Posts filed under Law (36)

December 9, 2014

Health benefits and natural products

The Natural Health and Supplementary Products Bill is back from the Health Committee. From the Principles section of the Bill:

(c) that natural health and supplementary products should be accompanied by information that—

   (i)is accurate; and

   (ii)tells consumers about any risks, side-effects, or benefits of using the product:

(d)that health benefit claims made for natural health and supplementary products should be supported by scientific or traditional evidence.

There’s an unfortunate tension between (c)(i) and (d), especially since (for the purposes of the Bill) the bar for ‘traditional evidence’ is set very low: evidence of traditional use is enough.

Now, traditional use obviously does convey some evidence as to safety and effectiveness. If you wanted a herbal toothache remedy, you’d be better off looking in Ngā Tipu Whakaoranga and noting traditional Māori use of kawakawa, rather than deciding to chew ongaonga.

For some traditional herbal medicines there is even good scientific evidence of a health benefit. Foxglove, opium poppy, pyrethrum, and willowbark are all traditional herbal products that really are effective. Extracts from two of them are on the WHO essential medicines list, as are synthetic adaptions of the other two. On the other hand, these are the rare exceptions — these are the  ones where a vendor wouldn’t have to rely only on traditional evidence.

It’s hard to say how much belief in a herbal medicine is warranted by traditional use, and different people would have different views. It would have been much better to allow the fact of traditional use to be advertised itself, rather than allowing it to substitute for evidence of benefit.  Some people will find “traditional Māori use” a good reason to buy a product, others might be more persuaded by “based on Ayurvedic principles”.  We can leave that evaluation up to the consumer, and reserve claims of ‘health benefit’ for when we really have evidence of health benefit.

This isn’t treating science as privileged, but it is treating science as distinguished. There are some questions you really can answer by empirical study and repeatable experiment (as the Bill puts it), and one of them is whether a specific treatment does or does not have (on average) a specific health benefit in a specific group of people.

 

November 6, 2014

State lines

Two very geographical graphics:

From the New York Times (via Alberto Cairo), a map of percentage increases in number of people with health insurance in the US.

insured-map

This is a good example of something that needs to be a map, to demonstrate two facts about the impact of Obamacare. First, state policies matter. That’s most dramatic in this region from the right-hand side, about halfway up:

insured-highlight

Kentucky and West Virginia implemented an expansion in Medicaid, the low-income insurance program, and had a big increase in number of people insured. Neighbouring counties in Tennessee and Virginia, which did not implement the Medicaid expansion, had much smaller increases.  The beige rectangle at the top left is Massachusetts, which already had a universal health care law and so didn’t change much. (Ahem. Geography and orientation apparently not my strong points. Massachusetts didn’t change, but that’s Pennsylvania, which only just started Medicaid expansion)

Second, there was a lot of room for improvement in some places — most dramatically, south Texas. The proportion of people with health insurance increased by 10-15 percentage points, but it’s still below 40%.

 

As a contrast, the Washington Post gives us this,

venn

which is, hands-down, the least readable marriage equality map I’ve ever seen.

 

October 7, 2014

Marriage equality maps

The US Supreme Court declined to review seven same-sex marriage decisions today. The StatsChat-relevant aspect is the flurry of maps this prompted:

I think the New York Times (via Twitter) is my favorite version: the square statebins use geography just as an index to make states easier to find, and (in contrast to the last statebins I linked to) they’ve moved Alaska to the right place

BzS1Q2zIQAAxW3Q

 

(more…)

September 18, 2014

Interactive election results map

The Herald has an interactive election-results map, which will show results for each polling place as they come in, together with demographic information about each electorate.  At the moment it’s showing the 2011 election data, and the displays are still being refined — but the Herald has started promoting it, so I figure it’s safe for me to link as well.

Mashblock is also developing an election site. At the moment they have enrolment data by age. Half the people under 35 in Auckland Central seem to be unenrolled,which is a bit scary. Presumably some of them are students enrolled at home, and some haven’t been in NZ long enough to enrol, but still.

