American Inquisition: The FDA's Persecution of Wilhelm Reich
The government's power to pass judgement on scientific investigations creates a gaping loophole in the First Amendment
Wilhelm Reich, born to an Austrian family in 1897, was trained as a doctor at the Vienna School of Medicine, the home of the early psychoanalytic school in Vienna. Though at first closely associated with Freud at Vienna's psychoanalytic polyclinic, Reich soon developed strong opposition to some of Freud's theories, resulting in his expulsion from the psychoanalytic community in 1934. He left Austria for Berlin but only two years later fled Germany for Scandinavia. In 1939, closely followed by Hitler's armies, he moved on to the United States.
In America, Reich began a series of experiments that convinced him that the universe is suffused with subatomic primordial energy, the sustaining force of all living phenomena. He called this life force orgone energy. Neurosis and physical disease, he maintained, arise from physiological blocking of its release in the living organism. Removal of these somatic blocks would not only rid the world of biopathies such as cancer but would remove sociological malfunctions such as authoritarianism and totalitarian governments. In place of fascist social structures, Reich advocated a pacifistic anarchic society he called work democracy. His motto was: "Work and love are the wellsprings of life. They should also govern it."
Reich established a research laboratory at Rangeley, Maine, where a number of physicians and medical doctors in the Boston area joined in his investigations. He constructed metal-lined boxes—"orgone energy accumulators"—which he claimed collected omnipresent energy for use in therapy. Patients were to sit in these boxes to receive the benefits of the accumulated energy. In published articles Reich claimed successful treatment of cancer, leukemia, and other diseases. As word of the "orgone boxes" spread, Reich's institute began sending accumulators to interested persons throughout the United States and the world.
FOOD AND DRUG WATCHDOG
Enter now the Food and Drug Administration. These accumulators, the FDA maintained, were misbranded and adulterated within the meaning of the Food and Drug Act—misbranded because their accompanying literature made claims of curative powers that were patently false; adulterated because their curative powers, if any, were manifestly below those claimed. On February 10, 1954, the FDA filed an action on libel of information, pursuant to US Code Title 21, Section 332(a), seeking an injunction against further introduction into interstate commerce or misbranding of orgone energy accumulators.
Reich declined to enter an answer or make an appearance in that action, which named him, certain codefendants, and persons acting in concert with them. He wrote to the presiding judge of the district court:
My factual position in the case as well as the world of science of today does not permit me to enter the case against the Food and Drug Administration, since such action would, in my mind, imply admission of the authority of this special branch of the government to pass judgment on primordial, preatomic cosmic orgone energy.
On motion of the government, defaults and a decree of injunction were entered. The defendants were perpetually enjoined and restrained from committing the practices set forth in the complaint; furthermore, all orgone energy accumulators were ordered recalled to the defendants' place of business in Rangeley, Maine, and there either destroyed or dismantled under the supervision of the Food and Drug Administration.
Additionally, in the words of the First Circuit Court on review of the lower court decision, "certain listed descriptive literature pertaining thereof were ordered destroyed." The "certain listed descriptive literature" included all of Reich's published books, which were ordered withdrawn from the market and prohibited from further sale.
BOOK BURNING OLD AND NEW
Reich ignored the court injunction. Brought before the court on civil and criminal contempt in May 1956, he was found guilty by a jury of violating the court's prior order and sentenced to two years in prison.
He appealed the decision, arguing that he was "engaged in basic scientific research which no agency of the Government had jurisdiction to interfere with or control." The court replied that refutation of this contention
is obvious from its mere statement. Of course, the United States Government has power to forbid and power to take appropriate steps to prevent the transportation in interstate commerce of devices of alleged therapeutic value if they are adulterated or misbranded.
Reich's books were withdrawn from circulation and his magazine and orgone energy accumulators seized and burnt in the presence of FDA representatives. In November 1957, after eight months of imprisonment, Reich died in Lewisburg Penitentiary.
In 1633 a predecessor of Reich's, a fellow speculator, found himself for the second time called upon to justify his advocacy of heresy. A victim of subtle psychological oppression by the Grand Inquisitors, Galileo Galilei can hardly be faulted for his final disavowal of the heliocentric hypothesis. But public renunciation of the theory was not enough for the Grand Inquisitors. They also ordered that Galileo be placed in the physical custody of the Holy See until further order of the pope and that all his published works be burned and never again printed.
The trials of Galileo and, earlier, of Socrates are among the chief examples of human narrow-mindedness and public oppression. Socrates was condemned for his political free-thinking; Galileo, for his challenge to the prevailing theology. From examples such as these, the societies of the West have learned an axiom of civilized life: the right of the individual to advance and teach ideas, without fear of official repression.
