Pharmaceuticals - Prescription Drugs

Pharmaceutical Pills Photo
There are many things that you should definitely know about pharmaceutical drugs. Most prescribed medications only treat the symptoms, so you need to address the causes and seek a cure. Please do your research.

Research - Bias in Research - Prescription Drug Warnings - Always ask Questions

Dosage - Errors - Interactions - Effects - Too Many Meds - Personalized Medicine - Placebos

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Emergencies - 1-800-222-1222 - 911 - First Aid - Food Poisoning

RX Dangers - Prescription Drugs Info - RX List - Generic - Open Science - DIY

Cost Plus Drugs - Affordable medication is your right. No middlemen. No price games. Huge drug savings. "Everyone should have safe, affordable medicines with transparent prices." – Mark Cuban.

Pharmaceutical Drug is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy or pharmacotherapy is an important part of the medical field and relies on the science of pharmacology for continual advancement and on pharmacy for appropriate management.

Men and Women can have Different Drug Reactions

Drug is any substance other than food that provides nutritional support or causes a physiological change in the body when inhaled, injected, smoked, consumed, absorbed via a patch on the skin, or dissolved under the tongue.

Stimulants - Bio-Similar Drug - Generic Drug

Parent Drug. The function of drug metabolism is to convert lipophilic compounds or the parent drug into more polar, hydrophilic compounds or metabolites that can easily be dissolved in an aqueous environment such as blood, bile, or urine to thus efficiently be excreted from the body.

Prodrugs are bioreversible, inactive drug derivatives, which have the ability to convert into a parent drug in the body. In the past, prodrugs were used as a last option; however, nowadays, prodrugs are considered already in the early stages of drug development.

Pharmacist are healthcare professionals who practice in pharmacy, the field of health sciences focusing on safe and effective medication use. A pharmacist is a member of the health care team directly involved with patient care. Pharmacists undergo university-level education to understand the biochemical mechanisms and actions of drugs, drug uses, therapeutic roles, side effects, potential drug interactions, and monitoring parameters. This is mated to anatomy, physiology, and pathophysiology. Pharmacists interpret and communicate this specialized knowledge to patients, physicians, and other health care providers.

Pharmacy is the science and technique of preparing and dispensing drugs. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The professional practice is becoming more clinically oriented as most of the drugs are now manufactured by pharmaceutical industries. Based on the setting, the pharmacy is classified as a community or institutional pharmacy. Providing direct patient care in the community of institutional pharmacies are considered clinical pharmacy. The scope of pharmacy practice includes more traditional roles such as compounding and dispensing of medications, and it also includes more modern services related to health care, including clinical services, reviewing medications for safety and efficacy, and providing drug information. Pharmacists, therefore, are the experts on drug therapy and are the primary health professionals who optimize the use of medication for the benefit of the patients.

Pharmacology is the branch of medicine and biology concerned with the study of drug action, where a drug can be broadly defined as any man-made, natural, or endogenous (from within body) molecule which exerts a biochemical and/or physiological effect on the cell, tissue, organ, or organism (sometimes the word pharmacon is used as a term to encompass these endogenous and exogenous bioactive species). More specifically, it is the study of the interactions that occur between a living organism and chemicals that affect normal or abnormal biochemical function. If substances have medicinal properties, they are considered pharmaceuticals.

Psychopharmacology - Neuropsychopharmacology (effects)

Pharmacokinetics is a branch of pharmacology dedicated to determine the fate of substances administered to a living organism. The substances of interest include any chemical xenobiotic such as: pharmaceutical drugs, pesticides, food additives, cosmetics, etc. It attempts to analyze chemical metabolism and to discover the fate of a chemical from the moment that it is administered up to the point at which it is completely eliminated from the body. Pharmacokinetics is the study of how an organism affects a drug, whereas pharmacodynamics (PD) is the study of how the drug affects the organism. Both together influence dosing, benefit, and adverse effects, as seen in PK/PD models.

Medicine is the science and practice of the diagnosis, treatment, and prevention of disease.

Allopathic Medicine the use of pharmacologically active agents or physical interventions to treat or suppress symptoms or pathophysiologic processes of diseases or conditions, by proponents of alternative medicine.

60% of all Drugs are Created by Biotech Companies, not pharmaceutical companies.

Biotechnology is a broad area of biology, involving the use of living systems and organisms to develop or make products. Depending on the tools and applications, it often overlaps with related scientific fields. In medicine, modern biotechnology has many applications in areas such as pharmaceutical drug discoveries and production, pharmacogenomics, and genetic testing or genetic screening. Pharmacogenomics is a combination of pharmacology and genomics, which is the technology that analyses how genetic makeup affects an individual's response to drugs. Researchers in the field investigate the influence of genetic variation on drug responses in patients by correlating gene expression or single-nucleotide polymorphisms with a drug's efficacy or toxicity. The purpose of pharmacogenomics is to develop rational means to optimize drug therapy, with respect to the patients' genotype, to ensure maximum efficacy with minimal adverse effects. Such approaches promise the advent of "personalized medicine"; in which drugs and drug combinations are optimized for each individual's unique genetic makeup. Biotechnology has contributed to the discovery and manufacturing of traditional small molecule pharmaceutical drugs as well as drugs that are the product of biotechnology – biopharmaceutics. Modern biotechnology can be used to manufacture existing medicines relatively easily and cheaply.

Drug Development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug. Accelerated Approval.

Abundant ‘secret doors’ on human proteins could reshape drug discovery. Identification of hidden vulnerabilities on surface of ‘undruggable’ proteins could transform treatment of disease.

Ligand Efficiency is a widely used design parameter in drug discovery. It is calculated by scaling affinity by molecular size and has a nontrivial dependency on the concentration unit used to express affinity that stems from the inability of the logarithm function to take dimensioned arguments.

Lab lights way to simple chemical synthesis. Photochemistry method eases manufacture of drug, chemical precursors. Scientists have developed a photochemical process to simplify the synthesis of drug and chemical precursors known as diamines. Inexpensive iron salts are a key to simplifying the manufacture of essential precursors for drugs and other chemicals, according to scientists at Rice University. They've refined the process of producing diazides, building-block molecules in the production of drugs and agricultural chemicals. Iron salts along with processes called radical ligand transfer and ligand-to-metal charge transfer (LMCT) make it affordable and environmentally friendly.

Pharmaceutical Engineering is a branch of engineering focused on discovering, formulating, and manufacturing medication, as well as analytical and quality control processes. It utilizes the fields of chemical engineering, biomedical engineering, and pharmaceutical sciences.

Drug Discovery is the process by which new candidate medications are discovered. Historically, drugs were discovered by identifying the active ingredient from traditional remedies or by serendipitous discovery, as with penicillin. More recently, chemical libraries of synthetic small molecules, natural products or extracts were screened in intact cells or whole organisms to identify substances that had a desirable therapeutic effect in a process known as classical pharmacology. After sequencing of the human genome allowed rapid cloning and synthesis of large quantities of purified proteins, it has become common practice to use high throughput screening of large compounds libraries against isolated biological targets which are hypothesized to be disease-modifying in a process known as reverse pharmacology. Hits from these screens are then tested in cells and then in animals for efficacy. Modern drug discovery involves the identification of screening hits, medicinal chemistry and optimization of those hits to increase the affinity, selectivity (to reduce the potential of side effects), efficacy/potency, metabolic stability (to increase the half-life), and oral bioavailability. Once a compound that fulfills all of these requirements has been identified, the process of drug development can continue, and, if successful, clinical trials are developed.