Some non-citizens probably don’t know that they are eligible — I almost missed out last time. So, if you know someone who is a permanent resident and has lived in New Zealand for a year, you might just ask if they know about the eligibility rules. Tomorrow is the last day.

August 18, 2014

Health/nutrition claims: baby and bathwater

Australia and New Zealand are introducing new food labelling legislation that will reduce the scope for bogus health and nutrition claims (the only bogus claims allowed will be the ones that slipped into the official code).  This is a Good Thing, as I have said in the past.

The legislation also says you can’t make health claims about booze. This is probably a Good Thing, although I don’t see why calorie/carbohydrate claims shouldn’t be allowed.  However, there’s a serious bug in the standards: one of the claims that’s specifically disallowed for alcoholic beverages is “gluten-free.”

It’s true that “gluten-free” has become a trendy bogus nutrition claim, but it’s also vital health information for some people, particularly those with coeliac disease. In that context, “gluten-free” is more like an allergen warning (“May contain nuts”) than a nutrition warning.  In fact, if you look at the section on “Mandatory Warning and Advisory Statements and Declarations”, Clause 4 includes

Cereals containing gluten and their products, namely, wheat, rye, barley, oats and spelt and their hybridised strains other than where these substances are present in beer and spirits standardised in Standards 2.7.2 and 2.7.5 respectively

along with peanuts, soybeans, eggs, milk, etc.  That is, declaring the presence of gluten is mandatory except in beer, where it is the only one of the Clause 4 mandatory warnings that becomes forbidden.  Banning gluten-free labelling on beer is deliberate and planned, it didn’t just fall between the cracks.

Since this is a trans-Tasman law, it’s going to be a pain to revise.  There seems to be one possible loophole. In the Nutrition/Health claims standards, there is provision for endorsements by independent endorsing bodies. These are exempted from most of the health/nutrition regulations: as the Explanatory Text says:

Endorsements are exempt from the other requirements of the Standard (except clause 7), to allow for endorsement programs which use the criteria set by the endorsing body.

It appears (though I may have missed something, and I’m not a lawyer) that Coeliac New Zealand could still endorse gluten-free beers, even though the brewers couldn’t make the same claims themselves.

[Further update: MPI contacted Keruru Brewery and say they are now working on a solution for gluten-free beer.]

[update: I heard about this on Twitter, but the blog post that kicked off Twitter is here]

May 22, 2014

Big Data social context

From Cathy O’Neil: Ignore data, focus on power (and, well, most of the stuff on her blog)

From danah boyd and Kate Crawford: Critical Questions for Big Data

Will large-scale search data help us create better tools, services, and public goods? Or will it usher in a new wave of privacy incursions and invasive marketing? Will data ana- lytics help us understand online communities and political movements? Or will it be used to track protesters and suppress speech? Will it transform how we study human communication and culture, or narrow the palette of research options and alter what ‘research’ means?  

 

May 21, 2014

When not to map

Maps are good because they take advantage of all the previous maps we’ve seen to provide background familiarity.  On the other hand, they use up both the available spatial dimensions before you’ve actually got any data, so you need to encode the information some other way. Colour is the obvious choice, but colour is much more limited than people appreciate.

Kieran Healy tweetedIt’s not like there’s a simple, tradeoff-free solution, but this is not a good map.”

BoH2_TfIMAACQIl

 

And he’s right; it isn’t. There are too many categories, and some of them are ordered but not all of them, so colour isn’t enough. Even if you’re going to try, these aren’t the right colours: for example, orange should be between yellow and red.  About the most you could do clearly with a single map is the three-way split: Yes, same-sex couples can just roll up to the registry;  No, not this week; or It’s Complicated.

Jacob Harris pointed to an article at Source, describing the design of graphics for a story about marijuana legalisation. It does much better

 

raja_final_product_1

 

They link to the classic piece “When maps shouldn’t be maps” by Matthew Ericson, which I’ve linked before. They also have a whole collection of articles on better maps, though it’s fairly programming-oriented.

