DRCNet Response to the
Drug Enforcement Administration
THE ILLICIT DRUG TRAFFIC AND THE DIVERSION OF PHARMACEUTICALS AND
|Modern science, technology and commerce have made possible the current problem of drug trafficking and the ready availability of drugs for abuse. Of all of the major drugs of abuse, only marihuana is available as a natural, harvested product. All of the others, whether illicit drugs such as heroin, cocaine, or methamphetamine, or narcotics, stimulants and depressants of legitimate manufacture, must be produced or manufactured using chemicals and techniques of recent origin. Thus we see that this traffic is heavily dependent on the availability of commodities from legitimate sources, whether it is the drugs themselves or the chemicals required for their synthesis.||What we see is that there are any number of ways to manufacture large quantities of drugs, no matter what the DEA does.|
|The history of social efforts to deal with the problem is largely the history of laws and treaties designed to restrict access to legitimate drugs and impose criminal penalties on illegal manufacture and distribution. More recently, these laws and programs have been extended also to the chemicals required for the refinement or synthesis of clandestinely manufactured drugs of abuse.||We invite everyone to read the history of these laws. See Historical References|
|The U.S. Drug Enforcement Administration (DEA) is the Federal agency responsible for the administration of these laws. The negotiation of the Hague Convention of 1911 and the passage of the Harrison Narcotics Act in 1914 marked the beginning of a series of laws and treaties which have evolved into the modern drug laws. The principal existing international treaties are the 1961 Single Convention on Narcotic Drugs, the 1971 Convention on Psychotropic Substances, and the 1988 U.N. Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances. The principal Federal law is the Controlled Substances Act of 1970, which has been amended on several occasions. One of the most significant additions was the passage of the Chemical Diversion and Trafficking Act of 1988 (CDTA) which extended the concept of commodity control to those chemicals most often used for the manufacture and synthesis of drugs of abuse. It should be noted, however, that the controls over chemicals are nevertheless substantially less than those imposed on drugs. In general, the drug laws have their counterparts at the state level and are based on the Federal model. The chemical controls have state counterparts only in states having a clandestine laboratory problem.|
The fundamental purpose of these laws and treaties may be described as follows:
(1) To prevent the diversion of controlled drugs and chemicals into the illicit drug traffic by restricting access through a variety of legal requirements;
(2) To detect such diversion as occurs through the examination of various records and accountability systems which are required to be maintained; and
(3) To identify, apprehend, and bring to justice, those persons responsible for diversion, whether through negligent or criminal acts.
|Within the DEA, the office responsible for the application of these laws is the Office of Diversion Control. The purpose of this paper is to describe briefly the nature of the problems encountered, the programs designed to deal with them, and to provide representative case examples to assist understanding. The Office is responsible for two distinct problems, which are: (1) the diversion of controlled pharmaceuticals, and (2) the diversion of controlled chemicals. Programs have been designed to deal with each of these problems utilizing a combination of civil, regulatory and criminal law enforcement measures. Each also has foreign and domestic aspects which are addressed through both field and headquarters activities.|
|Diversion of Controlled Pharmaceuticals|
|A great variety of narcotics, depressants and stimulants are manufactured for legitimate medical needs both in the United States and overseas. These are also drugs which are subject to abuse when available, and are therefore subject to diversion into the illicit traffic. The drugs which have been brought under legal control for this reason are listed individually in international treaties, the Controlled Substances Act and implementing regulations, and are referred to as "controlled substances."||The DEA is interfering in private medical care where it has no business. As a result, most of the pain patients in the United States cannot get adequate medication. For a more sinister view of the DEA's actions, see Deadly Morals. see also, The Tragedy of Needless Pain.|
|Pharmaceutical drugs of abuse comprise a unique aspect of the drug abuse problem. The goal of controls is not to eliminate their supply altogether, as with illicit drugs of abuse, but instead to both ensure their widespread availability for medical purposes and to prevent their distribution for illicit sale and abuse. Unfortunately, these drugs frequently reach the abuser through illegal manipulation of health care providers or by illegal activities by the providers themselves, and fraudulent health care claims often finance this abuse. Since these drugs are for the most part produced, distributed, and dispensed in the United States, and the principal "sources of supply" have a Federal and state license, this is one aspect of the drug abuse problem that is within our authority to control.||The DEA's approach to ordinary legitimate pain medications such as
morphine is massively abusive to pain patients. The Department of Health and Human
Services has estimated that two-thirds of all terminal cancer patients do not receive
adequate pain medication. The situation is even worse with non-terminal pain
patients. They commonly report that they must go through years of pain, medical
examinations, and legal problems to get access to ordinary pain medications. That is
why we formed the American Society for Action on Pain.
