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To repeal Chapter 6 Gorgas Hospital §300-320, to reduce demand for the 10 billion prescriptions and oppression that fuel the $1 trillion global drug market with $600 billion in pharmaceutical sales and $400 billion in illicit drug sales, $160 billion pharmaceutical and $65 billion illicit drug sales in the U.S. in 2001, to market antibiotics and highly safe and effective prescription medicines Over-the-counter (OTC), to require all heart medicine labels to state “antibiotics, hygiene, vegan diet and daily exercise, are known to cure endocarditis”, to fast track the clinical and animal trials of the antiviral DRACO that might cure HIV and the common cold, to promote the manufacture of metronidazole in the USA, to refocus Food and Drug Administration (FDA) staffing from 1,500 new drugs and 54 market regulation in 1998 to do the more than 3,200 pharmaceutical preparations in circulation social justice, to criminally prosecute the psychiatric enforcers of dangerous neuroleptic drugs, to dissolve the Bureau of Alcohol, Tobacco and Firearms (ATF) and transfer responsibility to an FDA Center for Alcohol and Tobacco (and possibly Marijuana (ATM) and Department of Justice (DoJ) Bureau of Firearms and Explosives (BFE), to transfer the Drug Enforcement Administration (DEA) to the Food and Drug Administration (FDA), prohibit DEA international offices and police finance and change its name to Drug Evaluation Agency (DEA), to hire exclusively doctors to be DEA Administrative Law Judges (ALJ) in preparation for the transition, 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 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, to stop doctors from receiving kickbacks from pharmaceutical companies, to divert pharmaceutical political contributions to independent candidates, to eliminate mandatory minimum sentencing and reduce sentences for illicit drug possession and trafficking, to make drug addiction treatment safe, accessible and judged by social worker licensed in addiction studies, to reschedule marijuana to Schedule III, establish an entirely new Type of classification for the Customary control of drugs and prohibition of pathogens and refund the mostly poor smokers of Roll-your-own tobacco and small cigars the unfair >2,000% excise tax increase of 2009 by guaranteeing a reduced tax rate of $1.828 for 17 years a year for small cigars and $1.0969 for 13.5 years a year for roll-your own

 

Be the Democratic and Republican (DR) drug party Dissolved, Referred to the 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,. 8th 25 November 2010, 9th Draft 11 October 2011

 

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 shift the focus of labor in the FDA from new drug research to the normalization of pharmaceutical industry and physicians prescribing habits, while making antibiotics and other reliably safe and effective drugs available Over-the-counter.  Second, to appoint licensed physicians and social workers to the  position of Administrative Law Judge to prepare the Drug Enforcement Administration (DEA) to change its name to Drug Evaluation Agency (DEA) and be transferred from the Department of Justice to the FDA while retaining the power of the Attorney General to make arrests. Third, to change the name of the Substance Abuse Mental Health Services Administration (SAMHSA) to Social Work Administration (SWA) to enable social workers to inherit mental health, substance abuse, traffic and divorce courts.  Fourth, 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).  Understanding of these necessary legal reforms will enable the FDA to more effectively retain the services of the Attorney General to criminally prosecute the legal defenders of neuroleptic and psychiatric drugs, sleeping aids and antipsychotics, which are the leading cause of fatal drug overdose reported to the Poison Control, and must be recalled for the FDA to win the confidence of consumers.  The FDA is arguably the best behaved federal agency online, since their Commissioner was removed from office for conflict of interest in 2007 and put on probation for lying about his stock holdings.  The FDA however continues to be negligent when it comes to social justice.  The recuse strategy seems to protect the authors and patients from potentially tortious conflict of interest and libelous recrimination.  The FDA may be safe, but is it effective?  While the research continues unmolested, the law of perversity - the least is known about the causes and cures of the most common diseases - leaves the patient hungry for an FDA approved cure.

