Kevin Drum - November 2013

You Own Your DNA, But Who Gets to Interpret It?

| Tue Nov. 26, 2013 7:39 PM EST

Yesterday the FDA ordered 23andMe to immediately stop selling its DNA testing service until and unless it gets agency approval. This is the end game of a very long cycle: regulatory reviews of genetic testing have been going on, in one form or another, for more than 15 years, and along the way there have been repeated bipartisan calls for more rigorous rules to ensure that consumers get accurate and judicious information. In 2010, for example, the GAO conducted an undercover investigation of four genetic testing companies and concluded that "GAO’s fictitious consumers received test results that are misleading and of little or no practical use."

Nonetheless, the FDA's action yesterday produced a flurry of criticism, especially from the libertarian right. Alex Tabarrok is typical:

The FDA wants to judge not the analytic validity of the tests [...] 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....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'm pretty sure this is nowhere near so cut and dried. The relevant distinction here is between medical information and medical advice: the former is protected speech while the latter isn't. And while your genome may be medical information, interpreting your genome and explaining whether it puts you at risk for different diseases is very close to medical advice. And not just general medical advice, of the kind that Dr. Oz purveys on television. It's specific, personal medical advice, of the kind that only licensed physicians are allowed to provide.

That's the argument, anyway. If 23andMe is going to perform a lab test and then send you a personal letter suggesting that you, personally, are or aren't at high risk for some disease, it's acting an awful lot like a doctor. But for better or worse, only doctors are allowed to act like doctors, and the FDA thinks that complex and sometimes ambiguous test results should be communicated to patients by licensed MDs who know what they mean.

It turns out there's more to this particular case, of course: the FDA's letter makes it pretty clear that they're fed up with 23andMe, which has apparently been almost arrogantly unresponsive to standard requests for documentation:

As part of our interactions with you, including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, we provided you with specific feedback on study protocols and clinical and analytical validation requirements, discussed potential classifications and regulatory pathways (including reasonable submission timelines), provided statistical advice, and discussed potential risk mitigation strategies.

....However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses....Months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies....FDA has not received any communication from 23andMe since May. Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA.

Ouch. By happenstance, this brought to mind a Felix Salmon post from yesterday. It was about GoldieBlox, another high-flying Silicon Valley startup that apparently believes federal laws apply only to ordinary mortals—not to rebelliously innovative and disruptive companies that are going to change the very way we interact with the world. Salmon describes the "Silicon Valley way" like this: "First you make your own rules — and then, if anybody tries to slap you down, you don’t apologize, you fight."

This sure sounds an awful lot like 23andMe. I'm actually sort of agnostic about the issue of whether personal genome services should fall into the category of highly regulated diagnostic tests. The line between information and advice is genuinely gray here. But regardless of that, this isn't something that suddenly popped up out of nowhere. It's been on the FDA's radar for a long time, and 23andMe was well aware of the FDA's requirements. They sure look an awful lot like a Silicon Valley company that figured they could stall them forever and never pay a price.

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Janet Yellen Is Now a Litmus Test for Right-Wing Sanity

| Tue Nov. 26, 2013 3:22 PM EST

Steve Benen notes that the increasingly shrill and hyperbolic Heritage Foundation has decided to make opposition to Janet Yellen a "key vote." That is, they'll count it on their end-of-the-year scorecard that tells everyone just how conservative you are:

Thanks to the “nuclear option” there’s very little chance Yellen’s nomination will fail — Joe Manchin appears to be her only Democratic opponent — but it now seems likely that most Senate Republicans will oppose the most qualified Fed nominee since the institution was founded.

That's true, which means this has become sort of a litmus test for wingnuttery. There's simply no serious reason to oppose Yellen, who is outstandingly qualified to be Fed chair by virtually any measure. So opposition to Yellen is now a pretty simple proposition: you oppose her if you're some kind of hard money lunatic or if you feel like you have to pander to the hard money lunatics. That's it. Everyone else votes to support her confirmation. Should be an interesting roll call.

POSTSCRIPT: For more on the Heritage Foundation's descent from a think tank beloved of Republicans to a bullying ideological cop now loathed on Capitol Hill, check out Julia Ioffe's report here. It's a precautionary tale that's well worth a read.

Lara Logan Taking Leave of Absence From "60 Minutes"

| Tue Nov. 26, 2013 2:51 PM EST

HuffPo's Michael Calderone tweets: "Lara Logan and producer producer Max McClellan taking taking leave of absence from 60 Minutes, per Fager memo." This comes shortly after Calderone reported that Logan "will no longer be hosting the annual press freedom awards dinner hosted by the Committee to Protect Journalists on Tuesday night, as she had long been scheduled to do."

That's not a big surprise. More to come on this, I'm sure.

