The American pharmaceutical and food industries and the U.S. Food and Drug Administration (FDA) are critical allies in the advancement of the health of Americans. These groups work together in concert—sometimes synergistic, but usually antagonistic—to advance the general welfare of the population. This advancement is not an easy undertaking, involving the creation of laws based on business and consumer needs, rooted in scientific study. Published almost ten years ago (2003) by writer Philip J. Hilts, “Protecting America’s Health” , lays out the history behind the challenges in creating regulations for the pharmaceutical and food industries.
Protecting America’s Health starts off describing the agrarian lifestyle and medicines of the 1800’s. 1800’s were the beginning of the industrialization of America. In 1883, the U.S. Department of Agriculture hired a brilliant chemist, Dr. Harvey Washington Wiley, to study the chemical nature of sugars from various substances such as sugarcane, honey, and sorghum. Wiley’s findings showed that there was a common practice of deception by manufacturers in the quality of honey, sugar, and syrup sold. These results were the first of a kind and aroused the interests of leaders in Washington.
Wiley hypothesized foods and drugs were being adulterated. He set up experiments to study the effects of products sold in the market on healthy young men. A strict diet of the products suspected of causing illnesses was to these volunteers. During the experiments, many of the men fell ill. Newspaper reporters called these the “poison squad” studies. In fact, because industry advertising heavily invested in the newspapers, many newspapers would not publish Wiley’s findings. The experiments, while not entirely scientific, helped to identify toxic and dangerous preservatives that were in common in use.
Wiley was a devout Christian, Republican, and honest man. He believed in science and free-enterprise. However, through his studies, Wiley concluded that industry could not self-regulate.
These practices continued until muckraking writers emerged. The book, The Jungle, by Upton Sinclair, described the unsanitary conditions of meat packers. Articles in the Ladies’ Home Journal and Collier’s by Samuel Hopkins Adams described the toxic ingredients used in medicines. Through these publications and nearly a quarter century of Wiley’s work, Wiley’s data finally resulted in proposed regulations for the industry.
These proposed regulations were challenged. Industries and their political proxies insisted that these provisions were unnecessary and unconstitutional. President Theodore Roosevelt was also skeptical of Wiley’s findings. He asked for an independent evaluation of the industry practices, but the conclusions were the same: industry cannot self-regulate.
The passage of the Pure Food and Drug Act of 1906 (also known as the “Wiley Act,” and the “Pure Food Law”) enacted legislative action This Act mandated independent inspections for the meat industry and accurate drug labels for the pharmaceutical industry. The Act required the Bureau of Chemistry to perform sampling and testing of food and drugs to ensure purity. The aim of the Act was to eliminate practices of adulterated and misbranded food and drugs.
After the passage of the 1906 Act, Wiley enforced the law with some success. However, more often than not, Wiley was hindered. Impure, adulterated, and misleading products were still being sold. Wiley tried to seize grain tainted with sulfur (done to hide the decomposition). Wiley was prevented by Secretary Wilson and President Taft from prosecuting a company under the Act. Wiley submitted his resignation in disgust. He then went on to head the Good Housekeeping Research Institute to further testing of foods.
Additionally, the 1906 Act could be easily sidestepped. In one case, Dr. Johnson of Kansas City claimed to cure cancer with his concoction, which had accurate labeling of content, but no evidence of healing. The Bureau of Chemistry tried to prosecute him but lost the case in the Supreme Court. The judges decided that the defendant was following the law: the law did not restrict drug producers from making false and misleading claims.
The Sherley Amendment of 1912 tried to prohibit manufacturers from labeling their products with false therapeutic claims. However, this 1912 Amendment and the 1906 Act were still insufficient to stop the problems that consumers and regulators faced. Since these Acts did not require proof that products were safe, there were no controls over false advertising. There were no food standards defined. The meaning of “adulterated” was vague. Anecdotal evidence and authoritative opinions were acceptable. The government had to show the intent of producer to adulterate or mislead, which could not be proven. Enforcement was minimal because it was not budgeted. And injuries from cosmetics could not be addressed. Further amendments passed could not address all of these problems.
In the 1920’s, little was done by the Republican Congress and Presidents. But, with the Great Depression, public sentiment paved the way for the election of Franklin D. Roosevelt (FDR). In his first hundred days in office, the FDR administration established laws and regulations to stabilize the economy.
