Drugs and Behavior - Test 1: Chapter 3: Drug Policy

1951 Boggs amendment

amendment to the Harrison Act, which established mandatory minimum sentences for drug offenses.

What was the focus of the Treasury Department when enforcing the Harrison Act?

Its experience was in taxing alcohol, and it would soon be responsible for enforcing Prohibition.

What is the greatest discrepancy between state and federal laws?

marijuana regulation The greatest discrepancy between state and federal laws is in the 13 states that provide for some form of legal access to marijuana for medicinal purposes Although the Obama administration has stopped raiding the dispensaries in general, federal prosecutors may target specific problem areas. *For example, in 2011, all dispensaries in Colorado that were within 1,000 feet of a school zone were ordered to close down or face federal prosecution under the Drug-Free Schools and Communities Act.*

During the reform era, the ____ _____ became increasingly popular.

moral model

As more states outlawed opium, the price rose in the black-market. This caused lower class opium-users to turn to _______ or ________, which were inexpensive and readily available.

morphine heroine

Many patients had developed ________ dependence under their doctor's care and relied upon their physicians and pharmacists for a regular supply. Physicians debated whether their morphine-dependent patients had developed a unique disorder requiring continued treatment (a ______ view of dependence), or whether they were merely weak-willed or simply seeking pleasure in the drug's effects (a _____ _____ of dependence).

morphine medical moral model

Commercial production of pure __________ from opium in the 1830s was followed by the introduction of the hypodermic syringe in the 1850s, and this more potent delivery method led to increasing medical recognition of the negative aspects of "________," an analogy with the term alcoholism

morphine morphinism

The period between 1890 and 1920 has been called the "_____" (lowest point) of race relations in the United States.

nadir

In the early 1800s, ______ was the medical doctor's most reliable and effective medicine, used for a variety of conditions but most notably as a pain reliever.

opium

The Harrison Act was a ___ law. It was not a punitive act, penalties for violation were not severe, and the measure contained no reference to users of "narcotics."

tax

If the FDA authorizes the testing of the drug in humans, the company can move into the first of ______ phases of clinical investigation.

three

The FDA formally enters the picture only when a drug company is ready to study the effects of a compound on *humans*. At that time the company supplies to the FDA a ________________________________; it is also required to submit all information from preclinical (before human) investigations, including the effects of the drug on animals.

"Notice of Claimed Investigational Exemption for a New Drug" (IND)

A drug was defined as:

"any substance or mixture of substances intended to be used for the cure, mitigation, or prevention of disease."

The 1930s had seen an expansion in the use of "___(a)____" drugs, which are effective antibiotics. In searching for a form that could be given as a liquid, a chemist found that ____(b)______ would dissolve in ____(c)_____ _________. The new concoction looked, tasted, and smelled fine, so it was bottled and marketed in 1937. ____(c)_____ _________ causes kidney poisoning, and within a short time 107 people died from taking "Elixir Sulfanilamide."

(a) sulfa (b) sulfanilamide (c) diethylene glycol

Effectiveness

***

Two Bureaus, Two Types of Regulation

***

******

****

****

*****

Issues Leading to Legislation

****************

FDA drug approval system: Why does it take so long?

- Not just of concern to the sick individual. Pharmaceutical manufacturers have a 20-year patent on a new drug. They usually patent the chemical as soon as there is some evidence that it is marketable. The manufacturers claim that, by the time a drug is cleared for marketing, they have only a few years left on the patent. From the mid-1980s to the late 1990s, the average approval time was reduced from 32 months to 12 months—but the increased speed of the FDA's approval process has been offset by an increased amount of time spent by companies in clinical trials—an average of almost seven years. The bottom line is that this is a high-risk, high-reward business. In any given year there are about 3,000 drug compounds undergoing some type of study, and about 30 new ones will be approved and marketed. Of those that are marketed, the industry claims that only about one in five will earn back all the development costs.

1906 Pure Food and Drugs Act

- Prohibited interstate commerce in adulterated or misbranded foods and drugs, bringing the federal government full force into the drug marketplace. - specifically referred to alcohol, morphine, opium, cocaine, heroin, Cannabis indica (marijuana), and several other agents - Each package was required to state how much (or what proportion) of these drugs was included in the preparation. - However, as long as the ingredients were clearly listed on the label, any drug could be sold and bought with no federal restrictions. - Its goal was to protect people from unscrupulous merchants, not from themselves. - provided the rootstock on which all our modern laws regulating pharmaceuticals have been grafted.

In what two ways was the new drug application important?

