You have no idea what you are doing, do you?

As it’s a random Friday afternoon in April, a guest post from my mole in the pharma publishing industry.

———
_Herbert Van Der Hibernator
University of Life_

There is a famous scene in The Life Of Brian where Brian is forced to hide from some Roman soldiers and finds himself standing on a rickety platform inexpertly nailed to the outside of Matthias’s house. The platform eventually collapses and Brian finds himself standing on a speakers’ platform with an expectant audience in front of him. Looking around for inspiration, he realizes that he is supposed to philosophize and begins with “Don’t pass judgment on other people, or else you might get judged, too.” The crowd respond with a mixture of rapture and bewilderment. What follows is a typically Python interchange as the hassled Brian is forced by an ignorant audience to clarify every point he makes. He inevitably makes a string of mistakes until the immortal line is cried: “He’s making it up as he goes along!”

It is probably a feeling familiar to us all. We are making our way in the world without a clear set of rules and no matter how closely we observe the successes and failures of others, no clear pattern of causality is evident and we remain in the position of making it up as we go along.

It has always been thus.

I was inspired to comment on this by this week’s press coverage of Armando Iannucci’s big screen adaptation of his successful television series In The Thick Of It. The film, entitled The Loop, depicts the comedic working life of British politicians in the run-up to the invasion of a middle-eastern country. Iannucci was quoted as deriving his inspiration from government reports regarding the invasion of Iraq and the particularly frightening discovery that a 22-year old graduate had been packed off “with his iPod” to draft the Iraqi constitution simply because he had a fresh degree in constitutional studies. Iannucci realized that the business of serious government, while fronted by grizzled old statesmen like Gordon Brown et al, is actually being conducted by a bunch of kids with no idea what they are doing and who are making it up as they go along.

We love to laugh at the government and its incredible incompetencies, and we probably enjoy the idea that the whole affair is a modestly formalized, reactionary college party with nuclear weapons. However, we should take care in adopting such a superior attitude. If we look closer to home, there are parallels that will at least cause us to blush and look at our shoes, and possibly lead us to pity and empathize with the constitutional studies graduate listening to Babyshambles as he considers whether or not Iraq should have a senate, a congress or both.

My chosen field is pharmaceuticals. I work with a range of drug companies from the very big and Swiss to the very small and Czech, and no matter how big and serious a pharma company is, it is still apt to make mistakes. People outside the business looking in may find this pretty alarming. Pharma companies are in the business of making drugs that are given to sick people to make them better, or at least make them feel no sicker than they felt the day before. The whole enterprise of medicine is so inherently risky that the industry has found itself regulated up to its eyeballs to ensure patient safety through brutally rigorous application of processes for the design, delivery and reporting of clinical trials. And rightly so. The medical profession and the public needs to be certain that the experiments conducted to determine the efficacy and safety of a new drug have been conducted to the very highest standards by people who are properly trained and highly experienced in the field.

The problem with this is that almost all of the people I work with are about the same age as me. We, the professionals running and reporting clinical trials, are about 30–45 years old. We can still remember our graduation night. We like to watch reruns of Top Gear because Clarkson is cool, we laughed at Jackass, and we are most definitely making it up as we go along.

The result of leaving my generation in charge of things is a series of truly gargantuan errors of judgment and a catalogue of mistakes that is too long to list. Some of the most notable examples come from the design and running of these supposedly flawless clinical trials. I have seen an instance where a company decided to do an unplanned interim analysis of the primary endpoint of a phase III trial without understanding that doing so altered the statistical power of the study. The result was that they missed significance of the primary endpoint in the planned analyses by 1% and their thousand-plus patient trial was a worthless, million-pound wreck. Another company designed a study with so many endpoints in it that statistical chance would make one of them positive. The investigators got very excited that they had a positive result until it was pointed out that a random number generator would have got the same result or better. There was also the painfully embarrassing tale of a team who drafted a dummy abstract for a major clinical congress to see how the abstract submission system worked. They must have done a good job because the abstract was submitted in error and accepted by the congress for an oral presentation. The author, Dr John Smith of the University of Orkney, however, did not exist.

I am going to go back to my desk now and wing it in the name of medical progress. As I do so, no matter what disasters befall me or those I work with, I will remember that off-the-cuff advice from Brian of Nazareth: “Don’t pass judgment on other people, or else you might get judged, too.”