The CDC falls under the Department of Health and Human Services and its mission is “to promote health and quality of life by preventing and controlling disease, injury, and disability.” Vaccines fall within the guidelines of operations of the CDC and they develop policies and procedures to control the resources and technologies in administrating them to the greater good of the people. The actual manufacturing of vaccines falls under the guidance of the Food and Drug Administration and strictly monitors each and every step of the vaccine’s developmental process. They too, do this for the greater good of the people.
Just like with food, the FDA deems what is safe and what is not in creating a vaccine. It dictates what you can add in the way of additives, preservatives, and stabilizers, although it is highly doubtful that sawdust or cardboard be allowed as fillers in a vaccine against rubella, as opposed to the acceptable levels in the average hotdog. Nonetheless, they try to preserve the integrity of all vaccines. These additional materials are required in building a vaccine for many reasons; certain types of vaccines might require live microbes of the disease and need food to survive, while others might need to maintain their environment without becoming diluted once entering the bloodstream, whatever the reason, these additional materials are also governed by the FDA.
If the FDA states an allowance of sawdust in hotdogs, it doesn’t state what kind of trees the sawdust must come from or inspects the plants where the sawdust is made; it just accepts the fact that it is a raw ingredient. Just as long as the hotdog manufacturer stays within the acceptable guidelines drawn by the FDA, no penalties or fines will come against them. Now if the hotdog manufacture produces a faulty lot and causes illness or worse, death, then many asses are going to be probed by the biggest of microscopes, including those supplying the raw ingredients. Same holds true with the building blocks of a vaccine. To create an additive, a preservative, or a stabilizer there is no need to follow the same procedures as a vaccine itself and apply for a Biologics License Application (BLA); verification by the vaccine creator is usually all that is required by a company since the FDA considers many of these as just raw ingredients, in other words, the sawdust of vaccines. As long as a biotech company creating the vaccine stays within the acceptable guidelines drawn by the FDA for any additional materials, no penalties or fines will come against them, and more importantly, no microscopes. They are free to use any raw materials as dictated by the rules of the business world: price and quality. Mainly the only difference between hotdogs and a vaccine is the vaccine must track each lot number of its raw ingredients, just to be on the safe side.
One of the most popular raw ingredients, actually a stabilizer for a few big named vaccines, is STB5 (what’s in a name?). It is very cost effective and is also used in flu shots worldwide, making it much in demand. This stabilizer is produced by Etimiz, a biotech company located in the western suburbs of Philadelphia, Pennsylvania. The STB5 is just one of many little sidebars that keep this relatively small privately held company afloat, that and a few subsidized federal funds in the way of annual research grants. STB5 was first created in the early part of the 80’s by Francis Simoski, a brilliant but bordering on unstable PhD. holder out of America’s seventh oldest college. Francis himself is the proprietor of over sixty different patents while his company is accountable for almost double that figure. Frank’s patents range from his now famous STB5 stabilizer (famous only in the biotech world), to cell division tools, and all kinds of nanotechnologies from bonding agents and catalysts, to micro identification tags. He has been a member of the National Science and Technology Council (NSTC) since its inception in 1993 and one of the key founding fathers of the Interagency Working Group on Nanotechnology, later changing its name officially in 2001 to the National Nanotechnology Initiative (NNI) under the Clinton administration. Yes, Dr. Simoski is considered to be one of the biggest names in the smallest of worlds, in other words, the world that is only one billionth of a meter in length, the world of the nano. His nickname of Dr. Smallski is rightfully fitting.
The almost average looking Francis Simoski is in his late 50’s, fifty-seven to be exact, average height, five ten to be exact, and of average weight give or take five pounds, still black hair with wisps of gray in the temples, brown uneventful eyes, and a nose that would help with a down payment on a plastic surgeon’s Bimmer. He’s unmarried, in fact, his last major girlfriend was in the 11th grade and since then it has been a box of tissues and the first five minutes of any porn movie; his mind has been occupied by many things other than the genitalia draw of a female companion—probably why his nickname (behind his back) of Dr. Smalldick is also rightfully fitting. He doesn’t have too many male friends either, only one or two that he has maintained communication with since his college days. To reiterate, Dr. Francis Simoski is not an average man in the grey matter capacity; common sense seems to dissipate when he’s lost in thought and compulsiveness rears its ugly head when he is at a loss for thought but he is never at a loss for words. The man can talk and most of the time it’s on a higher plane than his audience but given the opportunity to speak in front of his peers at any one of the many conferences throughout the year, watch out, he takes no prisoners and speaks his mind… right or wrong but the majority of the time Dr. Francis Simoski is never wrong, only because few could ever prove otherwise.