1) It changed the role of the FDA from testing and challenging some of the drugs already being sold to that of a gatekeeper, which must review every new drug before it is marketed. This increased power and responsibility led to a great expansion in the size of the FDA 2) The requirement that companies conduct safety research before marketing a new drug greatly reduced the likelihood of new drugs being introduced by small companies run by untrained people.

***Regulation of Pharmaceuticals***

1) Purity: 1906 Pure Food and Drugs Act (FDA), 1912 Sherley amendment (Congress) 2) Safety: 1938 Food, Drug, and Cosmetic Act; "New Drug Application" (NDA) sent to the FDA 3) Effectiveness 4) Marketing a new drug 5) Dietary Supplements

Current federal approaches to drug regulation in the United States can be traced to which three pieces of legislation?

1) The 1906 Pure Food and Drugs - regulated pharmaceutical manufacturing and salesAct 2) The 1914 Harrison "Narcotics" Act - regulated opioids and cocaine. 3) Alcohol prohibition, which was ratified in 1918 and implemented in 1919.

The ____ ___ _________ ordinance (city ordinance forbidding the practice of opium smoking, under the penalty of a heavy fine or imprisonment, or both) was the first U.S. law forbidding opium smoking. In 1882, New York State passed a similar law aimed at opium use in New York City's expanding _________.

1875 San Francisco Chinatown

An ______ ______ _____ permitted only American citizens to import opium or to manufacture smoking opium in the United States. It was partly in response to an _(year)___ agreement with China, which also forbade American citizens from engaging in the Chinese opium trade.

1890 federal act 1887

What is the amendment that outlawed "false and fraudulent" therapeutic claims on the label?

1912 Sherley amendment

The basic rules for introducing a new drug have been in place for more than __ years. Companies are required to demonstrate, through extensive chemical, biological, animal, and human testing, that the new drug they want to sell is both safe and effective. According to the pharmaceutical industry, the entire research and approval process now takes on average more than __ years and costs more than $1 _______.

40 10 billion

Morphine

A narcotic, the primary active ingredient in opium. (Heroine is made from morphine)

1962 Kefauver-Harris amendments

Added several important provisions, including: - the requirement that companies seek approval of any testing to be done with humans before the clinical trials are conducted. - Another provision required advertisements for prescription drugs (mostly in medical journals) to contain a summary of information about adverse reactions to the drug. - The most important change was one requiring that every new drug be demonstrated to be effective for the illnesses mentioned on the label. *** (As with the details of safety testing required by the 1938 law, this research on effectiveness was to be submitted to the FDA). - In 1966, the FDA began the process of evaluating the formulations of prescription drugs. - The FDA was also to begin a review of the thousands of products marketed between 1938 and 1962 to determine their effectiveness. [Ineffective ones were removed; In the next eight years (after 1966), 6,133 drugs manufactured by 2,732 companies were removed from the market].

Phase Three

Administers the drug to larger numbers of individuals (typically, 1,000 to 5,000) with the disease or symptom for which the drug is intended. If the compound proves effective in phase three, the FDA balances its possible dangers against the benefits for patients before releasing it for sale to the public

1937 passage of the Marijuana Tax Act

After newspaper reports linked marijuana smoking with crime, Anslinger adopted this new cause and began writing, speaking, testifying, and making films depicting the evils of marijuana. This effort succeeded in bringing public attention to the fight his bureau was waging against drugs and resulted in this act. Marijuana came under the same type of legal control as cocaine and the opiates, in that one was supposed to register and pay a tax to legally import, buy, or sell marijuana. From 1937 until 1970, marijuana was referred to in federal laws as a narcotic.

1988 Chemical Diversion and Trafficking Act

Allows the DEA to monitor chemicals that are not necessarily precursors, but are required for the illegal manufacturing of drugs (such as the acetic anhydride used in making heroin). (One issue of concern is that the over-the-counter drugs ephedrine and pseudo ephedrine can be converted into methamphetamine).

What did the Narcotics Division interpretation of the Harrison Act and all the arrests and prohibition cause?

American Medical Association had faith in that good doctors would not prescribe opium... Resulted in the growth of an illicit drug trade, which charged users up to 50 times more than the legal retail drug price. Opioid dependence came increasingly to be viewed as a police, rather than a medical, problem. The Narcotics Division also concluded that users in possession of heroin, morphine, opium, or cocaine who could not produce a valid prescription must have obtained the drug illegally, and they began to charge individual users with violating the Harrison Act. Thus, the use of the drugs was effectively criminalized for the first time, not because that was the intent of the 1914 Harrison Act, but because of the Narcotics Division's interpretation of it. Whether this would have eventually happened without the prohibitionist enforcement approach that resulted from alcohol prohibition being administered by the same agency is open to debate, but it almost certainly would not have happened as soon as 1919. Damn.

