by Dr. Adrian Raudaschl
There is a feeling that researchers, patients and healthcare providers are growing increasingly unhappy with the state of scientific and medical research (10, 11).
Patient groups like Alzheimer’s Society go as far as to use member donations to fund their own research and leverage internal expertise to help speed up the development of new treatments 1. This is a twist on the conventions of medical science, and arises out of frustration of the lack of attention and funding for certain medical conditions like dementia (12).
Combine this trend with a decrease in new drug discoveries, the rising costs of medication, a decreasing cost of scientific equipment/services, open access to scientific literature and I get the feeling a revolution in how patients and organisations engage with healthcare is coming.
Frustrations of patient relations to pharma & difficulties in drug discovery
Pharmaceutical companies have not been getting best press these days 9. It feels as if public perception of the industry has been souring for a while 8. An infamous example of this was last year’s outrage over Mylan increasing the price of the EpiPen by over 500 percent – much to the opposition of the company’s own employees, regulators, patients, politicians and the press 2. Of course they are not the only ones, and according to to Credit Suisse, list prices for prescription drugs across the drug industry rose 9.8% in 2016 which played a critical role in drug companies growth last year.
Developing a new drug today costs more than $2.8 Billion.
In this situation, pharmaceutical companies may need to overprice their very few successful drugs to compensate for the R&D failures of their portfolios. What we are left with is a marketplace of expensive medications, and stagnating medical innovation.
New rise of citizen science
Science is not just for scientists these days. Through the bulk of scientific activity takes place in commercial enterprises, government laboratories and universities there have always been people who have done their own scientific research. People who haven’t been employed by an institution or a firm. You could argue that Charles Darwin was such a person 13.
Nervous about possible pollution from a nearby road? Set up an Arduino powered nitrous oxide sensor. Want accurate feedback about glucose levels related to diet? Hack a glucose monitor to turn it into a continuous monitoring device and share your data online.
Technology can make scientists of us all. Data churned out by consumer gadgets equipped with satellite navigation, cameras, biometrics and other sensors have great potential to drive a boom in citizen science. Initiatives such as the EU Open Science policy aim to increase our access to personal data even further, so in future patients may even be able to access their medical test results and contextualise them on a timeline. In medicine, organisations like Findacure and Raremark aim to consolidate medical data from multiple patients to help inform treatment strategies and research.
Looking more to the fringes however, some people are taking this concept further and leveraging open access scientific research and cheaper equipment to start their own medical projects.
Just as hobbyists in the 1980s found new uses for home computers, so amateur biohackers are now experimenting with the tools of biotechnology such as the London Biohackspace. Though it’s a far cry from a professional biotech lab, it sends a clear message – motivated people can learn to bioengineer, experiment and manipulate biological entities without a university degree or expensive equipment.
This motivation is driven by the changes described above of the increasing difficulties many people have in accessing cutting edge medicine. This is interesting, because it’s not hard for me to imagine a group of motivated individuals, armed with knowledge and equipment to start taking on more ambitious projects in the world of healthcare.
How does citizen medicine manifest itself? An example is the response to the price hike of EpiPens last year. One group (Four Thieves Vinegar) released instructions and videos on how anyone could take a cheap off-the-shelf needle injector made for diabetics, and combine it with a syringe that can be preloaded with a $1 dose of epinephrine. They called it the EpiPencil, and it costs $35 to construct – a fraction of Mylan’s $600 brand name EpiPen.
The group says their mission is not about medicating necessarily, but about “empowering people, in sharing information” and enabling people “to talk about alternatives to expensive medication regimens” 6. Some believe the EpiPencil effort contributed to Mylan releasing a cheaper generic version of their pen soon after, as well as a few companies launching their own cheaper versions.
This is a good case study of how market pricing can motivate private citizens to protest in unconventional ways.
It may seem unusual to us, but remember that pharmaceutical piracy is not uncommon in countries where medications are unaffordable by the majority of the population 7.
Four Thieves Vinegar and other groups like it are also working on reverse engineering medications such as Pyrimethamine (AIDS, malaria and cancer) and Mifepristone (abortion) 6.
If people are starting to experiment with pharmaceutical synthesis there is always a high risk of contamination, sub-potency, super-potency or improper dosing with anything synthesised. It should come as no surprise that regulatory bodies have expressed disapproval over medical projects such as described above, and with good reason – people’s lives may be at risk.
