to Wildenthal's home.
etc, etc, etc

Also,


Both Wildenthal and Bassel have charged thousands of dollars to the credit cards for memberships in social and civic organizations. CBS 11's review found that donors' money from the Southwestern Medical Foundation was used to pay for Wildenthal's 2007 membership dues in the Dallas Symphony ($3500); Dallas Museum of Art ($5000); Nasher Sculpture Garden ($5000); British North American Committee ($6000); Dallas Women's Club ($850); and the SMU Town and Gown Club ($140).

As we noted earlier, the UT Southwestern mission statement is [with italics added for emphasis]:


* To improve health care in our community, Texas, our nation, and the world through innovation and education.
* To educate the next generation of leaders in patient care, biomedical science and disease prevention.
* To conduct high-impact, internationally recognized research.
* To deliver patient care that brings UT Southwestern's scientific advances to the bedside � focusing on quality, safety and service.

Somehow, I don't see anything about fancy wines, opulent dinners, and luxurious trips for the top leaders.

Once again, it appears that the leaders of large health care organizations fancy themselves different from you and me. They seem to feel entitled to membership in the power elite, to lead the high life (and not the version from a Miller beer commercial) while leading organizations that are supposed to focus instead on the community and to bring quality care to all patients' bedsides. I have no objection to good pay for people who work hard on behalf of the mission. But it is unseemly for leaders of not-for-profit health care organizations to live like minor nobility while so many health care needs remain unmet.

By the way, it may not be that what the University of Texas - Southwestern Medical Center was doing is unusual. In a summary of the case just published in the Nonprofit Quarterly, Rick Cohen wrote,


As studies from the General Accounting Office and the Congressional Research Service show, these nonprofit indulgences are frequently standard operating practice. The hospital has dismissed all criticisms by pointing out that UT Southwestern�s fundraising and expenditure patterns are right in line with nonprofit hospital practices nationally, including the proportion and nature of expenditures on fundraising including gifts for donors. They further suggest that donors to the UT Southwestern foundation fundraising arm know full well that their donations�classified as unrestricted�will be used for expenses that aren�t particularly focused on medical care or research, but for the CEO�s club memberships, upscale dinners and gifts for donors and bigwigs, and flower arrangements sent to the CEO�s home. Therein may be the real issue, not that UT Southwestern is behaving out of the norm, but that it is exactly within the mainstream of big nonprofit hospitals. And no one seems all that put out, because this is what is expected of big corporate institutions, for-profit, nonprofit, hospitals, universities, corporations, it really doesn�t matter all that much.

So it would surprise me not at all to find out that many executives of many academic medical centers and teaching hospitals are similarly living the high life. This, of course, goes along with many discussions on Health Care Renewal of health care leaders who seem to put their pocketbooks ahead of their patients. If this is as widespread as Rick Cohen and I think it is, why are we wondering why health care is increasingly expensive and inaccessible, while its quality declines, and health care professionals get ever more disgruntled?

Friday, 14 March 2008

Princess Health and Hacking an ICD - A Dual Medical Informatics/Ham Radio Perspective. Princessiccia

Princess Health and Hacking an ICD - A Dual Medical Informatics/Ham Radio Perspective. Princessiccia

Roy Poses wrote at "Hacking an ICD" that:

An ICD is a device whose correct operation is critical for the health and safety of patients in whom it is implanted. One would think that the managers responsible for the design of such devices would have pushed to make sure that the operation of such devices could not be hacked or accidentally altered in ways that could put patients' health and lives at risk.

Indeed.

It is probably not well known that in addition to being a Medical Informaticist, I am also a ham radio enthusiast, licensed at the Extra class. I know more about electronics than most physicians - and most IT people in hospitals to boot, although that often didn't matter in the dysfunctional world of hospitals and health IT.

As a medical informaticist and ham radio operator, I am concerned by the possibility of long(er) range hacking of implantable medical devices than that accomplished by researchers recently.