Why were there two different federal departments administering two different laws, when many of the drugs regulated by the two laws were the same?

Because the political issues to which each agency responded were different. The approach taken by each bureau was further shaped by court decisions, so that the actual effect of each law became something a bit different from what seems to have been intended.

It was the introduction of crack cocaine in the early 1980s and the fearful, emotional response generated by the media and politicians that led to significant amendments to the __________________.

Controlled Substances Act

Pure Food and Drugs Act was administered within the _________ __ _________.

Department of Agriculture (USDA)

Additional amendments in 1988

Designed to provide even more "teeth" for federal prosecutions. Components of this new law included more restrictions on aircraft registrations, requiring banks to report all transactions over $10,000 or other "suspicious activities," restricting firearms sales, and restricting chemicals used in the manufacture of drugs. The death penalty came back, this time for drug-related murders. A noteworthy change in the 1988 law was a toughening of approaches toward drug users, aimed at reducing the demand for drugs (as opposed to efforts to control the drug supply).

In the early 1900s, ________________, the father of American narcotics laws, decided the United States could gain favored trading status with China by leading international efforts to aid the Chinese in their efforts to reduce opium importation.

Dr. Hamilton Wright

Continued Issue

Drugs on Schedules II-V are available by prescription. Initially this system made it clear that there would be absolutely no legal access to Schedule I drugs such as heroin, LSD, or marijuana. Forty years later, this Schedule I distinction seems problematic. For about 30 years the drugs causing the most concern have not been Schedule I drugs (cocaine, methamphetamine, oxycodone, etc., are all available by prescription and therefore are not on Schedule I). Meanwhile, many states have passed medical marijuana laws that allow marijuana to be dispensed on a physician's recommendation. But marijuana remains on Schedule I under federal law, meaning no prescriptions are allowed and there is no legal method to provide marijuana. Perhaps the time has come to reevaluate the entire system of schedules.

Narcotic Control Act of 1956

During the height of the so-called McCarthy era, during which a mere hint by Senator Joseph McCarthy that someone associated with "known Communists" was enough to ruin that person's career. Anslinger and Hoover were aware that McCarthy, in addition to his widely known alcohol abuse, was dependent on morphine. Anslinger secretly arranged for McCarthy to obtain a regular supply of his drug from a Washington, DC, pharmacy without interference from narcotics officers. Meanwhile, Congress waged its public fight against both crime and communism by passing this act, with the toughest penalties yet. Under this law, any offense except first-offense possession had to result in a jail term, and no suspension, probation, or parole was allowed. Anyone caught selling heroin to a person younger than 18 could receive the death penalty. Anslinger commented on that particular provision by saying, "I'd like to throw the switch myself on drug peddlers who sell their poisons to minors."

Further amendment in 1994

Extended the death penalty to so-called drug kingpins (leaders of large-scale drug distributing organizations).

In October 1905, Collier's magazine culminated a prolonged attack on patent medicines with a well-documented, aggressive series titled "_____ ___________ _____."

Great American Fraud

Dr. Wright drafted a bill, which was submitted by Senator Harrison of New York, titled "An Act to provide for the registration of, with collectors of internal revenue, and to impose a special tax upon all persons who produce, import, manufacture, compound, deal in, dispense, or give away opium or coca leaves, their salts, derivatives, or preparations, and for other purposes." What is the name of the act?

Harrison Act of 1914

For the first time, dealers and dispensers of the opioids and cocaine had to register annually, pay a small fee, and use special order forms provided by the Bureau of Internal Revenue. Physicians, dentists, and veterinary surgeons were named as potential lawful distributors if they registered. Which act was this?

Harrison Act of 1914

Which law was the seed, which has since sprouted into all of our federal controlled-substance regulations? It is very important to remember that individual use or possession of any drug was not criminalized by this law, and that physicians were still free to prescribe heroin, cocaine, or any other available drug...

Harrison Act of 1914

Schedule II

High potential for abuse Currently accepted medical use Abuse may lead to severe psychological or physical dependence. Ex: Morphine, Cocaine, Methamphetamine

Schedule I

High potential for abuse No currently acceptable medical use in treatment in the United States Lack of accepted safety for use under medical supervision. Ex: Heroine, Marihuana, MDMA (Ecstasy)

The ____________ ______ _______ moved to close municipal narcotics clinics in more than 30 cities from coast to coast. From 1919 to 1929, the Narcotics Division arrested about 75,000 people, including 25,000 physicians and druggists.

