DAB chapter 4

Kefauver-harris requirements

Required companies submit plans for, and seek approval of, any testing to be done with humans before clinical trials are conducted. (see the following slide for a summary of phases of testing) Required advertisements of prescription drugs to contain a summary of adverse reactions. At the time, advertisements were found mostly in medical journals. Today we see this law in action on prescription drug commercials. Drug must be effective for the illness listed on the label. Gave the FDA authority to withdraw drugs from the market. The FDA reviewed thousands of drugs already on the market for safety, effectiveness, and honest labeling.

harrison act of 1914

"An Act To provide for the registration of, with collectors of internal revenue, and to impose a special tax on all persons who produce, import, manufacture, compound, deal in, dispense, sell, distribute, or give away opium or coca leaves, their salts, derivatives, or preparations, and for other purposes." It's a tax Law: It provides revenue and control of substances including the opiates and cocaine. ItwasputforthbytheTreasuryDepartment. The law governed the marketing and sale of narcotics, including regulating non-medical narcotic use, and made possession of narcotics without a prescription illegal. Not designed to penalize the user of the drug. Physicians could prescribe these drugs for "legitimate medical purposes" and "in the course of his professional practice."

Morphinism

1853: The hypodermic syringe was invented. Sadly, the wife of the inventor of the syringe died of a self-injected morphine overdose. In any event, the syringe helped to hasten the advance of the "Soldier's Disease" or "morphinism."

comprehensive drug abuse prevention and control act of 1970

Also known as the "Controlled Substances Act", this legislation had the effect of repealing, replacing, or updating all previous federal laws dealing with narcotics and dangerous drugs. It made provisions for prevention and treatment. Set federal penalties for possession and selling. Controlled substances were divided into five categories called Schedules. (see the next two slides for more on Schedules) TheDrugEnforcementAdministration(DEA)wasformedfromthe Bureau of Narcotics and Dangerous Drugs of the US Department of the Treasury and the Bureau of Drug Abuse Control of the United States Department of Health, Education, and Welfare in 1973. This was done by congress to support the 1970 act.

patent medicines

Before the first federal laws controlling drugs and drug use came about in the early 1900s, there was legal widespread use of many drugs such as heroin, cocaine, morphine, and alcohol. Many "patent" medicines were around that were touted to cure one thing or another, or everything. Likely, the large amounts of opiates and or alcohol helped the suffering person feel mighty good, but very little "curing" was taking place. These medicines were called "patented" because there was supposedly a patent on the ingredients or recipes, so no rivals could copy them. These elixirs could be made by anyone, and sold to anyone who had money to purchase them. The success of one product over another was more often than not due to good marketing and advertising, rather than being a better product. Lydia Pinkham (as seen in the previous slide) was particularly successful. She was someone a woman could turn to for her advice about a woman's maladies. In the late 1800s the most common addict was not a soldier, and was not a black man. The addict during those times was likely to be a woman, usually well-to-do. Why? Because these concoctions were given to her by physicians for all sorts of ailments, real or imagined.c

the great american fraud

By SAMUEL HOPKINS ADAMS This article deals with the dangerous powders and other preparations which are sold in large quantities as cures for headache, depression, and similar ailments. It is the fourth article in this series which aims to explain and expose the harm done to the public by the Patent Medicine industry. The next article "Preying on the Incurables," will be published in COLLIER'S for December 23

Food, drug, and cosmetic act of 1938

By the 1930s it was widely recognized that the Food and Drugs Act of 1906 was obsolete. Then came a shocking development--the deaths of more than 100 people after using a drug that was clearly unsafe. Sulfanilamide, an antibiotic, had been used safely for some time in tablet and powder form. There was a demand for the drug in liquid form. The company's chief chemist and pharmacist found that sulfanilamide would dissolve in diethylene glycol (today it is used as an automotive antifreeze. Very sweet and tasty, but deadly. It was also used in counterfeit Colgate toothpaste a few years ago...). The company control lab tested the mixture for flavor, appearance, and fragrance and found it satisfactory. Immediately, the company compounded a quantity of the elixir and sent shipments--633 of them--all over the country. The new formulation had not been tested for toxicity. At the time the food and drugs law did not require that safety studies be done on new drugs. Selling toxic drugs was, undoubtedly, bad for business and could damage a firm's reputation, but it was not illegal.

drug schedules

Controlled substances were included in one of five schedules based on: Potential for abuse and dependence Pharmacologicaleffects Risk to public health The drug schedules provided a framework for assessing legal penalties, with the highest penalties associated with Schedule I drugs. States are supposed to adopt these federal guidelines for creating their own penalties. The federal government would like for the penalties to be at least this strict, but they can be stricter (NOT more lenient). Schedule I drugs have a high potential for abuse, no accepted medical use, no prescriptions may be written. I know I know. How can marijuana be a Schedule I drug if they are using it for medical reasons??? A few things. First, I personally don't believe marijuana should be classified as a Schedule I drug, for many reasons. Second, states are taking back their sovereign rights of statehood and are making their own laws regarding some of these drugs. Third, oddly marijuana is used by some federal agencies, like medical marijuana in VA hospitals. So it all appears to be a big mess.