Drug Design is the inventive process of finding new medications based on the knowledge of a biological target. The drug is most commonly an organic small molecule that activates or inhibits the function of a biomolecule such as a protein, which in turn results in a therapeutic benefit to the patient. In the most basic sense, drug design involves the design of molecules that are complementary in shape and charge to the biomolecular target with which they interact and therefore will bind to it. Drug design frequently but not necessarily relies on computer modeling techniques. This type of modeling is sometimes referred to as computer-aided drug design. Finally, drug design that relies on the knowledge of the three-dimensional structure of the biomolecular target is known as structure-based drug design. In addition to small molecules, biopharmaceuticals including peptides and especially therapeutic antibodies are an increasingly important class of drugs and computational methods for improving the affinity, selectivity, and stability of these protein-based therapeutics have also been developed.

Rational Design is the strategy of creating new molecules with a certain functionality, based upon the ability to predict how the molecule's structure will affect its behavior through physical models. This can be done either from scratch or by making calculated variations on a known structure, and is usually contrasted with directed evolution.

Pharmaceutical Manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs by pharmaceutical companies. The process of drug manufacturing can be broken down into a series of unit operations, such as milling, granulation, coating, tablet pressing, and others. List of Pharmaceutical Companies (wiki).

Pharmaceutical Industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered (or self-administered) to patients, with the aim to cure them, vaccinate them, or alleviate the symptoms. Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy and marketing of drugs.

Films and Videos about the Pharmaceutical Industry

The Marketing of Madness: Exposes the mistakes made by Psychiatrists and the Pharmaceutical industry (youtube 1 of 18).

Psychiatry: An Industry Of Death (youtube)

Ben Goldacre: Battling Bad Science (youtube)

American Addict (2013) 1:29

War on Health - Gary Null's Documentary Exposing the FDA (youtube)

Science Fraud: The Price for Fame and Fortune (youtube)

Health Documentaries

The Power of the Pharmaceutical Companies | DW Documentary (youtube) - Profit or Life? How much is a human life worth? An innovative cancer therapy promises to save lives. But it is extremely expensive. Will the insurance companies pay for it? What is the manufacturer's return on investment? And do lobbyists drive up prices? In 2018, the Kymriah gene therapy was approved in Europe. Immune cells are taken from the patient, genetically reprogrammed into cancer killer cells and returned to the patient as an infusion. The results of the Kymriah study only cover a period of 18 months. In 40 percent of patients, lymph gland cancer does not return during this time. It is not clear whether Kymriah has a long-term effect. The Swiss pharmaceutical company Novartis offers the new therapy - it costs 370,000 Swiss francs per patient. Health insurance companies are not usually prepared to pay that much and are complaining about a lack of transparency.

Research Flaws - Sleep Advertising - False AdvertisingInformed Consent - Drug Dangers - Human Guinea Pigs

Disease Mongering is the practice of widening the diagnostic boundaries of illnesses and aggressively promoting their public awareness in order to expand the markets for treatment. Among the entities benefiting from selling and delivering treatments are pharmaceutical companies, physicians, and other professional or consumer organizations. (scumbag criminals).

DSM (Drug Dealers Guide Book) - Drug War - Drugs in Drinking Water - Human Experimentation

Illegal Drug Trade is a global black market dedicated to the cultivation, manufacture, distribution and sale of drugs that are subject to drug prohibition laws. Most jurisdictions prohibit trade, except under license, of many types of drugs through the use of drug prohibition laws. A UN report has stated that "the global drug trade generated an estimated US $321.6 billion in 2003." With a world GDP of US $36 trillion in the same year, the illegal drug trade may be estimated as nearly 1% of total global trade. Consumption of illegal drugs is widespread globally. Fake and low-quality medicines are prevalent in the developing world because of price gouging by pharmaceutical drug manufactures. How To Become a Drug Dealer (wiki).

Prescription Drug Alternatives (holistic) - Mom Gets Rid of Food in her Kitchen that She Believes was Hurting her Family (youtube) - "Let Food Be Your Medicine and Let Medicine Be Your Food" - Nutrition (food knowledge).

Pharmaceutical Sales Representative are salespeople employed by pharmaceutical companies to persuade doctors to prescribe their drugs to patients. Most sales representative never disclose all the serious side effects and dangers and under report them or down play them so they can make a profit. Drug companies in the United States spend $5 billion annually sending representatives to doctors, and most are not even qualified to give drug advice. 47 million prescriptions were stolen by doctors in 2018.

Benefit-Cost Ratio attempts to summarize the overall value for money of a project or proposal. Drug companies don't care how many people die or get injured from a drug as long as the drug company makes a profit.

Pharmacy Benefit Management is a third-party administrator of prescription drug programs for commercial health plans, self-insured employer plans, Medicare Part D plans, the Federal Employees Health Benefits Program (FEHBP), and state government employee plans. As of 2018 they have become industrial behemoths in the US health sector.

Patient Care America are War Profiteers who make 18 million a day, from $42 million a month to more than $300 million.

In 2021, big pharma is lobbying congress with $263M to keep drug prices high.

Tricare - DIY - Smart Drugs - Tailored Treatments

Price Gouging is the same as Murder when a person dies because they could not afford the medicine they need to live.

Greedy Drug Company trying to Gouge Patients in need of Cancer Drugs.

Good RX check prices for prescription drugs vary widely between pharmacies.

$5 billion worth of perfectly good medicines are wasted and thrown away. Despite the fact that the medicine has not expired and can still be used by those in need. 38 states have enacted laws allowing health officials to collect and redistribute unused prescription drugs. The medication is put through rigorous quality checks and then directed to people who could not otherwise afford it. There's over $50 million of wasted, needlessly discarded medicine in our nursing homes, correctional facilities and other institutions.

Bio-Pharmaceutical is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals.

Generic - Bio-Similar

Biosimilar is a biologic medical product which is almost an identical copy of an original product that is manufactured by a different company. Biosimilars are officially approved versions of original "innovator" products, and can be manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval.

Bio-Mimic - Synthetic or Natural - Bio-Similar Drugs could cut US health spending by $54 billion over next decade.

Generic Drug is a pharmaceutical drug that is equivalent to a brand-name product in dosage, strength, route of administration, quality, performance and intended use. The term may also refer to any drug marketed under its chemical name without advertising, or to the chemical makeup of a drug rather than the brand name under which the drug is sold. (Drug makers gamed the system to keep Generic Competition away. The Food and Drug Administration's release of a list of complaints against brand-name drugmakers for hindering access to samples for generic testing). Pay for Delay of Generic Drugs. 

Generic is something applicable to an entire class or group. Generic in computing is a program code written to operate on any data type, the type required being given as a parameter. Generic in biology is relating to or common to or descriptive of all members of a genus. Generic drug is a drug not protected by trademark. Any product that can be sold without a brand name. Generic wine that is a blend of several varieties of grapes with no one grape predominating; a wine that does not carry the name of any specific grape.

Reverse Settlement Payments or Pay to Delay are more criminal practices by the pharmaceutical industry where drug manufacturers pay competitors not to manufacture generic versions of their products, so drug manufacturers can continue to sell over priced drugs and steal millions from consumers and the elderly.

