Just Where Do Drugs Come From?

US Pharmaceutical sales topped $450 billion in 2016. This is a mega-industry with considerable political clout in the US. So, who watching the Big Pharma guys to make sure they play by the rules? Who is looking out for the rest of us who take the medicines they produce?

That would be the Food and Drug Administration (FDA). The FDA was started in 1906 under President Theodore Roosevelt (see photo and yes, he’s one of my favorite POTUS) when he signed the Food and Drug Act. This act was the basis for the modern USDA, being originally given the name of the Food, Drug, and Insecticide organization. The name eventually was shortened to the Food and Drug Administration (FDA) a few years later.

The FDA as it now exists is an agency of the US Department of Health and Services. The current FDA mandate gives it responsibility for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions medical devices, electromagnetic radiation emitting devices (ERED), and veterinary products. This role gives the FDA sway over a vast swath of the American society and economy.

The association between the industry and the FDA has morphed over the years into a partnership/adversarial/enforcement relationship that can work or it can look like a love-hate thing gone bad.

Suffice it to say that in The Pharm House, there are some goings on at Marshall Pharmaceutical Company that the FDA finds most interesting. What, you ask? Well, you’ll have to read the book!

In The Pharm House, Marshall Pharmaceutical Company is developing a new anti-viral drug that could potentially be a “blockbuster” (have peak annual sales greater than $1billion). But “things” start to happen and Nicholas Harding finds himself in the middle of those “things”.

Do you know how new drugs are discovered, developed and marketed? Unless you have worked in the pharmaceutical industry or are related to or know someone who is, I’m guessing you don’t.

Even though it is a multibillion-dollar powerful business sector, the pharmaceutical industry remains rather insular and professionally incestuous. In other words, unless you are an insider, it is unlikely you will know the internal machinations of the industry. The scientific and business professionals in the trade make up a rather small group that tend to move from company to company, hence the professional incest.

In order to get one new drug to market, you have to go back in time to start 10-15 years prior, start with 10,000 to 12,000 new chemicals to eventually narrow them down to one that is both safe and efficacious and you would need roughly $1.5 billion plus! That’s right, the whole process of drug discovery/development takes on average 10 plus years and one billion plus dollars! It’s a high stakes business, which can bring out the best in some and the worst in others.

Don’t get me wrong; the pharmaceutical industry does tremendous good for our society. Look at all the drugs that have significantly improved both the quality of our lives and our lifespans. But at the end of the day, these big mega-corporations exist to generate a return on investment for their shareholders.

What happens when a company has invested many years and hundreds of millions of dollars only to find a “dry hole” that yields zero return? Trust me, you don’t want to be around when that happens!

Come join Nicholas at The Pharm House and see what “things” start to happen…

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Weaving History Into Fiction

I may have mentioned before that I love history and consider myself a bit of an amateur historian (emphasis on amateur). I am fascinated by the Civil War era and turn of the century (19th to 20th) American history. It’s fun to sprinkle tidbits of historical references in my fictional writing. In The Pharm House, Nicholas and Don, also students of history, use the symbolism of Civil War events as an allegorical reference to one of their current situations.

“A collection of twelve original letters from Abraham Lincoln to his generals during the Civil War. Including some to Sherman and Grant. And one to McClellan, telling him to get off his ass and attack Lee.” Don went on, fascinated with his story. “Of course, he (McClellan) didn’t move his ass and Lincoln fired him.”

“Only to bring him back after Hooker lost at Antietam.” Nicholas added.

“Very good Dr. Harding. But alas, it was a short-lived return engagement. Lincoln was forced to re-fire Little Mac when he returned to passive form and refused to move his Army. Tell me Dr. Harding, what do you think of General McClellan?”

“I’ve always thought him one of the most fascinating characters of the Civil War, yet relatively little has been written about him. After all, at the age of 35, he gained command of the most powerful army on Earth and then proceeded to do absolutely nothing with it.” Nicholas expounded.

