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Category Archives: Ethical / Social

Ethical / Social

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The community speaks

Posted on 10 Mar 2016 by Bioentrepreneur
NBTat20As part of our anniversary issue, we approached over 90 thought leaders to talk about the challenges facing the biotech sector and to outline some of its most exciting frontiers. Here’s a snapshot of what some of them had to say.

Drew Endy, Stanford University: Languages are systems for communicating among humans (e.g., English) or between humans and non-human systems (e.g., C++). Biotechnology is begetting a new language for scaling communication between humans and living matter, broadly defined. Over time languages tend to become free-to-use or are abandoned and go extinct. Patents are great; they expire. Languages for programming life will become free.

R. Alta Charo, University of Wisconsin, Madison: Much of the past century was spent in fear of the destructive power of science, from pesticides to atom bombs. But now the creative power of science, whether to alter plants and animals or to construct novel life forms from off-the-shelf materials, will force us to reconsider our relationship with nature and our cherished notions of a deity as creator.

Greg Verdine, Warp Drive Bio: We are at the earliest stages of a revolutionary expansion in those molecular forms proven useful to treat human disease. These new therapeutic modalities will redefine what medicines can do—they will drug intractable intracellular targets, effect gains-of-function, and home selectively to target tissues via endocytic transport—and they will save and improve millions of lives worldwide. The mother of all technical challenges that must be overcome is to measure drug concentrations in real time in all tissues in a minimally invasive manner at the cellular lever.

Jonathan Moreno, University of Pennsylvani: If the key to happiness is low expectations, the biotech industry is in for a miserable future. Touted and feared for its potential to address a vast array of human maladies and unprecedented ‘improvements,’ biotech is now seen in some quarters as the last, best hope for revolutionary innovations that can save capitalism and even the planet. High time to lower expectations.

Emilia Díaz, Kaitek Labs: Our industry presents a considerable gap between technical advancement and global applications. We either don’t try to solve a problem or insist on solving the ones everyone is already working on. We must enable an active decentralization of biotech that allows new players from outside of the traditional tech and wealth hubs to develop solutions for underserved markets and needs.

John A. Rogers, University of Illinois at Urbana-Champaign: The recent emergence of biocompatible and bioresorbable semiconductor device technologies creates many exciting new frontiers in engineering science, from the development of novel discovery tools for research in biology to the creation of advanced bio-integrated devices for clinical medicine. Improved fundamental understanding of the behavior of these systems at the biotic–abiotic interface is needed to accelerate progress.

For comments from other members of the community, see our Community Crystalgazing article and Voices article.
Posted in Ethical / Social, Regional Initiatives

White Coat Rising

Posted on 01 Dec 2015 by Emilia Díaz

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Last year, in my very first post, I mentioned how my country has one of the lowest investment in research and development in the region. And yet, amazing research and promising technologies have arisen within Chile’s borders, like the case of Andes’ Biotechnologies I recently covered, and the recognition that Cartier gave to a brilliant Chilean biochemist, Komal Dadlani, for her efforts in democratizing science worldwide. And, like them, there are thousands of Chilean scientists making their best effort to contribute to the betterment of our country, in spite of the harsh conditions and harsher future prospects.

This constant struggle has reached a tipping point

Under the motto “Chile needs science” (hashtag #ChileNecesitaCiencia), and dressed in their labcoats, Chilean scientists have been gathering in front of the presidential palace and on social networks to oppose the government’s decision to not raise the country’s budget for research and development (again), and the reduction of science-related scholarships (again) and the delay in government grants and contests (again).

What started with the resignation of Francisco Brieva, former president of the National Committee for Scientific and Technological Research, has become a sort of revolution, crystallized in a complaint letter harshly titled “Our governments have chosen ignorance.” The letter has been signed by more than 2,000 scientists, including six National Applied Science and Technologies prize awardees, and around 20 presidents and representatives of scientific societies in the country. The outrage may have been fueled by Dr. Brieva resigning after working six months without pay. That alone should give you an idea of how bad it is to be a scientist here.

Science has become art in the worst possible way: nobody thinks you should be paid fairly for it. After all, spending 18 hours a day in front of a canvas or a petri dish cannot be considered “real” jobs, right? When my startup publicized a two-month internship offer for a 20-year old, I got emails from PhD holders saying they would happily work for the less-than-$200 per month we were offering. They would have made more money at McDonald’s.

