Thursday, July 8, 2010

Coming Out of the Cure Recession by Curbing the Trial Lawyers: Time for a data-crunching intervention on Avandia.

Avandia, the diabetes drug, is under fire.  The allegation is that taking it increases the likelihood of heart attacks.    But the policy question surrounding Avandia are larger than the drug itself.  That policy question is larger, even, than the millions of people directly affected by its use, or non-use.

The larger question is this: Do we want more medical research or less?  And if we want more, how should we go about fostering such medical research?  Most Americans probably have an instinctive feeling that "more" is better than "less," but once the policy questions surrounding medical research are asked--who pays? who gets?  who is responsible? who is liable?--most Americans tune out.    That's what elites, at their best, are supposed to do: they are supposed to hash out tough questions so that ordinary Americans can go about their lives, confident that experts are handing the problem.

But sometimes, during the course of human events, the elites demonstrate that they are not to be trusted.  By that I don't necessarily mean that the elites are operating out of bad faith; I simply mean that they, the elites themselves, might not know how to move forward on agreed-upon policies.  The elites might be so divided that they can't agree on a coherent plan.  Or the elites might simply be incompetent.  In a time of crisis--and this is a time of crisis, since we are suffering a cure recession, even amidst the larger economic recession--we should explore all possible explanations.

But in the meantime, there's the issue of Avandia.  The drug has plenty fans among consumers, and it also has plenty of defenders among the policy elite, such as Robert Goldberg, of the Center for Medicine in the Public Interest.

But this post will not even attempt an analysis of Avandia.   Instead, we will simply observe that the maker of Avandia, GlaxoSmithKline, is likely to be buried under a blizzard of lawsuits.  And we will ask: Is this a good policy?  Do trial lawyers put us on the path to better health?

The proverbial visitor from Mars might well conclude that we Americans think that trial lawyers are vital to our medical system.   If one Googles "Avandia lawsuits," one sees a robust litigation industry already sprung up, complete with myriad advertisements from case-chasing lawyers.   Here's a screengrab:

One of these sites is called, bluntly,; it offers the clicker a toll-free number so the lawsuit against Glaxo can get right under way, pronto.

Let's step back and ask: Is this good policy?  One is reminded of the analytical ice-breaking question frequently posed by the late management guru, Peter Drucker: "If we weren't doing it now, would we start?"  Suppose we wanted to have a robust industry in Serious Medicine, but we had to start from scratch.  Would we start up a multi-hundred-billion-dollar-a-year tort industry as well?  Do trial lawyers help along the process of discovering and manufacturing cures?   The answer is, of course not.   There's much to be said for our system of jurisprudence, but there's nothing good to be said about a legal system that cripples the medical system.

And that, unfortunately, is exactly what is happening.   Today we have a "cure recession" in American medicine that will likely only worsen in the years to come.  The lawyers have won out over the doctors.  Feel better?

Americans who are wondering who will cure them of a disease should keep in mind this chart, reproduced below, from Dr. Arthur Krieg of Pfizer, showing that drug output is down dramatically, even as drug spending is up dramatically--the average new drug now costs about $2.4 billion.  If  you look closely at the chart below, you will see that FDA approvals of "NME's (New Molecular Entities) have fallen by two-thirds since 1995.  Once again, that NME pipeline has shrunk, even as spending has risen--although, of course, spending actually fell in 2009.  (Evidently, the Obama administration is getting its wish--it is "bending the curve" downward, at least on medical R&D.)

This drug falloff is especially painful because the American people have not been consulted about the reasons for this falloff in any meaningful way.   Ordinary folks are just as eager for cures as they ever were, but for reasons noted above, they just don't have the bandwidth to follow all the zigs and zags of regulatory policymaking, to say nothing of all the lawsuits being filed.  Which is to say, we wake up and realize that the new drug pipeline is drying up.

Thus the paradox: demand is still strong, but the supply is faltering.  Economists call these scissoring trendlines "market failure."  And it's that market failure that has given us a "cure recession."

So what to do?  As argued here at SMS many times, the influence of the trial lawyers will be the death of us all--the premature death of us all.   The absolute and final proof that Obamacare was not focused on improving the national health was the omission of any meaningful steps against the trial lawyers in the bill that the President signed into law in March.

But, some might ask, if we were to reverse course and seek a "bull market in cures," by peeling back the tort bar, wouldn't that put Americans at risk?  Who would look out for the people?   Perhaps Avandia is dangerous.  Let's not forget thalidomide!

Here's where new technology can make a difference.  Computers could help us thresh the data--the data, for example, on all Avandia users--and help us to see who is at risk and who isn't.  It's distinctly possible--obvious, in fact--that Avandia affects different users in different ways.   If those differential effects were made visible, through computerized data-crunching, then it should be possible to identify who is more likely to be at risk from Avandia, and who isn't.

Those data might exist now, although as Jim Wootton has argued, fear of trial lawyers is distorting and corrupting all of medicine, including data-gathering.   And of course, absent legal reforms, computer companies might be chary of getting into the drug-data-crunching biz, because if they crunch wrong, and the wrong person takes the wrong drug, including Avandia, then the computer companies--deep-pocketed as they are--could be sued, too.   Wootton and his colleague, Missy Jenkins, are working on legislation that would let Silicon Valley enter the data-crunching game, as well as other functions, without the fear of being wiped out by lawsuits.

But in the meantime, some Silicon Valley visionaries are charging ahead, in their personal capacity, if not in their corporate capacity.  As noted here at SMS last week, Sergey Brin, the co-founder of Google, has taken the plunge anyway, for a cause that concerns him greatly, Parkinson's Disease.   As reported by Wired, Brin is seeking out ways to crunch all the data on Parkinson's, as a way of accelerating the process.   We might warn Brin that the points made by Wootton above--about the trial-lawyer-driven potential for reality-distortion--are a danger, because in the data-game, garbage in is out garbage out.

But of course, we wish Brin the best.   Because if he can prove out the concept of data-driven cure-discovery, then he will have opened up a new pathway to the development of Serious Medicine.

And if the Brin approach works, then it will be possible to look at a drug such as Avandia and say, "We have concluded that X-percent of the people interested in the drug should not, in fact, take it--and we know who those people are, based on their bio-info.   But everyone else is free to have it prescribed for them--subject, of course, to ongoing realtime data-updates."

That would a win-win-win.   It would be a win, for starters, for diabetes patients, who need Avandia, And it would also be a win for those diabetics who can't safely take the drug.  And finally, it's a win for all the rest of us, because we would see the drug pipeline--now in danger of being choked off--being reopened and even widened.

To get these good things, we will need to open the throttle on computers-in-medicine.  And slam the brakes on the tort bar.

1 comment:

  1. The litigation industry as it relates to medicine needs to be eliminated and replaced with Arbitration Boards and CAPS. Certainly the Obama Administration can identify with CAPS!

    Avandia affects different users in different ways. So does Peanut butter. If Doctors don’t want to use a certain drug, they will prescribe another.

    But it is those damn lawyers on Capitol Hill who are screwing everything up.

    Show me a person who says what this country needs is another Law School and I’ll show you an idiot!