 

 Bacterial Infections and Antibiotic Treatment

 

Bacteria

Infections

Usual Antibiotic

Comments

Actinomyces israelii

Actinomycosis, lumpy jaw disease, abscesses

Penicillin

An anaerobic infection

Arcanobacterium haemolyticum

Pharyngitis

Erythromycin

Rash similar to scarlet fever

Bacillus anthracis

Anthrax

Penicillin, ciprofloxacin, doxycycline

Rate in nature; was used as a bioterrorism weapon

Bacillus cereus

Diarrhea

Supportive care

Food borne

Bacteroides species

Abscesses

Metronidazole

Anaerobes; part of normal flora of the bowel

Bartonella henselae

Cat-scratch disease

None or azithromycin

Kittens are the usual transmitters

Bordetella pertussis

Whooping cough

Erythromycin, azithromycin

Infection can be prevented by immunization

Borrelia burgdorferi

Lyme disease

Doxycycline, amoxicillin, ceftriaxone

Transmitted by ticks

Borrelia recurrentis

Relapsing fever

Penicillin

Transmitted by body lice and ticks

Brucella species: abortus, melitensis, suis, canis

Brucellosis: flu-like symptoms

Doxycycline

Rare in the United States; acquired by animal contract or drinking unpasteurized milk

Burkholderia cepacia

Pneumonia

Meropenem

Causes illness in people with cystic fibrosis or chronic granulomatous disease

Campylobacter species: fetus, jejuni, coli

Diarrhea

Azithromycin

Transmitted by food and animals

Chlamydia psittaci

Psittacocis (pneumonia)

Doxycycline

Acquired from birds

Chlamydia trachomatis

Genital tract infection, newborn conjunctivitis, infant pneumonia, trachoma

Erythromycin, doxycycline

Sexually transmitted infection; newborns are infected during birth; trachoma rare in the United States

Clostridium botulinum

Botulism

Supportive care; antitoxin or antibody

Food-borne and infant botulism

Clostridium difficile

Diarrhea

Stop antibiotics, metronidazole

Occurs in people who have been on antibiotics

Clostridium perfringens

Food poisoning, diarrhea

Supportive care

Food-borne infection

Clostridium species: perfringens, sordellii, septicum, novyi

Gas gangrene

Surgery, penicillin

Anaerobic bacteria; uncommon infection of muscles

Clostridium tetanus

Lockjaw

Antitoxin, metronidazole

Rare in United States because of immunization

Corynebacterium diphtherieae

Diptheria

Antitoxin, erythromycin

Rare in the United States because of immunization

Escherichia coli

Sepsis, meningitis, urinary tract infection, diarrhea, others

Depends on the site of infection, trimethoprim sulfamethoxazole (Bactrim) for bladder

Can be part of normal flora of the bowel

Francisella tularensis

Tularemia

Streptomycin

Transmitted by fleas or ticks or contact with infected wild animals

Haemophilus ducreyi

Chancroid

Azithromycin

Sexually transmitted ulcer disease; unusual in the United States

Haemophilus influenza nontypeable

Otitis media (ear infection)

Amoxicillin clavulanate

Not all ear infections require antibacterial therapy

Haemophilus influenza type b

Meningitis, epiglottis, arthritis, pneumonia

Ceftriaxone

Now rare because of immunization

Helicobacter pylori

Ulcers

Combinations: amoxicillin, tetracycline, metronidazole, clarithromycin

Persistent infection increase the risk for cancer

Kingella kingae

Joint and bone infections

Penicillin

Not very common

Legionella pneumophila

Legionnaries disease (pneumonia)

Erythromycin

Rare in children

Leptospira species

Leptospirosis: fever, rash, flu-like illness, organs

Penicillin, doxycycline

Acquired through contact with dog or wild animal urine

Listeria monocytogenes

Sepsis, meningitis, stillbirth

Ampicillin or trimethoprim-sulfamethoxazole (Bactrim)

Occurs in pregnant women, newborns, and children with immune problems, food poisoning

Moraxella catarrhalis

Otitis media, sinusitis

Ampicillin clavulanate

Not all infections require antibacterial therapy

Mycobacterium leprae

Leprosy

Dapsone

Rare in the United States

Mycobacerium tuberculosis

Tuberculosis

Combinations: isoniazid, pyrazinamide, rifampin ethambutol

Most infected people have no symptoms; one third of the world’ population is infected

Mycoplasma pneumoniae

Bronchitis, walking pneumonia

Doxycycline, erythromycin

Common cause of pneumonia in school-aged children

Neisseria gonorrhoeae

Gonorrhea, newborn eye infection, joint infection

Ceftriaxone, cefixime

Sexually transmitted infection; newborns can acquire it during birth

Nocardia species

Pneumonia, skin

Trimethoprim sulfamethoxazole

Serious infection; usually in children with weakened immunity

Nontuberculous mycobacteria: Mycobacterium fortuitum, kansasii, marinum, avium-intracellulare