The DEA's policy toward legitimate medications is morally evil and unspeakably cruel. They have no business interfering in the legitimate medical treatment of severe chronic pain. See Linder v. US, 1925
|About 14 percent of all prescriptions written are for controlled substances and about 230 million prescriptions are written for them each year. Although the quantity which is diverted into the illicit traffic is unknown, these drugs account for over 30 percent of all the reported deaths and injuries associated with drug abuse.||That is only true if you do not consider the 400,000+ deaths from tobacco, or the 100,000+ deaths from alcohol. The DEA doesn't say where they get their figures for this paragraph, but under the highest estimates of deaths from illegal drugs, these prescription drugs could not account for more than about 6,000 deaths. By contrast, the American Society for Action on Pain estimates that there are about 7,000 suicides each year in pain patients who cannot get medication.|
|Legitimate drugs commonly found in the traffic are narcotics such as hydromorphone (Dilaudid), oxycodone (Percodan), codeine, methadone, and hydrocodone (Vicodin); stimulants such as amphetamine; and depressants such as alprazolam (Xanax) and diazepam (Valium).||Nearly all of these drugs are pain medications which are literally life-saving for many pain patients. Legitimate patients cannot get them because of the repressive policies of the DEA.|
|These legitimate drugs have effects more or less identical to illicit drugs and, like them, cost only pennies to produce but can be sold at a mark-up of several thousand percent. The initial act of diversion from an authorized source is accomplished in a number of ways, which requires some understanding of the system of legal controls.||The DEA has failed to note that there is no significant medical distinction between ordinary morphine and heroin (diacetyl morphine). There is simply no logical medical justification why this one particular variant of ordinary morphine should be banned entirely. If morphine is available to doctors to prescribe, there is no reason diacetyl morphine should not be available on the same basis.|
|Under Federal law, all businesses which manufacture or distribute controlled drugs, all health professionals entitled to dispense, administer or prescribe them, and all pharmacies entitled to fill prescriptions must register with the DEA. A registration can be denied, suspended or revoked on the basis of several criteria, including professional license sanctions, previous convictions, or incompatibility with public interest. A registrant must also maintain compliance with a series of regulatory requirements relating to drug security, records accountability, and adherence to standards. Consequently, drugs are diverted into the illicit traffic either by 1) criminal violations of these requirements, 2) negligent failure to meet requirements, 3) fraudulent manipulation of a health care provider, or 4) the use of force by an intruder. Once the drugs are diverted, they are sold in the illicit street traffic just like any other drug.||In actual practice, there is a poorly trained DEA agent who knows next to
nothing about medicine, knows absolutely nothing about the problems of pain patients, and
cares even less. The poorly trained agent simply looks at the list of doctors who
prescribed opiates and picks those who prescribe the most. This catches an
occasional pill-pusher, but far more often catches doctors who are prescribing to
legitimate pain patients. The DEA agent doesn't need to do much more than call the
doctor and mention that he is under scrutiny for his prescribing habits. Without
much more than a stupid decision and a stamp, the DEA agent can effectively give the
doctor such legal problems that few doctors want to risk tangling with them.
