FDA Roadblocks Revolution in Nutrition
There is a real scientific revolution taking place at the intersection of food, food extracts, and food supplements. Solid, peer reviewed scientific research is pouring forth from reputable research institutions, especially research universities such as Harvard, Stanford, and the like.
This research suggests that changes in diet could reduce both heart disease and cancer by as much as 90%. (For example, see Archives of Internal Medicine, Oct 22, 2007; 167(19): 2122-7.) Alzheimers too by a significant but still to be determined percentage (Neurology, 2007:69:1921-30).
This is not just a question of eating more fruits and vegetables, although that alone might increase lifespan by an estimated average of 14 years. It is also about specific nutrients. In many cases, there is strong scientific evidence that a specific nutrient may be used to prevent, moderate, reverse, or in therapeutic doses cure disease.
Scientific Research Censored by FDA
Unfortunately the American people do not hear about this research. Food producers would like to tell them about it. But FDA rules prevent it.
The FDA has imposed its "Extended Label" rule on food producers and dietary supplements manufacturers. This rule does not allow the circulation of truthful scientific information about food and nutrient health benefits.
Take cherries. Research from Harvard published in the Annals of Internal Medicine suggested that cherries could reduce heart attack risk (Ann Inter Med, 1996, Sept 1: 125 (5): 384-9). A large number of other studies published in prestigious journals have indicated that cherries could do that and also reduce pain and cancer. But the FDA says that cherry producers, sellers, and food manufacturers may not talk about this research.
In February 2008, the FDA even obtained a court order to silence 29 cherry orchards. The FDA held that any discussion of the health benefits of cherries automatically turned cherries into "unapproved" drugs. Moreover, the Agency says that any "claim" made for an "unapproved drug" is by definition false and legally actionable, even if the claim originates at the Harvard Medical School.
By the way, many people think of "health food" as less "tasty". But nobody dislikes cherries. And blueberries have a large amount of research supporting them as a "superfood" too.
The FDA presumably wants to protect the American public from "snake oil." But the best scientific research on critical health issues is not "snake oil." In general, there are a number of problems with the FDA's over-restrictive approach.
1) It defies common sense to call cherries or blueberries "drugs."
The FDA rejoinder is: take the food through the standard drug approval process anyway. Why not? For one thing, approval of a drug commonly costs hundreds of millions of dollars and has cost nearly a billion in some instances. No company can afford to spend even much smaller sums on a food or food supplement because neither can be patented. Even if cherries and blueberries and their juices are deemed to be "drugs," it is completely unrealistic to treat them exactly like patented drugs. The FDA knows this but just shrugs it off.
There have been very few instances of any foods actually being taken through the drug approval process. One recent exception is fish oil. For years, the FDA refused to accept any health claims for fish oil despite mounting research about its widespread health benefits for heart, cancer, depression, pain, and other conditions. Then a drug company decided to pay for the approval process. Its fish oil was approved, which means that Medicare and insurance companies will now pay for this particular brand of approved prescription fish oil. Happy ending to the story? Well, no. This prescription fish oil costs as much as ten times what good quality non-prescription fish oil costs.
What does a drug company usually do when a natural substance is proven to be of medical value? The usual approach is to "twist the molecules" of the natural substance until a "new" and patentable substance results. The trouble with this approach is that the "new" drug may or may not be as effective as the natural substance, but precisely because it is new to the human body, may be much more toxic and dangerous. Whether it is much more dangerous may also take years to find out. Even if the new drug really is safe and effective, it will cost vastly more than the original natural substance.
Melatonin provides a recent example of how this works. Melatonin is a natural substance. Our bodies produce it every day. It has been found to cure 'jet lag". So did drug companies take melatonin through the FDA approval process. No. Instead they created a new and thus patentable substance named Tasimelteon. This new drug binds to the same receptors in the brain that melatonin binds to, will do the same job with unknown toxicity. Unlike melatonin, Tasimelteon will be FDA approved, thus potentially prescribable under Medicare. Unlike melatonin, it will also cost an arm and a leg to buy it.
2) Logic and cost are key considerations. But there are equally important reasons to feel that the current FDA stance needs revision. In particular, communicating accurately about legitimate, peer-reviewed scientific research should be protected under the first amendment.
