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Our Biofuture

Life Sciences musings

You’re Ruining It for the Rest of Us: Ecuador and Intellectual Property

It appears that the global club of those who do not adequately appreciate intellectual property (IP) has gotten a new member: Ecuador. In the past few years the IP environment inside that small South American nation has deteriorated quite significantly, especially with regard to the protection of pharmaceuticals and biologics. And as the situation continues to worsen, those of us around the world paying attention are probably all thinking the same thing: You’re ruining it for everyone else.

Indeed, Ecuador’s weakening life sciences IP situation is just one of a long line of countries doing so around the world, including Canada, India, Nigeria, the Philippines, and South Africa. Ecuador’s decision to weaken its environment for life sciences IP risks perpetuating this global contagion effect. For example, since 2010 the nation’s main IP agency (responsible for ensuring IP rights, including enforcement and promotion) the Ecuadorian Intellectual Property Institute, has granted nine compulsory licenses (CLs) with 12 applications still pending. Six of those nine CLs were issued in 2014 alone, including one for Pfizer’s kidney and gastrointestinal cancer medication, Sutent. According to the World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights

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Can Competition Hurt Innovation?

A new NBER paper, “Starving (or Fattening) the Golden Goose?: Generic Entry and the Incentives for Early -Stage Pharmaceutical Innovation” (summarized here), asks whether competition from generic drugs disincentivizes research. The authors, Branstetter, Chatterjee and Higgins, find that this does broadly seem to be the case: drug development activity decreases after generic drugs are introduced. This result highlights the important tradeoff between research and consumption. When consumers pay for drugs, intellectual property (IP) policies play a large role in determining how much of that cost goes toward future drug development.

Pharmaceutical markets are risky: drug development takes 12 years from initial pre-trial preparation to bringing a drug to market, and between the complexity of the human body and the extended regulatory approval process only a small proportion of drugs make it all the way to market. Of the ones that do, a small minority make up the large majority of profits.

This riskiness means that policies play a critical role in getting pharmaceutical markets to work correctly: if companies do not have incentives that outweigh the risks, they will not invest in researching new drugs and bringing them

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IPRs and Access to Medicines: New Evidence

Intellectual property rights (IPRs) attempt to balance static and dynamic efficiency. By allowing innovators to appropriate a greater share of the value generated from their ideas, IPRs can create incentives for investment in research and development (R&D). With regard to pharmaceuticals for developing countries, incentives for drug development are critical, since many diseases prevalent in developing countries lack appropriate treatments. However, those in the global health community often allege that prices of new innovative drugs under patent make them unaffordable to most people in developing countries because of the absence of generic competition.

Thus, understanding the effects of IPRs on access and affordability are important for researchers, policymakers, and firms. In December 2014, Margaret Kyle and Yi Qian published a new paper investigating this with the National Bureau of Economic Research. Titled Intellectual Property Rights and Access to Innovation: Evidence from TRIPS, the authors examine the effect of pharmaceutical patent protection on the speed of drug launch, price, and quantity in 60 countries from 2000-2013.

The paper begins by noting that though the introduction of IPRs is an endogenous decision taken by policy makers, developing countries were required by

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Brave New Potato

On Friday, 7 November, the US Department of Agriculture cleared the path to commercialization for a “genetically modified” potato developed by J.R. Simplott.

This is big. This is very big.

It’s big for a host of reasons, but at the top of the list is one: French fries. The United States alone produces some 20 million pounds of potatoes each year, two thirds of which wind up in frozen products. Most of those are French fries. The American consumer eats 120lb of potatoes per year, on average. Global potato production is ~73 billion pounds/year (365 million tons). That’s a lot of spuds.

It’s also big because this is not the first time a biotech improved potato has been developed by innovators. In 1995, Monsanto developed a potato resistant to the Colorado potato beetle, its main pest, and shortly thereafter added resistance to major viral diseases. Though hugely popular with growers, who loved that they didn’t have to spray heavy duty pesticides to kill the notoriously adaptable beetle, organic ideologues intimidated and bullied McDonald’s and their major French fry suppliers into dropping the product, and Monsanto shelved it. But Simplot (a

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Demons Haunt Los Angeles

In 1997, the late Carl Sagan published a book titled “The Demon-Haunted World: Science as a Candle in the Dark.” It is an eloquent paen to the power of science and critical thinking to free humans from the demons of darkness and superstition. In it, he described one of his greatest fears:

I have a foreboding of an America in my children’s or grandchildren’s time — when the United States is a service and information economy; when nearly all the manufacturing industries have slipped away to other countries; when awesome technological powers are in the hands of a very few, and no one representing the public interest can even grasp the issues… when, clutching our crystals and nervously consulting our horoscopes, our critical faculties in decline, unable to distinguish between what feels good and what’s true, we slide, almost without noticing, back into superstition and darkness…

That day may be upon us.

According to the Los Angeles Times, “The Los Angeles City Council voted in late October to draft an ordinance that would prohibit the sale or planting of GM seeds and plants.

One individual in Los Angeles who

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GMOs, Neonicotinoids, and Aldo Leopold’s Land Ethic: The Fish & Wildlife Service Brings a “Whole Foods” Approach to Wildlife While Shooting Itself in Our Foot

With little fanfare, last summer the U.S. Fish & Wildlife Service announced it would formally ban the use of seeds treated with neonicotinoid pesticides, (a newer, safer generation of seed treatments to protect against pests) and the use of crops improved through biotechnology throughout the fish and wildlife refuge system.

