The Serious Medicine Crash

Editor's note: the charts in this post have been updated since original publication. 

We are in the middle of a crash in Serious Medicine--a steep decline in the number of medical devices approved, an even steeper decline in the number of drugs approved, and a drought in venture capital.

And yet few are noticing, at least not those engaged in the public policy debate, or those covering it.   A case in point is this article in Friday's Wall Street Journal, "J&J, FDA Clash Over Device." 

Two points to be made here:

First, note the verb in the headline: "clash." Undoubtedly, that's exactly what Johnson & Johnson and the Food and Drug Administration are doing: They are clashing over a device called Sedasys, which, as the Journal notes, "is used to mildly sedate patients about to undergo routine medical tests."  OK, fair enough.  But not all clashes are the same; in a private land dispute, for example, few outside observers might have any interest, or curiosity, in the outcome. But in the case of medical devices, if there's a clash between the government and an equipment maker, we all have an interest.  So it's unfortunate, if appropriate, that the headline doesn't quite capture the reality that we, the people, have a stake in the outcome of this case--because we want more safe medical devices--don't we?

I am not saying that the FDA should, or should not, approve Sedasys.   Instead, I am arguing, on behalf of all of us, that we want the most robust possible market for new devices (and drugs, and anything else that heals and cures).  And if, for example, the Obama administration, which has declared its determination to control healthcare costs, even as it expands healthcare coverage, is in any way putting its thumb on the scales to say "no" to new devices, well, we should know about that.   Because, as we shall see, the real story here is not the "clash" between J&J and FDA.  The real story is the crash of Serious Medicine.  

In fairness to the Journal, there's no way that a straight-news headline could capture our larger collective interest in the case, to say nothing of my own suspicions about a rationing-mindsetted FDA/HHS.  Happily we all can all be an interested party--and interested commentator--in this case if we wish to.   Of course, raising our voices is easy; making our voices heard is harder.  More on that in a bit. 

Second, if you look closely at the chart in the story, you see the recent history of the FDA's approval of new medical devices.  The overall trend of submissions to the FDA is down, slightly, and that's not good.  But the black part of each riser, at the top, is undoubtedly the most important, because it shows the number of new devices approved by the FDA each year, going back to 2003.  You might need a magnifying glass, but the chart shows that the number of devices approved has fallen.   But the chart obviously does not highlight that fall.   So here's another look at the number of new devices approved by the FDA, going back a decade, to 2001, according to the FDA:

Not encouraging, huh?   For those interested in the details, the fall from 60 approvals in 2001 to 27 in 2010 is a 55 percent drop.  As noted, we all have an interest in more medical technology. 

But perhaps, one might speculate, the fall-off in medical devices is a one-off.  Actually, the fall-off is part of a larger trend--a crash we might call it.  FDA approvals of new drugs (new molecular entities and biologics) is showing an even steeper falloff--63 percent--as shown, once again, by the FDA, with some additional data from Pharma Strategy.   Here, take a look at this chart:  

So we se the same trend, across three Presidential administrations and Congresses controlled by both parties.  A grim trend, to be sure.  

But of course, the fall-off in both drugs and devices should not be surprising, because as Rick Merritt of EE Times reported last fall, as many as three quarters of healthcare venture capitalists are leaving the field. 

So we can sum up the life-prospects situation that we all confront: The number of approved new devices down by 55 percent, the number of approved new drugs down by 63 percent, and the number of venture capitalists down by 75 percent: 

That's the Serious Medicine Crash.  And it's a matter of life and death to all of us. 

So what will it take to turn these baleful trends around?   How could we get a boom in Serious Medicine?  It would take a host of changes, of course, and that's the overall topic of this blog.  But the first mission is for all of us to point out what's happening to us.  And if enough of us do, the Journal, and other publications, will cover the story.   And that will be the beginning of the turnaround. 

* Drugs defined as new molecular entities + biologics.