DetailmenDetailmen and detailwomen are salespeople employed by pharmaceutical companies to persuade doctors to prescribe their medical drugs to patients. If the doctor does prescribe that drug company's medicine Drug companies spend $5 billion annually sending representatives to doctors' offices. Detailmen are often seen promoting their drugs to doctors during the doctor's business hours. Pharmaceutical companies say that detailing gives a an educational service by keeping doctorss updated on the latest changes in medical science. Detailmen have detailed personal information on doctors that include the names of the doctor's family members, golf handicaps, and even clothing preferences. Detailmen get information on what prescriptions the doctor is writing from IMS Health. Detailmen are under intense competitive pressure against other drug companies' medical drugs. Pharmaceutical Representative is a trade journal featuring sales tips for detailmen, such as how to sell to a stubborn doctor, or how to flatter a doctor, common tactics of any type of salesperson.
Detailmen also give doctors small gifts, such as free dinners, tickets to a ball game, clocks, free drug samples, pens, pads, and small toys with the company's logo. In 1990, the FDA passed laws banning "gifts of substantial value" (like VCRs, etc.) of drug companies to doctors. Minor gifts (like meals, tickets, cruises, and travel) are not banned. Sometimes detailmen will offer the doctors jobs so the doctor will be on the drug company's payroll. Critics say these are bribes that work - the doctor is much more likely to perscribe the drug company's drugs.
Detailmen also work the symposium circuit crowds. At a symposium, a drug researcher lectures about the benefits of a drug to an audience of doctors, while detailmen talk to individual doctors in the audience to get to know what they like personally. Detailmen then give the doctors what they want: sometimes free alcohol, women, and drugs, so say the detailmen. Critics compare detail men's methods to that of drug pushers of the illegal drug trade.
See also
- Pharmaceutical companies
- Sales
- Sales techniques
External links
- [http://www.washingtonmonthly.com/features/2000/0005.pomper.html Drug Rush]
Pharmaceutical companyA pharmaceutical company (or drug company) is a company licensed to discover, develop, market and distribute drugs.
History
Most large pharmaceutical companies were founded in the late 19th and early 20th century, and derive their market share from a few well-marketed preparations. There are currently more than 200 major pharmaceutical companies. [http://www.pharmacy.org/company.html see list] As in some other industries, economic pressures are forcing pharmaceutical companies toward greater efficiency.[http://www.infosys.com/industries/Lifesciences/SETLabs_Life_Sciences_Challenge.pdf]
Biotechnology company
A biotechnology company is any company that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use. Often biotechnology companies produce pharmaceuticals. Typically a biopharmaceutical made in this manner is composed of very large molecules that are unstable and must be administered by injection in a physician's office.
Drug discovery
Drug discovery is the process by which drugs are discovered and/or designed. In the past most drugs have been discovered either by identifying the active ingredient from traditional remedies or by serendipitous discovery. The new approach has been to understand how disease and infection are controlled at the molecular and physiology level and to target specific entities based on this knowledge.
New drugs begin in the laboratory with chemists, scientists and pharmacologists who identify cellular and genetic factors that play a role in specific diseases[http://www.ppdi.com/corporate/faq/about_drug_development/home.htm]. "They search for chemical and biological substances that target these biological markers and are likely to have drug-like effects. Out of every 5,000 new compounds identified during the discovery process, only five are considered safe for testing in human volunteers after preclinical evaluations. After three to six years of further clinical testing in patients, only one of these compounds is ultimately approved as a marketed drug for treatment. The following sequence of research activities begins the process that results in development of new medicines:"
Target identification
"Drugs usually act on either cellular or genetic chemicals in the body, known as targets, which are believed to be associated with disease. Scientists use a variety of techniques to identify and isolate a target and learn more about its functions and how these influence disease. Compounds are then identified that have various interactions with drug targets helpful in treatment of a specific disease."
Target prioritization/validation
"To select targets most likely to be useful in the development of new treatments for disease, researchers analyze and compare each drug target to others based on their association with a specific disease and their ability to regulate biological and chemical compounds in the body. Tests are conducted to confirm that interactions with the drug target are associated with a desired change in the behavior of diseased cells. Research scientists can then identify compounds that have an effect on the target selected."
Lead identification
"A lead compound or substance is one that is believed to have potential to treat disease. Laboratory scientists can compare known substances with new compounds to determine their likelihood of success. Leads are sometimes developed as collections, or libraries, of individual molecules that possess properties needed in a new drug. Testing is then done on each of these molecules to confirm its effect on the drug target."
Lead optimization
"Lead optimization compares the properties of various lead compounds and provides information to help pharmaceutical and biotechnology companies select the compound or compounds with the greatest potential to be developed into safe and effective medicines. Often during this same stage of development, lead prioritization studies are conducted in living organisms (in vivo) and in cells in the test tube (in vitro) to compare various lead compounds and how they are metabolized and affect the body."
Drug development
Drug development is considered a costly and intensive process. Of all compounds investigated for use in humans only a small fraction is eventually approved, and only after heavy investment in pre-clinical development, clinical data acquisition, clinical trials, and safety monitoring to determine the safety and efficacy of a compound. Most clinical trials are randomized. The cost for a new drug (new chemical entity) is estimated to be about $1 billion US$. This figure is however hotly disputed.[http://www.ppdi.com/corporate/faq/about_drug_development/home.htm] Depending on a number of considerations, a company may apply for and be granted a patent for the drug or the process of producing the drug for about 20 years. Only after rigorous study and testing, which can take as long as 12 years, will governmental authorities grant permission for the company to market and sell the drug. In special circumstances, such as the search for effective drugs to treat AIDS, the Food and Drug Administration (FDA) has encouraged an abbreviated process for drug testing and approval called fast-tracking.[http://www.ppdi.com/corporate/faq/about_drug_development/home.htm]
Clinical testing is usually described as consisting of Phase I, Phase II and Phase III clinical studies.[http://www.ppdi.com/corporate/faq/about_drug_development/home.htm] In each successive phase, increasing numbers of patients are tested. There are a large number of [http://www.healtheconomics.com/consulting.cfm firms] that support clinical trials.
Phase I Clinical Studies
"Phase I studies are designed to verify safety and tolerability of the candidate drug in humans and typically take six to nine months. These are the first studies conducted in humans. A small number of subjects, usually from 20 to 100 healthy volunteers, take the investigational drug for short periods of time. Testing includes observation and careful documentation of how the drug acts in the body -- how it is absorbed, distributed, metabolized and excreted."
Phase II Clinical Studies
"Phase II studies are designed to determine effectiveness and further study the safety of the candidate drug in humans. Depending upon the type of investigational drug and the condition it treats, this phase of development generally takes from six months up to three years. Testing is conducted with up to several hundred patients suffering from the condition the investigational drug is designed to treat. This testing determines safety and effectiveness of the drug in treating the condition and establishes the minimum and maximum effective dose. Most Phase II clinical trials are randomized, or randomly divided into groups, one of which receives the investigational drug, one of which gets a placebo containing no medication and sometimes a third that receives a current standard treatment to which the new investigational drug will be compared. In addition, most Phase II studies are double-blinded, meaning that neither patients nor researchers evaluating the compound know who is receiving the investigational drug or placebo."
Phase III Clinical Studies
"Phase III studies provide expanded testing of effectiveness and safety of an investigational drug, usually in randomized, and blinded clinical trials. Depending upon the type of drug candidate and the condition it treats, this phase usually requires one to four years of testing. In Phase III, safety and efficacy testing is conducted with several hundred to thousands of volunteer patients suffering from the condition the investigational drug treats."
New Drug Application
"(NDA)/Marketing Authorization Application (MAA) NDAs (in the U.S.) and MAAs (in the U.K.) are examples of applications to market a new drug. Such applications document safety and efficacy of the investigational drug and contain all the information collected during the drug development process. At the conclusion of successful preclinical and clinical testing, this series of documents is submitted to the FDA in the U.S. or to the applicable regulatory authorities in other countries. The application must present substantial evidence that the drug will have the effect it is represented to have when people use it or under the conditions for which it is prescribed, recommended or suggested in the labeling. Obtaining approval to market a new drug frequently takes between six months and two years."
Orphan drug
There are special rules for certain rare diseases ("orphan diseases") involving fewer than 200,000 people in the United States. Because medical research and development of drugs to treat such diseases is financially disadvantageous, companies that do so are rewarded with tax reductions and a monopoly on that orphan drug for a limited time (seven years).
Post-approval surveillance
Some medications only show to have safety issues after they are marketed, as clinical trials are of a limited size, such as the 3,000 test subjects required by the FDA. Post-marketing surveillance ensures that after marketing the safety of a drug is monitored closely. In certain instances, its indication may need to be limited to particular patient groups, and in others the substance is withdrawn from the market completely.
After the FDA (or other regulatory agency for drugs marketed outside the U.S.) approves a new drug, pharmaceutical companies may conduct additional studies, including Phase IIIb and Phase IV studies.[http://www.ppdi.com/corporate/faq/about_drug_development/home.htm] "Late-stage drug development studies of approved, marketed drugs may continue for several months to several years."
Phase IIIb/IV Studies
"Phase IIIb trials, which often begin before approval, may supplement or complete earlier trials by providing additional safety data or they may test the approved drug for additional conditions for which it may prove useful. Phase IV studies expand testing of a proven drug to broader patient populations and compare the long-term effectiveness and/or cost of the drug to other marketed drugs available to treat the same condition."
Post-Market Studies
"Post-market studies test a marketed drug in new age groups or patient types. Some studies focus on previously unknown side effects or related risk factors. As with all stages of drug development testing, the purpose is to ensure the safety and effectiveness of marketed drugs."
Products
Drug information
Drug information and data are provided by the FDA and are located at the [http://www.fda.gov/cder/ob/default.htm Orange Book] site. Drug information is commercially available at [http://www.pharmalive.com/subscriptions/ekb.cfm?from=%23urlEncodedFormat('/ekb') eKnowledgebase].
ICD and DRG
Diseases are classified by ICD-9 codes. These ICD codes are aggregated into approximately 500 diagnosis-related groupss (DRG) expected to have similar hospital use.
