Tuesday, March 17, 2009

The Fight for Medical Regulation

The average person today is well informed about any drug purchased from a retail vendor. The medicine has labels clearly stating its contents, intended use, side affects, and directions for proper dosage. The consumer knows the product has been rigorously tested and analyzed for any harmful properties. He/She knows that professionals, with proper education and training made the drug. None of these requirements that we take for granted existed at the beginning of the twentieth century. In fact, most of the significant legislation occurred during the 1960’s and 1970’s. These drug laws, however, would not be around if it was not for the Pure Food and Drug Act of 1906. This act was the first significant step towards regulating drugs. The legislation came to fruition as a result of hard work, being done simultaneously, by two individuals and one organization. First, the American Medical Association (AMA) reorganized, gaining political power and greater control of the medical field in America. Second, Dr. Harvey Washington Wiley, chief chemist for the Department of Agriculture, tirelessly fought on Capital Hill for legislation regulating drugs. Third, Samuel Hopkins Adams, published his serious The Great American Fraud starting on October 7th, 1905. Mr. Adams exposed the fraudulent medical world to the general public for the first time, and with the help of the AMA and Dr. Wiley, brought about the first law to regulate fraudulent drugs.

Language is very important in understanding any event. If the reader does not know the proper usage for the vocabulary, then the intended meaning is lost. The following are some common medical terms that are crucial to comprehending the early 1900’s. “Quacks” are the distributors of fake treatments and false diagnosis. “Nostrums” are fraudulent medicines sold through drug stores, manufactures, and/or the actual creator. Two other terms used for nostrums are “proprietary” and “patent” medicines. There is a very thin legal distinction at this time, and most nostrums called “patent medicines” are actually “proprietary medicines.” “Proprietary” means an individual has a copyrighted trademark on his/her product, legally owning that brand name. The actual ingredients are not protected under any law. A true-patented medicine is considered a medication whose creation method and/or contents are protected by the U.S. government. The ingredients of the product must be given in great detail to receive a patent, which means there are no “secret formulas” allowed. This deterred many quacks from actually patenting their concoction, but did not stop the general populace and medical organizations from using the term “patent medicines” when referring to nostrums or proprietary medicines. All of these words are used in every source on medical fraud during the late nineteenth and early twentieth centuries. These vocabulary distinctions are small, but necessary in comprehending the mind set of the time.

By the beginning of the twentieth century, the quack’s main distribution methods had evolved from a traveling salesman to an organized body consisting of retailers, wholesalers, and manufacturers. There were still individual salesmen during the 1900’s, trying to make a buck by advertising their latest nostrum made from their home laboratory. The lone quack, however, did not have the resources to produce large quantities of their product, or promote it across the nation. This created limited revenue in comparison to the manufacture, which created vast amounts of nostrums in their huge laboratories. Instead of going straight to the individual consumer, the manufacture made their fortune by selling to wholesalers. Then the wholesaler distributed the product to various drug stores across the country, which sold to the general public. There were no stores solely devoted to the selling of patent medicines. Just regular pharmacies or drug stores that sold both fraudulent and authentic medicines side by side. The three distribution groups (manufacturers, wholesalers, and retailers) formed many trade associations during the late nineteenth century. The most influential of these was created in the 1880’s, and was called the Proprietary Association of America (PAA). This group’s main goal was to protect and promote the common interests of its members. One of the larger interests for the PAA involved preventing legislation that restricted or altered the selling of nostrums. To accomplish this goal, they solidified their business relationship with the newspapers, which in-turn, created an effective lobbying machine to influence state and federal regulations.

In 1900, for every person in the United States, there had been issued 107.5 copies of daily, weekly, or monthly periodicals. The numerous newspapers and magazines illustrated the world to the average American, and could be described as the eyes and ears of the people. To help cover the cost of providing this service, periodicals often sold ad space. It is estimated that in the 1900’s, the patent medicine business, as a whole, spent forty million dollars annually on advertisements. Many publications could not have existed without the consistent revenue from these nostrum businesses. Recognizing this considerable dependences, F. J. Cheney president of PAA, devised a way to use his financial influence to an advantage. In Cheney’s advertising contract he added a “red clause” stating: “It is hereby agreed that, should your State, or the United States Government, pass any law that would interfere with or restrict the sale of proprietary medicines, this contract shall become void.” Soon after Cheney shared his secret, fellow PAA members added similar “red clauses” to their respected newspaper contracts.
Whenever a bill against patent medicines came to fruition in committee, the newspapers would receive a telegram reminding them of their duties to full fill their side of the agreement. Before long a barrage of newspaper articles would appear denouncing any nostrum regulation with little to no opposition. Personal letters would be sent to Congressmen or State legislators from newspaper editors declaring that the people did not care for drug laws. Truly the people did not care, but this is a result of a lack of information about the subject. The PAA’s lobbying system was very affective, and no state or federal nostrum legislation was passed until 1904. The eyes and ears of the people turned blind and deaf to the evils of patent medicines, securing their business while condemning their readers.

