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Beyond 23andMe’s Shutdown: The Role of the FDA in the Future of Direct-to-Consumer Genetic Testing

Kyle Edwards, Uehiro Centre for Practical Ethics and The Ethox Centre, University of Oxford

Caroline Huang, The Ethox Centre, University of Oxford

On November 22, in a harshly worded “warning letter,” the US Food and Drug Administration (FDA) informed the direct-to-consumer genetic testing (DTC-GT) company 23andMe that it had 15 working days to discontinue marketing of its services. By December 5, 23andMe had canceled television, radio, and online advertising and stopped selling its $99 ‘spit kit’ DNA test online.

To put it mildly, the FDA and 23andMe have some communication issues to resolve. A working relationship dating back to 2008 appears to have soured after a six-month period of silence from 23andMe, prompting the warning letter and causing many observers to comment on the apparent stupidity and mystifying nature of 23andMe’s communication ”strategy.” While the FDA’s letter is quite clear that 23andMe must communicate better, particularly in reporting the accuracy of its tests, it is not at all clear on how the FDA plans to regulate companies like 23andMe after these accuracy results are in. Moreover, it hints strongly that some tests may be banned even if they are as accurate as the tests you could receive through a physician. 

Assuming 23andMe follows through on its promise to cooperate with the FDA, how exactly should these DTC-GT services be regulated to best serve the public?

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How to deal with double-edged technology

By Brian D. Earp

 World’s smallest drone? Or how to deal with double-edged technology 

BBC News reports that Harvard scientists have developed the world’s smallest flying robot. It’s about the size of a penny, and it moves faster than a human hand can swat. Of course, the inventors of this “diminutive flying vehicle” immediately lauded its potential for bringing good to the world:

1. “We could envision these robots being used for search-and-rescue operations to search for human survivors under collapsed buildings or [in] other hazardous environments.”

2. “They [could] be used for environmental monitoring, to be dispersed into a habitat to sense trace chemicals or other factors.”

3. They might even behave like many real insects and assist with the pollination of crops, “to function as the now-struggling honeybee populations do in supporting agriculture around the world.”

These all seem like pretty commendable uses of a new technology. Yet one can think of some “bad” uses too. The “search and rescue” version of this robot (for example) would presumably be fitted with a camera; and the prospect of a swarm of tiny, remote-controlled flying video recorders raises some obvious questions about spying and privacy. It also prompts one to wonder who will have access to these spy bugs (the U.S. Air Force has long been interested in building miniature espionage drones), and whether there will be effective regulatory strategies capable of tilting future usage more toward the search-and-rescue side of things, and away from the peep-and-record side.

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Your password will probably be hacked soon, and how to (actually) solve the problem

By Brian D. Earp

See Brian’s most recent previous post by clicking here.

See all of Brian’s previous posts by clicking here.

Follow Brian on Twitter by clicking here.

 

Your password will probably be hacked soon, and how to (actually) solve the problem

Smithsonian Magazine recently reported: “Your Password Will Probably Be Hacked Soon” and delivered a troubling quote from Ars Technica:

The ancient art of password cracking has advanced further in the past five years than it did in the previous several decades combined. At the same time, the dangerous practice of password reuse has surged. The result: security provided by the average password in 2012 has never been weaker.

After the Twitter accounts for Burger King as well as Chrysler’s Jeep were recently broken into, Twitter apparently issued some advice to the effect that people should be smarter about their password security practices. So: use lots of letters and numbers, passwords should be 10-digits or longer, use a different password for every one of your online accounts and so on.

But this is nuts. Does Twitter know anything about how human beings actually work? Why do you think people reuse their passwords for multiple sites? Why do you think people select easy-to-remember (and easy-to-discover) factoids from their childhoods as answers to security questions?