Oftentimes, in college, he was locked in a lab, lost in his theories, but when he did venture away from the Bunsen burners, test tubes, and beakers he would pontificate about his visions of the world to anyone who would listen—and what a strange world it was, a strange “small” world. His mini lectures (pun intended) were given mostly with a cheap beer in hand talking about miniature robots fixing your heart, creating super glue out of mucus, or spying insects dropped from planes; people just assumed he was intoxicated, while others envisioned his screws were a wee bit loose. Outside of the lab, no one really took Francis Simoski seriously in the days of college… except for the one or two people in which he still maintains communication.
May the truth be known, it was these one or two individuals that helped Francis secure his own company. Fresh out of school with sheepskin in hand and no official lab to call home, he thought about staying at his alma mater and teaching but most of all, continuing with his passion. He thought about this briefly and quickly vetoed the idea for he wanted no part of prying eyes from deans, other professors, or even students—why be the giant whose shoulders they stand upon when the pay is better in the real world. So it was off to the outside world… . the real world. He landed a job at Bell Labs easily; they practically begged him and offered him a handsome salary from the get-go. After seven years he realized this was not the place—here too were prying eyes but most bothersome were the stealing of his credits and his ideas for patents all in the name of the company. He wanted more; he wanted to be on his own, away from the eyes and grabby hands, but was unsure of the first steps. Then out of the blue, a state representative called him, asked how he was, and could they meet for dinner. “Dinner with an old friend… . why not?” Since that dinner the world of grants and funding was ripe for the taking. Soon afterwards, Etimiz, contrived from his 11th grade girl friend’s name, secured a million dollar grant to study the relationship of microbes and cellular membranes within vaccines, and opened up shop.
Yearning to invoke his own concepts and designs he sought a place very close to his upbringing. With his grant money securely grasped in his fist and a good chunk of his seven year stint with Bell, he leased a fitting environment for his new lab, hired a few people, and got down to business—his business. Although he had other agendas, his first goal at hand was to develop his company into an established identity. Being able to support the company through its own technologies helps to prevent wandering eyes from the takers—mainly the IRS and the grant givers. For the better part of the first five years he teetered on the books that were magenta in color; if it wasn’t for the few grants from above, Etimiz simply would have faded away. Then he struck
pay dirt. Without getting into the nitty-gritty, Francis was able to increase the effectiveness of a vaccine stabilizer giving it an increase of over a three hundred fifty percent in shelf life. This new stabilizer was dubbed STB5 for the five new peptides introduced to its environment and became the corner stone for his company—in more ways than one.
Developing new ideas was now his primary focus. With a decent product to keep the company buoyant, he concentrated more towards his love of all things small—the nano. At his former employer he developed methodologies, tools, and theories, in which he carried forward and used these as a springboard into the pool of nanotechnology. He basically picked up where he left off from Bell Labs and dove, head first, into the shallow end. In actuality nanotechnology was in its infancy stage, still is to much degree, but no one knew more about it than Dr. Smallski. Although he wanted to keep as much as possible under his hat and did, the requirements for federal funding led him to sermonize in front of the masses. With each new grant came more and more responsibility—being placed on the board here, being chair of that committee there, speaking at this conference and that conference, writing white papers and proof of concepts and journal articles, all while treading water in the technology pool—it was more than just an aquatic ballet to entertain the troops. He became a predominate leader in this new world, which meant he alone could almost dictate the direction of a new era, even though most of it was just a façade. With his established leadership and very tight ties with the powers to be, he helped to forge government regulations and mandates from both a government sense and from the populace sense thus creating a moral boundary for this new technology, one that everybody seemed to agree upon, everyone except himself.
Etimiz was his company and to a certain degree it was able to govern itself. Why should anyone question the moral leader of the world of nanotechnology? Most people took him for his word—hook, line, and sinker as they say, and his grant givers loved every minute of it. After all, he preyed upon the fears of what this technology could accomplish if left in the hands of just the scientists—the fears of blending the human genome with silicon chips to create a new hybrid humanoid, the fears of releasing a man-made microbe with lethal proportion to that of a plague, the fears of every imaginable mad doctor schema coming to life in an instant. It was these fears he fought long and hard to suppress with the help of his counterparts and their moral ethics. But in reality, their moral lines drawn in the sands were just that, imaginary lines being erased by his left hand. The masses saw his visible right hand, a clear leader in the field but what they never saw was what his left hand was doing. It was more than just sleight of hand, for when being fooled, expect the old ‘hand is quicker than the eye routine’; no one thought they were being fooled. The tighter the restriction he himself helped place on the companies through mandates and regulations by the government, the more he strayed in the opposite direction. Again, who would ever question his ethics on the subject matter when their fears where his fears as well?
And those fears were all too real in the labs at Etimiz. When Dr. Francis Simoski was not out touring the conference circuit he was busy locked in a lab trying to create his own circuit. That was his main goal in life—to create a circuit… a nanocircuit, one fit for the human body. That was the one piece of the puzzle that was his responsibility, the one piece he knew he could deliver given time, the one piece of the puzzle to make the system a reality and not just a pipe dream—his part of the equilateral triangle. Dr. Simoski’s sleight of hand trick was to step over the boundaries he forewarned his colleagues about and insure the success of his system.