The net result is that the DEA's repressive policies are literally killing more people than the drugs themselves.
|DEA is obligated under international treaties to monitor the movement of licit controlled substances across U.S. borders, and for issuing import and export permits for that movement. Also, intelligence information and investigative reports are reviewed to determine weaknesses in foreign legitimate drug distribution systems, and to devise initiatives to deal with problems of international drug diversion.||Let's see now. They admit they cannot really control production of drugs in foreign countries, and they cannot control the flow of drugs across the border, and they cannot even control production of drugs within the United States. Now they want to take on the task of controlling a whole range of other chemicals which are not even drugs. The DEA is just going deeper into its own fantasy.|
|There exists generally a strong commonality of direction and purpose in Federal, state and local efforts to deal with controlled substances diversion.||This is genuinely funny. The lack of commonality was the original reason for the creation of the office of the Drug Czar. That didn't solve the problems, by any means.|
|However, authority for diversion control in the states is divided between medical licensing or pharmacy boards, state police, and/or specialized multiple agency Diversion Investigation Units. For this reason, DEA's diversion control program is the central source for national policy guidance, support and intelligence information.||Well, sure it is -- Nonsense Central.|
|Typical diversion cases involve physicians who sell prescriptions to drug dealers or abusers, pharmacists who falsify records and subsequently sell the drugs, employees who steal from inventory, executives who falsify orders to cover illicit sales, prescription forgers, and individuals who commit armed robbery of pharmacies and drug distributors. All of these are significant sources of diverted drugs; however, at the present time, it appears that the largest component of the problem results from the criminal activity of physicians and pharmacy personnel. The following are a few sample cases from the DEA files:||The existence of a few pill-pushers cannot justify the crimes that the DEA is committing against legitimate pain patients and the doctors who treat them. See the American Society for Action on Pain|
A four-year investigation into the activities of a Texas physician resulted in his being sentenced to 33 months in prison for Dilaudid trafficking. Investigation revealed that in the two year period of January 1988 to February 1990, Dr. Alberto Mares issued over 500 Dilaudid prescriptions totalling in excess of 54,000 dosage units of the drug. This quantity represented more than seven percent of all Dilaudid prescribed in Texas during that time period. Dr. Mares allegedly sold the prescriptions for $500 each with the assistance of his receptionist, who created fictitious patient charts and verified prescriptions for pharmacies in return for money and prescriptions. Dr. Mares also was ordered to pay approximately $80,000 restitution to the state Medicaid program.
A New York physician was convicted in 1995 for illegally distributing controlled substances within 1,000 feet of a public school, and conspiracy to do the same. Dr. Fevzi Ekinci wrote more than 3,200 prescriptions during a 14 month period for glutethimide (Doriden), a Schedule II narcotic, for other than legitimate medical purposes. More than 96,000 dosage units of glutethimide were distributed in New York as a result of these prescriptions, accounting for a substantial portion of all of that drug distributed in the state. At trial, several of Dr. Ekinci's patients testified that he worked in tandem with drug dealers stationed outside his office, which is located within a block of a public school. The doctor made a $100 profit on each prescription. Dr. Ekinci was sentenced to 41 months federal imprisonment and was fined $25,000. Civil forfeiture proceedings are pending against $423,000 seized from the doctor in 1993.
In January 1996, two federal search and seizure warrants were executed on the medical office of Dr. Eugene Youngue III and the Diet Rite Weight Loss Clinic located in Allegheny County, Pennsylvania. These warrants were based upon numerous undercover purchases, excessive controlled substance purchase reports provided by DEA Phoenix, and local pharmacy surveys. During the search it was learned that Dr. Youngue "lent" his DEA registration to Diet Rite Clinic for $250 per week and acted as a consultant, working two hours at the clinic weekly. A licensed practical nurse, whose nursing license had expired in 1992, was running the clinic, dispensing controlled and non-controlled substances and performing other medical procedures. In this nurse's absence, a receptionist/secretary dispensed medications. Dr. Youngue surrendered his DEA registration for the clinic, the Allegheny County Health Department closed the clinic down for lack of license, and DEA Pittsburgh removed approximately 90,000 dosage units of anorectic (weight loss) controlled substances.
Diversion of Controlled Pharmaceuticals from International Sources
During the last several years DEA has been involved in a number of investigations concerning the international diversion of legally produced controlled substances into illicit channels of distribution in the United States. These substances unlawfully enter international channels by way of concealment efforts as well as counterfeiting measures, and are diverted in the form of bulk powder or granules and as finished dosage units. The following examples underscore the importance of cooperation between DEA and foreign authorities in diversion control.