FDR’s transition team included many intellectual leaders, including Rexford Tugwell. Previously a professor of Economics at Columbia University, Tugwell became second in command to the Agriculture Department. He felt strongly that the welfare of the citizens was directly connected to food and drugs and took an interest in learning all he could about the deficiencies of the FDA.
Initially, Tugwell felt that the problems with the agency were due to internal issues but soon realized that this was not the case. Pressures from industry and political opponents and simply outdated laws were controlling the effectiveness of government mandates. Tugwell reasoned that the only way to tackle these problems was through new legislation that addressed the deficiencies of the current law.
There was resistance to this new law, and Tugwell’s bill ended up undergoing several revisions aimed at weakening it. The Department of Agriculture tried to raise public awareness of the problems with the infamous “Chamber of Horrors” exhibit, but the conservatives stopped this information from being spread to the people.
Five years later, the bill was approval after a tragedy involving children surfaced. Almost 100 children lost their lives when they were prescribed an antibiotic, Elixir Sulfanilamide, for streptococcal throat infections. Unfortunately, this medicine contained diethylene glycol, a poisonous solvent. The outcry from the public led to the introduction and approval of the Federal Food, Drug, and Cosmetic Act in 1938, which was stronger than Tugwell’s initial version of the law proposed.
The 1938 Act replaced the 1906 Act, requiring drugs sold must be proven scientifically to be safe. The 1938 Act also required inspection of factories that manufacture the product. Enactment of this law was a pivotal step in American and Internationals pharmaceutical industries and modern medicine. For the first time, the law also regulated medical devices, cosmetics, bottled water, and pesticide residues on food. Civil and criminal penalties were enhanced.
Through this law, the U.S. government hoped to integrate scientists and doctors in pharmaceutical companies to help the industry evaluate their medicine before selling. However, this collaboration did not occur.
After World War II, drug manufacturing evolved into huge rackets, operating in a machine-like fashion, with a philosophy of purchasing, patenting, and promotion. The pharmaceutical companies purchased their products and manufacturing processes from universities and governments. With little or no modifications, the company patented the products and processes. As far as safety, the company would just refer to papers written by university professors, which were typically small studies that would usually show only a slight advantage of the new drug over existing old drugs. Heavy promotion of the drug would then follow.
At first, marketing was targeted toward consumers. But later, companies found it more useful to target doctors instead. Companies would promote and sell the new drug as new curative wonders. Additionally, companies would make small modifications to the drug, and then repeat the process of patent and promotion to stretch out the money-making venture. In the end, it only confused professionals. If this was not enough, companies succeeded in getting laws passed that made it illegal for a pharmacist to substitute a generic drug for the brand-name drugs they offered.
But, the biggest problem was that companies would not disclose side-effects. FDA would approve the drug without proof of safety; the drug would be approved automatically if the FDA did not respond to an application within 60 days. Due to inadequate scientific data of safety and heavy promotion, dozens of drugs were recalled. At this time, no data on the effectiveness of a drug was needed. The Supreme Court ruled that companies could deny FDA inspectors from inspection of their unsafe and unsanitary manufacturing processes.
Resistance to change was fierce from drug companies. Unfortunately, again it took another tragedy to force changes into laws: Thalidomide.
Thalidomide was a drug for morning sickness and insomnia. Thalidomide was already approved in the less-regulated European market when the FDA was reviewing the application for its approval in the U.S. Unfortunately, the drug caused deformities in babies born to pregnant women taking the drug. (The manufacturer incorrectly assumed that the drug would not cross the placental barrier.) In spite of heavy pressure from manufacturer Richardson-Merrell, FDA reviewer Frances Oldham Kelsey  refused to approve the drug without further information. In the few months that followed, it was discovered that over 10,000 babies would be born with deformities, causing a huge public uproar.
Due to the tragedies, in October 1962, John F. Kennedy (JFK) administration introduced the Drug Amendments Act called the Kefauver-Harris Amendment. This amendment was to ensure that medicines sold were safe. JFK administration felt that drugs must show minimal side effects and more benefit over risk. Efforts by the JFK administration and the Congress insisted that drug developed had clinical studies to demonstrate safety and benefit with minimal risks.