Research and development made strides when no boundaries existed in the labs of Dr. Simoski; he was light-years ahead of anyone else in the field, still to this day, his technology is light-years ahead of anyone else. Now it wasn’t all him, it wasn’t all his ingenuity and time and money and hard work and dedication and because of his obligations it couldn’t have been all him; he had help, after all, he owned the company, he told his brain trust, his think tanks, his employees what to do, what to create, what to test, but what he did not tell them was what for or why. Departmentalization was the key to its success. Sure, one or two people very close to the project did ask, and those who did are no longer working for the company, in fact, through some outside intervention, those people are no longer working individuals—in the living and breathing sense. One may have committed suicide based on the pressures of work and marriage and one may have driven off the road coming home from a local bar after spending another Friday night alone. These things happen and one must move along and move along they did—at a rapid pace, at blinding speeds, and mostly under the radar gun of the government and their regulations or basically his regulations.
Advancements were made almost on a daily basis. His lab experimented with quantum dots, hydrogen bonding, ionic bonding, nanowires, nanotextured surfaces (a one dimensional object on the nanoscale), nanotubes (two dimensional), nanoparticles (three dimensional), and a whirlwind of other scientific terms well beyond the comprehension of most individuals. They built nanoswitches able to be turned off and on—a common thread with computers and their binary code of ones and zeros but much smaller in scale. They hammered out theories on conductivity with chemical catalysis and super conductors created from carbon and noble metal particles. They pushed the envelope in regards to passing these substances through the human body and even through the blood-brain barrier in order to power them through the central nervous system. This is where the true fears of the people lie, for once inside a living organism, different reactions can take place and they are almost unpredictable. These nanoparticles can accumulate in areas not destined for treatment or analysis, cause inflammation or infections, stress the immune system, or halt or stimulate the natural production of proteins and enzymes. They can be highly mobile, highly volatile, and highly difficult to trace. They can in fact, be highly dangerous within the biological world of the human anatomy but in order to make new strides in the name of science, warnings and cautions are thrown to the wind. Etimiz, the company that made many great strides, never once read the road signs, never once applied the brake pedals, never once looked in the review mirror, they just applied pressure to the accelerator and sped past their competitors.
Somewhere on the open deserted road of where nanotechnology meets biology, speeding along well over the limit, Etimiz made a few discoveries and created an invention the world has yet to know—the patent is pending, not that they would ever apply for one. Again, without getting into the nitty-gritty, they were able to generate a signal through the body from an object smaller than a cell. The object in discussion could in theory be called the world’s smallest passive transmitter, passive in the sense that it only transmitted a signal when a signal is received. It contained the most rudimentary components of a transmitter. It contained an oscillator, the circuit that creates a signal, a modulator, the circuit that varies this signal, and a power supply to produce this signal. After the circuitry was mapped for the oscillator, their first major road block was the modulator. In the beginnings, they hard coded the information that was to be transmitted; it was just a single digit number. Over the next few years, the company developed nanoswitches and was able to increase the signal to produce a thirteen digit number, and here’s the kicker, they were able to produce specific number sequences, sort of like a serial number. Their next obstacle was the power supply. They didn’t need New York City power grid type of energy but what they did need was a constant energy source. They had to look within the body itself for fuel. They played around with oxygen and glucose and even tried to use currents from the central nervous systems and the brain to no avail. Then while in Norway at a conference, Dr. Simoski found the answer. His plane flew over a machine sitting in the North Sea. His curiosity piqued when he found out that it was an oscillating water column. This device created energy from the waves of the ocean, from the constant ebb and flow of the tides. The light bulb almost blew it was s
o bright. There was a constant ebb and flow within the body as well, the blood stream. If only Etimiz could create a miniature version of the OWC, the power supply dilemma would be solved… . it was. On the underbelly of the nano device are fin-like nanoparticles that flex to and fro as the blood cycles pass. The flexing creates energy much like one of those handcarts on the railway tracks that are seen in old movies. That energy is able to produce enough power to generate a signal. This signal or wave was infinitesimal and undetectable to any known listening device made by man but in theory it was there. In order to help detect this signal an amplifier was also needed and created, as a result this invention almost doubled in size but still very small even on the scale of the nano. Even with this mini amplification, the signal was still undetectable.
Hearing this signal was indeed the crux of the big picture. The device was useless if it couldn’t be heard; if it couldn’t transmit its data, its series of unique numerical digits, the whole project would be deemed a failure. They couldn’t afford to fail—too much at stake, too many millions would go down the drain, too many man hours would be logged in vain, and too many ideals would go astray. To emphasize, hearing this device was the overall key to the project, to the system. They couldn’t afford to fail. They had to solve this problem, no matter what cost.
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