05 de setembre 2018

Khan el-Khalili based drug pricing

When is it too expensive? Cost-effectiveness thresholds and health care decision-making

In one week of difference, the same technology: CAR T-cells has had two different options for drug pricing. Last week, under NICE review the answer was no to Gilead, and yesterday was yes to Novartis. The first paradigm applied to Yescarta is well known: marginal effectiveness should be acceptable at an affordable cost (NICE). The second one applied to Kymriah is based on preferences and willingness to pay under confidential prices. It is also a well known system specially at bazaars like Khan el-Khalili in Cairo.
This is an example of how two systems are applied in practice and nobody cares about it. I'm concerned about transparency, and that's why I can't understand why with public money the expenditure is confidential. I would agree if somebody explain the budget impact that have been agreed, otherwise with public money Kahn el-Khalili system is not acceptable. After more than four decades, Torrance would ask himself if all this effort on cost-effectiveness analysis has had any sense to arrive at this point.
Anyway, the remaining question is: when is too expensive? This is precisely what this editorial asks. And the and the answer (?) is:
For deciding whether something is too expensive, thresholds are crucial. Depending on which perspective is taken, the word ‘threshold’ may either refer to the consumption value of health or the marginal cost-effectiveness of current spending. 
This is a standard health economics perspective that no health politician nowadays will buy. Right now they are not buying the idea, and I think that they prefer confidential prices. It allows to reflect power,  discretionality, or even worse arbitrariness. Khan el-Khalili system has won.

04 de setembre 2018

A controversial view of epigenetic inheritance

A critical view on transgenerational epigenetic inheritance in humans

A new article in Nature suggest that more evidence is needed to ascertain the role of epigenetic inheritance.
Even if the molecular mechanisms exist to transmit epigenetic information across generations in humans, it is very likely that the transgenerational transmission of culture by communication, imitation, teaching and learning surpasses the effects of epigenetic inheritance and our ability to detect this phenomenon. Cultural inheritance has certainly had an adaptive role in the evolution of our species, but the evidence for transgenerational epigenetic inheritance, as laid out above, is not (yet) conclusive. 
Let's wait for new evidence...


02 de setembre 2018

Overturning conventional wisdom


Clinical trials are the standard way to produce new evidence. A new book reminds us that this is quite new. It starts explaining the scurby case and how it took 50 years to apply its results (lemon) to avoid death among sailors. There is aplenty of details and experiments among medicine, social and policy domains. You'll find a reference to the Rand Health Insurance Experiment and nudge examples.
If you want a good review of the book, check this one or Diane Coyle.
The more we ask the question ‘What’s your evidence?’, the more likely we are to find out what works – and what does not. Scepticism isn’t the enemy of optimism: it’s the channel through which our desire to solve big problems translates into real results. If we let our curiosity roam free, we might be surprised how much we can learn about the world, one coin toss at a time.



31 d’agost 2018

Is there a room for autonomous medical diagnosis?

Pivotal trial of an autonomous AI-based diagnostic system for detection of diabetic retinopathy inprimary care offices

With an eye to AI and autonomous diagnosis

In Digital medicine you'll find the article on an artificial intelligence-based  diagnostic of diabetic retinopathy. It's the first AI system approved by FDA last April, and represents the begining of new aids for medical decision making. Therefore, there is a room for supporting decision making with AI, but maybe one day autonomous diagnosis could be the issue, who knows.
The prespecified sensitivity end point agreed with the FDA was 85.0% and this was met with a point estimate of primary sensitivity of 87.2%. However, the confidence intervals of this estimate were 81.8–91.2% (that is, spanned the superiority end point). The study also employed an intention-to-screen protocol; however, 40 participants successfully enrolled in the study were excluded from analysis as their images were subsequently found to be insufficient quality to be graded by the image reading center. The authors attempt to address this by considering a worst-case scenario where all such images are incorrectly graded and repeating the analysis. In this approach the sensitivity would
be 80.7% (76.7–84.2%).
 Although deep learning will not be a panacea, it has huge potential in many clinical areas where high dimensional data is mapped to a simple classification and for which datasets are potentially stable over extended periods. As such, it will be incumbent on healthcare professionals to become more familiar with this and other AI technologies in the coming years to ensure that they are used appropriately.

Alice Francis - Coco Baca Bum Bum

30 d’agost 2018

The uselessness of current hospital rankings

Personalized Hospital Ratings — Transparency for the Internet Age

Eric Topol said in a tweet: It's high time to transcend hospital ratings and move to indvidualized ratings of hospitals. He refers to an NEJM article that supports personalized hospital ratings like the Rand ones.
As currently constructed, the weighting systems that underlie overall hospital performance ratings are expressions of the values, preferences, and tastes of their creators. Why not ask patients what’s important to them instead?
It makes sense.

29 d’agost 2018

The paucity of public information about medical devices

The need for transparency of clinical evidence for medical devices in Europe

Last year EU approved a new law for assessing safety and efficacy of medical devices. Unfortunately, it comes late and it is not enough to solve current situation of lack of information on evidence. An article in Lancet explains precisely what should be done to increase the transparency of information on medical devices.All the details in this list:




 A small task force of regulators and invited stakeholders has recommended what information should be included in the summaries of safety and clinical performance and which components of the Eudamed database need to be open to public access. Those recommendations are now under revision. The European Commission has been delegated authority to translate them into further legislation, but it has indicated that it does not consider that to be a priority. Any member of the public or any organisation with an interest in these issues should therefore make representations now to the European Commission. The medical device regulations will take effect from 2020.
The time is now.