drug paraphernalia

Drug Paraphernalia: laws related to drug paraphernalia (cigarette rolling papers, water pipes, razors, etc.) have been passed: Problematicbecausemanyhouseholdproductscanbeconstruedas drug paraphernalia For example, straws to drink beverages can be used to snort cocaine

morphinism

During the civil war (1861-1865) surgery on the battle field was often traumatic due to the lack of proper anesthesia. The use of morphine began to spread. Morphine is found in raw opium. It is a pain-reliever and a depressant drug. During the Civil War, soldiers were often given enormous amounts of morphine to kill the pain of amputations and other surgeries. While the potential for addiction was already known at the time, simple humanitarian concerns ensured that soldiers remained liberally dosed with morphine and whatever other analgesics were available. Some sources have suggested that as many as 400,000 veterans were left addicted to morphine due to their wartime experiences.

drug schedule

Here are some common drugs and how they are scheduled. A complete list (it's VERY long—they don't miss a thing) can be found at the DEA website. Schedule I: Ecstasy, Psilocybin, Peyote, Methaqualone, Mescaline, Marijuana, LSD, Heroin, GHB, THC Schedule II: Coca leaves, Cocaine, Codeine, Morphine, Opium, Fentanyl, methadone, methamphetamine, Ritalin, Oxycodone, PCP Schedule III: Anabolic steroids, synthetic THC, Ketamine Schedule IV: Xanax, Valium, Rohypnol, Meprobamate, Ambien Schedule V: Codeine preparations,

1922-Jones-miller act

In 1922, in the Jones-Miller Act, Congress provided a fine for anyone, who fraudulently or knowingly imports or brings any narcotic drug into the United States or any territory under its control or jurisdiction, contrary to law, or assists in so doing, or receives, conceals, buys, sells, or in any manner facilitates the transportation, concealment, or sale of any such narcotic drug after being imported or brought in, knowing the same to have been imported contrary to law. The act also specified that the mere possession of the drug was sufficient evidence for conviction unless the defendant could explain the possession to the satisfaction of the jury. Among the undesirable effects of the legislation are the creation of the illicit traffic, and the stimulation of crime, particularly theft and prostitution. These effects followed from the high cost of the illicit drugs and from the fact that no legitimate sources of supply are open to most drug users. THISEFFECTIVELYTURNEDTHEADDICTINTOACRIMINAL

drug-related historical problems that led to reform

In the 1800s, life with drugs was much different than it is today. There was a laissez-faire attitude, in that the government took a hands-off approach to drug use in this country. Which isn't to say that things were fine and dandy. There were several problems during this time period that caused the federal government to become concerned, and therefore put forth drug regulations. Some of the big problems are listed below: Opium smoking among the Chinese Morphinism in soldiers Cocaine use among Blacks Patent medicines

mandatory minimum drug sentencing

In the mid-1980s the U.S. Congress enacted some mandatory minimum penalties focused on drugs and violent crimes: Reflects a zero-tolerance for drugs and with no exceptions. This sends the message that regardless of the context there will be minimum sentencing involved with drug offenses. There is more discussion on these last few slides in your text. You can decide for yourself if these drug laws are fair and appropriate, though it may be too soon for you to make an educated stand on these issues. As we go through the different drug chapters, keep this information in mind. Things may not be as cut and dry as you think...

chinese opium den

In the middle1800s, large numbers of unskilled laborers from China immigrated to America. During this time, about half of all Chinese lived in and around San Francisco. Their cheap labor was used for mining and laying miles of railroad tracks for the transcontinental railroad. They suffered from discrimination by some of the affluent white at the time so were targeted when Opium Dens became popular along the west coast. These were places where people went to smoke opium, a custom brought to America by the Chinese from China. They were usually lower- class establishments, owned mostly by, and frequented by, Chinese, though whites were often customers. There was outrage and indignation that the Chinese were supposedly corrupting the white people so laws were passed. In 1875 in San Francisco, an ordinance banning the operation or visiting of opium dens was enacted. It is worth noting that opium itself was not banned, only a particular setting (aimed at controlling use among Chinese immigrants). Opium use was widespread at the time. At this point in time, there are no federal laws against drugs or drug use. The states were responsible for passing legislation pertaining to the welfare of their people

cocaine use and black americans

Racism wasn't only applied to the Chinese. During the early 1900s, Black Americans were associated with using the drug cocaine. And supposedly, when under the influence of cocaine, they were especially dangerous: The Journal of the American Medical Association published an editorial stating, "Negroes in the South are reported as being addicted to a new form of vice - that of 'cocaine sniffing' or the 'coke habit.'" They were said to rape white women Cocaine supposedly Improved pistol marksmanship NY Times headline (1914): NEGRO COCAINE 'FIENDS' ARE A NEW SOUTHERN MENACE

1912 sherley amendment

The 1912 Sherley Amendment was enacted to remedy the fact that manufacturers could still put false and fraudulent claims on the label. It prohibited labeling drugs with false claims "intended to defraud the purchaser." It now became necessary to prove that there was intent to defraud, not just a fraudulent statement on the label. Outlawed false and fraudulent claims on the label. However, if you really did not know your claims were false, this got you off the hook. It allowed ignorant people to make drugs with no penalty.