Internal Revenue Service (IRS)

1994 Dietary Supplement Health and Education Act

It broadened the definition of dietary supplements to include not only vitamins, minerals, and proteins but also herbs and herbal extracts. The labels are not allowed to make unsubstantiated direct claims, such as "cures cancer," but they are permitted to make general statements about the overall health and "well-being" that can be achieved by consuming the dietary ingredient. The label must then say, "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." Nevertheless, growth in sales of herbal products and other dietary supplements has been enormous, probably in large part because many consumers don't distinguish between the vague, general claims made by supplements and the specific, demonstrated effectiveness required of drugs

What was the single most important legislation that has shaped the federal government's approach to controlled substances?

It wasn't a "drug law" at all but, rather, the 18th Amendment prohibiting alcohol. That law was also to be enforced by the Treasury Department, and a separate Prohibition unit was established in 1919. The Narcotics Division was placed within that unit, and Colonel Levi G. Nutt was appointed the first director, with 170 agents at his disposal. Although the Harrison Act had not changed, the people enforcing it had.** Just as with alcohol, these people believed that the cure for narcotic dependence was to prevent the user from having access to the drug (in other words, opioid "prohibition," at least for those who were dependent). So, the new enforcers interpreted the Webb case to mean that any prescription of a habit-forming drug to a dependent user was not a "legitimate medical purpose," and they began to charge many physicians under the Harrison Act.

Schedule IV

Low potential for abuse relative to III Currently accepted medical use Abuse may lead to limited physical or psychological dependence relative to III. Ex: Alprazolam (Xanax), Fenfluramine, Zolpidem (Ambien)

Schedule V

Low potential for abuse relative to IV Currently accepted medical use Abuse may lead to limited physical or psychological dependence relative to IV. Ex: Mixtures having small amounts of codeine or opium

1997 FDA Modernization Act

Made several more procedural adjustments, including guidelines for annual postmarketing reporting by the companies of adverse reactions to some medications (so-called Phase IV reporting). Also, the act allowed companies to distribute information to physicians about other, less well-researched, uses for an approved medication

How it works in Portugal

Mandatory minimum penalties were done away with, as was the death penalty. Decisions about how best to control specific drugs were to be taken out of the political arena and based on the best available evidence from both a health and law enforcement perspective. Five "schedules" of controlled substances were established, and initially the secretary of health was in charge of deciding which substances to control under which schedule, based on objective evidence balancing potential medical uses against abuse potential. A person convicted for the first time of possessing a small amount of a substance could be allowed a year's probation and, if no violation occurred during that year, the conviction could be "erased." Penalties for making or selling controlled substances were greater than for simple possession, but in the original law no sentence greater than 15 years was provided for a first offense of distribution.

Patent Medicines

Medicines sold directly to the public under various trademark names. Primarily associated with the period before 1906. Many patent medicines contained habit-forming drugs.

America's "_______ _________" with federal alcohol prohibition during the 1920s played a very important role in how the nation approached other substances associated with the social problems

Noble Experiment

1922 Jones-Miller Act

Partly in response to the growing illicit market. It more than doubled the maximum penalties for dealing in illegally imported drugs to $5,000 and 10 years of imprisonment. Included also was the stipulation that the mere possession of illegally obtained opioids or cocaine was sufficient basis for conviction, thus officially making the user a criminal. Because illegal opioids were so expensive, many users came to prefer the most potent type available, heroin. Womp.

The broadest impact on drug use in this country came from the widespread legal distribution of ______ ______.

Patent Medicines

Narcotics

Pharmacologically, the term refers only to drugs having certain effects, with the prototype being the narcotic analgesics derived from opium, such as morphine and heroin

Schedule III

Potential for abuse less than I and II Currently accepted medical use Abuse may lead to moderate physical dependence or high psychological dependence. Ex: Anabolic steroids, most barbiturates, Dronabinol (THC)

Drugs Tests in Public Schools

Privacy versus helping the young the U.S. Supreme Court in 1995 allowed drug testing of athletes, based partly on evidence from the school in question that its student athletes were at a higher than average risk for drug use In 2003, President George W. Bush endorsed random testing of all students, and provided federal funds to assist school districts in implementing these programs. However, as of 2012, the legality of random, suspicionless urine testing for all public school students has not been established at the federal level.

