Unapproved drugs

Imagine a world in which the pharmaceutical industry were permitted to develop drugs, then bring them directly to market, no regulatory process required. They develop a drug to treat a specific condition, like toe fungus or depression, then introduce it to market for pharmacies to sell and physicians to promote (since that is now the new de facto role of physicians: drug marketers). No FDA application required. The developer might have performed the usual phase 1, 2, and 3 clinical trials, they might have not. They can just bring it to market, no questions asked about safety, efficacy, or suitability for human consumption.

Imagine the mess that would result. It would be pure profiteering and marketing.

While the FDA process is far from perfect, it does introduce a level of scrutiny, a requirement to test for safety and, to some degree, efficacy. Anyone who has contributed to these sorts of trials or seen the incredible reams of paperwork filed for an FDA New Drug Applications knows how demanding these requirements can be.

There is no such requirement for food crops widely consumed by humans. This comment from two agricultural geneticists in the business of generating new wheat breeds sums it up well:

The growing world-wide demand for wheat is placing pressure on breeding programs to produce elite cultivars that can adapt to a range of environments without compromising agronomic performance, grain quality or disease resistance. Wheat-breeding efforts focus on developing new varieties with improved disease resistance (to nematode, fungal and/or viral infection), tolerance to abiotic stresses (such as heavy-metal toxicity, drought and cold tolerance) and numerous grain quality attributes that affect baking and other uses of the final product. The combination of existing knowledge and resources with modern biotechnology and functional genomics is providing the opportunity to study the genetic, biochemical and physiological basis of these complex traits. Current efforts aim to address the major challenge of capturing the information from both wheat and model organisms, such as rice and Arabidopsis, in order to define genes that underpin the unique attributes of wheat. The resources being developed using biotechnology include comprehensive mapping initiatives and genome-wide expression studies; these need to be implemented together with wheat-breeding programs, in conjunction with high-throughput screening, to efficiently develop new, improved wheat varieties.

Agricultural geneticists are concerned about issues like yield, disease resistance, drought tolerance, and aesthetic qualities of the final product (e.g., bread texture) . . . but not effects on humans who consume these crops. You could read on, but nowhere will you find a comment like this:

Given the extensive genetic changes we introduce into unique strains of plants, both anticipated and unanticipated, it is important to bear in mind that such changes frequently result in biochemical differences in the eventual end-product. Insertion of a simple stop codon, for instance, to prevent the translation/transcription of a specific polypeptide may result in ‘downstream’ expression of (or failure to express) other plant components. Unique amino acid sequences in plant proteins have potential to generate allergenicity and immunogenicity to humans in ways not previously seen. Such changes must be assessed biochemically and, in selected cases, in clinical studies to assess safety for consumers prior to distribution.

In effect, 50 years of plant hybridization, crossbreeding, backcrossing, chemical and radiation mutagenesis (induction of mutations) and now gene splicing (“genetic modification”) have allowed the appearance of new compounds in food crops, most of which have not been studied but are widely consumed by humans. Agricultural genetics has, in effect, permitted the appearance of multiple new “drugs” on the market without any regulatory scrutiny or safety testing in animals or humans. The result: Commercial foods that have poorly-understood effects on humans.


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Comments & Feedback...

  1. aerobic1

    Sort of reminds me when the discovery of hydrogenated fats occurred in the 1890”s and everyone thought it was revolutionary. Then, it took over 60 years before the light went on in someone’s head and realized the lipase enzyme could not breakdown and metabolize hydrogenated fats which resulted in the development coronary heart disease.

  2. One of the unintended consequences of “FDA approval” and government-required nutrition labels is that we are *not* sufficiently skeptical of drug or nutrition claims. For instance, some big problems right now are that statins and “healthy whole grains” have the government “seal of approval.” I would argue that if the government was taken out of the picture completely, as in your opening hypothesis, the result would *not* be chaos — especially in the Internet Age, where it is relatively easy to fact-check, and report on who is lying. I”d bet that there would be some private companies stepping in to fill the gaps, and that motivated private individuals would be capable of keeping them honest.