The FDA officials who presided over the burning of Wilhelm Reich's works no doubt were secure in the belief that their acts were in the furtherance of the public interest. Yet, overriding our transient and impermanent conceptions of the public good stands the enduring command of the First Amendment: "Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press.…" Is the advocacy of scientific theory any different from the assertion of religious or philosophic views? Can we facilely assume that the First Amendment has no relevance to the case of Wilhelm Reich?
TELLING THE TRUTH
The powers of the Food and Drug Administration over scientific investigation are substantial. Under the US Code, it can institute proceedings to condemn any "misbranded" drug or device. Devices may be ordered "detained" without prior court order for a period not to exceed 30 days. Apart from this summary procedure, the FDA can proceed by a libel of information in the federal district court to condemn any misbranded drug or device.
A drug or device is deemed "misbranded" if its "labeling is false or misleading in any particular." Thus, the FDA is directly responsible for determining the truth of representations in any packaging or any literature accompanying or explaining the device's use. Literature has been condemned as misbranded labeling even though sent by separate cover to persons ordering the devices, under the theory that any printed material intended to be distributed in relation to the misbranded device "accompanies" the device and is "labeling" within the meaning of the Food and Drug Act.
Finally, while the power of the FDA to review and require proof of safety and effectiveness formerly extended only to drugs, under the Medical Device Act of 1976, the agency is empowered to require all new medical devices to be submitted for testing and approval before being marketed. Without resort even to court hearing, the FDA can by regulation ban any device intended for human use if it determines that the device presents "substantial risk of deception or an unreasonable and substantial risk of illness or injury" not curable by alteration of the device's labeling. Such bans are subject only to a "substantial evidence" review by the circuit courts, which as a practical matter means that all but the most outrageously wrong determinations by the agency will be upheld in the courts.
As the case of Wilhelm Reich demonstrates, the FDA's mandate makes it the arbitrator of the soundness of scientific theories. It is required to judge the effectiveness of devices based upon such theories and, more directly, the truth of scientific literature related to such devices. If an FPA (Federal Publications Administration) were set up and authorized to review all newspapers and printed matter prior to publication to ensure that none of their contents were "false in any particular" and to condemn through libel of information any false printed matter placed in interstate commerce, I do not think the cry of censorship and infringement of First Amendment rights would go unnoticed. On what grounds, then, can we permit, consistent with the First Amendment's overriding principle, this treatment of scientific thought?
FIRST AMENDMENT SCIENCE
It is often argued that the speech protected by the First Amendment is political speech. Yet there is a direct and evident relationship between scientific and political speech. Political points of view often rest on factual propositions that look to science for their support. Moreover, scientific theories often carry very specific political implications.
This is well illustrated, for example, by the Soviet Union's former official boosting of the Lamarckian theory of evolution and disavowal of the Darwinian theory. Soviet leaders recognized that it was only a short set of deductions from the theory of natural selection to Herbert Spencer's social Darwinism.
The example of Wilhelm Reich furnishes further evidence. Reich believed that his theory of orgone energy had major political, sociological, and philosophical ramifications. Indeed, a good deal of his writings were directed toward these very subjects—and were destroyed by the FDA in their action against his devices.
In addition to political speech, artistic self-expression falls within the purview of the First Amendment. But here again scientific speech is related. Many works of literature are the result of the artist's reaction to some new and unsettling scientific discovery—for example, many of Milton's poems, in reaction to the Copernican hypothesis; or the late-19th-century English poets, Arnold and Tennyson, in reaction to the Darwinian theory. Lawrence Durrell maintains that his famous Alexandria Quartet is an attempt to apply Einstein's theory of relativity to the composition of a novel. The Italian author Italo Calvino has written a series of short stories, titled Zero, whose metaphors are lifted directly from scientific literature.
Scientific thought is, therefore, often the basis and foundation of speech that is unquestionably subject to the First Amendment. Shouldn't it, no less than political or artistic expression, be deemed to fall within the protections of the First Amendment?
Granting that scientific speech ought at least presumptively to be protected, argument can still be made that this presumption should fall away in the face of other considerations. One plausible argument is that the First Amendment was never intended to protect demonstrable falsehood, and since the Food and Drug Act purports only to restrict dissemination of false or misleading statements, there can be no constitutional objection. Another is that scientific propositions, unlike religious or philosophic statements, are subject to objective confirmation or disconfirmation, and because there can be no objection to suppressing demonstrably false statements, it is constitutionally permissible to restrict dissemination of demonstrably false scientific statements. But neither of these arguments manages to undercut the First Amendment with respect to scientific work.
