Medicine

Neil Harbisson is a cyborg

by on August 19, 2014 at 2:16 am in Medicine, Philosophy, Science | Permalink

Or should that title read “Is Neil Harbisson a cyborg?”

Protruding from the back of Harbisson’s skull is a metal antenna that allows him to convert the frequencies for color into frequencies for sound and vice versa. He was born colorblind and the appendage has essentially given him a sixth sense to make up for what his vision lacks.

…Harbisson gets visibly dizzy when his antenna is off center. Moving it slightly to the left, he closed his eyes and said, “If I do this, I feel unbalanced…it does feel like a body part, an extension of a bone or something.” Even though the antenna is metal and has no nerve endings, Harbisson says he can feel when someone touches it, the same as a natural body part.

There is more:

Moon Ribas, Harbisson’s partner, has an extension she wears on her arm that makes her body vibrate when there’s an earthquake. (She plans to one day have it implanted under her skin.) As a choreographer, Ribas takes inspiration from nature and thought the extension would enhance her creativity. It syncs with an app that collects data on earthquakes around the world to make her body vibrate when there’s seismic activity (it happens frequently enough that she vibrated once during our interview).

But the appendage cannot be submerged in water, and neither can Neil’s. They are both hoping to update their devices so that in the future they can go swimming. “Then I will be able to perceive the colors in the ocean,” Harbisson says.

There is more here, including a photo.  It is noted that security guards are sometimes unsympathetic to Harbisson, who is moving from Spain to New York, where he feels he will be seen as less unusual.

For a related pointer, I thank Samir Varma.

FDA Device Regulation

by on August 13, 2014 at 7:20 am in Economics, Law, Medicine | Permalink

In the interests of length I had to sacrifice a few points in my WSJ review of Innovation Breakdown by Joseph Gulfo (excerpted on MR yesterday). In the review, I argued that the FDA could speed the approval of medical devices and reduce uncertainty by not reviewing directly but becoming a certifier of certifiers as is done in Europe.

In fact, a US model is already in place. OSHA, the Occupational Safety and Health, requires that a range of electrical products and materials meet certain safety standards but it outsources certification to Underwriters Laboratories and other Nationally Recognized Testing Laboratories. We could and should do the same for medical devices and for drugs. Indeed, if a device or drug is permitted in a developed, advanced economy such as in Europe, Australia and Japan then I see no reason why it ought not to be provisionally approved in the United States (and vice-versa).

My paper with DiMasi and Milne showed that some FDA drug divisions appear to be much more productive than other divisions suggesting possibilities for substantial improvements if best practices were uniformly adopted. There also appear to be substantial differences between the regulation of drugs and devices especially in recent years. Ian Hathaway and Robert Litan have a new paper on Entrepreneurship and Job Creation in the U.S. Life Sciences Sector that shows that new firm creation in the medical device sector has fallen drastically since 1990 and far more than in the drug sector. Although there are likely many causes, the drop in the number of new firms is consistent with Gulfo’s experience of regulatory uncertainty and may suggest increases in regulatory cost for devices relative to drugs. Here is Hathaway and Litan:

The medical devices and equipment sector, on the other hand, saw new firm formations decline steadily and persistently between 1990 and 2011—falling by 695 firms or 53 percent during that period. Its share of new life sciences firms fell to 31 percent in 2011 from 50 percent in 1990. Unlike its life sciences sector counterparts, the decline in new firm formations in this segment appears to stretch beyond the cyclical effects of the Great Recession.

new device firms

Innovation Breakdown

by on August 12, 2014 at 7:47 am in Economics, Law, Medicine, Uncategorized | Permalink

From my review today in the WSJ of Innovation Breakdown by Joseph Gulfo:

Yo is a smartphone app. MelaFind is a medical device. Yo sends one meaningless message: “Yo!” MelaFind tells you: “biopsy this and don’t biopsy that.” MelaFind saves lives. Yo does not. Guess which firm found it easier to put their product in consumers hands? Oy.

In “Innovation Breakdown: How the FDA and Wall Street Cripple Medical Advances,” Joseph Gulfo tells the tumultuous history of MELA Sciences, the company that invented MelaFind. When Dr. Gulfo joined the firm as president and CEO in 2004, the company’s brilliant team of scientists had spent many years and tens of millions of dollars to develop MelaFind, a “camera with a brain”—optical technology that would scan potential melanomas in multiple spectra and then, using sophisticated algorithms and large datasets, diagnose which were most likely to be cancerous.

MELA Sciences conducts an extensive clinical trial according to a protocol agreed on by the FDA and all looks good. After the clinical trial is completed, however, the FDA backs away from the protocol and comes out against MelaFind.