    We trust the government entirely too much. The basic problem is government power. Because the government has so much power, it attracts corruption. The real solution is to abolish the USDA, FDA, and a couple of dozen other bureaucracies staffed by people who know less than nothing about medicine or nutrition, but have the power to dictate to you and me the drugs we are prescribed and the (dis)information in our food labels.

    • Jennifer Snow

      Yes, we totally need more government regulation. After all, the government has NEVER gone around promoting “healthy whole grains”. Clearly the government is the perfect source of health and nutrition advice, while those evil profiteering corporations who have to, say, actually worry about losing their customers and going out of business can”t POSSIBLY be trusted to provide us with quality products without somebody with a political agenda breathing down their neck.

      • aerobic1

        Please be careful what you wish for as you just might get it. Actually, we already have the government intervention you hope for in the form of government taxpayer subsidies to the wheat industry to the tune of $34,249,174,653.00 between 1995 and 2010. But, this bad behavior has gone on much longer than that. Our elected officials have been lobbied by the wheat industry to prop up this unhealthy commodity that cannot stand on its own two feet. What did all that government welfare get us: diabetes, heart disease obesity of course? I would not be so upset if they would subsidize healthy vegetable and fruits.

        If wheat is so good for all of us then this commodity should be able to stand on its own two feet be free of taxpayer subsidies. But today”s wheat is an inferior product. Subsidies invariably create overproduction and wheat surpluses. Wheat must then be literally exported at below world market prices so the grower”s profit is actually the subsidy itself courtesy of the US taxpayer.

        • It is truly an absurd comedy that has been created, Aerobic.

          I didn”t realize that the subsidies were so sizable. Hmmm. Good topic for discussion!

          • aerobic1

            If you suffer from high blood pressure you may not want to delve into this: http://farm.ewg.org/top_recips.php?fips=00000&progcode=wheat&regionname=theUnitedStates. You will see who received these subsidies and how much each one received. Some recipients were state governments and others were private corporations.

            Quoted from above source: The federal government provides a “safety net” to agricultural producers to help them through the variations in agricultural production and profitability from year to year – due to variations in weather, market prices, and other factors – while ensuring a stable food supply. However, this support is highly skewed toward the five major “program” commodities of corn, soybeans, wheat, cotton, and rice. A handful of other commodities also qualify for government support, including peanuts, sorghum, and mohair, though subsidies for these products are far smaller. Dairy and sugar producers have separate price and market controls that are highly regulated and can be costly to the government.

            Despite the rhetoric of “preserving the family farm,” the vast majority of farmers do not benefit from federal farm subsidy programs. Small commodity farmers qualify for a mere pittance, while producers of meat, fruits, and vegetables are almost completely left out of the subsidy game (i.e. they can sign up for subsidized crop insurance and often receive federal disaster payments).

            Notice the carb producers get the highest preponderance of taxpayer support. This in turn creates the multitude of co-morbidities we are faces with

        • Boundless

          > … Please be careful what you wish for as you just might get it.

          The USDA is also still running a price support program for tobacco, nearly a half century after the OSG exposed it as a poison.

          And for those who want more FDA intrusion, the FDA already has the power to investigate, and if needed, ban things sold as “food”, but is apparently doing nothing about wheat … not even asking their sister agency, the USDA “are you really sure about that grains thing on the plate”?

          • Jennifer Snow

            What we really need is to get the government out of the business of trying to run people”s lives for them. People ARE capable of making decisions on their own, after all. Wheat Belly being proof of this.

