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13 responses to “GMOs and the thing I should have said (or, why not all scientific expertise is created equal)”

1. 

   Patrick S. O’Donnell

   May 12, 2015

   Informative and helpful material: thank you.
   For now, permit me to raise two topics deserving more attention from all parties concerned, topics more (but not only) about “the forest” than “the trees.” The first topic concerns the role of conglomerate agribusiness corporations, which have inordinate political, economic, and legal power in shaping both scientific research and the “context” of application (e.g., vertical and horizontal integration of the food supply into fewer and fewer conglomerates) referred to in your piece, power that contravenes our attempts to accord democratic norms a role in the scrutiny and accountability of scientific and technological practices. This is a classic political economy question that is relevant to virtually all facets of post-academic science, but perhaps most conspicuously and urgently, with regard to the “biotechnosciences,” genomics, regenerative medicine, and the neurosciences (Hilary Rose and Steven Rose). This topic was addressed in a preliminary fashion in two recent articles in the Monthly Review: Fred Magdoff’s “A Rational Agriculture Is Incompatible with Capitalism,” and Michael Friedman’s “GMOs: Capitalism’s Distortion of Biological Processes,” March 2015 (Volume 66, Number 10): http://aglaw.blogspot.com/2015/03/capitalist-agriculture-biotechnology.html
   The second topic is raised your citing the FDA’s “many steps involved in [its] testing protocols for new drugs,” as indicative or representative of “a cautious, scientifically based approach” in recommending “FDA oversight for testing of new GMOs.” But we should bear in mind that the FDA mode of scientific oversight and testing is fraught with chronic (if not perhaps insuperable) problems (given the current political climate and neo-liberal economic order), not the least of which might be the well-known phenomenon of “regulatory capture:” “Critics have disputed the claim that the Prescription Drug User Fee Amendment has improved the speed of drug approvals. Former Editor of The New England Journal of Medicine, Marcia Angell, has stated that ‘It’s time to take the Food and Drug Administration back from the drug companies…. In effect, the user fee act put the FDA on the payroll of the industry it regulates. Last year, the fees came to about $300 million, which the companies recoup many times over by getting their drugs to market faster.’” Or, in the words of Philip Mirowski: “Because of various neoliberal deregulation initiatives, converting government activities into proto-market fee-for-service, some 12-17 percent of the FDA budget was accounted for by fees paid by pharmaceutical firms to expedite the regulatory processes at the turn of the millennium.” The rise of the “contract research organization” (CROs) after 1980 (Big Pharma’s outsourcing of clinical trials for ‘increased efficiency’ and ‘cost-savings,’ code words for capitalist profit imperatives), is a variable that complicates matters and exacerbates problems yet further, bringing with it the dark side of what John Ziman memorably identified as “post-academic” science, here emblematic of the “privatization of science” (see Mirowski’s 2007 book, Science-Mart, especially pp. 223-255, for details). To some extent the FDA acknowledges its problems, but one wonders if it has the staff and resources, not to mention requisite agency will, needed to overcome its myriad chronic problems with the testing of both food (especially supplements) and drugs.
   Consider, for instance, a 2006 report by the Institute of Medicine, “The Future of Drug Safety: Promoting and Protecting the Health of the Public.” We learn, in summary:
   In its report, The Future of Drug Safety: Promoting and Protecting the Health of the Public, the committee considered the drug safety system as the sum of all activities conducted by FDA and other stakeholders to monitor, evaluate, improve, and ensure drug safety. Although much of the committee’s work was focused around the drug review, safety surveillance, and related activities of the Center for Drug Evaluation and Research (CDER), the committee also reviewed some key aspects of the roles and considered the potential contributions of the pharmaceutical industry, the academic research enterprise, Congress, the health care delivery system, patients and the public.
   During its research, the committee found that
   • There is a perception of crisis that has compromised the credibility of FDA and of the pharmaceutical industry.
   • Most stakeholders—the agency, the industry, consumer organizations, Congress, professional societies, health care entities—appear to agree on the need for certain improvements in the system.
   • The drug safety system is impaired by the following factors: serious resource constraints that weaken the quality and quantity of the science that is brought to bear on drug safety; an organizational culture in CDER that is not optimally functional; and unclear and insufficient regulatory authorities particularly with respect to enforcement.
   • FDA and the pharmaceutical industry do not consistently demonstrate accountability and transparency to the public by communicating safety concerns in a timely and effective fashion.
   Noting that resources and therefore efforts to monitor medications’ risk-benefit profiles taper off after approval, the committee that wrote the report offered a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used. Recommendations include:
   • Labeling requirements and advertising limits for new medication
   • Clarified authority and additional enforcement tools for the agency
   • Clarification of FDA’s role in gathering and communicating additional information on marketed products’ risks and benefits
   • Mandatory registration of clinical trial results to facilitate public access to drug safety information
   • An increased role for FDA’s drug safety staff
   • A large boost in funding and staffing for the agency
   Since this report, there does not appear to have been substantial improvement such that FDA’s testing of new drugs would inspire confidence. See, for example, this post at Health News Review: “JAMA papers raise questions about FDA drug and device approval,” http://www.healthnewsreview.org/2014/01/jama-papers-on-the-fda-drugs-and-devices/
   And this from Medscape Medical News: “Faster Drug Approvals Linked to Safety Issues”
   http://www.webmd.com/news/20140814/drug-approvals-safety-issues
   “In total, label changes for all black box warnings plus withdrawals came to 208 (27.8%). Half of the warnings were issued within 12 years of approval, and half of the withdrawals happened within 5 years of approval. The researchers found that drugs approved after enactment of PDUFA were more likely to be withdrawn or to receive a black box warning. The rate of warning or withdrawal climbed from 21.2 per 100 drugs before PDUFA to 26.7 per 100 afterward. ‘New drugs have a one-in-three chance of acquiring a new black-box warning or being withdrawn for safety reasons within twenty-five years of approval,’ the researchers conclude.”
   For these and other concerns, see here: http://en.wikipedia.org/wiki/Criticism_of_the_Food_and_Drug_Administration#Charges_of_under-regulation