Apparently ICD's use a frequency of about 175 kHz for data communications. 175 kHz is in a band known as longwave. For comparison and orientation, the bottom of the familiar medium wave band -- a.k.a. ordinary AM radio-- is 520 kHz.

(An aside for those interested: shortwave starts at about 1,800 kHz or 1.8 MHz and extends to about 30,000 kHz or 30 MHz, and is called "shortwave" for historical reasons; the actual wavelengths are appx. 160 meters to 10 meters. These wavelengths were considered "short", comparatively speaking, in the early days of radio. The shortwaves have the property, under proper conditions, of being refracted back to earth by the earth's ionosphere and can be reflected by the earth itself. This allows the waves to do "multiple hops" and propagate over great distances far in excess of line-of-sight, even around the world. Hence the ability of ham radio enthusiasts to talk to people all over the world on the shortwave bands allocated to them.)

When I was 13 years old I built a one-transistor transmitter on a cigar box from a plan by Heathkit that transmitted low power morse code at a frequency of about 550 kHz. It ran off a few AA batteries and used a short wire as an antenna. It was easily receivable on a radio across the house.

The first cordless phones ca. early 1980s, wireless baby monitors, and other devices operated at about 1,700 kHz, just above the AM radio band. They were very low power devices with short antennas relative to wavelength (~175 meters) but were usable at dozens of feet from their base units.

Using an antenna, say, the size of a CB whip (properly loaded electrically to resonate at 175 kHz, not very efficient but usable), or even better, a directional loop antenna, plus a transmitter of 5 or 10 or, perhaps, 100 watts of power (not very hard to build), and using a sensitive receiver designed for those frequencies (my $150 retail Grundig Yacht Boy is an example, http://www.eham.net/reviews/detail/816) with modifications and a suitable low-noise receiving antenna, would potentially extend the range of communications with RF-controlled implantable devices.

Not to miles with any type of portable equipment, I should add, due to efficiency issues with very short antennas (relative to wavelength) and the low power of the ICD's transmitter, but tens of feet might be possible. Throw in digital signal processing on the hacker's receiver, which is available via common, cheap, off-the-shelf DSP chips and algorithms, and even more range would be likely. You would be surprised at what a DSP-equipped and/or computer-enhanced receiver can pull out of the "ether" even under extremely poor signal conditions.

One wonders if any ICD's transmitter and receiver are encrypted in any way - apparently the devices tested were not. My car FOB is, although even those can be hacked (e.g., "Prius Security System Cracked", http://www.treehugger.com/files/2007/08/a_talk_given_at.php):

A talk given at the computer security conference, CRYPTO 2007, explained how the key-fob system installed on the Toyota Prius has been cracked. The KeeLoq auto anti-theft cipher is used in common devices made by Microchip Technology Inc, which are also used by Chrysler, Daewoo, Fiat, General Motors, Honda, Volvo, Volkswagen, and Jaguar. The attack requires that the thief gets within range of your RFID keyfob, in order to break the encryption. This could mean stealing your keys, or just sitting next to you in a cafe with a laptop. The cipher used in these devices is 64 bit, which has always been theoretically possible to break, but has now been shown to be breakable in about an hour. This is important, because the shorter the amount of time required with the key, the more likely this attack is to become used outside of a research lab.

May I add that while encryption is not foolproof, lack of encryption seems the work of fools.

On a somewhat unrelated note, you can buy a wrist watch that picks up time-setting signals from an atomic clock via station WWVB, Fort Collins, Colorado (http://en.wikipedia.org/wiki/WWVB) at long wave frequency 60 Khz for $30. I have one and in Philadelphia, it works well.

Some hams bounce signals off the moon for earth-moon-earth communications. They use high power, high gain antennas, and very low noise receivers. It works quite well.

Never underestimate what can be done at RF.

On one (predictable) industry response:

Medtronic's Rob Clark said the company's devices had carried such telemetry for 30 years with no reported problems. 'This is a very low-risk event for patients that have these devices,' Clark said in a telephone interview."