The argument that the First Amendment was never intended to protect falsehood simply errs in its interpretation of the amendment. Although the Supreme Court has held that "the erroneous statement of fact is not worthy of constitutional protection," it has also recognized the need to protect "some falsehood in order to protect speech that matters." Why? Because errors in debate are inevitable, and penalizing erroneous factual assertions can "dampen…the vigor and limit…the variety of public debate" by inducing "self-censorship"
The Court's analysis rests upon a profound epistemological conception—that knowledge is always based upon and limited in its validity to a finite and changing set of data. Today's conclusions attempt to account for our experience to date; they are always subject to being modified or completely overturned by subsequent events and understanding. Whether we acknowledge this insight by stating that truth is "relative" to the limits of our finite experience or "contextual" to such limits, we may join in the observation of Judge Learned Hand in a letter to Justice Holmes in 1918:
Opinions are at best provisional hypotheses, incompletely tested. The more they are tested, after the tests are well scrutinized, the more assurance we may assume, but they are never absolutes. So we must be tolerant of opposite opinions or varying opinion by the very fact of our own incredulity of our own.
(Compare the eloquent statement of John Stuart Mill:
Complete liberty of contradicting and disproving our opinion is the very condition which justifies us in assuming its truth for purposes of action; and on no other terms can a being with human faculties have any rational assurance for being right.)
Because knowledge is limited by our experience, at any given time, theories that ultimately prove true may be unworthy of rational belief on the basis of information then available. To take a concrete example, the heliocentric hypothesis of Galileo had little to recommend it in the 17th century.
As advanced by Galileo, the planets and other heavenly bodies were thought to move in perfect circles around the sun. The mathematical formulae necessary to account for the observed movements of the planets under Galileo's version of the heliocentric theory were more complicated than the church-sanctioned geocentric system. The astronomer Tycho Brahe had earlier considered a heliocentric theory but rejected it because his astronomical observations, the most accurate of the age, recorded no evidence of the stellar parallax implied by the theory. In fact, it was not until 1838 that stellar parallax was first measured. Nor did the observations relied on by Galileo directly refute the geocentric theory. Given the state of knowledge in 17th-century Florence, it was not at all narrow-minded to reject the novel and ponderous heliocentric theory in favor of the received and well-tested geocentric system.
Examples could be multiplied far beyond the need to illustrate the point that there is hardly a major breakthrough in science that has not initially been greeted with howls of hostility and cries of quackery. "Proof" of scientific theories, it would seem, almost as often follows as precedes the theories' acceptance. Since the advance of science is an arduous process of debate, involving the assertion and testing of hypotheses and counter-hypotheses and the constant possibility of being updated, does not the Supreme Court's rationale for the protection of some speech that is "false" become all the more relevant in the case of scientific thought? Surely there is in science, perhaps more so than in any other branch of the ongoing human dialectic, the need to protect all ideas—recognizing that some will ultimately fall by the way—in order to give the freedom necessary for the debate ultimately to advance our understanding. A law that seeks to suppress false scientific conclusions is no more justified than a law drafted for the purpose of suppressing only false political or philosophic thought.
WHAT CAN BE PROVEN
Yet, turning to the second argument for overriding the constitutional presumption against restricting scientific thought, the Supreme Court has indicated that false or misleading advertising may fall outside of the First Amendment's protection. And it may be said that, similarly, scientific propositions—unlike philosophic, artistic, or religious expressions—are purported statements of fact and hence objectively disconfirmable.
In order to evaluate the relevance of this contention, it is necessary to consider the case law of the First Amendment's Establishment Clause as applied to the powers of the FDA. In 1969, in action brought against the Church of Scientology, the FDA sought to condemn as misbranded the E-meters used by scientologists in "auditing" church members and the accompanying literature explaining their use and function. As a defense against seizure and condemnation of the literature, the church raised the First Amendment's ban on any law "respecting an establishment of religion." The circuit court concluded:
Were the literature here introduced clearly secular, we might well conclude that under existing law it constituted "labeling" for purposes of the Act… However, such broad readings are not favored when they impinge upon constitutionally sensitive areas.…In light of these considerations,…we interpret the Act as not including within its concept of "labeling" the literature developing the doctrines of religion.
In so holding, the court relied heavily upon the 1944 Supreme Court decision in United States v. Ballard.
The Ballard case involved a criminal prosecution against several leaders of the "I Am" religious movement for representing to the public by use of the mails that they were empowered by St. Germain to cure all diseases. The trial judge had instructed the jury that it was to consider, not whether the statements of the accused were in fact true or false, but only whether their claims of healing powers were made in good faith. The Ninth Circuit reversed the trial judge's action, holding that the issue of truth or falsity was a proper one for the jury.