In 1991, the top 10 DRGs overall were:
- normal newborn,
- vaginal delivery,
- heart failure,
- psychoses,
- cesarean section,
- neonate with significant problems,
- angina pectoris,
- specific cerebrovascular disorders,
- pneumonia, and
- hip/knee replacement.
These DRGs comprised nearly 30 percent of all hospital discharges. The complete list with prevalence rates is given in [http://www.rcgp.org.uk/journal/supp/v55/Fleming-S1.pdf].
- List of diseases
Revenues
Industry revenues
2004 global dollar volume was $550 billion, a 7 percent increase over 2003—which in turn represented a 9 percent increase over 2002. US sales grew to $235.4 billion, a growth rate of 8.3 percent compared with 11.5 percent growth from 2002 to 2003 [http://www.pharmexec.com/pharmexec/article/articleDetail.jsp?id=177964]. The United States accounts for 46 percent of the world's pharmaceutical market.
According to Teradata Magazine,[http://www.teradata.com/t/page/131951/] "By 2007, $40 billion in U.S. sales will be lost at the top 10 pharma companies as a result of the slowdown in R&D innovation and the expiry of patents on major products," ... "Taking a broader look across the industry, no fewer than 19 blockbuster drugs are expected to hit patent crisis by 2008. Analysis suggests that 150 mid-sized new compounds will be needed by 2007-2008 in the U.S. alone to plug this gap."
Top 10 pharmaceutical companies by sales
The top 10 pharmaceutical companies by 2004 sales are: [http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/282005/169778/article.pdf]
Patents and Generics
Drugs are patentable. A typical patent lasts for 20 years. However, it often takes as long as 12 years to approve a drug for patient use. Patent protection allows the owner of the patent to charge high margins for the branded drug. When the patent for the drug runs out, a generic drug [http://www.fda.gov/oc/speeches/2005/GPhA0301.html] is usually created by a competing company and released, causing the price to drop markedly. Often the owner of the branded drug will introduce a generic version before the patent runs out in order to get a head start in the generic market.
Medicare Part D
In 2003 the United States enacted the Medicare Prescription Drug, Improvement, and Modernization Act (MMA), a program to provide prescription drug benefits to the elderly and disabled. This program is a component of Medicare (United States) and is known as "Medicare Part D." This program, set to begin in January 2006, will significantly alter the revenue models for pharmaceutical companies. Revenues from the program are expected to be $724 Billion between 2006 and 2015 [http://www.kff.org/medicare/upload/7044-02.pdf].
Pharmaceuticals developed by biotechnological processes often must be injected in a physician's office rather than be delivered in the form of a capsule taken orally. Medicare payments for these drugs are usually made through Medicare Part B (physician office) rather than Part D (prescription drug plan).
Sales and marketing
The pharmaceutical industry is different
The pharmaceutical industry is different from most industries in that the products are usually not chosen by the consumers or paid for by the consumers. Physicians control the choice of many drugs through prescription writing. Private or public insurance often pays for most of the drugs. Moreover, insurance companies restrict the drugs that can be prescribed through the use of formularies. This along with the high margins for the industry make pharmaceutical marketing a complex discipline.
Advertising to physicians
Physicians are perhaps the most important players in pharmaceutical sales. They write the prescriptions that determine which drugs will be used by the patient. Influencing the physician is key to pharmaceutical sales. Historically, this was done with large pharmaceutical sales forces. A medium-sized pharmaceutical company might have a sales force of 1000 representaives. The largest companies have tens of thousands of representatives. Currently, there are approximately 100,000 pharmaceutical sales reps in the United States pursuing some 120,000 pharmaceutical prescribers.[http://www.teradata.com/t/page/131951/] Drug companies spend $5 billion annually sending representatives to physician offices.
Direct to consumer
Since the 1980s new methods of marketing for prescription drugs to consumers have become important. Patients are far less deferential to doctors and will inquire about, or even demand, to receive a medication they have seen advertised on television. In the United States recent years have seen an increase in mass media advertisements for pharmaceuticals.
The payers
Public and private insurers affect the writing of prescriptions by physicians through formularies that restrict the number and types of drugs that the insurer will cover. Not only can the insurer affect drug sales by including or excluding a particular drug from a formulary, they can affect sales by tiering, or placing bureacratic hurdles to prescribing certain drugs. In January 2006, the U.S. will institute a new public prescription drug plan through its Medicare program. Known as Medicare Part D, this program engages private insurers to negotiate with pharmaceutical companies for the placement of drugs on tiered formularies.
Mergers, acquisitions, and co-marketing of drugs
A merger, acquisition, or co-marketing deal between pharmaceutical companies can occur if the companies have complementary capabilities. A small biotechnology company might have a new drug but no sales or marketing capability. Conversely, a large pharmaceutical company might have unused capacity in a large sales force due to a gap in the company pipeline of new products. It may be in both company's interest to enter into a deal to capitalize on the synergy between the companies. The difference between the value of the two companies after the deal and before the deal is known as the synergy value of the deal. News affecting the value of a pharmaceutical company can be obtained through [http://welcome.pharmasentry.com/ PharmaSentry].
Controversy
- Accusations of forging or suppressing clinical trial results to maximise uptake of some medications;
- Accusations of manipulating the market for their products by showering doctors with free gifts[http://www.nofreelunch.org/].
- Too much advertising materials in the doctor's office, such as clocks, poster ads, etc.
- Aggressive representation by pharmaceutical companies' salespeople (detailmen).
- Sponsorship of medical schools, with influence on the curriculum to discourage the teaching of alternative medicines.
- Increased number of drug tests on animals before FDA approval
- Criticism for the price of patented AIDS medication, which could limit therapeutic options for patients in the Third World, where the most people have AIDS. Under World Trade Organization rules, a developing country has options for obtaining needed medications under compulsory licensing or importation of cheaper versions of the drugs, even before patent expiration[http://www.wto.org/english/news_e/pres03_e/pr350_e.htm (WTO Press Release)]. Pharmaceutical companies often offer much needed medication at no or reduced cost to the developing countries. Proposals to allow the manufacture generic AIDS drugs are not without controversy; it is sometimes claimed that this might cause pharmaceutical companies to move away from AIDS drug research and focus their research on other, more profitable areas. In March of 2001, South Africa was sued by 41 pharmaceutical companies for their Medicines Act, which allowed the import and generic production of cheap AIDS drugs. The case was later dropped after protest around the world.
- Between 1980 and 1997, drug industry funding for academic research rose x8, as research costs rose, and the rate of federal support fell. Drug researchers not employed by pharmaceutical companies often look to companies for grants, and companies often look to researchers for studies that will make their products look good. 79% of papers written by independent researchers are favorable to new drugs. 98% of papers written by researchers sponsored by the drug companies are favorable. Sponsored researchers are rewarded by drug companies by putting them on symposium circuits to lecture, with the lecture scripts written by pharmaceutical companies. Some researchers who have tried to publish papers that show harmful effects of new drugs or cheaper alternatives have been threatened by drug companies with lawsuits.
- Drug companies spent $900 million on consumer ads in the first half of 1999 alone. Pharmaceutical companies often fund non-profit "patient groups" that consume their drugs. Patient groups can advertise for the drug companies, and are unregulated by the Food and Drug Administration (FDA). Advertising directly to consumers, however, is strictly regulated in the United States by the FDA, as described in [http://www.fda.gov/cder/guidance/1804fnl.htm FDA Guidance for Industry on Consumer-Directed Broadcast Advertisements].
- Where pharmaceutics have been shown to cause side-effects, civil action has occurred, especially in countries where tort payouts are likely to be large. Due to high-profile cases leading to large compensations, most pharmaceutical companies endorse tort reform.
Bibliography
Controversy
- Ray Moynihan, Alan Cassels: Selling sickness: How the world's biggest pharmaceutical companies are turning us all into patients". Nation Books, New York, 2005.
- Merrill Goozner: The $800 million pill. [http://www.businessweek.com/magazine/content/04_16/b3879046_mz005.htm] University of California Press, Berkeley, 2004, 297 S. ISBN 0-520-23945-8.
- Marcia Angell: The truth about the drug companies. Random House, New York, 2004, 305 S. ISBN 0-375-50846-5.
