How Edward Snowden Might Impact Big & Small Data Use in Healthcare

In the two weeks before Edward Snowden broke news about PRISM I gave two lectures about research ethics. It is traditional to note that what is ethically acceptable is in constant flux as technology changes and also that ethical principles tend to emerge in times of crisis, e.g. human experimentation that is also genocide. An observation that I made during these lectures was that the next crisis is probably going to relate to the use of ‘big data’ repositories in health. Well I didn’t quite nail the health part but bingo! – the use, security and privacy of individual’s data, in this case meta-data from telecommunications, email and text messaging, became the topic of the day.

The public is now aware that there are large repositories of data about themselves. There will start to be greater awareness that some of these data repositories include health records that are collated electronically. Currently, in Australia, these repositories and most other healthcare systems, these repositories are not very detailed but they do record if you’ve been to hospital, why you’ve been to hospital and a host of demographic information. This data is collected legally and is used legally for public health and planning purposes and in many cases for medical research, usually under additional regulation through ethics review processes.

The other bit of information that the public will become aware of is that these repositories of data are linkable. This means that a dataset collected in one system like healthcare is potentially linkable to a dataset in another sector like finance, or the justice system.

The issue becomes how the public, how society reacts to this knowledge and what it believes is reasonable use. The argument in the op-ed pieces in the major publications is that programs like PRISM serve a purpose in protecting the public from security threats. Indeed, surveys of the public in the US suggest that generally speaking people support this assertion. So there are some ‘reasonable uses’ in the public interest. No doubt, the same will apply to health data. The question is where the thresholds lie and how much transparency there will be.

But let’s get back to all of that metadata. Clearly there might be uses for tracking terrorists or gun-owners. But there might be healthcare applications. The concept of small data has recently emerged. The example is the notion that your phone company can track your movements through your mobile phone. If an older person was less active this could show up in their small data and indicate that they are sick. Who does this data belong to? The person or the phone company?

At the moment there are no answers but no doubt there will be trickle down implications from the Snowden affair to other applications like healthcare.

Repurposing old and unsuccessful medications

Sometimes drugs are tested in clinical trials and don’t meet their goals. In many situations this is the end of development for these drugs. Notably, given the amount of science that has gone into development of many agents it is not inconceivable that they could be repurposed to treat difference problems. Sildenafil (Viagra) is a case in point – it started as a treatment for hypertension and ended up being used for erectile dysfunction. This was a chance development and in reality most companies aren’t interested in pursuing further trials in other conditions given the cost of drug development.

In some circumstances there is a superimposed ethical problem. Some trials are stopped for overall lack of benefit but some participants may well have benefited. This often happens for orphan indications. This is actually probably true for most medications – they only work in some of the people that take them, in much the same way that they only cause adverse effects in some of the people that take them. The case of arbaclofen for treating Fragile X syndrome and autism is a recent example http://www.nytimes.com/2013/06/07/business/an-experimental-drugs-bitter-end.html?smid=pl-share

There are however potential ways to overcome the problem of withdrawing a ‘possibly effective therapy’. Regulators are now partnering with industry to deliberately encourage research into discarded medications. Medications which incidentally have been shown to be safe through previous clinical research but ineffective in their original target research. The NIH funds such a program http://www.ncats.nih.gov/research/reengineering/rescue-repurpose/therapeutic-uses/therapeutic-uses.html

A potential pathway in the case of arbaclofen to continue studies in these patients, and also supply of drug, would be crowdsourcing. The owner of the intellectual property – having decided that the product is worthless – could agree to either write-down its’ ownership and make the IP public domain or alternately allow public development with minimal claim on any patent royalties if the product is successfully developed or alternately to retroactively cover costs of development undertaken in the public domain through a limited buy-back of rights – all of these approached would be significantly less expensive than the traditional methods of developing the drug and financing that development. The drug manufacture could no doubt be cheaply outsourced to an Indian manufacturer and study data collection could move to open source models with independent review.

Developing novel methods to pursue drug development both of old and new drugs is important to ensure new treatments are developed and to ensure to viability of an industry which is increasingly poor at developing successful new drugs and increasingly unlikely to have them paid for by cash-strapped healthcare systems.