Lymph glands in the neck, pneumonia, blood

Surgery; antibiotic depends on the organism and infection

Lymph node infections in toddlers; invasive infections in children with weakened immunity

Pasteurella multocida

Bite wound infection

Penicillin

Common in cats and dogs

Prevotella species

Abscess (dental and lung)

Clindamycin

Anaerobic; part of normal flora of the mouth

Salmonella species

Diarrhea, bone, joint, kidney, meningitis

None for diarrhea; depends on site for other infections

Acquired by contact with animals or contaminated foods

Shigella species: sonnei, flexmero. Boydii. dysenteriae

Diarrhea

None, trimethoprim sulfamethoxazole (Bactrim), metronidazole, others

Food borne or contact with infected person

Staphylococcus aureus

Diarrhea, skin, pneumonia, joint, bone, heart

Nafcillin, vancomycin; depends on susceptibilities

Becoming more and more resistant to usual antibiotics

Steptobacillus agalactiae (group B streptococcus)

Meningitis, sepsis, pneumonia, skin, urinary tract infection

Penicillin

Serious in babies in pregnant women, endocarditis in susceptible adults

Streptococcus pneumoniae

Pneumonia, otitis media (ear infection), joint infection, meningitis

Penicillin, ceftriaxone, cefotaxime

Most serious infection (85%) prevented by immunization

Streptococcus pyrogenes (group A streptococcus)

Pharyngitis, skin, pneumonia, joint

Penicillin

Rheumatic fever, rheumatic heart disease, and glomerulonephritis can follow an infection after a week

Treponema pallidum

Syphilis

Penicillin

Sexually transmitted disease; can affect the fetus

Ureaplasma urealyticum

Urethritis

Doxycycline

Sexually transmitted disease

Vibrio cholerae

Diarrhea

Fluids, doxycycline

A risk for travelers

Yersinia enterocolitica

Diarrhea

Trimethprim/ sulfamethoxazole (Bactrim)

Food borne from pork, especially chitterlings

Yersinia pestis

Plague

Streptomycin

Rare in the United States; transmitted by rodent fleas

 

2. Broad spectrum antibiotics are the best medicine of the 20th century.  The only inventions that have increased longevity longer are clean water and sanitation.  Unfortunately, after WWII, when antibiotics hit the market the medical establishment splintered into a myriad of specialties, seemingly to endlessly and at great expense, treat symptoms of diseases that can for the most part be cured with the appropriate use of antibiotics.  To ensure Americans have access to affordable antibiotics and are not being denied life-saving treatment by unscrupulous doctors and being intentionally sickened by predatory capitalist hospital acquired nosocomial infections and medical and laboratory bills the FDA is highly advised to make generic antibiotics available at affordable prices OTC under 21CFR§330.10.  To ensure consumers and physicians are not misled by many medicines marketed for the treatment of heart disease the FDA must require that drug monographs, labels and consumer information given out with heart medicines, prominently state “antibiotics, hygiene, vegan diet and daily exercise, are known to cure endocarditis” under 21CFR§201.56(a) as an amendment to 21CFR§201.317.  The discoveries of the sulphonamide (1939), penicillin (1945) and streptomycin (1952) classes of antibiotics won the Nobel Prize for Medicine and Physiology.  Doxycycline (1967), the once a day antibiotic, is cheapest and highly effective against Methicillin Resistant Staphylococcus Aureus (MRSA), bubonic plague and acne but tetracycline class antibiotics cause permanent yellowing of developing teeth in children, and are for adults only.  Ampicillin (Principen), made from penicillin nucleus and 3H2O, to reduce the allergic reaction to penicillin from 5% to less than 1%, is the generally the first choice organic antibiotic for the treatment of Streptococcus pneumoniae of the lungs, ears and throat, as well as meningitis from such diseases as Listeria monocytogenes; synthetic streptomycin and amoxicillin are also generally considered effective.  Like aspirin, antibiotics are difficult on the digestive tract, which is home to more than a thousand times more bacteria than the rest of the body, and the excretory system is responsible for an estimated 80% of the body’s immune defenses, compromising the effectiveness of antibiotics.  Sulfamethoxazole-trimethoprim (Bactrim) is easier on the gut than most and is particularly useful for the treatment of bladder infections and Escherichia coli.  Metronidazole (Flagyl ER) (1960) is uniquely effective against gastroenteritis and liver disease; it cures Giardia lamblia, the most common waterborne pathogen in North America, in three days, heals ulcers, Clostridium difficile that causes antibiotic associated colitis, Entamoeba histolytica that attacks the liver, and Bactroides spp. that comprise 99% of normal gut flora, but is carcinogenic, and a month to six week rest should be taken between courses of five to ten days, not to exceed three weeks.  Metronidazole deserves special attention because so many unnecessary abdominal and thoracic surgeries such as appendectomies, costing $20,000, and heart surgery, costing upwards to $100,000, could be avoided with a 10 day course of generic metronidazole costing about $20 online without prescription as referred to the Indian generic pharmaceutical exporter Generics-discount.com, whereas no pharmaceutical corporation in the United States of America manufactures metronidazole, by Hospitals & Asylums’ Best Medicine Monographs HA-28-2-11. 