“And went on to become?” Don inquired gleefully knowing he had a playmate of equals on the topic.

What did Major General George B. McClellan (above on the
right) go on to do after the Civil War?

A little background, then I’ll let Nicholas and Don Marshall give you the answer. McClellan and Lincoln shared a common background prior to the Civil War. McClellan was a previous Vice-President of the Illinois Central Railroad and Lincoln, who was actually our first corporate lawyer president, was a prior legal counsel for the Illinois Central Railroad. The two men’s paths likely crossed during their corporate stent with the Railroad.

“And went on to become?” Don inquired gleefully knowing he had a playmate of equals on the topic.

“A losing presidential Democratic candidate against Lincoln in 1864 and then elected Governor of New Jersey in 1877.” Nicholas replied. “Though few know that. In fact, few probably remember who McClellan was.”

An example of how a touch of history can be weaved into a fictional story. You’ll have to read The Pharm House to see how Nicholas and Don use the story of General McClellan in reference to their situation and to see how other historical references are weaved into the story.

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The Marshall Family Estate

The drive from the Marshall Farm Business Complex to the Marshall family estate and mansion was only about 10 minutes. The Marshall estate was situated well off the main roads of Florham Park, so that none of the buildings on the estate could be seen from any public street.

As the car turned into the gated driveway of the estate, it appeared to be entering a heavily wooded forest, but after about half a mile, opened up into wide manicured lawns. The tree-lined drive led to a stonewall with another large gate. Beyond the stonewall gate the driveway became cobblestone and much wider. Once through the last gate and onto the cobblestone drive, the main mansion became visible.

The Marshall mansion and the surrounding grounds exuded the concept of money and power.
The mansion was a classical early 20th century style. Sweeping copper roofs, turreted towers and gables, four floors visible, expansive gardens and fountains. This was the result of the toil of two generations of Marshall work. Nicholas had read that the mansion had seventeen bedrooms and that Donald Marshall I – the founder – had built it to intimidate the locals. Must have worked, he thought.

The limousine pulled up through an arched cover by the front door and stopped. The front door of the house opened and a uniformed servant stepped forward to open the car door.

“Good morning Dr. Harding, this way please.” Said the servant as he led Nicholas into the house. He was middle aged – maybe early 50’s, obviously British and black. “If you’ll be so kind as to wait here.” He said as they entered a large open room that was obviously a library. “Mr. Marshall will join you shortly.”

When the servant left the room, Nicholas had an opportunity to explore. There were two levels with a mezzanine on the upper level. A large fireplace was on the wall to the right as you entered the room. Across the room, positioned so you could see the fireplace was the largest rolltop desk that Nicholas had ever seen. Nicholas had a fondness for rolltop desks. It was a dark heavy wood with dozens of small drawers and compartments. It was a beautiful piece of furniture. On the wall over the fireplace were two portraits of two middle-aged gentlemen who clearly resembled each other.

Nicholas recognized the two men as the founder of Marshall Pharmaceutical –Donald Marshall I and the II, Don’s father. No sign of the current Don’s portrait anywhere. There were literally thousands of books organized neatly and efficiently as any private library. Some appeared to be rare collector’s items. The outside walls had large eight-foot tall windows with a beautiful view of the manicured lawns. From the mezzanine windows you could make out the faint outline of the New York skyline. The windows had heavy velvet drapes of a rich dark blue that could be pulled to shield the books from sunlight.

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The Pharm House – Setting

The Pharm House is set in the present with the main portion of the story taking place in western New Jersey, the Morristown area. A lot of folks who have never visited New Jersey may have a rather jaded view based on what they see on television (think The Sopranos) or in movies (think Wise Guys). When they think of NJ, they may think of Newark or the Turnpike, but there’s a reason that Jersey is called “The Garden State”.