- [http://www.amazon.com/exec/obidos/tg/detail/-/0195300041/qid=1129321038/sr=8-4/ref=pd_bbs_4/002-2335749-2056041?v=glance&s=books&n=507846 On The Take: How Medicine's Complicity With Big Business Can Endanger Your Health (Paperback)]
Drug discovery and development
- [http://www.amazon.com/exec/obidos/tg/detail/-/0849342112/qid=1129321513/sr=8-1/ref=pd_bbs_1/002-2335749-2056041?v=glance&s=books&n=507846 The Process of New Drug Discovery and Development (Hardcover)]
- [http://www.amazon.com/exec/obidos/tg/detail/-/0471899801/qid=1129321513/sr=8-2/ref=pd_bbs_2/002-2335749-2056041?v=glance&s=books&n=507846 Drug Discovery : A History (Paperback)]
- [http://www.amazon.com/exec/obidos/tg/detail/-/0415282888/qid=1129321513/sr=8-3/ref=pd_bbs_3/002-2335749-2056041?v=glance&s=books&n=507846 Textbook of Drug Design and Discovery, Third Edition (Paperback)]
- [http://www.amazon.com/exec/obidos/tg/detail/-/3540423966/qid=1129321513/sr=8-8/ref=pd_bbs_8/002-2335749-2056041?v=glance&s=books&n=507846 Drug Discovery and Evaluation (Hardcover)]
- [http://www.amazon.com/exec/obidos/tg/detail/-/0471213845/qid=1129321513/sr=8-9/ref=pd_bbs_9/002-2335749-2056041?v=glance&s=books&n=507846 Drug Discovery Handbook (Hardcover)]
- [http://www.amazon.com/exec/obidos/tg/detail/-/0471601500/qid=1129321513/sr=8-4/ref=pd_bbs_4/002-2335749-2056041?v=glance&s=books&n=507846 Drugs-From Discovery to Approval (Hardcover)]
- [http://www.amazon.com/exec/obidos/tg/detail/-/B000063N91/qid=1129321513/sr=8-7/ref=pd_bbs_7/002-2335749-2056041?v=glance&s=books&n=507846 Speeding Drug Discovery [DOWNLOAD: PDF]]
- [http://www.amazon.com/exec/obidos/tg/detail/-/B00006KC61/qid=1129321513/sr=8-10/ref=sr_8_xs_ap_i1_xgl153/002-2335749-2056041?v=glance&s=magazines&n=507846 Drug Discovery & Development [MAGAZINE SUBSCRIPTION]]
- [http://www.amazon.com/exec/obidos/tg/detail/-/B0009VL0MW/qid=1129321513/sr=8-11/ref=sr_8_xs_ap_i2_xgl229/002-2335749-2056041?v=glance&s=office-products&n=507846 Ethnomedicine and Drug Discovery]
- [http://www.amazon.com/exec/obidos/tg/detail/-/047146127X/qid=1129321513/sr=8-12/ref=sr_8_xs_ap_i3_xgl14/002-2335749-2056041?v=glance&s=books&n=507846 Integrated Strategies for Drug Discovery Using Mass Spectrometry (Hardcover)]
- [http://www.amazon.com/exec/obidos/tg/detail/-/B000071FL0/qid=1129321513/sr=8-13/ref=sr_8_xs_ap_i4_xgl153/002-2335749-2056041?v=glance&s=magazines&n=507846 Drug Discovery Today [MAGAZINE SUBSCRIPTION]]
- [http://www.amazon.com/exec/obidos/tg/detail/-/B000071FFQ/qid=1129321513/sr=8-14/ref=sr_8_xs_ap_i5_xgl153/002-2335749-2056041?v=glance&s=magazines&n=507846 Current Opinion In Drug Discovery And Development [MAGAZINE SUBSCRIPTION]]
- [http://www.amazon.com/exec/obidos/tg/detail/-/1566769736/qid=1129321513/sr=8-18/ref=sr_8_xs_ap_i9_xgl14/002-2335749-2056041?v=glance&s=books&n=507846 Pharmacokinetics in Drug Discovery and Development (Hardcover)]
- [http://www.amazon.com/exec/obidos/tg/detail/-/0471668273/qid=1129321513/sr=8-19/ref=sr_8_xs_ap_i10_xgl14/002-2335749-2056041?v=glance&s=books&n=507846 Antiviral Drug Discovery for Emerging Diseases and Bioterrorism Threats (Hardcover)]
Management, mergers, acquisitions, co-marketing deals
- [http://www.amazon.com/exec/obidos/tg/detail/-/0973467622/qid=1129321513/sr=8-5/ref=pd_bbs_5/002-2335749-2056041?v=glance&s=books&n=507846 Building Biotechnology: Starting, Managing, And Understanding Biotechnology Companies (Hardcover)]
- [http://www.amazon.com/exec/obidos/tg/detail/-/186067464X/qid=1129322940/sr=1-1/ref=sr_1_1/002-2335749-2056041?v=glance&s=books Mergers and Acquisitions in Pharmaceuticals - Why and How? (Spiral-bound)]
- [http://www.amazon.com/exec/obidos/tg/detail/-/1578515556/qid=1129322940/sr=1-3/ref=sr_1_3/002-2335749-2056041?v=glance&s=books Harvard Business Review on Mergers & Acquisitions (Paperback)]
- [http://www.amazon.com/exec/obidos/tg/detail/-/B0001EYIPI/qid=1129323132/sr=1-1/ref=sr_1_1/002-2335749-2056041?v=glance&s=books Optimizing Promotional Alliances: Benchmarking Co-marketing and Co-promotion Strategies in the Pharmaceutical Industry [DOWNLOAD: PDF]]
- [http://www.amazon.com/exec/obidos/tg/detail/-/0333930983/qid=1129323132/sr=1-3/ref=sr_1_3/002-2335749-2056041?v=glance&s=books Brand Medicine : The Role of Branding in the Pharmaceutical Industry (Hardcover)]
- [http://www.amazon.com/exec/obidos/tg/detail/-/0658000063/qid=1129323132/sr=1-6/ref=sr_1_6/002-2335749-2056041?v=glance&s=books The Co-Marketing Solution: Strategic Marketing Through Better Branding, Improved Trade Relationships, Superior Promotions, Effective Fact-Bases Selling, ... Analyses O (American Marketing Association) (Hardcover)]
Sales and marketing
- [http://www.amazon.com/exec/obidos/tg/detail/-/0970415362/qid=1129321038/sr=8-2/ref=pd_bbs_2/002-2335749-2056041?v=glance&s=books&n=507846 Insider's Guide to the World of Pharmaceutical Sales, Seventh Edition (Paperback)]
- [http://www.amazon.com/exec/obidos/tg/detail/-/0595174183/ref=pd_sim_b_1/002-2335749-2056041?%5Fencoding=UTF8&v=glance Be Brief, Be Bright, Be Gone: Career Essentials for Pharmaceutical Representatives (Paperback)]
- [http://www.amazon.com/exec/obidos/tg/detail/-/0972467513/ref=pd_sim_b_3/002-2335749-2056041?%5Fencoding=UTF8&v=glance PharmRepSelect-Your Complete Guide to Getting a Pharmaceutical Sales Job (Pharmrepselect, 1) (Paperback)]
- [http://www.amazon.com/exec/obidos/tg/detail/-/0803993781/qid=1129323132/sr=1-4/ref=sr_1_4/002-2335749-2056041?v=glance&s=books The Rx Factor : Strategic Creativity in Pharmaceutical Marketing (Response Book) (Hardcover)]
- [http://www.amazon.com/exec/obidos/tg/detail/-/078901582X/qid=1129323132/sr=1-5/ref=sr_1_5/002-2335749-2056041?v=glance&s=books Pharmaceutical Marketing: Principles, Environment, and Practice (Hardcover)]
See also
- List of pharmaceutical companies or a [http://www.pharmacy.org/company.html better list]
- List of drugs
- Medicine
- Pharmaceutical marketing
- List of diseases for a huge list of 6000+ diseases, many very rare.
- Pharmaceuticals (China)
- Pharmaceuticals (India)
- Medicine (China)
- Traditional Chinese medicine
- Pharmacology
- Biotechnology
- Medicare Part D
- Medicare Prescription Drug, Improvement, and Modernization Act
- Food and Drug Administration
- Prescription drug prices in the United States
- National pharmaceuticals policy
- Chilean pharmaceutical policy
- Seneka Bibile
- Sri Lanka National Pharmaceuticals Policy
- State Pharmaceuticals Corporation of Sri Lanka
- clinical trial
- Protein structure prediction
- Drug design
- Rational drug design
- Bioinformatics
- Cheminformatics
- Biomedical informatics
- Orphan drug
- Physiologically-based pharmacokinetic modelling
- Big killers
- Complementary and alternative medicine
- Health profession
- Healthcare system
- Iatrogenesis (ill health caused by medical treatment)
- List of diseases
- List of medical abbreviations
- List of medical schools
- Important publications in medicine
- Medical equipment
- Rare diseases
External links
- [http://www.washingtonmonthly.com/features/2000/0005.pomper.html/ Drug Rush]
- [http://www.pharmexec.com/pharmexec/ Pharmaceutical Executive Magazine]
- [http://www.phrma.org/ Pharmaceutical Research and Manufacturers of America]
- [http://www.ppdi.com/corporate/faq/about_drug_development/home.htm PPD]
- [http://www.pharmalive.com/ PharmaLive]
- [http://www.micromedex.com/products/drugknowledge/drugknowledge_costjust.pdf Cost Justification: Pharmaceutical]
- [http://www.chemlin.de/chemistry/drug_design.htm WWW-Information resources: Drug Discovery]
- [http://www.ich.org ICH Website]
- [http://www.fda.gov/ FDA Website]
- [http://www.nofreelunch.org No Free Lunch]
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Category:Biotechnology
category:pharmacology
category:pharmacy
category:Clinical research
category:Pharmaceutical industry
Category:Industries
Category:Pharmaceuticals Policy
FDA
The United States Food and Drug Administration (FDA) is the government agency responsible for regulating food (human and animal), dietary supplements, drugs (human and animal), cosmetics, medical devices (human and animal), biologics and blood products in the United States. The FDA is headed by acting Commissioner, Dr. Andrew von Eschenbach, who succeeds Dr. Lester Crawford who resigned on September 23, 2005 only two months after his final Senate confirmation.
The FDA is a division of the Department of Health and Human Services (DHHS), which itself is part of the Executive Office of the President of the United States. The FDA is divided into five major Centers: the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research (CDER), the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM). Each center has its own origins and history, the oldest being the Center for Biologics, which oversees blood products, vaccines and newer therapeutics related to stem cells and gene therapy. The Center for Drugs, the center that receives the most public scrutiny, regulates pharmaceutical medicines.
The over-arching mandate of the FDA is to regulate the multitude of medicinal products in a manner that ensures the safety of the American public and the efficacy claims (label) of marketed drugs. The FDA's budget for approving, labeling, and monitoring drugs is roughly $290 million per year. "Review teams" employ around 1,300 employees to approve new drugs. The "safety team" has 72 employees to determine whether new drugs are hurting people. The safety team monitors the effects of more than 3,000 prescription drugs on 200 million people with a budget of about $15 million a year. The FDA requires clinical testing in populations of about 3,000 people.
One aspect of its jurisdiction over food is regulation of the content of health claims on food labels. However, because regulating the content of labels implicates the First Amendment, FDA must balance concerns about the public health with the right to free speech. Dan Troy, a lawyer who was Chief Counsel of the Food and Drug Division from August 2001 to November 2004, raised the agency's focus on First Amendment issues.
The FDA does not pre-approve dietary supplements on their safety and efficacy, unlike drugs. In contrast, the FDA can only go after dietary supplement manufacturers after they have put unsafe products on the market. However, certain foods (such as infant formula and medical foods) are deemed special nutritionals because they are consumed by highly vulnerable populations and are thus regulated more strictly than the majority of dietary supplements.
The FDA has come under much criticism from many groups, including the Government Accountability Office. FDA regulations are blamed for causing high drug prices, keeping life-saving drugs off the market, prohibiting access to emergency contraceptives, censoring information about nutritional supplements. Some propose that the FDA be relegated to a voluntary inspection agency in order to remedy these problems.
FDA and the public
According to the Small Business Guide to FDA, "Anyone may request or petition FDA to change or create an Agency policy or regulation under 21 CFR Part 10.30." This is called a Citizen's Petition and it is one method used to challenge specific approvals by the FDA.
