Well it certainly wasn’t pretty ... but fascinating. I agree...

Well it certainly wasn’t pretty ... but fascinating. I agree there is an element of Monty Python.

According to QRX this crash is actually only a flesh wound and its all the FDA’s fault.

Essentially the FDA are ditherers who can’t make up their minds about the rules. They haven’t analysed the data properly, they can’t be trusted because they go back on their agreements and they haven’t throught things through very well by imagining that Moxdou should conform to some rules for OTC products from the 1970s.

The funny thing is that there is probably an element of truth to what QRX are saying about the FDA. For those hardy souls who braved the AdCom meeting last night when we watched QRX present they were very good. Extremely clever “alpha” males, (with one exception) very confident in presenting without stumbles or hesitations and with plausible answers to everything.

The FDA representatives were mainly females in the role of humble government functionaries. Less self assured, wanting to be fair and subservient (on the surface) to the mainly male AdCom committee members who were the real experts.

If you added up the IQ on QRX’s side of the table it is probably 50% more than compared with the FDA side of the table. If you added up income on QRX’s side of the table it would be quadruple that of the FDA representatives. QRX fly first class – FDA functionaries in the back of the plane.

And this confidence is transmuted through to the market to essentially convey the impression that these guys know what they are doing and know it better than anyone else. Hence no one spots the huge risk that these guys were actually taking. Just like a mini Enron.

A simple example is the Special Protocol Agreement (SPA) that companies enter into with the FDA. These agreements spell out if you run a trial with x sample size, in Y patients with an agreed primary end-point and show statistical significant results approval from the FDA will follow.

There is tremendous confusion on QRX’s part whether or not they had a SPA for study 008 – which in fact is the crucial trial here (not Study 22). The truth is they didn’t. And while QRX say there were only minor quibbles around some statistical issues that was blocking an agreement ... the fact of the matter is that it is madness to start a study without being entirely clear whether or not a SPA is agreed. It is or it isn’t.

Now the regulatory expert for QRX whose hourly rate is probably 10 times mine claims SPA’s are not worth the paper they are written on. And he cites a case where the FDA went back on a SPA. Yes it happens – but it is rare and 99 times out of 100 the FDA does not backtrack on them. The whole reason companies enter into them is to create certainty.

SPA’s come at a price ... the bar on trials is raised but the trade-off is increased certainty. If the context has high uncertainty – and ideas are evolving as they were – this makes a SPA more (not less) compelling. To try and get some solid ground somewhere in the trial development process. And you would do this virtually at any price. But especially if the stumbling block are some minor statistical issues as QRX claims. And anyone could have told them that for $100.

Years ago a captain of a large passenger jet was told to taxi to the end of the runway for takeoff. Which he duly did. The plane was behind schedule by an hour because fog was rolling in. He was very annoyed he had not received the priority from air traffic control he thought he deserved.

He was impatient and decided just to takeoff. And promptly ran into another plane on the runway he couldn’t see because of the fog. He had not received clearance to actually takeoff from air traffic control. But he knew better, was cleverer, more experienced, more important, and earnt more than some lousy air traffic controller.

This is exactly what has happened here.

ABC2 should make a weekly film on clinical trial crash investigations. I suppose if you watched a few episodes you’d never invest in this sector again ... because it would quickly become clear that this process is a lot more riskier than flying.