Life Sciences musings
On Thursday, July 23, the “DARK” side took a hit. By a vote of 275 to 150, the House of Representatives passed H.R. 1599, the Safe and Accurate Food Labeling Act (introduced by Rep. Mike Pompeo), aimed at preempting state-level mandates for discriminatory, skull and crossbones labels on foods derived from crops improved through biotechnology, or “GMOs.”
Opponents of the bill, legions whipped into fearful frenzy by pro-labeling forces, mounted a full scale assault in an attempt to derail the bill, dubbing it the “DARK” (“Denying Americans the Right to Know”) Act, casting it falsely as a revived “Monsanto Protection Act,” and claiming it was aimed at denying consumers access to information. Those, and their other arguments, are both wrong and unpersuasive, which is why their efforts have increasingly failed to bear fruit. With House passage of the bill, the consistent thread of bipartisan support for agricultural biotechnology and science-based innovation we’ve seen in Congress since the end of World War II continues unbroken.
The bill represents real progress. Those who have tried to use fear and deception to advance a dogmatic world view, built
The title of William Saletan’s July 15 j’accuse in Slate, “Unhealthy Fixation” is spot on, but the subtitle really nails it: “The war against genetically modified organisms is full of fearmongering, errors, and fraud. Labeling them will not make you safer.” Longer than most blog posts, it’s well worth reading, as it lays out in meticulous and measured prose, with abundant citations, the panoply of shifting arguments and reversals that demonstrate to all who have eyes to see the intellectual and moral bankruptcy of the campaign spearheaded by Greenpeace against recombinant DNA techniques applied to improving agriculture. He does, however, elide the difficulty of overcoming this populist fear mongering.
Over the past couple of years we’ve seen something new: cautiously, and one at a time, courageous journalists have followed the data, interrogated their presuppositions, and begun to pull back the many layers of curtains to illuminate the true intentions driving the global campaign against modern innovations in agriculture, aka “GMOs.” Keith Kloor was among the first I noticed, with his column, also in Slate, noting the intellectual incoherence of those who accept the global scientific consensus on
There have been calls recently from predictable sources demanding “tougher regulations for genetically engineered (GE) crops under the federal Plant Protection Act.” They further “demanded [the U.S. Department of Agriculture (USDA)] regulate GE crops based on the process, not product….” While these demands may make headlines, we should be asking: Do they make any sense? Has something happened lately to increase the need for such regulation? What level of scrutiny is focused today on foods and crops that have been improved through biotechnology? How does this compare with the scrutiny leveled at other types of foods and crops?
Even the briefest glance suggests these alarums are unwarranted. Crops and foods improved through biotechnology are already subjected to more scrutiny, in advance, in depth and detail, than any other crops or foods in the history of humanity. This is not a matter of opinion. The USDA has been regulating these products since 1987. In the 28 years since, there has not been a single case of a negative health consequence to humans, livestock, companion animals, or the environment. Die-hard opponents of crop biotechnology have put forward one claim after another of
A near kin to the GMO controversies that ITIF deconstructed earlier this year in a comprehensive guide for policymakers is the drumbeat of often specious criticism directed at some of the other essential inputs for innovative, commercial-scale agriculture. The latest case in point was an announcement last week from the International Agency for Research on Cancer (IARC) that one of the world’s most widely used weed killers, this time 2,4-D, is “possibly carcinogenic.” Following on the heels of a similar, highly suspect and widely criticized claim regarding glyphosate a few months ago, one would be justified in asking the question: Does the evidence really indicate 2,4-D, widely used for seven decades, has been causing cancer in humans, and requires we change the way we handle it? In fact, no, it doesn’t. Let’s take a closer look.
The announcement from IARC comes in the form of a brief report of barely 1,000 words, of which one-third (about one page of text) is devoted to 2,4-D. The details of the evidence considered and the reasoning applied are largely relegated to the monograph that will follow, after the indefensible headlines are in the
Chipotle precipitated a media flurry with their recent announcement that they will henceforth “cook only with non-GMO ingredients.” They go on to say “A GMO is created by inserting genes from one species (typically bacteria or a virus) into the DNA of another. This can result in a plant with characteristics that wouldn’t occur naturally, such as producing pesticides or the ability to withstand high doses of chemical herbicides.”
Is Chipotle’s menu now free of “GMO ingredients?” Even if we accept their indefensible definition of GMO (see below), the answer is no. Consider cheese, a significant player on the Chipotle menu. The vast majority of cheese (80-90%) produced in the US is manufactured with fermentation produced chymosin (FPC) derived from genetically engineered bacteria. The FPC remains in the finished product, invalidating even the Jesuitical distinction between “containing” and “made with.” Also consider their soft drinks. Most of them contain high fructose corn syrup derived
This article was originally published in The Huffington Post. It is co-authored by Val Giddings and Jon Entine
Recently on the Huffington Post we came across a disturbing article – an attack by Jeffrey Smith on two respected university professors who apply a critical eye to the claims made by various advocates alleging dangers to human health linked to genetically modified organisms (GMOs.)
Smith, if you are not familiar with him, heads up a one-man band rabidly anti-GMO organization known as the Institute for Responsible Technology–he and his organization are controversial to say the least, but more on that later.
The subject of the attack piece was co-written by University of Illinois emeritus professor Bruce Chassy and University of Melbourne geneticist David Tribe. It appears on the website of AcademicsReview, an independent non-profit set up by the scholars to address the maelstrom of misinformation that passes for debate on the GMO issue. In one of their most pointed and heavily circulated critiques, Chassy and Tribe examine one of Smith’s two self-published books that supposedly ‘prove’ that GMO foods are reckless and dangerous.
Chassy and Tribe’s critique titled “Yogic Flying
Today, the International Agency for Research on Cancer (IARC) has departed from the scientific consensus to declare glyphosate, the active ingredient in Roundup®, to be a class 2A “probable human carcinogen”. This contradicts a strong and long standing consensus supported by a vast array of data and real world experience, and comes from an organization that rarely addresses potential pesticide carcinogenicity, perhaps because the real concerns in this area are minimal, and lie elsewhere. The IARC statement is not the result of a thorough, considered and critical review of all the relevant data. It is beyond the pale.
A vast body of relevant information, including dozens of detailed genotoxicity, studies, animal bioassays, peer-reviewed publications and regulatory assessments, that show no evidence of carcinogenicity, and confirm its safety were presented to the IARC, but seem to have been ignored. On the other hand, witnesses report one paper so severely criticized and discredited that it was condemned by the scientific community and withdrawn by the publisher was actually taken on board by IARC.
That the IARC seems to have even considered such a fatally flawed and withdrawn paper
Anti-GMO advocates assert that they are winning in their campaign to free the world of GMOs by pointing to the passage of labeling laws in a scant handful of states. To listen to them, it is only a matter of time before labeling is required everywhere, and from there it is a short step to the “market” demanding non-GMO food. Now that the dust has settled from all the activity of 2014, it is time to take stock and see where things stand.
Proponents did manage to get a law passed in Vermont in 2014. But if that was a “victory” it was Pyrrhic. As predicted, it was immediately challenged in court (by food companies, not, as opponents claim, by Monsanto), where it is likely doomed on multiple grounds. Earlier passage of similar bills in Connecticut and Maine require a trigger before they would come into effect, and that trigger—in essence, requiring New York to pass a mandatory labeling requirement—is unlikely to be met. Campaigns mounted in more than 30 states have been conspicuous by their (costly) failures, including expensive battles over the past decade in states like California,
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
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