Not all publications were influenced by the PAA, and information about fraudulent drugs could be found in a few areas of the lay press. This was especially true as the spirit of the Progressive era grew during the early 1900’s. Unfortunately, the few pure periodicals, like McClure’s Magazine, Collier’s Weekly and the Emporia Gazette, were a couple of voices amongst thousands. In addition, the articles produced rarely contained significant accurate data and/or concrete examples of quackery and fraudulent medicines. Edward Bok, editor of The Ladies Home Journal, wrote an article warning women against the dangers of the patent medicine industry without mentioning the name of a single quack or nostrum to guard against. In another article, “The ‘Patent-Medicine’ Curse,” Bok claimed that Doctor Pierce’s Favorite Prescription contained alcohol, opium, and digitalis (heart stimulant). The chemical analysis Bok relied on was over twenty-five years old, and the current drug contained none of these ingredients. The patent medicine company promptly filed a libel suit for $200,000 against the magazine. Fortunately for Bok, the jury only rewarded $16,000. These failures helped fuel the fiery rebuttals launched by the PAA and their newspapers denouncing any drug regulation. Bok does deserve credit for fighting the nostrum evil. His attempts, however, had too many errors and The Ladies Home Journal was rarely read by the average voting male. This combination proved ineffective in awakening the public or Congress to the dangers of patent medicines.

Those fighting against fraudulent drugs did not quit after experiencing a few setbacks. Editors like Bok increased their investigational efforts to dig up as much information as possible. Norman Hapgood, the editor of Collier’s Weekly, started the most successful of these investigations in 1904. After clearing his paper of nostrum advertisements, Hapgood hired Samuel Hopkins Adams to further inspect the business of patent medicines. Adams had gained a respectable reputation working for McClure’s Magazine from 1900-1904. He was considered an excellent muckraker, and was credited for helping expose the corruptions of many big businesses. When approached by Hapgood to do the series, Adams was willing, but was also loyal to his current employer. McClure, however, was not very interested in the idea, therefore, Adams signed on with Hapgood. The reporter immediately began his inquiry into the patent medicine industry. During months of research Adams: studied nostrum advertisements, had drugs chemically analyzed, gathered opinions from around the medical world, researched the sources of advertised testimonies, and interviewed the owners/manufactures of certain patent medicines. The end result of his work was a series called The Great American Fraud that was first published on October 7th, 1905.

Adams did not say anything in his series that had not been said already. He simply added more accurate details, facts, and examples than any other anti-nostrum article. This can be illustrated by exploring his investigation of Peruna, a nostrum made by Dr. S. B. Hartman. First, Adams answered a vital question. What are Peruna’s ingredients? “Any one wishing to make Peruna for home consumption may do so by mixing half a pint of cologne spirits (alcohol), 190 proof, with a pint and a half of water, adding thereto a little cubebs for flavor and a little burned sugar for color.” This concoction of water and liquor is supposed to cure catarrh, which is the cause of all diseases. For example, pneumonia and consumption (tuberculosis) are catarrh of the lungs. Dyspepsia (indigestion) is catarrh of stomach, and canker sores are catarrh of the mouth. The list goes on, but Dr. Hartman refuses to directly claim Peruna is a cure all. The quack explains this in an interview with Adams. “He [Dr. Hartman] stated to me specifically and repeatedly that no drug or combination of drugs, with the possible exception of quinin for malaria, will cure disease. His claim is that the belief of the patient in Peruna, fostered as it is by the printed testimony, and aided by the ‘gentle stimulation,’ produces good results.” Dr. Hartman was not the only quack to contradict their written work when interviewed by Adams.

After illustrating Dr. Hartman’s hypocritical nature, Adams stated some opinions of both medical and federal organizations in regards to Peruna. The biggest issue for both was the nostrums addictive nature. The Office of Indian Affairs, a section of the Department of the Interior, recognized Peruna as liquor and banned the nostrum from being sold within Indian territories. The acting Commissioner, F.C. Larrabee believed, “As a medicine something else can be substituted; as an intoxicant it has been found too tempting and effective.” The patent medicine was so popular that some towns had coined the phrase “Peruna drunk” when referring to rowdy individuals. Physicians had seen a number of these cases where patients drunk large amounts of Peruna to get intoxicated. The person usually started using the product as a tonic until their addiction grew large enough for it to become a cocktail. People who were hospitalized from consuming too much Peruna were treated as alcoholics. Like Adams, the honest medical professional and the Office of Indian Affairs viewed Peruna as liquor and nothing more.