Some Arvo Part

Concerto for Violincello and Orchestra “Pro et contra” (1966) Dedicated to Mstislav Rostropovitch and Perpetuum Mobile, Op.10 (1963) dedicated to Luigi Nono. Cello played by Frans Helmerson

Symphony No.1 (Polyphonic) (1964) Dedicated to Prof. Heino Eller.

Symphony No.2 (1966)

Symphony No.3 (1971) Dedicated to Neeme Jarvi

Played by the Bamberg Symphony Orchestra under the direction of Neeme Jarvi

arvoparticon

Stravinsky: Works for Chamber Orchestra

Roger Norrington conducts the Zurich Chamber Orchestra in works for chamber orchestra by Igor Stravinsky.

Concerto for Chamber Orchestra in E flat “Dumbarton Oaks”
Danses Concertantes for Chamber Orchestra
L’Histoire du Soldat Suite 1920

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Joaquin Rodrigo, Antonio Vivaldi and The Romeros

From Mercury Living Presence

The San Antonio Symphony Orchestra conducted by Victor Alessandro and with the Romeros – Celedonio, Celin, Pepe and Angel

by Joaquin Rodrigo
Concierto de Aranjuez for Guitar and Orchestra (Angel on guitar)
Concierto Andaluz for Four Guitars and Orchestra

by Antonio Vivaldi
Concerto in B minor for Four Guitars and Orchestra (transcribed from the Concerto for Four Violins and Orchestra Op.3, No.10) (“L’Estro Armonico)
Concerto in C for Guitar and Orchestra (transcribed from the Concerto in C for Mandolin and Orchestra) (Celedonio on guitar)
Concerto in G for Two Guitars and Orchestra (transcribed from the Concerto in G for Two Mandolins and Orchestra) (Pepe and Celin on guitar)

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When policies are too big not to implement: the failure of evidence based policy making

So I attended another administrative meeting today. One of the jobs was to review (& approve) a policy that came from ‘above’. There was a lot of pressure from ‘above’ to implement this policy despite the intention of the Federal Government to support subsidiarity (put simply – local decision making). The fact is that the policy is poor and not-evidence based. Many parties outside our local health district oppose the policy. And in fact our local opponents to the policy could site evidence that it is poor policy. Our ‘local’ decision was to compromise and endorse the policy and produce an in-house business rule to overcome the short-comings of the policy – or, in other words, we’ll endorse it and ignore it. I’ve seen this happen several time before in other guises, for example, yes we endorse the policy but we have no money to implement so we will endorse and do nothing. In the National Standards good governance is the number 1 standard: unfortunately this will be about process rather than outcome. Surely it would be better to reject and develop good policy rather than adapt to bad policy.

Regulation of mHealth apps – let the debate begin

imedicalapps has reported that Apple may be starting to impose tighter restrictions on the approval of mHealth apps through the iTunes store. This follows on the appropriate oversight of the uCheck urine analyzer application (a way for automated reading of urine dipsticks).

The implication of the report is that Apple will only accept medicines information that is endorsed by the manufacturer of the medicine. Whilst this is a liability issue for Apple in some respects it is also fair guidance although one would argue that endorsement of the manufacturer might simply constitute dissemination of medicines information in accordance with the approved Product Information (PI) rather than written endorsement by the manufacturer.

Whilst such an approach is in keeping with law in actual medical practice a large number of medications are used according to valid evidence but outside information in the PI, also known as ‘the label’.

There is an urgency for a public debate about the best way to deal with this issue. Given the number of apps already in existence and the number of medications it is not likely that a regulator or an individual company has the resources to review everything in a timely fashion. The best approach might be to pursue (international) standards as proposed by organisations such as Happtique rather than a draconian regulatory approach.

Just as the NSA scandal has revealed the level of involvement of IT companies in our day to day lives we must also remember that these companies….Apple, Samsung, Google, etc, are now also the largest healthcare providers and the main conduits for health information both for practitioners and patients.

imedicalapps article

Happtique