Orphan Drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease. Orphan drug designation is intended to spur development of drugs for rare diseases by bestowing drugmakers with tax breaks, FDA fee waivers and seven years without generic competitors. Orphan drugs generally follow the same regulatory development path as any other pharmaceutical product, in which testing focuses on pharmacokinetics and pharmacodynamics, dosing, stability, safety and efficacy. However, some statistical burdens are lessened to maintain development momentum. For example, orphan drug regulations generally acknowledge the fact that it may not be possible to test 1,000 patients in a phase III clinical trial if fewer than that number are afflicted with the disease. Government intervention on behalf of orphan drug development takes several forms: Tax incentives. Exclusivity (enhanced patent protection and marketing rights). Research subsidies. Creating a government-run enterprise to engage in research and development as in a Crown corporation. A 2015 study of "34 key Canadian stakeholders, including drug regulators, funders, scientists, policy experts, pharmaceutical industry representatives, and patient advocates" investigated factors behind the pharmaceutical industry growing interest in "niche markets" such as orphan drugs. Fast Track.

Some pharmaceutical companies are using Orphan Drug Act of 1983 to charge high prices for needed drugs, while taking millions of dollars in government incentives and tax credits. When a drugmaker wins approval of a medicine for an orphan disease, the company gets seven years of exclusive rights to the marketplace, which means the FDA won't approve another version to treat that rare disease for seven years, even if the brand name company's patent has run out. By salami slicing the disease into subgroups, it allows them to get the orphan drug approval with all the government benefits and even some of the subsidies, to facilitate development of orphan drugs — drugs for rare diseases such as Huntington's Disease, myoclonus, ALS, Tourette syndrome and muscular dystrophy which affect small numbers of individuals residing in the United States.

Drug-Makers Manipulate Orphan Drug Rules To Create Prized Monopolies. Despite the success of the Orphan Drug Act, 95 percent of rare diseases still have no treatment options, FDA reviewers failed to show they had checked how many patients could be treated by a drug being considered for orphan drug status; instead, they appeared to trust what drugmakers told them. The program was being manipulated by drugmakers to maximize profits and to protect niche markets for medicines being taken by millions. 1983 Orphan Drug Act to motivate pharmaceutical companies to develop drugs for people who lacked treatments for their conditions. Rare diseases had been ignored by drugmakers because treatments for them weren't expected to be profitable. The law provides waivers from FDA fees, tax incentives for research and seven years of marketing exclusivity for any drug the agency approves as an "orphan." GAO analysts examined FDA records for 148 applications submitted by drugmakers for orphan drug approval in late 2017. FDA's reviewers are supposed to apply two specific criteria — how many patients would be served and whether there is scientific evidence the drug will treat their disease. In nearly 60 percent of the cases, the FDA reviewers didn't capture regulatory history information, including "adverse actions" from other regulatory agencies. Of the 148 records the GAO reviewed, 26 applications from manufacturers were granted orphan status even though the initial FDA staff review was missing information. The GAO report, while not analyzing the same years, found that 38.5 percent of orphan drug approvals from 2008 to 2017 were for drugs that had been previously approved either for mass-market or rare-disease use. About 71 percent of the drugs given orphan status were intended to treat diseases affecting fewer than 100,000 people. KHN's investigation found that popular mass-market drugs such as cholesterol blockbuster Crestor, Abilify for psychiatric conditions, cancer drug Herceptin and rheumatoid arthritis drug Humira, the best-selling medicine in the world, all won orphan approval yet were already on the market to treat common conditions. In addition, more than 80 orphan drugs won FDA approval for more than one rare disease — or several — each one with its own bundle of rich incentives. The average cost per patient for an orphan drug was $147,308 in 2017 compared with $30,708 for a mass-market drug, according to a 2018 EvaluatePharma report on the 100 top-selling drugs in the U.S. Celgene's chemotherapy drug Revlimid was the top-selling orphan with $5.4 billion in sales and $184,011 in revenue per patient.

Rare Disease is a disease that affects a small percentage of the population. Estimated that more than 300 million people worldwide are living with one of the 7,000 diseases they define as "rare" orphan disease. In some parts of the world, an orphan disease is a rare disease whose rarity means there is a lack of a market large enough to gain support and resources for discovering treatments for it, except by the government granting economically advantageous conditions to creating and selling such treatments. Orphan drugs are ones so created or sold. Most rare diseases are genetic and thus are present throughout the person's entire life, even if symptoms do not immediately appear. Many rare diseases appear early in life, and about 30% of children with rare diseases will die before reaching their fifth birthday. With only three diagnosed patients in 27 years, ribose-5-phosphate isomerase deficiency is considered the rarest known genetic disease. No single cut-off number has been agreed upon for which a disease is considered rare. A disease may be considered rare in one part of the world, or in a particular group of people, but still be common in another. The US organization Global Genes has estimated that more than 300 million people worldwide are living with one of the approximately 7,000 diseases they define as "rare" in the United States. Rare Diseases.

Too Much Medication - Not Enough Education

Medicine Cabinet Almost six million prescriptions for some type of controlled substance were written last year alone in Connecticut. That’s almost double the amount of people who actually live here.

Overdoses - Deaths - Drug War

The amount of money the world spends on prescription drugs could rise to $1.5 trillion by 2021.

There were 45 new drugs approved by the FDA last year and 41 in 2014. That's more than double the number that's been approved in 2016, which as of December 5 was just 19 new drugs. Homeopathic.

Mayo Clinic Researchers say that nearly 70 percent of Americans are on at least one prescription drug, and more than half take two. The most commonly prescribed are antibiotics, antidepressants and painkilling opioids. Twenty percent of patients are on five or more prescription medications. Spending on prescription drugs reached $250 billion in 2009.

Survey found that 119 Million Americans over the age of 12 took prescription psychotherapeutic drugs. That's 45 percent of the population. First Aid Kits.

Poly Drug Use refers to the use of two or more psychoactive drugs in combination to achieve a particular effect. In many cases one drug is used as a base or primary drug, with additional drugs to leaven or compensate for the side effects of the primary drug and make the experience more enjoyable with drug synergy effects, or to supplement for primary drug when supply is low.

DSM - Worst Pills - Discount Generic Drugs

Polypharmacy is the use of four or more medications by a patient, generally adults aged over 65 years. Polypharmacy is most common in the elderly, affecting about 40% of older adults living in their own homes. About 21% of adults with intellectual disability are also exposed to polypharmacy.

Polypill is a medication that is a drug product in pill form such as a tablet or capsule that combines multiple active pharmaceutical ingredients. The prefix "poly" means "multiple", referring to the multiplicity of distinct drugs in a given "pill".

Too Many Meds for the Elderly - Deaths - Fraud Alerts

Overprescribed Medications for US Adults: Four Major Examples. To understand possible medication overprescribing, it would be important to know which classes are the most prescribed, for which indications, for what duration, and for which age groups. Among the 10 most frequently prescribed medication classes for US adults, four were evaluated for overprescribing, and systematically assessed in relation to their primary indication. The assessment included usage patterns, trends, age of recipients, treatment duration, and benefits versus adverse consequences. The findings in this selective review are supported by an extensive search of the medical literature. The four selected medication categories and their most common indication included opioids for chronic pain, proton pump inhibitors for indigestion, levothyroxine for subclinical hypothyroidism, and antidepressants for subsyndromal levels of depression. These medications, grouped by their most frequent indication along with polypharmacy, have experienced major prescription increases in recent years, particularly among older patients. Most concerning is that they have been frequently prescribed for extended periods, usually with inadequate evidence of benefit. High drug usage patterns can aid in quantifying overprescribing within polypharmacy by age group.