 

 Common AIDS Symptoms and Medicine

 

Pathogen

Symptoms

Drug Monograph

Human Immunodeficiency Virus (HIV)

Positive HIV test, Elevated viral load

efavirenz/emtricitabine/tenofovir (Atripla) possibly new antiviral cure - DRACO

persistent generalized lymphadenopathy (PGL)

Rapid enlargement of a previously stable lymph node or a group of nodes

Begin or intensify antiretroviral therapy, causes vary, use antibiotics, Cidofivir (Vistide) is the anti-herpes for AIDS substitute for Acyclovir (Zovirax), that may be improved with Foscarnet Sodium (Foscavir) injection

Coronavirus, Rhinovirus, Influenza A & B, Parainfluenza, Respiratory syncytial virus

Swollen lymph nodes, cold and flu-like symptoms lasting 4 days to a week, bronchiolitis, pneumonia

Cold remedies: Diphenhydramine (Benylin, Benadryl), Chlorpheniramine (Telachlor, Chlo-Amine, Chlor-Trimeton, Aller-Chlor), Brompheniramine (Bromphen, Nasahist B, Dimetane Extentabs) Bed rest for fevers. Flu

 vaccine ineffective.  OTC Theraflu, Allegra (Sanofi-Aventis) and Children's Allegra (fexofenadine) and Allegra-D (fexofenadine and pseudoephedrine); Prescription Oseltamivir (Tamiflu) and Zanamivir (Relenza).  Antibiotics for pneumonia, ampicillin (Principen), azithromycin (Zithromax), levofloxacin (Levaquin). Avoid asthma inhalers that contain corticosteroids that suppress the immune system.  Fatal adverse events with salmeterol inhalers. Smoke jimson weed for asthma and mullein for bronchitis.

Adenovirus, Norovirus, Echovirus and Rotavirus acquired from children                       

Upper and lower respiratory tract infections (URI, LRI), conjunctivitis, diarrhea

Rotovirus vaccine (Rotarix GlaxoSmithKline GSK) (Rotateq Merck & Co.), LigoCyte phase II intranasal norovirus, White rice water diet. Imodium (Loperamide), Immune Globulin IV for severe cases

Salmonellosis

Salmonella spp bacteria acquired by ingesting contaminated food and water

Severe diarrhea, fever, chills, abdominal pain and, occasionally, vomiting, contagious when shed in bile

Hydration, white rice water diet, imodium (Loperamide), trimethoprim-sulfamethoxazole (Septra), metronidazole (Flagyl ER) 10 days max

Candidiasis

Candida albicans acquired from antibiotic resistance

Inflammation of the mouth or genitals and thick white coating on the mucous, called thrush, usually found in children.

Antimycotics, antifungal drugs: topical clotrimazole (Fungoid Solution, Gyne-Lotrimin, Lotrimin, Lotrisone, Mycelex), topical nystatin (Mycostatin, Mykacet, Nystat-Rx, Nystop, Pedi-Dri), fluconazole (Diflucan), and topical ketoconazole (Extina, Nizoral, Nizoral A-D, Xolegel). Take metronidazole (Flagyl ER) to avoid antibiotic resistant Candidiasis

Cryptosporidiosis

Cryptosporidium spp.

