Sunday, January 31, 2010

Why Fund J and J / Animas / DexCom Close Loop Trials?

Note: notes like this [d1] are footnotes to more discussion at the bottom of the posting.

Why Fund J and J / Animas / DexCom Closed Loop Trials?

About two weeks ago, JDRF made a big announcement that they were helping to fund research into a closed loop system.  Basically, they are working with Animas (insulin pump manufacturer and division of Johnson and Johnson) who work with DexCom (CGM manufacturer).  JDRF was putting in about 8 million dollars over about 3 years [d0], and was hoping for clinical trials within a year, and FDA approval of a device (although not a full Artificial Pancreas, or AP) within 4 years. 

So the first thing that popped into my head was "why bother?".  By which I meant, why should JDRF bother?  I don't have any problem with JDRF funding commercial companies [d1].  But Johnson and Johnson (especially) is a huge company which could easily fund it's own clinical trials. And it is clear to me (and many others) that closed loop systems were the next big thing in pump technology.

It so happens that last weekend I found myself talking to two guys who know more about corporate research into type-1 than I do, so I asked them this very question: Why should JDRF fund research that Animas was going to do anyway, when Johnson and Johnson had the money to do it?  Their reply was simple:
Animas would never have started the research into a closed loop trial, without the money and public support of JDRF behind it.
My initial reaction was disbelief.  I pointed out that Animas was in the pump business, and the obvious next step in pump development was a closed loop of some kind.  The first company to market a closed loop pump would have a huge advantage over all the other ones.  Of course they would do a closed loop clinical trial.  It had never occurred to me that any of the pump makers would not do a closed loop clinical trial.

But I was wrong.  As I quickly learned by searching through the FDA's clinical trial site.  In fact, Animas was not doing a closed loop trial; None of the big pump companies is currently doing a closed loop trial without JDRF's involvement. [d2]. There were two reasons why not.  The first reason was pretty simple: no pump company knows how to get a closed loop pump through the FDA approval process.  For one thing, no one's ever done it.  For another thing, a closed loop system would involve both a drug and a device.  In the world of the FDA, drugs have one set of rules (and are governed by one part of the agency) while devices have a completely different set of rules (and are governed by a completely different part of the agency) and of course the rules are not coordinated, and the two parts of the agency don't talk to each other much.  So there is a lot of uncertainty about exactly what sort of testing will be required [d3].  How long it will take, and so on.  And uncertainty can be fatal to big company research.  If J and J puts 10 million of their money into it, they will not know if it will take 3 years or 10 years to get through the regulatory process.  And that's a big difference when your stockholders want quarterly profits.

The second reason was simple: if no one does it, then no one has to do it.  This is the downside of capitalism when there are only a small number of companies.  There are only a few companies that market pumps in the US.  And they are all big and highly regulated, and they know pretty much what each other are doing.  So as long as they know that none of their (limited) competition is developing a closed loop system, they don't have to develop one [d4].

So here are some reasons why funding a closed loop clinical trial is a good thing for JDRF to do:

1. It (hopefully) gets one closed loop approved, so people can use it.
I'll put together another post on why closed loop is a good thing, even if it is not a cure.  It's too big a subject to put here, but as a quick summary: an AP is likely to lower many (if not all) of the long term complications of type-1 diabetes.  An AP is likely to be easier to use than a pump, and require much less work on the part of the diabetic.  An AP is likely to prevent the worst single complication of type-1 diabetes: "dead in bed". And an AP may well be required by the eventual cure, because excellent BG control from an AP may be required to regrow beta cells as part of an eventual cure.

2. It might motivate other big pump companies into starting their own clinical trials.
Capitalism is based on competition between companies.  So having JDRF work with one company is likely to motivate other companies to start, hurry, or continue their own research.  So putting money into Animas helps them directly, but also motivates Medtronic and Omnipod to put more of their money into similar research, or to work with JDRF themselves [d5].

3. Once one closed loop system is approved, it will be easier for the others.
One of the problems with the FDA approval process (especially for a combined drug/device), is that the first one through the gate pays a big price both in terms of extra work, but more so in terms of extra uncertainty.  So everyone wants to be second through the process.  Let someone else figure out the rules, and once they are known, then just go through.  Let someone else clear the path.  So if JDRF's money helps clear the path (ie. push Animas through the approval process first) it will end up benefiting Medtronics and Omnipod as well.  And in the end, all type-1 diabetics.

Put another way, consider this: If you have a problem, then you have a problem.  But if you can solve that problem with money, then you merely have an expense.  Companies don't like problems, but understand expenses very well.   Right now, getting FDA approval for an AP is a problem; no one knows the details of how it will be done.  However, if JDRF can spend some money and work with Animas to figure out how to solve that problem, then it will merely be an expense.  And companies know how to deal with expenses.  And an AP will be forthcoming sooner.

More Discussions

[d0] Although a lot of people focus on the money (as I do here), JDRF is bringing more to the table than just money.  They are bringing their previous research (especially previously tested algorithms), and well as a patient recruitment network, etc.

[d1] I think that the goal of JDRF should be to speed development of a cure for type-1 diabetes, and if they think the best way to do that is by funding a researcher at a University, great.  And if they think the best way is to fund a researcher at a company, great.  I don't care where the money goes; I care that it speeds development of a cure.

[d2] This surprised me, but it's true.  Using the FDA's clinical trials database:
There are three studies using Animas, but not a closed loop or feedback study.
There are four studies using Omnipod, but not a single closed loop or feedback study listed.
There are thirty one studies using Metronics, but only one testing a closed loop system and that one is a joint venture of Medtronic and JDRF: http://www.clinicaltrials.gov/ct2/show/NCT00831389
There are thirteen studies covering closed loop devices in diabetes.  One of them is the joint Medtronic/JDRF trial described above.  Of the remaining twelve, all are funded and sponsored by government agencies, hospitals, or universities.  Not one is funded by a company. 

So it is clear to me that the pump companies are not going to fund clinical trials aimed at getting a closed-loop system through the FDA approval process, unless JDRF catalyzes the process.  


[d3] There have been some drug/device combinations improved in the past. For example, drug covered stents.  However it does involve much more uncertainty than either a drug or a device alone.

[d4] This is not a matter of an evil conspiracy, more a case of no one spending money on something they don't have to.   They all think, since none of my competitors is working on a closed loop, then I'll spend my millions on something else.  If one of them does start, then I will start the year after, and still be pretty close to them.  Medical pumps are not a business where being a month (or even half a year) ahead of your competition matters that much, anyway.

[d5] And it is important to remember that JDRF is not playing favorites with companies.  They already have a similar agreement with Metronic, so this one with Animas will be their second, and it shows clearly that JDRF will partner with any company that is moving the research ahead.

This blog posting was unusual in that I asked several people to review it for me and provide suggestions and feedback.  I'd like to thank all of these reviewers.  

Joshua Levy
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF news, views, policies or opinions.

2 comments:

Khurt said...

You can used the named anchor to create "jump" to section of your page.

So instead of just putting a [d1] in the middle of your text you would put this:

<a href="#d1">[d1]</a>

Then at the end of the page put the anchor

<a name="#d1">Some stuff.</a>

So

I don't have any problem with JDRF funding commercial companies [d1].

becomes

I don't have any problem with JDRF funding commercial companies <a href="#d1">[d1]</a>

in HTML with

[d1] I think that the goal of JDRF should be to speed

becoming

<a name="#d1">Some stuff.</a> I think that the goal of JDRF should be to speed

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