It would have been just a bit harder to hack a computerized device 30 or 20 or even 10 years ago. When kids can buy a laptop with computing power exceeding that of the Cray supercomputer for $500 and crack into, say, the Pentagon's systems, we are indeed living in different times.

Dr. Poses also wrote that:

The most charitable explanation for why they [the manufacturers] did not think to [engineer ICD's to be exceptionally hacker-proof] is that they really did not understand the clinical context in which this device would be used.


I think a better explanation is that the manufacturers' management has little imagination and underestimate the capabilities of people much smarter and more creative than themselves (e.g., tech-savvy kids). It would not surprise me to find engineering memos warning management that more safeguards needed to be incorporated, only to be asked "What's the ROI?"

The bottom line is: manufacturers might need to work a little harder when they deploy wireless devices, as hacking of gadgets and computerized equipment such as cell phones seems to be an increasingly common pastime for today's youth. (It's too bad ham radio is itself losing numbers as the previous generation ages and dies out.) The internet itself is used to spread techniques and malicious code among hackers.

One can imagine the consequences of a malicious RF device hacker or smart-but-delinquent kid in, say, a crowded shopping mall.

Finally, ham radio experimenters worldwide are not unfamiliar with longwave experimentation. Note in particular the bolded statement below:

With no Amateur Radio low-frequency [longwave -ed.] allocation in North America, stations operating under FCC Part 5 Experimental licenses in the US or under special experimental authorizations in Canada nonetheless continue to research the nether regions of the radio spectrum. By and large, LF experimentation is occurring in the vicinity of 136 kHz--typically 135.7 to 137.8 kHz--where amateur allocations already exist elsewhere in the world. The FCC rejected the ARRL's 1998 petition for LF allocations at 135.7 to 137.8 kHz and 160 to 190 kHz, however, after electric utilities objected that ham radio transmissions might interfere with power line carrier (PLC) signals used to control the power grid.

"Most of the new LF activity of Part 5 licensees has been in the shared 137 kHz amateur allocation available in some parts of the world," says low-frequency experimenter Laurence Howell, KL1X/5. "Although not in the Amateur Radio Service, these Part 5 experimental stations continue to add to our knowledge on propagation and engineering."

The holder of Part 5 Experimental license WD2XDW, Howell who's also GM4DMA, previously operated LF from Alaska. He's since relocated to Oklahoma, and has now resumed his LF work on 137.7752 and 137.7756 kHz. Already he's reporting some spectacular success, despite antenna limitations. On October 28, New Zealand LFer Mike McAlevey, ZL4OL, copied WD2XDW's 137 kHz carrier "bursts" over a path of more than 13,000 km (8000 miles).


The take-away message is that:

  • In biomedicine, the most meticulous resilience engineering is never a bad idea.

When drug and device manufacturers understand this fully, perhaps we will no longer have incidents of bad health informatics that can kill.

-- SS
Princess Health and Hacking an ICD. Princessiccia

Princess Health and Hacking an ICD. Princessiccia

Implantable cardiac defibrillators (ICDs) are battery-powered, computerized electronic devices implanted in the body. They are designed to detect dangerous heart rhythms and administer a shock to the heart to stop these them. We have discussed these devices before, including a story about how one manufacturer suppressed data that suggested some of their ICDs were less reliable than heretofore thought.

It appears that a new, and potentially worrisome adverse effect of these devices has just been discovered.

An article to be published in the IEEE Symposium on Security and Privacy [Halperin D, Heydt-Benjamin TS, Ransford B et al. Pacemakers and implantable cardiac defibrillators: software radio attacks and zero-power defenses. IEEE Symposium Security Privacy 2008; in press. Link here.] demonstrated the vulnerability of an implantable cardiac defibrillator to computer hacking.

Let me set the stage. ICDs, and other implantable devices may need to be tested, and sometimes their functional parameters need to be adjusted. Obviously, it would be cumbersome and hazardous to remove such a device after it was implanted to check and adjust it. So the devices incorporate methods to check and adjust them remotely. It appears most do so using "wireless" means. Wireless, of course, is the traditional UK term for radio.