UPDATE: Calderone has a full copy of the Fager memo here, along with a summary report of an investigation into Logan's Benghazi segment from Al Ortiz, Executive Director of Standards and Practices at CBS News. It validates virtually every outside criticism made of Logan's piece, which relied on the testimony of Dylan Davies, a security consultant who was in Benghazi on the night of the attacks and went on to write a book about it:

Logan’s report went to air without 60 Minutes knowing what Davies had told the FBI and the State Department about his own activities and location on the night of the attack....The wider reporting resources of CBS News were not employed in an effort to confirm his account....[Davies'] admission that he had not told his employer the truth about his own actions should have been a red flag in the editorial vetting process.

....[Logan's] assertions that Al Qaeda carried out the attack and controlled the hospital were not adequately attributed in her report.....In October of 2012, one month before starting work on the Benghazi story, Logan made a speech in which she took a strong public position arguing that the US Government was misrepresenting the threat from Al Qaeda, and urging actions that the US should take in response to the Benghazi attack. From a CBS News Standards perspective, there is a conflict in taking a public position on the government’s handling of Benghazi and Al Qaeda, while continuing to report on the story.

....The book, written by Davies and a co-author, was published by Threshold Editions, an imprint of Simon & Schuster, part of the CBS Corporation. 60 Minutes erred in not disclosing that connection in the segment.

That's a whole lot of errors, all of which were preventable. Logan was just too anxious to tell this story in a particular way, and decided not to let reporting get in the way of it.

Also worth checking out: Jeff Stein's Newsweek piece a few days ago suggesting that Logan's husband may have played an instrumental behind-the-scenes role in shaping her Benghazi report.

America is the Stingiest Rich Country in the World

| Tue Nov. 26, 2013 1:21 PM EST

Over at the Economist, Steven Mazie directs me to a recent New Yorker piece on income inequality by John Cassidy. Its most revealing chart, Mazie says, is one that compares raw income inequality in various rich countries (as calculated by GINI scores) to income inequality after taxes and government transfers. In other words, it helps us see which countries do the most to fight the relentless rise in income inequality over the past three decades.

But I wanted to see that more directly, so I re-charted the data. All I did was calculate how much taxes and transfers reduced inequality in every country that had high inequality to begin with. Unsurprisingly, whether you use raw number or percentages, the United States is #1:

The United States is one of the richest countries in the world, with a top 1 percent that's seen its income triple or more in the past three decades. And yet, we also do the least to fight the rising tide of income inequality. Government programs in America reduce the level of inequality by only 26 percent. Nobody else is so stingy.

Happy Thanksgiving.

Obamacare is a Done Deal

| Tue Nov. 26, 2013 11:52 AM EST

Ezra Klein gives us a progress report on Obamacare:

A spin through HealthCare.Gov this morning went smoothly. The site loaded quickly. The process progressed easily. There were no error messages or endless hangs....My experience isn't rare. There are increasing reports that HealthCare.Gov is working better — perhaps much better — for consumers than it was a few short weeks ago. "Consumer advocates say it is becoming easier for people to sign up for coverage," report Sandhya Somashekhar and Amy Goldstein in the Washington Post.

....Reports from inside the health care bureaucracy are also turning towards optimism. People who knew the Web site was going to be a mess on Oct. 1st are, for the first time, beginning to think HealthCare.Gov might work....The Obama administration is certainly acting like they believe the site has turned the corner. Somashekhar and Goldstein report that they're "moving on to the outreach phase, which had taken a back seat as they grappled with the faulty Web site.

....It's clear that HealthCare.Gov is improving — and, at this point, it's improving reasonably quickly. It won't work perfectly by the end of November but it might well work tolerably early in December. A political system that's become overwhelmingly oriented towards pessimism on Obamacare will have to adjust as the system's technological infrastructure improves.

I think the best translation of that last sentence is, "Republicans will soon have to find something else to gripe about." But it won't work. Conservatives have always known that once Obamacare is up and running, it will become a popular program that's impossible to repeal. That's one of the reasons they've been so frantic to stop it before January 1. And they've been right about this. People respond far more passionately to the prospect of losing something than they do to gaining something, and once they have Obamacare they'll fight to keep it. In a few months, it will be nearly as enshrined in the American social welfare firmament as Social Security and Medicare.

Republicans have run out of time, and they know it. Their fixation on Obamacare already looks sort of balmy—this weekend's deal with Iran was designed to draw attention away from Obamacare? Seriously?—and it's only going to look loopier as time goes by. Getting Obamacare to the end zone wasn't easy, and Obama almost fumbled the ball at the one-yard line, but he's finally won. There's nothing left for conservatives to do. Love it or hate it, Obamacare is here to stay.

