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By Expert ID: 10003, MD, Ph.D.

Are they cursed? Or are patients with complex medical problems, who appear to resist responding to treatments that are standard of care, merely reacting to an environment they do not see or know? Are their physicians incompetent or merely ignorant of the environment in which they live and function?

Most of the US population as well as medical providers, from physicians to support staff, have little knowledge of the US Federal Register, the laws related to agriculture, or the laws governing the manufacture of food and drugs. This lack of knowledge is a corollary to the general population’s lack of knowledge of the raw materials and machinery used to produce food products, the preservatives added and other methods utilized to counteract environmental fluctuations, shipping, packaging, etc. Few people are aware of what has become labeled “good manufacturing practices”. For example; in a bakery, a given batch of dough might have anti-caking agents, or anti-molding agents added off label to offset hourly fluctuations in humidity and temperature. Few people are aware that the average medication “pill” needs to be stabilized not only to prevent contamination by environmental micro-organisms, but also to prevent caking of the ingredients. To accomplish this, a medication capsule may contain about 20 compounds not on the label; whereas the average tablet has up to 100 compounds. In response to moment-to-moment temperature, humidity and other environmental fluctuations, these off-label additives may vary not only from medication lot-to-lot, but within a lot. In addition, there are unmeasured compounds that are naturally added through the normal wear and tear of the processing equipment. An example is the metallic particles from the stamping head; which through wear and tear are increasingly added to the tablets being stamped. The stamping head is typically made from stainless steel. Stainless steel consists of iron and carbon to which nickel, chrome and/or cobalt are added as oxygen scavengers. Any or all of these can become part of the pill one swallows. Nickel, chrome and cobalt are common nutritional minerals, as well as allergens and carcinogens. This ignorance of manufacturing processes complicates the inability of the medical field to identify sources of agents which might contribute to, if not cause, chronic and recurrent medical problems.

The purpose of food and drug laws and regulations is to assure that the food and drugs are safe from micro-organisms which can promote infection as well as from toxic levels of known toxins. In addition, the laws and regulations were established to facilitate shipping foods that constitute a healthy diet to remote areas in a timely manner. Otherwise, the population of these remote areas might suffer from malnutrition due to a lack of access to a well-balanced diet.

For example, in the early 1900’s, goiter from iodide deficiency was prevalent in the heartland of the US. To bring iodide to these areas, the manufacturing of salt to which iodide was added was encouraged. The addition of iodized salt to many processed foods, off label, was permitted as part of good manufacturing process, or on label but listed merely as ‘salt’. Moreover, fresh sea water fish is naturally high in iodide. In the early 1900s, it took several days to ship fish from the coasts to the heartland. If the fish was frozen, it looked pale and tasted bland. If the fish were shipped on ice (refrigerated), by the time it arrived, days to weeks later, it smelled and tasted poorly and was a potential infection risk. The solution was to create the regulated term “Catch of the Day” which allowed fish to be treated off-label with formaldehyde releasing compounds, food dyes, salts, flavoring agents, and anti-sliming agents in order that it be maintained as “fresh” when refrigerated for up to 6 weeks. Unrealistically, the population was (and is) expected to know that the common term “today’s catch” and the official regulatory term “Catch of the Day” have disparate meanings. Meanwhile, it was recognized that the population would have no clue to the disparate meanings. Thus functionally, the term of law “Catch of the Day” attracts ignorant individuals to purchase and eat fish caught up to 6 weeks earlier. For most people, the goal to get iodide-containing foods into the diet is accomplished. Unfortunately, there is a minority who may react to these hidden compounds. This is similar to the goal of helping the population avoid cholesterol and triglycerides by choosing “Non Diary” products. Unfortunately, since “Non-Dairy” only means no milk fat, those individuals allergic to milk proteins will blindly be exposed.