marijuana tax act of 1937

The Marijuana Tax Act of 1937 came about for several reasons. First, it was associated with Mexicans and Blacks so fear and racism played a role. Second, hemp was used to make paper products, and a good way to help owners of forests and paper mills was to eliminate the competition of hemp. The Act levied a tax equaling roughly $1 on anyone who dealt commercially in cannabis, hemp, or marijuana. That sounds OK on the surface, a regulatory reform. TheActdidnotitselfcriminalizethepossessionorusageofhemp, marijuana, or cannabis. It did include penalty and enforcement provisions to which marijuana, cannabis, or hemp handlers were subject. However, the fines for not complying exactly to the letter of the law were far out of scale of that $1 fee, making physicians leery of dealing with the drug. e.g. Violation of these procedures could result in a fine of up to $2000 and five years imprisonment. The once thriving hemp industry was wiped out within a few years.

pure food and drug act of 1906

The Pure Food and Drug Act of 1906 required that certain specified drugs, including alcohol, cocaine, heroin, morphine, and cannabis, be accurately labeled with contents and dosage. The law allowed the government to enter the drug marketplace with the intent to regulate what was stated on the drug label. The Bureau of Chemistry (a bureau under the US Department of Agriculture. It later became the FDA) was in charge of enforcing the law. Drug producers had to indicate what was in their product—No misbranding. The product had to be pure and honestly labeled. However, drugs could still be bought and sold with no federal restrictions. There is some evidence that there was a reduction in opiate sales after the passing of this legislation. A big "oops" was that this law did not prohibit false therapeutic claims.

june 3, 1905 collier's weekly

The first major editor of Collier's weekly, Norman Hapgood, bought a report through Edward Bok, editor of Ladies' Home Journal, aimed against patent medicines and turned it into a year-long series by Samuel Hopkins Adams called "The Great American Fraud." This, coupled with the publication of "The Jungle" by Upton Sinclair, (though this was not the intent of his book—it was about poor working conditions in factories, among other things) is credited with leading to Congress passing the first federal legislation concerning drugs and packaged food products.

food, drug, and cosmetic act of 1938

The incident hastened final enactment in 1938 of the Federal Food, Drug, and Cosmetic Act, the statute that today remains the basis for FDA regulation of these products. Administered by the FDA. Required pharmaceutical companies to file a New Drug Application with the federal government documenting that the new drug they wanted to market was safe (test it for toxicity). Law excluded already-existing drugs. Drug labels should give adequate directions for use or be sold by prescription. Here was the first time that a distinction was made between prescription and over-the-counter drugs. HOWEVER: drugs marketed did not have to be proven effective. This law largely replaced the Pure Food and Drugs Act of 1906.

harrison act continued

The last point on the previous slide is interesting. It caused a lot of confusion because doctors prescribed opiates to their addicted patients, and remember, there were a lot of people at that time addicted to opiates and other drugs. The medical establishment at the time held the belief that addiction was a disease. The Treasury Department, however, had a different take. They did not believe prescribing addicts opiates was legal in the context of the new law and they began to arrest doctors for this practice. Doctors then stopped writing prescriptions for the drugs and addicts could not obtain their drugs legally. In two Supreme court rulings in 1919 and 1922, the Court upheld it was illegal for a physician to prescribe narcotic drugs to an addict-patient for the purpose of maintaining his or her use and comfort. This made it nearly impossible for addicts to obtain drugs legally. However, in1925, those rulings were reversed, but by then it was too late. Doctors were too afraid to give prescriptions to their addict-patients.

1962 kefauver-harris amendments

Then there was the horrible Thalidomide disaster. Thalidomide was a sedative (and also relieved nausea in pregnant women) sold in a number of countries across the world from 1957 until 1961 when it was withdrawn from the market after causing birth defects in what has been called "one of the biggest medical tragedies of modern times." The effects of the disaster in the US were not as bad as in other countries. The FDA did not approve the application for marketing and sale in the US, though tablets made it here anyway.

kefauver-harris phases

Today, the Phases of Clinical Testing are as follows: 1. Pre-Clinical Studies: It involves in vitro (test tube or cell culture) and in vivo (animal) experiments using wide-ranging doses of the study drug to obtain preliminary efficacy, toxicity and pharmacokinetic information. 2. Clinical Trials--Human Testing: Phase 0: A relatively new phase. Give very small amounts to only 10-20 humans. Exploratory. Phase I: Test on a small group of healthy people (20-100) for side effects, safety and dosage range. Phase II: Test on larger group of healthy people and patients (100- 300) to evaluate effectiveness and safety. Phase III: Test on yet a larger group (1000-3000) to ensure effectiveness and safety. Very time-consuming and costly. Phase IV: Post-marketing surveillance studies. Designed to detect any rare or long-term adverse effects over a much larger patient population and longer time period

war on drugs

War on Drugs: People agree that drug abuse is undesirable, but should drug abuse be treated as a criminal or public health problem?