Do this make you want to put on your labcoat and hoist an angry sign? We could continue down that road, of course, but it does not lead very far. What we need to ask ourselves is: how can we move past outrage and become a constructive force? What can we, as a country, do to overcome this predicament?

Luckily, some of the country’s most brilliant scientists – names also seen on the open letter mentioned above – have given this issue more than a passing thought. Here is what they propose:

In the short term, and so that the discussions around the topic can once again become polite (in other words, no more protestors singing, “All scientists are going to quit / If you insist in paying us like ____”), there has to be an increase in the country’s budget for science and technology, and the conversation should finally be directed toward creating a Ministry of Science and Technology. Once this entity has been created, we could design a funding entity that goes in accordance both with what the country really needs in terms of new economic opportunities and of available human resources. What is arguably among the most brilliant people in the country’s workforce is being completely underused and even at risk of becoming idle. This is the perfect time to start again and aim for newer, more appropriate, better things.

After all, consider what Chile has managed to accomplish even with such harsh conditions. Universal cancer drugs starting their clinical trial stage, minimally invasive magnetic surgical systems waiting for FDA approval, apps that eliminate scientific illiteracy already undergoing pilot studies, and other cases of Chilean biotech that have started getting noticed worldwide.

Just imagine what we could do if we didn’t have to use our time and energy to engage in unnecessary battles. We all know what we need, and we agree on what is best for Chile. The only thing our nation must do now, once and for all, is to choose knowledge over ignorance.

Emilia Diaz

 

Posted in Ethical / Social

Transgenesis vs. gene editing

Posted on 11 Aug 2015 by Luiz Antonio Barreto de Castro
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brushes-2-1423105-640x480I have worked with plant genetic engineering since 1980, when I was at CENARGEN/EMBRAPA before the first genetically engineered plant was obtained by Luiz Estrella at Marc Montagu’s lab at the University of Ghent. More than three decades later, I see at least two almost unavoidable problems that still limit the release of GM organisms: the cost to perform all the experiments required by the FDA, USDA and EPA in the US – and by our Technical National Biosafety Commission (CTNBIO) in Brazil – is so high that only large corporations can handle them. EMBRAPA is the largest and most competent institution in Brazil dealing with biotech, but the institution could never take GM products to market unless through partnership with large corporations, something we did twice, once with Monsanto to deliver RR soybean, and the other with BASF to obtain a soybean tolerant to another herbicide. We could not afford to do it ourselves. Equally, universities and small companies could never get through the regulatory requirements by CTNBIO. Thus, we’re kept out of the market not by incompetence, but by regulatory costs.

The second unavoidable (and persistent) problem is the myth that transgenic organisms are bad for you, even after many decades lacking scientific evidence to support this. We at CENARGEN (building on the work done in Carlos Bloch’s lab) had peptides that could be genetically inserted into cocoa to prevent witches’ broom, a devastating crop disease. The cocoa industry did not accept this solution because the peptide was derived from the genome of a frog. We have a long-standing partnership with Elizabeth Maga at UCDavis to introduce by genetic engineering insulin and lactoferrin into dairy milk to reduce infant diarrhea that claims the lives of millions. The dairy industry, at least in Brazil (I cannot speak to Europe, where it may be worse), will never accept it because they believe that people will not consume a genetically engineered milk. One company in Brazil told me to produce insulin by my method and purify it, and said the company would then add it to the milk but would not say the method used was genetic engineering.

People think transgenes are bad for you. After seeing this persist for many decades despite a lack of evidence, I think this will not change, and what is worse is that industry and some regulatory agencies will not accept it. The Golden Rice has never reached the market, while millions die due to lack of Vitamin A. Even the GM sterile mosquito produced by Oxitec is waiting for approval by FDA. Fortunately the same mosquito was released by CTNBIO in Brazil where the dengue fever affects hundreds of thousands of people. So it is not only the cost – the FDA has never cleared a genetically modified animal.

Now we have gene editing using CRISPR-Cas9; in the US this technology is being vastly used. So far they have not faced regulatory hurdles because they are not transgenics.The regulatory agencies will now work to determine if rules are needed, according to Science. Certainly this will be the case if human embryos are intended to be targeted with gene editing, but probably not for plants and other animals.  The decision should come in July 2016.

