Drugs Chp3

What national figure was most prominent in the passage of the 1906 Pure Food and Drug Act, after prodding from physicians and scientists?

Theodore Roosevelt

What was the proposed U.S. drug enforcement budget in 2010?

$15 billion

What two main reasons do private corporations have for adopting drug testing?

1). 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. 2). 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.

Name at least four problems that lead to drug legislation that began at the turn of the twentieth century

1). Opium- In the early 1800s, opium was the medical doctor's most reliable and effective medicine, used for a variety of conditions but most notably as a pain reliever. Physicians prescribed various forms of opium liberally and with only limited concern about patients developing dependence. Commercial production of pure morphine 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 "morphinism." By the start of the 20th century, most physicians were aware of the dangers of morphine overuse, but many patients had developed morphine dependence under their doctor's care and relied upon their physicians and pharmacists for regular supply. Physicians debated whether they had developed a disorder requiring continued treatment (medical view of dependence) or whether they were simply weak-willed and seeking the pleasure in the drug's effects (moral model of dependence). During the reform era, the moral model became popular.

What is a Schedule II drug? Name a few.

1.High potential for abuse 2.Currently accepted medical use 3.Abuse may lead to severe psychological or physical dependence Ex. Morphine, cocaine, meth

What is a Schedule I drug? Name a few.

1.No currently acceptable medical use in treatment in US 2.Lack of accepted safety for use under medical supervision 3.High potential for abuse Ex: Heroin, Marijuana, MDMA

What act, pushed by Anslinger, was extremely punitive and included the death penalty for anyone selling heroin to a person under 18?

1956 Narcotic Drug Control Act.

Name at least four problems that lead to drug legislation that began at the turn of the twentieth century

2). Patent medicines- The broadest impact on drug use in this country came from widespread legal distribution of patent medicines. Patent medicines were dispensed by traveling peddlers and were readily available at local stores for self-medication. Sales of patent medicines increased from $3.5 million in 1859 to $74 million in 1904. Conflict increased between the steady progress of medical science and the therapeutic claims of the patent medicine people. The alcohol and other habit forming drug content of the patent medicines was also a matter of concern. ("Great American Fraud")

Name at least four problems that lead to drug legislation that began at the turn of the twentieth century

3). Opium and the Chinese- In the mid-1800s, many British and some American merchants were engaged in the lucrative sale of opium to the Chinese, and many reformers and world leaders disapproved. In 1833, the US signed its first treaty agreeing to control international trade in opium, and a regulatory tax on crude opium imported into this country was legislated in 1842. The US imported Chinese workers after the Civil War, mainly to help build the rapidly expanding railroad, and some of the people brought with them the habit of smoking opium. As always happens when a new habit is introduced into society, the practice smoking opium spread rapidly. Also as always happens, the new practice upset the status quo, and cause society to react. This 1875 San Francisco law was the first US law forbidding opium smoking. In 1882 the New York State passed a similar law aimed at opium used in New York City expanding Chinatown. In 1890 federal permitted only American system to import opium or to manufacture smoking opium in the United States. Although this law is sometimes viewed as a racist policy, it was partly in response to an 1887 agreement with China, which also forbade American citizens from engaging in the Chinese opium trade. As more states and municipalities outlawed opium den, the cost of black market opium increased, and many of the lower class opium users took up morphine or heroin, which were readily available and inexpensive.

Name at least four problems that lead to drug legislation that began at the turn of the twentieth century

4). Cocaine - pure cocaine became available in the mid-1800s, and its use increased over time. By 1900, its presence in many patent medicines and tonics, and its ready availability by mail order and pharmacies led medical experts to be increasingly concerned about the effects of overuse. In early 1900s, drug reformers repeatedly raise the public issue: cocaine sniffing has become widespread among southern Negroes, and it was responsible for an increase in violent crime perpetrated by those among the lower class of blacks in the South. The widespread distribution of this largely unsubstantiated fear was especially important in building support for federal drug laws among southern senators and congressmen despite their typical states rights opposition to increasing federalism.

What did the 1938 Food, Drug and Cosmetic Act provide for?

A critical change in the 1938 law was 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 report of investigation 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. The new drug application provision was important in two ways: first, it changed the role of the FDA from testing and challenging some of the drug 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. Second, 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. The 1938 act 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.