New Jersey is rich in history; in the winter of 1779/1780, George Washington encamped the Continental Army at Jockey Hollow, near Morristown. As an amateur history buff, I have sprinkled several Civil War references throughout The Pharm House.

Western New Jersey is known for its rolling hills of farmland and horse country; a well-hidden secret. After the Civil War, the US industrial boom created a new class of wealthy industrialist working out of New York. Many of these industrialists and financiers amassed great fortunes and looked to build large estates mimicking European aristocracy. The open spaces of western New Jersey were a perfect locale.

Railroad lines took these captains of industry into New York, while their families remained on their estates in the small towns of western New Jersey, e.g., Morristown, Bernardsville, Peapack, Mendham, Florham Park, etc. Many of the manor homes of these estates, which ranged in size from 50 to 500 acres, have been lost to time and development, however several remain even today.

In The Pharm House, Marshall Pharmaceutical is located in the middle of Marshall Farms, now a sprawling private industrial park, but once the home of a manor house and estate at the end of the 19th century.
Parts of The Pharm House also take place in Manhattan, Washington, D.C. (with a few more historical tidbits), London and Tokyo.

Join Nicholas and friends and see parts of New Jersey that most Americans have never seen.

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Characters of “The Pharm House” Part 2

Jack O’Connor – Nicholas’ boss at Marshall Pharmaceutical

Jack was a Senior Vice President and a member of the Marshall Board of Directors. Tall, barrel-chested with gunmetal gray crew-cut hair, Jack was one of those over-testosteroned manly men who thought that regardless of whose company he was in, his was the superior intellect present and by default, the leader.

O’Connor’s office was on the R&D building executive – fifth- floor. As head of all Marshall R&D, both clinical and non-clinical, Jack ruled his global empire with an iron fist. Nicholas had read an article on James Baker, Secretary of State under George H. W. Bush. Baker was described as ‘the velvet hammer’, someone who welded extreme power, but with finesse and class. Given that, O’Connor’s style could be described as ‘the rusty spiked hammer’. When Jack was in the room, there was space for only one opinion – his.

Nicholas had some degree of technical respect for O’Connor, but felt that his bullying, micromanaging style was about 30 years outdated. As a member of the Marshall Board of Directors, Jack carried considerable clout. He’d long ago wiped out all potential enemies and competition and the rumor was he lusted after the company C.E.O. position.

O’Connor’s lair was spacious and designed to intimidate; a large open anteroom with chairs for waiting victims far away from the workspace of his secretary, Roberta. That way if you’re waiting for Jack, you can’t see what she’s working on. And Roberta was a piece of work. She ruled over all the R&D secretaries like the Wicked Witch of the East ruled her flying monkeys. Roberta was one of those secretaries who took glee from using her bosses’ power to terrorize everyone else in the organization.

Nicholas learned long ago that two people you absolutely never want to piss off are the bosses’ secretary and spouse in that order. So, every Secretary’s Day or Administrative Assistant’s Day or whatever the current politically correct term was, even though he hated it as holiday created by and for Hallmark and the florist industry, every Christmas and on her birthday, Roberta received flowers and candy from Nicholas. Consequently, Roberta, Queen of the Vampires, had a soft spot in her cold, hypertrophied heart for Nicholas.

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Characters of “The Pharm House” Part 1

Beth Cowlings

Beth is Nicholas’ attorney. She is from Raleigh North Carolina and is an old friend of Nicholas’ mother, Dorothy Harding. Beth and Dorothy had met and become friends in the racially charged segregated south in the later half of the 20th century.

Beth is licensed to practice law in New Jersey and at Dorothy’s request, she comes to NJ to help Nicholas with the mess he seems to have gotten himself entangled in at Marshall Pharmaceutical.