…The title of Dr. Gulfo’s book is “Innovation Breakdown” but “Innovator’s Breakdown” might have been more apt. The letter sent the author into survival mode. He battled the FDA, calmed investors, and defended against the lawsuit all while trying to keep the company afloat. Under stress, Dr. Gulfo’s health began to decline: He lost 29 pounds, his hair began to fall out, and the pain in his gut became so intense he needed an endoscopy. When his wife begged him to quit, he refused. They turned into roommates. “We were nothing more than cordial. I basically shut my wife out of my life,” he writes.

…The climax to this medical thriller comes when, in “the greatest 15 minutes of [his] life,” Dr. Gulfo delivers an impassioned speech, à la “Twelve Angry Men,” to the FDA’s advisory committee. The committee voted for approval, 8 to 7, and, perhaps with the congressional hearing in mind, the FDA approved MelaFind in September 2011.

It was a major triumph for the company, but Dr. Gulfo was beat. He retired from the company in June 2013—just in time to save his marriage.

Yet remarkably, given his experience, Mr. Gulfo writes that he still believes in a strong FDA. He argues in the book that better “leadership” and a few tweaks to existing rules can fix the problem. He’s wrong.

Compare MelaFind’s experience in the U.S. with its reception in Europe: MelaFind was submitted for marketing approval in Europe in May 2011. It was approved just five months later. One key reason for Europe’s efficient approval process is that European governments don’t review medical devices directly. Instead they certify independent “notified bodies” that specialize and compete to review new products. The European system works more quickly than the U.S. system, and there is no evidence that it results in reduced patient safety. Rather than tweak the current system, why doesn’t the U.S. just adopt the European model and call it a day? Our health and our economy would be better off for it.

Google’s Sergey Brin recently said that he didn’t want to be a health entrepreneur because “It’s just a painful business to be in . . . the regulatory burden in the U.S. is so high that I think it would dissuade a lot of entrepreneurs.” Mr. Brin won’t find anything in Dr. Gulfo’s book to persuade him otherwise. Until we get our regulatory system in order, expect a lot more Yo’s and not enough life-saving innovations.

In Defense of Johns

by on August 7, 2014 at 2:58 am in Economics, Law, Medicine | Permalink

Jim Norton writing in Time:

…When I first began soliciting sex for money, it never occurred to me that some of them are possibly forced into prostitution or have abusive pimps. I must have known it deep down on an intellectual level, but hadn’t witnessed anything to confirm it.

Until I did.

The only experience I’ve had with an element of violence being present was driving on 48th Street in New York once and talking to a girl through my passenger window….As we were speaking, a van full of girls stopped and a guy who I assume was her pimp, bounced her across the hood of my car and threw her in the van.

This is why I’m a firm believer that prostitution should be legalized and pimps should be thrown down an elevator shaft.

Law enforcement stings designed to shame men who pay for sex are nothing more than the state blowing its own morality horn. Being a comedian who is single allows me a luxury most johns don’t have, which is the freedom to discuss the topic openly. And not from a ‘case study’ point of view, but from the honest point of view of someone who has spent the equivalent of a Harvard Law School education on purchasing sex.

By keeping prostitution illegal because we find it “morally objectionable,” we allow (or, more accurately, you allow) sex workers to constantly be put into dangerous situations. Studies have shown that rapes and STDs dropped drastically between 2003 and 2009 in Rhode Island after the state accidentally legalized it. The American Journal of Epidemiology showed that the homicide rate for prostitutes is 50 times higher than the next most dangerous job for a woman, working in a liquor store. You don’t need a Masters in sociology to understand it would be much safer for sex workers if they were permitted to work in places that provided adequate security. Legalizing prostitution would also alleviate the fear a sex worker may have about reporting the abusive behavior of a john out of fear of arrest.

…Give sex workers rights. Give johns a break.

Ebola and the FDA

by on August 5, 2014 at 7:20 am in Economics, Medicine | Permalink

The Telegraph reports:

The two American doctors who have caught Ebola have been treated with a new “secret serum” which could potentially save their lives.

…A source close to the Atlanta hospital, where Dr Brantly is being treated, told CNN: “Within an hour of receiving the medication, Brantly’s condition was nearly reversed. His breathing improved; the rash over his trunk faded away.”

One of his doctors reportedly described the events as “miraculous.”

…Dr Writebol was also administrated with the drug, which was transported to Liberia in a special sub-zero container. She showed a less remarkable recovery, but is hoped to travel to the US on Tuesday to continue her treatment.

