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Drug Regulation (DR)

 

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To Amend Chapter 8 Gorgas Hospital, to transfer the Drug Enforcement Administration (DEA) Office of Diversion Control to the Food and Drug Administration (FDA) and change its name to Drug Evaluation Agency (DEA), to change the name of the Substance Abuse Mental Health System Administration (SAMHSA) to Social Work Administration (SWA), to transfer the Secretariat of the International Narcotic Control Board (INCB) to the World Health Organization (WHO), to remove Drugs from the name of the Office of Crime (OC), to give Afghanistan 80% of the national and 75% of international opium quota until opium demand from the war economy has subsided, to rewrite the Controlled Substances Act, patent, and protection of human research subjects statute in order to identify, isolate, control, prohibit and destroy the pathogens that are used in bio-medical research to cause disease in laboratory animals or potentially injure humans, to commission a study of Schedule of Psychotropic Substances to identify and prohibit from circulation the pathogens that cause serious mental illness, to terminate automatically refilled contracts under DEA Form 222, to repeal the loophole in the statute that has hypothetically caused PTSD and Gulf War Illness since Vietnam, to provide for the regional Poison Control Centers to assist the federal government to monitor the possession and use of all poisons and pathogens used in bio-medical research laboratories, to inspect those laboratories and receive reports from the public regarding abuse of disease pathogens, to stop doctors from receiving kickbacks from pharmaceutical companies, to divert pharmaceutical political contributions to third party candidates, to eliminate mandatory minimum sentencing and reduce sentences for illicit drug possession and trafficking, to make drug addiction treatment safe and accessible, to reschedule marijuana to Schedule III and establish an entirely new Type of classification for the Customary control of drugs and prohibition of pathogens.

 

Be the Democratic and Republican (DR) poison party Dissolved, Referred to the Food and Drug Administration (FDA)

 

1st Draft done as a Political Science Thesis in 2000, 2nd Fall of 2004, 3nd Martin Luther King Jr. Day 17 January 2005, 4th Halloween 31 November 2005, 5th American Pharmacists Month 15 October 2006, 6th 8 August 2007, 7th 5 November 2009

 

1.This Act amends Chapter 8 Gorgas Hospital Title 24 US Code 301-320 that is preserved in two sections, 301 and 302 pertaining to the change of name of Ancon Hospital to Gorgas Hospital. It may be cited as the Patent Remedy Act of 2009. The major institutional reforms proposed in this Chapter are: First, to change the name of the Drug Enforcement Administration (DEA) to Drug Evaluation Agency (DEA) and transfer the DEA from the Department of Justice to the Food and Drug Administration (FDA) while retaining the power of the Attorney General for arrests and firearms. To realize this reform Title 21 of the Code of Federal Regulations and Controlled Substances Act at Title 13 of the United States Code is amended to serve as the readmission of the Secretary of Public Health after her expulsion from the Department of Health, Education and Welfare in 1979, for unspeakable things, upon her recognition of this amendment in Public Health Service Statute that shall be renumbered from Chapter 6A to Chapter 1 of Title 42 of the United States Code.. Second, to change the name of the Substance Abuse Mental Health Services Administration (SAMHSA) to Social Work Administration (SWA) to empower social work professionals to chop down psychiatry and adjudicate mental illness, drug addiction and substance abuse. Third, on the international front, the Secretariat of the International Narcotics Control Board (INCB) must be transferred to the World Health Organization (WHO) and the Office of Drugs and Crime (UNODC) must change their name to Office of Crime (UNOC) as precondition for the full support of the United States for the Secretary of the United Nations (SEA) and Socio-Economic Administration (SEA) of the United Nations Charter Legitimate Edition (UNCLE).

 

2. The pharmacist is a health professional who is the expert on medicines. Pharmacists are also given the responsibility to help people to maintain good health, to avoid ill health and, where medication is appropriate, to promote the rational use of medicines and to assist patients to acquire, and gain maximum therapeutic benefit from, their medicines. Pharmacists are responsible for maintaining vigilance that the supply of medicines and medical devices for patient self-care is sufficient and are that drugs are not counterfeit or substandard and that prescriptions are not given in error by a physician, causing an adverse reaction with other medication, in excess, or causing the individual side effects. Physicians have recognized for years that individuals respond differently to medicines. may have to try several different products before finding the right treatment. In providing high quality medical care, safety monitoring of personalized medicine is essential to the ongoing effective use of medicines. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse affects or any other possible drug-related problems. In 2003 it was estimated that in the United States the number of people having in-hospital, adverse drug reactions (ADR) to prescribed medicine was 2.2 million of which 106,000 were fatal, of 2.4 million mortalities.