California Bullet Train Might Be Breathing Its Last

| Mon Nov. 25, 2013 8:59 PM EST

Sacramento Superior Court Judge Michael Kenny, following up on a ruling earlier this year, might have finally put a stake through the LA-San Francisco bullet train:

Kenny ruled that the state does not have a valid financing plan, which was required under the 2008 bond measure, Proposition 1A. The measure included provisions intended to ensure the state did not start the project if it did not have all of the necessary funds to complete a self-supporting, initial operating segment.

The state rail agency created a funding plan, but it was an estimated $25 billion short of the amount needed to complete a first working section of the line. Kenny ruled that the state must rescind the plan and create a new one, a difficult task because the state High-Speed Rail Authority hasn't identified sources of additional revenue to allocate to the project.

As near as I can tell, the HSR authority's plan all along has been to simply ignore the law and spend the bond money on a few initial miles of track. Once that was done, no one would ever have the guts to halt the project because it would already have $9 billion sunk into it. So one way or another, the legislature would keep it on a funding drip.

It's a time-tested strategy, and it might have worked if not for a meddling judge. But I don't see how Kenny could have ruled any other way. The bond measure is clear about the financing requirement, and the authority's flouting of the requirement is equally clear. Not only does it not have a plan to fully fund even a part of the HSR project, there's no remotely plausible plan they can put forward. The federal government is plainly not going to provide any further money, and the prospect of private funding is laughable. No one in his right mind believes either the authority's ridership projections or its cost projections anymore.

I've been a skeptic of this project from the start. Its numbers never added up, its projections were woefully rose-colored, and it was fanciful to think it would ever provide the performance necessary to compete against air and highway travel. Since then, things have only gotten worse as cost projections have gone up, ridership projections have gone down, and travel time estimates have struggled to stay under three hours.

I've said it before and I'll say it again: this is the kind of project that gives liberals a bad name. It's time to kill it. For a whole bunch of reasons, LA to San Francisco just isn't a good choice for high-speed rail.

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How Not to Argue With Your Crazy Relatives at Thanksgiving

| Mon Nov. 25, 2013 4:50 PM EST

Can I waste some time venting about a teensy little pet peeve of mine? Thanks. Here's a brief Twitter conversation I just had with Chris Hayes:

Hayes: Devoting our whole show on Wednesday to how to talk about politics, news with conservative family members. Should be fun!

Drum: Will be interesting if it's real. Usually this stuff isn't. Needs to be arguments that actually address conservative worldview.

Hayes: Oh, I don't think it will be useful. No one ever persuades anyone of anything. But will be fun!

I don't really mean to fire off any cruise missiles at Hayes or anyone else over this, but every year there's a spate of blog/magazine pieces about how to discuss the political hot potato du jour with your crazy right-wing relatives at Thanksgiving. And every year they're fake. Mostly they provide stock liberal responses to imaginary conservative talking points, and as Hayes says, they don't really do any good.

Now, maybe there's no help for this. Liberals and conservatives have been arguing for centuries, and so far neither side has convinced the other to surrender. Still, wouldn't it be more interesting to at least try and write something real? That is, come up with the kinds of comments that your Fox-watching aunts and uncles are really likely to drop into the conversation, and then come up with replies that might actually persuade someone who's a conservative. The downside is that this isn't as much fun: there will be no killer facts and figures in this list that demolish Uncle Joe's Obamacare tirade and leave a smoking crater in his place. (In our collective imaginations, anyway.) Instead, we'll have a collection of items that turn the battleship a few degrees at best. No one's going to suddenly decide that Paul Krugman has been right all along, but maybe you'll be able to seed a few doubts about Sean Hannity's commitment to the straight dope.

This would be hard work. You'd have to actually watch Fox News for a while to make sure you know what's really on conservatives' minds these days. Listening to a bit of talk radio and reading some chain emails would help too. And that's not all. You'd almost certainly have to team up with an actual conservative to help you understand both the worldview at work and the kinds of arguments that might appeal to his ideological comrades-in-arms. And why would a conservative help you with this project? Beats me. Maybe you could trade: you get some arguments that appeal to actual conservatives and he gets some arguments that appeal to actual liberals.

Anyway, somebody ought to do this. I'm a hermit, and my entire family is pretty liberal, so I'm not a very good candidate. But someone out there is. Who wants to do the country a public service?

Americans Are Surprisingly Clear-Eyed About American Health Care

| Mon Nov. 25, 2013 2:42 PM EST

Austin Frakt draws my attention to a new Gallup poll with this tweet: "Consistent with my hypothesis that people think their care is good/efficient, others is bad/wasteful." Here's the poll:

I'd draw a different conclusion. For starters, keep in mind that public sentiment on this question hasn't changed much over the past decade. There are some ups and downs in recent years about the quality of national health care coverage, possibly based on the ups and downs of Obamacare, but it mostly looks like noise to me.