"Black Pearls" are illegally imported and distributed in the United States as Chinese herbal medicines to treat arthritis and other maladies of the elderly. These shiny black pills contain controlled substances such as diazepam, and other prescription drugs such as indomethacin and mefenamic acid, but are sold over-the-counter at health food stores and oriental markets. The user experiences temporary relief but the preparations are highly toxic. Their use has resulted in numerous injuries and some deaths. One Black Pearls investigation DEA conducted led to the seizure of 31 million Black Pearls, other controlled substances and assets totalling $11,000,000. As a direct result of this investigation, the source of supply was identified and an additional 19 million Black Pearls seized.
Flunitrazepam is an extremely potent sedative marketed in numerous foreign countries under the trade name Rohypnol. In the United States, where it is not approved for medical use, it is known as the "date rape" drug. Some street names for the drug are Rophies, Mexican Valium, and Roches (derived from the name of the manufacturer, Roche Pharmaceuticals). Rohypnol is being smuggled in increasing quantities from Mexico, Colombia and other South American countries. A survey of the border crossing at Laredo, Texas, revealed that in a three week period, over 100,000 dosage units of Rohypnol were transported into the United States under the guise of personal medical use. In 1996 investigations involving this drug more than doubled as smuggling incidences increased greatly. Two seizures of over 50,000 tablets each were made in Texas in early 1996, and a kilogram of Rohypnol was seized in Puerto Rico.
An international diversion scheme to smuggle legitimately-manufactured diazepam into the United States from Canada was uncovered by DEA's Long Island Resident Office. A non-registered pharmaceutical firm was used as a front for a drug trafficking ring. This firm was assisted by employees of a legitimate pharmaceutical manufacturer located in Toronto, which produced the diazepam 10 milligram tablets. In the course of this investigation, the major defendant revealed that he used his import/export business in Guyana, among other methods, to smuggle drugs into the United States.
Diversion of Controlled Chemicals
Most of the drugs in the illicit traffic are products of illicit processing or synthesis. Cocaine, for example, although a naturally occurring substance, can only be extracted and converted to its preferred form, hydrochloride salt, by using a tremendous quantity of industrial chemicals. Heroin must be synthesized by using an acetylating agent (i.e., acetic anhydride) after the morphine has been extracted by chemical process from the raw harvested opium. Examples of purely synthetic drugs manufactured from chemical precursors include methamphetamine, amphetamine, PCP, LSD, MDMA, methaqualone, and a range of so-called "designer drugs."
Ready access to legitimate supplies of a variety of chemicals is therefore critical to drug traffickers in all parts of the world. In general, there has been no difficulty for traffickers to obtain these chemicals even though the quantities purchased were far in excess of any demonstrable legitimate need. Traffickers are able to obtain chemicals in large quantities at relatively low cost as a result of the ignorance, indifference, or collusion of chemical distributors and international brokers. In fact business norms are such that inquiry is seldom made of a potential customer beyond establishing their ability to pay. Until recently, there were substantially no legal impediments to obtaining such chemicals, no records required to be maintained for inspection, and no penalties for negligence or willful diversion.
Domestic Chemical Diversion
The domestic features of the CDTA became effective on August 1, 1989. They include 1) requirements to identify customers, 2) requirements to maintain records for inspection by the DEA, 3) requirements to report suspicious transactions, and 4) civil and criminal penalties for negligent or willful acts. Immediately following the law's implementation, orders were issued for a national survey of all affected businesses with instructions to visit each company and advise them of the new requirements and penalties. The Office also organized a series of nationwide seminars for the business community to provide in-depth briefings and to establish government and industry cooperation. The results have thus far exceeded expectations. The number of clandestine laboratories seized during the first three years following the law's implementation reversed the trend of the last three decades and declined by 61 percent. In addition, injuries attributable to illicitly manufactured controlled substances that were reported through DAWN declined by almost 60 percent between 1989 and 1992. This represents an extraordinary law enforcement success in a brief period of time.
In the fall of 1985, DEA drafted legislation to impose certain limited but effective controls over the commerce in a list of critical chemicals. This resulted in the 1988 passage of the CDTA which went into effect at the end of 1989. At the same time, DEA, with the support of the State Department, pursued the same goal on the international level which resulted in the incorporation of Article 12 into the U.N. Convention Against Illicit Drug Traffic of 1988. This provision establishes similar controls over a list of 22 critical chemicals commonly diverted for the production of the major drugs of abuse.