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Pedophilia, Preemptive Imprisonment, and the Ethics of Predisposition

The first two weeks of 2013 were marked by a flurry of news articles considering “the new science” of pedophilia. Alan Zarembo’s article for the Los Angeles Times focused on the increasing consensus among researchers that pedophilia is a biological predisposition similar to heterosexuality or homosexuality. Rachel Aviv’s piece for The New Yorker shed light upon the practice of ‘civil commitment’ in the US, a process by which inmates may be kept in jail past their release date if a panel decides that they are at risk of molesting a child (even if there is no evidence that they have in the past). The Guardian’s Jon Henley quoted sources suggesting that perhaps some pedophilic relationships aren’t all that harmful after all. And Rush Limbaugh chimed in comparing the ‘normalization’ of pedophilia to the historical increase in the acceptance of homosexuality, suggesting that recognizing pedophilia as a sexual orientation would be tantamount to condoning child molestation.

So what does it all mean? While most people I talked to in the wake of these stories (I include myself) were fascinated by the novel scientific evidence and the compelling profiles of self-described pedophiles presented in these articles, we all seemed to have a difficult time wrapping our minds around the ethical considerations at play. Why does it matter for our moral appraisal of pedophiles whether pedophilia is innate or acquired? Is it wrong to imprison someone for a terrible crime that they have not yet committed but are at a “high risk” of committing in the future? And if we say that we can’t “blame” pedophiles for their attraction to children because it is not their “fault” – they were “born this way” – is it problematic to condemn individuals for acting upon these (and other harmful) desires if it can be shown that poor impulse control is similarly genetically predisposed? While I don’t get around to fully answering most of these questions in the following post, my aim is to tease out the highly interrelated issues underlying these questions with the goal of working towards a framework by which the moral landscape of pedophilia can be understood.  Continue reading

Invoking and banishing the dread demon “Lead”

Some researchers have fingered a surprising culprit for the crime wave that ended in the 1990s: lead, mainly from leaded fuel. We know that lead leads to development difficulties in children, and in country after country, lead emissions closely mirror the crime rate 23 years later – after those children have grown up into mature, irresponsible adults.

A nice story – only problem is, people aren’t very interested in it. We prefer to tell stories about actual human villains, morality tales with clear blame and praise and entertaining situations (contrast the amounts spent fighting terrorism versus road accidents). Lead causing crime just isn’t sexy.

So to combat this universal human tendency, that causes us to misdirect our efforts and our focus, I propose we should treat Lead as an human-like villain. In its oily lair, the demon Lead rubes its metallic hands together in glee, imagining the millions of children whose developments it is stunting, and the thousands of young men it tipped into criminality, and the wailing of their victims. It plots further increases of its empire of crime, and gnashes grey teeth in frustration as heroic regulator squeeze its powerbase out of the air, the fuel, and the water.

You should already feel your emotional priorities shifting. This alternative visions should enable us to give Lead the attention it deserves, in comparison with other lesser threats with more appealing stories. Use our story-biases in the service of good – we can feel the appropriate amount of joy when we triumph over Lead; emotions, not just reason, are needed to keep up our motivations in dealing wit these threats.

And then the demon can be joined in its dark imaginary lair by the vicious Vampire Malaria, the Zombie-Lord of the Road Traffic Accident, and the bloody Psychopathic Death Cult of Cardio-Vascular Diseases. To arms, good citizens of the world, against these sinister anthropomorphised and correctly prioritised threats!

Armstrong and Hesch: A tale of two athletes

Last week, shockwaves went through the sporting media as Nike officially cut ties with Lance Armstrong and Armstrong stood down as chairman of his Livestrong charity in the light of a massive swathe of damning evidence released by USADA, the USA’s anti-doping agency. Lost in the waves were the ripples of another doping story: little-known US runner Christian Hesch admitted to two years of EPO (erythropoietin; hormone controlling red blood cell production) use. Little needs to be said about the achievements of Armstrong, the most celebrated cyclist in modern sporting history. A ‘road warrior’, Hesch is a member of a sub-elite class of athletes who earn their living travelling from road race (running) to road race picking up small winnings, sometimes with a little travel/equipment support from racing teams. With a 3:58 mile best, he has never and will never make the Olympics; he is unknown outside of the USA’s running community where he made himself visible with flamboyant racing outfits and finish-line stunts.