Overmedication is an overutilization of medication wherein a patient takes unnecessary or excessive medications. Persons who feel that they are overmedicated tend to not to follow their physician's instructions for taking their medication.

Number Needed to Treat

With Americans now filling four billion prescriptions a year, 59,000 children in the U.S. each year end up in the emergency room after accidental poisonings that involve taking medicine. In 48 percent of cases, kids got into their grandparents' medicines.

Anxiety and Sleeping Pills 'Linked to Dementia'

Expiration Dates on medication are important because medication can become toxic or ineffective over time. Self Life.

Personalized Medicine

U.S. Companies Losing $10 Billion a Year Due to Workers' Opioid Abuse. And no one is getting arrested, just like the Bankers.

At least 100 people die from drug overdoses every day in the U.S. More than 36,000 people die from drug overdoses annually and most of these deaths are caused by prescription drugs. We have a serious problem when our treatments cause people to die, Asking for help shouldn't kill you, or put innocent people and family members in danger. The misuse and abuse of prescription painkillers was responsible for more than 475,000 emergency department visits in 2009, a number that nearly doubled in just five years. Today it is estimated that 100 million people in the U.S. suffer from chronic pain – more than the number with diabetes (26 million), heart disease (16 million) and cancer (12 million). Many who suffer from chronic pain will be treated with opioids. It is estimated that 5.1 million Americans abuse painkillers.

The Drug War is a Misguided Clusterfuck - FUBAR

How did a war on drugs not include scumbag Doctors and criminal pharmaceutical companies when they clearly caused more deaths and more damage? The justice system is in on these crimes, accessories to murder. Another problem to solve.

Injury Prevention & Control: Prescription Drug Overdose.

America’s Addiction to Opioids: Heroin and Prescription Drug Abuse.

The Risk for Death when Prescribed Antipsychotics to Control Behavioral Problems in Demented Patients (NPR)

"Drug companies are not here to bring health to the population but to scam them on one level for vast amounts of money, by treating the symptoms and not addressing the cause." William Osler.

H.R.6 - 21st Century Cures Act - 114th Congress House Bill

Doctor's Open Payments from Drug Companies - More Crimes

Doctors Oath - Healthcare Inequality

IMS pharmaceutical market analysis firm, estimates the 2010 revenues for pharmaceuticals to be over $955 billion, and will exceed $1 trillion dollars by 2013. Big Pharma also shows revenues of around $300 billion in medical devices in 2012, and close to $320 billion in 2013. So the total revenues that Big Pharma will derive just from pharmaceuticals and devices will be around $1.32 trillion. According to the World Health Organization, estimated 2013 global revenues for vaccines is around $24 billion.

Crazy People treating crazy people, now that's just crazy.

America and New Zealand are the only 2 developed countries in the world that allow Direct to Consumer Advertising of drugs. So it's no surprise that 80% of all pharmaceutical drugs are consumed by Americans, and America is only 5% of the worlds population. Pharmaceutical companies also spend over 4 billion dollars on advertising these drugs to Americans, which the consumer pays for. So Americans are paying to be manipulated and drugged. So why are we the Ginny Pigs?

34% of Older Adults in the US are Prescribed Potentially Inappropriate Drugs. The prescription of potentially inappropriate medications to older adults is linked to increased hospitalizations, and it costs patients, on average, more than $450 per year. As the human body ages, the risk of experiencing harmful side effects from medications increases. Potentially inappropriate medications are drugs that should be avoided by older adults due to these risks outweighing the benefits of the medication, or when effective but lower risk alternative treatments are available. Among the potentially inappropriate medications examined were antidepressants, barbiturates, androgens, estrogens, nonsteroidal anti-inflammatory drugs, first-generation antihistamines, and antipsychotics. Among the 218 million-plus older adults surveyed, more than 34% were prescribed at least one potentially inappropriate medication. Those patients were, on average, prescribed twice as many drugs, were nearly twice as likely to be hospitalized or visit the emergency department, and were more likely to visit a primary care physician compared to older adults who were not prescribed potentially inappropriate medication.

Prescription Drug Take Back. According to the 2019 National Survey on Drug Use and Health, 9.7 million people misused prescription pain relievers, 4.9 million people misused prescription stimulants, and 5.9 million people misused prescription tranquilizers or sedatives in 2019. The survey also showed that a majority of misused prescription drugs were obtained from family and friends, often from the home medicine cabinet. Unused prescription drugs are a risk for children, people with substance use disorders and animals. 50,000 young children are sent to the emergency room every year because they get into medicine while adults are not watching.

Donating your Unused, Unexpired Prescription Medications. In many states, only a health facility or pharmacy is allowed to donate drugs. There are some states that allow patients to donate. Usually the packaging must be unopened and sealed, or the drugs must be packaged in individual doses (usually in sealed blister packs). $5 billion worth per year is the amount of medications that go to waste each year in the United States. Drug Donation Repository. Medications that are flushed or thrown out hurt the environment. Drugs that are flushed down the toilet or drain can contaminate waterways.

Psychiatric Drugs - Antipsychotics

Antipsychotic are a class of medication primarily used to manage psychosis, including delusions, hallucinations, paranoia or disordered thought, principally in schizophrenia and bipolar disorder. They are increasingly being used in the management of non-psychotic disorders. The long-term use of antipsychotics is associated with side effects such as involuntary movement disorders, gynecomastia or man breasts, and metabolic syndrome. They are also associated with increased mortality in elderly people with dementia. medication tend to block receptors in the brain's dopamine pathways, but atypicals tend to act on serotonin receptors as well.

Major Psychiatric Disorders Have things in Common, fewer genes involved in signaling between neurons, and more genes related to neuroinflammatory cells. Shared molecular neuropathology across major psychiatric disorders parallels polygenic overlap.

Anti-Depressants - Treating Depression - Suicidal Thoughts

Psychotherapeutic Drugs are used to treat psychosis, which refers to a group of mental disorders for example depression, schizophrenia, manic-depressive disorders and so on. They affect mood and behavior.

Psychotropic Medications are used to treat psychiatric conditions that are on the market in the United States (this list is incomplete; the title of the entry is "List of Psychotropic Medications" and what follows is a list of psychiatric drugs - not all psychotropic agents are used to treat psychiatric conditions. A couple of examples are 'Tramadol' and 'Morphine').

Psychopharmacology is the scientific study of the effects drugs have on mood, sensation, thinking, and behavior. It is distinguished from neuropsychopharmacology, which emphasizes the correlation between drug-induced changes in the functioning of cells in the nervous system and changes in consciousness and behavior.

Psychedelic Therapy refers to therapeutic practices involving the use of psychedelic drugs, particularly serotonergic psychedelics such as LSD, psilocybin, DMT, MDMA, mescaline, and 2C-B, primarily to assist psychotherapy. As an alternative to synonyms such as "hallucinogen", "entheogen", "psychotomimetic" and other functionally constructed names, the use of the term psychedelic ("mind-manifesting") emphasizes that those who use these drugs as part of a therapeutic practice believe these drugs can facilitate beneficial exploration of the psyche. In contrast to conventional psychiatric medication which is taken by the patient regularly or as-needed, in psychedelic therapy, patients remain in an extended psychotherapy session during the acute activity of the drug and spend the night at the facility. In the sessions with the drug, therapists are nondirective and support the patient in exploring their inner experience. Patients participate in psychotherapy before the drug psychotherapy sessions to prepare them and after the drug psychotherapy to help them integrate their experiences with the drug.