These successes have also revealed weaknesses in the chemical law and domestic strategy which require response. The law itself does not cover chemicals which have been rendered into legitimate medicines for the commercial market. As a consequence, a small but significant number of distributors have been selling large quantities of ephedrine tablets to drug traffickers to use in the manufacture of methamphetamine and methcathinone. This loophole in the law was closed with the passage of the Domestic chemical Diversion and Control Act of 1993 (DCDCA). The major provisions of this new law include a registration requirement for all manufacturers, distributors, importers and exporters of List I chemicals. The DCDCA also removed the previous record keeping and reporting exemption for single entity ephedrine drug products. The DCDCA became effective April 16, 1994, and the record keeping and reporting requirements for single entity ephedrine drug products went into effect November 10, 1994. Proposed regulations to implement the DCDCA were published in the Federal Register October 13, 1994.
Since 1992 there has been an influx of major Mexican traffickers involved in the manufacture and distribution of methamphetamine. This trend is reflected in current DAWN data that show an alarming increase in the abuse of methamphetamine, especially on the West coast. Increased demand, combined with strict domestic chemical control laws, have forced these Mexican traffickers to locate sources of ephedrine outside the United States. Seizures made by the U.S. Customs Service at Dallas/Fort Worth International Airport in 1994 confirmed this fact. The seizures revealed that traffickers had made large cash purchases of bulk ephedrine from India and the Czech Republic through Swiss brokers. DEA is presently undertaking diplomatic initiatives with the countries involved to eliminate sources of ephedrine supply for the Mexican traffickers.
Foreign Chemical Diversion
The most urgent priority among the various foreign problems involving chemical diversion is the diversion of a great volume of chemicals into the Andean countries for the manufacture of cocaine hydrochloride. It is estimated that perhaps 20,000 metric tons of various industrial chemicals are annually used for this purpose, most of which must be imported into these countries. Principal among the chemicals are acetone, toluene, methyl ethyl ketone, ether, potassium permanganate, and hydrochloric and sulfuric acid. Prior to passage of the CDTA, the evidence indicated that most of these chemicals were obtained from suppliers within the United States who were unaware of the purpose for which they were being purchased.
The CDTA required that all U.S. exporters of controlled chemicals provide a list of their regular customers to the DEA for investigation in cooperation with the concerned foreign governments. As a consequence, 60 percent of the customers located in Colombia and 25 percent of the customers in other Latin American countries were disapproved. This meant that they were not likely to be approved for any subsequent chemical shipments, and in fact, none have been made. The law also requires that the DEA be notified of all impending exports of controlled chemicals and permits the shipments to be suspended if there is reason to believe that the chemicals may be diverted. Using this authority, DEA suspended 22 individual shipments, most of them to Colombia, for a total of 1,400 metric tons of material. Overall, however, working with the chemical industry and foreign governments, DEA has blocked 49 chemical shipments worldwide totalling 3,800 metric tons.
It has been obvious from the beginning that an international control effort would be necessary if traffickers were to be denied the current, unrestricted access to chemicals. For this reason, the DEA undertook an aggressive international control effort at the same time that it pursued domestic legislation. This resulted in the inclusion of Article 12 in the Vienna Convention, the International Conference on Chemical Diversion held in Brussels in June of 1990, the formation of the Chemical Action Task Force by the Group of Seven economic summit in July of 1990, and the first Conference on Chemical Operations organized by DEA in Lyon, France in September of 1991. A second major international chemical operations conference was co-hosted by DEA and the Commission for the European Union in Rome, Italy in June 1993. DEA organized two additional conferences in 1992 and 1994 to focus attention on drug and chemical control issues in Eastern Europe and the former Soviet republics.
All of this activity has resulted in a broad level of international agreement regarding the actions which must be taken. DEA has worked closely with the European Commission on chemical control. Chemical control measures recommended by the Chemical Action Task Force were incorporated into a European Community Council Regulation which came into force January 1, 1993 and is binding upon Community member nations. In addition, significant progress has been made in establishing cooperation with the German government which has halted several large chemical shipments to suspicious firms. Despite this action, operational cooperation with European chemical exporting countries is occurring only on an intermittent basis. Thus, traffickers are often still able to obtain the chemicals they need. DEA continues to aggressively pursue establishment of informal cooperative arrangements with chemical exporting countries to prevent chemical diversion to clandestine drug laboratories.