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2. 

   Raistlin

   May 12, 2015

   I think you’re being a bit coarse grained here.
   Climate change isn’t in fact a single thing – one can study weather the climate is changing, in what direction, and to what degree relative to historical trends; wether that change if any is attributable to human action, and if so what kinds of human action; and if that change pose any threats to humans, and if so in what regard. Each of these sets of questions requires different sets of expertise.
   Thus, to discount the scientific consensus among geneticists because they don’t study the health effects of GMOs at the population level seems a bit gratuitous. Yes, having those studies would be nice and they should be done (and the experts engaged in this discussion), but foodstuffs danger to human health can be regularly traced back to some gene or genes in the relevant plant. So to say that geneticists, who are experts on what genes were inserted where and how, have a less relevant expertise, strikes me as unfair.
   If a gene from another crop, which has been found to confer heat/drought resistance to that crop, is inserted into another plant, in a way and in a region that geneticists don’t think will disrupt or significantly alter any of the plant’s native genes or their expression then I think that is very good evidence of the GMO’s health safety.
   Again, the epidemiological studies should be done, but to waffle on the safety of GMOs because they are not does seem mean choosing to err on the side of anti-science.
   I will note that I focused here on the health effects, I think concern over the environmental effects is a much more legitimate concern (though perhaps because I’m less familiar with the field?), which you do mention (alongside health concerns).

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3. 

   Roberta L. Millstein

   May 12, 2015

   Thanks for your comments (a blog post in themselves, as most of your comments to me seem to be). If things are not all they should be with respect to the testing of new drugs, they are that much less with respect to GMOs.

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4. 