  3. ri

    Hi Dr Davis
    i know you”ve previously touched on the topic of saturated fat and peoples concerns with consuming this fat in their diets but could you please reiterate for me what your take on saturated fat in the diet is because everywhere i go i read that these are ”bad fats” found in meats butter cream etc and we should steer clear and consume only good fats (or unsaturated and monounsaturated fats) – im concerned about any health implications that might come with consuming too much saturated fat such as clogging of arteries and of course dreaded weight gain since there are more calories per gram of fat than there are per gram of carbohydrates. I was searching for a post on the topic but nothing came up. If there is a link you could send me that would be great-or a page number in the book (im currently in the middle of reading it for the second time). I do love the rich taste of cream in my coffee as opposed to skim milk but i must admit it feels like a bit of a guilty pleasure..
    Thanks again!

    • Jeff

      Everywhere you go, you”re seeing the “conventional thinking” (some call it conventional wisdom, but it clearly isn”t). It”s looking at the caloric difference that caused the errors in judging what”s good and what”s bad. Just because carbs have fewer calories than fat doesn”t make carbs better for you than fat. Humans evolved on a high-fat, low-carb diet. It is the high-carb, low-fat Standard American Diet (SAD) that has gotten Americans so out of shape, not fat. In the book, Dr Davis explains that if you use dairy, use the full-fat versions. Of the “good” fats listed in Wheat Belly, coconut oil is a saturated fat. The body needs fat in the diet to convert to energy. If you restrict your fat intake, you may lose muscle on a weight-loss effort instead of fat. To lose fat on a diet, you must consume fat.

    • Jennifer Snow

      There”s no evidence to support the idea that saturated fats will clog your arteries and lead to heart disease, and, in fact, there”s strong evidence that one of the major contributing factors to the progression of heart disease is consumption of carbohydrates, wheat included. Carbohydrates cause your body tissues (including your arteries) to gradually degrade and go rigid due to a process called glycation.

      Mono and poly-unsaturated fats, on the other hand, have been strongly linked to higher incidence of cancer, perhaps in part due to their cholesterol-lowering attributes. People with lower cholesterol generally develop more cancer.

      Given the choice between fat that doesn”t actually cause heart disease and fat that likely DOES contribute to cancer, I know I prefer saturated fats all the way.

    • Ri: You need to sharpen up your Google search terms, just search ”why saturated fats are good”, here, I did it for you, and especially click on the link ”Enjoy Saturated Fats, They”re Good for You! by Donald W. Miller, Jr.”. http://goo.gl/uvB1A

      Good natural saturated fats DO NOT clog your arteries, coconut oil melts at 76 degrees, butter at 95, so the only way these two could ever become a solid in your 98.6 degree body is if your arteries are at room temperature, which would mean you”ve got bigger problems than just eating butter & coconut oil! If you ever hear anyone tell you to avoid fats that are solid at room temperature, RUN!, get away as fast as you can because that person is a MORON!

      “Cholesterol and cancer: The parent omega-6 connection explained:
      It’s not the saturated fat. It’s the adulterated parent omega-6 that clogs arteries and impedes blood flow. Contrary to what we have heard for decades, it is not the saturated fat clogging your arteries. A groundbreaking 99 Lancet article reported investigating the components of arterial plaques; they measured the individual components. In an aortic artery clog, they found that there are over ten different compounds in arterial plaque, but NO saturated fat.
      There was some cholesterol in the clog. This is explained by the fact that cholesterol acts as a protective healer for arterial cuts and bruises just like a scab forms over external cuts. What is the predominant component of a clog? You probably guessed it—the adulterated omega-6 polyunsaturated oils—those that start out containing properly functioning EFAs but get ruined during commercial food processing. Many similar analyses showing the same result have been carried out regarding arterial clogs and published in the medical journals, but few physicians have seen them.” http://goo.gl/xGEB2

      There is NO biological mechanism in the human body for dietary fat to store as excess body fat causing obesity, the primary metabolic pathway of dietary fats is for beta oxidation, your cells use them to produce energy. http://goo.gl/4a0JF

      That”s also why fats have 9 calories per gram while carbs & protein only have 4, and people forget that the ethanol in the alcohol has 7 calories. You actually get fatter and gain more water weight from carbs than from fats, Wikipedia explains why:

