Coyote Blog

I can't think of any justification for the FDA's shutdown of 23andme's genetic testing service except one of pure control.  It is yet another case where you and I are not smart enough or sophisticated enough to be trusted with information about our own bodies.  Because we might use the information in some way with which Maya Shankar might not agree.

Let me be clear, I am not offended by all regulation of genetic tests. Indeed, genetic tests are already regulated. To be precise, the labs that perform genetic tests are regulated by the Clinical Laboratory Improvement Amendments (CLIA) as overseen by the CMS (here is an excellent primer). The CLIA requires all labs, including the labs used by 23andMe, to be inspected for quality control, record keeping and the qualifications of their personnel. The goal is to ensure that the tests are accurate, reliable, timely, confidential and not risky to patients. I am not offended when the goal of regulation is to help consumers buy the product that they have contracted to buy.

What the FDA wants to do is categorically different. The FDA wants to regulate genetic tests as a high-riskmedical device that cannot be sold until and unless the FDA permits it be sold.

Moreover, the FDA wants to judge not the analytic validity of the tests, whether the tests accurately read the genetic code as the firms promise (already regulated under the CLIA) but the clinical validity, whether particular identified alleles are causal for conditions or disease. The latter requirement is the death-knell for the products because of the expense and time it takes to prove specific genes are causal for diseases. Moreover, it means that firms like 23andMe will not be able to tell consumers about their own DNA but instead will only be allowed to offer a peek at the sections of code that the FDA has deemed it ok for consumers to see.

Alternatively, firms may be allowed to sequence a consumer’s genetic code and even report it to them but they will not be allowed to tell consumers what the letters mean. Here is why I think the FDA’s actions are unconstitutional. Reading an individual’s code is safe and effective. Interpreting the code and communicating opinions about it may or may not be safe–just like all communication–but it falls squarely under the First Amendment.

I know that libertarians want to kill the FDA altogether.  That is never going to happen.  But what might be more realistic is to shift their governing law from validating that medical treatments are safe and effective to just safe.

Brad Warbiany has more, including real life examples of how 23andme's service has been useful to his family.

Radley Balko has a fascinating discussion about a switch in government policy in Fountain Hills, AZ  (a suburb of Phoenix and a town I visit for various reasons all the time).  Apparently, residents of the town got to actually select from competing trash vendors (lucky folks!) until recently when the town selected and enforced a monopoly trash provider.  Balko has a fascinating discussion of why progressives seem to universally support this decision and oppose the previous choice-based approach.

It may be odd at first to see a self-styled progressive mocking someone for criticizing a corporation for exercising too much power.  John Cole writes sarcastically:

My GAWD. I feel so violated. I'm going through my bills before the Steelers game and I just realized that Allied Waste is contracted to pick up my trash, so my personal liberties have been impinged by the creeping totalitarianism of nanny-statism. To show solidarity with the oppressed Fountain Hills trash protesters, I am going to dress up in my "Don't Tread on Me" t-shirt, stand at the edge of my driveway at dawn during trash pick-up on Thursday, and throw pocket constitutions at the sanitation workers. We shall overcome, patriots!

This from a progressive bunch who runs to the government for legislation when their Big Mac has one too few pickles on it.  If you can understand why progressives attack any corporation that they voluntarily do business with for having too much power, but defend any corporation backed by government authority, you will start to figure out exactly what progressives are really after.  Just remember that progressives have a deep distrust of individual choice related to any activities that don't touch on sex.  And they are much more comfortable with lines of accountability that run through government officials (elected or not) rather than accountability enforced by competition and individual choice  (more on progressives here).

I will just add this to the story -- Fountain Hills is a suburb to which the verbs tony, wealthy, and exclusive could all apply.  Given its position in the foothills around Phoenix, it is perhaps one of the most attractive suburbs in the metropolitan area.  It is the last place one would point to as having some sort of problem with unkept houses and rotting garbage.  This is entirely a power play by the city -- it has nothing to do with the quality of the area.

Brad Warbiany has even more on the story here.

Mostly unrelated facts about Fountain Hills

1. Fountain Hills was a development of the McCulloch family (of chain saw fame) as was parts of Lake Havasu City.  Both developments had a centerpiece attraction.  Fountain Hills has a spectacular fountain (one of the five highest in the world) while Lake Havasu City has the transplanted London Bridge.  As to the latter, the story goes that McCulloch thought he was buying the much more dramatic Tower Bridge, which American tourists often confuse with London Bridge.  As a further aside, I met the guy once who did the gunnite on the bottom of the transplanted London Bridge.  He was a pool guy and applying it over his head rather than under his feet was fairly new to him.  He said he never allowed his little kids to sing "London Bridge is Falling Down" in his presence, it made him too nervous.
2. Our egregious Sheriff Joe Arpaio lives in Fountain Hills.  On a recent crime sweep of his home town, which he claimed had nothing to do with immigration, he arrested (or at least detained) almost all people of Mexican decent, in fact more Mexicans than I thought one could find in Fountain Hills, even on a bet.