   Roberta L. Millstein

   May 12, 2015

   Thanks for your comments.
   I think you’re splitting hairs a bit about expertise concerning climate change (I think that people are not so siloed as all that, even if they focus their own research on one area), but I’ll let others who know more about climate change speak to that.
   I think you’re attributing to geneticists a knowledge about how genes will interact in new contexts that we simply don’t have yet. Effects are unpredictable in a new context. As for “waffling,” all I am saying is that consumers should have the information they need to decide for themselves if they want to take the risk, since it is their risk. Again (as I say in the article), this is a matter of their values and not just a matter of expertise about predicted effects.
   You have focused on health effects, yes. But as I said in the article, it is the environmental effects that I think have demonstrated harms, and are thus arguably of greater concern.

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5. 

   Joe

   May 12, 2015

   It’s always nice to distinguish what people believe from why they believe it, and of course it’s reasonable to have concerns about bias and non-ideal epistemic positions on both sides of the issue. But to be fair, if a PhD-trained geneticist is at a slight epistemic disadvantage (that is, their ‘position’ is not ideal), this disadvantage is vastly disproportionate to the epistemic position of many high-profile anti-GMO lobbyists, plenty of whom have no scientific training whatsoever. A quick glance down the list of Board of Directors of the “Anti-GMO Project” turns up zero PhDs or MAs in science. Instead, most of them either (a) own “healthy” food chains, (b) have MBAs or (c) art degrees, or have just independently authored books on healthy living. By comparison to the people you’re saying are not “in a position to know”, these folks are light years away from that position.
   Moreover, we can’t lose sight of the fact that a huge amount of the social inertia behind that movement comes not from peer-reviewed studies, but from posts on sites with names like like http://www.i-heart-freethoughtevolution.net which are shared on social media and achieve an extraordinary degree of influence over popular opinion. It is true that opposition to GMOs is not necessarily anti-scientific, but this should not distract us from the fact that a huge amount of it actually is.

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6. 

   Roberta L. Millstein

   May 12, 2015

   I think I agree with almost everything you say here. But my case for concerns about GMOs doesn’t come from consensus from anti-GMO lobbyists, whose expertise I would never appeal to. More generally, although I think consensus-of-experts is important, it can’t be the whole thing, so even in the climate change case there have to be substantiated models and evidence as well as consensus (and I think there is). My point was just the smaller one that if we’re going to appeal to consensus-of-experts, let’s make sure they are experts in the question at hand.
   You’re right, some anti-GMO critics may be anti-science in some sense, although in truth I find the phrase “anti-science” vague and problematic. This is in part because of the reasons I give in the article (that for GMOs, science and values are very much connected, and so questions of GMOs are not just about science), and in part because it assumes a broad sweeping rejection of Science on the part of the critic that may not in fact be warranted. Perhaps it would be better to say that many anti-GMO critics say things that show that they are scientifically misinformed about the relevant science. And it would be better if GMO defenders would not say that all criticisms of GMOs are anti-science, which seems to imply that GMOs are immune from critique.

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7. 

   Patrick S. O’Donnell

   May 12, 2015

   Joe speaks of “high-profile anti-GMO lobbyists,” but whatever their apparent mass media profile, it is in no way commensurate with their political power, with few and fairly feeble exceptions (in this country at least), and is thus clearly far less than the corporate power and influence of high-profile scientists who lobby on behalf of GMOS, a finding not surprising given the power of money in contemporary politics. Moreover, one might have a look at the edited volume by Sheldon Krimsky and Jeremy Gruber (philosophy and law backgrounds): The GMO Deception (Skyhorse Publishing, 2014). Most of the articles are by those with PhDs in science, genetics, genomics or a closely related field (and some have backgrounds in law or philosophy, or combinations thereof), and the book does not at all have an “anti-science” tone (many of the pieces first appeared in GeneWatch, the magazine of the Council for Responsible [i.e., not ‘anti-‘] Genetics). It certainly cannot be said of the contributors that they “say things that show that they are scientifically misinformed about the relevant science.” I think it’s a oft-repeated (and untrue) canard (thus anecdotal) that “a huge amount of” opposition to GMOs is anti-science.

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8. 