Pharmacotherapy is therapy using pharmaceutical drugs, as distinguished from therapy using surgery (surgical therapy), radiation (radiation therapy), movement (physical therapy), or other modes. Among physicians, sometimes the term medical therapy refers specifically to pharmacotherapy as opposed to surgical or other therapy; for example, in oncology, medical oncology is thus distinguished from surgical oncology.

Interactions - Mixing Dangers

Drug Interaction is a situation in which a substance or drug affects the activity of another drug when both are administered together. This action can be synergistic (when the drug's effect is increased) or antagonistic (when the drug's effect is decreased) or a new effect can be produced that neither produces on its own. Typically, interactions between drugs come to mind (drug-drug interaction). However, interactions may also exist between drugs and foods (drug-food interactions), as well as drugs and medicinal plants or herbs (drug-plant interactions). People taking antidepressant drugs such as monoamine oxidase inhibitors should not take food containing tyramine as hypertensive crisis may occur (an example of a drug-food interaction). These interactions may occur out of accidental misuse or due to lack of knowledge about the active ingredients involved in the relevant substance.

Dosage - Errors - Tolerance - Side Effects - Effectiveness

Pharmacokinetics is measuring the fate of a chemical from the moment that it is administered up to the point at which it is completely eliminated from the body.

Some drugs irreversibly accumulate in body tissue.

Chemo Brain - Food Chemistry

Contraindication is a specific situation in which a drug, procedure, or surgery should not be used because it may be harmful to the person. There are two types of contraindications: Relative contraindication means that caution should be used when two drugs or procedures are used together. Absolute contraindication means that event or substance could cause a life-threatening situation. A procedure or medicine that falls under this category must be avoided. Contraindication is a condition or factor that serves as a reason to withhold a certain medical treatment due to the harm that it would cause the patient. Contraindication is the opposite of indication, which is a reason to use a certain treatment. Absolute contraindications are contraindications for which there are no reasonable circumstances for undertaking a course of action. For example, children and teenagers with viral infections should not be given aspirin because of the risk of Reye's syndrome, and a person with an anaphylactic food allergy should never eat the food to which they are allergic. Similarly, a person with hemochromatosis should not be administered iron preparations. Relative contraindications are contraindications for circumstances in which the patient is at higher risk of complications from treatment, but these risks may be outweighed by other considerations or mitigated by other measures. For example, a pregnant woman should normally avoid getting X-rays, but the risk may be outweighed by the benefit of diagnosing (and then treating) a serious condition such as tuberculosis. Relative contraindications may also be referred to as cautions, such as in the British National Formulary.

Soluble - Water-Soluble - Fat Soluble

Combining certain meds with ibuprofen can permanently injure kidneys. Commonly prescribed hypertension drugs may be harmful in combination with ibuprofen. Anyone who is taking a diuretic and a renin-angiotensin system inhibitor for high blood pressure should be cautious about also taking ibuprofen, according to new research.

Reduce Accumulation of the Drug - Elimination Kinetics

Plasma Protein Binding is a drug's efficiency may be affected by the degree to which it binds to the proteins within blood plasma. The less bound a drug is, the more efficiently it can traverse cell membranes or diffuse. Common blood proteins that drugs bind to are human serum albumin, lipoprotein, glycoprotein, and α, β‚ and γ globulins.

Therapeutic Index is a comparison of the amount of a therapeutic agent that causes the therapeutic effect to the amount that causes toxicity. The related terms therapeutic window or safety window refer to a range of doses which optimize between efficacy and toxicity, achieving the greatest therapeutic benefit without resulting in unacceptable side-effects or toxicity.

Absorption in pharmacokinetics is the movement of a drug into the bloodstream. Absorption involves several phases. First, the drug needs to be introduced via some route of administration (oral, topical-dermal, etc.) and in a specific dosage form such as a tablet, capsule, solution and so on. In other situations, such as intravenous therapy, intramuscular injection, enteral nutrition and others, absorption is even more straightforward and there is less variability in absorption and bioavailability is often near 100%. It is considered that intravascular administration (e.g. IV) does not involve absorption, and there is no loss of drug. The fastest route of absorption is inhalation, and not as mistakenly considered the intravenous administration. Absorption is a primary focus in drug development and medicinal chemistry, since the drug must be absorbed before any medicinal effects can take place. Moreover, the drug's pharmacokinetic profile can be easily and significantly changed by adjusting factors that affect absorption.

Bioavailability is a subcategory of absorption and is the fraction of an administered dose of unchanged drug that reaches the systemic circulation, one of the principal pharmacokinetic properties of drugs. By definition, when a medication is administered intravenously, its bioavailability is 100%. However, when a medication is administered via other routes (such as orally), its bioavailability generally decreases (due to incomplete absorption and first-pass metabolism) or may vary from patient to patient. Bioavailability is one of the essential tools in pharmacokinetics, as bioavailability must be considered when calculating dosages for non-intravenous routes of administration. For dietary supplements, herbs and other nutrients in which the route of administration is nearly always oral, bioavailability generally designates simply the quantity or fraction of the ingested dose that is absorbed. Bioavailability is defined slightly differently for drugs as opposed to dietary supplements primarily due to the method of administration and Food and Drug Administration regulations.

Medical Toxicology is a medical subspecialty focusing on the diagnosis, management and prevention of poisoning and other adverse health effects due to medications, occupational and environmental toxicants, and biological agents. Medical toxicologists are involved in the assessment and treatment of acute or chronic poisoning, adverse drug reactions (ADR), overdoses, envenomations, and substance abuse, and other chemical exposures. Body Burden.

Distribution in pharmacology in pharmacology is a branch of pharmacokinetics which describes the reversible transfer of a drug from one location to another within the body. Once a drug enters into systemic circulation by absorption or direct administration, it must be distributed into interstitial and intracellular fluids. Each organ or tissue can receive different doses of the drug and the drug can remain in the different organs or tissues for a varying amount of time. The distribution of a drug between tissues is dependent on vascular permeability, regional blood flow, cardiac output and perfusion rate of the tissue and the ability of the drug to bind tissue and plasma proteins and its lipid solubility. pH partition plays a major role as well. The drug is easily distributed in highly perfused organs such as the liver, heart and kidney. It is distributed in small quantities through less perfused tissues like muscle, fat and peripheral organs. The drug can be moved from the plasma to the tissue until the equilibrium is established (for unbound drug present in plasma). The concept of compartmentalization of an organism must be considered when discussing a drug’s distribution. This concept is used in pharmacokinetic modeling.