What is the "Uniformed Controlled Substance 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 six states have a different breakdown of schedules(four, six, or seven categories), and three states have a completely different method of categorizing illicit drugs that is not based on "schedules."

How much money does the Department of Homeland Security allocate to drug Control efforts annually? What percent of its' overall budget does that represent?

About $2 billion, or 20% of its overall budget, to drug control efforts

Why did Congress create the position of "Drug Czar" in 1988?

To better coordinate all these federal efforts, the 1988 law established the cabinet-level position of director of national drug control policy.

How, and with what legislation, was marijuana first controlled in the U.S.?

Anslinger 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 the 1937 passage of the Marijuana Tax Act. Marijuana came under the same type of legal control as cocaine and opiates, in that one was supposed to register and pay a tax to legally import, buy, or sell marijuana.

What Federal Agency administered the Harrison Act?

Bureau of Internal Revenue (Treasury Department)

What were the main implications of the 1994 Dietary Supplement Health Education Act?

Certain druglike products, such as vitamin pills, are not drugs but rather are considered dietary supplements and treated more as foods. They don't need to be proved to be effective for a specific intended purpose. Many questions arose about whether such new products needed to be reviewed for safety before marketing them and whether some of the beneficial claims made by people selling them constituted mislabeling. In 1994 dietary supplement health and education act cleared up many of those issues. If 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 statement about the overall health and "well-being" that can be achieved by consuming the dietary ingredient. The label must then say, "the statement has not been evaluated by the FDA. 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 a large part because many consumers don't distinguish between the vague, general claims made by supplements, and the specific, demonstrated effectiveness required of drugs.

Assume that drug enforcement efforts do not work. Give a rationale

Critics have pointed out that despite escalating expenditures, more agents, and an increasing variety of supply-reduction effots, the supplies of cocaine, heroin, and marijuana have not dried up; in fact, they may have increased. Although there have been record-breaking seizures of cocaine year after year, the price of cocaine has actually decreased since the 1980s. The US gov't made a decision in 1924 to make heroin completely unavailable, and after more than 80 years it has consistently failed. Efforts to eradicate illegal coca fields in South America failed (more popping up than there were destroyed). Even if eradication and interdiction efforts resulted in a major disruption of a particular source of a country's production, it would take only about two years for the market to push production back to the previous levels.

The Act separated law enforcement from scientific evaluation of drugs. Who was given responsibility of control (law enforcement) and who was given scientific control (which drugs to control)?

DEA - law enforcement Department of Health, Education, and Welfare (now Department of Health and Human Services for research treatment, and prevention efforts.

What was the significance of the "Elixir Sulfanilamide" incident in 1937?

Diethylene glycol causes kidney poisoning and within a short time 107 people died from taking it. The federal government could not intervene simply because the mixture was toxic - there was no legal requirement that medicine be safe. The FDA seized the elixir on the grounds that a truly elixir contains alcohol and this did not. Public crisis arose, which led to the passage of the 1938 Food, Drug, and Cosmetic Act.

What Supreme Court case declared that narcotic prescriptions were not legal as part of a "cure" program?

Dr. Webb- telephone orders for opioids. (Harrison Act)

The Controlled Substance Act changed enforcement authority from one department to another.......What departments are we referring to?

From the Treasury Department to the Justice Department's new Drug Enforcement Agency (DEA)

Name the two most common types of drug screening methods that have minimized problems with invasion of privacy?

Hair and Saliva

What act made it mandatory for dealers and dispensers of narcotics to register annually with the Treasure Department's Bureau of Internal Revenue? What was the year of its passage?

Harrison Act of 1914

Who was the first commissioner or "drug czar" of the Bureau of Narcotics

Harry Anslinger

What was the nature and importance of the 1911 overturning of a government ban on a particular cancer cure?

In 1911, the 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 in 1912 Sherley amendment, which outlawed "false and fraudulent" therapeutic claims on the label.

What was the rationale for the establishment of two narcotic farms in 1929?

In 1929, Congress viewed this enormous expenditure for drug offenders as an indicator that something was wrong and decided that users should be cured rather than repeatedly jailed. It voted to establish two narcotic farms for the treatment of persons dependent on habit-forming drugs who had been convicted of violating a federal law.

What is the role of the DEA in foreign countries? How many countries have DEA involvement?

