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Book Cover for the book Safe, Effective, Fraudulent: Choose Two: When Money is the Drug by Jim E. Durand

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Safe, Effective, Fraudulent: Choose Two: When money is the drug by Jim E. Durand

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Foreword to Safe, Effective, Fraudulent: Choose Two: When Money is the Drug by Jim E. Durand

Pharmaceuticals. Saving lives. But full of corruption. This story of sex, power, riches, and intrigue drives a compelling understanding of how the keys fit into the locks to shove an industry forward. Though a fiction novel in that the names, places, and situations have been changed to mask the real events, there were real events. And as the real events unfolded I was there and saw it all. The novel’s author is justifiably humble in his fields of physics and philosophy, yet still fears not to tread where acquired skill in story-telling will serve a noble purpose, illustrating that real people in the pharmaceutical industry truly care about you, the ultimate customer. He brings a moral compass and a gavel in judgment to the story line in his ability to add color and personality far beyond my subdued observing.

You must read this book. You’ll be caught up in the balance between condemning and yet understanding the redemption of those who both cure our cancers but yet fleece us and those we love. And as with the current opioid crisis, it’s supposed to be just collateral damage if a few die along the way.

Decades of caring for patients, prescribing medications, and working inside the pharmaceutical industry have shown me the consistency and replicability of the often-bumbling process of drug discovery and development. Whether the medications are overwhelming successes such as penicillin and insulin or undeniable tragic disasters such as diethylstilbesterol or thalidomide, the process grinds forward in the midst of proponents and critics, hostilities and benefactors, coercion and facilitation.

There are people in the United States who complain about the price of medications, not understanding that we in the Unites States have fueled the progress in medicines for the last century. In the 2006 film, The Devil Wears Prada, the character Miranda Priestly (played by Meryl Streep) makes the famous “cerulean sweater speech”. She explains that while high fashion begins with Oscar de la Renta or Yves Saint Laurent, through the next few decades that high fashion cascades down to the discount clearance bin at the bargain basement store. So the whole expensive top part of designer fashion fuels the entire multi-billion dollar clothing industry, top to bottom, worldwide, for decades.

This same top-to-bottom flow is true for medications. Walk into your local drug store. See the thousands of bottles and boxes of medicines of all sorts for every conceivable condition? Every single one of those started its journey as a new, expensive, branded drug. As the years go by all the good ones become more available and cheaper. Modern medicine can do what it can do today because our grandparents bought these medications, and our parents bought them, and we buy them. They’re only seem expensive if you don’t have vision and don’t have a calendar, you only live for yourself and for today.

And if one understands this comprehensive view, our children must also buy them. Look around you at this huge, rambling medical care system we have. Hospitals, clinics, doctors, nurses, emergency departments, urgent care clinics. Expensive facilities, expensive professional employees. It all costs a lot of money. How to save money? The least expensive way to treat any illness is with a medication, if we have a safe and effective medication to treat it. If you’re dying of pneumonia and an antibiotic will cure it, you’re saved. We can now cure hemophilia and sickle cell disease genetically. Not just treat these disorders, cure them. Why would anyone want to diminish this part of the medical care system. We all know there are specific problem companies and problem people. Shut them down, fine them, jail them, get rid of them. But the bad apples are not the whole bushel. We don’t throw out the baby with the bath water.

Introduction to Safe, Effective, Fraudulent: Choose Two: When Money is the Drug by Jim E. Durand

The background to this story is the universal background to how drugs are developed. The marketing and sales division is a good place to start. They are key, oddly enough. If there’s no market for a drug, if you can’t sell it to anyone, it will never become available. The billions needed to develop a single medication is far too high a price for a charity effort. If there is a market, then call in the clowns. These are the scientists, physicians, statisticians, and many other professionals who actually find and develop our next miracle drug.

Most of us might think that these bright scientists are the important group. But the marketing division truly controls the process and they view the scientists as their worker bees, their pieces on the chessboard. Because until you sell a drug, it’s worthless. A team could discover the world’s best next drug, but unless a sales team guided by the marketing division sells it, no one will buy it. Few will even know about it. It’s not possible to successfully promote a medication by word of mouth.

So the marketers see a place to sell a specific drug and start the ball rolling. First, they need a group to make the drug so that they have something to sell. But wait, you say, what about the physician scientist who discovers a new drug and wants to get it to patients? The doctor’s only doorway to get it to patients is to go talk to the marketing division. If there’s a great market for it, the doctor will get the research money and permission to move the drug’s development forward. No market, no dice. If the new drug does not really have a market but a similar drug would, the marketing division leaders will tell the doctor to go back to the lab and make this other new drug that does have a market. And so it goes.

Often along the way in development the new drug will reach a decision point. Now $10 million have been spent, but the next phase will cost $100 million. Should the candidate drug move forward? If the scientists and marketers agree to either stop development or continue onward, all is well, the die is cast. What if the physician scientists huddle and say, “No, wait, it’s not effective enough. It’s not safe enough.” And the marketing and sales groups come together and say, “You know, this could be a blockbuster. Maybe peak year sales of $15 billion.” The scary part is, it’s not clear who would win this disagreement of opinions. Most often, the marketing division wins.

And so our story begins. As with a Shakespearian play or an Agatha Christie murder mystery, the theme is universal while the story and characters, love them, hate them, or cry for them, are specific. Time to find out who lives and who dies…

Denis F. Darko, M.D.
Fellow, American College of Physicians
Distinguished Life Fellow, American Psychiatric Association
CEO and Managing Member
Neuroscience Research and Development Consultancy, LLC

Used With Permission

This announcement, the Introduction, and the Foreword are used with permission.

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