Controversy
Regarding high drug prices
Many maintain that FDA regulations and policy cause unnecessarily high drug prices in America. They argue that regulations against importing cheaper drugs from foreign sources is anti-competitive which keeps drug prices artificially high in the United States. Prices of almost all pharmaceutical drugs in Europe are significantly lower than in the U.S. where import is allowed. [http://www.stopfda.org/june99-ripoff.htm] Also, at issue, is what some believe to be an excessively costly approval process that, in effect, keeps potentially beneficial drugs from being brought to market and requires that companiess charge unnecessarily-high prices to recoup their investment.
Others point out that importation is not banned by FDA, so long as the imported drug complies with FDA regulations regarding importation. They observe that the FDA requires imported drugs to meet the same safety, efficacy, and manufacturing standards as those manufactured in the United States. This practice is not different from that of European regulatory agencies. Many drugs that are approved by European regulatory agencies are not approved in the U.S. due to a stricter regulatory environment.
Some offer the observation that prices of nutritional supplements in Europe are much more expensive in than in the U.S. [http://www.lef.org/magazine/mag2005/jul2005_awsi_01.htm] They note that nutritional supplements are regulated in Europe, but not in the U.S. (as a result of the result of the passage of the Dietary Supplement Health and Education Act that severely limits the ability of the FDA to regulate them). Many nutritional supplements require a prescription in Europe, but not in the U.S. Hence, they reason that a cause of high pharmaceutical costs in the U.S. is regulation. Consequently, they reason that if the FDA discontinued regulating pharmaceuticals that they would be much more affordable. [http://www.lef.org/magazine/mag2005/mar2005_awsi_01.htm]
Lower drug prices in Europe and Canada are widely attributed to price controls imposed by governments, rather than to less stringent regulatory requirements. Those who hold this view also contend that these price controls contribute to artificially low revenues, which in turn lead to less available capital for research and development. Because of this, many contend, the international (non-U.S.) pharmaceutical industry spends less on research and development than the U.S. pharmaceutical industry [http://www.phrma.org/issues/researchdev/index.cfm].
Regarding drug approval
One of the key issues of drug safety dealt with by the FDA, and responsible for much recent controversy, is related to the concept of patents. When a patent is awarded, the drug's creator is given exclusive manufacturing rights. If the drug is extremely popular, this motivates other companies to invent their own (different) drugs which accomplish the same effect. (Because a drug is patented, they cannot produce the exact same drug). For example, Cialis was created because of the popularity of Viagra. However, the question is, when new, competing substances come out should they be approved, not because of their absolute safety, but because of their relative safety compared to an approved drug. For example, say "drug b" was created to compete with "drug a". Now if "drug b" was the first one out, and it had a 5 percent chance of heart attack, the FDA might find this acceptable. However if "drug a" was already out, and it had a 2.5 percent chance of heart attack, then the FDA would be reluctant to approve "b". Only people who were ignorant of that higher risk would take drug b -- unless it were significantly cheaper, and the purchaser preferred the price savings of "b" to the relative safety of "a".
This phenomenon is at the center of a present controversy over the recall of Vioxx, which is causing more attention to be brought to the FDA. David J. Graham, a scientist with the FDA, says he was pressured by his supervisors not to warn the public about dangers of drugs like Vioxx, and so recommended to congress that a separate agency be created which is dedicated to continuously monitoring drug safety.
The FDA charges fees to pharmaceutical companies that wish to "expedite" the drug approval process. This is considered by many to be a conflict of interest, as the companies who are supposed to be regulated by the FDA are those who are paying them to speed up approvals. They reason that this "pay-off" to expedite the process may sacrifice the quality of studies. These concerns are based on an inadequate understanding of the process, however. Several options exist for bringing additional focus to the review and approval of a drug. All of these options require the drug company to show that the proposed drug meets several criteria, all designed to ensure the priority or expedited review is in the interest of the public health. The user fees charged by FDA are meant to offset FDA staff costs and expenses related to the review and approval. These fees are charged regardless of the priority or expedited status of the review. This process is governed by the [http://www.fda.gov/oc/pdufa/overview.html Prescription Drug User Fees Act].
Regarding incentive to delay approval of new drugs
A controversial concept. Economists Milton Friedman, Daniel B. Klein and Alexander Tabarrok are three economists who argue that the FDA causes harm. Many economists who study the FDA are critical.
Friedman (1979) notes that the FDA can make two types of errors. Type 1 is to approve a drug that has deadly or harmful side effects in a large number of people. If you make this error, like approving a thalidomide, you will be blasted by the news media, and your reputation will be ruined.
Type 2 is refusing approval of a drug that is capable of saving many lives or relieving great distress and that has no untoward side effects. If you make a type 2 error, few will know it, as the people whose lives might have been saved will not be around to protest, and their families will have no way of knowing that their loved ones lost their lives because of the caution of an unknown FDA official.
The following table from http://www.fdareview.org/incentives.shtml illustrates the two types of error and the reason for systematic bias toward type 2 errors.
This dichotomy was brought to the fore in the early days of AIDS. Noted AIDS author Randy Shilts published a future timeline analysis in the San Francisco Chronicle showing a minimum delay of 20 years to approve the new AIDs drugs and get them to patients.
Standard industrial project expediting techniques of identifying critical paths and starting tasks in parallel were foreign to the medical bureaucracy. A massive demonstration by ACT UP and other groups occupied FDA headquarters, hanging a "Silence = Death" banner over the entrance. Afterwards, the "Pert chart" for approval of protease inhibitors and other drugs was given a major rework and procedures introduced for expediting timelines for both normal and compassionate/experimental drug introduction.
Friedman theorizes that the harm the FDA causes results from the nature of the bureaucracy and would happen even with the best intentioned and benevolent individuals in charge: "With the best will in the world, you or I, if we were in that position, would be led to reject or postpone approval of many a good drug in order to avoid even a remote possibility of approving a drug that will have newsworthy side effects?"
Regarding Wilhelm Reich
The early reputation of the FDA was tarnished by directing one of the few government book-burnings ever to take place in the United States. Acting against the interstate shipment of "orgone accumulators", an experimental device built by an aging Dr. Wilhelm Reich the FDA went to court. Reich refused to appear in court to debate scientific matters, writing to the court:
"My factual position in the case as well as in the world of science of today does not permit me to enter the case against the Food and Drug Administration, since such action would, in my mind, imply admission of the authority of this special branch of the government to pass judgment on primordial, pre-atomic cosmic orgone energy."
The FDA and the court responded by jailing Reich and ordering the burning of his published works, including those that had no reference to the orgone accumulator, at the Gansevoort Destructor Plant in Manhattan.
Regarding Blood Donation
In the past, it was the practice in America and other countries to separate blood donations on the basis of race, ethnicity, or religion, or to exclude certain groups from the donor pool on those bases. Currently, in the US, these practices have been eliminated, although American Red Cross and Food & Drug Administration policies prohibit accepting blood donations from gay men, specifically from any "male who has had sex with another male since 1977, even once," [http://www.harbus.org/main.cfm?include=detail&storyid=171199&page=2] or from IV drug users or recent immigrants from certain nations with high rates of HIV infection. While the inclusion of gay men on the prohibited list has created some controversy, the FDA & Red Cross cite the public policy need to protect the blood supply from HIV & similar diseases as justification for the ban.
Regarding Nutritional Supplements
The FDA has also been criticized for intervening in the controversial nutritional supplement business. It has conducted at least one well-publicized raid on an establishment that sold and manufactured such products, the "Life Extension Foundation," which is a significant player in the industry. The FDA gained entrance to a store by smashing through the glass doors with a battering ram [http://www.lef.org/fda/victory.htm]. After a costly and lengthy legal battle, the Life Extension Foundation was cleared of all charges.
The FDA has been criticized for engaging in censorship when it forbids makers of nutritional supplements from making claims that have been supported by scientific studies. A bill was introduced in the US House of Representatives on May 12, 2005 by Congressman Ron Paul to allow consumers to prevent the FDA from censoring this information. It is currently pending. [http://www.oklahomahealthfreedom.org/CAHIA.html] Julian Walker, M.D. of the Health Freedom Action Network says: "This rogue agency illegally prohibits manufacturers of food and dietary supplements from giving accurate information about their products' health benefits." [http://www.lef.org/featured-articles/consumer_alert_100605.htm] Life Extension Foundation claims that the prohibitions are a violation of the Constitutional Right to Free Speech. [http://www.lef.org/featured-articles/consumer_alert_091905.htm] On November 10, 2005, Ron Paul introduce a bill for the Health Freedom Protection act (H.R. 4284) to stop "the FDA from censoring truthful claims about the curative, mitigative, or preventative effects of dietary supplements, and adopts the federal court’s suggested use of disclaimers as an alternative to censorship.from censoring consumer information ([http://www.lewrockwell.com/paul/paul288.html Free Speech and Dietary Supplements])
The FDA was also criticized for banning the essential amino acid Tryptophan after a manufacturing incident in Japan contaminated one batch. Regardless of the origin of the toxicity, Trp was banned from sale in the US, and other countries followed suit. Such bureaucratic action neglecting the most important fact established regarding the biochemistry of Trp: that it is an essential amino acid that humans cannot live without eating, led to renewed questioning as to whether the FDA was a science based or political agency.
History
- 1927 — The "Bureau of Chemistry" is reorganized into two separate entities. Regulatory functions are located in the "Food, Drug, and Insecticide Administration", and nonregulatory research is located in the "Bureau of Chemistry and Soils".
- 1930 — The name of the "Food, Drug, and Insecticide Administration" is shortened to "Food and Drug Administration" (FDA) under an agricultural appropriations act.
- 1990 FDA passes laws banning "gifts of substantial value" from drug companies to doctors. Minor gifts (like meals, tickets, and travel) are not banned.
- 1992 Congress passes a new law creating a faster approvals process to legalize new drugs. The FDA must hire more reviewers and speed up reviews without sacrificing proper study and testing. The drug industry must pay "user fees" with every new drug application. Approval times drop from 30 to 12 months on average. 60% of new drugs come on the market in the U.S. first, before other countries. Before this law, when the approval process was slower, more new drugs came out in other countries first.