Biological Activity describes the beneficial or adverse effects of a drug on living matter. When a drug is a complex chemical mixture, this activity is exerted by the substance's active ingredient or pharmacophore but can be modified by the other constituents. Among the various properties of chemical compounds, pharmacological/biological activity plays a crucial role since it suggests uses of the compounds in the medical applications. However, chemical compounds may show some adverse and toxic effects which may prevent their use in medical practice. Activity is generally dosage-dependent. Further, it is common to have effects ranging from beneficial to adverse for one substance when going from low to high doses. Activity depends critically on fulfillment of the ADME criteria. To be an effective drug, a compound not only must be active against a target, but also possess the appropriate ADME (Absorption, Distribution, Metabolism, and Excretion) properties necessary to make it suitable for use as a drug. Bioactivity is a key property that promotes osseointegration for bonding and better stability of dental implants. Bioglass coatings represent high surface area and reactivity leading to an effective interaction of the coating material and surrounding bone tissues. In the biological environment, the formation of a layer of carbonated hydroxyapatite (CHA) initiates bonding to the bone tissues. The bioglass surface coating undergoes leaching/exchange of ions, dissolution of glass, and formation of the HA layer that promotes cellular response of tissues. The high specific surface area of bioactive glasses is likely to induce quicker solubility of the material, availability of ions in the surrounding area, and enhanced protein adsorption ability. These factors altogether contribute toward the bioactivity of bioglass coatings. In addition, tissue mineralization (bone, teeth) is promoted while tissue forming cells are in direct contact with bioglass materials. Whereas a material is considered bioactive if it has interaction with or effect on any cell tissue in the human body, pharmacological activity is usually taken to describe beneficial effects, i.e. the effects of drug candidates as well as a substance's toxicity. In the study of biomineralisation, bioactivity is often meant to mean the formation of calcium phosphate deposits on the surface of objects placed in simulated body fluid, a buffer solution with ion content similar to blood.

Drugs affect individual cells differently, finds new Surrey research. A new state-of-the-art method that measures the amounts of drugs and lipids or fats in individual cells could help health professionals target more effective treatments for diseases such as tuberculosis.

Peptide are short chains of between two and fifty amino acids, linked by peptide bonds. Chains of fewer than ten or fifteen amino acids are called oligopeptides, and include dipeptides, tripeptides, and

Bioactive Peptides have been defined as specific protein fragments that have a positive impact on body functions or conditions and may ultimately influence health. At present, milk proteins are considered the most important source of bioactive peptides. Bioactive peptides may affect the major body systems—namely, the cardiovascular, digestive, endocrine, immune, and nervous systems. The strain should not be too proteolytic and must have the right specificity to give high concentrations of active peptides. The concentration of bioactive peptides appears to rely on a balance between their formation and further breakdown that in turn depends on storage time and conditions.

Closer look at unexamined interactions could improve drug purification process. Rensselaer engineers aim to make better biopharmaceuticals through deeper analysis. The process of purifying biopharmaceutical drugs remains a costly and time-consuming challenge. A deeper understanding of how unwanted elements within biomanufactured proteins bind to the molecules developed to remove them could help researchers make purity processes more efficient, more complex, and increasingly scalable.

Chromatography is a common unit operation for purification of biopharmaceutical products. Chromatographic separations exploit differences in molecular properties between the desired product and impurities that may be present in the process solution. Chromatography is a laboratory technique for the separation of a mixture. The mixture is dissolved in a fluid (gas or solvent) called the mobile phase, which carries it through a system (a column, a capillary tube, a plate, or a sheet) on which a material called the stationary phase is fixed. The different constituents of the mixture have different affinities for the stationary phase. The different molecules stay longer or shorter on the stationary phase, depending on their interactions with its surface sites. So, they travel at different apparent velocities in the mobile fluid, causing them to separate. The separation is based on the differential partitioning between the mobile and the stationary phases. Subtle differences in a compound's partition coefficient result in differential retention on the stationary phase and thus affect the separation. Chromatography may be preparative or analytical. The purpose of preparative chromatography is to separate the components of a mixture for later use, and is thus a form of purification. Analytical chromatography is done normally with smaller amounts of material and is for establishing the presence or measuring the relative proportions of analytes in a mixture. The two are not mutually exclusive.

Full-Spectrum means that an extract retains the complex profile of naturally occurring therapeutic compounds, without the lipids and fats that hold those compounds together but do not have medicinal benefits. The goal of a full-spectrum extract is to maintain the complex range of desirable compounds in a cannabis plant without altering them through decarboxylation or oxidation. Full-spectrum extraction, also known as broad-spectrum extraction, differs from other extraction methods in that the final product preserves the flavonoids, phenolic amides, and sterols while removing the plant material.

Personalized Medicine

Personalized Medicine is a medical procedure that separates patients into different groups—with medical decisions, practices, interventions and/or products being tailored to the individual patient based on their predicted response or risk of disease. The terms personalized medicine, precision medicine, stratified medicine and P4 medicine are used interchangeably to describe this concept though some authors and organizations use these expressions separately to indicate particular nuance. While the tailoring of treatment to patients dates back at least to the time of Hippocrates, the term has risen in usage in recent years given the growth of new diagnostic and informatics approaches that provide understanding of the molecular basis of disease, particularly genomics. This provides a clear evidence base on which to stratify (group) related patients..

Male and Female Differences - Health Plans Based On Your DNA

Personalized Diet is the most important responsibility that all humans have. Microbial Balance - Personalized Food - Personalized Education - Epigenetics.

Precision Medicine is a medical model that proposes the customization of healthcare, with medical decisions, treatments, practices, or products being tailored to the individual patient. In this model, diagnostic testing is often employed for selecting appropriate and optimal therapies based on the context of a patient’s genetic content or other molecular or cellular analysis. Tools employed in precision medicine can include molecular diagnostics, imaging, and analytics.

Precision drugs could unmask cancers to immune system and boost effects of immunotherapy.

Evidence-Based Medicine is an approach to medical practice intended to optimize decision-making by emphasizing the use of evidence from well-designed and well-conducted research. Although all medicine based on science has some degree of empirical support, EBM goes further, classifying evidence by its epistemologic strength and requiring that only the strongest types (coming from meta-analyses, systematic reviews, and randomized controlled trials) can yield strong recommendations; weaker types (such as from case-control studies) can yield only weak recommendations. The term was originally used to describe an approach to teaching the practice of medicine and improving decisions by individual physicians about individual patients. Use of the term rapidly expanded to include a previously described approach that emphasized the use of evidence in the design of guidelines and policies that apply to groups of patients and populations ("evidence-based practice policies"). It has subsequently spread to describe an approach to decision-making that is used at virtually every level of health care as well as other fields (evidence-based practice). Whether applied to medical education, decisions about individuals, guidelines and policies applied to populations, or administration of health services in general, evidence-based medicine advocates that to the greatest extent possible, decisions and policies should be based on evidence, not just the beliefs of practitioners, experts, or administrators. It thus tries to assure that a clinician's opinion, which may be limited by knowledge gaps or biases, is supplemented with all available knowledge from the scientific literature so that best practice can be determined and applied. It promotes the use of formal, explicit methods to analyze evidence and makes it available to decision makers. It promotes programs to teach the methods to medical students, practitioners, and policy makers. Evidence-Based Practice.

Systems Pharmacology is the application of systems biology principles to the field of pharmacology. It seeks to understand how drugs affect the human body as a single complex biological system. Instead of considering the effect of a drug to be the result of one specific drug-protein interaction, systems pharmacology considers the effect of a drug to be the outcome of the network of interactions a drug may have.

Advancements: Pharmacotherapy is improving Personalized Medicine by Printing a Precision Dose of Medicine.

Personalized Mental Health Treatment - Mental Health Evaluation (assessments) - Bias in Research

Stratified Medicine is based on identifying subgroups of patients with distinct mechanisms of disease, or particular responses to treatments. This allows us to identify and develop treatments that are effective for particular groups of patients.

Medical Prescription s a health-care program implemented by a physician or other qualified health care practitioner in the form of instructions that govern the plan of care for an individual patient. The term often refers to a health care provider's written authorization for a patient to purchase a prescription drug from a pharmacist.