Halperin et al found that they could communicate with a representative ICD, the Medtronic Maximo DR VVE-DDDR model via radio. Note that the ICD they tested was not implanted in a patient, but sitting on a bench, and that their radio equipment used to "hack" it was in close proximity to it.

Once they figured out how to communicate, the found that they could:
- Discover patient data such as name, date of birth, medical ID number, and medical history
- Monitor electrophysiological telemetry data
- Turn off specific ICD functions
- Induce the ICD to deliver a shock, potentially one that could cause a severe rhythmn disturbance
- Increase the power consumption of the ICD so that its battery would fail prematurely.

Further, they found that they could overcome a design feature of the ICD meant to prevent anyone from communicating with it from more than a very short distance. The ICD is not supposed to respond to radio signals unless it is first exposed to a strong local magnetic field which triggers a magnetic switch in the device. But the investigators found, "in order to rule out the possibility that proximity of the magnet ... is necessary for the ICD to accept programming commands, we tested each ... attack with and without a magnet near the ICD. In all cases, both scenarios were successful."

Thus, this article suggested this ICD could be hacked, and that hacking it could pose significant risks to patients who had the ICD implanted.

Some people doubted that such hacking could actually take place in real-life, as opposed to laboratory settings. For example, per the AP story, FDA spokesperson Pepper Long "acknowledged a hacker could use specialized software and a small antenna to intercept transmissions from a defibrillator. But she said the chance of that happening � or of a defibrillator being maliciously reprogrammed using a technique similar to the one a doctor would use to program it � was 'remote.'" Furthermore, per the Reuters story, "Medtronic's Rob Clark said the company's devices had carried such telemetry for 30 years with no reported problems. 'This is a very low-risk event for patients that have these devices,' Clark said in a telephone interview."

In my humble opinion, however, the problems that Halperin et al found with the Medtronic ICD have real importance. Let me first note that both the FDA and Medtronic representatives treated the issue epidemiologically. They based their pronouncements on the assumption that an adverse event that has not happened in the past due to a device in wide use is not likely to happen in the future. That does not make sense if the potential adverse event would involve conscious, malicious human action. Just because hackers have not yet attacked an ICD does not mean they will not do so in the future, especially after the possibility of doing so has gotten wide publicity.

Another way some have minimized the practical importance of their findings is that the experiment by Halperin et al was carried out on an ICD on a bench, using equipment that was in close proximity. Some may thus feel that the possibility of hacking carried out from longer range is low. I strongly believe that is not a good assumption. Many features of the ICD and its radio communication system suggest that hacking could be carried out from considerably longer range. There are hints in the Halperin et al article that could suggest to anyone moderately knowledgeable about radio how this could be done. I do not want to discuss these in any more detail, because I do not want to facilitate such long-ranging hacking. But I believe it is a real danger.

But why is this relevant to Health Care Renewal? It seems glaringly obvious that the risk of hacking could have been substantially reduced had the ICD been designed so it would not respond to any radio communication that did not have an appropriate authorization code, and/or if communication with it were encrypted. In fact, Halperin et al suggested some relatively simple measures that could be used to increase the security of these devices. Yet the Medtronic ICD, and presumably other ICDs and implantable devices, were not designed with such elementary security precautions in mind. As security expert Bruce Schneier wrote (reported in Information Week),

Of course, we all know how this happened. It's a story we've seen a zillion times before: The designers didn't think about security, so the design wasn't secure.

But an ICD is a device whose correct operation is critical for the health and safety of patients in whom it is implanted. One would think that the managers responsible for the design of such devices would have pushed to make sure that the operation of such devices could not be hacked or accidentally altered in ways that could put patients' health and lives at risk. The most charitable explanation for why they did not think to do so is that they really did not understand the clinical context in which this device would be used.

This is yet another reminder that those who run health care organizations often fail to think about patients' welfare first instead of other considerations. We need to change the culture of health care organizations to put patients first. Until we do so, we are going to get hacked.