- 1997 FDA loosens restrictions on consumer advertising. Drug companies are allowed to spend less time describing risks and side effects on TV commercials. A large increase in TV drug ads caused a large increase in drug sales within months.
- The Naval Ordnance Laboratory White Oak site was aportioned to the FDA to become its new headquarters. However, budget reductions have delayed the move to White Oak for many FDA offices.
Related legislation
- 1906 — Pure Food and Drug Act
- 1938 — Federal Food, Drug, and Cosmetic Act
- 1944 — Public Health Service Act
- 1951 — Food, Drug, and Cosmetics Act Amendments PL 82–215
- 1953 — Flammable Fabrics Act PL 83–88
- 1960 — Federal Hazardous Substances Labeling Act PL 86–613
- 1962 — Food, Drug, and Cosmetics Act Amendments PL 87–781
- 1965 — Federal Cigarette Labeling and Advertising Act PL 89–92
- 1966 — Fair Packaging and Labeling Act PL 89–755
- 1966 — Child Protection Act PL 89–756
- 1970 — Federal Cigarette Labeling and Advertising Act Amendments PL 91–222
- 1972 — Consumer Products Safety Act PL 92–573
- 1976 — Medical Device Regulation Act PL 94–295
- 1986 — Comprehensive Smokeless Tobacco Health Education Act PL 99–252
- 1988 — Anti—drug Abuse Act PL 100–690
- 1990 — Nutrition Labeling and Education Act PL 101–535
- 1992 — Prescription Drug User Fee Act PL 102–571
External links
- http://www.fda.gov/ Official FDA website
- http://www.fdareview.org/ Is the FDA Safe and Effective?
- [http://www-hoover.stanford.edu/pubaffairs/we/2004/henderson02.html End the FDA's Monopoly by David R. Henderson] "Pare back the FDA's powers to that of an information agency"
- [http://www.stopfda.org/ Consumers Against High Drug Prices] - an organization blames the FDA for High Drug Prices
- [http://www.lef.org/magazine/mag2005/mar2005_awsi_01.htm Death By Regulation] Asserts that the FDA regulations defrauding Americans out of health and money
- [http://www.phrma.orgThe Pharmaceutical Research and Manufacturers of America (PhRMA)] represents the leading research-based pharmaceutical and biotechnology companies in the United States
- [http://64.233.161.104/search?q=cache:yVvp4VM2UGkJ:www.ita.doc.gov/td/chemicals/drugpricingstudy.pdf Pharmaceutical Price Controls in OECD Countries Implications for U.S. Consumers, Pricing, Research and Development, and Innovation] by U.S. Department of Commerce
- [http://www.lewrockwell.com/paul/paul288.html Free Speech and Dietary Supplements] A speech given before the U.S. House of Representatives by Ron Paul on Nov 10, 2005, introducing the Health Freedom Protection Act (H.R. 4282) and criticizing the FDA for censoring consumer information
Articles
- [http://news.bbc.co.uk/2/hi/business/4024195.stm US drug safety checks 'slack']
References
# [http://www.worldpharmacongress.com CHI World Pharmaceutical Congress 2005 Website] and final agenda in print form. Verified 03-07-2005.
# [http://www.fda.gov/ora/fed_state/Small_business/sb_guide/petit.html How to Petition the FDA]. Retrieved 2005-03-20.
# [http://www.fdareview.org/ FDAReview.org]
# Friedman, Milton & Rose (1979). Free to Choose. New York: Harcourt Brace Jovanovich. ISBN 0-15-133481-1.
Category:Nutrition
Category:Pharmacology
Category:clinical research
Category:United States Department of Health and Human Services
Illegal drug trade
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In jurisdictions where legislation restricts or prohibits the sale of certain popular drugs, it is common for an illegal drugs trade to develop. For example, the United States Congress has identified a number of controlled substances which each have corresponding illegal drug trades.
For some drugs, large-scale drug production is not located where those drugs are illegal — rather, those drugs are smuggled into the region for illegal trade. Other drugs are often produced locally either because they can be grown surreptitiously or manufactured with common ingredients.
Regardless of the source, high demand for illegal drugs on the black market leads to the formation of complex illegitimate production, smuggling, and distribution networks that span national borders and generate billions of dollars of revenue.
Soft drugs
Many people do not find the hard/soft drug distinction useful, as it is the drug users' behavior that is the most important determinate of harm, not the choice of drug: all drugs can be harmful if misused. A more useful distinction ranks drugs according to their toxicity and addictive potential. However, the legal treatment of drugs still seems influenced by perception rather than fact, so this article will group the discussion accordingly.
"Soft" drugs are generally drugs which are perceived to have less potential for causing physical or mental health damage to the user than "hard" drugs. History may play a part in a society's perception of what is a soft drug; for example alcohol and tobacco are both very addictive and known to cause health issues, but are legally traded in many more juridictions than other soft drugs. Occasional attempts to make alcohol and tobacco illegal have lead to situations such as the United States Prohibition period, which are instructive to study regarding how illegal trade immediately organized around the controlled substances. Conversely, changing societal views have led to suggestions of further decriminalizing other soft drugs.
For the purpose of this article, the following drugs will be considered soft drugs:
- Anabolic steroids
- Cannabis
- Ecstasy (MDMA)
- Ketamine
- LSD
- GHB
- PCP
- Psilocybin mushrooms
Anabolic steroids trade
For detailed information on anabolic steroids, see the article Anabolic steroids
Illegal use of anabolic steroids, a class of hormones, is primarily to improve the muscular system of the human body for either increased performance (for example by athletes) or better bodybuilding results.
Anabolic steroids are not known to be chemically addictive, but can be psychologically addictive for people with body dysmorphic disorders.
The societal and health risks of regular anabolic steroid use is debatable, but a few jurisdictions (the US, Canada and Sweden) now consider anabolic steroids controlled substances; in the US it is a Schedule III controlled substance because it is a low abuse risk, has legitimate medical uses, and is has low physical dependency effects. Furthermore, the US Congress passed the Anabolic Steroids Control Act of 2004 to further clarify which related substances were considered controlled.
Many international sports organizations, and now (after intense government pressure) most American professional sports organizations, are taking increasingly tougher stands against athletes who use anabolic steroids as performance enhancing drugs. While this will presumably decrease the illegal trade related to athletes, there is still a very high demand for anabolic steroids from amateur bodybuilders.
Anabolic steroid production
Anabolic steroids need sophisticated pharmaceutical processes and equipment to produce, so are generally produced by legitimate pharmaceutical companies.
In the 1990s most of the US producers such as Ciba, Searle and Syntex stopped making and marketing anabolic steroids within the US. However, in many other regions, particularly Eastern Europe, they are still produced in quantity. European anabolic steroids are the source of most medical grade anabolic steroids sold illegally in North America.
However, anabolic steroids are still in wider use for veterinary purposes, and many illegal anabolic steroids are actually veterinary grade.
All the usual problems with illegal drug trades, including substitutions, cutting, diluting, and faking affect illegal anabolic steroids so that when it reaches distribution the quality may be questionable or possibly dangerous.
Anabolic steroid trafficking
Since the anabolic steroids are produced in different countries than in which they are distributed, they must be smuggled across international borders. Like most significant smuggling operations, sophisticated organized crime is involved, often in conjunction with other smuggling efforts (including other illegal drugs).
Unlike cannabis and heroin, there have not been many high profile cases of individual smugglers of anabolic steroids being caught.
Anabolic steroid distribution
The majority of illegal anabolic steroids are distributed by interested parties (i.e. bodybuilders and athletes who themselves are users), rather than organized crime gangs.
The anabolic steroids are often dealt by contacts made at fitness centers and on athletic teams. Steroid users are fairly easy to recognize and therefore initial contact is generally easy.
Anabolic steroids can be distributed in either pill or injectible forms. The pills look like any other medical pills, but have the drawback that metabolising them is known to cause liver damage. Injectible steroids are generally distributed in vials, either a type that needs to be broken open or with rubber stoppers through which the needle draws the fluid. Pill form needs to be taken about every few days and injectible steroids need to be injected about once per week to maintain full effectiveness. Injections are intramuscular, not intraveneous.
Cannabis trade
For detailed information on cannabis, see the article Cannabis.
Marijuana and hasheesh are the main drug forms of cannabis, while hemp is the main industrial form.
Cannabis use is primarily recreational. Because it typically gives users a state of relaxation and non-aggression, it has been considered as a peace drug, especially among the hippie culture. Proponents for legalization of cannibis claim that its use benefits users and society.
However, long-term, regular use of cannabis is known to create health problems, for eample lung disorders due to the smoking).
Furthermore, because it is easy to produce, illegal trade in cannabis is highly profitable and therefore attracts serious criminal organizations.
Cannabis high-demand strains
See Wiktionary Appendix of Cannabis Slang.
Cannabis production
Cannabis is a plant and therefore production is relatively easy. The main distinction in production is whether it is grown indoors or outdoors.
Indoor cannabis production usually takes the form of "grow-ops" (i.e. growing operations) which are often suburban houses that are modified to become hydroponic hothouses. This often entails stealing electricity to power the grow lights and irrigation systems, and the heat and moisture often ruin the house as a living quarters. Immigrant families are often given housing at grow-ops in order to give the appearance of normalcy to the house to avoid reporting by neighbors. Law enforcement trying to detect grow-ops often look for unusual electricity consumption and also will use thermal imaging of rooftops to see if the house is hotter than expected. A collateral problem to grow-ops is that they are often done in rented houses, ruining the property of the landlords.
Outdoor cannabis production is typically done in plots that are hidden in forested or jungled remote areas. The forest services in many juridictions known for cannibis cultivation have active programs scanning for cannabis plots. In some cases the plots are so large that controlled fires are used to destroy the crop.
Once harvested, the cannibis is separated (into leaves, stems, seeds and buds) and cured to create smokable marijuana, or pressed to create hasheeh.
Cannabis Terms related to production
- Indoor is cannabis grown indoors. Sometimes pronounced "indoe", sounding much like the Latin endo-, which has a similar meaning when spoken as "indoe-weed". As a rule of thumb, indoor weed is (usually) better quality than outdoor because of the protection it gets inside, though there are obviously exceptions as this depends on a number of factors.