Selective Serotonin Reuptake Inhibitor are a class of drugs that are typically used as antidepressants in the treatment of major depressive disorder and anxiety disorders. (SSRI)

Symptomatic Treatment is any medical therapy of a disease that only affects its symptoms, not its cause, i.e., its etiology. It is usually aimed at reducing the signs and symptoms for the comfort and well-being of the patient, but it also may be useful in reducing organic consequences and sequelae of these signs and symptoms of the disease.

Pharmaceutical Compounding is the creation of a particular pharmaceutical product to fit the unique need of a patient. To do this, compounding pharmacists combine or process appropriate ingredients using various tools. This may be done for medically necessary reasons, such as to change the form of the medication from a solid pill to a liquid, to avoid a non-essential ingredient that the patient is allergic to, or to obtain the exact dose(s) needed or deemed best of particular active pharmaceutical ingredient(s). (There are risks with compounded drugs because there is no FDA approval, like with certain homeopathic medicine. There is also fraud and drug errors too, so please be very careful).

Pharmaceutical Industry (too many drugs)

Liaison Psychiatry is the branch of psychiatry that specializes in the interface between general medicine and psychiatry, usually taking place in a hospital or medical setting. The role of the consultation-liaison psychiatrist is to see patients with comorbid medical conditions at the request of the treating medical or surgical consultant or team. Liaison psychiatry has areas of overlap with other disciplines including psychosomatic medicine, health psychology and neuropsychiatry. (also known as consultative psychiatry or consultation-liaison psychiatry).

Worst Pills - Drug Dangers - Vaccines

Medicine Information - Medications Information

Archives of Internal Medicine - Pharmacopeial Convention

Annals of Internal Medicine - Pharmaceutical Research

Drug Errors - Chemistry

Too Many Meds Given to Senior Citizens - The Human Brain

Greed is the Biggest Killer in Healthcare

Atomwise Neural networks examine 3D images—thousands of molecules that might serve as drug candidates—and predict their suitability for blocking the mechanism of a pathogen.

Novartis-MIT Center for Continuous Manufacturing

Knowing when to stop taking medications and preparing a person for the changes that they may experience when stopping meds.

Adherence to Treatment.
Medication Adherence in Children.
Non-compliance with Medical Treatment and Teens.

Providing more information to the Patient and the Doctor will help make better choices and decisions. Informulary.

Mental Health Failures - We need to improve and provide better mental health care services.

Science Direct - Serotonin Theory of Depression (PDF)

Low levels of the "happiness" neurotransmitter, serotonin. Anti-depressants are are only fully effective roughly 30 percent of the time, and often come with troublesome side effects. Elevated serotonin levels that are released and used by the brain during depressive episodes trigger processes that promote rumination -- the obsessive negative thinking that is the hallmark of Depression. Then, because they facilitate the production of serotonin, SSRI treatments exacerbate rumination and actually worsen symptoms of depression, especially at first. Over time, in some cases, the SSRIs can reverse ruminative processes and reduce symptoms -- but this is in spite of the medication, not because of it. As people and physicians become more aware that antidepressants only work for a limited period of time, and are less safe than they have been supposed, the use of antidepressant medications will decline and the use of Psychotherapies will increase.

Engineers develop new tool that will allow for more personalized cell therapies. A new quantitative approach gives scientists and engineers more control over the DNA editing process. The process of site-specific recombination involves using enzymes that recognize and modify specific sequences of DNA in living cells. It has important applications for treating myriad diseases using cellular therapies.

Tailored Treatments - Women, Men, Races or Cultures

Tailored Treatment versus a Non-Tailored Treatment. Women and Men and Races have differences when it comes to Medication amounts and medication types.

Personalized Medicine

Customized Care: An intervention to Improve Communication and health outcomes in multimorbidity.

Women's Health Research - Women's Health - Status of Women Data

Biological Sex affects genes for body fat, cancer, birth weight. Sex influences gene production in every human tissue. Biological sex has a small but ubiquitous influence on gene expression in almost every type of human tissue, reports a new study. These sex differences are observed for genes involved in many functions, including how people respond to medication, how women control blood sugar levels in pregnancy, how the immune system functions, how cancer develops and male pattern baldness. The information could be used for diagnostics, drug development and predicting outcomes.

Sex-Based Differences in Drug Activity - Sex and Gender-Based Analysis (SGBA)

Scientists uncover a difference between the Sexes.

Personalized Medicine based on Microbial Balance.

Sex Does Matter: Key molecular process in brain is different in males and females.

Big Data - Women's News - Geo-Medicine

Sex Bias in Pain Research. Females process pain differently, but search for pain medication still based on hypotheses drawn from work in males.

Why Medicine often has Dangerous Side Effects for Women (video)

Brain disease research reveals differences between sexes. Scientists highlight a growing body of research suggesting sex differences play roles in how patients respond to brain diseases, as well as multiple sclerosis, motor neuron disease, and other brain ailments. They are urging their colleagues to remember those differences when researching treatments and cures. Alzheimer's disease, Parkinson's disease impact men and women differently, affecting cure and treatment.

International Center for Research on Women (ICRW)

UCLA Center for the Study of Women.

Antibiotics affect male and female gut microbiomes differently. Sex-specific changes in the gut bacteria of lab rats treated with antibiotics

Office of Minority Health Resource Center. He was one of a group of 14 researchers who found that diversity in biomedical research often does not reflect the American population.

Racial and Ethnic Minority Populations.

Taking Race out of human genetics you can't make the genetic conclusions based on someone's race or ancestry. Subordination of different groups and social groupings based on myths about their biologic or genetic predispositions is not always accurate.

How Racism makes us Sick: David R. Williams (video and interactive text)

Black mothers in the U.S. die at three to four times the rate of white mothers. Black woman is 22 percent more likely to die from heart disease than a white woman, 71 percent more likely to perish from cervical cancer, but 300 percent more likely to die from pregnancy- or childbirth-related causes. In a national study of five medical complications that are common causes of maternal death and injury, black women were two to three times more likely to die than white women who had the same condition.

Looking at married couples who were together less than 20 years and couples together for more than 50, similarities were found between partners, like kidney function, total cholesterol levels, and the strength of their grips, which is a key predictor of mortality. Gerentological Society of America.

Cannabis affect Men and Women Differently. The influence of sex hormones like testosterone, estradiol (estrogen) and progesterone on the endocannabinoid system: Men are up to four times more likely to try cannabis -- and use higher doses, more frequently. Male sex steroids increase risk-taking behavior and suppress the brain's reward system. Men and women differ not only in the prevalence and frequency of cannabis use, pattern and reasons of use, but also in the vulnerability to develop cannabis use disorder. Female rat hormone estradiol affects control of movement, social behavior and filtering of sensory input to the brain -- all targets of drug taking -- via modulation of the endocannabinoid system, whose feedback in turn influences estradiol production. Female rats have different levels of endocannabinoids and more sensitive receptors than males in key brain areas related to these functions, with significant changes along the menstrual cycle. As a result, the interactions between the endocannabinoid system and the brain level of dopamine -- the neurotransmitter of "pleasure" and "reward" -- are sex-dependent.

Genetic differences in body fat shape men and women's health risks. New findings about body fat help explain the differing health risks men and women face - and set the stage for better, more targeted treatments. Collaborators have determined that differences in fat storage and formation in men and women strongly affect the activity of 162 different genes found in fat tissue. Further, 13 of the genes come in variants that have different effects in men and women.

