FOOD AND DRUG AGENCIES

Because foods and drugs are intimately involved with the quality of life, their purity and safety have been of deep concern to many citizens and the governmental agencies dedicated to human welfare. Throughout the world the purpose of food and drug agencies is to certify that foods are safe and drugs effective. Consequently these agencies have as one of their chief goals the prevention of adulteration—debasing foods or drugs by diluting them with less valuable ingredients or adding substances to make the food or drug appear to be what it is not. Adulteration has ethical consequences; for example, the dilution of a cancer drug may hasten rather than hinder death. Corrupt companies can use scientific knowledge and chemical techniques to thwart detection of their adulterated products, forcing food and drug agencies to develop advanced techniques to ferret out fraudulent drugs and thereby protect the public from harm. Science and technology are thus inextricably involved in the ethics of food and drug agencies and industries.

Early History

During the Latin Middle Ages writers of herbals and medical treatises expressed ethical qualms about adulteration and proposed remedies. These writers found that scarcity of supply played a role in fraudulent practices. In 1202 King John instituted the first English food law, which prohibited the admixture of inferior ingredients in publicly sold bread. In Germany and France rulers passed statutes that fined brewers for doctoring beer and wine. Arabs of medieval Islam appointed police officers to test the genuineness of foods and drugs in markets. Medicinal compounds had to be prepared before a supervisor, who was the guarantor of the drug's purity.

With the European voyages of discovery in the fifteenth and sixteenth centuries, new foods and herbal drugs became part of an expanding global marketplace. To preserve foods on long journeys, producers and transporters used chemicals to retard spoilage and color foods. These practices led to abuses, and some European governments passed laws to prevent and punish harmful or deceptive practices. In the seventeenth century Robert Boyle, a British physicist and chemist, invented a device for determining specific gravities, which gave pharmacists a new way to detect drug adulteration. With the increasing sophistication of scientific knowledge in the eighteenth century, technical books by Adolph Gottlob Richter, Jean-Baptiste-Augustin Vanden Sande, and others appeared on adulteration and its detection and eradication. Although these authors used the new knowledge of chemistry and highly developed apparatus of the Scientific Revolution, they also analyzed the ethics underlying nefarious practices by merchants, pharmacists, and physicians. They suggested such remedies as better education and more effective laws to correct the injuries being done to customers and patients.

Food and Drug Agencies

As the first country to combat food and drug fraud through a comprehensive set of laws, Great Britain became the model for many other nations. Beginning in the eighteenth and early nineteenth centuries with laws on the adulteration of tea, wine, and beer, the British were able to protect the integrity of these and other important commodities and, through revenue officers, enhance state income. New technologies such as the microscope helped scientists detect the adulteration of coffee with chicory, but scandals associated with injurious foods and drugs forced legislators, in a series of new laws, to shift from noninjurious adulteration to the illegal addition of substances to foods and drugs that caused physical harm.

In colonial America the earliest food adulteration laws closely followed British examples, but in the late eighteenth century the first U.S. food law clearly targeted those persons, corrupted by greed, who sold unwholesome food in Massachusetts. Once convicted, such persons could be fined, imprisoned, or pilloried. The first U.S. federal drug law was passed in 1848, and it prohibited the importation of adulterated drugs. In 1862 President Abraham Lincoln signed legislation creating the U.S. Department of Agriculture (USDA), which included a Division of Chemistry (renamed the Bureau of Chemistry in 1901). This agency, which was a precursor of the Food and Drug Administration (FDA), employed chemists to identify adulterants in foods. During the rapid growth in population and industry after the Civil War (1861–1865), interstate traffic in foods and drugs also increased, as did tragedies associated with the addition of harmful dyes and preservatives to food and drink. An outraged public clamored for remedies, and between 1880 and 1906 more than a hundred bills were introduced in the U.S. Congress, but not one passed both houses.