“Beth Cowling was the type of person who became the center of attention, no matter where she was. A tad on the short side, compensated for by high-heels, her favorite color was white. And today, she was a vision of flowing white from her shoes, to her white pantsuit with long floor-length vest. She had piercing grey wolf-like eyes, but the most striking aspect of Beth today and most others was her hair – snow white and shoulder length. Somehow the white hair actually made her look younger than the mid 50’s she was.

Nicholas had quietly entered living room where Beth was holding court with Dorothy, Michael and Andrea.

She had that slow melodious swaying southern accent – the kind used by refined southern ladies. And could lull you into a false sense of superiority. Nicholas had always been fascinated by the fact that the average American hearing a southern accent automatically deducted about 15 IQ points. That same person hearing a refined British accent would add 15 IQ points to the speaker. He suspected that Beth made ample use of this trick and had been under estimated by many a foe – mostly likely to their serious detriment.

“I hope you don’t go skiing in that outfit.” Nicholas said from across the room.

“Not to worry. Why I’d just melt the snow with my charm.” She said walking towards Nicholas, extending her hand.

Waiting for the others to arrive, Nicholas stared at Beth as she sat slowly smoking her cigar and drinking her brandy.

“Why what is it Nicholas, dear?” She purred.

Nicholas laughed. “I’ll bet you have six inch fangs.”

“I’ve never heard it put quite that way, but very perceptive dear, very perceptive.”

Beth turns out to be quite the charmer…

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Evolution of “The Pharm House”

How did I come up with the story and title for The Pharm House?  My first attempt at writing a novel length story was during graduate school. It was science fiction, about half-finished and is beyond awful. I still keep it as a painful reminder. I waited several years and was ready to start another novel length story. You always hear “Write what you know”. My choices were to write about something I was already knowledgeable about, or go off and do the research in order to become knowledgeable. Working full time in the pharmaceutical industry, doing research on a new topic wasn’t viable given the time required. That was when I decided to set my story inside a fictional pharmaceutical company – Marshall Pharmaceutical.

Several of todays pharmaceutical businesses started out as family concerns, in some cases family pharmacies, e.g., Merck, Pfizer, McNeil, etc. Some of these businesses were originally called the “House of…”

Big pharmaceutical companies are often referred to as Big Pharma. Using a play on words, I decided to title my book, The Pharm House.

Even though The Pharm House is set in a pharmaceutical company, it is really a story about family. It’s about Nicholas Harding, a young scientist/executive at Marshall Pharmaceutical. Nicholas is a regular guy – a single Dad trying to raise a precocious 11-year-old daughter while clawing his way up that ever so slippery middle management ladder.

But unknown to Nicholas, there are dark forces inside Marshall Pharmaceutical and he is about to be drawn into their plans and finds himself fighting for his career, his family and perhaps even his life.

The Pharm House is a suspense thriller novel set in today’s international pharmaceutical industry.

What if a young scientist, Dr. Nicholas Harding, working in a pharmaceutical company is just trying to take care of his family, but gets caught up in an international plot?

This is the basis for my story – The Pharm House, – a thriller set in a fictional New Jersey pharmaceutical company.

The protagonist, Nick Harding, is struggling to raise a young daughter as a single parent and climb the corporate ladder when he stumbles across a global plot to take over the company where he works, Marshall Pharmaceutical Corporation.

Mysterious deaths occur, including Nick’s mentor. Nick’s career, family and life are threatened. Nick is kind of like Alan Gregory in the Stephen White stories, just a guy trying to get through life and take his family, but things (bad people) keep getting in the way.

The Pharm House is the first in a series of three stories about the Harding Family.

I invite you to join me and see how events play out for Nick, his family and friends in The Pharm House.

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The Borgias

 

Speaking of Toxicologist (as in Nicholas Harding in The Pharm House), any aficionados of The Borgias out there? As a toxicologist, of course I knew who the Borgias were – early adaptors to the art of toxicology. Lucrezia and Cesare and their daddy Pope Alexander VI (Rodrigo); one would want to be most careful when invited to dine at the Borgia manor. Lucrezia was rumored to be a notorious poisoner (toxicologist) and master of political intrigue; a strong independent woman no doubt.