It is worth quoting at some length the announcement, which came via a memo from the Chief of the National Wildlife Refuge System:

The Leadership Team agreed that by January 2016, the System will only use an agricultural practice where it specifically contributes to wildlife objectives. This conforms to 601 FW 3, the Service’s Biological Integrity, Diversity and Environmental Health policy (BIDEH). BIDEH directs us to maintain and restore the biological integrity, diversity, and environmental health of refuges and is based on the underlying principle of wildlife conservation that favors management that restores or mimics natural ecosystem processes or functions to achieve refuge purpose(s).

By January 2016, we will no longer use neonicotinoid pesticides in agricultural practices used in the System. Service policy 569 FW 1 Pest Management directs that we use long-standing integrated pest management principles to guide and

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Maize

Points to Consider: Republication of Discredited and Retracted Paper on Rats, GMOs, and Cancer

“Original” Paper: “Republished Study: Long-term Toxicity of a Roundup Herbicide and a Roundup-tolerant Genetically Modified Maize,” by Gilles-Eric Séralini, et. al., June 24, 2014, Environmental Science Europe,

This is a re-framed re-publication of a paper first made public in 2012. That article was subsequently retracted by the journal publisher, followed by an explanatory note from the editor.

Primary Claims:

This paper recycles claims made in the original paper, specifically:

  • Glyphosate (Roundup) tolerant corn (maize) causes cancerous tumors in rats that consume it.
  • Glyphosate itself causes cancerous tumors in rats that consume it.

It adds some related claims as well:

  • That the retraction of the original paper was imposed even though the publisher admitted that “the data were not incorrect, that there was no misconduct, no fraud or intentional misinterpretation in our complete raw data…Our study was however never attended to be a carcinogenicity study”
  • The retraction of the original paper was unjustified, as “Censorship of research into health risks undermines the value and the credibility of science, thus we republish our paper.”
  • They also claim that the retraction illustrates “a historic example of conflicts of interest in
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glyphosate

Points To Consider: Unfounded Claims of Glyphosate Accumulation in Breast Milk

Original Sources:  Press Release: “Glyphosate Testing Full Report: Findings in American Mothers’ Breast Milk, Urine and Water,” Mom’s Across America; Article: “World’s Number 1 Herbicide Discovered in U.S. Mothers’ Breast Milk” by Zen Honeycutt and Henry Rowlands, Sustainable Pulse

Primary Claims:

  • “In the first ever testing on glyphosate herbicide in the breast milk of American women… found ‘high’ levels in 3 out of the 10 samples tested. The shocking results point to glyphosate levels building up in women’s bodies over a period of time, which has until now been refuted by both global regulatory authorities and the biotech industry.”
  • “The levels found in the breast milk testing of 76 ug/l to 166 ug/l are 760 to 1600 times higher than the European Drinking Water Directive allows for individual pesticides (Glyphosate is both a pesticide and herbicide). They are however less than the 700 ug/l maximum contaminant level (MCL) for glyphosate in the U.S., which was decided upon by the U.S. Environmental Protection Agency (EPA) based on the now seemingly false premise that glyphosate was not bio-accumulative.”

Salient Facts and Context:  

  • This “study” is not a
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Points to Consider: GM Crops Have Provided Global Environmental Benefits

Ideological opponents of innovations in agriculture are mounting a major campaign to denigrate and discredit crops improved through biotechnology. They face a tough challenge, as the economic and environmental benefits of such crops have, due to their undeniable virtues, been adopted by farmers around the world more rapidly than any other innovation in the history of agriculture. Opponents are often aided in their struggles by journalists who recycle their press releases rather than digging for the truth. We take a closer look at a recent example.

ORIGINAL ARTICLE: U.S. GMO Crops Show Mix of Benefits, Concerns – USDA Report, Reuters: http://www.reuters.com/article/2014/02/24/usda-gmo-report-idUSL1N0LT16M20140224

THE USDA REPORT: http://www.ers.usda.gov/publications/err-economic-research-report/err162.aspx#.Uwz0fPldWSo

PRIMARY CLAIM IN THE ORIGINAL ARTICLE:

  • “U.S. farmers are continuing to see an array of benefits, but the impacts on the environmental and on food production are mixed, and high farmer use of a popular herbicide on GMO crops is a cause for ongoing concern.”

SALIENT FACTS & CONTEXT:  

  • The reporter that wrote this piece, Cary Gilliam, has acquired a well-deserved reputation for finding the most negative way to convey even the most positive information about crops improved through biotechnology. This latest offering continues
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world

Points to Consider: The Worldwide Scientific Consensus on GMO Safety

Ideological opponents to crops improved through biotechnology work very hard to convince people of their alleged dangers. They are hampered in these efforts by the existence of a robust, worldwide consensus on the safety of these crops and the foods derived from them. They claim, therefore, that this consensus does not exist, and hold up a variety of alleged authorities who deny the consensus to argue that it doesn’t exist. We take a closer look.

ORIGINAL PAPER: European Network of Scientists for Social & Environmental Responsibility (ENSSER) Statement: No scientific consensus on GMO safety  

PRIMARY CLAIMS OF THE ORIGINAL PAPER:

  • There is no consensus among scientists on the safety of crops and foods improved through biotechnology.
  • The scientific studies claimed to show the safety of GMOs have been bought and paid for by industry.

SALIENT FACTS & CONTEXT:  

  • What does “consensus” mean? Per Miriam Webster Dictionary “the judgment arrived at by most of those concerned.”
  • There most definitely is a global scientific consensus on the safety of crops and foods derived through biotechnology on the market today. It is wide, deep, and extraordinarily strong.
  • This consensus follows from decades of
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