I think they mean it in the sense that when developing a new medicine whose degree of efficacy is unknown, you can't just test the medicine and show benefits. You need to test the medicine and separately test a placebo version of the treatment and show that the medicine (+the inherent placebo effect) is more effective than the placebo effect alone.

Ok but then the choice of words is not appropriate. It’s not “difficulty”. It’s just due diligence.

Needing to do the due dilligence is part of the challenge of doing pharma correctly, and thus, its difficulty.

That the work is necessary doesn't make it not part of the challenge.

How are you defining "difficulty" here?

I guess my point is that difficulty is a relative thing. It depends on the task and on the individuals performing it.

Paying people to do the testing properly and, collecting and organizing the results. Making all those schedules. Making sure that the math needs is solid. Founding volunteers. Etc. All of that. It costs a bunch of money.

In the abstract, it could be said that it is a difficult process. I would not would not be able to organize it.

But for the people who are involve in those tests, and that have done that kind of thing hundreds of times, that is not a difficulty. It's routine.

If we are going to define "a difficulty" that way, then anything that a big company does is "a difficulty".

I would absolutely consider many or most of the mandatory tasks of keeping a company, any company, running are the difficulties of having a company, regardless of how difficult any individuals at that company consider those tasks to be.

Yes, successful pharma companies are good at overcoming the challenges involved, some of which you listed. The point is that being able to do so is necessary for that success, and thus, an obstacle.