I think this article makes it clear that, no matter what the rhetoric, the only health care cost control idea Obama and the Democrats ever had was saying "no" to care.  Whatever one calls this (managed care, rationing, death panels) it is really not that much different from what insurance companies have been doing for years.  And it is areal irony that Democrats passed this legislation feeding off anger of voters with insurance companies saying "no", when their plan really depends on the government saying "no" even more often  (or else there won't be any cost savings).

The author argues that information is important for patients to make better decisions:

When patients are given information about potential benefits and risks, they seem to choose less invasive care, on average, than doctors do, according to early studies. Some people, of course, decide that aggressive care is right for them "” like the cancer patient (and palliative care doctor) profiled in this newspaper a few days ago. They are willing to accept the risks and side effects that come with treatment. Many people, however, go the other way once they understand the trade-offs.

They decide the risk of incontinence and impotence isn't worth the marginal chance of preventing prostate cancer. Or they choose cardiac drugs and lifestyle changes over stenting. Or they opt to skip the prenatal test to determine if their baby has Down syndrome. Or, in the toughest situation of all, they decide to leave an intensive care unit and enter a hospice.

I agree, but I would go further -- information and incentives are important.  And the absolute most important bit of information when it comes to cost control is price, and patients under Obamacare have absolutely no incentive to give a sh*t about price even if they were informed of it.  Exactly the opposite of the incentives I have had since I took on a high-deductible health care policy several years ago.

Update: Brad Warbiany discusses the proposed IPAB and its powers to shape health care spending in the context of Congress as an addict trying to control its impulses.  However, I think Brad underestimates the power of the board to be captured.  What will result is rulings for more coverage of procedures with powerful lobbies, offset by less coverage of procedures with weaker lobbies, irrespective of the science.   Just look at the diseases the NIH and NSF gives grant money for -- the grants have nothing to do with the science of where research could be most productive and everything to do with diseases that have large and powerful constituencies.

Update #2: Isn't it interesting to see the NY Times, after arguing for months that Obamacare was not about rationing, is now admitting that rationing is the key to success.  It reminds me of this that I wrote a while back:

I have decided there is something that is very predictable about the media:  they usually are very sympathetic to legislation expanding government powers or spending when the legislation is being discussed in Congress.  Then, after the legislation is passed, and there is nothing that can be done to get rid of it, the media gets really insightful all of a sudden, running thoughtful pieces about the hidden problems and unintended consequences of the legislation.

For the first time in five years, I am apparently mathematically eliminated after the first weekend, with my best possible finish in 7th.    Congratulations to our current leaders, who navigated through an incredible series of upsets far better than I did:

Perhaps even more incredibly, Todd Ramsey is shown to have a 71+% chance of winning it all, which are pretty unprecedented odds in our pool this early in the tournament.

Kevin Drum says:

The Consumer Product Safety Improvement Act makes it illegal to sell toys that haven't been tested for lead content.  In general, I think that's a perfectly fine idea.

He can't understand, though, why its effects seem so perverse and Draconian when its core is such a "perfectly fine idea."  It is amazing to me that the law of unintended consequences is so hard even for seasoned political observers to grasp.

A sensible restriction might be that a child cannot by any reasonable use of the product ingest more than X concentration of lead.  But of course that is not what the government does.  The government requires that every toy undergo expensive testing and batch tracking (almost like that of an aircraft part).  This is not by any means the same as simply requiring products to limit lead exposure.  It is a one-size-fits-all regulation of process, rather than true safety.  It imposes huge testing and tracking expenses on products that can't possibly have any lead in them.

And, like many laws of this kind, it imposes a huge penalty on small competitors and new entrants and rewards larger toy makers who both have the scale to pay for the testing and the political clout to shape the law in their favor.  In fact, the big winner from the legislation has actually been Matel, the company whose recalls actually led to the law in the first place.

The Consumer Product Safety Improvement Act (CPSIA) requires third-party testing of nearly every object intended for a child's use, and was passed in response to several toy recalls in 2007 for lead and other chemicals. Six of those recalls were on toys made by Mattel, or its subsidiary Fisher Price.

Small toymakers were blindsided by the expensive requirement, which made no exception for small domestic companies working with materials that posed no threat.

"¦

So while most small toymakers had no idea this law was coming down the pike until it was too late, Mattel spent $1 million lobbying for a little provision to be included in the CPSIA permitting companies to test their own toys in "firewalled" labs that have won Consumer Product Safety Commission approval.

The million bucks was well spent, as Mattel gained approval late last week to test its own toys in the sites listed above"”just as the window for delayed enforcement closed.

Instead of winding up hurting, Mattel now has a cost advantage on mandatory testing, and a handy new government-sponsored barrier to entry for its competitors.

Update: Brad Warbiany has similar thoughts.