In addition to exposing Peruna’s falsehoods, and denoting the opinions of the medical field and the government, Adams explained why people would drink Peruna instead of liquor. “There are two reasons, one of which is that in many places the ‘medicine’ can be obtained and liquor can not.” In the early twentieth century, many reformers were fighting for prohibition, and before the federal law was enacted many state governments banned the sale of liquor. These laws, however, did not stop people from getting drunk as long as there were patent medicines like Peruna available. “The other reason why Peruna or some other of its class is often the agency of drunkenness instead of whisky is that the drinker of Peruna doesn’t want to get drunk, at least she doesn’t know that she wants to get drunk.” Adams reprinted an article from the Journal of the American Medical Association to illustrate this point. The story was about a priest who fell ill as a result of chronic alcoholism. This was a shock to the son, who never had seen or heard of his father drinking any kind of liquor. The physician then asked if the priest had been taking any medication. It was revealed that he had been drinking Peruna for about six months to help with fatigue.

Peruna was just one of the two hundred sixty-four nostrums and/or quacks that Adams attacked in The Great American Fraud. The patent medicine industry responded very harshly with their periodical army, and many tried to sue Collier’s Weekly. Adams, however, had learned from the mistakes of Edward Bok. His information was very current and accurate. As a result only one suit actually made it to court, and the trial ended in favor of Adams. The muckraker had accomplished something that no other reporter had. Adams revealed the evils of the patent medicine industry to the masses, and did it with such care and detail that he was left unharmed by any repercussions. His work was so accurate and insightful that many of those fighting for the Pure Food and Drug Act often quoted from The Great American Fraud.
The American Medical Association was especially impressed, and would reprint The Great American Fraud for years to come. One of the reasons Adams received this praise was he did what the AMA, and others, had been trying to do for years. Adams awakened the general populace to the evils of quacks and nostrums. A problem the AMA had in accomplishing this objective was its publication methods. The articles denouncing patent medicines were only published in medical journals like the Journal of the American Medical Association (JAMA). These periodicals were not readily available to the public, and the lay newspapers would not reprint something that would jeopardize their ad revenues. The average American, therefore, never had access to the issues being raised in medical publications. Medical journals, including the JAMA, were also guilty of selling ad space to nostrum producers. This proved confusing when a patent medicine was denounced on one page and advertised on the next. As early as 1892, medical professionals denoted this hypocritical position and many suggested that, “Every medical journal should condemn…both in its reading-columns and its advertising-space, everything which tends to make medicine more blind and uncertain.” The AMA finally purified its journal in July of 1905, as part of a larger reorganization campaign.

The AMA was unorganized since its birth in the 1840’s, and was attempting once again to fix this situation during the early 1900’s. A new legislative body was formed named the House of Delegates, giving the AMA a central body to reform, discuss, and bring up major issues effecting the profession. This body consisted of representatives from each state medical association, the AMA, and the United States Armed Forces-Hospital Service. The House of Delegates had many objectives to undertake during the first few decades of the twentieth. The most successful accomplishments included: the incorporation of the AMA; the establishment of well-defined educational requirements for becoming a physician; and an improvement in the quality of information in the JAMA.

The most prudent goal of the House of Delegates, in regards to the passage of the Pure Food and Drug Act, was the creation of an affective political machine. This was accomplished through the State Auxiliary Legislative Committee and the Committee on National Legislation. These committees would often work together, and they were collectively known as the Committee on Medical Legislation. In the first few years of the twentieth century, the Committee on Medical Legislation had created a vast network of local, state, and national professionals. This network was used as a lobbying force when relevant legislation was brought to fruition, and acted as a counter weight towards the PAA’s influence. By July of 1905, the number of contacts for the Committee on Medical Legislation was over 2,800. In addition to communicating with doctors, the Committee on Medical Legislation registered local political leaders and their positions on key issues. By 1905, there were over 11,000 politicians listed from about 900 counties, with information on the political situation for each area. When the Pure Food and Drug Act started to manifest in Congress in early 1904, the AMA had an established and affective lobbying network of physicians and politicians.