According to CNN, the drug was developed by the biotech firm Mapp Biopharmaceutical, based in California. The patients were told that this treatment had never been tried before in a human being but had shown promise in small experiments with monkeys.

…health workers said drugs that could fight Ebola are not particularly complicated but pharmaceutical firms see no economic reason to invest in making them because the virus’ few victims are poor Africans.

Of course, pharmaceutical firms are not going to invest millions in getting a drug through FDA trials for a disease that has only killed a few thousand people since being discovered in 1976. Nevertheless, some people find this simple logic difficult to accept.

 Prof John Ashton, Britain’s leading public health doctor, termed the “moral bankruptcy” of profit-driven drugs developers.

The logic of profit-driven drug developers is no different than the logic of profit driving automobile manufactures. It isn’t profitable to make cars for people who can’t afford them but the auto firms are rarely called morally bankrupt for not giving cars away to the poor. Moreover, it’s not at all obvious why the burden of producing unprofitable drugs should fall on the drug manufacturers. To the extent that there is an ethical case for developing drugs for the poor it’s a burden that falls on all of us.

As Eric Crampton notes there are at least two possible solutions. Either ensure at taxpayer expense a return on investment by subsidizing, offering prizes (as I suggested in Launching) or publicly investing in orphan drugs or

ease up the FDA trials for drugs in this kind of category. Does it really make sense to mandate placebo trials for drugs hitting diseases with 60% fatality rates? We are condemning people to a very high risk of death for the sake of ensuring that there aren’t drug side effects and that the drugs are more effective than placebos (pretty easy to tell quickly where the fatality rate is otherwise 60%!).

It would be much easier if (some) people would simply say “Of course this normally should be kicked back into the legislature for clarification.  But I don’t want to do that because I don’t regard Republican control of the House, and how that control is used, as a legitimate form of rule.”  One may agree, or not, but the nature of the case is pretty clear.

Instead we read irrelevant blog posts and tweets about how the experts meant to have subsidies at all levels all along.  Of course they did.  But did Congress know what it was doing in a detailed sense, one way or another?  Hard to say, personally I doubt it, and Alex says no.  The basic starter hypothesis here is that many of them knew this was a health care bill, it would extend coverage, it had a mandate, it had some subsidies, it had a Medicaid expansion, it had some complicated cost control, it was approved by leading Democratic Party experts, it met some CBO standards, and beyond that — if you pull out those who were confused on the details of the exchanges and the subsidies do you still have majority support?  I doubt it.  Most absurd of all are the tweets asking the critics to show Congress intended no federal-level subsidies.

So, to return to the title of this post, the import of the Gruber fracas is to show that if he can be confused (more than once, at that, and is “confused” even the right word?) a lot of ACA supporters in Congress probably were confused too.

So given that across-the-board subsidies are not written into the bill formally, and given the importance of precedent, and rule of law, why not kick the matter back into the legislature for redrafting?  Which brings us back to the first paragraph of this blog post…

I have drawn on some Ross Douthat tweets in thinking through this post.

What’s important to remember politically about this is if you’re a state and you don’t set up an exchange, that means your citizens don’t get their tax credits — but your citizens still pay the taxes that support this bill. So you’re essentially saying [to] your citizens you’re going to pay all the taxes to help all the other states in the country. I hope that that’s a blatant enough political reality that states will get their act together and realize there are billions of dollars at stake here in setting up these exchanges.

There is more detail here, from Peter Suderman, along with the video and also the fuller context for those (such as myself) who have not been following this issue very closely.

From Becker, Philipson, and Soares (pdf):

GDP per capita is usually used to proxy for the quality of life of individuals living in different countries. Welfare is also affected by quantity of life, however, as represented by longevity. This paper incorporates longevity into an overall assessment of the evolution of cross-country inequality and shows that it is quantitatively important. The absence of reduction in cross-country inequality up to the 1990s documented in previous work is in stark contrast to the reduction in inequality after incorporating gains in longevity. Throughout the post–World War II period, health contributed to reduce significantly welfare inequality across countries. This paper derives valuation formulas for infra-marginal changes in longevity and computes a “full” growth rate that incorporates the gains in health experienced by 96 countries for the period between 1960 and 2000. Incorporating longevity gains changes traditional results; countries starting with lower income tended to grow faster than countries starting with higher income. We estimate an average yearly growth in “full income” of 4.1 percent for the poorest 50 percent of countries in 1960, of which 1.7 percentage points are due to health, as opposed to a growth of 2.6 percent for the richest 50 percent of countries, of which only 0.4 percentage points are due to health. Additionally, we decompose changes in life expectancy into changes attributable to 13 broad groups of causes of death and three age groups. We show that mortality from infectious, respiratory, and digestive diseases, congenital, perinatal, and “ill-defined” conditions, mostly concentrated before age 20 and between ages 20 and 50, is responsible for most of the reduction in life expectancy inequality. At the same time, the recent effect of AIDS, together with reductions in mortality after age 50—due to nervous system, senses organs, heart and circulatory diseases—contributed to increase health inequality across countries.

