Find It, File It, Flog It—exposing Big Pharma's route to blockbuster profits
A tale of greed on steroids...
Something I wrote in 2015
I was royally hacked off when none of my former colleagues in the pharma industry took any meaningful notice of the sage advice I offered in Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and Biologics, (Wiley, 2011I).
That spurred me on to write a second in 2015. This book presented a caricature of the industry, in the guise of an addictive gambler, as described in the book below:
Big Pharma was crippled by a debilitating addiction many years ago. As with any addiction, lifestyle choices are at the center of the problem. For the addictive gambler, the roots of their demise lie in early success. Seduced by the rush of easy money, it becomes a way of life. The gambler doesn’t feel the need to go out and work, preferring instead to focus on beating the odds. Nothing is as important as the next win, and possessions and relationships often are discarded in order to fuel the habit. By the time the gambler realizes the problem, it is all too late: no home, no family, and few friends, little money, and no prospect of being able to hold down a job
Titled Find It, File It, Flog It: Pharma's Crippling Addiction and How to Cure it, the book aimed to inform stakeholders in the industry (patients, healthcare professionals etc) of what was truly happening underneath. This is the Preface:
“I almost didn’t write this book. My maiden attempt at a book, despite great reviews, was a disappointment in terms of sales. I had been certain the world was hungry to hear the messages within, not just to inform and educate on my speciality subject—strategic management of the supply chain—but also to help catalyze change for the better in the pharmaceutical industry.
As I think back, the important messages were disguised within a relatively high-priced textbook in an industry where the topic of professional management of end-to-end supply chains was as popular as the Conservative Club in Moscow.
Undeterred, I continued to preach the messages at conferences, in professional journals, and through webcasts and podcasts.
The presentation I gave at conferences in the United States and European Union was purposefully provocative. I resorted to giving the drug development and commercialization process a funny name, Find It, File It, Flog It, and semiridiculing the notion of scientists discovering blockbuster drugs in the dead of night, surrounded by test tubes, Bunsen burners and other apparatus involved in deep chemistry.
The audiences were always polite. No one challenged me on what I said, although there must have been a lot of skepticism underneath. The only manifestation of that was when I presented at a conference in Tuscany, where a senior Food and Drug Administration official had a coughing fit halfway through my presentation and had to leave.
She did not return until I had finished.”
The opening of CHAPTER 2—Return to a Misspent Youth
It wasn’t always like this
It has recently struck me that the pharmaceutical industry for many people has always been the same as it is today. A trade journal reporter declaring “Pharma has traditionally been business-to-business” confirmed this realization.
This is certainly not the case, and those of more mature years, such as myself, remember a different time.
The reporter’s comment made me wonder how this perception occurred and how widespread it was. If the misconception is common, then I should explain.
When today’s drug companies were in their infancies, probably in the 1950s, things were very different. GlaxoSmithKline (then Glaxo) started by making powdered milk for babies.
Beecham’s (now GlaxoSmithKline) was famous for its flu powders, Johnson & Johnson was famous for baby hair shampoo, and Novartis wasn’t even a twinkle in its grandfather’s eye.
Blockbusters hadn’t been invented, and Big Pharma companies generally had clear views of the customer constituencies they were serving.
All had an underpinning focus on the need to satisfy patients first. The words of George W. Merck, the founder of Merck & Co, provides evidence:
“We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. The better we have remembered it, the larger they have been!”
Are these words now lost in the mists of time? We hope to find out as we progress.
VIEWS, OBSERVATIONS, AND PERSONAL EXPERIENCES OF THE AUTHOR
During my early days at Bayer manufacturing in Wales, the manufacturing and supply process was pretty much integrated, from the point where raw materials arrived at the back door and the finished product was made and sent directly to customers—hospitals, Pharmacies, and sometimes patients—in the home market and to other Bayer entities around the globe.
Those Bayer entities had local presence and distribution capabilities in their own home markets. Links with customers were direct, and the staff at Bayer, the company holding the license to sell the products, could handle customer complaints.
The staff making Alka Seltzer for Europe had a standing joke. A polystyrene packing piece was at the top of each glass bottle as a cushion to prevent the tablets from moving and breaking. It was a frequent occurrence for customers to send the piece back to the plant with a complaint that it wouldn’t dissolve. The reply was always polite and understanding, but It was hard to resist a wry smile.
***********************************************************************************************
That was life before the blockbuster era.
Let’s go back to the days of Big Pharma as a little boy in short trousers.
Rich pickings begin
Pickings began to get rich starting in the mid-1970s, mostly from the battle of the stomach ulcer drugs Tagamet (Smith Kline & French) and Zantac (Glaxo).
Even though Tagamet was the first to market (1976), Zantac overtook Tagamet soon after its launch in 1981 with what was reported to be a superior marketing effort. This seems to have been the birth of the blockbuster era.
By the early 1980s, industry players learned that a patented compound—new molecular entity—with an important license to sell could use nimble marketing to make huge profits under the shelter of patent protection.
The industry focused increasingly on patenting as many compounds as seemed reasonable, selected the most promising for development, and then marketed the bones out of them once approved.
Figure 1 shows a gifted scientist who has found a compound from the patent library that is showing some promise in the test tube. He’s having an ‘eureka’ moment.
Figure 1. The reigning paradigm of drug development (courtesy Expert Witness Dr Graham Cox for the cartoons)
We see that our eager scientist phones his boss, who is under pressure from above to move compounds into development, and he is more than happy to hear the news that the finding has potential. The race is now on to get the magic powder into trials by making larger quantities to test on animals. Figure 2 shows the scientist’s baby hastily passed along the development conveyor belt as the patent clock ticks
The scientist moves on to find further medical breakthroughs—or not, as the case may be.
Other scientists take over the baton and head toward the finish line. The next step is proving that this compound is safe for clinical trials to begin and has some scientific rationale as to why it is going to work.
In the name of conserving remaining patent life, the industry puts things on fast-forward. The patent fairy (or is it a wicked witch?) is omnipresent, and every pause for thought must be met with a poke of her broom handle or a whack with the bristles.
To recap in the real world, this “lifestyle” approach involved finding a promising patented compound (Find It), placing it into a development pipeline intended for regulatory approval to market (File It), and then marketing the approved product with the utmost verve and vigor (Flog It).
In mathematical terms, we have: F1 + F2 + F3 = $$$
Where: F1 = Drug discovery (Find it)
F2 = Regulatory review and approval (File it)
F3 = Marketing (Flog it)
$$$ = Megabucks
This is the equation that has driven the industry ever since—with devastating outcomes. From here on, we will refer to this approach of drug development and commercialization as Triple F, as we continue our exploration of the pharmaceutical industry.
The race to the clinic begins
We now dig more deeply into the “File It” stage, where Pharma companies must prove their compounds are fit to be marketed. We pick up where “Find It” is completed, where a fresh team of scientists takes over from our discovery friends above.
They will be conscious of the wicked witch’s presence from years of conditioning. A day lost in development is a day’s patent life and, more important, lots of money in lost sales if it’s a blockbuster. Minds are concentrated appropriately.
It’s time to get cracking with preclinical testing…
Here is your PDF copy of the book proof Amazon CreateSpace did for me
This is the printing proof created by Amazon as part of the publishing process:
Find It, File It, Flog It: Pharma's Crippling Addiction and How to Cure it
Hope you enjoy it!
Amazon also created the cover, showing two ‘clever’ scientists believing they had a blockbuster drug in the bag, even though it was still only a small quantity of liquid hastily produced in their laboratory.
That’s it for now!
Hedley