Archive for May, 2013

Letters to Nature…

In Phase 2, scienceleftuntitled left its sheltered shores and took off for the far reaches of cyberspace. Australia to be exact — becoming a regular part of the scenery over at Australian Science.

To further its eternal quest for world domination, Phase 3 has now begun. And it begins on Nature’s Scitable blogs. A collection of blogs from a collection of writers, bloggers, and scientists in training on a range of different topics. From neuroscience, geology, oceanography, physics and more.

The environment shall be our “beat“. More specifically we shall focus on the interplay between science and policy. And the humans stuck in the middle.

“The science is the easy part (he says without a hint of hyperbole). More and more we shall come to learn that the most difficult thing, the most complicated mechanisms, the most complex systems at play, lay quite firmly on the human side. On the human interactions and manipulations of Earth.”

Our first exploration into this topic can be found here. And be sure to tune in on a regular basis as me and my co-blogger cover all things environmentally!

India, Novartis, and Australia’s new patent law…

blue pill

April 1 and about the only thing on the internet that wasn’t a huge Poisson d’Avril was the “landmark” ruling that came from the Indian Supreme Court early on Monday. The result was delivered from a packed room, the two judges probably had to raise their voices to be heard. Poetry to the simple fact that their voices would be heard far and wide, as the story gets echoed through media outlets the world over. Landmark, in legal terms it was — in simple terms it wasn’t. What it really signified was a wake up call for Big Pharma — demonised for putting profits in front of patients (or rather patents in front of patients).

The case will begin a long overdue conversation on access to medicines. More and more we are coming to the conclusion that current models are broken. Or, if not broken, then shifted… biased.

“This is a huge relief for the millions of patients and doctors in developing countries who depend on affordable medicines from India, and for treatment providers like MSF,” said Dr. Unni Karunakara in a press release, MSF’s international president. “The Supreme Court’s decision now makes patents on the medicines that we desperately need less likely. This marks the strongest possible signal to Novartis and other multinational pharmaceutical companies that they should stop seeking to attack the Indian patent law.”

The drug is imatinib, commercially known as Gleevec. Novartis sought a patent for a new formulation — the beta crystalline form of Imatinib Mesylate. In the end, the final verdict was 112 pages long. With the last ten a nice comparison of the differences between the old and new formulations.

“In view of the findings that the patent product, the beta crystalline form of Imatinib Mesylate, fails in both the tests of invention and patentability as provided under clauses (j), (ja) of section 2(1) and section 3(d) respectively, the appeals filed by Novartis AG fail and are dismissed with cost.”

The end of Novartis’ seven year court battle. Indeed the ramifications for patients are important. The case is landmark but in no way unique.

In 2007, Thailand threw caution to the wind in a blatant affront to intellectual property rights and the considerations of pharmaceutical companies. Thailand announced that they would issue what is known as a compulsory licence to manufacture low-cost versions of already patented HIV and heart disease drugs from Sanofi Aventis, Abbott and Merck. A clear violation of international intellectual property rights. In that case, it was a technical legal grey area — exploiting a clause in the 1995 World Trade Organisation agreement on intellectual property that gives governments a large amount of freedom to bypass patents on drugs if they face any kind of health crisis. The question being what constitutes a national health crisis?

Big Pharma appealed, stating the act, although to the letter of the law, was not in the spirit of the law. Argentina and Philippines have already come under criticism for ignoring intellectual property rights. And with a global slowdown of the pharma industry, it is getting harder and harder for companies to chase profits. To put it another way — without the financial rewards that long-term patents offer there are less incentives to develop new medicines. The cost of creating that first pill is now estimated to be US$ 1 billion.

Some might dismiss the violation of intellectual property rights as the devil-may-care actions of rogue emerging states, but more and more the conversation is happening in other nations.

In October of 2012, Australia commissioned an expert panel to review the appropriateness of the extension arrangements for pharmaceutical patents. “In certain circumstances, pharmaceutical patents can be extended by up to five years beyond the normal patent term. These provisions were introduced back in 1998, and are due for review,” said Mark Dreyfus, Parliamentary Secretary for Industry and Innovation.

As a consequence, Australia’s intellectual property system has had its most comprehensive overhaul in two decades. The new law comes into full effect on 15 April 2013. Some call it a set of tough new laws that punish and privilege both sides of the equation — an attempt to “raise the bar.” The new law makes it increasingly difficult to obtain a valid patent, increasing the standards required to receive patent protection.