That reminder is from Aaron Schwartz.  And of course that is the Becker, yet another contribution from Gary Becker.

Do note, by the way, that medical progress is usually egalitarian per se.  A common metric is something like “health outcomes of the poor” vs. “health outcomes of the rich,” and that may or may not be moving in an egalitarian direction.  But very often the more incisive metric is “health outcomes of the sick” vs. “health outcomes of the healthy,” and of course most medical treatments are going to the sick.  The more desperate is the lot of the sick, the more likely that medical progress is egalitarian per se.

Technological decline seems more plausible [as a cause]; see this Brookings Institution paper for the extended argument. Basically, health-care innovation is expensive, and for roughly the last decade, we’ve been doing less of it. As old innovations come off patent or are refined into cheaper and better versions, costs fall.

If you think health-care innovation is all useless me-too drugs, you should be pleased that we’re getting less of it. As it happens, I don’t think that’s the case, so while I’m pleased about the budget impact, I’m less pleased at the prospect of fewer new medical technologies. The good and the bad news is that the authors of that Brookings paper don’t necessarily expect the experience of the last decade to be continued in the future — good, because “whee, new treatments!” And bad, because, well, money.

The most worrying possibility is that this reflects a broader slowdown in how fast everything can grow. Certainly, it’s clear that the Great Recession caused a major slowdown in health-care costs everywhere; if you graph the data from the Organization for Economic Cooperation and Development, there’s a sharp, across-the-board inflection point in 2009.

There is more here.

…when it comes to health care spending, the picture is starting to look more global. After decades when health spending in the United States grew much faster than it did in other Western countries, a new pattern has emerged in the last two decades. And it has become particularly pronounced since the economic crisis. The rate of health cost growth has slowed substantially since 2000 in every high-income country, including the United States, Canada, Britain, France, Germany and Switzerland, according to data from the Organization for Economic Cooperation and Development.

The world’s health-care systems are also converging in important ways. New drugs and medical advances, which were once adopted locally and spread more slowly, are now experiencing international launches. Medical technology companies are increasingly global, and seeing regulatory approval in many markets at once. Strategies that can reduce the need for expensive hospital stays, such as performing surgeries in outpatient clinics, are expanding around the world.

Findings from medical research and the ways that doctors practice are also spreading faster and wider. “We’re learning from other countries, and the best practices take a year or two to diffuse, whereas in the past they might have taken five or 10 years,” said Gerard Anderson, a public health professor at Johns Hopkins. “We’re getting a convergence because of a more rapid diffusion of information.”

Two recent papers highlighted the trend. One in The Journal of the American Medical Association compared the United States with countries in the O.E.C.D. Its author, David Squires of the Commonwealth Fund, a New York health care research group, concluded that the similarities in spending growth suggested that “the factors that stimulated the slowdown in the United States also affected other industrialized countries.”

The other paper, from the O.E.C.D.’s own economists, made a similar point, highlighting that what really differentiates the United States from other countries is the high prices we have long paid for medical care, not big differences in how doctors are treating their patients.

That is all from Margot Sanger-Katz at The Upshot.  I would note that those mechanisms of transmission still seem a little murky to me.

Peter Orszag: We have had incredibly good news over the past three to five years. If I’d been told when I was director of either CBO or OMB that we would have a 12-month period when Medicare spending was basically flat in nominal terms — and therefore on an inflation-adjusted, per-beneficiary basis, significantly negative — I would have thought impossible and yet that’s exactly what we’re living through.

If this continues, it’s massive — everything you think you know about the nation’s long-term fiscal gap would be wrong.

That is from Vox, there is more here.  Note that since Medicare spending is slowing down too, this phenomenon probably is not just from slow economic growth.  From Wonkblog (don’t get confused) here is further commentary, arguing the fiscal gap still will be a problem.