I will keep my fingers crossed. This may end up being the democratization of genetic engineering because the technology is in the hands of everybody. In November, the Brazilian Biotechnology Society will hold its 6th Congress, titled Frontiers of Biology in Brasilia. The CRISPR-Cas9 subject will be discussed by distinguished speakers that I’ve invited from UCDavis and Oxford. Registration is now open.

Luiz Antonio Barreto de Castro

Posted in Ethical / Social, Regulatory | Leave a reply

Standing up for GMOs

Posted on 09 Apr 2015 by Luiz Antonio Barreto de Castro
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beeOn October 25th, 2013 I blogged about standing up for preclinical tests, written after the Instituto Royal in Brazil was invaded by vandals. They destroyed all the laboratories at the Institute, stole more than two hundred beagles and forced the Institute to close its doors. Bruce Alberts and ten eminent scientists earlier wrote an editorial for Science with a similar title: Standing up for GMOs. This after activists destroyed Golden Rice experiments at the Philippines International Rice Institute. Golden Rice is waiting to be released commercially, while thousands die every year, blind, due to the lack of Vitamin A.

Vandals again attacked in Brazil. I call them terrorists, but either way, they invaded the premises of Field Experiment Station of Futuragene in the State of São Paulo and destroyed 14 years of science accumulated by this company concerning eucalyptus GM. About 1,000 women from Brazil’s Landless Workers Movement, or MST, in early March occupied the scientific research center of Futuragene to protest against the possible introduction of genetically modified eucalyptus trees in Brazil. They claim the honey of the GM eucalyptus is contaminated by pesticides. The eucalyptus could have been designed to be resistant to insects using a Bt gene, similar to a dozen plants worldwide. But these, in fact, were produced to reduce cellulose and shorten the life cycle of the tree. BIO, the lobby group for biotechnology, came out against this action.

Pesticides have been used since the end of the Second World War, when DDT was discovered and commercially used to control lice and later malaria. Sixty years later the European Union issued a partial ban on three neonicotinoids that were suspected to harm bees, butterflies and other non-target species. Cohort studies in the United States are beginning to map out the troubling effect of pesticides on the developing brain: exposure to pesticides could perhaps cause autism and intellectual deficiencies, said Phillip Landrigan, director of the Environmental Center for Youth Health at Mount Sinai.

Also, more than 300,000 people are believed to commit suicide every year by swallowing pesticides, a big problem in Asia. There is plenty of room for improvement when it comes to pesticides, yet it seems like we’ll never be without them.

The MST has never acted against the overuse of pesticides. Instead, the resistance to genetically modified crops in the world is scientifically inexplicable, and it seems to be far from an end, regardless that there has never been a recorded adverse effect to humans, animals or the environment.

Of course new technology always dislodges one in the market or prevents growth of ascending technologies. In this case, GMOs prevent the growth of “organicos.” The father of “organicos” is Prince Charles. He funds NGOs in Brazil to battle GMOs. It is hard to believe that activists are working without any financial benefit. There is no free lunch.

Luiz Antonio Barreto de Castro

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Mixing Science and Politics

Posted on 12 Jan 2015 by Luiz Antonio Barreto de Castro
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mixingAquaBounty’s saga to register its GM salmon at FDA constitutes the longest case in history of a GM organism attempting to be cleared anywhere in the world. The United States has a role as leader in the subject of commercializing Gm plants as food. I wrote a letter to President Obama. Others have, as well. In mine, I basically said that science and politics do not mix.

In the last century Stalin denied the Russian people the right to study in the schools, he denied them the modern genetics of Thomas Hunt Morgan. Morgan won the Nobel Prize in Physiology in 1933 and established a Division of Biology at Caltech that yielded seven other Nobel Prizes. Russia today imports grain, a lot of it from Brazil, where the genetics of Morgan was —  fortunately – widely disseminated amongst our geneticists.

The United States has been a tremendous example to the world in dealing with science independently of politics. However, I smell political influences preventing a decision in the US.

The subject is not complex. I’ve read the AquaBounty proposal. If there are relevant scientific reasons not to register the GM salmon, I have not seen them. Regardless, if reasons exist, FDA must simply deny the registration. This has not happened, and the application has been in the hands of FDA for many years now. President Obama could easily ask for independent advice; he has hundreds of excellent scientists at his disposal in the United States.