This logic then was applied to frozen foods to facilitate and encourage the population to eat vegetables throughout the year. If, as a method to destroy bacteria and insects in vegetables prior to freezing for long term storage, one cooks the vegetables, they become blanched, lose taste and frequently stick together. To resolve this problem, an off-label process of “good manufacturing practice” was permitted to allow the frozen vegetables to remain tasty. For example, carrots destined to be frozen first are boiled in a stainless steel vat (nickel, chrome and cobalt again) containing salts (possibly iodized salts), orange food dye, tartrazine (a yellow food dye to enhance color and decrease the metallic flavor added from the stainless steel), propylene glycol (to prevent the sticking), sugar, preservatives and more. Since these compounds are added according to good manufacturing process, they remain off-label. In addition, since there are no clear laws governing “all natural”, the final bag of frozen carrots can be legally labeled as “Carrots, all natural, no added salts, dyes, flavoring agents or preservatives”. The term “added” applies only to what is added after what is done as part of good manufacturing processes.

In addition, one cannot forget the laws related to the packaging. These hot frozen carrots on the conveyer belt will be delivered into a hot plastic bag coming down another conveyer belt. Once filled, the bag either will be heat- sealed or glued closed. Simultaneously, acrylic dyes are sprayed onto the bag surface to provide the package labeling. There are laws governing the amount of acrylic that can pass through the hot plastic and enter the food from the glue as well as from the labeling. There does not appear to be any law related to the total acrylic from the two processes.

One must consider the source of the water for cooking. Typically this will be tap water. This water travels from the local water processing plant to the manufacturing facility through underground pipes. Depending on the age of the community, these pipes can be made of wood, copper, steel, metal alloys, plastics, joined together by a variety of compounds over the decades to centuries. Laws govern the materials used in new pipes; no laws require that the plumbing system of a community be dug up and updated to correspond with current safety requirements. The composition of the water leaving the processing plant itself varies; corresponding to what was required to purify the water based on day-to-day fluctuating bacterial and/or fungal counts, chemical contaminants, etc. For example, if there had been a drought during a hot, humid period, the bacterial and fungal counts will be elevated. Additional chlorides or similar halogens will be added to kill off these organisms. The resulting water will smell and taste like swimming pool water. Thus, it is treated with aluminum to precipitate out the chlorides. If the water has a murky color, then nickel or cobalt blue can be added to make it appear more like fresh lake water.

To add complexity to this, each ingredient may contain a composite of other ingredients which may themselves contain additional composition. Using the example above, the sugar likely had carbamates; a sulfa based neurotoxic insecticide, added to keep ants and other insects from populating the sugar. A variety of salts, including sodium chloride (common table salt) was likely added to keep the sugar from clumping. This salt might contain iodides. It has been suggested that if all the ingredients inside the ingredients were put on a package label using the typical package ingredient label font, then a box of Cheerios® would be filled on all sides with the list of these components leaving room to mention the product name once.

This example may elucidate why certain disease scenario etiologies remained unexplained with evidence suggesting possible links, but never quite firmly establishing these links. The population (including the physicians and academic researchers) appear to be ignorant of the manufacturing rules and regulations of sugar; especially related to its consumption and hyperactivity in children. Few, if any, of the individuals involved ( from academic researchers to the patients), have noted the possible presence of carbamates, which may have been added at milling to the sugar. Carbamates are neurotoxins and have been associated with behavioral abnormalities in the carbamate manufacturing industry.

Another example concerns saccharine in artificially sweetened drinks. The population became concerned about potential ill effects of saccharine and demanded its removal from common foods and drinks. Instead of saccharine, aspartame was added as the artificial sweetener. Aspartame has a limited life expectancy when exposed to air. If the aspartame-sweetened drink is sold in a large container for multiple uses, the beverage will become progressively less sweet. Thus, these aspartame sweetened drinks may have saccharine included off-label (as part of good manufacturing practices), in order to maintain the sweet flavor after the aspartame loses its effectiveness.

Thus, the curse theory probably is without foundation. Nonetheless, for complex and treatment-resistant patients (and their doctors), a world of discovery is mandated in order for both patient and doctor to unravel the cause, prevention and cure of their medical problem.

By Expert ID: 10003