*The Falling Sky*

by on July 15, 2014 at 2:06 am in Books, Education, Medicine, Philosophy | Permalink

The subtitle is Words of a Yanomami Shaman, and the shaman is Davi Kopenawa from the Amazon, with transcription and assistance from French anthropologist Bruce Albert.  Imagine 487 pp. of a highly intelligent, articulate shaman telling you what he thinks, and perhaps more importantly telling you what he thinks about.  Here is one bit:

As children, we gradually start to think straight.  We realize that the xapiri [spirits] really exist and that the elders’ words are true.  Little by little, we understand that the shamans do not behave as ghosts without a reason.  Our thought fixes itself on the spirits’ words, and then we really want to see them.  We take hold of the idea that later we will be able to ask the elders to blow the yakoana into our nostrils and give us the xapiri’s songs.  This is how it happened for me a long time ago.  The spirits often came to visit me in dreams.  This is how they started to know me well.

For those who are willing to swerve in the direction of the mystical, I recommend this strongly, read the Amazon reviews at the first link above.  Here is a brief excerpt from one: “This is an astonishing book, a gripping story, and a poetic revelation of an entirely different world view than our own. Every single page sparkles with provocative meditations on the impact that industrial societies have on the environment and the role of Yanomami shamans in protecting it for the sake of all humanity.”  You won’t find cost-benefit analysis here.  Here are some selections from the book.  Here is one blog review from LSE.  Google is not turning up too many other reviews, but this came out in late 2013 and it is a truly significant work deserving of further attention and it is rather dramatically under-reviewed.

There is a new NBER paper by Scott Cunningham and Manisha Shah:

Most governments in the world including the United States prohibit prostitution. Given these types of laws rarely change and are fairly uniform across regions, our knowledge about the impact of decriminalizing sex work is largely conjectural. We exploit the fact that a Rhode Island District Court judge unexpectedly decriminalized indoor prostitution in 2003 to provide the first causal estimates of the impact of decriminalization on the composition of the sex market, rape offenses, and sexually transmitted infection outcomes. Not surprisingly, we find that decriminalization increased the size of the indoor market. However, we also find that decriminalization caused both forcible rape offenses and gonorrhea incidence to decline for the overall population. Our synthetic control model finds 824 fewer reported rape offenses (31 percent decrease) and 1,035 fewer cases of female gonorrhea (39 percent decrease) from 2004 to 2009.

Alas, I do not see ungated versions on Google, or maybe try this one (pdf).

I have read a good deal on this topic and I am not very satisfied with most of it, from either side.  Too often citing and then refuting weaker claims from the other side is conflated with showing that one’s own view is right.  Here are a few issues we ought to consider and indeed focus on:

1. Five to ten years from now, how much do we think employment will have gone down as a result of ACA?  (That is from the employer mandate, high implicit marginal tax rates because of the subsidies, and also from a lesser need to stay employed to have health insurance.)  By the way, you can’t in other contexts believe strongly in rigidities and then confidently point to a small employment response within a one year time frame and claim to know these labor market effects are small ones.

1b. How will the effort to introduce greater equality of health care consumption fare if wage and income inequality continue to rise?  Will this attempt at consumption near-equalization require massively distorting incentives?

2. Given your answer to #1, and given how much employment itself boosts health, will ACA even have improved overall health in America?  What outcome indicators might show this?

3. Given that prices in the individual insurance market already seem to have gone up 14-28 percent, and may go up more once political scrutiny of insurance companies lessens, what is the overall individual welfare calculation from this policy change?  I mean using actual economic policy analysis, of the CBA sort, not just noting that more people have health insurance.

4. Given supply side constraints, how much did ACA increase the consumption of health services in the United States?  (I take the near-universal bafflement over the first quarter gdp revision a sign of how poorly we understand what is going on.)  And how good or bad a thing is the ongoing but accelerated shift to narrow provider networks?

5. How much of the apparent slowdown of health care cost inflation is a) permanent, b) not just due to the slow economy, and c) due to ACA?  Or how about d) the result of trends which have been operating slowly for the last 10-20 years?

Is there one of these questions we know the answer to?  Know the answer to much better now than before?

“This study finds total marijuana demand to be much larger than previously estimated,” Colorado’s study concluded.

And this, which I think suggests the laws in other states are binding for many consumers:

Colorado concluded that visitors account for 44 percent of recreational marijuana retail sales in the Denver area. In the mountains and other vacation spots, visitors to Colorado account for 90 percent of recreational dispensary traffic.

And this, which sounds tautologous, but is not:

“Heavy users consume marijuana much more often, and more intensely, than other consumers,” the study concluded.

Overall heavy users seem to account for about seventy percent of total demand.  Here is some detail:

Colorado’s market numbers bore out survey estimates that most marijuana is consumed by heavy daily users. For example, survey authors estimated that a third of all Colorado’s pot consumers use the drug less than once a month. But that group accounts for just 0.3 percent of the total market, analysts concluded.

The full story is here, the study itself is here.  For the pointer I thank C., who I believe is not part of that seventy percent of market demand.