By Ali Afnan
As I watch the snow flakes blow horizontally outside my window this December day, I’m imagining Santa and his reindeer braving the cold and wind to deliver Emil Ciurczak’s gifts, and those on Pedro’s, Girish’s, Gawayne’s and other holiday wish lists for the pharmaceutical industry.
I wonder how the wishes on Emil’s list, as well as Pedro’s more serious one–was it more serious?–could be delivered. How will common sense travel down a chimney, Girish? And would one really read Karl Popper’s “The Logic of Scientific Discovery” on Christmas day, Gawayne, or pass it on to others on Boxing Day?
Weather reports suggest that a dusting of snow will remain on the ground tomorrow, just a lingering trace of today’s snow fall. Is this dusting similar to the industry’s recruiting some of the world’s best scientists, yet teaching them to disconnect science and engineering principles from their day to day work?
Are pharma’s practices magic? Why else would Gawayne wish for those in industry and FDA to read and follow Karl Popper’s book, and Ajaz warn the FDA of falling into the Popperian trap?
I am still dumbfounded that first-class engineers who have studied control theory even choose to work for this industry. In practice, many of them only get to demonstrate their superior knowledge of control in the form of signatures on pieces of paper. So their engineering training, too, is like that thin dusting of snow.
But wait. The snow has just stopped falling.
Surely Emil, you are old enough to know about Santa- unless, perhaps, you are Santa. You look a little like the mythical character; you even have the red nose, just missing the beard. ( Although I think you look much better without the beard).
Emil, not many people listened to, or perhaps even understood, what you were saying years ago. So why do you think your old lab notebooks would be of any use today?
Whether we believe that Emil has reindeers and can go down and up chimneys, all these wish lists suggest an industry that finds it impossible to change, even though, as Pedro points out, each manufacturing site has a change department! His wish list reminded me of my first week in the pharmaceutical industry, straight out of the chemical industry.
Imagine my shock when I learned that I was working for a cash-rich company that didn’t believe in process control.
As instructed, I prepared a report on manufacturing practices, and proposed a number of projects that would make pharmaceuticals accountable to standards similar to those used routinely in the chemical industry.
I will never forget the consequential meetings with my line manager and his boss. They thought I had been using hallucinogens, AND believed in Easter bunnies. The report has been burning in the pharmaceutical industry’s fireplace ever since, no doubt, making that chimney less welcome to Santa.
It took seven years of hard work to convince one man that there was another way, that control was not a certificate of analysis, that batch quality could not be assured with 20 samples, and that three consecutive batches did not identify or address variability critical to the process and product.
Alas, the changes required were too many, too big and revolutionary.
It was now time for me to meet the change control group. I am so sorry Pedro, but the change department’s real role is to ensure no change. It is called “change control” just to tease people who like to do things differently, and, perhaps even better. Its ultimate goal? To stifle scientific discovery and maintain a static culture in which industry and regulators continue to blame each other.
I soon realized that science was not the loadstone preventing change. Instead, many independent but interacting layers had to be peeled away and changed, one at a time.
Sound science would not tolerate “unknowns” in stability samples of a marketed product.
It would not have dissolution testing for a product done at 39o C, just “because.” (That practice turned out to be the result of a typographical error, which had been signed off on by regulators worldwide, and followed, unquestioned, by manufacturers everywhere!)
Another mystery was FDA’s “Office of Pharmaceutical Science,” where I used to work. Wouldn’t it have been better to name it with the plural? After all, there is more than one science. But what, exactly, is regulatory science? Perhaps, Santa, you can elucidate? You wouldn’t even have to come down the chimney.
My real wish, Santa, is to find at least one pharmaceutical company executive, senior enough to have the executive authority, and to make it his or her business, to understand these wish lists, and the need for change, and to take action. If the nature of these questions is understood, there’s no need to question Santa’s existence.
The pharmaceutical industry depends on, and is made up, of individuals, from the lowliest operator, reviewer or inspector to the CEO or Commissioner.
In the end, it is what we choose to make it.
May each member of our industry consider his or her contribution, implement the best science possible, and take action, each day, for the good of society.
Wishing you all a very happy holiday and a science-filled 2011.
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