Knowledge is power but should it be free?
I spent last night eating and drinking with two old friends who happen to be web programmers. It is fair to say that we have a lot to learn from the way they share knowledge, and our evening’s conversation made me feel very uncomfortable about the whole medical research machine.
The origins of the internet lie in sharing of information among like-minded individuals, initially scientists. Much of the protocols, programming, infrastructure and software of the internet rely heavily on web programmers not to patent their ideas and to make them available to the broader public. Ideas and innovations are often introduced for free and programmers and experts evaluate, give feedback and improve ideas. Although Bill Gates and many others have hugely profited from various aspects of mushrooming of IT in the past few decades, imagine a world where we had to pay per e-mail, or pay for the right to write this very blog which you are currently reading! Open knowledge and an ethos “for the greater good” ensure this culture.
In medicine, the two major types of knowledge we share are innovations (most commonly of drugs or devices) or research studies (from basic science to epidemiology, from animal studies to patient studies). The way in which these new types of ideas are shared or disseminated is generally through publication in peer-reviewed journals, which are either subscription only, or open-access. Subscription-only journals involve a cost to readers and open-access publication involves a cost to the author or their institution. Subscription-only journals have started releasing certain articles as open-access. The cost is justified by the cost of peer review and the cost of publication.
The balance of medical research is very much tipped in favour of intellectual property rights rather than open information. Sharing of data is relatively uncommon, either because of fears of “data theft” or due to conflicts of interest, particularly in industry-funded studies. The conclusions of the research are heavily influenced by the way in which the research is funded and there is good evidence that researchers and clinicians can be influenced. Open-access datasets are a relatively new and evolving concept.
Research careers and progression are still very much judged by the publication model: “publish or perish” and often only indirectly by ability of knowledge to change practice and change norms. Although clinicians and researcher are driven by the Hippocratic oath and wanting to do good for patients, the current research model is often too investigator-driven or funding body-driven and only relatively recently have the end users (the patients) been involved in designing and prioritising research. The current global interest in the Polypill is an example of how different research institutions around the world are competing to gain the accolade of being the first to conduct the first trial of the Polypill. All the Polypills being suggested use generic drugs, but they will all be patented and promoted as new entities. Imagine if the different research groups worked together with “open Polypill” technology and the Polypills remained generic.
I was asked for examples of medical research where researchers put open access to knowledge before their own interests. Three examples came to my mind. Firstly, defibrillation as a process has never been patented. Secondly, oral rehydration therapy was originally trialled to treat cholera in Bangladesh and has been used to treat hundreds of millions of people with diarrhoea and dehydration worldwide without patent of process or the product. Thirdly, the results of the Human Genome Project are being made gradually openly available. Let me know of the other examples that must exist so that I can defend medical researchers better next time....
Medical Device update
Here is an update to the weeks reporting on the research published on medical devices in the UK by CEBMblog in the BMJ
Lack of clinical data for medical devices is putting patients' lives at risk
The Guardian - Carl Heneghan - May 16, 2011
Medical device recalls are rising, yet manufacturers are not willing show clinical data related to the recalls. read more
Doctors call for tougher rules on devices. By Andrew Jack of the Financial TImes. May 16 2011
Europe’s regulatory system for medical devices such as heart valves and diagnostic imaging equipment should be tougher, more centralised and transparent to improve patient safety, leading doctors warn. read more
Paul Flynn MP
In 1993 I had a debate that I could now dust down and repeat in the House of Commons without changing a word.
It would still be relevant. Then it concentrated on the racket in marketing hip prostheses. There were 60 on the market then. One was different to all the others because it was blue. One had been used on thousands of patients and failed them all within four years. Tomorrow the BMJ and Channel 4's Dispatches renew that attack. read more
Early day motion 1819 as a parliamentarty question
That this House thanks Channel Four Dispatches and the British Medical Journal for revealing that defective UK regulations in the use of medical devices are exposing patients to suffering serious injury or worse; is concerned to learn that Suzanne Ludgate of the Medicines and Healthcare Products Regulatory Agency says she was appalled at how many devices are brought to market with a lack of appropriate clinical data; notes that recalls of devices are rising but manufacturers are not willing to publish information on device failures; and calls for a review that will ensure that UK patients have guarantees on the safety and efficacy of devices equivalent to that of patients in the US. read more
Finally see the whole program on channel 4 dispatches here
£7 billion and the failure to deliver electronic health records
£7 billion has been spent on developing electronic medical records within the NHS since 2002, part of the ambitious £11.4bn NHS IT project. It turns out that £7 billion is a common figure in NHS stats. It could buy you GP services in England for a year. £7 billion is spent annually on NHS services in Kent, Surrey and Sussex. It is the amount that stroke costs the NHS per year. The NHS would save £7 billion if it used generic or unbranded drugs instead of branded medicines. The NHS Institute reckons it could save £7 billion per year by implementing six scaleable interventions across hospitals, general practice and community health services.
But the important one is that between 2003 and 2006, the government spent the same amount on private consultancy firms to advise on health policy and services, and a lot of that money was spent on IT.
I qualified as a doctor in 2002, and it still beggars belief that little has changed when I go to see a hospital patient admitted in the middle of the night and ask for the old notes. The old notes are requested by the ward clerk who looks them up on a computer, often predating the machines Bill Gates cut his teeth programming on. Any amount of time from hours to sometimes days can elapse before these important documents are located. I think every patient should have the opportunity to see the sometimes prehistoric conditions old notes are kept in.
For the third time, the National Audit Office has found little progress and doubts whether the deadline of 2016 (already 6 years late) will be met, but even though electronic health records are the norm in primary care settings, hospitals are not getting there quickly, despite many improvements, including electronic image viewers, electronic discharge letters and prescriptions.
There is no question that electronic health records can be a game-changer in healthcare, whether in hospitals or general practice; whether in medical emergencies or in care of chronic diseases, but we are not close to bringing this to all NHS patients yet. Interestingly, e-health record systems for more than 10 million patients do not seem to work. Perhaps we can take some consolation that our friends across the pond have not yet decided how keen they are on e-health records either.
Medical Device recalls
Today we published in BMJ open an article on Medical-device recalls in the UK and the device-regulation process.
Our conclusion is the number of medical devices subject to recalls or warnings in the UK has risen dramatically. A whopping 1,220% increase.
A substantial number of these devices may have caused serious adverse effects in patients and contributed to healthcare costs. Also significant problems exist in the UK with a lack of access to transparent data and a registry of the highest-risk devices.
The articles worth a read to see the sort of problems we faced in trying to access clnical data on recalled devices. There is also a linked anlysis we wrote in the BMJ
This is what the independent made of the story, "patients lives are put at risk by faulty medical implants."
If you want to know more then look out for tonight's episode of Dispatches on channel 4.