Protozoal parasite acquired from soil, bird or bat droppings

Intestinal and bowel infection causes severe diarrhea, cramps, malnutrition and weight loss in AIDS patients

White rice water diet,

Primary: nitazoxanide (Alinia)

Alternates: metronidazole (Flagyl ER), Trimethoprim-sulfamethoxazole (Septra)

Cryptococcal meningitis

Cryptococcus neoformans

Fever, hallucinations, headache, nausea and vomiting, sensitivity to light, stiff neck

Antimycotics: fluconazole (Diflucan), flucytosin (Ancobon), amphotericin B IV (Amphotec, Abelcet, AmBisome), Paromomycin Sulfate (Humatin)

Tuberculosis (TB) Mycobacterium tuberculosis acquired from cough or sneeze droplets

Only 10% develop pulmonary TB involving fever, dry cough, weight loss and abnormalities, 10% of these develop TB pleuritis that infects the lining between the lung and abdominal cavity and causes chest pain.  TB kills two out of three with untreated symptoms, death rate is 5% with treatment

Isoniazid (Rifamate, Rifater), rifampicin (Rifadin, Rimactane, Rifamate, Rifater), pyrazinamide (Daraprim, Rifater), and ethambutol (Myambutol) for two months, then isoniazid and rifampicin alone for four months. Cured at six months (2 to 3% relapse). For latent tuberculosis, standard treatment is six to nine months of isoniazid. If the organism is fully sensitive, isoniazid, rifampicin, and pyrazinamide for two months, combination Rifater (sanofi-aventis) followed by isoniazid and rifampicin for four months, ethambutol need not be used.  Hepatoxic

Toxoplasmosis

Toxoplasma gondii

Spread by cat feces

Enlarged lymph nodes, headache, mild fever, muscle pain, sore throat, in AIDS patients, retinal inflammation and seizures

Combination - Antibiotic: sulfadiazine ie. Trimethoprim-sulfamethoxazole (Septra) and Antimalarial : pyrimethamine (Daraprim) and Antidote: leucovorin (Wellcovorin)

 

Alternate: Atovaquone (Mepron)

Varicella-zoster virus

Chicken pox and shingles

Measles, Mumps, Rubella and Varicella vaccine (MMRV, ProQuad, Merck & Co., Inc.) or Varicella vaccine (VARIVAX, Merck & Co.);

Cidofivir (Vistide), Acyclovir (Zovirax), Valtrex (Valacyclovir)

Cytomegalovirus (CMV) herpes virus acquired from bodily fluids

After long latency causes damage to the eyes, digestive tract, lungs or other organs, tumorigenic

Cidofivir (Vistide), Acyclovir (Zovirax), Foscarnet Sodium (Foscavir) injection, topical interferon alpha-2B for eyes and epidermal eruptions

Kaposi’s sarcoma

human herpesvirus-8 (HHV-8)

Bluish-red or purple bumps on the skin, caused by tumor of the blood vessel walls, may involve organs, in lung maybe bloody sputum, shortness of breath

topical interferon alpha-2B, Cidofivir (Vistide), Acyclovir (Zovira), Foscarnet Sodium (Foscavir) injection, intense AIDS drugs, Antineoplastic: Cisplatin (Platinol)

Lymphomas

Begin with painless swelling of the lymph nodes in neck, armpit or groin

Topical or pegylated interferon alpha-2B, Cidofivir (Vistide), Acyclovir (Zovirax), Foscarnet Sodium (Foscavir) injection, Antineoplastic: Cisplatin (Platinol)

 