Scientists in the US want to know the scientific issues FDA is wrestling with before denying or accepting the registration of Acquavantage. They stated so in a letter, which I also read in Brazil. We are all astonished with AcquaBounty’s struggle to register their GM salmon. A few months ago, we dedicated an entire page to this matter in Jornal do Brasil. When I wrote to President Obama, I did so as a concerned scientist dealing with molecular biology for half a century in my country – this technology could benefit Brazil. But I also wrote as the President of the Brazilian Biotechnology Society. I’ve also blogged about it before, found here.

A few months ago I attended and excellent International Scientific Congress in Brasilia. The subject was animal biotechnology. Aquabounty came up many times, and the general opinion was that politics are staying the FDA’s hand. This will leave a stain on the scientific history of the US. Credibility takes a long time to build but only one small example to be destroyed.

GM technology faces a continuous, political campaign against its use from European NGOs (though it is entirely devoid of fundamental science). Yet after decades of GMO consumption, there is not one example of demonstrated harm. Given the lack of action by FDA, one might wonder if the inhabitants of the White House are listening to the European anti-GMO campaigns.

Luiz Antonio Barreto de Castro

Posted in Entrepreneurship, Ethical / Social, Regulatory | Leave a reply

Southern Science

Posted on 27 Aug 2014 by Emilia Díaz
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forward_arrowI recently had the pleasure of attending an international summit for young bio-leaders of the future. My fellow attendees (including 4 Chileans out of a total of a 100 guests picked worldwide – a fact that admittedly filled me with pride) formed a diverse, rowdy and interesting crowd. The speaker selection was more conservative and homogeneous. A very wide range of biotechnology-related topics were discussed, from anti-aging techniques to patent managing to sustainability, but even with such a wide spectrum of talks, I saw a pattern emerging.

Every story the speakers (deans, professors, C-ranked executives) told happened in Europe or the US, in the biotechnology clusters located there. When they talked about developing countries, they were referring to China and India, who have a pretty comfortable advantage over my home country, as they are placed second and tenth in the UN’s list of countries by GDP for 2012. (Chile ranked 36 and we should have probably thrown a party.) Over the course of the summit, the talks focused on the EU or US and China and India for the “exotic” factor; the rest of the world was not mentioned.

This meant that the problems discussed did not stray beyond those borders, either. Don’t get me wrong, I understand that excellence clusters statistically produce the vast majority of advances in biotechnology, and things like age-preventing technologies are always interesting from the biological perspective. But aging is not an issue in the vast majority of the world. “Not aging” would describe it better.

If biotechnology developments continually come out of First World clusters, we will come up with solutions for only First World problems. Of course, there are always philanthropists that will direct their research towards the Third World, but that’s not enough, and more importantly, that’s not the point.

We do have great scientists over here. We can do great things, too. Southern science, or Third World biology, can be just as great as northern or First World science. The distribution of talent does not favor anyone in particular (not even in the clusters: a considerable amount of their scientists come from abroad), it’s the economic factors that drive talents away from their native countries and off to the traditional, renowned clusters. We need to figure out a way to reverse that. The reason is that while you can explain your particular problems to others, you are actually the person most qualified to solve them. In this regard, we need southern scientists that will tackle issues of water purification in remote areas, and Third World scientists battling child mortality.

To attack our own problems, we need to form new clusters with new priorities, new goals, new areas of action and expertise. I know that my current best option as a student, or as a biotechnologist, would be to flee my native Chile and try my luck in a traditional excellence cluster. But that’s not what I want. I want Chile to be a cluster, too, with its own local problems, goals and priorities, and I want it tackling those problems through international interaction. Local development is, in my opinion, key to broadening the scope and impact of our technologies.

Instead of putting down people who stay in their home country (hopefully this issue is limited to Chile, where local talent used to fly under the radar unless it literally flew over our borders) and insisting everyone leave for big clusters, we should start pursuing excellence locally. Showcase local talent. Drive efforts towards local issues. This way we could finally form an international net of clusters, each one tackling their own problems, and collaborating to make “the bigger picture” better. Science can’t – and I think, shouldn’t – be confined to certain borders. Let’s be broader. Let’s move forward.