Controlled Substances Act

Provides that the attorney general may include on the schedules any "immediate precursor" of a controlled substance. An immediate precursor would be the raw material that could be made in one step into the controlled substance.

***State and Local Regulations***

Regarding the legal sales of prescription and over-the-counter drugs, there is considerable uniformity across the states, but some details do differ. More or less the same schedules, but penalties can vary greatly between states. Federal versus state charges...

2005 Combat Methamphetamine Epidemic Act

Requires identification and a signature for all sales of products containing these drugs in the United States.

Comprehensive Drug Abuse Prevention and Control Act of 1970

The 1970 law threw out everything that went before and started with a clean slate, based on current research and a rational approach that attempted to balance public health concerns with law enforcement issues. Part of the law gave increased funding to the Department of Health, Education, and Welfare (now the Department of Health and Human Services) for research, treatment, and prevention efforts. The other major part established that certain drugs were to be controlled directly rather than through tax or interstate commerce laws. The responsibility for this enforcement was transferred to the Justice Department's new Drug Enforcement Agency (DEA), a branch of the Department of Justice.

In conclusion of the 1970 reform:

The 1970 reform was widely greeted as an improvement, both by people concerned about the overly harsh and punitive nature of previous laws and by law enforcement people looking for a more logical and consistent framework. However, subsequent events have led to amendments that have reversed most of these benefits and once again resulted in a system that is both very complex and quite punitive in nature.

Amendments to the Controlled Substances Act in 1986

The 1986 law stiffened penalties for selling drugs, and reinstituted mandatory minimum sentences and sentences without parole. Congress established specific amounts of drugs in possession that would trigger the higher "trafficking" penalties This discrepancy has proved to be quite controversial in recent years and led to an important 2007 Supreme Court decision. Overall, the longer sentences, mandatory minimums, and no-parole provisions of the 1986 law have contributed greatly to a huge growth in prison populations over the past 20 years.

In the 1930's, there was no legal requirement that medicine be safe. How then, did the federal government (FDA) manage to seize the elixir which caused kidney poisoning and led to the death of 107 people? What did this lead to?

The FDA seized the elixir on the grounds that a true elixir contains alcohol, and this did not. The chemist committed suicide, the company paid the largest fine ever under the 1906 law, and a public crisis arose, which led to passage of the 1938 Food, Drug, and Cosmetic Act.

The 1906 publication of Upton Sinclair's ___ _______ exposed the horribly unsanitary conditions in the meatpacking industry, shocking Congress and America. (Five months later, the Pure Food and Drugs Act was passed).

The Jungle

1925 Linder case

The U.S. Supreme Court declared it could be legal for a physician to prescribe opioids for a dependent user if it were part of a curing program and did not transcend "the limits of that professional conduct with which Congress never intended to interfere." However, the damage had been done, and most physicians would have nothing to do with drug-dependent patients.

What is the most important issue that arises from these "Schedules"? (US)

The most important issue to arise out of this has to do with the difference between Schedule I (the most restrictive) and all the other schedules. The key point is that Schedule I drugs have "no currently acceptable medical use in treatment in the United States." Physicians are not allowed to prescribe Schedule I drugs, and they are not found in pharmacies.

In 1997, the Food and Drug Administration began to allow commercials on radio and television to mention drugs by name. What did the ads have to mention?

The most important warnings and possible side effects associated with the drug...

What was a critical change in the 1938 Food, Drug, and Cosmetic Act?

The requirement that before a new drug could be marketed its manufacturer must test it for toxicity. The company was to submit a "new drug application" (NDA) to the FDA. This NDA was to include "full reports of investigations which have been made to show whether or not such a drug is safe for use." If the submitted paperwork was satisfactory, the application was allowed to become effective.

Sentencing

The sentencing system has once again evolved into a bureaucratic nightmare. Too complex and many factors involved, like possession versus distribution, first or repeated offense, Homeland Security, etc.

Symbolic impact

The symbolic results of the legislation provide status benefits to the supporters of criminalization regardless of how effectively the laws are actually enforced. The people who promote such laws gain immediate social status, first by being identified as supporting goodness, morality, and decency, and then when the law passes by being on the winning side. (Regardless of how effectively the laws are actually enforced).

President _______ ________ recommended in 1905 that a law be enacted to regulate interstate commerce in misbranded and adulterated foods, drinks, and drugs

Theodore Roosevelt

Prescription Drug Marketing Act of 1988

Tightened the procedures whereby drug company salespeople could provide free samples to physicians, after Congress had heard testimony about widespread diversion of samples. Also, because counterfeit and adulterated drugs had found their way into the U.S. market from abroad as shipments of "American goods returned," new regulations were added covering the transfer and reimportation of drugs.