3. At the dawn of the 21st century anti-retroviral drugs for the treatment of HIV/AIDS have been the most successful new drugs to enter the market and the auto-immune disease is no longer a swift and certain death but a manageable chronic disease complicated by a number of opportunistic infections requiring constant medical attention.  Viral loads are dramatically reduced, with ever improving drug treatment that has most recently been simplified from combination treatment to a single drug named Atripla (efavirenz/emtricitabine/tenofovir), but AIDS drugs are not considered effective for common use in the treatment of viral infections, nor are they free of side-effects.  The philanthropic distribution of anti-retrovirals to impoverished and highly infected populations around the world, particularly in sub-Saharan Africa, over the past decade, have been successful in reducing both the rate of infection and mortality from HIV/AIDS everywhere, but in Washington DC where 5% of the population is infected and South Africa where the reduction in infected population was explained in terms of mortality, achieving UN Millennium Development Goal 6 for 2015 early.  Cancer drugs, and understanding of the benefits of an organic diet and chemical free lifestyle, have significantly reduced death rates from cancer over the past decade.  Cisplatin (Platinol), manufactured with the precious metal platinum, stands out as being a broad spectrum antineoplastic that is effective against most cancers alone, without any combinations, and minimal but still severe side-effects.  Radiation treatment is reported to be about 80% effective in bringing cancers to permanent remission.  Foscarnet sodium and Immune Globulin IV treat a broad spectrum viral infections ranging from warts, the common cold and other minor respiratory tract infections and hepatitis, to extremely serious diseases, such as rabies, AIDS, and at least 18% of all types of cancer. Drugs that kill viruses have proved difficult to develop because viruses live only within body cells and there is a danger that antiviral drugs will damage the host cell as well as the virus.  Antiviral drugs given by mouth or injection can cause nausea and dizziness, and, rarely, in long-term treatment, kidney damage.  Interferons are antiviral substances produced by many animal cells in response to infection by certain viruses.  Cloned gene technology has now made interferons available and it has been useful as an injection in the treatment of hepatitis C and as a drop or cream in Acyclovir (Zovirax) resistant, cytelomegalovirus infection.  Highly effective vaccines prevent poliomyelitis, measles, mumps, rubella, hepatitis, yellow fever, human papilloma, rotavirus and post-exposure rabies.  The rotavirus vaccine (2006) reduced childhood ER visits for gastroenteritis by 85%.  Corticosteroid inhalers were discontinued by the manufacturers for fluorocarbon concerns and consumers have had to scramble to find OTC inhalers such Flovent that can be purchased online without prescription. The FDA removed 600 OTC cold and flu remedies, and to be fair should probably approve the prescription flue treatment Tamiflu (Oseltamivir) for sale OTC.  In August 2011 a new antiviral drug named DRACO entered clinical trials.  In the laboratory DRACO killed HIV and dozens of common cold viruses without harming human cells.  DRACO may improve life expectancy as dramatically as antibiotics did in the 20th century, the FDA needs to fast track DRACO, as they have for AIDS drugs, cutting the estimated time of pre-market trials in half, from ten years to five years, under 21USC(9)(V)(A)§356. 

 

4. It can be estimated that the gross aggregate global sale of pharmaceutical drugs is probably greater than $500 billion from 10 billion prescriptions.  More than a million prescriptions are written every hour of the working day, in a year’s time eight prescription will be written for every man, woman and child in the United States.  In more than 700 million annual office visits in the United States, a prescription of a drug is the single most likely outcome.  Between October 2004 and September 2005 a total of 3.6 billion prescriptions were filled in the United States.  Total US pharmaceutical sales in 2005 were estimated at $250 billion.  66.4% of these sales were domestic.  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).  This classification of prescription drugs is not a scientific overview but a collective analysis of the irresponsible prescribing habits of physicians.  It is true antifungals have been omitted because the safe and effective ones are so cheap OTC and antivirals were omitted because they are new, toxic and wisely prescribed, however cardiovascular and neuroleptic medicine are so highly duplicated that this list could be rewritten (1) psychiatric drugs (antidepressants, antipsychotics, analeptics and sleep aids), (2) cardiovascular drugs (Statins, anti-hypertensives, ARBs, ACE inhibitors, calcium or beta-blockers (3) anti-ulcerants, (4) antibiotics, (5) anti-arthritics (COX-2 inhibitors), (6) antihistamines, anti-asthmatics and anti-allergy drugs (oral, nasal steroids), (7) analgesics and (8) bone density regulators.  Then one could more clearly see how ineffective drugs are prescribed more than effective drugs.  Physicians must learn to avoid the capitalist peer pressure of blockbuster drugs and prescribe the medicine most likely to cure the condition.   

 

