We carefully packed the sculptures in our suitcases when we returned from Africa, using our dirty clothes to cushion them from damage. Leave it to the airlines to outsmart us and find the weak spots in our preparation. When we got home, three of the sculptures were broken.
No problem. A little SuperGlue, and now, from a distance, they look fine.
It’s not so easy with a presentation. I recently worked on an Advisory Board presentation at the FDA. We worked hard to locate the weak spots in our data, prepared arguments to stress the appealing risk/benefit profile, and told our story to the distinguished physicians on the board.
Leave it to those who treat the patients on the front line to find the weak spots in our argument, and send us packing to get more data to ensure the safety of those they treat.
It’s hard to protect the weak spots. Perhaps no amount of packing could have saved our African sculptures from damage, given the mauling they were destined to get on their way to the States. Similarly, perhaps no amount of back-filling argumentation could have saved us from the weakness in our data, given the bruising skepticism of physicians entrusted with the public interest.
I believe wishful thinking plays a part in these two episodes. My wife and I were exhausted at the end of our trip. We had too many bags. They were overweight. We had to fit the sculptures in the best we could. We crossed our fingers, and hoped.
On the professional side, my clients and I may have brought wishful thinking to the FDA as well. We were desperate for a new compound to be approved: the company had not had a winner in a long time. We saw a chance that this new one might get over the hurdles. We made the commitment, ratcheted up our belief, and began to prepare. The train left the station, and once it was rolling, we had to keep believing, even when weak spots emerged.
The day arrived, we did our best, but a jury of our peers poked a hole in our claim that the drug’s benefits outweighed its risks.
Back to the drawing boards we go…for a couple of years. It takes more than SuperGlue to fix a clinical trial.