 

Emilia Díaz

 

Posted in Entrepreneurship, Ethical / Social, Regional Initiatives | Leave a reply

Ebola: No Overnight Magical Tricks

Posted on 15 Aug 2014 by Julia Fan Li
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hatThe world has its eyes on West Africa and the UN World Health Organization has declared the spread of the Ebola virus in West African states an international health emergency. The Ebola virus, a single-strand RNA filovirus and only 19 kilobase pairs long, has claimed 1,000+ lives in West Africa this year (out of about 2,000 cases). The virus causes fever, central nervous system damage and impaired blood clotting. The virus is highly contagious (through bodily fluids) and there is no known medical intervention approved for treatment other than rest and oral rehydration.

Due to the fact that outbreaks are rare (the virus was first discovered and classified in 1976 in the Democratic Republic of the Congo, formerly known as Zaire), unknown root causes, highly contagious and no medical treatment exists, the outbreaks elicit one predominant emotion: fear. Recommendations for caring for Ebola-stricken patients include isolation, protective gear for health workers and clean washing. However, in many resource-low settings, where medical personnel are scant and already stretched, frontline health workers in rural communities are not fully equipped to respond to the outbreak (they lack training, diagnostic equipment and protective gear).  

Global citizens are looking for public health leadership, from country Heads of State, from Centres of Disease Control, to the WHO and to biotechnology and pharmaceutical companies. Why are there no cures for this disease? Why do we not understand it? Given the speed of technological innovation and biomedical research, perhaps rightly, the public have begun to expect overnight medical cures to almost any ailment.

However, the R&D funding for neglected diseases of the poor is simply not there. There is a clear lack of economic incentives for innovation into a sporadic, rare disease that disproportionately affects rural populations in low-income countries in sub-Saharan Africa with weak healthcare systems. For example, out of 1,393 new chemical entities marketed between 1975 and 1999, only 16 (1.15%) were for neglected diseases. The statistics since the turn of the Millennium do not improve much. Eleven years after the Millennium Development Goals were established, out of the 850 new therapeutic products registered in 2000-2011, 37 (4%) were indicated for neglected diseases[1]. The Ebola virus is very much a neglected disease. With commercialization R&D projects in drugs and vaccines costing hundreds of millions of dollars to develop, the business model of biotech and pharma cannot embrace the long-term risk management and capital requirements of R&D into rare viruses. With end patients having little purchasing power to buy the developed therapeutics (resulting in limited commercial markets), many manufacturers give up the R&D game early.

Just because diseases of the poor are neglected commercially, it does not mean there are zero scientific leads. A number of life science companies have sprung into action this past week responding to the global call and urgent need to contain this outbreak. Political pressure backed by government funding and the return of a menacing disease have brought stakeholders back to research and development. These companies include:

  • GlaxoSmithKline: Acquired a preclinical candidate from its Okairos buyout last year that has shown early promise in animal models. It is now working with the NIH to accelerate it into Phase I trials in humans in 2015.
  • Johnson & Johnson’s Crucell Vaccine Unit: Also collaborating with NIH on a vaccine covering Ebola and Marburg to head into Phase I trials in 2015/2016.
  • Mapp Biopharmaceutical has supplied ZMapp, an experimental drug, to two Americans infected with Ebola who have been taken to Atlanta for treatment. The US Department of Defense plans to award a contract allowing Mapp to accelerate clinical work.
  • Vaxart, a California company, worked on Ebola and Marburg vaccines two years ago but ended its R&D work due to lack of funding and prioritization of other disease indications for its platform, including seasonal influenza.
  • Tekmira, a Canadian company, has seen its share price soar on the FDA decision to revise a hold on its experimental Ebola drug (to a partial hold) that started in human clinical testing in January. The hold is foucsed on safety criteria on dosing concerns.

The CEOs of these companies are aware that the public’s interest alone does not sustain a risky R&D critical path into a new vaccine or drug. CEOs also look to governments, WHO and Heads of State for global leadership in policy setting, in strengthening in health systems and investing in biomedical research in times of disease control and outbreak alike. CEOs of the company above will look to collaborate with government agencies and academic research institutions to share resources and progress clinical work faster than if left to their own internal company rankings based on net present value estimates.

To the public and taxpayers: There are no overnight magic tricks in drug discovery or vaccine commercialization.  Infectious diseases in our globalized world is everyone’s concern.  We should be mentally prepared to invest in R&D for the long-run and aim for our best response to each and every disease threat.