Diversion of Steroids
The newest area of responsibility for the Office regarding controlled pharmaceuticals is steroids. The Anabolic Steroid Control Act was passed by the Congress in the fall of 1990 and became effective on February 21, 1991. It classified 27 named steroids as Schedule III substances under the Controlled Substances Act which DEA administers. This legislation represented an initiative by the Congress following hearings which determined a national health problem of steroid abuse affecting perhaps six million people. No additional resources were provided to the DEA for the purpose of enforcing the Act. Nevertheless, Congress had identified a problem which involved illegal distribution and smuggling similar to the traffic in other drugs. As a consequence, DEA expanded existing regulatory and enforcement programs to include the control of these substances. A Special Enforcement Program devoted exclusively to steroids was developed and implemented. These efforts have been successful domestically. In the short period during which this program has been in effect, most of the diversion from legitimate domestic sources has ceased. Supplies are now usually smuggled into the United States from Mexico, South America or Western Europe and subsequently distributed much like any other illicit drug. The issue of international control of steroids needs to be incorporated within the State Department's strategy for supporting drug law enforcement.
The following cases give an impression of the type of activity and individuals involved:
A Brooklyn, New York high school teacher was arrested following an undercover operation in which he exchanged anabolic steroids for $15,000. This investigation was initiated after the teacher offered steroids to an individual at a school function. Following his arrest, the teacher agreed to implicate his source, a professional bodybuilder. The body builder then implicated his source, a Russian resident alien. This individual stated that he was supplied with steroids four times a year by a Russian living near Moscow. Following the arrests of the bodybuilder and resident alien, search warrants were served which resulted in the seizure of steroids worth $65,000, over $17,000 cash and two firearms.
Victor Terra, a former Mr. Universe title holder, pled guilty in July 1994 to conspiracy to import and distribute anabolic steroids. His organization, which included his brother and sister, was responsible for the distribution of large quantities of steroids throughout New England and California. Three separate deliveries of steroids from the U.K. totaling in excess of 260,000 dosage units were seized by DEA's Boston Division in June 1992.
A major international steroid smuggling operation involving hundreds of thousands of dollars worth of steroids was dismantled through the efforts of DEA Los Angeles, the FBI and Italian authorities. The steroids were diverted from licit sources in Italy and other European countries. The drugs were smuggled by couriers from Italy to the United States through New York's JFK airport. The FBI is seeking corruption charges against two USDA inspectors who routinely escorted the couriers past U.S. Customs. This case has resulted in four U.S. arrests and nine arrests in Italy, with another 45 Italian individuals' arrests pending.
In an ongoing conspiracy investigation involving a clandestine steroid manufacturing laboratory, three individuals were arrested in California. An organization manufactured and distributed counterfeit anabolic steroids which were produced from pulverized steroidal cattle implant pellets. Also being produced were non-sterile injectable products containing no active ingredient which were labelled as anabolic steroids. This highly sophisticated operation had obtained fraudulent packaging, labels, bottles, vials, and package inserts. Among the huge volume of items seized during the course of this investigation were labelling, an ampule sealing machine, two million counterfeit or bogus dosage units, $50,000 cash, and several firearms. Search warrants also were served at the firms which had produced the fraudulent labelling, resulting in the seizure of additional counterfeit packaging materials.
The Office of Diversion Control consists of approximately 145 personnel located at the DEA headquarters in Arlington. Of these, 80 are professional persons including diversion investigators, special agents, chemists, pharmacologists, program analysts and others. About 35 persons are engaged entirely in the process of annually registering some 800,000 physicians, 60,000 pharmacies, 12,500 hospitals, 6,000 researchers, 1,000 methadone treatment programs, 1,000 wholesale distributors, 400 manufacturers, and 250 importers and exporters. The Office's activities include:
Program field personnel consists of approximately 400 diversion investigators in 53 offices responsible for all aspects of civil and criminal diversion investigations; and 25 registration assistants responsible for liaison with state licensing boards. In addition, six diversion investigators are assigned to overseas posts.
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