Take the Fourth (17 page)

Chapter 27
 

V
accines have eradicated smallpox, placed polio on the endangered list, and have measles on the run. In due time maybe HIV and even certain types of cancer will be on the ropes. Yes, vaccines are an important part in the fight against diseases. They are simple in design. They are nothing more than a delivery method for weakened and even dead microbes to the immune system in order to build immunity against the known destructor. They are also complex to build, to test, and to prove to the public they are safe. Vaccines have been around for quite some time, as far as two hundred years ago when Edward Jenner first inoculated a small boy with cowpox. From there Louis Pasteur continued the work and eventually coined the word vaccine derived from the Latin word vacca, meaning cow, in order to honor Jenner in his work with the cowpox disease. Without vaccines the world population might have been on the decline, either that or the wheelchair business would have been booming. Yes, vaccines are an important part in the fight against diseases, a very important part and governments know it.

That’s why legislation has been in place even since the mid 1800’s in order to protect its people. In 1840 the UK passed the first law regarding vaccines and in 1853 made it even more stringent by requiring every child between the ages of three and four months to be vaccinated. Included in this Act was a bylaw requiring proof to the local registrar of births that the inoculations have been completed. The U.S. followed suit by providing law upon law and even upholding its laws as in the Supreme Court ruling of 1905 in the case of
Jacobson
v.
Commonwealth
of
Massachusetts.
This case marked that the state could require vaccinations for the greater good of its people. Since then, many states require vaccinations before attending public school and even private schools must require it if they want to receive any type of state or federal funding. The federal government laid down the law again with the National Childhood Vaccine Injury Act of 1986. This act mandated that each health care provider must record the name of the individual receiving the vaccine, the date, the manufacturer, and the vaccine lot number into the immune registries or Immune Information Systems. The IIS are nothing more than computerized databases for maintaining a system of record to ensure timely immunizations and consolidation of information. This information is then to be used by schools, daycare centers, and health professionals but must meet strict privacy measures put in place by the Center for Disease Control and Prevention.

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 11
^th
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 11
^th
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?