Mark’s Daily Apple

The Heparin Controversy7

If you're new here, you may want to subscribe to my RSS feed. Thanks for visiting!

Bag of Trouble

This morning’s New York Times reports that the FDA is now echoing what many scientists and industry experts have been saying for weeks: the contaminated stores of heparin that have been associated with 81 deaths and 785 severe allergic reactions in the U.S. was likely adulterated on purpose. In March, the FDA issued a major recall of heparin following increasing reports of adverse reactions and deaths connected with the drug.

Tests have shown that heparin components made by a company in China (Changzhou SPL) were contaminated by a manipulated form of a dietary supplement, oversulfated chondroitin sulfate. Because the cheaper additive resembles heparin, routine screening didn’t reveal the contamination. Contaminants comprised up to a third of some heparin samples that were tested. Dr. Janet Woodcock, director of the Food and Drug Administration’s drug center explained, “[I]t does strain one’s credulity to suggest that might have been done accidentally.”

Heparin is a blood thinner used in dialysis, heart surgery and other medical treatments. Components, known as active pharmaceutical ingredients or APIs, of the drug were made by the Chinese company and then used by Baxter International to manufacture the final product.

Earlier this week family members whose loved ones had died after receiving the drug spoke before a Congressional subcommittee, as did FDA officials and leaders of Baxter International, who support the claim that the heparin ingredient was deliberately contaminated.

The incident has caused a major uproar on Capitol Hill with members bearing their teeth for cameras. As recent commentary in the New England Journal of Medicine notes, the target of their ire is the FDA, the federal agency in charge of regulating “$1 trillion of consumer products or 25% of the U.S. consumer economy” with a budget of “$1.57 billion — less than 75% of the budget for the school district in its home county in Maryland.” The FDA doesn’t have anywhere in the ball park enough to cover the inspection needs of today’s global marketplace. At best, the agency has the manpower and funding to inspect 7% of foreign drug/API manufacturers. Despite switching to a risk-based model to prioritize inspections, the inspection system is fraught with issues, including an inability to perform inspections without notification and limitations in inspection thoroughness because of inadequate translation services.

While the FDA is being grilled over hot coals, little if any complaint is being directed at Baxter International itself, the company that outsourced the production of the heparin components in order to enhance its profit and not conduct its own inspections to ensure safe manufacturing practices. Before the anti-capitalist accusations start slinging our way, it’s important to note that we have nothing against companies making money. (Shouldn’t that be obvious?) But the question of the day is who will protect consumers from the deleterious effects of adulterated drugs? Call us what you will, but we believe people should be able to take the drugs they need without wondering if they’re getting what the label says they’re getting or if they’re playing a medical version of Russian roulette.

And as for the argument that the companies will choose to ensure safe practices in order to avoid lawsuit? Well, the heparin controversy is case in point to show companies don’t always operate on those principles. Some do, some don’t. And it may only get worse. As another commentary from last week’s NEJM noted, this February the Supreme Court ruled that FDA approval of medical devices “precludes lawsuits brought by patients against the manufacturer over adverse events in state courts.” As a result of this ruling, patients cannot bring a lawsuit (or truly expect to win one anyway) when harmed by a medical device that the FDA has previously certified as “generally safe and effective.” The Supreme Court will hear a “similar case” regarding pharmaceuticals later this year. This should get interesting.

We aren’t, are not, in no way, shape or form, arguing against a free market. But the “market,” as we know, serves people – mothers, fathers, kids, grandparents, neighbors and friends. We simply can’t have it every way: no inspection responsibility for manufacturers, no real money or authority for a federal regulation agency, and (potentially, later this year) no recourse for patients and their families.

With more than 80% of drugs or pharmaceutical components now made in other countries (primarily China and India) the problem isn’t going to magically dissipate into the atmosphere (although it might disappear into the back pages of newspapers for a while as other events grab the media’s attention). Fixing this debacle takes some hard questioning about how we want our system to operate. The question becomes: who should we trust as we swallow that prescription? Bottom’s up!

Tell us what you think.

flippy rice Flickr Photo (CC)

Further Reading:

Deconstructing Healthcare in America - A Modest Proposal

Where Have All the Studies Gone?

Pharmalot: Should Drugs Carry Country of Origin Labels?

Posted: Big Pharma

News on the Seedling Front4

Protect those seedlings!

A report out this week offered some of the latest news on children’s health in the United States. Researchers from Duke University and the Foundation for Child Development studied trends in the health of children up to eleven years of age. We always want the good news first, right?

