A History of Drug Advertising, Federal Drug Regulation, and the Doctor-Patient Relationship

My name is Oliver Vande Stouwe and I am a Chemistry and Economics double major at Grinnell College. I was born and raised in Grinnell but, it wasn’t until late in my high school career that I knew Grinnell College was the school I would attend. I knew Grinnell as a great academic institution with one of the most diverse student bodies in Iowa and those two things are what ultimately made me decide to attend. I am quite happy with my experience at the school and my post-graduation plans include exploring career options in different parts of the country. I am very excited to see what my future holds and for my upcoming final year at Grinnell.

Throughout the history of American medicine, many things have affected the doctor-patient relationship. Two of the most influential factor include direct to consumer medical advertising and federal drug regulation. Through my research I looked to answer the question of how these two factors have shaped the doctor-patient relationship during the 20th century. I was able to determine that drug advertising directed towards consumers drove individuals towards self-diagnosis and treatment, and over time federal drug regulations have worked to give medical authority back to physicians, while allowing patients to be informed and have some say in medical treatment.

To begin, I looked to gain background knowledge regarding how individuals could obtain drugs in the late 19th century. By the late 1800’s every state required that physicians obtain a state issued medical license. These medical licenses allowed physicians to write prescriptions for patients, but at the time prescriptions were not required and were merely seen as “a convenience to be used or not as the situation indicated” [1]. A prescription written by a doctor and taken to a pharmacist, like today, was just one of three ways that individuals could obtain prescriptions. Consumers could also go directly to pharmacists without a prescription and receive the same medicines. The final way of obtaining drugs was directly from a physician, which presented additional bias as the physicians had additional economic incentive to prescribe the drugs they were selling instead of referring patients to pharmacists [2].

At the turn of the century, medicines were placed into two categories: ethical medicines and patent medicines. Ethical medicines were drugs found in the United States Pharmacopedia (USP), which was supported by the American Medical Association (AMA) [3]. The USP was established in 1820 by a group of 11 physicians who met in Washington D.C. and evaluated drugs based on safety and effectiveness. There are six ethical medicines that we still consider effective today: digitalis, morphine, quinine, diphtheria antitoxin, aspirin, and ether [4]. These ethical medicines were not advertised to consumers and there was very little advertising directed to physicians and pharmacists at the beginning of the 20th century. Patent medicines consisted of undisclosed ingredients, which usually only included water and alcohol or opium. Patent medicines were widely advertised to consumers, making up about half of newspaper advertising revenue at the time. These adverts included highly exaggerated claims of effectiveness such as the “cure-all” medicine. A few examples of patent medicines are: Lydia E. Pinkham’s Vegetable Compound, Hamlin’s Wizard Oil, Warner’s Safe Cure for Diabetes, and Cocaine Toothache Drops [5]. In 1905, we saw the birth of the Council on Pharmacy and Chemistry, a sub-group of the AMA that set standards for evaluating drugs. The goals of the Council were to steer patients towards effective pharmaceuticals and away from self-treatment. Additional the Council urged physicians not to prescribe patent medicines and for medical journals not to run their advertisements [6].

On June 30, 1906, the Federal Drug Administration (FDA) was established, and along with it came the Pure Food & Drug Act. The act did not seek to dissuade self-medication, rather it sought to provide consumers with more information to be able to make educated decisions. The act focused on stricter labelling requirements including disclosure regarding the presences and amounts of dangerous substances including cocaine, alcohol, and heroin. In 1911, the United States Supreme Court case U.S. v. Johnson ruled that the Pure Food & Drug Act did not make false therapeutic claims illegal, it only covered misrepresenting ingredients. In 1912, Congress passed the Shirley Amendment which made false therapeutic claims intended to mislead consumers illegal. However, it was fairly difficult to prove intent to mislead so the new amendment did very little to affect how patent medicines advertised [7].

The Food, Drug, and Cosmetics Act of 1938 was enacted in large part due to over 100 people dying from taking elixir sulfanilamide. The goal of Food, Drug, and Cosmetics Act was to provide directions on the labels of drugs that would be easy for everyone to understand. Additionally, this was the first time that FDA pre-market approval was required for drugs. However, prescriptions were still not required to obtain medicines. There were some very specific exceptions made by the FDA that required a caution label on certain drugs that stated “only to be used with the prescription of a physician, dentist, or veterinarian.” Even though this label was present on the drugs, prescriptions were still not required to purchase them. The directions on the labels of these drugs were to be incomprehensible to a common person, which the FDA believed would dissuade people from using them without consulting a physician. This obviously was not the case and therefor made these drugs even more dangerous because people did not know how to properly use them [8].

By 1941, the FDA had identified over 20 different drugs they believed were too dangerous for individuals to use without the prescription of a doctor [9]. However it was not until 1951 with the Durham Humphrey Amendments that prescriptions were finally required for certain medicines. This is the time when we make the distinction between prescription medicines and over the counter medicines. The goal of the Durham Humphrey Amendments was to dissuade people from self diagnosis and administration of potentially dangerous drugs by requiring that physicians approved these medicines before they fall into the hands of the public. This is finally giving medical authority to physicians, at least regarding how people could obtain pharmaceuticals. Between 1939 and 1959 we saw spending on pharmaceuticals grow from around 300 million dollars annually to over 2.3 billion dollars. All but 4 million dollars of this increase was due to prescription medicines. This gave obvious motive for pharmaceutical companies to restructure their target audiences and focus more on physicians and pharmacists [10].