5. Studies show inappropriate drugs were prescribed for 1 out of 5 elderly patients and 60 percent of the patients went home with a drug that wouldn’t benefit them.  Annually at least 1-3 million people are severely injured, 400,000 overdose and 100,000-140,000 die from adverse drug reactions.  No other type of accident causes a million hospital admissions a year.  There is clearly a need for drug regulation.  Yet, the FDA only receives an estimated 1% of adverse drug reaction reports.  Neither consumers nor physicians seem to have much confidence in the FDA.  Physicians are much more likely to report adverse drug events to the manufacturer than the FDA.  To monitor the safety of 3,200 approved drugs taken daily by millions of people, the FDA has a staff of just 54 in 1998, by comparison, to evaluate an average of 25 new drugs a year, the FDA has 1,500 chemists, doctors, toxicologists and statistical experts.  In 1998 only about 4 percent of the FDA budget for drug evaluation went to monitor the safety of existing drugs.  The four basic drug safety tests are addiction, cancer risk, unusual toxicity and cardiac effects.  Of the top 50 drugs, 7 can cause addiction, 18 have cancer risks, 18 are unusually toxic, and 25 have cardiac risks.  More than 90 percent of drugs are potentially hazardous to pregnant women and only five, including folic acid, are considered safe.  One out of eight drugs can damage the bone marrow, the critical source of new red and white blood cells.  Neuroleptics (antipsychotics and antidepressants) and hypnotics (sleep aids) are the leading cause of fatal drug overdose reported to the Poison Control Center and massive recalls and criminal prosecution of corrupt practices are needed to terminate all psychiatric licenses.  On the other hand, Antibiotics, insulin and contraceptives are so effective they should be made available over-the-counter.  If given for an infection against which the antibiotic is effective, it will be effective about 90 percent of the time.  It is highly important to note that antibiotics are an effective cure for bacterial endocarditis while heart medicines endlessly treat symptoms.  Contraceptives are better than 99 percent effective at preventing pregnancy and for those with juvenile onset diabetes insulin is virtually a 100 percent effective alternative to dying. 

 

6. As of 2011 the FDA has been divided into (1) food, (2) drugs, (3) medical devices, (4) vaccines, blood and biologics, (5) animal and veterinary, (6) cosmetics (7) radiation emitting products and most recently (8) tobacco products.  Government regulation of pharmacy began with edict of Frederic II of 1240 that separated the pharmacy and medicine professions.  At the time pharmacists had to prepare every medicine and the specialization allowed for mass production and technological advances.  Today the pharmacist is a health professional who is the expert on more than 3,200 prescription pharmaceutical drugs.  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 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. American colonists blended Native American Indian and European medicine exercising a right to self-medication.  In the 19th century the patent medicine industry regulated drugs that were inspected by the Bureau of Chemistry of the Department of Agriculture.  The Pure Food and Drug Act of 1906 established the current regulatory regime that prohibits the interstate commerce in adulterated or misbranded food and drugs and was named the Food and Drug Administration (FDA) in 1930.  Having zealously outlawed cocaine and opium that kept patients addicted to the patent medicine industry after World War II and the marketing of broad spectrum antibiotics, the medical establishment defensively fragmented into specialties in an unseemly attempt to deprive sick people consuming expensive treatments of the antibiotics likely to cure them.  After a brief era of family medicine in the 1960s was subsidized by Medicare in 1966 and in 1973 DEA licensing gravely infringed on the independence and integrity of medicine and pharmacy.  Over the next few decades medical costs skyrocketed and US medical expenditure and prison slavery became the highest in the world. 

 

7. The fatal flaw in patent protection has long been that there are no provisions in the classification system to expedite the prohibition of pathogens to prioritize the protection of human and biological life.  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 laboratory pathogens, biological weapons and malicious computer software it is a human necessity that the inventors are required by the government to effectively prohibit their invention.  This ommission 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.  Effectively prohibiting the deadly and disabling pathogens and harmful drugs that make trillion of dollars for the health care industry annually by harming the public health is an important ethical duty of all health care practitioners including pharmacists, researchers, academics and government officials as citizens.  To dramatically improve public health the government needs to name, catalogue, control and prohibit all pathogens known to laboratory research.  To neutralize the threat of armed attack the FDA should put the armed inspectors of the DEA Office of Diversion Control to good use licensing, inspecting, cataloguing, controlling and prohibiting the manufacture, acquisition, possession, stockpiling and abuse of pathogens used in corporate and academic biomedical research and toxicology laboratories rationally classified according to the hazard they pose.  To safely responsibility for the registration of laboratory pathogens the DEA must first repeal the military loophole in Form 222, terminate contracts 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 independently licensed hazardous materials handlers, they inspect.  The pharmacologic goal would be to reduce drug consumption by reducing disease pathogens to create a healthier and saner population protected by a rational prohibition of poison, without any legislative accommodations for the crazy, hypocritical, politicized and corruptly subsidized judicial “enforcement” of addictive narcotic and torturous psychiatric drugs.                  

