My client, Mike, was a young physician who led an effort to develop a new antidepression drug. In view of the FDA’s strict system of constraints, he wondered whether he was a leader at all, rather than just someone following the rules. But he learned that following-the-rules requires immense organizational dexterity. So, ask yourself:
Leadership comes in many forms, depending on what you are leading. So, learn to adapt. Otherwise, no matter how great your vision and determination, you may not succeed.
It’s one thing to lead when you can call all the shots (“Follow me! I’m in charge!”) and quite another when you’re bound by constraints on what you can do and how you should do it. In that latter case, can you even be said to lead, at least insofar as that term is commonly understood? You may feel like you’re trying to lead in a straitjacket.
Mike was in this situation. He was leading the approval process for a new psychotropic drug while contending with the FDA’s tangled rules. He felt overwhelmed.
But it wasn’t Mike’s nature to give up.
A few years ago, he’d developed a hunch about this drug, and he couldn’t rest until he found out whether it worked—that is, whether it was good enough to be brought to market. His problem was convincing himself that he had the leadership skills necessary to finish the job.
So, my role was to provide encouragement and, more precisely, to help Mike define his role as a leader within the FDA’s rigid system of constraints. I had to help him feel that he was making consequential decisions and that following FDA protocols still allowed him to be creative, to exercise foresight, and to manage teams of professionals (not to mention his own capacity to keep on going).
Looked at from another perspective, while the FDA established a general plan, it was up to Mike to follow through with good organization.
It’s important to realize what leadership is when your work is mostly admin and organization.
When Mike first came to see me, he had a hunch about ketamine, a compound that seemed to have a remarkable effect on depressive states. When it was used as an anesthetic in surgical procedures, patients reported waking up with a feeling of euphoria. So, Mike wanted to study ketamine for potential use as a psychopharmacologic agent.
Mike knew it would be an uphill battle, but he couldn’t let go of the idea. He didn’t realize, at that point, the scope of the project.
Now he was leading research to develop ketamine as a drug to treat depression. The FDA would require rigorous trials.
The whole process seemed mind-bending—and this was before the FDA began its review. From end to end, the process could take years and billions of dollars.
The trick, I told Mike, was organizing a team experienced in the phases of this vast undertaking. My point was that notwithstanding the FDA diktats, Mike would be exercising recognizable leadership skills by managing the project efficiently and effectively.
I told him, “A leader has to stand back and take in the big picture. Breakthroughs happen slowly.”
This helped. Based on the results of his animal studies, Mike summoned the courage to seek an FDA grant to demonstrate ketamine’s efficacy in humans. “Now this is a clear instance of good organization,” I told him. You knew what would be required, and you figured out how to meet the requirement.
Mike got the grant, and the initial results were impressive. As a sign of the drug’s promise, ketamine clinics were springing up in private practices, with psychiatrists and anesthesiologists collaborating to help patients—even before the drug had received formal FDA approval.
I told Mike that one sure sign of leadership is that people volunteer to support you. In effect, Mike had worked the system to his advantage. He used the system—the FDA straitjacket—to enlist other people to help push the drug towards approval. He could draw on their results to bolster his own. The point, of course, is that when you’re trying to lead within a system of constraints, you can use the system to support your initiative.
But how to deliver ketamine (other than as an anesthetic) was still an issue. However, Mike’s boss, the dean of the medical center and a huge figure in psychiatry, had a novel idea: Administer it as a nasal spray.
Mike told me that he wished he’d thought of that idea. “But,” I said, “as a leader, your job is to draw people into the project, and the dean is a big draw.” Again, he was leading and didn’t know it. “In this sense,” I said, “the dean is now a part of your team. You just organized the delivery team.”
Moreover, the dean had the clout to obtain funding for full-scale clinical trials, necessary to bring the drug to market. He partnered with a Big Pharma company through a medical center office that specialized in commercialization. Ultimately, they developed a ketamine nasal spray and brought it to market for treating refractory major depression.
So, we learn from Mike’s experience that:
At first, it seemed as though there was no room for maneuver. But then Mike realized that once you know what maneuvers you’ll need, you can organize how to satisfy the requirements—and lead.
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