The Harrison Act was administered by the _____ __________.

Treasury Department

Testing Methods

Urine testing, the standard method for many years, is said to be capable of detecting most kinds of drugs for up to three days, as the drug, or its metabolites, clears the system. But that depends on how much drug was used and on the detection levels set for triggering a positive result The metabolites of marijuana can be detected in the urine for five days or more. For someone who has been smoking a lot of marijuana for a long time, urine tests may be positive for a couple of weeks or more after the last dose. One concern employers and officials have about urine testing is whether a drug user can beat the test, by substituting a clean urine sample from someone else, by diluting the urine, or by ingesting something that will mask the presence of a drug in the urine.

Experiment in Portugal

While drug trafficking is still illegal, drug possession has been decriminalized, for all drugs. Focus on prevention and treatment, and less on criminal prosecution and imprisonment.

To better coordinate all these federal efforts, the 1988 law established the cabinet-level position of director of national drug control policy (commonly referred to as a "_____ ____"). This individual is ordered by the legislation to prepare a national drug-control strategy and an annual consolidated drug-control budget for all federal agencies involved, to advise the National Security Council, and to report directly to the president. The Office of National Drug Control Policy was reauthorized and given additional authority in 1998.

drug czar

Pure cocaine became available in the mid 1800's, and its use increased over time. "Negroes" used it a lot in the south and it raised violent crimes. This caused a widespread fear which helped build support for _____ ______ ______ ______ among Southern senators and congressmen despite their typical "state's rights" opposition to increasing federalism.

federal drug control laws

From its beginning, the FDA had adopted the approach of encouraging voluntary cooperation, which it could obtain from most of the manufacturers through educational and corrective actions rather than through punitive, forced compliance. As more and more cases were investigated, FDA officials determined that many of the violations of the 1906 law were unintentional and caused primarily by _________________ and __________________________________. The FDA began developing assay techniques for various chemicals and products and collaborated extensively with the pharmaceutical industry to improve standards.

poor manufacturing techniques an absence of quality-control measures

What is one issue that should be of concern for users of dietary supplements?

rather than the company demonstrating the safety of the supplement before it is marketed, the FDA must prove that the product is unsafe before its sale can be stopped.

Misbranding

referred only to the label, not to general advertising, and covered "any statement, design, or device regarding...a drug, or the ingredients or substances contained therein, which shall be false or misleading in any particular."

After the passage of the federal 1970 Controlled Substance Act...

states began to adopt the Uniform Controlled Substances Act, a model state law recommended by the DEA. The majority of states have adopted the same five schedules as in the federal law, but not all.

In 1924, another act prohibited importing opium for the manufacture of heroin. Already by this time several important trends had been set:

- Users were criminals at odds with the regulatory agency - The growth of the illicit market was responded to with greater penalties and more aggressive enforcement - The focus was on attempting to eliminate a substance (heroin) as though the drug itself were the problem.

Although the ___________________ controlled opioids, which are narcotics, and cocaine, which is not, the enforcement effort focused so much on the opioids that eventually the enforcement officers became known as narcotics officers, the office within the _____________ _______ officially became the Narcotics Division, and people began to refer to the "Harrison Narcotics Act," though the word narcotics was not in the original title. ** The meaning of the term changed so much in political use that later federal laws incorrectly classified cocaine and then marijuana as narcotics. ** Bruuuuuh

1914 Harrison Act Treasury Department

Scheduling

A 1984 law allowed the Justice Department to "trump" the secretary of health by immediately placing a drug on Schedule I, pending later review. This provision was used right away to place the hallucinogen MDMA (Ecstasy) on Schedule I. Since then, the DEA has had the major voice in determining which drugs to schedule and at what level. In an even greater overturning of the original logic of the scheduling system, in 2000 Congress itself mandated that GHB, which had surfaced as a date-rape drug, be placed on Schedule I.

The Bureau of Narcotics

Answering the call for new approaches to dependence, and in response to the end of Prohibition and to charges of corruption in the previous Narcotics Division, in 1930 Congress formed a separate Bureau of Narcotics in the Treasury Department. Harry Anslinger became the first commissioner of that bureau in 1932 and took office with a pledge to stop arresting so many users and instead to go after the big dealers. Anslinger became the first "drug czar," although he wasn't called that at the time. To some extent, he followed the lead of J. Edgar Hoover, director of the Federal Bureau of Investigation (FBI). Each of these men was regularly reappointed by each new president, and each built up a position of considerable power and influence. Anslinger had almost total control of federal efforts in drug education, prevention, treatment, and enforcement for 30 years, from 1932 to 1962. No federal orPage 60 state drug-control law was passed without his influencing it, and he also represented U.S. drug-control interests to international organizations, including the United Nations.