 

3. At the dawn of the 21st century, it is not so much the new drugs, but the pharmacological understudy of toxicology, whose prohibition of bio-medical laboratory pathogens offers the greatest benefit to public health, happiness and longevity. At the beginning of the 20th century narcotic drugs underwent regulation and the predecessor of the Food and Drug Administration (FDA) prohibited many addictive and fraudulent patent remedies. During the 20th century average life expectancy in developed countries increased by over 20 years. Anti-biotics and vaccines wiped out entire classes of bacterial and viral infections, but incidence and death from the mysterious pathogens causing heart disease, cancer and diabetes, as well as obesity have increased. Progress continues albeit at a slower rate and new medicines are attributed to have generated 40 percent of the two-year gain in life expectancy achieved in 52 countries between 1986 and 2000. This increase in life expectancy has however made little progress in Sub-Saharan Africa and Afghanistan where he HIV/AIDS crisis and many wars have caused life expectancy to go down in the past 50 years in these least developed nations from 50 years to as low as 30. It has become a primary objective of the pharmaceutical industry to reverse these downward trends by ensuring that everyone is entitled to life saving treatment regardless of if they can pay or where they live. The government must take responsibility to control and prohibit the pathogens causing deadly and disabling disease and torturous conditions, with all the virulence currently directed at the illicit drug trade, in part by ensuring that international health assistance and trade is nearly entirely labeled, packaged, sealed and sterile patent remedies.

 

Major International Contributors to Global Health 2004

 

4. A total of 3.6 billion prescriptions were filled in the United States between October 2004 and September 2005. Total US pharmaceutical sales in 2005 were estimated at $250 billion. 66.4% of these sales were domestic. It can be estimated that the gross aggregate global sale of pharmaceutical drugs is probably greater than $500 billion from 10 billion prescriptions. In 2003 the US biopharmaceutical sector was responsible for $63.9 billion in direct output, $38.8 billion of which was for research and development in 2004, and employed over 450,000 people across the U.S, 82,000 in research and development. $23.6 billion in taxes are attributed to the pharmaceutical industry, $6.4 billion of which were corporate taxes. In July 2005, the ratio of generic/brand share of market by volume (weighted average) was 54/46. In 2006, it is estimated to be 58/42. In 2003 there were 17 therapeutic classes of prescription drugs. These classes in order of sales are (1) Antidepressants (SSRIs, SNRIs) (2) Anti-hyperlipidemics (Statins) (3) Anti-ulcerants (Proton-pump inhibitors) (4) Anti-hypertensives (ARBs, ACE inhibitors) (5) Antibiotics (Broad- and medium-spectrum) (6) Diabetes Therapies (Oral, injectible) (8)Anti-arthritics (COX-2 inhibitors) (8) Antipsychotics (9) Antihistamines (Oral) (10) Neurological Drugs (For seizures or pain) (11) Other Vascular Drugs (Calcium- or beta-blockers) (12) Anti-asthmatics (13) Analgesics (Non-narcotic) (14) Bone Density Regulators (15) Oral Contraceptives (16) Anti-allergy Drugs (Nasal steroids) (17) Analeptics (ADHD treatments).

 

Trillion Dollar Global Market for Pharmaceutical and Illicit Drugs 2000

 

5. In 2000 180 million people worldwide - 4.2% of people aged 15 years and above - were consuming illicit drugs in the late 1990s; this figure includes 144 million consuming cannabis, 29 million people consuming amphetamine type stimulants, 14 million people taking cocaine and 13 million people abusing opiates, 9 million of whom were addicted to heroin. In 2000 the international trade in illicit drugs was estimated at $400 billion. Profits are reported to be so inflated that profitability of the illicit drug trade would be affected only if 75% of such shipments were intercepted. Current efforts only intercept an estimated 13% of heroin shipments and 28%-40% of cocaine shipments. In 1999, the estimated worldwide production of opium reached a record of 5,778 metric tons derived from 217,000 hectares of poppy. Estimated global production of coca-leaf mounted to 290,000 metric tons from 183,000 hectares of coca. The United States is reported to be the largest consumer of illicit drugs, in 2000, U.S. citizens were estimated to spend a total of $64.8 billion - $36 billion on cocaine, $10 billion on heroin, $5.4 billion on methamphetamine, $11 billion on marijuana, and $2.4 billion on other substances. In the United States 15.9 million people ages 12 and older (7.1%) reported using an illicit drug in the month before the survey was conducted and 1% were reported as being dependent. In 1981 there were only 503,586 prisoners in the United States. As the result of mandatory minimum sentencing legislation in the 1980s and 90s, that forced the judiciary to unfairly target drug offenders, the US prison population increased 357.9% between 1980 and 2002 at an average annual growth rate of 3.6%, in 2004 it was estimated that there were more than 2.1 million people were behind bars.  It can be estimated that there are now more than 500,000 otherwise harmless drug offenders in some form of penal institution who are entitled to release. Drug courts and substance abuse treatment are innovative approaches to helping drug offenders achieve a drug- and crime-free life. The Supreme Court has ordered the Courts and Congress to eliminate mandatory minimum sentencing.