      “Fatty acids are an important source of energy because they are both reduced and anhydrous. The energy yield from a gram of fatty acids is approximately 9 Kcal (37 kJ), compared to 4 Kcal/g (17 kJ/g) for carbohydrates. Since the hydrocarbon portion of fatty acids is hydrophobic, these molecules can be stored in a relatively anhydrous (water-free) environment. Carbohydrates, on the other hand, are more highly hydrated. For example, 1 g of glycogen can bind approximately 2 g of water, which translates to 1.33 Kcal/g (4 Kcal/3 g). This means that fatty acids can hold more than six times the amount of energy per unit of storage mass. Put another way, if the human body relied on carbohydrates to store energy, then a person would need to carry 67.5 lb (31 kg) of hydrated glycogen to have the energy equivalent to 10 lb (5 kg) of fat.” http://goo.gl/jqDYU

      Incidentally, before I quit drinking regular milk I seemed to throw a lot of it away cause it would go bad before I could use it, no matter how small a carton or bottle i bought. When I switched to heavy whipping cream I noticed I could toss a couple pints in the fridge and leave them for 2 or 3 weeks before I wanted to use one and they were STILL GOOD! I”d use a bit then close it up & put it back and then not use any for another 2 or 3 weeks and it”s STILL GOOD! The fats in heavy cream are SO stable it has to sit for a really long time before it goes bad, just one more example of how cream is densely nutritious, WAY better than the toxic regular, low fat, 1 or 2% “milk”.

  4. Ri

    Thanks Jeff i couldnt agree more with the rationale that we need fat in order to lose fat however what about the negative health implications ie. clogged arteries from consuming too much saturated fat in the diet?that”s my main concern.

    • Tyrannocaster

      Read “Good Calories, Bad Calories”, by Gary Taubes. He will tell you much more than a blog post could about this very topic.

    • Uncle Roscoe

      The mainstream “fat is bad for you” dogma is an unscrupulous lie.

      Using human trials it is impossible to prove a negative. In other words, it”s impossible to prove that some food is not bad for you. It”s only possible to prove that a food is bad for you. The mainstream dogma, “fat is bad for you”, represents an unscrupulous exploitation of this distinction.

      Carbohydrates are cheaper to produce than saturated fats, so there are vastly more studies attempting to prove that saturated fats are bad for you. And to the last study, they all conclude just that. But to the last study they all suffer from the same design flaw. They test diets of carbohydrates and saturated fats against diets of carbohydrates.

      ………totally invalid and biased. Where are the human trials which test diets of carbohydrates against diets of saturated fats? For the most part they don”t exist.

      Pathway science is quite a different matter. But pathway studies prove how foods work, and not how foods don”t work. Pathway studies have shown precisely the opposite of the food industry trials, that coronary atherosclerosis is caused by carbohydrate ingestion. Pathway science proves that coronary atherosclerosis is caused by compact low density lipoprotein (CLDL) particles.

      Loosely CLDL particles are fat particles, but they are caused by ingestion of carbohydrates. LDL particles are cholesterol particles. Abundant cholesterol is a requirement for sustaining human life. The liver creates cholesterol particles from ingested fat. A healthy cholesterol profile includes a spectrum of LDL and high density lipoprotein (HDL) particles which includes no CLDL particles ……..ZERO.

      Given a population which lives on a diet of carbs and fat. Deny people fat, and you deny them the ability to produce harmful CLDL particles. But you also deny them the fat requirements for producing healthy cholesterol. You deny them the requirements for a healthy life. Conversely, if you deny them excess carbohydrates, particularly the dangerous carbohydrates found in wheat and sugar, you deny them the ability to produce CLDL particles. However, you also provide them with the fat requirements for producing healthy cholesterol. You provide them with the requirements for a healthy life.

      Dr. Davis”s Heart Scan Blog (Track Your Plaque Blog) is all about busting the mainstream “fat is bad for you” myth:


    • Jeff

      You”re using outdated thinking again. Saturated fat doesn”t clog arteries. Jennifer Snow”s comment sums it up well.