In 2010, Hesch was hit by a car, picking up minor injuries and putting him ‘out of business’ for 5 months. With no workman’s comp, he turned to EPO to speed his return to racing fitness. While Armstrong was retiring from competitive cycling, Hesch was making trips down to Tijuana, Mexico, and smuggling EPO vials back into the USA, stuffed into his pockets. Armstrong was part of what USADA has referred to as “the most sophisticated, professionalised and successful doping programme that the sport has ever seen”; Hesch was architect of his own doping programme, injecting himself 54 times over the course of two years. He was rarely tested; eventually team-mates from Nike Team Run LA found evidence of drug use in his possession and presented him with an own-up-or-we’ll-tell ultimatum. They contacted USADA on September 6th and Hesch promptly confessed. While breaking the news himself on popular running forum http://www.letsrun.com, he posted “I want to make it clear that I don’t blame anyone for any & all feelings against me, it’s my bed that I’ve made and I will sleep in it… hopefully, someday I can earn your respect back.”

When it comes to the very top level endurance sport athletes, where the bar is set in terms of legal vs. illegal enhancements appears largely irrelevant. The current legal list currently includes altitude tents for the ‘natural’ EPO effect, high doses of caffeine, medication to correct previously undiagnosed asthmatic and thyroid conditions and a lot more. The USADA evidence suggests that in many cases where illegal doping is happening in combination with these legal supplements, it is being very closely monitored by medical teams. The argument for saying “make everything legal and be damned with it” is clear.

Is the same true for athletes coming through, and athletes on the cusp of the professional ranks? Is a scenario where, to compete with the pros or even be noticed it is a requirement to be on EPO and HGH, in the best interests of athletes; especially young athletes? Become a top athlete and you have a medical team to monitor you; until then, the choice may end up being between Tijuana, a syringe and a bathroom stall, or being an also-ran. Consider also the implications for athletes in developing nations like Kenya (where reports of more widespread doping are starting to appear); drugs with significant risks attached like EPO can be fairly cheap and easy to procure, medical supervision can be less so.

Given that we cannot protect all athletes with medical monitoring, is it better to protect them with a culture in which use of these drugs is wrong,  and with the knowledge that even the mightiest and best-protected of cheaters can fall?

Why strongly encouraging or legally enforcing bike helmets is not necesserily a good idea

In Australia and New Zealand wearing bike helmets is compulsory. In the United States, bike helmets are strongly promoted. The message in these countries is clear – not wearing a bike helmet is stupid because it can significantly damage your health. The stigma attached to cycling without a helmet may even be comparable to that attached to smoking cigarettes.

If you crash but were wearing a helmet (properly!), you will be less likely to suffer a head injury. Bike helmets may thus prevent disability and even death in this way. I don’t want to question that. (Though it has been questioned -it has been said that bike helmets give both cyclists and drivers a false feeling of protection resulting in more risk-taking behaviour on both sides; given that most helmets are not worn properly, this could overall be more dangerous than not wearing helmets.)

But, is the fact that bike helmets may reduce head injuries a sufficiently weighty reason to strongly encourage or legally enforce wearing bike helmets?

Perhaps I’m biased. I’m from Belgium – a cycling-friendly country where hardly anyone wears helmets. Why? It’s uncool, it messes up your hair, it’s safe enough to bike here (just reciting reasons people give), it’s impractical, it’s uncomfortable, it’s annoying to have to carry your helmet around when you get to your destination, it spoils the ‘freedom-feeling’ on a bike, etc. No doubt, there are costs to wearing a helmet.

So why should cyclists be required or strongly encouraged to wear helmets? Surely there are many other activities where the risk of head injuries is high? For example, playing in a children’s playground is equally, if not more, dangerous in that respect (other examples are hiking, walking or running at swimming pools, and simply getting into your bath). Is there something special about head injuries that result from bike crashes? Surely we wouldn’t argue for strongly encouraging or making ‘playground helmets’ compulsory (or ‘bath helmets’ – imagine that!). It would be terribly impractical, and uncomfortable for children. It would somehow restrain them in their freedom – it would just make playing on a playground less fun. But the best reason for why we don’t make playground helmets compulsory is that there are alternative ways for reducing the risk of head injuries at playgrounds that have fewer disadvantages. One measure that has increasingly been implemented in various countries is to provide playgrounds with a softer ground. This too helps to prevent head injuries, but without any of the disadvantages playground helmets would have.

