The ownership of drugs data

Starting in 2014, clinical trials data of drugs approved by European agency will have to be released publicly. This has been a major claim by researchers and some regulators that are "concerned that too many drugs are approved based on selective evidence that exaggerates benefits and plays down the risks" as FT explains.
However, the news is that several companies are suing European Union to avoid such release of data, saying that this will harm their "competitive advantage". We are at a crucial moment. If these companies achieve what they want in the courts, it will be extremely difficult in the future to apply what it is expected for next January, the release of data to check safety and efficacy of drugs.
My understanding is that once you ask for authorisation you have to follow what the regulator has established, otherwise you should avoid such process and go to another market. Breaking the rules through the courts may be a successful strategy in corporate terms, but the firms can't forget that the final buyer and payer of pharmaceuticals is mostly the government, and it is the government who has considered that ownership of data is public once the drug is authorised. This is the cost of playing this game.

Back to essentials (2)

In many cases, delay is not feasible. Decisions need to be made, even if the environment is one of limited attention, information, and processing capacity, so shortcuts, or heuristics, are necessary. A heuristic is a decision rule that utilizes a subset of the information set. Since in virtually all cases people must  economize and cannot analyze all contingencies, we use heuristics without even realizing it. Medical decision making is plagued with heuristics and biases. Sometimes may be helpful and others may distort and have serious consequences for health and costs.
Once a government has set up a program to identify low-value medical interventions (Essencial), a list of what should be avoided, the most difficult part is how to translate it into practice. Of course, right now there are only 9 interventions and it is quite easy, but with larger complexity it would require a new framework for medical decision making. We need to understand deviations from what should be expected, and what to do about it: a "behavioral" medical decision making framework. Information and rules are not enough. Unfortunately, we still don't have a universal toolkit to fix such issue, only some pieces that may help. Anyway, this is not a rationale to fold the arms.

PS. The opposite of bad can be worse, by the Incidental Economist.

Back to essentials

Fortunately, we have started a new paradigm.A little bit late, but last Friday the government announced what I call clever budget cuts. The readers of this blog are familiar with the concept, here you'll find an example. The Essencial program of the government will focus on:

• Promoure una pràctica clínica que eviti la realització de pràctiques que no aporten valor a la ciutadania i que, en conseqüència, millori la qualitat de l'atenció sanitària.

• Informar la comunitat professional i la ciutadania sobre procediments que, segons l'evidència científica i el consens d'experts, no aporten beneficis per a la salut.
• Fomentar la participació dels professionals sanitaris en la identificació de pràctiques de poc valor.
• Avaluar l'impacte de les recomanacions en el sistema sanitari, tant des del punt de vista de procés com de resultats finals

Congratulations! Hope this will bend the expenditure curve and improve quality of care.

PS. Mediterranean diet, interesting comment at GCS blog.

It's all about economies of scale

Last week I participated in a round table on pharmacy. The biggest concern right now is when the government will pay the bill. The pharmacists are waiting four months but things suggest that may worsen. In such situation the pharmaceutical dispensing problems are so immediate that the challenges for the pharmaceutical distribution will be delayed for another day.
Beyond the issue of payment, I focused my speech on the need to make the most of economies of scale in dispensing drugs. The current situation is unsustainable, and unless there is a reform led by proposals from the professional side, the market and the state will decide the future. The excess of capacity is around us, you can see pharmacies with practically no stocks and daily distribution from more than 4 wholesalers in each pharmacy. The number of wholesalers is beyond what should be expected in this sector.
The time for a new structure of pharmaceutical distribution has arrived. Has anybody heard about it?

Still waiting after all these months

Waiting lists may be considered the most prominent consequence of a publicly funded health system. Without price barriers, the queue for an operation may take months. Data to compare the situation of waiting lists between countries is not that easy to find. However, in the last report by OECD you can get the indicator of how many patients were waiting for more than 4 months in several countries. Take a look at this OECD report (p.42). Only one country in its worst year achieved 41% (UK).
Right now data show that we have the record.  The latest information (p.7) highlights that 100% of interventions for elective surgery required waiting for more than 4 months during 2012. This represents 1,63 more months than in 2011. That's a lot. The number of persons waiting is 93,2 per 10.000 inhabitants (70.814), but 5.000 patients that were on the list and tired of waiting declined the intervention once they were allocated them to a hospital (unfortunately, there is no information about the impact or how they have solved it).
Definitely, waiting lists is a hot topic. they should be fixed and indicators should be close to international standards. Right now we are far, too far away.

The patent cliff is not over

Imagine for a while that the size of a market drops by 290 billion between 2012 and 2018. This is the case of pharmaceuticals. This is not new. Now we can start to check the strategies to cope with this cliff and wether the companies are succesfull or not. Nature RDD explains details, must read. A picture is worth one thousand words:

A startling achievement

INFORME MENSUAL DE SEGUIMENT DE LA PRESTACIÓ FARMACÈUTICA

Pharmaceutical expenditure in 2012 has dropped 14,27%, double of last year. That's unusual, a confirmation of trend reversal started in 2011. The total expenditure was €1.450 m, the decrease in prices 8,2% and on prescriptions 6,5%. The exact reasons behind such a fall are known: the introduction of copayments, the reduction of prices and benefits, and the changes in prescription. We still don't know the size of the impact for each factor.
The question is only one: Has this change affected the population health?. If not, why have we had to wait until now to do it? Unfortunately we can't aswer properly right now. I expect we'll show results in some months time.
Anyway, on one hand my congratulations to the regulator -he has finished vacation at least in pharmaceuticals-, and on the other hand I would like to remind everyone that the expected decrease in the pharmaceutical budget was 27%, therefore the deviation is 13%. I said in this post that it was very difficult to acomplish. The facts confirm my prediction.

PS. January data confirm the trend, on interannual basis a decrease of 15,95%

PS. A non-democratic failed state, yesterday voted to block any potential self-determination referendum, although 78% of its deputees were asking for that. This is a clear message for the international community. Next steps are closer to unilateral declaration.

PS. The beloved princess of the king (not the queen) and lobbyist of the failed state in the press. NTA.