Libertarian Regulation of Pharma

A Different Way to Regulate Drugs?

Many of you probably know already that I am a cynic when it comes to the drug industry.  The problems emerge from several factors:

• The incentives are royally screwed up. Pharma R&D spends tens of millions developing drugs that may or may not work.  So not only is there a huge temptation to push the boundaries with the results, there is also a big risk of self-delusion that the results are better than they really are.
• The research publications industry has problems of its own, generally only publishing significant results. So all of the studies that find a drug doesn’t work never make it into the public eye.  We are biased from the get go that a drug is better than it really is.
• The health care industry has problems too – doctors are so rushed seeing patients that they definitely don’t have time to read a ton of research studies. So they have to rely on the pharma companies to tell them what a drug does.
• Drugs are sold by salespeople working on commission. They clearly have incentives to push drugs a little harder than perhaps the drug merits.  Not necessarily deceptive sales practices (although unfortunately that happens too), but the unconscious power of incentives is extremely strong.
• The real world is complex.  We never really know if a drug is working once it is released. Controlled trials are controlled for a good reason.
• There are several self-delusion effects among patients. Our passionate hope to get better leads us to want drugs, even if they have questionable effectiveness. Even to the point where doctors will prescribe drugs just to shut us up (yes that happens, perhaps also to prevent lawsuits from dissatisfied patients). The placebo effect makes us feel like the drug is working even when it is not.
• The FDA is not without some of the responsibility. FDA rules get bogged down in politics. Regulations get watered down in the promulgation process. FDA inspectors are too few and not paid enough. And if it is missing data that concerns them, there is no way to inspect for that.

All of this results in billions of dollars of spending on drugs that may or may not work and we will never really know.  For example, one of the few follow-up field studies found that anti-depressants might reduce depression by 10-20% in up to 35% of patients (the numbers are based on memory, but it was something “depressing” like this).  And that is if the patient is willing to try them all until they find one that works for them. If not, the numbers are even lower.

The Libertarian Mind

This situation came to mind as I was reading David Boaz’ book “The Libertarian Mind: A Manifesto for Freedom.” I believe that small “l” libertarian principles are often the most effective ways to govern and live. Boaz is a bit of an extremist along this line and I don’t think I recommend the book unless you just want 400 pages of go-go libertarian sermonizing.

The extreme position when it comes to things like drug regulation is that the market and Adam Smith’s invisible hand will take care of it. Pharma companies can release drugs at will.  Doctors know this, so they will not prescribe just anything. Drug companies will have to build up reputations that their drugs work. If not, no one will buy their drugs and they will go out of business.  Unethical behavior will be made public and those companies will disappear too.   By eliminating the millions of dollars in testing, companies can try out many more drug candidates and we will end up with better drugs.

But this depends on two things that I don’t think exist. First is that he assumes that the drug companies have read Adam Smith’s earlier book “The Theory of Moral Sentiments” that instructs people that they should behave ethically as well as in their self-interest.  All of the reasons I described above make this pretty unlikely even if drug companies want to. 

The second is the asymmetry of information. The efficacy and safety of drugs is not discoverable by the market and its invisible hand could not work its magic.

A New Way?

So what if we turn the whole process on its head?  What if drug companies were required to publish all of their data in real time into an open access database?  The FDA’s budget could be redirected on creating the database so that it is open source and platform independent so that it would be easy to create analytics for.  A new industry for the big data analysis would emerge to parse the data and demonstrate which drugs work and which don’t.  Deep, sophisticated, extensive programs would be expensive, but would be worth it for a hospital or large medical practice to use. Smaller systems that are more like search engines could be developed for patients through smartphone apps.  Independents could create trusted repositories that list what drugs work, how well, for whom, and what the side effects are.

It would take time for this to emerge so the FDA would have to keep its current system in place in parallel for a while. But there is already an open source drug data movement that is growing in strength so some of the work has been done.  As the cost of health care increasingly strains the economy, there is more of a desire to do something different.

Thoughts?

This Week in EID - Episode 59

This week, we ended with our first guest article from EID site manager France Jackson. If you didn’t read her post, I recommend it. It was about working at home and demanding some help from your employer on setting it up to maximize your productivity and your comfort.

The other three articles follow our normal schedule.  On Innovation Monday, I talked about adding GPS capability to our umbrellas so we can find the ones we lose. To me, this is one of those features that is not exactly annoying (unless I get notifications), but it doesn’t seem particularly useful either.

Tuesday was an interesting case of one of my favorite topics, the way our brains process information that doesn’t follow what people refer to as rationality.  In this case, it is the staying power of first impressions and why it is so hard to change our minds.

Wednesday was a safety in practice article.  We focused on safety practices and mixed motivations in the Bakken oil fields.  Because of the gold rush mentality, safety often goes out the window.

As always, your comments are welcome.

Racial Identity Transition

When Bruce Jenner transitioned to Caitlyn Jenner, there was a lot of talk about the genetic and biological origins of gender (all the way down to the chromosomes) and yet . . .  and yet, the brain still has the power to give someone a different gender identity. 

As those debates (because a lot of people disagreed with this position), I spent a lot of time thinking about my own identities. I have never had any gender uncertainty.  I am certainly not an alpha male by any stretch, but never doubted the basic category.  But I have other identities too and those have much less genetic and biological roots.

My strongest identity could be Jewish. That has ethnic, cultural, and religious components.  But the evidence is clearly that people change all three of these identities all the time.  So whereas my Jewish identity has been strong since as long ago as I can remember, it is not surprising that others transition.

Another identity I have is of being Caucasian (although I dislike the term).  But even this has been shown to have no genetic basis.  And if you send your DNA to one of those genealogy testing labs, they will most likely tell you that you are 12% this group, 10% that group, 15% another group . . . .  It is not black and white (literally and figuratively).  We all have some of each, as well as red, yellow, blue and green.  Some people show one side more than another (very pale or very dark skinned etc).  But if you look at history, there were rules like “one drop of black blood” or “even one Jewish great grandparent” that locked you into one particular identity as far as the law was concerned.  Mixed race children were often defined first by the color of their skin, as interpreted by the people around them as they grew up.  Not be personal preference.

So that gets me (finally) to my point. Can you change your racial identity like Caitlyn Jenner changed her gender identity?  If you are born to white parents (who probably both have x% African-origin DNA) and your skin color is white, can you feel black the way Bruce Jenner felt female?  Or vice versa?  Based on the biology, this should be more likely than with gender.

It is unfortunate that one of the first examples in the wake of Caitlyn Jenner’s transition is Rachel Dolezal (http://www.seattlepi.com/news/us/article/Rachel-Dolezal-s-world-crumbles-after-racial-6329347.phpv).  She claimed to be white for a long time as seems to have “transitioned” more based on deception and the desire to further her civil rights career than for any real feelings of racial identity.  If this turns out to be wrong, I apologize for doubting her. But based on the descriptions of her past behavior, it certainly seems that way.

But putting her case aside, I suspect that this is more common than we realize. In part because most people would react the way they did with Ms. Dolezal, even if an individual has a legitimately different feeling of racial identity than their parents would provide genetically or socially at home.