Julia Fan Li

[1] Pedrique, B., Strub-Wourgaft, N., Some, C., Olliaro, P., Trouiller, P., Ford, N., . . . Bradol, J. (2013). The drug and vaccine landscape for neglected diseases (2000-11): a systematic assessment. The Lancet Global Health, 1(6), 371-379.

Posted in Ethical / Social | Leave a reply

Failing To Control Earth’s CO2

Posted on 19 Mar 2014 by Luiz Antonio Barreto de Castro
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flood

The threat of rising ocean levels.

The whole world gathered in Copenhagen recently for the XV COP for Climatic Changes. On the agenda was how to cope with the rise in CO2 emissions, which, in addition to ocean acidification, could elevate the ocean level as much as 60 cm by the end of the century. This will jeopardize those living on islands and along shorelines – it’s estimated 100 million people may be menaced. In fact, humans are pumping 7 Gt of CO2 in the atmosphere yearly. The level of CO2 in the atmosphere today is around 370 ppm – according to specialists, it needs to remain below 420 ppm through the end of this century to keep global warming below 2oC. Most solutions to reduce this trend are not short-term ones. An integrated approach to carbon abatement in the automotive sector could reduce global passenger vehicle greenhouse emissions by 2.2 Gt by 2030, much of it using proven technologies. Sugarcane-based ethanol produced in Brazil on 8 million Ha can be substantially increased, but that must be done without harming the environment. The ethanol produced from 200 million tons of corn in the US will help reduce greenhouse emission by car. Together both countries supply today only a fraction of what will be needed to replace the automotive fossil fuel in years to come.

This means abatement will not come from first-generation biofuels alone, but from a combination of second generation biofuel, traffic flow shifts and a mix of several other technologies. Carbon capture and storage can handle a few million metric tons of CO2 /year, while 6 billion metric tons of coal are burned each year, producing 18 billion tons of CO2.

Brazil hopes to revert deforestation in the Amazon that in the last decades claimed an area larger than Germany, according to the National Institute of Air Space – INPE. To accomplish this, the National Plan of Climatic Changes in Brazil was presented in Copenhagen, and it included efforts to achieve reforestation by 2020. This is a costly and long-term effort.

But deforestation is not a problem of the tropical forest alone. The vegetation of other ecosystem have been drastically reduced. There is just 7% of the original vegetation of Mata Atlântica left. The “Cerrado” is being destroyed at a rate of 0.5% a year. Inadequate use of this biome, for ethanol production, for instance, could destroy the 17% remaining of the Cerrado.

So what can be done if the level of CO2 cannot be kept under control? Geo-engineering proposes simulated volcanic eruptions to reduce the planet temperature and the level of ocean rise, based upon observations made after Mount Pinatubo volcanic eruption in June 1991. The eruption injected 10 Tg S in the stratosphere which caused detectable short-term cooling of the planet. One simulated injection of SO2 as an aerosol precursor equivalent to the Mount Pinatubo eruption every two years would cool the planet and consequently keep the sea level rise below 20 cm for centuries ahead, although the (relatively less deadly) ocean acidification due to CO2  would persist.

I attended several discussions on this subject where most people accepted this fate, like lambs to the slaughterhouse. I proposed a strategy to desalinize sea water for irrigation or as a source of potable water where water is needed most: arid regions of developing countries. If the ocean level rises at a rate of 6 mm/year and since oceans occupy 360 x 106 million Km2, the amount of water to be desalinized is 2.16 x 1012 m3. Considering that there is at least 10% of arid regions in the planet, this amount of water corresponds to only 14 mm of rain falling in 15 million square km2.

So the amount of desalinized water from ocean rise alone may be insufficient to irrigate adequately large areas. Desalinized water could also be stored in reservoirs and underground aquifers. Potable water is scarce in many regions of the world, particularly in the Sub Sahara. Lack of good quality potable water threatens today the lives of 1.1 billion, according to UNEP worldwide, due to infections resulting from unclean drinking water. Throughout most of the world, the most common contamination of raw water sources is from human sewage and in particular human faecal pathogens and parasites. In 2006, waterborne diseases were estimated to cause 1.8 million deaths each year, while about 1.1 billion people lacked proper drinking water. Thus, it is clear that people in the developing world need to have access to good quality water in sufficient quantity, be able to purify water and distribute it.