Researchers found some (very) positive trends, including “dramatic improvements” in mortality rates. The mortality rate for children one to four years of age in 2005 was 29.4 per 100,000 births compared with 42.9 per 100,000 just eleven years earlier in 1994. Death rates in middle childhood fell by 27% during the same time period. Finally, lead poisoning levels have fallen by 84%. Now that’s news worth celebrating.

On the flip side, however, researchers confirmed what other studies (and a quick look around the mall) have suggested. The report says the overall health of American children is now compromised by higher obesity rates and an increase in the percentage of babies born with low birth weight.

While U.S. children overall have seen improvements in their well-being in recent years, American children aged 6 to 11 are four times more likely to be obese than similarly aged children in the 1960s, the report found. …The researchers found obesity among children in middle childhood is nearly four times more common than in children of the same age in a national survey in 1960s. For children aged 2 to 5, it is three times higher. …They also found that the percentage of babies born with low birth weight rose 12.3 percent from 1994 to 2005, an increase they said was likely tied to delayed childbearing among working mothers and an increased use of fertility drugs. Low birth weight has been linked in large studies to a higher risk of developmental and learning problems and to lower academic achievement. It also has been linked with higher rates of chronic health conditions.

via Yahoo! News

Unfortunately, the bad news doesn’t end there.

Another recent report by a California-based health care provider estimates that the diabetes rate among pregnant women skyrocketed between 1999 and 2005, doubling in number. Researchers based their estimate on the records of over 175,000 mothers who gave birth in a consortium of hospitals between 1999 and 2005. Diabetes in pregnancy results in higher risk of birth defects, miscarriage, and stillbirth. As mentioned yesterday, women who have developed insulin resistance can pass that condition on to their children.

Clearly, we have the medical knowledge and resources available to ensure the health of our children and save lives. The improvement in mortality rate is a testament to that potential. Nonetheless, we struggle with the most basic principles of healthy living, and our children are suffering for it. Diabetes and its associated risks as well as childhood obesity threaten to undo the benefits modern medical developments offer. And as for the rise in low birth weight, though the researchers chose to chalk it up to fertility drugs and older mothers, there are plenty of other primary causes for low birth rate, including poor nutrition, abnormal pre-pregnancy weight, smoking, anemia, multiple gestation and medications or conditions that inhibit nutrient absorption. Hmmm. How common might those be in women of child-bearing age in our country today?

The bottom line is this: our society has yet to make a real commitment to children’s total health and well-being. Every player in the game (schools, parents, businesses, government, etc.) could do better. Our conceptualization of health care is too heavily based on a condition treatment model. No condition? No care or concern necessary. Health is more than a lack of symptoms and disease. It’s a spectrum of wellness with lack of disease and symptoms not on the positive end but smack dab in the middle. We’re failing our kids with our low health expectations, which we pass down to them like we apparently do our myriad of medical conditions.

Comments? Rants? Solutions? Share ‘em please.

Beppie K Flickr Photos (CC)

Further Reading:

School Menu Trends - ‘A’ for Effort?

That’s Fit: Babies Need Sleep to Protect them from Obesity

fitsugar: Gym for Kids?

Posted: Health, Prevention, Raise Healthy Seedlings

10 Ways to “Get Primal”25

Here at Mark’s Daily Apple, we advocate the Primal Blueprint Lifestyle, that is, a health philosophy that in large part acts to mimic the diet and physical activity of our pre-agricultural ancestors.

And, while we’ve explained in the past what it means to “Get Primal,” we figured what’s not to love about a bulleted list that reminds us how to incorporate these methods into our everyday lives.

Read on to learn how you can get primal on every level on every occasion:

Hike:

Whether it was searching for food, shelter or just greener pastures, our ancestors spent a lot of time taking the heel-toe express! (Though, it wasn’t exactly heel-toe in those days.) These days, of course, we have planes, trains and automobiles to get us from A to B, which means hoofing it has become our least likely mode of transport. To get back to the Primal Blueprint, set aside some time every week to participate in sustained activity as a way to return your body to its natural state (that is, being in a constant state of motion). And, although hiking was the primary modality for sustained exercise for our predecessors, feel free to substitute it for biking or any other low-level physical activity you can do for a long period with little interruption.

Sprint:

Although eat or be eaten is no longer really considered a threat in today’s society, for our ancestors, it was a pretty big (and potentially lethal) deal. The solution? Run fast, run hard, and run for your life! You can incorporate these same theories by adding a series of short sprints into your exercise routine (see Mark explain his sprint routine here). The idea here isn’t necessarily to be the fastest kid on the block (although that would be awesome), but rather to give all you’ve got for a brief period of time. Also, bear in mind that this concept of going hard and fast for a few seconds isn’t limited to the act of sprinting; you could try water sprints, power cycling, jump rope intervals or any other activity that requires short, intense bursts of energy.

