By Phil Bereano

from GeneWatch 28-2 | June-Sept 2015


Book Review: "Altered Genes, Twisted Truth," by Steven M. Druker. (Clear River Press)


In the months since its publication earlier this year, Steven Druker's book has been widely circulated among GE campaigners and has been the subject of many internet comments. It contains a wealth of valuable information, some interesting analyses, and many strongly-worded charges against the US government. Indeed, its popularity probably bears some relationship to its unabashed claims that US agencies (particularly the FDA) have acted "illegally," have committed "fraud," and have broken the law in numerous ways. As a result, in Druker's shotgun spray of loaded words, government has been "corrupted," science is "subverted," the public "systematically deceived," environmental protection has been "eroded," American media has "malfunctioned," and scientists have become "spin doctors." This colorful aspect of the book undoubtedly contributes to its apparent popularity.

As readers of GeneWatch may already know, the US is alone among major countries in not adopting special legislation to regulate biotechnology. Instead, the anti-regulation, pro-corporate Reagan administration announced a "Co-ordinated Framework" based on existing legislation [51 FR 23302, June 26, 1986]. Although the existing laws do not really cover many of the actual GE commercial activities which have developed, this approach sidestepped any Congressional hearings and any attendant news articles which might have given publicity to the problematic aspects of GE technologies.

The Framework rested on three tenets: (1) U.S. policy would focus on the products of genetic engineering techniques, and not the process itself, (2) any regulations must be grounded in verifiable scientific risks, and (3) GE products are merely on a continuum with existing products and, therefore, existing statutes provide sufficient bases for reviewing these products.

Druker played an important role in the early days of opposition to genetic engineering policies adopted by the US government. His organization was a principal plaintiff in the first lawsuit, brought by the Center for Food Safety, challenging the FDA's implementation of this policy. The FDA approach, "non-regulation," was based on the notion that a GE variety of a food crop was "substantially equivalent" to the unmodified variety. Hence it would be deemed "generally recognized as safe - GRAS" and not regulated. The companies could voluntarily consult with FDA and were obligated to inform the agency if there were new problems arising (eg, allergenicity); this procedure is a bit of a farce since the FDA response to any company submission on a new GE variety clearly states that it is accepting the company's claims; and if there were serious health risks no company would choose to proceed with developing the food. The FDA also turns a blind eye to the fact that the companies also go to the Patent Office and argue the complete contrary: that the GE varieties were totally new and unlike anything which existed before.

Although the lawsuit was not successful,[1] during the discovery phase leading into the litigation, documents were received from the FDA files indicating that many of its senior scientists strenuously objected to the agency's approach declining to exercise any real regulatory oversight. [2] This revelation has been of significant importance in subsequent citizen oppositional activity.

Druker has written an important book which does three main things: (1) provide an interesting history of the early evolution of concerns about GE technology (when it was still a series of laboratory science experiments); (2) compare its evolution with that of the computer; (3) and make charges of official illegality. While the first two subject areas are not particularly noteworthy (interestingly, Druker fails to mention the Council for Responsible Genetics, the world's first NGO to oppose genetic engineering, in his history), this review will concentrate on Druker's legal analysis.

First, some context, if you will allow this lawyer to indulge: What exactly is "the law" and hence what does "illegal" mean? There are a number of approaches to this question; although an exploration seems highly philosophical, it is actually highly practical and evidenced in many Supreme Court decisions and dissents.

This book seems to me to be based on a "natural law" jurisprudential approach, sometimes defined as a belief that the "law" (rights or values) can be found in human reason or human nature. This is an ancient view, reflected in writings of Aquinas, Hobbes, and Locke, among others. Indeed, the first sentence of the Declaration of Independence refers to the "laws of Nature and Nature's God." And the second reads in full "We hold these truths to be self-evident, that all men are created equal, that they are endowed by their Creator with certain unalienable Rights, that among these are Life, Liberty and the pursuit of Happiness." Druker's frequent claims of governmental "illegality" thus appear to me to rest on this sort of an idealized notion of what the law "is" or should be.

Although it may be just coincidence, at the time of the Bio-Integrity lawsuit, Druker was active in a "Natural Law Party" which was associated with the Maharishi International University and advocated the practice of Transcendental Meditation; it ran a presidential candidate in three elections before largely dissolving in 2004. The NLP was concerned about the reckless growth of genetic engineering; over the years, NLP activists have supported lectures and interviews by NLP authors in many parts of the world and this network has assisted in the spread of their ideas. This seems to be the case with Altered Genes.

