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t • p~ Legal Backgrounder WASHINGTON LEGAL FOUNDATION 2009 MASSACHUSETTS AVENUE, NW • WASHINGTON, D.C. 20036 •(202) 588-030: Vol. 9 No. 10 April 22, 1994 SPEAKEASIES IN A NEW AGE OF PROHIBITION by Sandy Shaw and Durk Pearson Prior restraint is a particular kind of prohibition imposed by governments when they seek to prevent the exercise of choice in the idea and information marketplace. Even in the so-called "information age," prior restraints by government on speech and press are numerous and burdensome. As the twentieth century comes to a close, we find ourselves immersed in a sea of information that is channeled by government strictures designed to benefit some special interests and to increase the power of elected and unelected officials at the expense of the American people. • • It is a truism that information is essential for decision making, whether that be a decision to vote for a particular candidate or to buy a particular product. Although in the days of Valentine v. Chrestensen, 316 U.S. 52 (1942), governments were overt about their intentions to suppress information flow, today they have become a bit more sophisticated. The new form of prior restraint interferes with information flow by restricting access to or use of different speech fora and by granting monopoly control of those fora to certain special interests fueled by a neo-prohibitionist agenda and beholden to the government. This new form of prior restraint is far more insidious than the outright bans of the past because it is often imposed by unelected bureaucrats on discrete industry segments and it often slips by without much public notice. The First Amendment's protections for free speech and press were intended to form a bulwark against government restraints on the free flow of information requisite to a free society. It was not until Valentine that the Supreme Court considered "commercial speech" less deserving of protection than noncommercial speech. The Constitution's Framers understood speech to include commercial expression. They did not segregate "commercial speech" from speech generally and they afforded both commercial and noncommercial speech the same high degree of protection from government. Today, the First Amendment's guarantee of free speech has been carved into several categories, some fully protected, others less protected, and still others not protected at all. A New Style of Alcohol Prohibition. While in former years governments were obsessed with imposing prior restraints on the sale of goods and services, governments of the modem age often resort to a new style of prohibition, one that focuses on speech accompanying the sale of goods and . i~ Sandy Shaw and Durk Pearson are scientists who have been studying aging mechanisms since ~ 1968. They have published three best-selling books, including the million plus copy, number one best- ~ seller Life Extension: A Practical Scientific Approach (Warner Books, 1982). Their new book, ~ Freedom of Informed Choice: FDA vs. Nutrient Supplements is specifically about commercial speech ~ and the First Amendment. The authors gratefully acknowledge the assistance of Jonathan W. Emord, q~ their attorney, who specializes in First Amendment, communications, and food and drug law. „Q GC~ tiVLF publications are available on the Mead Data Central LMs/NF.A7s" online information service. ~ The Washington Legal Foundation ("WLF") is a 501 (C)(3) tax exempt organization and is America's largest pro-free enterprise public interest law & policy center. This Legal Backgrounder is one of a series of original papers written especially for and published by WLF's Legal Studies Division.

, S • services. Modern governments have replaced prohibitions on, for example, the sale of alcohol with those on speech attendant to the sale of alcohol. Although a return to full alcohol prohibition is all but impossible, restrictions on speech pertaining to alcohol flourish, largely unnoticed by the public but keenly felt by alcohol producers, manufacturers, and distributors. Although not as effective as the old prohibition, this neo-prohibition imposed upon speech concerning alcohol accomplishes many of the same goals of discouraging alcohol consumption. Government suppression of speech results in the loss of a significant amount of truthful, non-misleading information that would help consumers acquire a better appreciation for the benefits and disadvantages of alcohol consumption. The information suppressed would aid consumers in making informed choices. In the absence of that information, consumers often fail to appreciate the full significance of the choices they make in the market. There have been several recent human studies that find moderate alcohol consumption reduces dramatically the risk of cardiovascular disease. Although it is unclear exactly how alcohol does this, human studies have identified two possible mechanisms: (i) moderate alcohol consumption increases protective HDL cholesterol and (ii) moderate alcohol consumption reduces platelet aggregation (part of the initiation process of blood clot formation). A new study reports that alcohol drinkers have a reduced risk, compared to nondrinkers, of contracting colds from five strains of cold viruses. The new form of prohibition focuses on preventing alcohol beverage companies from disseminating truthful, non-misleading information on the potential health benefits of drinking alcohol. These new restraints have the same ultimate effect on consumption of alcohol as the old forms of prohibition: a reduction in demand for the products. Since information on negative effects of alcohol circulates without restriction (and, indeed, is mandated by law), any lack of information on the positive effects tends to make alcohol appear to be inherently evil to many who might well think differently if a free information marketplace were in place. A recent decision by the Bureau of Alcohol, Tobacco, and Firearms to allow a U.S. vintner, Beringer Vineyards, to include some information on the cardiovascular protective effects of moderate alcohol consumption on bottles of their red wine, is heartening. The agency resisted until Beringer threatened to file suit challenging the regulations on First Amendment grounds, which demonstrates that the First Amendment is still feared by agencies when confronted by the rare commercial firm willing to risk their ire. The agency, which had earlier called communication of any health information on alcohol - whether truthful or not - "inherently false and misleading," changed its mind and issued a statement that the information on cardiovascular disease protective effects "presents two sides of [the] issue ... has balance ...