- Outdoor, sometimes pronounced "outdoe" or instead called exo- or ecto- (to contrast with endo), is cannabis that has been grown outdoors. Although it is almost always lower quality than indoor, some extremely potent strains in this class do exist, such as those grown in southern Mexico and Central America, as well as the famed Alaskan thunderfuck, which is grown in 24-hour natural sunlight.
- Hydro, also called hydroponic, is a separate method of growing, where the plants are grown in water and a medium routinely flushed with nutrients.
- Aeroponics, a relatively recent and perhaps still somewhat experimental hydroponic cultivation method in which no medium is used and the roots are directly exposed to water and nutrients. Some growers use fish aquariums housing feeder fish, whose waste provides the necessary nutrients. This technique is still very uncommon.
- Organic simply refers to the use of organic growing methods (including fertilizer, medium, and pest-control), which can also be used for hydroponic set-ups. If inorganic pesticides were used during the flowering phase of the plant's life cycle, then the smoked buds will sometimes pop and crackle, emitting bursts of sparks due to the chemicals present in the pesticides.
Cannabis wholesaling
Wholesale market for cannabis exists on a variety of levels. Typically a "wholesale" purchase would consist of anything more than a quarter-pound (113.4g). However, legal definitions of "possession with intent to distribute" vary considerably between jurisdictions — in some places, much smaller quantities of marijuana or simply having marijuana in more than one container may constitute legal intent to distribute, with concomitantly increased legal penalties.
Due to the existence of different strains and different degrees of potency, along with varying degrees of anti-drug law enforcement in different jurisdictions, the wholesale price of marijuana varies widely. For example, it is not unheard of for low-potency Mexican "schwag" to be purchased in multi-ton quantities. These type of purchases are executed by large poly-drug criminal organizations that work with other national and international crime cartels. It is not uncommon for these crime cartels to employ a professional smuggler to assist with packing and shipping the contraband. The importers of these drugs tend to be associated with violence and often import other drugs such as cocaine and heroin. In the United States, the Mexico-US border is usually the source for these large wholesale transactions.
Higher-grade marijuana tends to trade on a much smaller scale due to the nature of the product — higher potency means that less must be smoked to achieve the desired effects. Where a pound of schwag can sell for $500 wholesale, high grade marijuana can fetch up to $4,400 per pound. High grade marijuana typically originates in small scale domestic indoor and outdoor growing operations. High-grade marijuana is also imported into the United States on a small scale from Canada or in some rare instances from the tropics and Mexico. Of course, some zealous traffickers will bring multi-ton shipments of this product over the border as well. Many of these large traffickers are also associated with other much harder drugs, violence, and gangs. The typical indoor grower usually tends to be an otherwise law-abiding citizen who would not consider violence or strong arm tactics in marijuana dealing.
In the majority of cases, a local grower will give cannabis to "distributors". Each distributor will take between a quarter ounce and one pound and then divide it up and sell it to street-sellers. Because it costs very little to grow cannabis, and because the distributors are generally personal friends of the grower, any money made from this is almost 100% profit. Distributors can afford to distribute to sellers for as little as a dollar a gram, but typically charge half street value. The grower takes the most sizable cut of the money, but the particulars and percentages vary depending on local market conditions, the individuals involved, and whatever agreement they come to. It is not unheard of for the grower to keep all the monetary profit and pay his distributors in cannabis (although in this case the assumption often exists that the distributors are keeping a small amount of the money for themselves without the grower's direct knowledge).
Law enforcement attention to these "lesser" wholesaling transactions is typically reduced; most law enforcement concern is over large-scale wholesaling and cartels.
Cannabis trafficking
Certain types of cannabis that are unique to a particular area, such as Maui-wowie, hula-bud, may be shipped great distances due to popularity and demand.
On the United States' Pacific coast, a cannabis "superhighway" of sorts exists, along which most exotic strains are traded, anti-cannabis laws are relatively relaxed or are not as actively enforced, and large numbers of growers reside.
At the northernmost end of this "highway" is Alaska, where northern lights and Alaskan thunderfuck are produced. Further south is British Columbia, home of the famous BC bud, which comes in a wide array of qualities and forms, the most desired of which is the hydrochronic, or hydroponically grown chronic. South of British Columbia is Washington, which is the home of the annual Hempfest, has an extremely high number of local growers, and imports massive quantities of hydrochronic from British Columbia, Maui-wowie and hula-bud from Hawaii, Thai-sticks from Thailand, yellow cab from Idaho, northern lights and thunderfuck from Alaska via British Columbia, and red-hair bud from southern Mexico via California and Oregon. Washington is also famous for its chemo-bud grown at the University of Washington. South of Washington is California, where consumption of cannabis is likely as high (per-capita) as in Washington, and is thus a major player in cannabis trade. At the southernmost end is Mexico, which, although known mainly for its low-quality "dirt weed", facilitates the trade of highly potent strains from southern Mexico and Central America into the United States.
Along this "superhighway", major cities such as Vancouver, BC, Tacoma, San Francisco, and Los Angeles offer the lowest prices for the greatest quantities of cannabis, whilst Tacoma, San Francisco, and L.A. offer the greatest variety of exotic strains. These exotic strains become increasingly rare and expensive when one moves into the smaller surrounding towns. Away from the west coast as a whole, the cost of even low-quality or "schwag" cannabis may be double what one would pay for good-quality cannabis in, for instance, Washington.
Cannabis trade jargon
Note that while this is relatively standard jargon, any of these terms may have related, sometimes more specific, sometimes more generic, and very often overlapping meanings in both regional jargons and slang. Each of these terms also has a stunningly large array of slang synonyms. While the vernaculars of stoners vary greatly from region to region and group to group, and range from simplistic and poorly defined slang to locale- or clique-specific jargons with enormous vocabularies and even more greatly stratified, complex terminologies with more specific and exacting definitions, the terms outlined below are almost universally understood, albeit generic and necessarily somewhat ambiguous.
See Wiktionary Appendix of Cannabis Slang.
Ecstasy (MDMA) trade
see: Ecstasy article
Ecstasy production
Ecstasy trafficking
Ecstasy distribution
Ketamine trade
For further development
Ketamine production
Ketamine trafficking
Ketamine distribution
LSD trade
LSD (also known as Acid) is a highly potent hallucinogen which is synthesized artificially. The availability of LSD in the United States dropped sharply circa 2000, when two distributors alleged by the government to have been manufacturing 95% of all LSD available in the US were captured (see LSD). Unlike other drugs, the production of LSD is very complicated and involves obtaining highly controlled precursors. It is said that someone with a PhD in organic chemistry could produce LSD, but anybody with less education and experience would have a very difficult time synthesizing a decent product. Historically, LSD was distributed not for profit, but because those who made and distributed it truly believed that the psychedelic experience could do good for humanity, that it expanded the mind and could bring understanding and love. Most of the main distributors traveled with the Grateful Dead until Jerry Garcia's death.
LSD production
LSD trafficking
LSD distribution
GHB trade
GHB production
GHB trafficking
GHB distribution
PCP trade
For further development
PCP production
PCP trafficking
PCP distribution
Psilocybin Mushroom trade
The trade of Psilocybin containing mushrooms (virtually always psilocybe cubensis) is a profitable, but less common one. While Psilocybin mushrooms can be found in the wild, this is not the typical method through which they are acquired, especially for sale. This method is highly inefficient and very few people are confident enough to be able to positively indentify them and even fewer are actually right. The people who sell Psilocybin mushrooms typically grow the mushrooms themselves, which is why they are less commonly found, but highly profitable as it is generally 100% profit for the seller or a seller and growing partner splitting profits 50% each.
Mushroom Types
There are several types of psilocybin-containing mushrooms, including:
- Psilocybe cubensis
- Psilocybe azurescens
- Psilocybe cyanescens
- Psilocybe mexicana
- Psilocybe subcubensis
Psilocybe cubensis is the most common, therefore popular, strain, perpetuated by its recommendation in most methods, including the PF Tek method, as being a relatively easy-starting strain.
Mushroom production
Personal growing of mushrooms is extremely easy, thanks to the legal status of spores and mycelium (varies in different countries and states). One can purchase kits through the mail or internet that include everything one needs for personal growing. These grow kits are often used by amateurs, producing only enough for personal use and sharing with some friends. These amateur growers typically go on to create "Flushes" (When mushrooms cover the entire grow surface. Typically one container will grow 2-3 flushes before needing fresh mycelium containing material.) which produce 1 lb or more of dried mushrooms. The skills required for this profitable method of growing are generally learned in the amateur growing phase. The most common reason for failure at any scale is contamination of the material and containers that are to be innoculated by spores. The most common grow method is known as the PF Tek method, most other methods are based on this method which has been circulating on the internet for several years. The creator of this method is known as PF Tek and used to sell supplies and spore syringes, however PF Tek has since bowed out of this.
Most of the supplies needed for mushroom cultivation (mason jars, petri dishes, scalpels, rye) can be easily obtained from many stores. Amateurs who actually take the time to research mushroom cultivation would not need to start off with a grow kit and can easily make their own grow space.
Mushroom trafficking
Mushroom distribution
Alcohol
In a few predominately Muslim countries, such as Saudi Arabia, alcohol is strictly forbidden by law. Many drinks such as absinthe are, or were until recently illegal to sell in many European countries. Absinthe remains illegal in the USA.
In the USA, there still are communities (called "dry" counties) with a ban of the sale of alcohol. Almost one-half of Mississippi's counties are dry. It is also illegal to transport unopened bottles of alcohol across any dry county line in the state.
Tobacco trade
The illegal trade of tobacco is motivated primarily by increasingly heavy taxation. When tobacco products such as name-brand cigarettes are traded illegally, the cost is as little as one third that of retail price due to the lack of taxes being piled on as the product is sold from manufacturer to buyer to retailer. Meanwhile, the sale of tobacco, legal or not, seems motivated almost entirely by addiction, with social/recreational motives being the cause of initial consumption.
Hard drugs
'Hard drugs' are generally drugs considered to create a high degree of physical dependence (i.e. addiction) or considered to be a serious detriment to society or personal health.
Illegal supply of these so called hard drugs is driven mainly by the economics of drug prohibition coupled with the addiction of their users, with huge profit margins available due to the collision of high demand for the drugs with harsh laws that attempt to prohibit their supply and use. The vast profits on offer mean that the trade is run by highly organized and often violent criminal organizations.