Though groups likes Four Thieves Vinegar supports FDA safety reviews and clinical trial tests for new drugs, their position is that they are simply providing knowledge, and it’s up to individuals to do with that information what they wish.
We are seeing the emergence of a new subgroup of individuals who are taking citizen science further and are leveraging passion, open access to medical knowledge and equipment to take control of their problems in research and healthcare.
When a parent (Terry) discovered her children had been born with a rare genetic disease called pseudoxanthoma elasticum she said “We [as parents] look at things differently. We look at what matters to us, and not some biological pathway that absolutely is important but isn’t going to give us the answers we need right away.” 11. Terry and her husband set out and borrowed a lab bench at Harvard University and set about tracking down the gene responsible for their children’s connective-tissue disease. With no science background it took them a couple of years, but remarkably, they did find the gene.
Though I don’t approve or advocate the human use of unofficially synthesised medications or medical devices, the knowledge and skills these patient/public communities have obtained to achieve these goals has great potential for good in the world.
In the same way that the first home computers and web services were developed by enthusiasts and hackers, I wonder if we will see a similar trend in medicine with a new generation of regulated biotech startups, public laboratories and pharmaceutical companies. The world clearly does not have a shortage of health problems, and some fresh perspective in an industry with few established players might be in everyone’s interest.
- Alzheimers Society – Current Projects. https://www.alzheimers.org.uk/info/20053/research_projects/562/current_projects. Accessed 18/06/17
- Outcry Over EpiPen Prices Hasn’t Made Them Lower. The New York Times. https://www.nytimes.com/2017/06/04/business/angry-about-epipen-prices-executive-dont-care-much.html?_r=0. Accessed 18/06/17
- Diagnosing the decline in pharmaceutical R&D efficiency. Nature Reviews Drug Discovery 11, 191-200 (March 2012) | doi:10.1038/nrd3681. http://www.nature.com/nrd/journal/v11/n3/full/nrd3681.html
- Jacob Glanville. http://www.distributedbio.com/. Accessed 18/06/17
- Sharon Terry. http://www.geneticalliance.org/about/staff/sterry. Accessed 18/06/17
- Was the EpiPen Hack Ethical?. https://ww2.kqed.org/futureofyou/2017/01/23/was-the-epipen-hack-ethical/. Accessed 19/06/17
- USTR: 97% of Counterfeit Drugs in US Shipped From Four Countries . http://www.raps.org/regulatoryDetail.aspx?id=24853. Accessed 25/06/17
- The public’s view of pharma just keeps getting worse. https://www.statnews.com/pharmalot/2016/08/30/gallup-poll-drug-firms-negative/. Accessed 25/06/17
- Pharma’s Reputation Continues to Suffer — What Can Be Done To Fix It?. https://www.forbes.com/sites/johnlamattina/2013/01/18/pharmas-reputation-continues-to-suffer-what-can-be-done-to-fix-it/#2159e4292aa5. Accessed 25/06/17
- Young, talented and fed-up: scientists tell their stories. Nature. http://www.nature.com/news/young-talented-and-fed-up-scientists-tell-their-stories-1.20872. Accessed 09/07/17
- Patients Increasingly Influence The Direction Of Medical Research. NPR. http://www.npr.org/sections/health-shots/2016/11/28/502904826/patients-increasingly-influence-the-direction-of-medical-research. Accessed 09/07/17
- Ensuring the future of dementia research. Alzheimers Society. https://www.alzheimers.org.uk/info/20052/research_strategy/433/ensuring_the_future_of_dementia_research. Accessed 09/07/17
- Darwin Online. http://darwin-online.org.uk/biography.html. Accessed 09/07/17
Sharon Terry with a background in theology, whose children were diagnosed with pseudoxanthoma elasticum (PXE) in 1994, became a researcher and data-sharing advocate. Her name is now on more than 140 scientific papers. With her husband, she discovered the ABCC6 gene that was responsible for her children’s illness 5.
Jacob Glanville – a ex-Pfizer scientist who left his job to pursue the creation of a ‘universal flu vaccine’ 4. Jacob developed his knowledge of sequencing, protein engineering, immunology, and algorithm development to create a vaccine from his lab in Guatemala. Though the focus is currently to develop a vaccine for pigs, Jacob hopes to use his research and profits to develop a human vaccine in future.