[and] therefore is not misleading and conforms to [the] requirements of [the] Federal Alcohol Administration Act of 1935. " Deadly FDA Prohibitions on Truthful, Non-misleading Speech. The Food and Drug Administration (FDA) has long had the dubious distinction of being the government agency with the worst track record on violating speech rights. It has imposed some of the most restrictive regulations on speech by manufacturers and vendors of the products it regulates, which include food, dietary supplements, medical devices, over-the-counter drugs, and prescription drugs. Forty-four percent of all cancer patients receive treatment that includes at least one drug with an off-label use (a use of that drug not officially approved by the FDA). Formal FDA approval for a new use of a drug already approved for a different use is extremely expensive, costing (depending upon whose estimates you use) $100,000,000 and up, and often taking eight to twelve years to prosecute through the FDA. The FDA does not permit clinical information on new uses of approved drugs to be communicated by pharmaceutical companies to doctors, even though off-label uses are often the most advanced and effective methods of treatment available. The restriction on communication of the prohibited information includes FDA bans on the distribution to doctors of papers published in peer-reviewed scientific journals and even of standard medical textbooks, including publications by third parties having no connection to a pharmaceutical company or a particular commercial drug. Regular consumption of low dose aspirin (1/4 to 1/2 tablet a day) has been shown to provide a substantial protection against first or subsequent heart attacks. The risk reduction is particularly dramatic in men over 50 (a 44 °k reduction in risk of a first heart attack) and in postmenopausal women. The protective effect of aspirin is so widely recognized that, at emergency rooms and in Copyright m 1994 Washington Legal Foundation 2 ISSN 1056 3059

. , • • doctors' offices, a majority of patients who arrive with severe chest pains of uncertain origin are routinely given aspirin. Prompt administration of aspirin can reduce the degree of damage of an evolving heart attack. The FDA does not allow aspirin companies to communicate this information to doctors or to the general public. A group of cardiologists has filed a Citizens Petition with the FDA, arguing that the use of aspirin during a suspected heart attack should be an approved indication and that 30,000 lives a year could be saved if aspirin were used more widely for this purpose.' Indeed, Dr. Carl J. Pepine, editor-in-chief of the Journal of Myocardial Ischemia, calls for going directly to the public with a national education campaign on the use of aspirin during a suspected heart attack, since the risk associated with such use is small. He writes, "Think how many lives might be saved if a bottle of aspirin were standard item in first-aid kits - whether in airplanes, sports stadiums or any other public place - or if people experiencing symptoms of a possible heart attack knew to take an aspirin while waiting for an ambulance to arrive." The FDA prohibits information concerning the health benefits of low dose aspirin from appearing on aspirin labels or in aspirin labeling. The FDA also prohibits information concerning the health benefits of antioxidant vitamins C and E and beta carotene from appearing on nutrient supplement labels and in nutrient supplement labeling. This prohibition, by FDA edict, includes not only advertising, but even a copy of published, peer-reviewed scientific paper if it is placed near the product in a store, even if the article placement is by a third party. There is, however, an enormous and growing body of scientific literature that consumption of antioxidants markedly reduces the risk of cardiovascular disease and many forms of cancer. That truthful information cannot legally be communicated to consumers by, or even to doctors by, pharmaceutical or dietary supplement companies, despite the fact that tens of thousands of premature deaths every year could be prevented if the public were aware of the information. After much delay and agonizing (and long after the scientific evidence supported it), the FDA has now published rules permitting a health claim for folic acid that consumption of 400 micrograms a day of the vitamin by women of childbearing age may reduce the risk of giving birth to a child with a neural tube defect, such as spina bifida. However, the FDA prohibits communication by food or dietary supplement companies of any information on how much the consumption of the folic acid may reduce the risk, including a ban on citing the U.S. Public Health Service's estimate of a 50% risk reduction with consumption of 400 micrograms of folic acid a day. An individual's likelihood of going to the trouble of taking a preventive measure, such as increasing folic acid intake, certainly has something to do with the perceived degree of associated risk reduction, yet the FDA forbids providing the available information. The FDA attempted to impose a full prohibition on high potency vitamins in the early 1970s by redefining vitamins in amounts higher than 1 1/2 times the Recommended Daily Allowance as "unapproved drugs," but was stopped by a grass roots lobbying effort by consumers and dietary supplement companies that resulted in Congressional passage of the Proxmire Amendment. Since then, the FDA has imposed a prohibition on the communication of truthful, non-misleading information on the potential health benefits of certain high potency vitamins, including the dissemination of copies of papers published in peer-reviewed scientific journals when associated with