What were the different international political interests that helped bring about the Harrison Act of 1914?

At the request of the United States, an international conference met in 1912 to discuss controls on the opium trade. Great Britain, which was giving up a very lucrative business, wanted morphine, heroin, and cocaine included as well, because, as opium was being controlled, these German products were replacing it. Eventually, several nations agreed to control both international trade and domestic sale and use of these substances. In response... the bill was drafted by Dr. Wright.

Prison versus Treatment

By 1928, people sentenced for drug violations made up 1/3 of the total population in federal prisons. Even though the 1920s were the period of alcohol prohibition, twice as many people were imprisoned for drug violations than for alcohol. In 1929, Congress decided to focus on treatment rather than punishment. Created "narcotic farms", one in Kentucky in 1935.

Phase One

Encompasses studies with relatively low doses of the drug on a limited number of healthy people—typically, 20 to 80 company employees, medical school personnel, and others who volunteer for such trials. At this stage the researchers are primarily interested in: - learning how their drug is *absorbed* and *excreted* in healthy people - learning about the *side effects* it may trigger.

carbamazepine

Example of "off-label" prescribing drug. Originally tested and approved for use as an anticonvulsant. Based on published research as well as clinical experience, the drug is also widely prescribed as a mood stabilizer, even though it has not received FDA approval for that use.

ephedra

FDA became concerned in 1997 about this dietary supplement, which is found in many herbal weight-loss products. In high doses, this herbal product can cause dangerous increases in blood pressure and interfere with normal mechanisms for reducing body heat during exercise. It took seven years and the well-publicized deaths of some athletes before ephedra was banned in 2004

Reason for adopting Drug tests for private employers

First, companies believe that drug-free workers will be absent less often, will make fewer mistakes, will have better safety records, and will produce more and better work. Second, by spending relatively few dollars on drug tests, they protect the company against negligence suits that might follow if a "stoned" employee hurt someone on the job or turned out a dangerously faulty product. Companies doing business with the federal government have an additional reason—they are required to have drug-free workplace rules in place.

After the Civil War, blacks moved north to take jobs in factories; the U.S. Army battled Native Americans in the West; Chinese immigrants came in large numbers to build the intercontinental railroads and to work in mines; Mexican laborers came to the South and Southwest to work in the fields; and immigrants from Italy, Ireland, and other parts of Europe also came to contribute labor to all these efforts.

For some, this was just too much social change in too short a time period. For many Americans, concerns about drunkenness, crime, drug misuse, and other forms of deviant behavior came to be associated with minority racial groups, adding fuel not only to beliefs about the immorality of members of those races, but also to the desire to pass tough laws regulating these undesirable behaviors. The legacy of those beliefs and those laws remains with us today.

The Food and Drug Administration (FDA) went on testing products and pursuing any that were adulterated or didn't properly list important ingredients, but they also went after many companies on the basis of their therapeutic claims. In 1911, what incident occurred that made Congress pass an amendment, and what was it called?

In 1911, government action against a claimed cancer cure was overturned by arguing that the ingredients were accurately labeled and that the original law had not covered therapeutic claims, only claims about the nature of the ingredients. Congress rapidly passed the 1912 Sherley amendment, which outlawed "false and fraudulent" therapeutic claims on the label.

** After the Harrison Act **

In 1914, it was estimated that about 200,000 Americans—1 in 400—were dependent on opium or its derivatives. Until the 1920s, most users continued to receive opioids quietly through their private physicians, and in most large cities public clinics dispensed morphine to users who could not afford private care. Early enforcement efforts focused on smugglers and did not result in a large number of arrests.

Military and Federal Employees

In 1986, President Reagan first declared that random urine tests should be performed on all federal employees in "sensitive" jobs. He also urged companies doing business with the federal government to begin testing their employees if they had not already done so. Since then, most federal employees have become subject to at least the possibility of being asked to provide a random urine sample, although the actual frequency of such tests is rare in most federal occupations.

International (fun fact)

In a challenge to the international ban on drug trafficking, Uruguay became the first nation to completely legalize the sale and use of marijuana. Some have hailed this move as beneficial to peace in the Americas and have nominated Uruguay's president Mujica for the Nobel Peace Prize. But the chief of the United Nations' Narcotics Control Board has criticized him for violating international treaties.