I missed the first season of The Borgias, but stumbled across it On Demand, couldn’t get enough and was completely hooked. I mean really, what’s not to love about that family!

Lucrezia was born on April 18, 1480 near Rome. Her mother was Vannozza dei Cattanei, one of the mistresses of her father, Cardinal Rodrigo de Borgia (later Pope Alexander VI). At one time, she reigned as the Governor of Spoleto, a position usually held by cardinals of the Roman Catholic Church.

She married three times, her family arranging marriages for her that advanced their own political positions.

Numerous rumors have persisted throughout the years of extravagant parties thrown by the Borgia family with allegations of incest, poisoning and murder on the part of Lucrezia.

It was whispered that she was in possession of a hollow ring that she used frequently to poison drinks.

After a long history of complicated pregnancies and miscarriages, on June 14, 1519, Lucrezia gave birth to her tenth child. She had become very weak during the pregnancy, fell seriously ill after the birth and died on June 24, 1519 at the age of 39.

Cesare was Lucrezia’s older brother. He was groomed for a career in the Roman Catholic Church from an early age. Both his great-uncle, Alphonso Borgia and Rodrigo Borgia served as Pope. Cesare was made Cardinal of the Church at the age of 18. Of course, his birth records needed a little modification, since he was the illegitimate son of Cardinal Rodrigo and his mistress, Vannozza dei Cattanei.

Cesare eventually resigned as Cardinal and was appointed commander of the papal armies and ruler of his own state in northern Italy.

Leonardo da Vinci was briefly employed by Cesare as a military architect and engineer, between 1502 and 1503.

Upon the death of his father, Pope Alexander VI in 1503, Cesare’s power began to fade. In 1507, he was attacked by an enemy party of knights; trapped in an ambush where he received a fatal wound from a spear and died shortly after.

The Church fought over where to bury Cesare’s remains with the final resolution coming in 2007, 500 years after his death, when his remains were moved back into the Church of Santa María in Viana.

Enough, about the Borgias. But aren’t you a bit curious about what the toxicologists in The Pharm House are up to?

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Just what is a Toxicologist?

Nicholas Harding, the protagonist in my first novel, The Pharm House, is a toxicologist by training, like myself. When I inform most people that I’m a toxicologist, I often receive a puzzled look. So in the event you are one of the puzzled, here is the definition of toxicology according to Wikipedia:

“Toxicology (from the Greek words τοξικός – toxicos “poisonous” and logos) is a branch of biology, chemistry, and medicine concerned with the study of the adverse effects of chemicals on living organisms. It is the study of symptoms, mechanisms, treatments and detection of poisoning, especially the poisoning of people.”

Yes! It’s the study of poison! Isn’t that cool!

All pharmaceutical companies employ toxicologists. When you go to the drug store to purchase drug X to do whatever it is you and your doctor desire it to do, how do you know that it will not make your hair fall out, your heart palpitate, cause you to lose consciousness, have seizures or much, much worse? That’s where your toxicologist comes in. Before and during human clinical studies, we study new drugs looking for potential adverse effects or toxicities. It gets rather complicated, so I will avoid boring you with the details.

So, how did a “normal” guy like me get into studying poison? I majored in biology in undergrad and was trying to figure out what I was going to do with a degree in that field. The summer after my sophomore year, I got a part time job in a toxicology lab at the National Institute of Environmental Health and Sciences (NIEHS) in the Research Triangle Park in North Carolina.

After being exposed to toxicology, to quote Nicholas Cage who played Stanley Goodspeed, a toxicologist in The Rock (one of the best Action/Adventure movies ever made and with a kickass soundtrack), “Got my first chemistry set when I was seven. Blew my eyebrows off. We never saw the cat again. Been into it ever since.”!