International effots aimed at reducing the drug supply include State Department programs that provide aid to individual countries to help them with narcotics controls, usually working in conjunction with the DEA. The DEA has agents in more than 40 countries, and they assist the local authorities in eradicating drug crops, locating and destroying illicit laboratories, and interfering with the transportation of drugs out of those countries.

What led to the 1986 and 1988 amendments to the Controlled Substance Act

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.

Why is it legal to drug test public high school athletes and band members but not the entire study body?

Many believe that testing the gen pop is an invasion of privacy, and that testing a student without reasonable cause destroys the amount of trust between students and school officials. The US supreme court in 1995 allowed drug testing of athletes, based upon the evidence from the school that its student athletes were at a higher than average risk for drug use. A 2002 Supreme court case upheld the testing in extracurricular activities, since they are voluntary.

What legislation shaped the federal government's approach to controlled substances more than any specific "drug law"?

The 18th Amendment which prohibited alcohol.

What was the most important change added to the 1938 Food, Drug, and Cosmetic Act by the 1962 Kevauver-Harris amendments?

The 1962 amendments added several important provisions including a 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 the effectiveness was to be submitted to the FDA. The FDA was also to begin a review of the thousands of products marketed between 1938 and 1962 to determine their effectiveness. Any that were found to be ineffective were to be removed from the market.

What stand did the AMA take regarding the prescribing of opiates to dependent users?

The AMA supported the view that reputable physicians would not prescribe morphine or other opioids to dependent users.

What industry was first to use random urine testing on a large scale?

The Navy, followed by other armed forces, was the first to use random urine screening on a large scale. Soon to follow were tests of people in various high-risk high-profile positions, oil field workers, air traffic controllers, and professional athletes.

Assume that drug enforcement efforts do work. Give a rationale

The laws do work at one level. 10-15% of the illegal drug supply is seized by federal agencies each year. These efforts make it difficult and expensive to do business as a major importer. Evidence that supply is restricted can be found in the high prices charged on the street. The price is many times more than the cost of the drug itself if sold legally. It is likely that the high cost influences the amount taken by some of the users. Local efforts make a difference. Small pushers forced to work out of sight are less able to contact purchasers and both the buyer and the seller have a higher risk of being hurt or cheated in the transaction. This not only raises the cost of doing business, but it also probably deters some people from trying the drugs. Another kind of success is reported by many of those who are in treatment or who have completed treatment: they probably would not have stopped using when they did if they had not been arrested or offered treatment as an alternative to jail.

Why did Congress pass the Orphan Drug Act in 1983?

The 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 have stayed away from much research on rare disorders because they couldn't earn enough to recover the enormous research costs.

What is the most important practical concern associated with drug testing?

The rate of false positives.

What was the main prohibition that came about after the passage of the 1906 Pure Food and Drug Act?

This 1906 act prohibited interstate commerce in adulterated or misbranded foods and drugs, bringing the federal government full force into the drug marketplace. A drug was defined as any substance or mixture of substances intended to be used for the cure, mitigation, or prevention of disease. Of particular importance was the phrasing of the law with respect to misbranding. 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. The act specifically referred to alcohol, morphine, opium, cocaine, heroin, marijuana, and several other agents. Each package is required to state how much or what proportion of the strategy was included in the preparation. This meant for example, that the widely sold "cures" for alcohol or morphine dependence and to indicate that they contained another habit-forming drug. However, as long as the ingredients were clearly listed on the label, any drug could be sold and bought without federal restrictions. The goal was to protect people from unscrupulous merchants, not from themselves. The 1906 pure food and drug act provided the root stock on which all of our modern laws regulating pharmaceuticals have been grafted

The use of illegal drugs increased dramatically in the 1960's. This was exemplified by the percentage of emergency room calls in a number of large cities that involved adverse drug reactions. What was the percent?

Up to 15%

What "disagreement" over excise taxes on whiskey clearly established that the federal government had the power to enforce federal laws within states?

Whiskey Rebellion (1791-1794)

Under the Anti-Drug Abuse Acts what are some of the possibilities when convicted of possession?

•Civil fine up to $10k •Forfeiture of the car, boat, or plane conveying the substance •Loss of all federal benefits, including student loans and grants, for up to one year after the first offense and up to five years after a second offense