Due to the new requirement of prescriptions for most of the drugs being sold ninety percent of funding spent by pharmaceutical companies on advertising was directed towards physicians and pharmacists by 1960. In order to distinguish between very similar medicines, doctors and pharmacists relied heavily on “detail men”. Detail men were representatives for pharmaceutical companies and doctors often considered these people more as friends than as salesmen [11]. Patients now became very reliant on physicians for their medical needs, which at face value seems to be a good thing. However, in retrospect this made it okay for patients to be relatively uninformed [12]. During the 1950’s and 1960’s consumers were not being bombarded with drug advertisements, in fact, consumers were often kept completely out of the loop. It was a very common practice during this time for physicians to prescribe a treatment or medicine without giving the patient any insight to other treatment options. Furthermore, patients often did not even receive an explanation of their diagnosis, which meant they were fully in the dark about their medical well-being [13].

The 1970s brought forth the patients rights movement. This movement focused on requiring physicians to provide patients with information about their diagnosis and about different treatment options. However, during this time there was still little advertisement focused on consumers which meant patients would only know about the treatment options that were presented to them by their doctors [14].

In the 1980s we saw the rebirth of direct to consumer medical advertising. Direct to consumer advertising was used as a vehicle by pharmaceutical to introduce their products to the end users. For advertising to be effective, companies needed to improve the knowledge and increase the influence of patients in medical decision making. This paralleled the goals of the patients rights movement of the 1970s, and these two strategies paired together were quite effective in accomplishing this goal. An additional goal of these companies was to improve market efficiency which is very similar to the purpose of the consumer rights movement of the 1990s [15].

The 1990s brought the consumer rights movement, and as mentioned before the goal of this movement was to optimize market efficiency. This movement focused on requiring health insurance to disclose information regarding different benefits and policy options. In an economic sense, this would provide more perfect information and therefor level the playing field in the pharmaceutical market [16].

The doctor-patient relationship has evolved a great amount over the 20th century. Early on, patients had nearly all medical authority when it came to the drugs they could obtain and their treatment options. This was not the best because obviously patients did not have the proper medical knowledge to make those types of decisions. As we moved to the middle 20th century, there was a huge swing in authority, and doctors had almost complete medical authority. Though doctors did have the correct knowledge, this was still not ideal because patients were often kept in the dark about their diagnosis and different treatment options. Finally, towards the end of the 20th century, federal regulation and direct to consumer advertising had balanced the scales and provided a good medium where doctors had control over prescriptions, but individuals were also informed about their medical well-being and about different treatment options that were available.


[1] P. Temin, Taking Your Medicine: Drug Regulation in the United States. (Cambridge, Mass.: Harvard University Press, 1980).

[2] Ibid.

[3] Ibid.

[4] P. Starr,  The Social History of American Medicine, (New York: Basic Books, 1982).

[5] JH Young, The Toadstool Millionaires: A Social History of Patent Medicines in America before Federal Regulation, (Princeton, N.J.: Princeton University Press, 1961).

[6] Starr, History of American Medicine.

[7] Julie Donohue,  A History of Drug Advertising: The Evolving Roles of Consumers and Consumer Protection, (The Milbank Quarterly, 2006): 663.

[8] RP Juhl, Prescription to Over-the-Counter Switch: A Regulatory Perspective, (Clinical Therapeutics, 1998), 115.

[9] JP Swann, FDA and the Practice of Pharmacy: Prescription Drug Regulation before the Durham-Humphrey Amendment of 1951, (Pharmacy in History, 1994), 56-59.

[10] RR Rehder, Communication and Opinion Formation in a Medical Community: The Significance of the Detail Man, (Academy of Management 1965), 287.

[11] Ibid, 287.

[12] KJ Arrow, Uncertainty and the Welfare Economics of Medical Care, (American Economic Review, 1963), 962.

[13] DJ Rothman, Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision Making, (New York: Basic Books, 1991).

[14] Donohue,  A History of Drug Advertising, 671.

[15] Ibid, 677.

[16] Ibid, 685.

Additional Readings

  1. Collinson, Shannon, Kamran Khan, and Jane M. Heffernan. “The Effects of Media Reports On Disease Spread and Important Public Health Measurements.” PLoS ONE 10, no. 10 (2015): 1-22.
  2. Gagnon, Kendra, and Carla Sabus. “Professionalism in a Digital Age: Opportunities and Considerations for Using Social Media in Health Care.” Physical Therapy 95, no. 3 (2015): 406-415.
  3. Gentile, Douglas A., Charles Oberg, Nancy E. Sherwood, Mary Story, David A. Walsh, and Marjorie Hogan. “Well-Child Visits in the Video Age: Pediatricians and the American Academy of Pediatrics’ Guidelines for Children’s Media Use.” Pediatrics 114, no. 5 (2004): 1235-1242.