But the Supreme Court, in a now famous opinion by Justice Douglas, vindicated the trial court's instructions:
Freedom of thought which includes religious belief is basic in a society of free men.…It embraces the right to maintain theories of life and death and of the hereafter which are rank heresy to followers of the orthodox faiths. Heresy trials are foreign to our Constitution. Men may believe what they cannot prove. They may not be put to the proof of their religious beliefs.
The Ballard and Church of Scientology cases appear to establish that the Food and Drug Act can have no application to written materials, even though accompanying a misbranded or adulterated device, so long as the content of the literature is religious. But if this analysis applies to religious thought contained in such literature, why not to all forms of First Amendment speech contained in such written materials?
It is no doubt true that there are many religious or philosophic statements that are simply not verifiable. Yet others most certainly are. Consider the following three statements:
1. God will cure you if you pray.
2. Orgone energy boxes cure cancer.
3. Socialism will cure the ills of society.
There is, of course, no question that (1) and (3) fall directly within the protections of the First Amendment. On what grounds can (2) be excluded? It cannot be on account of being alone capable of verification: (1) is no less verifiable than (2). Obviously, we could gather data and determine whether there is a positive correlation between cure and prayer. Yet the Ballard and Church of Scientology decisions conclude that the Constitution prevents us from performing that test. I perceive no grounds for dissimilar treatment of statements (1) and (2): Both purport to be statements of fact, both are testable, and both are intended to induce action on the parts of others.
Indeed, the Supreme Court has in recent years become more sensitive to the logical impossibility of limiting the First Amendment's impact to those classes of speech traditionally protected by it—religion and political opinion. The gradual constitutionalization of the civil law of defamation illustrates this contention. That law has been tempered by First Amendment considerations in a series of decisions concerning recovery under libel suits. In effect, the Court has rewritten the long-standing strict liability rule of common-law defamation, holding that a person is privileged to speak falsely so long as the false statement is not the result of a negligent disregard for its truth or falsity.
If the First Amendment permits one to defame so long as it is not done negligently, and to represent one as having divine curative powers so long as done in good faith, on what grounds can scientific thought be suppressed without condition or qualification? It cannot. The law regulating scientific investigation must be constitutionalized, perhaps along the following lines.
First, I do not think that scientific thought can be suppressed, either by regulation or positive law, unless it is shown by the appropriate standard of proof that the allegedly false contention is made either with knowledge of its falsity or with negligent disregard for its falsity, measured by customary standards of scientific prudence. This principle is directly analogous to the rules developed in court opinions regarding defamatory and religious statements. This limitation on the legitimate reach of the State's power must be brought to bear on the FDA's power to condemn literature accompanying "misbranded" devices or drugs under the Food and Drug Act.
Second, the summary seizure provisions of the Food and Drug Act are subject to question once the applicability of the First Amendment is accepted. As now written, the law permits seizure of "misbranded" devices and accompanying literature without notice. This directly contravenes the long-standing First Amendment principle that no seizure of presumptively protected materials is to be tolerated unless there is an opportunity for speedy judicial determination of the material's right to First Amendment protection. Certain provisions of the Food and Drug Act probably would not bear up under scrutiny of this point.
Third, it may well be that some forms of scientific investigation simply lie beyond the power of the State to regulate. Accepting the protected status of scientific thought, it is, of course, true that the First Amendment does not shield any and all conduct in furtherance of it. As the Court has stated, the First Amendment
embraces two concepts—freedom to believe and freedom to act. The first is absolute, but in the nature of things the second cannot be. Conduct remains subject to regulation for the protection of society.
Nevertheless, where First Amendment freedoms are at stake, the power to regulate conduct must be exercised so as not, in obtaining a permissible end, "unduly [to]…infringe the protected freedom." The Supreme Court has also characterized the end to be furthered as necessarily "compelling" or "substantial" and required that the "incidental limitation on alleged First Amendment freedoms is no greater than is essential to the furtherance of the interest."
Judged by these standards, it seems to me that there are scientific investigations—not merely abstract thought or theorization—that lie beyond the regulatory power of the State. In effect, I would argue that the First Amendment should be deemed to create a zone of privacy around the scientist into which the State should not intrude absent a showing of "compelling" or "substantial" need. I do not know what result this line of thinking might have had if applied to the case of Wilhelm Reich; I do think that Reich's insistence that his work was constitutionally privileged should have been taken seriously.
Copyright ©1979 by Don Erik Franzen
Don Franzen is a partner in a Los Angeles law firm, where he specializes in constitutional law and representation of exempt motor carriers. This article is adapted, with permission, from one published in Law & Liberty.