The Wiki Leaks Party is proposing to promote ‘scientific policy’; decision-making based on research, evidence and clear, transparent principles. It is also supporting Internet freedom: “the WikiLeaks Party will be fearless in its opposition to the creeping surveillance state, driven by globalised data collection and spying agencies, both state and corporate controlled. We will demand that all information on data seizure and storage of citizens’ data by government agencies and allied corporations be made public.”
Both of these are laudable aims.
Now explain to me how the Wiki Leaks Party will operationalise these actions in relation to health care and health care data. Over the last few decades best practice in health care has been driven by the evidence based medicine (EBM) movement so the Wiki Leaks Party has a solid platform to base its’ promotion of scientific policy making. Interestingly EBM is now coming into collision with the era of big data. The problem is that we don’t have enough access to the data we already have and we aren’t collecting and using enough of the data we need to really inform the decision making process. By we I mean health care providers both Governmental and private.
I guess the trite response is that the approach to health care data will be through the principle of transparency. Well there are already many claims about transparency from the existing powers and health care providers. So lets have some detail about the the Wiki Leaks Party will handle big health data.
One of the things they didn’t teach in medical school is how to continue to the conversation of the consultation after the actual physical consultation is over. Supposedly shared decision making leads to better decision satisfaction and outcomes but what happens once the patient leave the consulting room.
In some cases they leave with a pile of printed information. They may have taken their own notes. Or a carer may have taken the notes and been the second pair of ears. But I know the wrong messages may have been taken away or there will be lots of questions.
One way to deal with the problem is to ensure that the patients have had an opportunity to ask the questions in the first place – question prompt lists can help with this.
Another potential way is to provide a record of the consultation. This can be a written summary or alternately it can be an audio record of the consult. Some doctors are set up to do this but these days it most commonly happens when patients ask me if they can record the conversation and then they use their mobile phone.
An alternate potentially useful method is to develop your own resources to refer the patients to. I’ve just started, albeit extraordinarily slowly due to time commitments, to develop videos using the Explain Everything platform. Hopefully my patients will find these useful both for innformation about their treatment and to inform decisions.
Here is my talk on Xeloda Side Effects
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.
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.
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.
In the last month I’ve been to @TEDMED and seen Laura Deming talk about prolonging life. I’ve also been to #TEDxSydney and seen David Sinclair discuss his research in anti-aging drug development. Each week there seem to be new publications in the scientific journals and reaching the mainstream media. There has been success in animals and human trials are in progress.
I don’t need to tell you how obsessed the world is with aging and slowing it down. Even if we get past the issue of vanity the key metric of economic prosperity is probably not per capita GDP but the life expectancy of its’ citizens.
Let me propose that an actual treatment, and I assume it ill be a drug, that slows aging, will be a game changer for how the pharmaceutical industry functions.
If we look at the history of prolonging life expectancy we can really identify a few key transition points that include:
– basic sanitation and food and water security are probably the single most important things for prolonging life. Keeping clean and having regular access to safe food and drink is the starting point. Value adds include refrigeration, electricity (to support heating and cooling) and running potable water). The main impact of these ‘innovations’ is to reduce infectious disease.
– second order innovations include vaccination and antibiotics to fight infectious disease
– the third tier of innovations is prevention and treatment of diseases related to abundance i.e. heart disease, tobacco related illness and although it hasn’t been properly tackled yet, morbidity related to obesity.
I like to say to my patients that they didn’t die from infectious disease in childhood and their heart specialist kept them alive after their heart attack so they can live long enough to get cancer or dementia (or death from complications of frailty). Successful anti-aging drugs will need to not only prolong life but reduce the chances, or at least, not increase the chances of cancer or dementia, and do so in the context that the chronologically aging but not physically aging person is staying fully functional. This is a very important distinction: often doctors will refer to a ‘good 85 year-old’ versus the ‘poor 75 year-old’ as a reference to physiological age not chronological age.
So lets assume this ideal anti-aging drug can be developed and lets assume it is actually very successful i.e. it prolongs functional life in good health by a meaningful period of time….let’s say a decade. What does it mean for the pharmaceutical industry?