 

6. The Convention on Psychotropic Substances of 1971 and establishment of the DEA in 1973 precipitated civil wars in the major narcotic producing nations of Afghanistan and Columbia. Total Andean cocaine production (currently estimated at 640 metric tons) has dropped nearly 30 percent (260 metric tons) since its peak of 900 metric tons in 2001. To end 30 years of civil and foreign military intervention the Andean Community must establish a Regional Narcotic Agency to regulate the cultivation and distribution of coca and opium to supply the quotas of international and national pharmaceutical markets for the benefit of the indigenous peoples living there. Between 2003 and 2004, seizures of cocaine in the Andean region increased by 28 percent to reach 157 metric tons. 95 percent of the Andean cocaine seizures took place in Colombia. In 2004 the Andes produced $860 million in farm value coca. The US spent an equivalent amount on eradication programs. Afghanistan must make peace with the legitimate opium trade and open a red light district, within their borders, for legal opium to elicit the support of the people to arrest heroin manufacturers and smugglers and foster tourism by adopting a National Opium Agency strategy so that the International Narcotics Control Board would grant the nation 75% of the global opium market demand and the DEA 80% until the dependency to opium from the war economy has subsided. Around 9,000 tonnes of opium are harvested annually worldwide, 6,500 tonnes illicit. Since 1994 Afghanistan has been the leading producer of opium, producing 5,500 tonnes in 1999, but in 2000 the Taliban prohibited opium and production went down to 500 tonnes but since the occupation production has increased to a new recod of 6,500 tonnes, 96% of illicit production. Legitimate global demand for opium can be estimated at 2,000,000 kg, 2,000 metric tons. This would give Afghanistan a quota of 1.5 million kg that could be purchased from local growers by the National Opium Agency for $500 a kg for $750,000,000 total. Afghanistan would sell the opium at a 5 time mark up to the international medical, pharmaceutical and scientific research market-$2,500 a kg, $3.75 billion yearly total, $1.875 billion a harvest. This would show a net profit of $3 billion the first year.

 

7. The general obligation of drug policy is to limit exclusively to medical and scientific purposes the production, manufacture, export, import, distribution of, trade in, use and possession of drugs. The goal is simple: inspire informed conversations between patients and physicians about healthcare, disease prevention and the medicines that might help treat or cure illness. People have treated diseases, including pain and suffering, with medicines since ancient times. A legitimate medical purpose is not inconsistent with the public interest nor should the artistic use of psychotropic drugs be totally disregarded as a source of inspiration and productivity in legitimate venues. Unless there was substantial proof that a substance is harmful, it should remain uncontrolled. Parties are to take all practical measures for the prevention of abuse of psychotropic substances and for the early identification, treatment, education, after-care, rehabilitation and social reintegration of the persons involved. The medical use of narcotic drugs continues to be indispensable for the relief of pain and suffering, adequate provision must be made to ensure the availability of narcotic drugs for such purposes yet addiction to narcotic drugs constitutes a serious evil for the mental health of the individual that is fraught with social and economic danger to mankind. In general psychotropic drugs abuse tends to cause a state of dependence, and central nervous system stimulation or depression, resulting in hallucinations or disturbances in motor function or thinking or behavior or perception or mood. Addicts have a tendency to become psychotic when they quit their drug and should be made aware of the symptoms of mental illness before they suffer the withdrawal. The scheduling of Marijuana as a Schedule I most dangerous, addictive and useless drug is testimony to the shabby science undermining the hypocritical regime of judicial drug policy and it is rescheduled to Schedule III whereas marijuana is so pleasantly therapeutic that is indeed psychologically addictive but should not be subjected to heightened control by customs.