3) Even if it weren't stretching the Constitution beyond recognition and violating our most basic American values, censorship of science also thwarts technological advance. Technological advance means using science and telling people about it, not hiding it in little read journals.
4) The taking of specific nutrients in foods or supplements (or the withholding of the same, for example by denying iron to cancer cells -- see August 2007 Journal of Integrative and Comparative Biology) is not only a very promising approach to preventing, moderating, or even curing disease. It is also a much cheaper approach than drugs or surgery. At a time when spiraling healthcare costs are threatening jobs and our economy, we should be embracing new science to help reduce healthcare costs.
Top University Medical Schools Highlight Benefits of "Functional Foods"
Besides cherries and blueberries, many other foods and food extracts and food supplements are currently thought by researchers to offer significant health benefits. Some of us have received a mailing from the Harvard Health Letter, published by the Harvard Medical School. The mailing says that a free copy of a booklet with 26 health tips has been reserved for the recipient. The tips are all taken from peer-reviewed scientific studies vetted by Harvard. Just under a third of the tips concern food or supplements. Topics include: vitamin B-3; coffee; effects of foods on blood pressure; vitamin D for bones, cancer, multiple sclerosis, and heart disease (they could have added flu); red wine; and chocolate. Before we leave vitamin D, it is worth mentioning that a controlled, double blind study of 1180 older women showed a 60% lower risk of all types of cancer from taking 1,000 IU of vitamin D a day rather than the usual 400 IU (Am J Clinical Nutrition, 2007 Jun;85(6): 1586-91). Many other studies have produced similar results.
A mailing from the University of Virginia Medical School (Summer 2008 issue) focuses more on the health benefits of specific fresh foods: berries, kiwi, cantaloupe, red and green peppers, tomatoes, brussel sprouts, red cabbage, kale, parsley, collards, broccoli, papaya, spinach, wheat germ oil, leafy green vegetables, sunflower seeds, hazelnuts, avocados, beans, pumpkins seeds, ginger root, pecans, split peas, Brazil nuts, walnuts, garlic, carrots, and almonds. (On second thought, better restudy almonds now that the FDA has required high heat or radiation of the nut before sale). The previous Spring 2008 issue extolled fish, fish oil, eggs (yes eggs), and flaxseed for heart, beta glucans (a kind of yeast, usually in supplement form) for Alzheimers and cancer prevention, vitamin B-3 also for Alzheimers and cancer prevention, green tea to reduce brain and neurodegenerative problems, and pomegranate juice for prevention of Alzheimers and possibly aggression (could have added heart trouble).
A study from Nature Reviews Neuroscience was featured in the July 19 edition of the Economist on page 87. The study is a meta-analysis of 160 studies relating to the effect of food on the brain by Dr Gomez-Pinilla, professor of neurosurgery and physiological science at UCLA. "Some foods," he concludes, "are like pharmaceutical compounds: their effect is so profound that the mental health of entire countries may be linked to them."
Is all of this a fad? It doesn't seem likely. Look at Science News, the leading summary of recent scientific studies for the layman. Studies on the profound health effects of foods and food supplements appear at least once or twice per issue on average.
The Role of Supplements -- Why Diet Alone Won't Do It
A few critics will accept that there is a revolution taking place linking nutrition directly to health. But they think that we should just focus on food, not on food extracts and supplements. There are at least two problems with this. First, studies show that the nutritional content of food has been declining for as long as the last 50 years (see especially the work of Dr David Thomas). The USDA has recently confirmed this analysis for more recent years. The problem seems to lie in depleted soil.
Second, nutrients sometimes have to be concentrated to have full therapeutic benefit. No one can get enough vitamin D from food. We also get it from exposure to sunlight on our skin, but use of suntan lotion prevents it. Food supplements often make sense either for routine day to day use in lower potencies or as higher potency therapies devised and supervised by doctors.
FDA Mission At Odds With Its Actions
The FDA's own mission statement says that the Agency "is responsible for...helping the public get the accurate, science-based information they need to use medicines and foods to improve their health." Given this mission, it is perverse to allow pharmaceutical companies to spend so many billions on consumer advertising but not to allow food producers to tell the public about legitimate and revolutionary food research. This is all the more true given our heritage of free speech and free science, the opportunity to save or prolong million of American lives, and the need to use every resource at our command to rein in surging and economically destructive healthcare costs.
By Hunter Lewis, President, AAHF
