Today the folks in Indy are not just celebrating the Colts victory yesterday they are also celebrating the 36th anniversary of the FDA’s approval of Humulin. The approval process of this drug was outlined in a nice piece written by Henry Miller in today’s Wall Street Journal. Dr. Miller was the founding director of the Office of Biotechnology at the FDA. In the piece Dr. Miller writes;
“The back story, however, is revealing. My team and I were ready to recommend approval after four months’ review. But when I took the packet to my supervisor, he said, “Four months? No way! If anything goes wrong with this product down the road, people will say we rushed it, and we’ll be toast.” That’s the bureaucratic mind-set. I don’t know how long he would have delayed it, but when he went on vacation a month later, I took the packet to his boss, the division director, who signed off.”
While we can sympathize with why Dr. Miller feels this way, we can also understand the FDA’s mind set. We all complain about the time it takes the agency to approve new drugs and devices. Yet Dr. Miller supervisor was right when he said the agency would be toast if anything went wrong. We witnessed this with the Avandia debacle and may be seeing history repeat itself as the FDA begins their investigation of Medtronic.
Everyone including Medtronic was surprised how quickly the FDA approved the 670G. An approval that was hailed as a major step forward in the treatment of diabetes. An approval which based on what we now know may have been premature. With the 670G and any other sensor augmented insulin pump the FDA has entered a new world, a world in which all the links in the chain must work together, any failure between these connected links and the entire system falls apart.
This faster than anticipated approval also put Medtronic in a conundrum, how do they get the system into the hands of patients when it wasn’t quite ready for prime time. Although the company will never admit it the folks in Northridge knew there were some issues with the 670G. The biggest being the new sensor which worked with the 670G, a sensor they had difficultly manufacturing in scale. It’s one thing to make sensors for clinical trials but a whole different story when it comes to scaling up production.
Yet the company had publicly committed to the 670G, made promises to the investment and diabetes communities plus they wanted to capitalize on all the favorable free publicity generated by the approval. They were well aware that Animas and Tandem were floundering back then and the 670G gave them an opportunity to deliver a final knockout blow. Rather than wait and workout the issues with sensor production off they went. Simply put the train had left the station although the train really wasn’t ready to go.
The irony here is there was no reason to rush the 670G, the company had the 630 which seemed to be working just fine. Additionally, they already owned the insulin pump market. They could have delayed the launch while taking pre-orders for the 670G. They could have easily done this with no fanfare rightly stating that the faster than anticipated FDA caught them off guard. No one would have been the wiser. It was the perfect cover story.
However rather than wait and fix the production issues with the sensor off they went. A decision which they may be regretting today given the well-known issues with the 670G. Issues which have been known in the diabetes community and now are the subject of an FDA investigation. Worse it appears the company in an attempt to cover up issues with the system has been using fancy semantics when it comes to adverse event reporting.
Since the FDA has just begun their investigation, we have no idea what action if any they plan on taking. But we do know this should the FDA discover the company has been less than truthful, that the company has attempted to cover up a problem they will be ruthless and not just because they were lied to. They will be ruthless because it will be major CYA time. The agency approved the system faster than anyone anticipated and as Dr. Miller’s supervisor noted should anything go wrong, they will be toast and the FDA doesn’t want to be toast.
Since we became aware of the issues and began our investigation one question keeps swirling around in our mind; Why? Why did the company act this way? There is no logical explanation. The company owns the insulin pump market, they own formulary position. They knew Animas was on the way out and even if Tandem did become financially solvent, they could not match Medtronic vast resources. There was no need to rush the 670G especially since they had the perfect cover story.
We can only speculate as to why but at the end of the day it’s just that speculation. The reality is the company could now be forced into a very uncomfortable situation. The decisions they made could well come back to haunt them. The FDA doesn’t like to be fooled and will swing a heavy bat should they discover the company was less than honest.
Listen we can fully appreciate just how difficult it is for any company in the medical device arena. As way cool and whiz bang these toys are, they are at the end of the day medical devices. Devices which can and do fail or malfunction. Yes, they are great when they work but when they don’t there are serious consequences. It is not an understatement to say lives are at stake here.
Which brings us back to why? Why the rush? A mind-blowing question considering there was no logical reason for the rush. It’s not like the company needed the 670G on the market quickly. They were in no danger of losing their monopoly. They were in no danger of losing their formulary advantage. While the competition was coming out with their own way cool whiz bang toys, none of them could match Medtronic’s size or resources. The goose that lays those golden eggs was not in danger of becoming a dead duck.
We have no idea how this all will play out, but we do know the heat is on. The FDA is investigating and could well turn up the heat. The company is also facing at least two whistleblower lawsuits, one related to deceptive sales practices, the other on how they report deaths related to their insulin pump systems. All of a sudden that goose that looked to be in no danger is starting to feel uncomfortable.