 

8. Having expressed concern for the evils of addiction and the judicial torture of forcing addicts to withdraw at the pleasure of the State, it is important to ponder the meaning of medicine. The primary concern with drugs is not the drugs themselves, although they generally poison a microorganism, can have harmful and deadly side-effects and can be abusively prescribed, but the toxicology of the pathogen causing the ailment the drugs are supposed to cure. The prohibition of narcotic drugs covers up the wide-scale torture to which justice is addicted and the interests of pharmaceutical companies to prohibit opium and coca along with the patent remedies of the 19th century, so practitioners can sell their second rate derivatives without recalling the pathogens causing the lucrative diseases, abused people seek medicine for. The expansion of judicial prohibition to mind expanding drugs in the 1970s failed to do justice to the torturer, negligently authorizing the possession and dispensing of the pathogen(s) causing serious mental illness, eg. LSD, by all law enforcement officers and elite scientists and practitioners, resulting in long term social inequality in the United States and around the world. To gain control of controlled substances in the 21st century, both drugs in need of control and pathogens in need of prohibition, the government, from within the Public Health Department, with the support of the armed forces, law enforcement and customs officers, who shall never possess biological weapons or pathogens, shall prosecute their abuse, breaking their vow of silence to prohibit the torturous laboratory pathogens causing the vast majority of illness and death in contemporary society. Pharmacology is subject to control as a health profession whereas it has an understudy called toxicology due the process of prohibition.

 

9. The fatal flaw in patent protection has long been that there are no provisions in the classification system to expedite the prohibition of pathogens (inc. computer malware) like the bio-hazard dumps in any clinical laboratory and the government and scientists are ostensibly free to use the invisible weapons as they see fit. The guiding principle is that patents are only for inventions that are useful, but pathogens bring into question the fundamental utility of the patent for the inventor to dictate the terms of use of the invention. In regards to pathogens, biological weapons and malicious computer software the inventors must be directed by the government to effectively prohibit their invention. This flaw was aggravated in 1971 when the Strasbourg Agreement on the International Patent Classification System failed to agree with the Strasbourg Agreement of 1675 that was the first treaty to prohibit the use of poison and poison weapons. Disagreement thereabouts held up the implementation of the Patent Cooperation Treaty until 1980 when the HIV pandemic began. To do justice the United States Patent and Trademark Office (USPTO) and Patent Cooperation Treaty (PCT) really need to pathogens inferior to their medical and veterinary products in their classification systems. To create an effective system of prohibition the PCT would name the Organization for the Prohibition of Chemical Weapons as their search office and the USPTO would use the services of the Food and Drug Administration, Agency for Toxic Substances and Disease Registry, and the Drug Enforcement Administration. By patenting pathogens information would freely flow in technological development circles where containment, detection and anti-toxin technology useful for prohibiting pathogens, could be patented.

 

10. Effectively prohibiting the deadly and disabling pathogens that make trillion of dollars for the health care industry annually will not be an easy task but it is an important ethical duty of all health care practitioners including pharmacists, researchers, academics and government officials. To dramatically improve public health the government needs to name, control and prohibit all pathogens known to laboratory research. The best method would be to put the DEA Office of Diversion Control to good use for the Food and Drug Administration (FDA) licensing, controlling and prohibiting the manufacture, acquisition, possession, stockpiling and use of pathogens. This law transfer the agency to the FDA and establishes a new rational system to classify the Types of drugs and pathogens for the purpose of regulation - Type I poison, II deadly pathogen, III disabling pathogen, IV chemotherapy and hard drugs, V prescription drugs, VI over-the-counter drugs, VII alcohol, tobacco, marijuana, opium and coca, VIII tea, coffee and stimulating beverages, IX endangered species, toxic plants and animals and X medicinal herbs, dietary supplements, vitamins and minerals. To take responsibility for the registration of laboratory pathogens the DEA must first repeal the military loophole in Form 222, terminate the contracted there under and do a thorough epidemiologic study of the mental illness hypothetically caused by the pathogens mixed in their Schedule I with marijuana and other pleasant drugs and eliminate the pathogens from their warehouses. Furthermore to protect the prison and general population the DEA and all law enforcement officers would be strictly forbidden from ever possessing pathogens, relying upon licensed hazardous materials handlers. Under adequate supervision by the FDA the DEA could then begin to register all laboratories manufacturing, distributing, possessing and using pathogens and there could be a dramatic reduction in the amount of disease pathogens circulating. The pharmacologic goal would be to reduce drug consumption.

 

Sanders, Tony. Patent Remedy Act. Chapter 8: Drug Regulation. Hospitals & Asylums7th Draft. 148 pgs. HA-5-11-09 www.title24uscode.org/DAY.doc

Test Questions www.title24uscode.org/drtest.doc