a potential for product sales. What the FDA could not achieve by restricting access to products, they have at least partially achieved by restricting access to potentially lifesaving information about those products. The First Amendment and Restrictions on Commercial Speech. Government restrictions on communication have been applied to speech content, to time, place, and manner of communication, and to specific speakers. All these restrictions on free speech have the effect of reducing the flow of information necessary to informed decision making. O C & P (Bell Atlantic), 830 F. Supp. 909 (E.D. Va. 1993), aff'd v S The recent decision in U ~ . . . No. 93-2340, 93-2341 (4th Cir. 1994) (where the court struck down a prior restraint in the Cable Act ~ ~.D 'Some people should not use aspirin, including those with a sensitivity to it, who have an ulcer, or who have a ~ bleeding disorder (or are taking a blood "thinner" drug). Individuals with uncontrolled severe hypertension or a familial history of hemorrhagic (bleeding) strokes, should consult with a physician before going on low dose aspirin. Copyright ° 1994 Washington Legal Foundation 3 ISSN 1056 3059 iti

0 • • i.~ ® ~ ~ , t~n Copyright ® 1994 Washington Legal Foundation 4 ISSN 1056 3059 W ~ barring a telephone company from providing video programming to its service area subscribers), reflects the underlying similarity of First Amendment issues between that case, where particular speakers (telephone companies) were not allowed to communicate certain kinds of information (television programs) via a specific mode of communication (telephone lines), and the above examples, where particular speakers (alcohol or pharmaceutical or dietary supplement companies) were not allowed to communicate specific truthful information (health information) and were not allowed to communicate via specific means of communication (on product labels and in advertising or other "labeling" closely associated with the product). The Bell Atlantic decision indicates a new willingness by the courts to curtail, on a First Amendment basis, the government's mounting use of regulations on the flow of information and communication. much "prohibited" information, despite government attempts to restrict its availability. If the U.S. ' An amicus curiae brief submitted on behalf of the telephone companies in the government's appeal of Bell Atlantic notes: "Section 533(b) transgresses the First Amendment not only because it is content-based and speaker specific, but also because it interferes with the freedom of telephone companies to circulate information through their own medium of communication and impermissibly prefers the speech of broadcasters over that of telephone companies." "Moreover, Section 533(b) singles out telephone companies for discriminatory treatment. It is thus speaker specific. Cable companies are not likewise prohibited on broadcast television." "...[A]n accepted principle of First Amendment law is that `[o]ne is not to have the exercise of his liberty of expression in appropriate places abridged on the plea that it may be exercised in some other place.'" These are points that apply to all forms of government regulation of speech, whether they involve alcohol, aspirin, dietary supplements, or telephone communications. The Commercial Press. Since the landmark 1976 Supreme Court decision Vrginia State Board of Pharmacy v. Virginia Citizens Consumer Council, Inc., 425 U. S. 748 (1976), the courts have defined commercial speech as that which does no more than propose a commercial transaction. It is rarely the case that labels and advertising just propose a commercial transaction. Often they include certain kinds of information that when communicated by different speakers via a different medium would clearly be considered fully protected speech. Labels and ads are speech fora because, like newspapers, they communicate information. Most newspapers choose what they publish partly on the basis of what content sells. Thus, newspapers, labels, and advertisements are all, in fact, part of the commercial press. There is a logical convergence between commercial and non-commercial speech which has rendered the Court's attempts at distinctions nonsensical. The framers of our Constitution were well aware of commercial speech (indeed, Ben Franklin made his living by publishing it (See Benjamin Franklin, "An Apology for Printers," The Pennsylvania Gazette, June 3/10, 1731)) and chose not to exclude commercial speech from full First Amendment protection. All speech, regardless of its commercial content, ought to receive full First Amendment protection. To do otherwise is to accept a system where free speech rights gradually vanish as the ever fluctuating definitional outer limits of the commercial speech doctrine come to encompass more and more speech useful in our daily lives. Information Prohibition Fails When Information Is Cheap. Lech Walesa said in an interview that the single most important reason for Eastern Europe's break with the USSR was the availability of cheap information technology. Easily accessed knowledge of the true state of the rest of the world led to the USSR's loss of legitimacy. The same thing is happening to the FDA's attempts to prevent certain uses of products by prohibiting the communication of information on those uses. Biomedical databases are proliferating and can be used to determine quickly the accuracy of the FDA's scientific judgment on the benefits and risks of foods, nutrients, and drugs. Time is mmning out for agencies that, like the FDA, depend upon a perception that only they can determine whether scientific information will be useful for consumers to make informed choices. As a result of increasing sources of information, well educated, well read people are able to get s ban against such government Supreme Court finally decides to enforce the First Amendment censorship then information, including potentially lifesaving information, will become available to all. To receive information about previous Washington Legal Foundation publications contact Alan M. Slobodin, President, Legal Studies Division. Material concerning WLF's other legal activities may be obtalned by contacting Danie, 1. Popeo, Chairman.