For the purposes of this article, the following drugs will be discussed as hard drugs:
- Cocaine
- Heroin and Opium
- Methamphetamine
Cocaine trade
Because of the extensive processing it undergoes during preparation and its highly addictive nature, cocaine is generally treated as a hard drug, with severe penalties for possession and trafficking. Demand remains high, and consequently black market cocaine is quite expensive. Unprocessed cocaine, such as coca leaves is occasionally bought and sold, but this is exceedingly rare as it is much easier and more profitable to conceal and smuggle the concentrated processed form. Therefore, powdered cocaine (its usual form) is described here.
Most cocaine is smuggled in large quantities in trucks, boats, or small airplanes. Smaller gangs will often send out a mule, often a young woman, with kilos of cocaine strapped to her waist or legs or hidden in her bags. If she gets through without being caught, the gangs will reap most of the profits. If she is caught however, gangs will sever all links and she will usually stand trial for trafficking by herself.
Colombia still produces around 75% of the world's cocaine.
Cocaine production
Cocaine comes from the coca plant. The leaves are stripped from the plants and dried, then crushed into a paste, commonly using cement mix (containing sodium carbonate), lime and water. This then allows extraction of the cocaine alkaloid into kerosene. The resulting water immiscible solvent (kerosene) acts to extract water insoluble cocaine alkaloids from the mixture. The plant leaves are usually agitated by stomping on them or, occasionally by using a so-called agitation machine. The cocaine alkaloids and kerosene mostly separates from the water and leaves, and then needs to be strained.
The alkaloids should be extracted from the kerosene by adding a dilute hydrochloric or sulfuric acid mix then strained again. Potassium permanganate is usually added then the mix should be allowed sit for 4-6 hours. The paste is usually further strained and ammonia added. A dubious precipitate will be formed, known as cocaine base.
The base is dried and converted to cocaine hydrochloride (HCl) by soaking it in acetone and straining it. Adding diluted hydrochloric acid or Ether (cutting) should cause a precipitate to form which is usually dried under heat lamps, resulting in concentrated cocaine hydrochloride.
Cocaine trafficking
Organized criminal gangs operating on a large scale dominate the cocaine trade. Most cocaine is grown and processed in South America, particularly in Colombia and Peru, and smuggled into the United States and Europe, where it is sold at huge markups.
Cocaine distribution
DRAFT SECTION To be written
Cocaine is often adulterated or "cut" with a variety of substances prior to sale. Common adulterants include Mannitol, a sugar based baby laxative, Benzocaine to cause a numbing effect, Methylphenidate or (ritalin) -- a drug which when taken by way of insufflation, mimics many of the euphoric and "speedy" effects that are attributed to cocaine.
Purity of cocaine varies widely over a range of approximately 10 to 90 percent - with larger quantities generally being more pure, and smaller quantities generally being less pure.
Crack Cocaine trade
Crack cocaine in the United States is usually more prevalent in lower income urban communities which are often predominantly Hispanic or African-American. This is largely due to the way a drug is marketed rather than its specific effects. Crack cocaine is often sold in $5 hits, a piece of which will fit into a small glass vial (pipe). The small amounts and low price make crack an easy sell in crowded poor neighborhoods.
Crack is more addictive and more dangerous than normal powder cocaine because when it is smoked it delivers a stronger high because it reachs the blood stream quicker. Powder cocaine does not burn well and cannot be efficiently smoked, whereas crack cocaine can easily be absorbed through the mucus membranes in the nose. This has to do with the structure of the molecule and whether a hydrochloride bond is present or not. In the cases where it is not present the cocaine is known as under slang as freebase. Almost every drug can exist in either a salt form (as in with a hydrochloride bond) or a freebase form, but only freebase cocaine takes the slang name.
True freebase cocaine is difficult to manufacture and involves explosive chemicals to process. Before the 1980s it was the only form of “rock” cocaine. Crack in contrast is safely and easily made and is manufactured from imported powdered cocaine usually in small batches by urban dealers. Using a simple process involving baking soda and water the dealers can make a rough “freebase” of the cocaine. Because baking soda is added in the process crack cocaine is actually less pure – whereas a true freebase is more pure.
Crack cocaine is associated with street gangs that distribute it; the money earned from its sale is used for, but not limited to, the following: drug-wars, illegal firearms, and turf-wars.
Processing
To be written
Street selling
To be written
Heroin and opium trade
Opium is the dried latex resin of the opium poppy. Most of the world's illegal opium has been grown in Afghanistan and the Golden Triangle region of southeast Asia for a long time. Although, in recent years, a growing amount comes from Latin America, particularly from Mexico and Colombia (in the latter country it has displaced to some extent the cocaine trade because it is easier to refine into a marketable product, heroin), and production has also taken root in the Caucasus Mountains.
The legal production of opium for the variety of opiate-based products used by the medical market is more than 50% of global opium production and takes place mostly in Tasmania and India. In these countries, it is used strictly in its natural form, which contains a number of active ingredients. It is smoked, eaten, or prepared as a drink to produce the opiate effects. It is also widely used as local medicine in its native countries; the resin requires minimal processing involving boiling in water, filtering, and drying. Illicit trade in opium is relatively rare, since major smuggling organizations prefer to further refine opium into heroin. A given quantity of heroin is worth much more than an equivalent amount of opium; therefore trade in opium is comparatively rare, since heroin is much more profitable.
Heroin is manufactured through the chemical processing of opium, and smuggled into the United States and Europe. Purity levels vary greatly by region with, for the most part, Northeastern cities having the most pure heroin in America. According to a recently released report by the DEA, Elizabeth and Newark, New Jersey, have the purest street grade heroin in the country.
Heroin and opium trafficking
To be written
Heroin and opium distribution
To be written
Methamphetamine trade
Since the early 1970s, outlaw motorcycle clubs such as The Hells Angels, The Pagans
and the Aryan Brotherhood prison gang have been active in the manufacture of crystal methamphetamine in North America. However, in the last two decades they have been joined by large scale operations based in Mexico and Asia, and small scale meth labs which have popped up throughout North America, which often create environmental hazards for those living near them due
to the amount of toxic chemicals used in methamphetamine production. The proliferation of small scale
meth labs began in California, then spread to the rest of the Western United States, and from there
spreading to the midwest and now throughout almost all of the country, paralleling the epidemic
in meth abuse which currently is taking place in all sections of the United States except for the Northeast, as well as spreading into most of Canada. A wide variety of groups are involved in
the distribution of methamphetamine, from the aforementioned prison gangs and motorcycle gangs to
street gangs, traditional organized crime operations, and impromptu small level networks made up
of users. The government of North Korea is said to promote the manufacture of crystal meth, and
allegedly plays a role in distribution networks throughout Asia as well as those in Australia and even in
North America. Regardless, meth trafficking is not exclusively dominated by cartels along the lines of
Colombia's cocaine cartels or Pakistan's heroin cartels....
Methamphetamine production
To be written
Methamphetamine trafficking
To be written
Methamphetamine distribution
To be written
----
Because of physical dependence, the high cost of illegal addictive drugs is one of the major causes of crime. Some estimates placed the value of the global trade in illegal drugs at around four hundred billion U.S. dollars in the year 2000.
Major consumer countries include the United States and European nations, although consumption is world-wide.
As with legal commerce, the illegal drug trade is multi-layered and often multi-national, with layers of manufacturers, processors, distributors, wholesalers and retailers. Financing is also important, generally involving money laundering to hide the source of the illegal profits. All of these are made more complex by their illegality, but the normal laws of economics still apply, with the efforts of law enforcement regarded by the drug trade as an extra business cost.
The drug trade is a very fragmented industry with the most popular product, cannabis, being grown locally by many individuals with little collaboration. Similarly, drugs like LSD with very low profit margins are sold more for philanthropic reasons than for profit. The main organized drug cartels deal with cocaine, heroin, and MDMA, and it is these that are the primary focus of the United States Drug Enforcement Administration. Largely manufactured drugs also induce the foundation of satellite organizations that supply some of the needed chemical precursors. In places where alcohol is illegal, such as Saudi Arabia, it may also be the subject of illegal trading. In the United States during Prohibition, trade in alcohol was dominated by the Cosa Nostra.
Some prescription drugs are also available by illegal means, eliminating the need to manufacture and process the drugs. Prescription opiates for example, are sometimes much stronger than heroin found on the street.
They are sold primarily via stolen or unscrupulous prescriptions sold by illegitimate medical practices and occasionally from Internet sale. However, it is much easier to control traffic in prescription drugs than in illegal drugs because the source can often be readily found and neutralized.
Legal Drugs like tobacco can be the subject of smuggling and illegal trading if the taxes are high enough to make it profitable.
Because disputes cannot be resolved through legal means, participants at every level of the illegal drugs industry are liable to compete with one another through violence. Some of the largest and most violent drug trafficking organizations are known as drug cartels. For this (and other reasons, namely the inability for governments to control, regulate and tax distribution), many have argued that the illegality of popular drugs worsens the problems around these substances.
The most well known recent groups were the Cali and Medellín cartels in Colombia and the Juarez, Tijuana and Tamaulipas cartels in Mexico.
Manufacturing and processing
Illegal drugs can be broken down into two major classes: those extracted from plants, and those synthesized from chemical precursors.
For the first class, such as marijuana and cocaine, the growing area is important, and substantial farming is needed for mass production.
For the second class, such as MDMA and methamphetamine, access to chemical precursors is most important.
Major drug farming and manufacturing countries include
- Colombia and other Latin American countries for mainly cocaine
- the Asian Golden Triangle of border areas of Thailand, Burma and Laos for opium.
- The United States for Methamphetamine
- Afghanistan and border areas of Pakistan
Synthetic illegal drugs can either be manufactured in the country of consumption, or abroad.
For the most part, the manufacturing of botanically-based drugs consists of several layers which may be isolated or conglomerated: growing and harvesting, initial botanical processing, chemical processing, and final processing.
The initial botanical processing prepares the plant for chemical processing, by cutting, drying if applicable, separating parts with a low concentration, and etc. The chemical processing extracts the drug, and the final processing sizes it, provides assurance of quality, packages it, and may convert it to another form (such as crack from cocaine).