More importantly, though, I don't interpret this as a belief that coverage for other people is either bad or wasteful. I interpret it as a surprisingly accurate assessment of U.S. health care. About two-thirds of Americans have either Medicare or company-provided health care (or something similar), and they correctly tell Gallup that their own personal coverage is pretty good. And it is! At the same time, most people also think that overall health care coverage in America is pretty mediocre, and that's true too. How can you call national coverage good or excellent when 50 million people are uninsured and have crappy access to medical care?

If Gallup had called me, this is precisely the response I would have given them. My own personal coverage is quite good. Thanks, MoJo! However, I'd also say that overall coverage in the U.S. is terrible. Obamacare will, perhaps, upgrade that to merely unsatisfactory, but that's about it.

The Kids Are Alright, Video Game Edition

| Mon Nov. 25, 2013 1:09 PM EST

This post comes with an even stronger warning than usual that a single study is just a single study; correlation is not causation; and even well-done studies can't account for every possible confounding factor. In other words, You Have Been Warned.

And yet, this study is pretty interesting!

Typical daily hours viewing television and playing electronic games at age 5 years were reported by mothers of 11,014 children from the UK Millennium Cohort Study....Change in adjustment from age 5 years to 7 years was regressed on screen exposures; adjusting for family characteristics and functioning, and child characteristics.

RESULTS: Watching TV for 3 hours or more at 5 years predicted a 0.13 point increase [] in conduct problems by 7 years, compared with watching for under an hour, but playing electronic games was not associated with conduct problems. No associations were found between either type of screen time and emotional symptoms, hyperactivity/inattention, peer relationship problems or prosocial behaviour. There was no evidence of gender differences in the effect of screen time.

This comes via Aaron Carroll, who adds this comment: "Yes, these are young kids, and it’s unlikely that they have been playing much GTA 5 or Battlefield 4. So I’ll look forward to more data. But that this point, it’s hard to point to a large study like this and find a smoking gun. Figuratively or literally."

In other words, if it's a choice between letting your young kids watch more TV or play more video games, go with the video games. Until some other study comes out, anyway.

Conservatives Have No Incentive to Support a Deal With Iran

| Mon Nov. 25, 2013 12:04 PM EST

Dan Drezner says he understands why conservatives might not be crazy about the interim nuclear deal that Western nations cut with Iran over the weekend. But freaking out about it? That's just dumb:

Seriously, game this out. Let's assume you implacably oppose the negotiations going forward. If the deal holds up — and before you laugh, consider that Netanyahu is now describing the much-derided-at-the-time Syria deal as a "model" to follow — then you've undermined your reputation before the really big negotiations start. So whatever justified opposition you might have to such a deal will be largely discredited. On the other hand, if the deal falls apart — and there's a decent chance of that — then you'll get blamed for obstructionism for reflexively opposing it from the get-go.

Now say you announce that despite your reservations, you'll support the Obama administration's steps towards peace provided the necessary security guarantees are procured, etc. In this universe, if the deal falls through, it's on the Obama administration, and you get to shake your head sadly and cluck about how you should have known better than to trust them. If the deal succeeds but a comprehensive deal fails, that's also on the Obama administration, nothing has been lost, and you look like a sober statesman. Finally, if a comprehensive deal really is reached, you can oppose it then. Indeed, your opposition will be bolstered by the fact that you supported the interim negotiations, suggesting that you're not opposing diplomacy like a knee-jerk automaton.

Drezner asks at the end, "Am I missing anything?" Why yes, Dan, you are! Republicans are concerned with at least two meta-issues:

  • Showing that they can't be suckered. This has been a key part of the conservative mentality for a long time, and it's only grown more intense in recent years. To go along, even tentatively, with this interim deal would suggest a softness that the Republican base can't abide. In poll after poll, they're the ones who oppose compromise of any sort.
  • Opposing President Obama on all things at all times. At this point, I wouldn't be surprised if Sarah Palin wrote a Facebook post denouncing the presidential turkey pardon later this week. Why is Obama trying to shove his vegan socialist agenda down America's throat?

If a Republican supports the interim deal and it then falls apart, they're unmasked as a sucker, both for trusting the Iranians and for trusting Obama. If they support an interim deal and it produces a permanent deal, they've helped facilitate surrender to the enemy—for you can be sure that any permanent deal with Iran will be viewed as a sellout. The sad truth is that supporting the interim deal, even tentatively, is a lose-lose proposition for most Republican politicians these days. They don't care about you or me or the Beltway consensus. They care about the base. And the base has no interest in seeing Satan make a deal with the devil.