Life Sciences musings
By most accounts, patients in the United States and across the globe are in the midst of a new era of medical discovery, one in which new treatments and cures for costly diseases will become increasingly commonplace.
As ITIF noted in a recent report, our nation has benefited from public policies that support innovation and discovery, including strong intellectual property (IP) protections, limits on price controls for innovative medicines, data protections for biologic drugs, and strong government research and development expenditures on health care.
Unfortunately, these core fundamentals are being set aside by proponents of expanding “march-in” rights to address concerns about the price of drugs.
“March-in” rights were included as a privilege for the government under the Bayh-Dole Act, which was enacted with bipartisan support in 1980 to address intellectual property created (at least in part) from government-funded research. The law has played a significant role in driving impactful medical discovery and life-sciences innovation by allowing academic and other research institutions to patent inventions created by federally funded research and exclusively license them to industry for further development and commercialization. As The Economist has written about Bayh-Dole, it
The headlines are breathless: “Gene-edited CRISPR mushroom escapes US regulation: A fungus engineered with the CRISPR–Cas9 technique can be cultivated and sold without further oversight.” So Nature magazine announced a recent decision by the biotechnology products regulatory division of the U.S. Department of Agriculture. The herd followed suit.
Let us pray that it does not frighten the horses.
The Twitterverse predictably erupted with lamentations and alarums, predictions of doom, and condemnations of the “outdated” regulatory system under which this miscarriage was promulgated. The Washington Post declaimed, “A new fungus shows just how murky our understanding of the technology – and our policy surrounding it – remains.” The reporter may be confused, but neither our understanding of the technology nor the relevant policy is at all “murky.” The idea that an innovation solving a problem might not present sufficient hazard to justify a requirement for pre-market approval seems unimaginable to some. It is clearly time to revisit the raison d’etre of government regulation.
The entire point of regulation is to mitigate hazard and manage risk. The definition of risk is exposure to a hazard. If there is no hazard,
Over the last two decades we’ve witnessed something unprecedented and remarkable in agriculture. Scientists have learned how to improve seeds by harnessing techniques cribbed directly from Mother Nature herself, whom we have discovered to be unexpectedly wanton, promiscuous, and generous in her sharing of genes between the far flung branches of the tree of life.
Using methods of the same sort nature used to make a viral DNA sequence the most common gene in the human genome, researchers have learned how to armor plants to fend off insect pests without the use of pesticide sprays; how to make plants that allow farmers to manage weeds more easily; and how to improve the productivity, nutritional value, flavor, and safety of foods derived from plants or animals in myriad ways, while at the same time dramatically reducing their environmental impacts, particularly greenhouse gas emissions.
The result of this explosion of innovation has been that seeds improved with these techniques have been adopted by farmers at stunningly rapid, in fact unprecedented rates wherever farmers have been allowed to buy them. Starting from zero only 20 years ago, the growth in adoption of
On March 17, the Boulder County Commission directed county staff to map a plan to begin to “phase out” the use of genetically modified (GM) crops on county open space land. This land has been acquired from farmers to preserve and sustain agriculture in the county and leased back to local family farmers. The criteria governing the management of these lands are public, and most reasonable people would find little in them with which to disagree. The guidance from the present commissioners to move towards eliminating GM crops was not part of the enticement previously used to encourage farmers to cooperate with the county in preserving Boulder’s diminishing open space.
The organic industry would like this to be seen as a trend, part of a burgeoning demand for organic food. But according to the Boulder Daily Camera, and in spite of increased organic sales, U.S. Department of Agriculture data show that “organic acreage declined nationally by 10.8 percent from 2008 (4.1 million acres) to 2014 (3.7 million acres). Colorado saw larger declines of 34 percent during that same time, from 153,981 acres in 2008 to 115,116 acres in 2014….
The Economic Research Service of the U.S. Department of Agriculture has just released a report titled “Economic Issues in the Coexistence of Organic, Genetically Engineered (GE), and Non-GE Crops.” It estimates the costs to producers of delivering harvests using organic methods versus “genetically engineered” (GE) seeds versus non-GE seeds, and it concludes that “In 2014, 1 percent of all U.S. certified organic farmers in 20 States reported that they experienced economic losses (amounting to $6.1 million, excluding expenses for preventative measures and testing) due to GE commingling during 2011-2014.”
To put these numbers in perspective, in 2012, organic crops were grown on 5.4 million acres, nearly 1.4 percent of the total U.S. crop area of 390 million acres. Despite “organic corn and soybean prices that are generally two to three times higher than conventional crop prices,” they accounted for less than half of 1 percent (366,000/390M) of total crop area. The total value of US agricultural production in 2012 was “nearly $395 billion.” In other words, though the injury to the farmers affected was no doubt significant, in the overall picture it falls several orders of magnitude below
Zika, a formerly unremarkable virus named for the forest in Uganda where it was discovered in 1947, is now the latest emergent disease to spawn serious concerns around the world. It is spread by a familiar mosquito, Aedes aegypti, and probably by the closely related Aedes albopictus, vectors notorious for spreading yellow fever, dengue, and chikungunya. Until recently, Zika had been reported at low frequency in various tropical locations, but since 2014, for reasons not fully understood, it has spread explosively throughout much of South America, especially Brasil. One key to its rapid spread has been the distribution of the mosquito vector, which has rebounded after robust and effective control measures were allowed to lapse throughout the Americas after their success in reducing the prevalence of yellow fever.
The mild fever that usually results from infection with the Zika virus is not the source of concern. The alarm associated with Zika follows the suspicion that infection during pregnancy causes mothers to deliver babies with microcephaly, a type of abnormal brain development marked by irreparable neurological defects with profound, lifelong implications. Even though the cause has not been determined
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