May 3, 2014

White House report: ‘Big Data’

There’s a new report “Big Data: Seizing Opportunities, Preserving Values” from the Office of the President (of the USA).  Here’s part of the conclusion (there are detailed recommendations as well)

Big data tools offer astonishing and powerful opportunities to unlock previously inaccessible insights from new and existing data sets. Big data can fuel developments and discoveries in health care and education, in agriculture and energy use, and in how businesses organize their supply chains and monitor their equipment. Big data holds the potential to streamline the provision of public services, increase the efficient use of taxpayer dollars at every level of government, and substantially strengthen national security. The promise of big data requires government data be viewed as a national resource and be responsibly made available to those who can derive social value from it. It also presents the opportunity to shape the next generation of computational tools and technologies that will in turn drive further innovation.

Big data also introduces many quandaries. By their very nature, many of the sensor technologies deployed on our phones and in our homes, offices, and on lampposts and rooftops across our cities are collecting more and more information. Continuing advances in analytics provide incentives to collect as much data as possible not only for today’s uses but also for potential later uses. Technologically speaking, this is driving data collection to become functionally ubiquitous and permanent, allowing the digital traces we leave behind to be collected, analyzed, and assembled to reveal a surprising number of things about ourselves and our lives. These developments challenge longstanding notions of privacy and raise questions about the “notice and consent” framework, by which a user gives initial permission for their data to be collected. But these trends need not prevent creating ways for people to participate in the treatment and management of their information.

You can also read comments on the report by danah boyd, and the conference report and videos from her conference’The Social, Cultural & Ethical Dimensions of “Big Data”‘ are now online.

March 18, 2014

Big Data & privacy presentation

If you have time, there’s an interesting event that will be streamed from New York University this (NZ) morning (10:30am today NZ time, 5:30pm yesterday NY time)

..the Data & Society Research Institute, the White House Office of Science and Technology Policy, and New York University’s Information Law Institute will be co-hosting a public event entitled The Social, Cultural, & Ethical Dimensions of “Big Data.” The purpose of this event is to convene key stakeholders and thought leaders from across academia, government, industry, and civil society to examine the social, cultural, and ethical implications of “big data,” with an eye to both the challenges and opportunities presented by the phenomenon.

The event is being organised by danah boyd, who we’ve mentioned a few times and whose new book I plan to write about soon.

November 26, 2013

Should recreational genotyping be illegal?

The US Food and Drug Administration has sent a letter to 23andme, one of the companies that will genotype you and provide lots of information from the sample, telling them to stop. It’s a tricky situation.

This product is a device within the meaning of section 201(h) of the FD&C Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. For example, your company’s website at www.23andme.com/health  (most recently viewed on November 6, 2013) markets the PGS for providing “health reports on 254 diseases and conditions,” including categories such as “carrier status,” “health risks,” and “drug response,” and specifically as a “first step in prevention” that enables users to “take steps toward mitigating serious diseases” such as diabetes, coronary heart disease, and breast cancer. Most of the intended uses for PGS listed on your website, a list that has grown over time, are medical device uses under section 201(h) of the FD&C Act. Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions.

On the one hand, I can’t see any valid social interest in stopping people from knowing their genotypes if they want to. On the other hand, the FDA has a point about marketing.

They raise two isssues.  The first is that 23andme make lots of (fairly weakly supported) claims about the usefulness of the results in disease prevention. The second is that some of the genotype information is actually clinically relevant and that they have not demonstrated sufficient accuracy in their results. The first issue is essentially a misleading advertising problem; the second is a quality assurance problem.

There are two things that can go wrong with the clinically useful results. The first is simple error: the genotype assay could give the wrong result, or you could be given results from someone else’s sample. This should be low probability, but it’s important to know how low — 1 in a 1000 would definitely be too high.

The second issue is interpretation. Suppose you have a lot of family members with breast cancer, and you suspect a BRCA1 mutation is responsible. You might be relieved if you test negative, and think your risk isn’t especially high, but that’s only a reliable conclusion if your family’s cancer risk was actually due to a BRCA1 mutation, not to some other genetic risk factor.

 

Update: I should probably note that 23andme could fix what I think are the actual problems, but this wouldn’t necessarily satisify the FDA.  The FDA aren’t currently being unreasonable oppressive Luddite statist bureaucrats, but they’re probably happy to be to if that’s the option on offer.