Of course, there is a lot of transportation that goes into it, as well. The botanical extracts must be conveyed to the...
Distribution and wholesaling
There are two primary means of distribution: a hierarchy and a hub-and-spoke layout. A hierarchical arrangement includes the manufacturer who uses his own men to smuggle, wholesale and store, and distribute the narcotics. A hub-and-spoke layout takes advantage of local gangs and other localized criminal organizations. The cartel is at the center, with satellite organizations that may provide certain services to the manufacturer, and then there is a plurality of distinct groups, each with its own chain.
Smuggling is typically accomplished via small boats and yachts, air vehicles, and by gangs paid with a chunk of the merchandise.
Wholesalers routinely accept the materials from the smugglers (often more than one and of varying types), cut it, and sell it to the distribution chain or chains. For the most part, wholesalers are not individual people. It is typically an expansional endeavor by already-established rogue enterprises, such as Mafias and, rarely, gangs. The more experienced instances may re-manufacture the wares to increase (or decrease, because profit comes from cutting) the purity, mixing it (a few may fabricate amalgamated, specialty products at fleeced prices), or altering the chemical composition of the material (such as freebasing cocaine). Wholesalers may also manufacture and disseminate general contraband, including non-narcotic controlled substances (like date rape drugs), paraphernalia, and any panoptic, high-demand item that they may receive.
Distribution may traverse a selectively chosen group of cartel employees who purchase from a wholesaler and utilize a prominent population of "mules," or it may encompass a heavy chain of users who are selling to finance their own use.
- to be written -- topics include:
- smuggling
- →opium smuggling against laws of China in 19th century, w/regard to Howqua, Forbes family, Cabot, Perkins family, Russell and Company, Opium War
- security problems similar to distribution of other high-value materials
- and hence gang-on-gang crime
Retail selling
Availability of Controlled Substances Over the Internet
"No Prescription Websites" (NPWs) offer to sell controlled substances without a valid prescription. NPWs were first recognized by the U.S. Justice Department in 1999, indicating that such sites had been operating at least through the late 1990s. NPWs enable dealers and users to complete transactions without direct contact. While many NPWs accept credit cards, others only accept cash thereby further reducing any papertrail. Many NPWs are hosted in countries in which specific categories of controlled substances are locally legal (e.g. prescription opioids in Mexico), but because of the global nature of the internet, NPWs are able to do business with customers around the globe. In addition to prescription opioids, stimulants, steroids and sedatives, marijuana seeds are also readily available, while marijuana generally is only advertised in chat rooms and forums. To date, no websites have been found offering to sell heroin, methamphetamines, or cocaine - but all other categories of drugs are readily available online.
Punishments in various countries
U.S. Justice Department") warns passengers disembarking in Taiwan of the potential consequences.]]
To be written
Australia
There is a movement in Australia to make some narcotics decriminalised, particularly marijuana, the possession of such, in most states being a non-convictable offence (the definition of what constitutes possession differs however). Heroin trials have been tried in various states with mixed results.
As a result of the decriminalisation, the punishments for drug use and drug dealing in Australia are typically very small, with many convicted small-time drug dealers not having to spend any time in jail.
There is an associated pro-drugs culture amongst a minority of the youth of Australia. The popular national youth radio station, Triple J radio often refers to drug use with a neutral sentiment, rarely discouraging their use. Many take this neutrality as an encouragement to use drugs, and a feeling of drug abuse being acceptable in Australia.
The Netherlands/Holland
In the Netherlands, marijuana and other soft drugs are fully decriminalised in small quantities. Contrary to popular belief, marijuana is still illegal, mostly to satisfy the country's agreements with the United Nations. Coffee shops are tolerated across the country, and pay taxes like any other business for their sale of "coffee", although distribution is a grey area that the authorities would rather not go into as it's not decriminalised. The majority are found in Amsterdam and cater mainly for the large tourist trade; the local consumption rate is far lower than in the US.
Similarly to the rest of the European Union member states and American democracies, controlled drugs are illegal in the Netherlands. Nevertheless, illegal narcotics are consumed worldwide, causing concern in the international community. According to the United Nations Drug Control Program (UNDCP, 2001) results in their World Drug Report estimate
“that the extent of drug abuse in the world involves about 180 million people, which represents 3% of the global population. The majority of drug users (80%) used cannabis, followed by amphetamine-type stimulants such as methamphetamine, amphetamine and substances of the ecstasy group (16%), cocaine (8%), heroin (5%) and other opiates (2%)”.
The administrative bodies responsible for enforcing the drug policies include the Ministry of Health, Welfare and Sport (VWS), the Ministry of Justice, the Ministry of the Interior and Kingdom Relations, and the Ministry of Finance. It is important to note that local authorities also shape local policy, within the national framework. The prohibition policy is heavily influenced by the international community (through the United Nations), especially the neighboring states of France and Germany, which pressure the kingdom to be more strict, for they are directly affected through the illegal trafficking of narcotics coming from the Netherlands.
Legally, possession, manufacturing, trafficking, importation and exportation are forbidden. Nonetheless, it is not an offense to use drugs (Ministry of Foreign Affairs, 2003). There are different penalties involved when breaking the law, which may include a monetary fine, imprisonment, or both. To apply the law, the government differentiates between soft and hard drugs. Soft drugs are considered to produce less harm to both the individual and society, these being used mainly for homeopathic and recreational purposes. This category encompasses cannabis (nederwiet), hashish and some fungi. Hard drugs are considered to cause considerable personal harm through addiction and physical detriment, as well as nuisance to society, by increasing crime and deteriorating families. Cocaine, heroine and ecstasy belong to this category.
Along with these two categories, there is a pyramid of priory when it comes to prosecution by law enforcement agencies. The handling and trade of hard drugs is on the zenith, being a joint target not only by the Netherlands, but also by the international community. This can be punished by maximum sentences of twelve years of imprisonment and/or a fine of up to €45.000. The second priority is given to the production and trade of soft drugs. Deviation from the AHOJ-G criteria for coffee shops may result in up to four years of imprisonment and/or a fine of €45.000. This point will be further explained in the next paragraph. The third priority focuses on hard drugs users. Unlike other countries, consumers are not considered criminals. This label would bring negative repercussions to the individual, and it would keep users from seeking help. The state aims to rehabilitate users and prevent others from becoming addicted. However, disturbance to society cased by this consumption can result in one year of prison and/or €11.250. Lastly, individuals possessing more than five grams for personal consumption, or disturbing the public, can go to prison for one month and/or be fined €2.250. There are of course varying rules within this categories, for example the amount possessed, the role played in the transaction, and the intent of the goods.
As regards coffee shops, the line between law and practice thins. A coffee shop is a heavily controlled business establishment where individuals can purchase a personal dose of soft drugs in the form of joints, pastry, drinks, and packages. In theory illegal, these shops must abide by governmental and local regulations, as well as meet the AHOJ-G criteria, an acronym for: No Advertising, Hard drugs, Nuisance of any kind, Jongens (minors), and a limit of five grams per transaction. Additionally, the maximum stock at any time is five hundred grams. Local governments may impose additional rules, such as closing times, zones (coffee shops may not be close to schools), and parking restrictions. The rationale behind coffee shops is to keep citizens away from the harmful hard drugs scene, bringing them to a safe, social, and regulated environment.
When analyzing the Dutch model, both disadvantages and advantages can be drawn when comparing the results with other countries. On a moral argument, tolerating soft drugs can be seen as the defeat of the government against hedonism. Additionally, decades of growing and perfecting cannabis and hashish has resulted in increased levels of the active stimulant tetrahydrocannabinol (THC), as levels have doubled, making the derived products more powerful. At that rate, soft drugs could eventually become hard drugs.
On the other side, Gedoogbeleid has considerable advantages, making it the most successful policy in the post-industrial world. To begin, this tolerance did not result in hordes of young Dutch queuing in coffee shops after school. Though there was a slight increase of use at the beginning, the rates balanced out a couple years afterwards. The presence of coffee shops does not translate in public urge for experimentation. In fact, most people that did not consume drugs before the enhancement of the policy continue not to use them.
Tolerating soft drugs also leads to a more cohesive society, where everyone is represented, even those who decide to use drugs as a recreational item, just like Heineken, a pseudo-symbol of national pride, is widely consumed and exported around the EU and the world. Having users as part of the public sphere also aids the government to conduct studies on the medical and psychosocial consequences of drugs, allowing it to draft improved policies, and serve as an example to the world, as well as aiding those who need professional help, which would hesitate less to seek help if there is no stigma associated with their practice. Eliminating the taboo element associated with illegality, many curious consumers would not even ponder soft drugs as a source of deviance. Incorporating drugs in the market economy also entitles the government to regulate doses and the contents of the products, further reducing potential harm to individuals. The dangers of the underground market are also highly reduced by condoning small-scale trade, making the establishments more accessible to the public.
When compared to other countries, Dutch drug consumption falls in the European average at six per cent regular use (twenty-one per cent at some point in life), and considerably lower than the Anglo-Saxon countries headed by the United States with an eight per cent recurring use (thirty-four at some point in life). Experts have come to the conclusion that the policies applied do not play a striking role in these statistics, though there is debate over this issue (CEDRO, 2004).
It would be hypocritical to accept that the government pretends to maintain the well-being of its citizens by prohibiting drugs, for it is widely known that substances such as cigarettes and alcohol pose a much higher risk factor to the consumer, resulting in cancer, addiction, liver problems, as well as other predicaments. A move of the Dutch government towards the right, in addition to increased international pressure, endanger the current gedoogpolicy, and its future is uncertain. The number of coffee shops (one third of them located in Amsterdam) has decreased by roughly one fifth and is expected to further decrease, as local governments tighten regulations. There is however some hope that the political climate could change, as some countries such as Germany have decriminalized the personal use of soft drugs for recreational and medicinal purposes.
National drug use prevalence in the Netherlands, 1997 and 2001 (weighted percentages)
Drug 1997Lifetime 2001Lifetime 1997Last year 2001Last year 1997Last month 2001Last month
Tobacco 67.9 66.4 38.1 34.1 34.3 30.2
Alcohol 90.2 91.6 82.5 83.8 73.3 75.1
Hypnotics 17.4 18.5 8.5 9.5 5.5 |