A very different notion from natural law is, as I was told in law school, that "the law is what the sovereign says it is." This is called the "positive law" approach and defined in Black's Law Dictionary as "law actually and specifically enacted or adopted by proper authority for the government of an organized jural society." A statute and usually an agency's regulations issued pursuant to statute are examples of this. In one formulation, extreme but often accurate, responding to the conundrum of what is really the basis for a court decision, Judge Jerome Frank is said to have remarked that it "depended on what the judge had eaten for breakfast." In other words, "the law" consists only of real-world outcomes.

The real world, however, is usually not so clear-cut about jurisprudential philosophies. In truth, we all may hold a bit of each of the different approaches. For example, Justice Scalia argues that there was no idea of gay marriage when the 14th Amendment was enacted (a positive law position), but somehow found that corporations were intended to have free speech rights as well as economic ones (in his own private natural law universe).[3] And the struggle underlying many great dramatic trials of the ages (e.g. Galileo charged by the Church for blasphemy in claiming that the earth orbits the sun), is the clash between what the powerful announce as "the law" and what conscience (or telescopic observation) suggest.

This book's major contribution is dealing with this rarified intellectual space in a very down-to-earth way. However, anyone appreciating any validity of a positive law orientation will be continually irked by Druker's frequently repeated charges that the FDA acted "illegally," that its policies are "illegal," and numerous pejorative variations on this theme. Chapter 5, on the Federal framework and the lawsuit against the FDA, is chock full of them.

Under either theory of the law, but especially under positive law notions, conduct which is verboten should be clearly delimited. In other words, before something can be called "illegal," there should be a clear boundary which has been crossed; then the perpetrator is said to have the necessary mens rea (bad intentions), such as is required for criminal prosecution. For certain bad actions, however, there is particular intentionality required. For "fraud," which Druker frequently charges, intentional and knowing deceit is required. Druker gives no evidence whatsoever of the existence of such state of mind on behalf of any FDA official. Thus, while strenuously opposing what the FDA has done, I am not comfortable with labeling its actions "illegal," which suggests to most lay readers that criminal conduct has occurred.

As a civil libertarian, I am constantly fighting to embody abstract natural law ideals in hard positive law. But I recognize the Federal Framework and the FDA's use of the cockamamie concept of "substantial equivalence" to be bad policy choices, adopted under the pressure of powerful economic and political interests; a bad or wrong exercise of power, but not an "illegal" one.

Druker's book tells us a lot about "what" happened, but it is limited by not sufficiently exploring the "why." Although he touches very lightly on aspects of the sociology of science to probe the spectacle of "rational" scientists uttering so much nonsense, he does not use the insights of that discipline sufficiently. And he does not do much at all to systematically analyze the factors leading to the US government acting "illegally."[4]

Altered Genes, Twisted Truth contains a great deal of information for the interested citizen/activist and seems to be reaching such an audience. I just hope readers testifying at the next legislative hearing on GE don't insist that the Feds are acting illegally in not regulating the technology. The FDA is attacked as being rogue on many fronts - supporting vaccines, advocating water fluoridation, and the like. I have been squeamish, however, when my work is lumped together with the claims of illegal action made by anti-vaxxers.


Phil Bereano, JD, was a co-founder of the Council for Responsible Genetics and AGRA Watch. He participated in the negotiations of the Cartagena Biosafety Protocol, its Supplemental Protocol on Liability and Redress, and meetings of the UN's Codex Alimentarius dealing with GE food issues, such as labeling.




1 Alliance for bio-Integrity v. Shalala, 116 F.Supp 2d 166 (D.D.C. 2000)

2 For example, Linda Kahl, Ph.D., an FDA compliance officer, wrote in a January 1992 memo "Are we asking the scientific experts to generate the basis for this policy statement in the absence of any data?" . . . . There is no data that could quantify risk."

3 For example, in June's Marriage Equality decision of the Supreme Court, Justice Kennedy's majority opinion is replete with natural law elements, focusing on the abstract concept of human "dignity" and the evolving meaning of the Constitution's "equal protection" and "due process" phrases; more than one of the dissents is based on positivism-- the fact that the authors of those phrases in the 14th Amendment meant Black people, not gay ones.

4 The ideology supporting the biotech industry has not been limited to the Reagan era. E.g, the Clinton Administration issued a White Paper setting forth an elaborate (but really simplistic story of American progress being based on a succession of technologies-the canals, railroads, telegraph, electrification, automobiles, aviation, TV, computers-claiming that genetic engineering was the next technical wonder to propel us to endless prosperity. Thus the industry could not be sent any "negative signals" (eg, labeling GE foods). The US government has continued to advance corporate interests through all administrations, by initiating a WTO challenge against the EU's regulations, and by pressuring other countries, particularly in the Third World, to rely on the technology, as in Obama's "New Alliance for Food Security and Nutrition in Africa"

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