    • aerobic1

      Weston Price is a very good source of information on fats, however, they are also a bad place to get information on “Properly Prepared Grains”. I used to follow their dogma on grains until I tried one of the meals which all tend to be pro-carbohydrate and highly insulinotropic— “breakfast porridge” and I did a one-hour post prandial glucose check. My glucose shot up from a 85 fasting to 168 in 60 minutes! This in despite having a Hb1ac of 5.1.

      • Excellent, Aerobic!

        As you can see, checking your own glucose after eating is the way to individualize your personal carbohydrate tolerance . . . and it usually ain”t good!

  5. Great article Mary thanks for the link! i think ill still stick to low fat dairy milk though because you still get all the same nutriets as you would full fat milk -but i wont be afraid of other fats so much ie full fat cheese, butter and certain oils (coconut, olive)

    • Uncle Roscoe

      Makes sense to me. They take the fat out of milk, replace it with water, and charge you more. Then they add the removed fat to butter and cheese, and charge you again.

      Works for me.

    • Ri: WRONG! The real nutrients ARE the fats, low fat diets & low fat products will destabilize your cell membranes & impair nutrient flow into & waste flow out of the cell causing disease & death. Fifty percent of the 100 trillion cells in your body are made from fats and are crucial for proper cellular membrane structure, neuronal myelin sheaths since the brain is over 60 % fat, and every sterol & hormoine in your body depends on a steady supply of natural saturated & vegetable poly oils.

      Processed milk is toxic, homogenization forces milk thru screens that break up and damage the fat molecules so severely they never come back together and also makes the fragments small enough to pass directly thru the intestinal lining and enter the bloodstream, and pasteurization kills off all the beneficial bacteria, you”d be much better off drinking either full fat whipping cream or water and just give up the mutant low fat in between form of an already bad for you product. http://goo.gl/2d3O9 scroll up & down inside the text box there to read more.

    • Robinowitz

      Ri: If you”ve read Dr. Davis”s book why are you thinking natural animal fats are bad for you? I know his focus is on wheat elimination, but he does cover the fat issue in there, I believe. I recommend Why We Get Fat by Gary Taubes…easier for someone just starting out looking for answers. The Dr”s Eades have some good books, too.

      Bottom line: natural animal fats ARE good for us. Wheat and other inflammatory grains are bad for us.

    • PJ

      Why would you bother with low fat dairy? Low fat dairy milk is nothing more than sugar water that doesn”t have anywhere near the nutrients that whole milk has, especially if you can get raw dairy products where you live. Enjoy cream in your coffee!

  6. No johnny-come-lately modified foods for me. I stick with the tried-and-true traditional foods. Like Classic Coke. :)
    But seriously, a lot of modern food ingredients really are pretty scary. The one that concerns me more than anything else is aspartame, especially since it”s in all my favorite diet drinks.

  7. Ri

    Thanks for all your responses and Rob i did read Dr Davis” book and know that natural animal fats are good for you but i shop at my local grocery store not a farm so i cant get raw milk -my choices are homo, 2%, 1% and skim or soy..i do drink soy but i usually opt for skim milk because there are less calories..homo is too creamy tasty i like 2% though-has that been less processed than skim??

    • Brandon K

      All three choices are bad, and soy is probably the worst for a whole host of reasons. Soy, when it isn”t traditionally processed, that is, soaked, steamed, and fermented is not a health food and carries many potential negative effects with long term use that have just recently been attracting growing attention and concern. Not to mention the fact that most soy world wild is GMO which introduces another set of potential concerns / unknowns; Japan won”t touch the stuff — they mark every soy product with “doesn”t use GMO soy beans”

      If you can”t get unhomogenized, whole milk (not necessarily raw, but that would be best), you”d be better off with no milk at all in your diet. Plain, whole milk, long fermented yoghurt id probably the best choice if you want dairy, or moldy cheeses.