Lift Hard:

Think Cavemen killed time pounding weights in a dingy gym? Think again! Our ancestors tested their strength only in real-life situations (as opposed to having a pose-off with the meathead in the cut-off shirt!) and grew strong by doing, for the most part, weight bearing exercises. Naturally, they focused on activities that would help them carry out real life functions. Want to work out like your primal ancestors? Try weight bearing activities such as squats or dead lifts, which our ancestors did when lifting a heavy rock or log for building; lunges, which mimic the action of transversing steep terrain or stepping into a throw; pull-ups and standing rows to mimic the movement of pulling a heavy object towards the body; pushing, to mimic the motion of… well, pushing things; and twisting motions such as medicine ball throws or cable woodchoppers, which our ancestors did when throwing spears or hoisting objects. For a new challenge (and an exercise that combines just about all of the above motions, try the Turkish get-up:

Ditch Grains and Sugar:

With the tagline “so simple even a caveman could do it,” the commercial suggests that our ancestors were, well, not the sharpest tools in the shed. But, clearly they were smart enough to shun grains and sugar (a feat that the majority of current day Americans have yet to accomplish). In fact, according to some anthropologists, our ancestors only consumed about 80 g of carbohydrates per day, largely because sources of carbohydrates – such as grains, beans and potatoes – are toxic in raw form. To keep it primal, avoid all grains, including bread, pasta, rice and noodles, and all refined sugar. It should also probably be noted that the majority (if not all) of processed foods are packed with carbs - either in the form of a grain, sugar, or both - so it’s best to cut those out too!

Eat Meat and Fish:

When dinner time rolled around for our ancestors, they weren’t exactly reaching for the yellow pages! Instead, they were reaching for a spear, ax or some other weapon to catch their meal. While we’re certainly not advocating that you begin hunting for your own entrees (people might talk!) we do recommend that you begin thinking about your diet in a way that resembles their dietary habits. That is, if you can’t catch it or find it in nature, you can’t eat it. In short, opt for meat and fish and don’t get hung up on the fat content. Not only is fat integral to health, it will also help keep you feeling satiated longer!

Eat Berries, Nuts and Unbridled Amounts of Veggies:

Again, when selecting foods, remember that you’re playing the role of the hunter and gatherer, so feel free to indulge in foods you would find in nature. Specifically, the Primal diet recommends berries, which are low in sugar and packed with vitamins, antioxidants and other beneficial nutrients, and nuts, including walnuts, brazil nuts, macadamias and almonds (but not peanuts which are a legume and should also be avoided for fear of aflatoxins). When it comes to vegetables, seek out root vegetables including carrots, turnips, parsnips, rutabagas and Swede (but not potatoes or other starchy, high-carb varieties), leafy greens, tomatoes and other brightly-hued vegetables (which not only add color to dishes, but also seriously improve the nutrition value).

Drink Water:

Although there is some back and forth about how much water our early ancestors actually consumed (with some anthropologists suggesting that early man got most of his water from the vegetables he consumed as opposed to risking his life standing in line with the other predators and prey at the local waterhole), the reality is that even if early man didn’t consume that much pure water, he certainly wasn’t reaching for a Coke. Get back to your primal roots by ditching the Gatorade, the soda (including the diet ones – they’re nearly as bad!) and especially the juice. All you really need is water, and lucky for you, it’s as easy as turning on the tap.

Sleep Smart:

When the sun went down, early man started prepping for bed. When the sun sets today, most men (and women) will do the dishes, watch Grey’s Anatomy, finish up paperwork, pay bills and check their email before falling asleep with the television blaring Conan O’Brien. No offense to Mr. O’Brien, but when nature starts heading to bed, so too should you. To catch Zzzs like our ancestors, remove all electronics from the bedroom and focus on creating an environment that is dark, quiet and serene. Also, while it might seem counterintuitive to not close the blinds, allowing natural light to be your wake-up call is far more refreshing (and natural) then waking to the shrills of an alarm clock.

Relax:

As much as we harp on about how hard early man had it (what with having to work hard to survive and all that), make no mistake, early man liked his downtime too! Unlike our ancestors, however, many of us tend to spend our downtime plunked in front of the TV or computer engaged(?) in mindless activity for hours on end. To get back to our primal roots, select an activity that will clear your mind and help you recharge and refocus. And don’t forget that part of this getting up and moving around a bit.