Most desalination plants yield around 107  m3 of desalinized water annually, in recent years. Alternative technologies may be needed to allow for desalination of 2.16 x 1012 m3/year, the equivalent to 6mm of ocean rise/year. A project alone that desalinizes water from the Red Sea in Jordan has the capacity to produce 850 million m3 of desalinated water/year. That’s 10 times the yields of the recent past and the cost will be more than $10 billion but will benefit Israel, Jordan and the Palestinian Authority. Under the leadership of the Ministry of Water and Irrigation of Jordan, the project may need to gather funds of close to $40 billion for its complete implementation; this is achievable if additional bidders come aboard.

The project will stand as a symbol of peace and cooperation in the Middle East. One project alone yielding 8.5 times 10 to the eight means 10,000 projects of this magnitude are needed. Ted Levin from the Natural Resources Defense Council says that more than 12,000 desalination plants already supply fresh water in 120 nations, mostly in The Middle East and Caribbean. The market for desalination according to analysts will grow substantially over the next decades.

Luiz Antonio Barreto de Castro

 

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Aggregate value to Brazil’s agribusiness – or else

Posted on 20 Feb 2014 by Luiz Antonio Barreto de Castro
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Brazil needs to both increase crop yields and protect natural resources such as the Amazon.

A Science editorial quoted the Food and Agriculture Organization as saying that the challenge of “lifting a billion people out of poverty and feeding an extra 2.3 billion by 2050” will require “increasing cereal production by 70%, doubling the output of developing countries.”

Jeff Tollefson, in a Nature article titled “The Global Farm,” emphasized the growing role of Brazil in food production but questioned if Brazil can continue to make agricultural gains without destroying the Amazon. The Economist called attention to “The miracle of the cerrado” – acidic savannah soil conquered for agriculture in Brazil.

Indeed, if Brazil is to be a key player in feeding the world, then it must do so with the Amazon and the Cerrado carefully in mind. During the last two-and-a-half decades, Brazil has destroyed an area of the Amazon rainforest as big as Germany. The Cerrado we knew 50 years ago, when Brasilia became the capital of Brazil, has just 17% of its original vegetation left.

Can Brazil increase production and be a good shepherd to these areas? There are signs to suggest we can. Since the ’60s, Brazil has doubled its grain production every twenty years. This was done without substantially increasing land usage by implementing plant breeding – performed by a dozen good geneticists – and by putting in place seed and plant breeder’s laws. It was done because the largest six multinationals corporations have invested in Brazil: Dow, Dupont, Syngenta, BASF, Bayer and Monsanto. And it was done because the regulatory system, particularly the Biosafety and Cultivar laws in Brazil, facilitates the relationship between expert breeders for tropical plants and the corporations that have genes available. Thus, 30 million hectares of biotech soybean, corn and cotton are cultivated in Brazil – second globally to only the US. Can we double it once more in the next 20 years without destroying these precious biomes?

It will be difficult, but it is possible – Brazil has trained tens of thousands of students, in-house and abroad, and has already seen its world scientific output jump from 0.4% in the ’70s to a current level six times higher. This is faster growth than even our soccer, for which we are renowned – we won the World Cup five times, but it took us 55 years to do that. Applying our increased scientific capabilities in ag-biotechnology is our best hope to continue to increase output and protect our natural resources.

Our success raises an important question: Why isn’t similar innovation happening in Brazil’s pharmaceutical sector? The answer is partly because the large pharmaceutical corporations – Abbott, Pfizer, Merck, etc. – do not invest in Brazil. These firms claim that Brazilian patent law is restrictive, and that access to the huge biodiversity of Brazil is denied by the regulatory system in effect. Unless this regulatory system is modified to attract investments from abroad, innovation in the pharmaceutical biotechnology sector will have to wait.

Meanwhile, The Royal Institute – the only institute capable of performing animal preclinical trials in Brazil – was invaded by activists in October. Close to two hundred genetically selected beagles were stolen, and all the rodents. The activists damaged the insides enough that the Royal Institute was forced to close. Public authorities, well aware that it is impossible to develop drugs without preclinical tests in animals, have not pursued these criminals.