Dr. Harvey Washington Wiley used this newly formed political machine of the AMA, and the information in The Great American Fraud to help push through Congress the Pure Food and Drug Act of 1906. As the chief chemists for the Department of Agriculture, Dr. Wiley had gained a notable reputation for his twenty-year fight against the adulteration of food. He was renowned for his energetic and original presentations. During a session with the House Committee on Inter-State and Foreign Commerce, Dr. Wiley made five-minute whiskey. According to a reporter from the New York Times:
Dr. Wiley produced an outfit of chemical apparatus, got out a bottle of alcohol, burnt sugar, and some other stuff, and went to work. In five minutes he had a red liquor ready, which he passed around among the committee members to be tested. They took it, tasted, and smacked their lips.
Dr. Wiley’s main focus was on fraudulent food, but he was also well aware of the patent medicine industry. In 1903 he created a drug laboratory, within the Bureau of Chemistry, which was many devoted to analyzing nostrums. Dr. Wiley became close friends with Samuel Adams, and aided him in his investigation into the nostrum industry. The good doctor also had consistent communication with the AMA. Charles Reed, chairman of the Committee on Medical Legislation (AMA), wrote to Dr. Wiley, “This office is at your disposal and we will do anything that we can to help the good cause along.” Most importantly, Dr. Wiley worked with the federal government for years to produce pure food and drug bills in Congress.

In November of 1905, Dr. Wiley met with President Theodore Roosevelt, in hopes that pure food and drug regulations would receive his support. Roosevelt was unusually sluggish in voicing his opinion on the subject, but in a speech to Congress the following month he dedicated three sentences to the cause. The Presidents support was small, but very effective in stimulating Congress to debate the matter. At the same time, The Great American Fraud had aroused public interest in nostrum regulations, and the AMA reorganized solidifying their political machinery. Dr. Wiley contacted his allies in the AMA, and the organization wrote to sympathetic Congressman asking for their support of a pure food and drug bill. Throughout the Congressional debates, Dr. Wiley was present to offer any help he could. In February, the Senate passed its version of the bill with little debate. The House of Representatives, however, was very slow in coming to an agreement on various amendments. The Proprietary Association of America still had supporters in the House, and would not allow the bills passage without a fight. Fortunately, through the efforts of Dr. Wiley, Samuel Adams, and the AMA enough Congressmen knew the truth about the patent medicine industry. Those supporting quacks and nostrums were ridiculed. “Indeed,” said a House member, “Peruna seems to be the favorite Congressional drink.” In addition, Upton Sinclair published his novel The Jungle. The book increased the public demand for regulation that was initiated by The Great American Fraud. On June 23, 1906, the House passed their bill, and a week later Theodore Roosevelt signed the Pure Food and Drug Act.

Despite its flaws, the Pure Food and Drug Act was the first step towards medical regulations. Passing the legislation was not an easy task, and took the combined efforts of many organizations and individuals. The Proprietary Association of America did not want to see its profits disappear, and created an army of opposition. This army’s main weapon was the American newspaper. It was an effective tool that allowed nostrums and quacks to go unmolested throughout the nineteenth century. There were, however, three great fighters that attacked this evil during the early 1900’s. The American Medical Association, Samuel Hopkins Adams, and Dr. H. W. Wiley all led their assaults simultaneously, but on different fronts. The AMA focused on the medical profession; Adams enlightened the general public; and Dr. Wiley pushed the bill through Congress. None of these movements could have succeeded without the other, and it was the combination of the three that brought about medical regulations in 1906.

Bibliography
Books
Burrow, James. AMA Voice of American Medicine. Baltimore: The Johns Hopkins Press,
1963.
Holbrook, Stewart H. The Golden Age of Quackery. New York: The MacMillan
Company, 1959.
Young, James Harvey. The Medical Messiahs. New Jersey: Princeton University, 1967.
Articles
Adams, Samuel Hopkins. “The Great American Fraud.” Collier’s Weekly, 1905-1907.
Allen, Philip Loring. “The Making of a Medicine Man: Dosing the Public as a Business.”
Leslie’s Monthly Magazine, March 1904.
Bok, Edward. “Why ‘Patent Medicines’ are Dangerous.” The Ladies Home Journal,
March 1905.
“American Medical Association Publishes ‘Nostrums and Quackery’ Warning the Public
against Humbugs.” New York Times, January 14th, 1912.
“The Duty of Medical Journals.” Medical News, November 12, 1892.
“Whisky Five Minutes Old.” New York Times, February 28, 1906.
Web Site

Young, James Harvey. “The Toadstool Millionaires: A Social History of Patent
Medicines in America before Federal Regulation.” www.quackwatch.org
(accessed April 27, 2005).

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