The person largely responsible for breaking this deadlock was Harvey Wiley (1844–1930), chief chemist at the USDA from 1883 to 1912 and the "Father of the Pure Food and Drug Law." Convinced that many food and drug businesses were placing profits ahead of public health, Wiley hired idealistic young chemists, who were nicknamed the "Poison Squad," to study how chemical additives in foods affected health. Reports of their results aroused public concern, but "Wiley's Law" would never have been realized were it not for Upton Sinclair (1878–1968), whose novel The Jungle (1906) dramatized the repulsive practices in the Chicago meatpacking industry. The Pure Food and Drug Act of 1906 prohibited the "manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors." The Bureau of Chemistry administered the law, and Wiley and his successors developed an organization that won many victories for pure foods and drugs in the courts.

During the three decades after passage of the new law, weaknesses in its provisions appeared, because unscrupulous manufacturers were able to use advances in scientific knowledge and techniques to circumvent the statute. Muckraking journalists charged the food, drug, and cosmetics manufacturers with using 100 million Americans as "guinea pigs," and they provided examples of cosmetics that blinded women and drugs that caused children to suffer agonizing deaths (Kallet and Schlink 1933). Although administrative modifications were made (the Agricultural Appropriation Act of 1930 changed the agency name to the Food and Drug Administration), it was not until 1938 that Congress passed the Federal Food, Drug, and Cosmetic Act, which required manufacturers to provide scientific proof, through tests on animals and humans, that all their products were safe before they were put onto the market.

To isolate the FDA from advocacy groups, it was transferred from the USDA to the Federal Security Agency in 1940. World War II expanded the FDA workload, and during and after the war the number, variety, and power of new drugs increased dramatically. Food and drug companies grew in size and influence, which precipitated both abuses and legislative remedies. During the 1950s and 1960s, the 1938 act was periodically amended, and after the FDA became part of the Department of Health, Education, and Welfare in 1953, it used these new laws to give control of new drugs to doctors and FDA officials. The Delaney Clause (1958), which prohibited the use of substances in food if they caused cancer in laboratory animals, led to the controversial ban on saccharin, an artificial sweetener and weak carcinogen (this clause was replaced, in 1996, with the less stringent standard that "no harm will result from pesticide residues on raw and processed foods").

In the late 1950s, because of the widespread use of the sedative thalidomide by pregnant women in Europe, thousands of deformed infants were born, which eventually led to stronger drug laws in many countries. This drug was not widely available in America because of the valiant efforts of Frances Kelsey, an FDA examiner, whose suspicions about thalidomide led to her repeated rejections of applications to market it in the United States. Congress responded to the thalidomide tragedy by passing the Kefauver-Harris Amendment in 1962. This law changed the ways in which drugs were created, rested, developed, prescribed, and sold. The burden was now on the companies sponsoring a new drug to show that it was safe and effective. The FDA also issued new regulations that made the drug review process extremely stringiest, leading to criticisms that drug approval became glacially slow, because FDA officials, fearful of another thalidomide-like calamity, required study after study.

Criticizing the FDA—and Ethics

During the last four decades of the twentieth century the FDA came under attack by industry executives, congressional subcommittees, and public action groups. These FDA critics proposed that 200 million Americans were now being used as guinea pigs, because they were ingesting drugs and food additives that were even more deadly than those of the 1930s (Fuller 1972). Congress responded with a series of laws that, for example, strengthened FDA authority to regulate medical devices and commercial baby foods. These changes did not prevent the generic drug scandals of the 1980s, and in the 1990s the FDA continued to be an agency struggling to regain its credibility as the guardian of national health.

As with similar agencies in other countries, the FDA is charged with protecting public health, and in doing so it is often entangled in controversial ethical issues made more complex by advances in science and technology. For example, the FDA is responsible for regulating investigational new drugs (INDs). These drugs, not yet approved for sale, must be scientifically tested on animals, because an adverse effect on an animal often correlates with a similar effect on humans. Animal rights advocates have objected to this phase of IND development as unethical, whereas other groups have objected to the next three phases of IND testing, because humans are involved. In Phase I, small groups of healthy volunteers are given the IND to help researchers study its effectiveness, dosage, and metabolism. In Phase II, one to 200 patients with the drug-targeted disease are monitored for drug safety, efficacy, and side effects. In Phase III, even larger numbers of patients take the drug to refine optimum dosages, and placebos are given to some patients to make sure that IND effects are not due to chance or a developer's optimism.