So why don’t we do the same for bikes? Obviously, there is an alternative to wearing bike helmets too. We can change the environment and make cities safer for bikes such that fewer crashes will happen. It’s not that biking is intrinsically very dangerous. My daily bike ride to work,  at a moderate pace on safe bike paths away from the road is probably not more dangerous than walking on the footpath. (Of course, I’m not implying that it would be unwise to wear a helmet when racing or when going off the road on rocky ground.)

Perhaps one could say that, in bike-friendly cities, cyclists shouldn’t be enforced or strongly encouraged to wear helmets. It’s relatively safe to bike there – like it’s relatively safe to play on a playground with a soft ground. The overall health benefits of biking (better health for the cyclist and less air pollution) outweigh the risk of head injuries. But, one may say, people should surely be legally enforced or strongly encouraged to wear helmets in cities that are currently very bike-unfriendly (like Oxford).

However, I think this is too quick. It may take away incentives to make cities more bike-friendly. It sends the message that it is cyclists that need to adapt, not drivers. We should, however, keep in mind that there is an alternative to enforcing or strongly encouraging bike helmets: it’s making cities bike-friendlier. This may be costly, but it should be seen as a public health and environmental measure. We should  not forget that discouraging people from cycling (by requiring them to wear a helmet) also has significant costs.

 

 

 

 

What is the chance of an MP being wrong?

When MPs took a maths exam it showed that the members of parliament are pretty bad at elementary probability. When asked “if you spin a coin twice, what is the probability of getting two heads?” 47% of conservatives and 77% of the Labour MPs gave the wrong answer. About 75% of the MPs felt confident when dealing with numbers, although they generally though politicians did not use official statistics and figures correctly when talking policy.

How should a rational person react to this news?

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A fatal irony: Why the “circumcision solution” to the AIDS epidemic in Africa may increase transmission of HIV

By Brian D. Earp

See Brian’s most recent previous post by clicking here.

See all of Brian’s previous posts by clicking here.

Follow Brian on Twitter by clicking here.

 

A fatal irony: Why the “circumcision solution” to the AIDS epidemic in Africa may increase transmission of HIV

1. Experimental doubts 

A handful of circumcision advocates have recently begun haranguing the global health community to adopt widespread foreskin-removal as a way to fight AIDS. Their recommendations follow the publication of three [1] randomized controlled trials (RCTs) conducted in Africa between 2005 and 2007.

These studies have generated a lot of media attention. In part this is because they claim to show that circumcision reduces HIV transmission by about 60%, a figure that (interpreted out of context) is ripe for misunderstanding, as we’ll see. Nevertheless, as one editorial [2] concluded: “The proven efficacy of MC [male circumcision] and its high cost-effectiveness in the face of a persistent heterosexual HIV epidemic argues overwhelmingly for its immediate and rapid adoption.”

Well, hold your horses. The “randomized controlled trials” upon which these recommendations are based are not without their flaws. Their data have been harnessed to support public health recommendations on a massive scale whose implementation, it has been argued, may have the opposite of the claimed effect, with fatal consequences. As Gregory Boyle and George Hill explain in their extensive analysis of the RCTs:

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World funds: implement free mitigations

The future is uncertain and far. That means, not only do we not know what will happen, but we don’t reason about it as if it were real: stories about the far future are morality tales, warnings or aspirations, not plausible theories about something that is going to actually happen.

Some of the best reasoning about the future assumes a specific model, and then goes on to explore the ramifications and consequences of that assumption. Assuming that property rights will be strictly respected in the future can lead to worrying consequences if artificial intelligence (AI) or uploads (AIs modelled on real human brains) are possible. These scenarios lead to stupidly huge economic growth combined with simultaneous obsolescence of humans as workers – unbelievable wealth for (some of) the investing class and penury for the rest.

This may sound implausible, but the interesting thing about it is that there are free mitigation strategies that could be implemented right now. Continue reading

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