The 1938 Law and the 1962 Kefauver-Harris Amendment aimed to make the American public safe with the products aimed at them. Public health triumphed over health care product businesses. Experiments on people could not be carried out without prior approval from the FDA, and proper record keeping had to be taken. Well-designed scientific studies transferred evidence of drug safety and efficacy from the “expert” opinions on data.
With the passage of the Kefauver-Harris Amendment, all medicinal products in the market at that time underwent an examination of safety and efficacy with the Drug Efficacy Study of the National Academy of Sciences, National Research Council. Of the 5,000 drugs evaluated, 300 drugs were eliminated and banned. The author describes in detail the story of Panalba, a combination antibiotic manufactured by Upjohn. Despite repeated FDA warnings that the drug was both ineffective and unsafe, Upjohn would not stop production of the drug. The company ended up exporting the drug to maintain the multimillion dollar profits it was collecting for this dangerous medicine.
In the years after the Kefauver-Harris Amendment, the industry has continued its onslaught aimed at chipping away authority from the FDA. During the Nixon administration, Republicans were appointed in both the FDA and lower-level technocrat positions. These conservatives were more lenient is approving drugs. During the Reagan administration, funding was cut, and improvements in laws delayed, including mandatory label inserts for patients taking drugs, and the ban on raw milk. Not all changes proposed by Republicans were for the worse: the Waxman-Hatch Act of 1984 was instrumental in expanding the availability of generics.
But, in the early 1990’s, Congress was considering strengthening food and drug laws, which made the health-food industry nervous and it pushed for a law which banned FDA regulation in dietary supplements. The health-food industry won and in 1994, the Dietary Supplement Health and Education Act passed. This law was bad. Because it allowed untested and ineffective dietary supplements to be sold, the New York Times labeled this Act as the “Snake Oil Protection Act.” Additionally, the FDA could take action against a dietary supplement company only if the FDA was able to prove that the supplement was harmful.
Conservative-advocacy non-profit corporations have tried to limit FDA regulations. The Washington Legal Foundation sued the FDA for allowing drug manufacturers to distribute information to physicians regarding off-label uses of their drug in the name of “free speech,” and thankfully it won.
Because conservatives insisted that the FDA approval process was too slow, in 1996, organized by Gingrich and other ultra-conservative Republicans, Congressional hearings were held to determine if the FDA should be abolished, or completely side-stepped with an own approval process. David Kessler, director of the FDA, testified that this was in error and that the approval process was faster in the US than most countries.
Ironically, Kessler was appointed by George Herbert Walker Bush, a Republican. Kessler is a modern day Wiley and was trained both in medicine and law. He worked actively to foster science standards expected of the agency under the legislations of America and honest trade practices. Kessler encouraged companies’ incentives to innovate safe products of high standards. He also enforced rules to discourage and eliminate dishonest, fraudulent promotional practices. Kessler worked to contain the acquired immune deficiency syndrome (AIDS) epidemic, ban silicone breast implants, regulate tobacco, and improve x-ray mammography standards. Kessler was also momentous in introducing and setting up proper food labels that include nutritional information on packaged foods.
The best part of Protecting America’s Health is the epilog, on “greed and goodness”. The book tells a story of J. Scott Armstrong, a professor at the Wharton School of the University of Pennsylvania. During class, he presented the problem of Panalba to students and asked students to play the role of Upjohn executives. Would students continue to sell a drug that was shown to be both ineffective and unsafe? To his dismay, the students made the same wrong decisions: roles dominate behavior . Time and again, for-profit corporations cannot be trusted to make decisions that the benefit the public.
In conclusion, despite the age of Protecting America’s Health, I urge those interested to read this book. As George Santayana said, “Those who cannot remember the past are condemned to repeat it.”
- Hilts PJ. Protecting America’s health: The FDA, Business, and One Hundred Years of Regulation. The University of North Carolina Press. 2004
- Harris G. The Public’s Quiet Savior from Harmful Medicines. New York Times, Sept 14, 2010. http://www.nytimes.com/2010/09/14/health/14kelsey.html.
3. Armstrong JS. The Panalba role-playing case. University of Pennsylvania Scholarly Common. August 1, 1976. (see http://marketing.wharton.upenn.edu/ideas/pdf/Armstrong/Instructors_Notes_Panalba_Case_.pdffor additional instructions