That’s not to say that Brazil has not made progress in the pharma realm.  In the past decade, it has invested heavily in “genericos” – copies of approved chemical drugs. Last year, this sector of the pharmaceutical industry grew 14%. But Brazil has never registered a molecule with the FDA or EMEA – quite the opposite: last year it imported $12 billion of biologicals to supply its SUS with drugs. These companies import active principles to fill, finish and sell.

The Brazilian-funded pharmaceutical sector is now investing in biosimilars: copies of biological molecules with expiring patents. This should be a large market – tens of billions of dollars – and of course will be on the agenda of Big Pharma. Can we compete here?

I doubt it. Our investment is very limited – our entire sector is worth less than 15% of Pfizer’s value. We also have to compete with South Korea, India and China, who are more experienced than we are at expressing genes in bacteria, yeast and mammalian cell lines, as many intend to do. Instead of lining up against these countries to compete with Big Pharma, we should aim to express genes in the milk of mammalian animals, such as rEVO Biologics is doing in Boston, or use plants as biofactories, like Medicago is doing in Canada, producing vaccines for H5N1 in six weeks using tobacco plants.

Brazil has to do better. We need to bring in value through our agribusiness and then apply it to pharmaceuticals. Brazil could be leader in the production of Heparin. Brazil could improve the meat of Nelore by marbling it.

The list goes on and on

Luiz Antonio Barreto de Castro

Posted in Ethical / Social, Regional Initiatives, Regulatory | Leave a reply

Standing Up for Preclinical Tests

Posted on 25 Oct 2013 by Luiz Antonio Barreto de Castro
Reply

busted glassOn September 20, Bruce Alberts and ten other eminent scientists published an editorial in Science, titled “Standing Up for GMOs” after a field trial of Golden Rice was destroyed by vandals at the Philippine Rice Research Institute August 8.

Rice is a major dietary staple for almost half of humanity, but common rice lacks Vitamin A. Ingo Potrikus and Peter Beyer developed by genetic engineering a rice variety with grains that accumulate beta carotene. It took them more than a decade to develop this strain, and a few ounces of this cooked rice provide enough beta carotene to eliminate the morbidity and mortality of Vitamin A deficiency that causes blindness in children and adults.

While this was accomplished scientifically more than a decade ago, Golden Rice is not yet available to resource-poor farmers. Getting it to them will take longer now, thanks to the vandalized field trial. It’s deplorable for those who disagree with technologies developed on top of sound science to simply take the law in their hands. Vandalism has happened elsewhere: in Brazil, the Instituto Royal in São Paulo was invaded, and close to 200 beagles intended for preclinical testing were stolen. Those preclinical tests are followed, of course, by several phases of clinical tests in humans, and all marketed drugs today had to go thru preclinical tests before approval. So the question is, Is the Instituto Royal performing pre-clinical tests with rodents and beagles somehow at the margin of Brazilian law?

Absolutely not. The Institute follows all the requirements of The National Council to Control The Experimentation with Animals (CONCEA), created by Law 11794 on October 8, 2008, satisfying Article 255 of the Brazilian constitution. The law requires any institution performing experiments for teaching or scientific purposes with animals must establish a CEUA (Ethical Commission for Animal Use), which includes a representative of the Animal Protection Society. Instituto Royal is the highest preclinical institution operating in Brazil over the past decade. Most drugs registered at The Agency for Health Vigilance (ANVISA , equivalent to US’s FDA) are the result of preclinical tests performed at the Institute.

At the Instituto Royal break in, laboratories containing no animals were entirely destroyed, costing millions of dollars in damage and negating more than a decade of scientific achievements. What will happen? Probably nothing. The highest executives in Brazil never touch these issues. And this is not the first time something like this has happened. Some years ago, the Biotechnology Institute of the Federal University of Rio Grande do Sul was broken into and vandalized. Nobody was arrested. GM experiments in Brazil are destroyed all the time and nothing happens.

The Brazilian Law for Animal Experimentation has a section analyzing ways to reduce the use of animals in preclinical tests, but so far, there are no drugs in the world market that skipped preclinical tests with animals. Instituto Royal was under scrutiny by the authorities, seeking to verify that no animals were being mistreated.  All evidence for that investigation has now been destroyed and the animals have disappeared.

Can Brazil pass better legislation? If possible, this is the way to go. Destroying law-abiding institutions is an activity that will lead us straight back to the dark ages.

Luiz Antonio Barreto de Castro

Posted in Ethical / Social, Regional Initiatives | Leave a reply

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