Crack a Coconut, Spear your Dinner and Sleep in a Cave:

Ok, maybe we’re kidding on this last one. But imagine how primal it’d make you feel!

mutbka, Jasmic, hrtmnstrfr, Bern@t, Genista, paurian, Snap, jahdakine, Mai, OnuRoca Flickr Photos (CC) and nightowl27 YouTube Clip

Further Reading:

My Knee is Killing Me… No Really.

Would Grok Chow the Cheese Plate?

What Mark Eats in a Day

Posted: Diet, Fitness, Health, How To, Nutrition, Personal Improvement, Primal Health, Stress, The Tuesday 10, Videos

Dear Mark: Gene Expression10

Covering Your Bases

I received tons of emails from last week’s Gene Expression: Location, Location, Location post. Thanks to everybody for their feedback and questions. In the comment section of last week’s post, Ed was interested in other concrete examples of gene expression (the ability of a gene to produce a biologically active protein). In personal emails, others asked for more explanation of the difference between genes and gene expression. Still others wanted to hear more about the interaction between their gene expression and lifestyle choices. Given the range of reader questions this week, I thought I’d reframe this week’s Dear Mark to include more of an overview of this recurring MDA theme. There’s a lot to be said on the subject, and I promise this post won’t be the last word on it. Nonetheless, there’s no time like the present to give a proper introduction and dive right in.

Let me just say that gene expression is one of my favorite areas of interest, and it’s truly at the heart of the Primal Blueprint. In fact, it’s the real beauty of it as well. It confirms that the day-to-day choices we make have incredible impact. And we can influence gene expression to a far greater degree than anyone ever thought possible.

Everyone has the DNA “recipe” to build a human being. The DNA itself is not really so much a “blueprint” (as many people assume) as it is a recipe. As with all recipes, it allows for a little variation to spice things up and even room for improvement. That means that some ingredients can change a little and you still wind up with the intended result. A little more sugar, a little less salt, an added spice, a lower cooking temperature: the end result still resembles the picture in the cookbook.

We often hear about the computer hardware/software analogy. An analogy I like to use is that of a book and its readings. Your genome itself (your DNA) is fixed and can’t be changed. It is the book itself. Once it’s been written (and in this case each of your 60 trillion cells has the exact same copy of your story), you can’t change the words. But a book, even though it’s fixed, can be read differently by different people. (Imagine three different screenwriters taking the same book and coming up with three very different movie versions). The lines themselves are altered in the context of the interpretation.

Similarly, while your genes are “fixed”, the expression of those genes – the amount of proteins they cause to be made, whether or not they are even switched on or off at all – depends on the “environment,” the circumstances surrounding those genes. Diet, exercise, exposure to toxic chemicals (or fresh air), medicines, even the thoughts you think (which generate actual chemical signals) all influence gene expression – positively and/or negatively, depending on the choice. Eat a diet that is high in sugar, and gene expression moves in a direction that produces more insulin, that shuts off insulin receptors, that down-regulates lipase and other enzymes involved in fat-burning, that increases pro-inflammatory cytokines, etc. When you change to a diet low in sugars and rich in healthy fats, those or other genes are directed to reduce inflammatory expression, down-regulate insulin-producing metabolic machinery, up-regulate insulin receptors and rebuild cell membranes to reflect the presence of better building materials (omega 3 fatty acids, etc.). Research in gene expression is exploding right now and is examining both the impact of environmental factors and the promise of epigenetic therapies. The connection between insulin resistance and genetic expression (particularly in relation to exercise) was raised in last week’s comments. Diet and toxin exposure have been shown to influence gene expression in laboratory studies. Here are a few study abstracts to pique your interest: PubMed 1, 2, 3.

The interaction between lifestyle choices and gene expression goes on every second of every day you’re alive. You are literally rebuilding yourself all the time. That’s the message of hope that the Primal Blueprint offers. Even if you have so-called markers for “defective” genes, that doesn’t mean they will be expressed. Gene interaction is such that environmental factors can potentially allow for someone with BRCA1 and BRCA2 (associated with a very high risk for breast cancer) to never get breast cancer if those and related genes are properly controlled through environment. On the other hand, a woman with no risk factors can still get breast cancer if she directs gene expression towards pro-inflammatory pathways, then down-regulates other parts of her immune system.