Well I think we need to look back at the other game changers in longevity promotion listed above. Access to food, water and sanitation is considered a basic human right. The second and third levels of innovation probably haven’t quite become universal human rights but only in the sense that they are contingent on the first innovation and the reality is that those without access to the 2nd and 3rd set of innovations often haven’t had their universal human rights fulfilled.
So I would make the case that should an anti-aging drug become available, and if it demonstrates tangible flow on health (an other benefits) then access to the drug will become a right rather than a privilege based on economic advantage. In this case there might not be the usual monopoly advantage that pharmaceutical giants usually exert as populations won’t accept it. And remember, it is more than likely the drugs will need to be taken forever, from what ever age is deemed acceptable.
Now it could play out that the usual pathway of drug access occurs and that actually by the time we are really understanding the pros- and cons- of these agents the patents are expiring but I don’t think this is really going to happen. These drugs, if they really meet the aims of prolonging life without complications, will be marketed like Viagra-on-steroids.
Clean water is a universal human right. Who would have thought that internet access would become a universal right but it is rapidly becoming so. A successful anti-aging medication would probably also become a universal right.
Addendum: people will argue we shouldn’t use such drugs because it isn’t how things are meant to be (i.e. we have a natural lifespan). We maybe so but this quite simply isn’t what humans do….we meddle with nature to try and make it (and ourselves) better…..there may be a philosophical argument but it will be trumped by reality.
One of the emerging movements in healthcare is the quantified self movements. Led by a bunch of tech-savvy self-confessed geeks the quantified self movement is all about collecting personal data and using it to inform life decisions, health care decisions and behaviour change to improve overall well-being. These life-loggers are measuring their habits, food intake, activity levels, mood, heart-rate, blood pressure, blood sugar and a host of other person-reported outcomes and physiological measures and charting them on paper or in spread sheets. Whilst this seems like a small sub-culture most people with smart phones have downloaded at least one health related app that can be used for life-logging. Persistent use is not always durable and perhaps it is because life-logging, like much other healthcare activity is burdensome. You have to spend a lot of time entering data yourself. Well maybe this is all starting to change and being a quantified self is becoming less burdensome.
Victor Montori has been advocating for minimally disruptive medicine, the aim being to reduce the overall burden of healthcare (not just the burden of disease) for patients, particularly those with chronic medical conditions like diabetes. Many chronic medical conditions actually already require individuals to include some form of life-logging as part of their healthcare routines e.g. recording blood sugar levels or blood pressure.
Smartphones and other smartphone facilitated devices are starting to enable data collection in a minimally disruptive way. For example accelerator and GPS-enabled smartphones, or smartphones linked wirelessly to other small devices like a Fitbit or a Nike Fuelband, can track exercise and other activity levels. Calorie consumption can be inferred and flights of stair counter. The same phone or added devices can be used to measure sleep patterns. Increasingly attachments to the phones can measure various physiological parameters in a non-invasive way. Apart from the occasional re-charge (they aren’t solar or movement powered yet) they are pretty much plug & play, set & forget. All you need to do is make an effort to check out the data in the form of customised reports and decide how you will act on them.
To take it a step further companies such as Soma Analytics have apps that move beyond you recording your mood directly to actually inferring your mood by analyzing your voice patterns during phone conversations. This in turn allows a calculation of your stress levels and can give you feedback and advice about stress management.
Another variation is to use the phone using the GPS tracking facility to record activity levels as a marker of a patients’ “social pulse”. For example, if an older person changes their activity patterns based on monitoring of the phone movements then this might be a sign of decline in functional status. Deborah Speaking at @TEDMED Deborah Estrin has referred to this as our “small data” and is encouraging processes to obtain this data from telecommunications providers.
All of this data can be used for personal use but uploaded to the cloud and given the right permission your medical practitioner could access the data remotely and in return provide analysis, interpretation and clinical advice on the basis of your data. Automated alerts flowing to healthcare provider or patients could be a form of minimally present telemetry.
Looking at these existing and emerging technologies one can see that having a data-driven life doesn’t need to be a full-time job even if you are collecting data 24/7/365. Even the activities which might require an effort at data entry, like recording diet or medication use, might become more automated through image recognition software or barcode/QR-code scanning. This could be continuous and uninterrupted for individuals using google glass. I think we can call this the minimally disrupted quantified self.