I worked in the NIEHS lab until I graduated, and then went on to get a M.S. and Ph.D. in toxicology – I was home! I got paid to work with poison – how cool is that? Well, in a nerdy sort of way, maybe.

With all my knowledge of toxicology and the pharmaceutical industry, I decided to make my protagonist a toxicologist. I think we kind of get looked over in entertainment. Check out The Pharm House and see what Nicholas is up to.

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The Power of Poisons

A couple of years ago, when I saw that the American Museum of Natural History in New York, was running an exhibit entitled, “The Power of Poisons”, I just had to attend. Why you might ask. It all started when after my sophomore year of college; I took a part time job in a toxicology laboratory at the National Institute of Environmental Health and Sciences at the Research Triangle Park in the Raleigh-Durham, NC area. Well, it was love at first sight – toxicology; and me and we have been together ever since! In case you may not know, toxicology is a discipline incorporating biology, chemistry, pharmacology and medicine that involve the study of the adverse effects of chemical substances on living organisms; i.e., the study of poisons. The word toxicology comes from the ancient Greeks and Byzantines, meaning poison and study of. I went on to the University of Cincinnati to get a Masters and Ph.D. in toxicology and then, you may not believe this, figured out a way to get paid to study poisons! Is America Great or what! How, you ask did I pull this off? Here’s the secret – technically, everything is a poison, it’s just a matter of the dose!

Where are poisons found?

  • Animal – For example, reptilian venoms are among nature’s deadliest innovations. Every year, these expensive weapons (because of the energy needed to produce the venom), delivered through the fangs of vipers, cobras and numerous others, kill up to 200,000 people.
  • Plant – Over millions of years of evolution, plants have developed an array of chemical defenses against insects, herbivores and even other plants.
  • Mineral – Some metals can be toxic. Arsenic and mercury are two well known examples.

 

How do poisons work? Poisons are defined by the systems that they effect.

  • Neurotoxins like strychnine and mercury affect the signaling mechanisms of nerves.
  • Cytotoxins like ricin (from castor beans, remember you Breaking Bad fans?) and arsenic disrupt cell functions.
  • Hemotoxins, found in leech saliva and many snake venoms inhibit blood clotting.
  • Mycotoxins found in some vipers destroy muscle tissue.
  • Some viper venoms combine neurotoxins, mycotoxins and hemotoxins. A bite from some of these vipers can result in death in a matter of minutes!

 

 

Here are just a few other poisonous animals…

 

Golden Poison Frog:  The golden poison frog is considered one of the most toxic animals on Earth. A single specimen measuring two inches has enough venom to kill ten grown men. The indigenous Emberá people of Colombia have used its powerful venom for centuries to tip their blowgun darts when hunting, hence the species’ name.

Scientists are unsure of the source of this frog’s amazing toxicity, but it is possible they assimilate plant poisons, which are carried by their prey. Poison dart frogs raised in captivity and isolated from insects in their native habitat never develop venom.

 

Wandering Spider or “Banana Spider: Remember those panicked reports of people finding deadly spiders-perhaps the deadliest on Earth-in bunches of bananas? Those reports referred to the Brazilian wandering spider, whose bite can cause severe burning, sweating, and goose bumps followed by high or low blood pressure, nausea, hypothermia, blurred vision, vertigo, and convulsions.

The Guinness Book of World Records considers the Brazilian wandering spider the most venomous in the world. Hundreds of bites are reported annually, but a powerful anti-venom prevents deaths in most cases.

 

The Giant Silkworm Moth Caterpillar (see the little cutie below) is a species of moths from South America. It is famous for its larval form, rather than the adult moth, primarily because of the caterpillar’s defense mechanism, spiny bristles that inject potentially deadly venom. The caterpillar has been responsible for many human deaths, especially in southern Brazil.

 

So, remember, everything is a poison; it’s just a matter of the dose! And before you pickup some cute little crawly thing; some poisons come in very cute packages…

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