As I mentioned last week, most of today’s genome investigation centers on SNPs (single nucleotide polymorphisms) that predispose the possessor to a particular condition (cancer, heart disease, obesity, diabetes, arthritis, etc). I’ve always said that a predisposition is not your final destiny. Even aging itself is highly influenced by gene expression over time. In the course of a lifetime, stem cells divide to repair injury (e.g. inflammation). In doing so, the cells are continually aged. The more the cells have to repair, the faster a person ages. This, of course, is a manifestation of gene expression.

The whole idea behind my Primal Blueprint is this: we know that we can influence gene expression, but – more than that – we know HOW to influence it in a direction of health, fitness, productivity, happiness, etc. The “blueprint” is not the DNA but a set of lifestyle and behavioral guidelines that, if followed, allows you to recast yourself as a healthy, fit person using “controlled gene expression”. The “primal” part comes from the recognition that our basic human DNA is relatively unchanged from the past 10,000 years. As long as we understand what it took to evolve to that point, we can find ways to continue to influence gene expression that are in alignment with that pre-agricultural DNA.

Thanks again for your comments and questions, and please keep them coming.

Dollar Bin, ott1mo Flickr Photos (CC)

Further Reading:

More Primal Blueprint posts

Gotta Love that Genome

Posted: Health, Personal Improvement, Prevention, Primal Health

Urban Areas Becoming Supermarket “Deserts”2

Where have all the grocery stores gone?

A study published in the International Journal of Health Geographics suggests that as more and more supermarkets leave cities to set up shop (literally!) in the suburbs, urban areas are increasingly at risk of becoming “food deserts.”

For the study, researchers at the University of Western Ontario in London, Ontario, used geographic mapping techniques to map the locations of supermarkets in 1961 and 2005 and then analyzed the results based on neighborhood location, socioeconomic characteristics and access to public transportation.

Based on this analysis, the researchers determined that fewer than 20% of residents living in the “urban core” of London have access to supermarkets today, down from more than 75% who had easy access in 1961. They also note that spatial disparities in access to supermarkets have increased significantly, with residents of inner city neighborhoods with the lowest socioeconomic characteristics experiencing the poorest access to supermarkets.

Although this study was conducted in Canada and focuses only on supermarkets in London, Ontario, the researchers note that similar trends have been observed in Northern America as well as the United Kingdom.

So what’s causing the exodus? The researchers hypothesize that increased urban development as well as the constant need for space could partially be to blame, but note that in the end, it all comes down to dollars. You see, supermarkets need to be located in affluent areas in order to be successful and have actually begun targeting their product lines (i.e. catering to those searching for “one-stop-shopping”) in order to meet the needs of the suburban market.

Now, if you’re wondering what us city dwellers do, you’re pretty much in the same position as urban planners and public health policy experts. Why would they get involved? Well, the bottom line is that access to food – and produce in particular – is directly associated with health. In fact, a report by the New York City Department of Health has suggested that neighborhoods with the least access to fresh produce have greater rates of obesity, which in turn increases the likelihood of chronic disease, including type 2 diabetes, heart disease and certain types of cancer.

But before you get all bogged down and begin to think that the poor city mice are starving, consider this: many large cities have taken steps to increase access to fresh produce. In New York City, for example, lawmakers recently passed legislation to add 1,000 more “green carts,” that is, vendor stands serving only fruits and vegetables, to the city’s existing fleet of 4,000. While these carts have traditionally been clustered on the city’s wealthy Upper East Side, this time, the permits require the carts to be set up in low-income and otherwise under served neighborhoods, where access to fresh produce is often scarce.

Elsewhere, many cities are jumping on the farmers’ market bandwagon. According to recent statistics from the U.S. Department of Agriculture (USDA), the number of farmers’ markets nationwide increased more than 7 percent from 4,093 in 2005 to 4,385 in 2006. As a result of this increase, total sales volumes for farmers’ markets increased from an estimated $888 million in 2000 to about $1 billion in 2005, with 25% of farmers participating in a recent survey reporting that they relied on farmers’ markets as their sole source of farm-based income. Furthermore, the USDA has created programs such as the Women, Infants and Children (WIC) Farmers Market Nutrition Program and the Senior Farmers’ Market Nutrition Program to both support the farmers and ensure that low-income residents have access to fresh produce.

So while the study does support the theory that supermarkets are declining in urban areas (and what they do stock isn’t worth showing off in a fruit bowl!), it would seem that city residents have a number of new options for obtaining produce.

Don’t have any farmers’ markets in your area? Visit this site for information on who to contact and what to do about adding one in your town!

kansasexplorer, Steve Crane Flickr Photos (CC)

Further Reading:

It’s My Neighbors Fault I’m Fat

The Poor Body

High-Density Fast Food Joints = High-Fat Fast Food Eaters

Posted: Health