Phase Two

Involves patients who have the condition the candidate drug is designed to treat. These studies involve a few hundred patients who are chosen because the new agent might help them.

What was the Agriculture Department's aim when administering the law (Pure Food and Drugs Act)?

It aimed at ensuring that drugs (and then food) were pure and honestly labeled.

What did the 1938 Food, Drug, and Cosmetic Act also stipulate?

It also stipulated that drug labels either give adequate directions for use or state that the drug is to be used only on the prescription of a physician. Thus, the federal law now recognized a difference between drugs that could be sold over the counter and prescription-only drugs.

Dangers of reporters and new drugs coverage:

Most news stories do not fully convey the risks and costs of drugs. Fame for investigators/institutions, future research grants , and corporate profits are often at stake, so reporters are barraged with daily news releases, expert testimonials, and public relations phone calls, which can cloud news judgment. Overstating drug benefits can create demand among consumers, with the possible effect of physicians writing prescriptions for expensive drugs with potentially harmful side effects.

1983 Orphan Drug Act

Offers tax incentives and exclusive sales rights for a guaranteed seven years for any company developing a drug for rare disorders afflicting no more than 200,000 people. Up to that time, companies had stayed away from much research on rare disorders because they couldn't earn enough to recover the enormous research costs. By 2011, more than 360 drugs developed under this act had received FDA approval. However, because of the limited market, many of these orphan drugs are extremely expensive, with some costing more than $100,000 per patient per year.

What are the two important classes of drug laws?

One group of laws regulates the practices of pharmaceutical companies, pharmacists, physicians, dentists, veterinarians, and others who manufacture or dispense "legal" drugs. (Similar to laws that regulate the safety of other kinds of products, such as automobiles, furnaces, and toys). The other class of laws are those that have resulted in the criminalization of certain types of drug use, possession, and sales.

In the late 1950s, the U.S. Senate began a series of hearings investigating high drug costs and marketing collaboration between drug companies. What was one major concern?

One major concern was that some of the most widely sold over-the-counter medications were probably ineffective. (Ex: Carter's Little Liver Pills) No law required the medicines to actually do anything. Amendments to the Food, Drug, and Cosmetic Act were written but were bottled up in committee.

The new practice of smoking opium, introduced by Chinese workers brought to US after the Civil War, upset the status quo and caused society to react. A contemporary report in 1882 described both the spread of opium smoking in ___ ___________ and the reactions it elicited.

San Francisco

Analogue Drug Act in 1986

States that any drug or any chemical intended for human use that is substantially similar to a controlled substance is also controlled under the same schedule. However, the law was overturned on the grounds of being too vague.

What are the two kinds of impacts after the criminalization of certain types of drug use, possession and sale?

Symbolic and Instrumental

"Designer drug"

Term coined in the 1980s to refer to chemicals that are close relatives of controlled substances but not themselves listed on one of the schedules.

What "disaster" raised public awareness and congressional concern before major reforms were implemented?

Thalidomide, a sedative and sleeping pill, was first marketed in West Germany in 1957. The drug was used by pregnant women because it reduced the nausea and vomiting associated with the morning sickness experienced early in pregnancy. An American company submitted an NDA in 1960 to market thalidomide, but luckily the FDA physician in charge of the application did not approve it quickly. In 1961 and early 1962, it became clear that thalidomide had been responsible for birth defects. In West Germany, hundreds of children had been born with deformed limbs. The American company had released some thalidomide for clinical testing, but, because its NDA was not approved, a major disaster was avoided in the United States.

Drug Abuse Control Amendments of 1965

The early 1960s saw not only an increase in illegal drug use but also a shift in the type of drugs being used illegally. Most users were supposed to be educated but there were many emergency calls from abusing these drugs (Barbiturates, amphetamines, and hallucinogens). So although amphetamines and barbiturates were legal prescription drugs, it was felt that they should be under the same types of controls as opioids, cocaine, and marijuana. Amendments referred to these as dangerous drugs and included hallucinogens, such as LSD. The Bureau of Narcotics became the Bureau of Narcotics and Dangerous Drugs. Young people with money were buying these drugs nonetheless.

Instrumental impact

The instrumental impacts of criminalization refer to the consequences to those affected by the implementation of the laws: Effects on local, state, and federal budgets, effects on the lives of those who are arrested and their families, and effects on the police agencies, prosecutors, prison guards, and others whose livelihood may depend upon the implementation of the laws.