Critics have raised doubts about FDA procedures on INDs. For example, in the 1970s, the General Accounting Office (GAO) studied ten of the more than 6,000 drugs then classified as INDs, concluding that in eight cases the FDA failed to halt human tests after learning that the new drugs were unsafe. Furthermore, the GAO found that drug companies delayed reporting adverse drug effects to the FDA. Other critics have attacked the FDA for approving too many drugs too quickly, thereby increasing risks, whereas still others blamed the FDA for approving drugs too slowly, thus depriving people of beneficial treatments.

Because of physicians' professional involvement with nutrition, prescription and nonprescription drugs, and medical technologies, they have a vested interest in food and drug companies as well as the FDA. This interest can raise ethical conflicts. According to some studies, physicians are protective of their independence and the integrity of the doctor–patient relationship, and many doctors are wary of governmental intrusions into how they practice medicine. Some critics have nevertheless pointed out the dangers of the close relationship that has developed between many doctors and drug companies.

Congressional subcommittees have questioned the ethics and legality of certain drug company activities. For example, in 1988 generic drugs became the focus of interest when investigators discovered that three generic drug companies were receiving accelerated approval of their drug applications in exchange for payoffs to FDA employees. By the time this scandal was over, federal courts had convicted ten companies and forty-two people of corruption. This scandal also revealed a potentially corrupting collusion between FDA workers and pharmaceutical companies, because FDA employees often leave their government jobs for highly paid positions at the companies they have formerly regulated.

Other controversies associated with science, technology, and ethics have involved artificial hearts, genetically engineered foods, and pediatric drugs. In these and other cases some ethicists claim that the law of the marketplace has contaminated the ethic that has generally guided scientists. For instance, they believe that profits rather than a genuine concern for humans and the environment have guided research on genetically modified plants and animals. Because many newborns have died after receiving drugs unsuited to their undeveloped organs, ethicists have pleaded with pharmaceutical companies and the FDA to do more research on proper drug doses for infants and children. Other ethicists have been troubled by the predominant use of white males in many drug studies, to the exclusion of women and minorities, whose genetic make-up and susceptibility to certain diseases are different from white males.

Assessment of FDA Influence and Future Prospects

Food and drug industries are among the largest and most lucrative in the world, and the governmental agencies that have evolved to regulate them have also become massive and complex. Because of the accelerating growth of science and technology, some predict that these industries and agencies will continue to expand, but others have warned that pharmaceutical companies are not creating new drugs at a rate necessary to maintain their viability in the marketplace. Although global funding for drug research doubled in the last decade of the twentieth century, the number of new drugs declined by 50 percent. The reasons for this decline are controversial. Some blame an industrial emphasis on "blockbuster drugs" that generate huge profits. But others blame the gargantuan costs required to develop new drugs. At the end of the twentieth century it typically took fifteen years and $900 million to develop a new drug, but only a very small percentage of these drugs actually become commercial successes. Still other critics have proposed replacing governmental food and drug agencies with free-market certification agencies, arguing that economic incentives are more conductive to effective results than bureaucratic incentives. Furthermore, simple drug solutions to such complex diseases as cancer and Alzheimer's have proven to be illusory.

Optimists believe that new technologies will be able to lessen these skyrocketing costs. For example, some have predicted that the sequencing of the human genome will revolutionize drug creation, but so far the mass of new data has confused rather than clarified future prospects. Scientists have used rational drug design, combinatorial chemistry, and high-throughput screening to accelerate the development of new drugs, but pessimists point out that, although the quantity of potential new drugs has increased, their quality has not. These critics also emphasize a fundamental ethical conflict between commercial interests and human needs for life-enhancing foods and lifesaving drugs.

As the need for safe, high-quality foods and drugs has grown, possible solutions to the problems posed by pessimists have been offered. Some believe that the reason so many useless drugs are generated is poor understanding of basic life processes. These analysts hope that, with more research in molecular and cell biology, the information needed to create precisely targeted drugs will become available. Others believe that computers will be able to predict how certain "new molecular entities" will bond to target compounds in human cells, thus fulfilling Paul Ehrlich's dream of "magic bullets." Still others believe that the solutions will be found in the plants populating the rain forests of the world. For a growing number of scientists, the future of healthful foods and safe and effective drugs lies in combining all of these solutions together, but with a realization that new foods and drugs must be created, developed, and marketed in ways that are compatible with the most profound ethical ideals of the human family.