   E

   May 12, 2015

   “I think you’re attributing to geneticists a knowledge about how genes will interact in new contexts that we simply don’t have yet. Effects are unpredictable in a new context.” If that were true, there wouldn’t be GMO’s to begin with.

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9. 

   Roberta L. Millstein

   May 12, 2015

   If scientists determine that a gene behaves in a certain way in a certain organism, they can try transferring that gene to a different organism. But there is no guarantee that it will express itself in the same way. If it does, then great, we might have a product (but we still have to check for other effects, since genes affect the expression of other genes). If it doesn’t, then no product, back to square one. But it’s the unknown side effects that I am really talking about.

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10. 

    E

    May 12, 2015

    There are unknown side effects of everything we do. To suggest that biologists (they are not as “siloed” either) haven’t made significant advances in understanding how genes interact, and what downstream effects they have, is not accurate. There are multiple lines of evidence that many genes are more localized and “modular” in their effects than one might have expected. Not least from all the scientific work that has gone into creating GMO’s. Also from the discovery of common genetic material occurring across distantly and very anciently related species (some of what excites the evo-devo movement). Also from the discovery of much more widespread lateral gene transfer across very distantly related species than was initially suspected. Maybe you think biologists still don’t have enough knowledge. But what’s supposed to count as enough here is a different matter.

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11. 

    Roberta L. Millstein

    May 12, 2015

    “Biology” is pretty broad; “biological sciences” is more accurate, and yes, it is my impression that the vast majority of geneticists are neither involved with studies of human health or environmental impacts. There is some degree of siloing.
    I’m not going to argue about whether most genes are modular or not because I don’t think that anyone knows the answer to that question. But the question at hand is whether the particular genes being transferred are modular or not in their new genetic context. And I don’t see how anyone could know the answer to that question ahead of time, at least not with our current state of knowledge.
    Also, the prevalence of lateral gene transfer (the extent of which is still also somewhat debated) says nothing about what happened after the transfer. An effect could be “fine” for the species but not be “fine” for the other species who eat it.

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12. 

    E

    May 12, 2015

    Perhaps my experience with the biological sciences is different and unrepresentative. While an undergraduate at Cornell University, working in a botany lab and on a biology major for a time, I witnessed a lot of collaboration among those who primarily work in genetics, those who primarily work in botany, those who primarily work in the agricultural sciences, etc. I certainly knew biological scientists working primarily in one field more knowledgeable about other biological fields than most philosophers of biology. For many that I knew, it would take a lot to convince me that most climate scientists are more knowledgeable about all the various issues involved there than these biological scientists were about the issues involved in GMO’s from genetics on up to the latest research of their effects on the ground. I guess I’m just arguing from personal experience here, but I don’t think the “siloing” is as complete as you suggest.
    Is there any evidence to think that the particular genes in GMO’s are likely to have more adverse effects than the multitudes of kinds that get transferred via non-human means throughout the world everyday? If you appeal to the idea that GMO’s come from very distantly related species, then you are simply ignoring the lines of evidence I mentioned rather than just refusing to engage on the issue of “modularity”. I agree that there is not certainty here. Perhaps we differ over precautionary principle sorts of stuff. I just want to be clear that there is a lot of evidence, of different kinds, available. There is a difference between claiming the kind of complete ignorance in a domain that you appear to claim there is and claiming that the available evidence is not quite sufficient for the kinds of decisions that are being made with it.
    And that evidence includes the after-effects of lateral gene transfer (you are right that the precise extent is debatable. That it far surpasses what anyone ever previously guessed is not). The route to its discovery was not via seeking explanation for otherwise inexplicable sickness or injury from organisms consuming it.

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13. 

    Roberta L. Millstein

    May 13, 2015

    Yes, it seems that you and I have had different experiences. I am always glad to hear about interdisciplinary work.
    It’s not just my imagination that there is a correlation between how distantly related the two species are and the likelihood of unintended effects. See here: http://www.nap.edu/openbook.php?record_id=10977&page=64 (I link to this in the article).
    I am not sure what sort of “complete ignorance” claim that you think I am making.

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