 

8. The creation of the Bureau of Alcohol, Tobacco and Firearss (ATF) in the Gun Control Act of 1968 revived the prohibition fervor from whence the DEA was created in 1973.  After an extremely unjust Tobacco Tax of 2009 and gun running scandal to the drug war in Mexico under Operation Fast and Furious it is obvious that the ATF needs to be dissolved.  Wherefore both Alcohol and Tobacco regulatory functions shall be transferred to the FDA in cooperation with the Treasury Alcohol, Tobacco Tax and Trade Bureau (ATTB) while the Bureau of Firearms and Explosives (BFE) shall remain in the Department of Justice (DoJ).  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 as well as an oil embargo by hashish smoking OPEC nations offended by classification of Cannabis as a Schedule I narcotic.  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 and consumers 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.  A quota of 1.5 million kg for the Afghan National Opium Agency bought at $500 a kg for $750,000,000 total would undergo 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, enough to fully finance the national government and some social welfare.  In the USA the scheduling of Marijuana as a Schedule I most dangerous, addictive and useless drug is testimony to the shabby science undermining the CSA and marijuana must be rescheduled to Schedule III whereas it is so pleasantly therapeutic that is indeed psychologically addictive but is a much safer alternative to alcohol with no known fatalities or side effects.  A growing number of states have legalized medical marijuana and many would like to completely legalize it.  Tobacco is the true schedule I psychotropic drug whereas nicotine withdrawal is so severe it is a mental illness in the DSM-IV.  However apartheid-like discrimination against mostly poor smokers of roll-your-own tobacco and small cigars was evident in the >2,000 excise tax on those products smoked by the poor, that drove up the price on these products 500%, although pre-rolled cigarettes were subjected to only a negligible 158%. Before a cost conscious pack a day tobacco addict could be satisfied for $1 a day in rolling tobacco or small cigars but now the cost is the same as the $5 a day for pre-rolled, wherefore many people substitute pipe tobacco.  For the newly create Center for Tobacco Products to be trusted to make a beneficial contribution to society the FDA needs to advocate to Congress that this tobacco tax, that was capitalized on to create a tobacco regulatory agency, unfairly discriminated against the poor smokers of roll-your-own and small cigars who be allowed a refund of 30 years at the old tax rate under 26USC(F)(65)(B)§6423(c)  

 

9. 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.  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 unprepared. Drug courts and substance abuse treatment are innovative approaches to helping drug offenders achieve a drug- and crime-free life.  These courts should be judged by licensed social workers to create a clearer distinction between drugs and crime in the minds of the people as well in the Office of Drugs and Crime (UNODC) that must change their name to Office of Crime (UNOC) and Secretariat of the International Narcotics Control Board (INCB) that must be transferred to the World Health Organization (WHO).

 

10. 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.  Injustice holds back the social development of the pharmaceutical industry and health sector in an extortionate and subversive form of medical capitalism more akin to slavery than feudalism, that requires constant socialization.  The pharmaceutical marketing strategy of offering physicians kickbacks arose and was prohibited under 42USC(7)(XI)§1320a-7b(b).  Most recently the tactic of stopping production to create an often unspoken demand for an increase in the price of the drug has come under regulation of a 6 month advance notice to the FDA under 21USC(9)(V)(A)§356c.  The freedom of pharmaceutical corporations to finance lobbying is challenged to prohibit the financing of Democratic and Republican (DR) candidates, and allow the voluntary redistribution of pharmaceutical profits to only independent candidates, parties, 527 political organizations, 501c nonprofit corporations and public charities as well as bona fide poor people and patients.  Ultimately the FDA is destined to liberate DEA Registrants from injustice, but some pharmaceutical corporations, namely Eli Lilly and other producers of psychiatric medicine, who sell dangerously defective and adulterated products, perjure, censure and intimidate witnesses with impunity as the result of the long and corrupt enslavement of psychiatry by Probate, obstinately demand to be criminally prosecuted.  For the FDA to fulfill social justice and civil rights obligations safely and effectively the FDA must (a) purchase fines for a reasonable price to retain the author, (b) attempt to negotiate scientifically with licensed health corporations and (c) retain the Attorney General to criminally prosecute first the corrupt superior orders of judges, prosecutors and lawyers in defense of scientific misconduct and secondly the misconduct of scientists, pharmacists and medical personnel under their influence. 

 

Sanders, Tony. Patent Remedy Act. Chapter 8: Drug Regulation. Hospitals & Asylums 9th Draft. 193 pgs. HA-24-10-11 www.title24uscode.org/DR.doc  

Test Questions www.title24uscode.org/drtest.doc