ROBERT J. PARADOWSKI

SEE ALSO DDT;Food Science and Technology;Organic Foods;Regulation;Science, Technology, and Law.

BIBLIOGRAPHY

Abraham, John. (1995). Science, Politics, and the Pharmaceutical Industry. New York: St. Martin's Press. The author, an English sociologist, argues that corporate bias creates political problems, causing patients to take ineffective or unsafe drugs.

Burkholz, Herbert. (1994). The FDA Follies. New York: Basic. Analyzes in lurid detail how the FDA failed in its mission to protect the health of Americans during the Ronald Reagan and George Bush administrations.

Fuller, John G. (1972). 200,000,000 Guinea Pigs: New Dangers in Everyday Foods, Drugs, and Cosmetics. New York: Putnam. A sequel to 100,000,000 Guinea Pigs in which the author claims that, forty years later, the American public is being exposed to new and more dangerous poisons in their food, drugs, and cosmetics.

Grabowski, Henry G., and John M. Vernon. (1983). The Regulation of Pharmaceuticals. Washington, DC: American Enterprise Institute for Public Policy Research. The authors argue that the FDA does not deal with new drugs neutrally, because there exists an imbalance of benefits and risks among manufacturers, patients, and FDA officials.

Hilts, Philip J. (2003). Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation. New York: Knopf. A general history of the FDA, its founding, development, and involvement in many controversies.

Hinich, Melvin J., and Richard Staelin. (1980). Consumer Protection Legislation and the U.S. Food Industry. New York: Pergamon Press. After an introductory history of federal regulation of the food industry, the authors analyze the regulatory mechanisms of such agencies as the FDA and USDA.

Jackson, Charles O. (1970). Food and Drug Legislation in the New Deal. Princeton, NJ: Princeton University Press. A political and historical analysis of the complex struggle leading to the Food, Drug, and Cosmetic Act of 1938.

Kallet, Arthur, and F. J. Schlink. (1933). 100,000,000 Guinea Pigs: Dangers in Everyday Foods, Drugs, and Cosmetics. New York: Grosset & Dunlap. The authors inform readers of the dangers of many foods, drugs, and cosmetics, and also make suggestions about how ordinary people can defend themselves against these dangers.

Lamb, Ruth deForest. (1936). American Chamber of Horrors: The Truth about Food and Drugs. New York: Grosset & Dunlap. Despite the provisions of the Copeland Food and Drugs Bill, Americans continued to suffer from dangerous foods, drugs, and cosmetics, according to this author, who pointed to the need for further legislation.

Marsa, Linda. (1997). Prescription for Profits: How the Pharmaceutical Industry Bankrolled the Unholy Marriage between Science and Business. New York: Scribner. A history of the rise and fall of the American pharmaceutical industry from the Second World War through the 1980s, showing how the lure of large profits corrupted what was once a "golden age" of medical research.

Nestle, Marion. (2003). Safe Food: Bacteria, Biotechnology, and Bioterrorism. Berkeley and Los Angeles: University of California Press. The author argues that safe foods intimately involves politics, since billions of dollars and the safety of hundreds of millions of people are at stake.

Patrick, William. (1988). The Food and Drug Administration. New York: Chelsea House. The author analyzes how science, technology, and politics interacted in helping the British cope with serious problems of drug adulteration.

Stieb, Ernst W. (1966). Drug Adulteration: Detection and Control in Nineteenth-Century Britain. Madison: University of Wisconsin Press.

Temin, Peter. (1980). Taking Your Medicine: Drug Regulation in the United States. Cambridge, MA: Harvard University Press. Both a narrative of drug regulation and an analysis of how federal regulators came to distrust the ability of doctors and consumers to choose drugs for themselves.

Turner, James S. (1970). The Chemical Feast: The Ralph Nader Study Group Report on Food Protection and the Food and Drug Administration. New York: Grossman. A critique of the FDA for acting to benefit the gigantic American food industry at the expense of consumers.

Young, James Harvey. (1989). Pure Food: Securing the Federal Food and Drugs Act of 1906. Princeton, NJ: Princeton University Press. A historical study of how pure food advocates, chemists, and politicians cooperated to make the Pure Food and Drug Law into a reality.