A recent article in the journal Meat Science acknowledged that “a sector of the population perceives meat as a food that is detrimental to their health” because of studies associating meat consumption with heart disease and cancer. “For these reasons, these meat consumers look for healthier food alternatives as a means to maintain good health;” so, this represents a good opportunity for the industry to develop some new products. Natural foods could be added to meat to reach those health-oriented consumers by boosting antioxidant levels, for example. Foods like flax seeds and tomatoes are healthy, associated with reduced risks of cancer and cardiovascular disease. So, by making flax seed-tomato burgers, they figure they can reduce saturated fat intake and maybe eat less sugar somehow? It’s like their flax seed-fed pork idea, to produce “enriched lard.” Wouldn’t it be easier to just cut out the middle-pig and eat flax seeds ourselves?

Flax seeds have been described as a “miraculous defense against some critical maladies.” I’m a fan of flax, but this title seemed a bit over exuberant; I figured something just got lost in translation. But then, I saw this study, and realized maybe that title was not too far off.

Rarely do we see a dietary study of this caliber. A prospective, double-blinded, placebo-controlled, randomized trial—you know how hard that is in a nutrition study? For drugs it’s easy, you have two identical looking pills: one’s active, one’s placebo, and until the end of the study neither the researcher nor the patient has any idea which is which, hence, double blind. But people tend to notice what they’re eating. So, how did they sneak a quarter cup of ground flax seeds into half of the people’s diets without them knowing? They created all these various flax- or placebo-containing foods, and even added bran and molasses to match the color and texture; so, it was all a big secret–until six months later, when they broke the code to see who ate which.

Why test it on hypertension? Because having a systolic blood pressure over 115—that’s the top number—may be the single most important determinant for death in the world today. If you take a bunch of older folks, most of them on an array of blood pressure pills and don’t improve their diet at all, despite the drugs, they may start out, on average, hypertensive and stay hypertensive six months later. But those who were unknowingly eating ground flax seeds every day dropped their systolic blood pressure about ten points, and their diastolic, the lower number, by about seven points. That might not sound like a lot, but a drop like that could cut stroke risk 46%, heart disease 29%, and that ten-point drop in the top number could have a similar effect on strokes and heart attacks. And for those who started out over 140, they got a 15-point drop. “In summary, flaxseed induced one of the most potent antihypertensive effects ever achieved by a dietary intervention.” In other words, the magnitude of this decrease in blood pressure demonstrated by dietary flax seeds, is as good or better than any other nutritional interventions, and comparable to many drugs, which can have serious side effects. And they’re not exaggerating about the comparable to drugs bit. The flax seeds dropped systolic and diastolic up to 15 and 7. Compare that to powerful ACE inhibitors, like Vasotec, which may drop pressures only 5 and 2. Calcium channel blockers, like Norvasc or Cardizem, 8 and 3–half of what the flax can do. Side effects include… Compare this list to the side effect of flax seeds–its pleasant nutty flavor.

During the six-month trial, there were strokes and heart attacks in both groups. Even if the flax seeds can cut risk in half, though, any avoidable risk is unacceptable. Isn’t high blood pressure just inevitable as we get older? No. The prevalence of hypertension does increase dramatically with age, but not for everyone. People who eat more plant-based diets or keep their salt intake low enough tend not to exhibit any change in blood pressure with advancing age. So, flax is great, but always better to prevent the disease in the first place.

Dr. Esselstyn’s landmark study showing even advanced triple vessel coronary artery disease could be reversed with a plant-based diet has been criticized for being such a small study. But the reason we’re used to seeing such large studies is they typically show such small effects. Drug manufacturers may need to study 7,000 people in order to show a barely statistically significant 15% drop in ischemic events in a subsample of patients, whereas Esselstyn got a 100% drop in those who stuck to his diet—all the more compelling given that those 18 participants experienced “49 coronary events [such as heart attacks] in the 8 years before” they went on the diet. And these were the worst of the worst—most of whom having already failed surgical intervention. So, when the effects are that dramatic, how many people do you need?

Before 1885, symptomatic rabies was death sentence until July 6^th, when little Joseph Meister became the first to receive Pasteur’s experimental rabies vaccine. “The results of this [and one other] case were so dramatic compared with previous experience” that the new treatment was accepted with a sample size of two. So dramatic, compared with previous experience, no randomized controlled trial was necessary. “Would you—having been infected by a rabid dog—be willing to participate in a randomized controlled trial…when being in the control group had a certainty of a ‘most awful death’?” Sadly, such a question is not entirely rhetorical.

In the 1970s, a revolutionary treatment for babies with immature lungs called ECMO, extracorporeal membranous oxygenation, “transformed mortality in these [babies] from 80 per cent [down] to 20 percent, nearly overnight”—from 80% dead to 80% alive. Despite this dramatic success, they felt forced to perform a randomized controlled trial. They didn’t want to. They knew they’d be condemning babies to death. “They felt compelled to perform [such] a trial, because their claim that ECMO [worked] would, they judged, carry little weight amongst their medical colleagues unless supported by a [randomized controlled] trial.”

And so, at Harvard’s Children’s Hospital, 39 infants were randomized to either get ECMO or not—just get conventional medical therapy. They decided to stop the trial after the fourth death, so as not to kill too many babies. And, that’s what they did. The study “was halted after the fourth [conventional medical therapy] death,” at which point nine out of the nine ECMO babies had survived. Imagine being the parent of one of those four dead children—just as one can imagine being the child of a parent who died from conventional medical or surgical therapy for heart disease.

“Medical students in the United States are taught [very] little about nutrition. Worse yet, their training [actually] biases them against the studies that show the power of dietary approaches to managing disease,” by encouraging them “to ignore any information that does not come from…double-blind, randomized controlled trial[s]. Yet human beings cannot [easily] be blinded to a dietary intervention.” They tend to notice what they’re eating. As a result, physicians [may be] biased [in favor of] drug treatments and against dietary interventions for the management of chronic disease.”

“Evidence[-based medicine] is a good thing. However, the medical profession [may be] focusing too much on one kind of evidence, to the exclusion of [all] others”—degenerating into a “ignoring-most-of-the-truly-important-evidence[-based] medicine.”

And heart disease is the perfect example. On a healthy-enough plant-based diet, our #1 cause of death may “simply cease…to exist.” The Cornell-Oxford-China Study showed that even “small amounts of animal-based foods [was] associated with small, but measurable increases in [the] risk of [some of these chronic] disease[s].”

“In other words, the causal relationship between dietary patterns and coronary artery disease was already well established before…Ornish…and…Esselstyn…undertook their clinical studies. The value of their studies was not so much in providing evidence that such a dietary change would be effective, but in showing that physicians can persuade their patients to make such changes,” and also providing interesting “data on the speed and magnitude of the change in severe atherosclerotic lesions as a result of dietary therapy.”

So, “[a]ny complaints that these studies were small or unblinded are simply irrelevant. Because the evidence of the role of diet in causing atherosclerosis is already so overwhelming, assigning a patient to a control group [eating the Standard American Diet could be considered a] violation of research ethics.”

“Evidence of the value of…plant-based diet[s] for managing [chronic disease] has been available in the medical literature for decades.” Kempner at Duke; John McDougall; The Physician’s Committee for Responsible Medicine. “Denis Burkitt warned us” that the Standard American Diet “is the standard cause of death and disability in the Western world,” for decades. “Yet physicians,…in the [U.S.], are still busily manning the ambulances at the bottom of the cliff instead of building fences at the top.