How the law plays out it still remains to be seen. Indeed, there seems to be a clear intention to curb the rise of “evergreening” by pharmaceutical companies — something that seems to stifle innovation and subsequent competition.

In the end there are no simple solutions in trying to balance profits on access to medicines. Big Pharma will always seek to make new drugs and market them to us. “Novartis most certainly will continue to seek patents for its innovative products in India,” said Ranjit Shahani, vice chairman and managing director of Novartis India. “We believe it is the legitimate way to go. Novartis will be cautious in investing in India especially with regard to introduction of innovative medicines.”

Image — source

15 million mobile phones used to track malaria…

mobile malaria

We all know that mosquitoes spread malaria. What we never quite realise is that humans also spread malaria — and quite significantly. In some places, the spread of malaria is directly linked to the mass movements of human populations. The movements of infected humans seem to increase the dispersal of parasites beyond what would be possible by mosquitoes alone.

Fifty years ago, when we first tried to eradicate malaria, it failed — and among the main culprits (along with drug resistance and unsustainable funding) was listed movements of human populations. Historically, movements of infected people from areas where malaria was still endemic to areas where the disease had been eradicated led to a resurgence of the disease. As people and populations move, they can increase their risk for acquiring the disease, or increase the risk of transmitting it.

As always wars and civil unrest tend to favour disease transmission, and malaria is no different. During the 1980s in Angola, 15 years of continuous war had displaced hundreds of thousands of people. As a direct result, malaria moved from sixth to first place as the leading cause of mortality. This, simply because the capital city Luanda underwent an unprecedented population increase — and the malaria endemicity rose along with it. In a population that wasn’t ready for it.

The relationship between malaria transmission and population movement is undoubtedly complex. Population movements that either place people at risk for malaria or cause them to pose a risk to others cannot be stopped. But it seems now they can be tracked and we can mitigate for it.

In June of 2008, the movements of approximately 15 million people in Kenya were tracked using their mobile phones. Tracked, not by governments or refugee aid organisations, but tracked by researchers from the Harvard School of Public Health. During a 12 month period, every call or text made by each individual to one of 11,920 cell towers located within the boundaries of 692 settlements was logged and recorded.

Surveillance is a term that loses more and more of its meaning with every single advance in technology. Usually we picture more nefarious intents and purposes for tracking citizens. Within that year in Kenya, starting points and destinations of all 15 million individuals were tracked — giving each person a primary settlement to call home and mapping their movements in relation to malaria prevalence. Researchers determined where each person spent most of their time based on the location of the majority of their call and text records — this was their home base.

Mapping that onto malaria prevalence for the entire country allowed researchers to estimate and infer an individual’s probability of being infected and the probability that visitors to the settlement will become infected. Researchers built up what was essentially a parasite movement network.

There was some directionality to the net movements of people and parasites between settlements. Settlements can either be characterised as “source” or a “sink” — net emitters of people and parasites are sources and net receivers are sinks. As the capital city, Nairobi and its immediate surroundings, become a major destination for both humans and parasites. And from there, two sources of importation of malaria parasites exist. First, individuals visiting endemic areas may become infected during their stay, depending on the malaria endemicity of the destination, and may carry parasites back to their primary settlement. And secondly, infected individuals can carry parasites with them towards other settlements.

In analysing the movements of people within Kenya, researchers discovered that returning residents contribute to some movements of parasites between regions within Lake Victoria and coastal areas. Nairobi imports the largest proportion of infections from returning residents — those infected coming back from journeys to the coast and central Kenya.

It turns out that the structures of the networks of parasite and people movements were remarkably stable over the course of the year. Meaning that elimination efforts can also be robust.

Spatial analysis using maps to associate geographic information with disease can be traced as far back as the 17th century. In this day and age we are able to gather vast amounts of data with relative ease. GPS systems mean it is possible to integrate highly accurate geographic location with virtually any measurable observation — in real time and across multiple measurable observations.

The ease of gathering this much human health-related data points to the question of ownership and confidentiality. Essentially, big data problems.

The idea is that with those vast amounts of data collected, mitigation will be easier — early warnings and detections, hazard preparedness and the like. It is a somewhat new concept in the way we approach global health. Taking into consideration the universal and trying to capture the entire picture. Of course, every intervention is local… but this time it starts out at the global.

Image — source

What had I twaught…

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