Concussion protocols are based on research of mostly men. What about women? Overall Difference in Concussion Recovery Time Seen for Male and Female Collegiate Athletes.

Binge Drinking affects male and Female Brains Differently. Genes linked to hormone signaling and immune function are altered by binge alcohol drinking in females, whereas genes related to nerve signaling are affected in males. Binge Ethanol Drinking Produces Sexually Divergent and Distinct. Changes in Nucleus Accumbens Signaling Cascades and Pathways in Adult C57BL/6J Mice.

Study shows differences between brains of girls, boys with autism. Girls with autism differ in several brain centers compared with boys with autism, suggesting gender-specific diagnostics are needed, a new study using artificial intelligence finds. Among children with autism, girls had different patterns of connectivity than boys did in several brain centers, including motor, language and visuospatial attention systems. Differences in a group of motor areas -- including the primary motor cortex, supplementary motor area, parietal and lateral occipital cortex, and middle and superior temporal gyri -- were the largest between sexes. Among girls with autism, the differences in motor centers were linked to the severity of their motor symptoms, meaning girls whose brain patterns were most similar to boys with autism tended to have the most pronounced motor symptoms.

Neuroscientists have found that immune cells called microglia work differently in the developing brains of male and female rodents, even in the absence of any infection. These microglial actions, reflected in studies of people, may predispose boys to neural differences and disorders early in life, the researchers speculate, but could protect them later on. Scientists have also identified several genes involved in immune responses that could help to explain heightened risks for girls and women from puberty onward. With time, a better understanding of these differences might lead to sex-specific treatments.

Men with chest pain receive faster, more medical attention than women. Women with possible heart attack wait longer and undergo less testing, study finds. Among younger adults visiting the emergency department for chest pain, women may be getting the short end of the stick. Compared with men of similar age, women were triaged less urgently, waited longer to be seen, and were less likely to undergo basic tests or be hospitalized or admitted for observation to diagnose a heart attack, according to new research.

Math model suggests optimal treatment strategies. A biology-based mathematical model indicates why COVID-19 outcomes vary widely and how therapy can be tailored to match the needs of specific patient groups. the viral load (the level of SARS-CoV-2 particles in the bloodstream) increases during early lung infection, but then may go in different directions starting after Day 5, depending on levels of key immune guardian cells, called T cells. T cells are the first responders of the immune system that effectively coordinate other aspects of immunity. The T cell response is known as adaptive immunity because it is flexible and responds to immediate threats. In patients younger than 35 who have healthy immune systems, a sustained recruitment of T cells occurs, accompanied by a reduction in viral load and inflammation and a decrease in nonspecific immune cells (so-called "innate" immunity). All of these processes lead to lower risk for blood clot formation and to restoring oxygen levels in lung tissues, and these patients tend to recover. In contrast, people who have higher levels of inflammation at the time of infection -- such as those with diabetes, obesity or high blood pressure -- or whose immune systems are tilted toward more active innate immune responses but less effective adaptive immune responses tend to have poor outcomes. The investigators also sought to answer the question of why men tend have more severe COVID-19 compared with women, and found that although the adaptive immune response is not as vigorous in women as in men, women have lower levels of a protein called TMPRSS2 that allows SARS-CoV-2 to enter and infect normal cells. Based on their findings, Jain and colleagues propose that optimal treatment for older patients -- who are likely to already have inflammation and impaired immune responses compared with younger patients -- should include the clot-preventing drug heparin and/or the use of an immune response-modifying drug (checkpoint inhibitor) in early stages of the disease, and the anti-inflammatory drug dexamethasone at later stages. In patients with pre-existing conditions such as obesity, diabetes and high blood pressure or immune system abnormalities, treatment might also include drugs specifically targeted against inflammation-promoting substances (cytokines, such as interleukin-6) in the body, as well as drugs that can inhibit the renin-angiotensin system (the body's main blood pressure control mechanism), thereby preventing activation of abnormal blood pressure and resistance to blood flow that can occur in response to viral infections.

Racial Bias in Healthcare - Healthcare Inequality

Health Equity are differences in the quality of health and healthcare across different populations. Health equity falls into two major categories: horizontal equity, the equal treatment of individuals or groups in the same circumstances; and vertical equity, the principle that individuals who are unequal should be treated differently according to their level of need. The United States historically had large disparities in health and access to adequate healthcare between races, and current evidence supports the notion that these racially centered disparities continue to exist and are a significant social health issue. The disparities in access to adequate healthcare include differences in the quality of care based on race and overall insurance coverage based on race. Both gender and sex are significant factors that influence health. Sex is characterized by female and male biological differences in regards to gene expression, hormonal concentration, and anatomical characteristics. Minority populations have increased exposure to environmental hazards that include lack of neighborhood resources, structural and community factors as well as residential segregation that result in a cycle of disease and stress.

Equity is acting in harmony with rules or standards. The treatment of different views or opinions equally and fairly. Equity in law is a legal tradition dealing with fairness and ethics.

Differences in Physicians' Verbal and Nonverbal Communication With Black and White Patients at the End of Life.

Racial Bias May Be Conveyed by Doctors’ Body Language.

Patient Centered Communication
Patient-Centered Communication, Ratings of Care, and Concordance of Patient and Physician Race (PDF)

Differences between Racial and Ethnic groups in Health Care (PDF)

Cultural Diversity at the End of Life: Issues and Guidelines for Family Physicians.

Heart disease is the leading cause of death for African Americans.

African American Health Disparities Compared to Non-Hispanic Whites.

Walking as a revolutionary act of self-care: T. Morgan Dixon and Vanessa Garrison (video and interactive text)

Why genetic research must be more diverse, Keolu Fox: (video and interactive text)

Significant Racial disparities persist in hospital readmissions. Black patients enrolled with Medicare Advantage are far more likely to be readmitted to the hospital after a surgery than those enrolled on traditional Medicare. Health Affairs.

Blacks And Hispanics More Likely To Receive Low-Value Care Than White - Drug War.

How medical schools can transform curriculums to undo racial biases. Lectures and assessments misuse race, play a role in perpetuating physician bias, Penn Medicine researchers found.

Increasing Diversity, Equity, and Inclusion in the Scientific Workforce.

Health disparities among former NFL players. Black, other nonwhite athletes report more pain, physical impairment, mood disorders and cognitive problems than white peers. Among former NFL players, Black, Hawaiian, and athletes from other racial backgrounds report worse physical, mental health outcomes than white players. The widest health gaps emerged between Black and white former NFL players. Black former players reported worse health outcomes in all five health categories, compared with their white peers. Presence of health disparities among former NLF players reflects the deep and pervasive nature of systemic inequities that persist even among elite athletes, study suggests.

Infant health inequality has increased since 2010, study finds. After decades of narrowing gaps in health between infants born to the most and least advantaged American mothers, infant health inequality is increasing, portending a rise in health and social inequity that could last for decades. Between 1989 and 2010, the health gap between infants born to the most socially advantaged mothers -- those who are married, highly educated and white -- and infants born to the least socially advantaged mothers -- those who are unmarried, without a high school diploma and Black -- steadily decreased. But according to a new study, that trend began to reverse in 2010, creating an ever-widening gulf that could last for generations.

Racism in Therapy and Mental Health Care

Decolonizing Mental Health aims to dismantle racism in mental health care and redress the ways psychiatric illness and health have historically been defined.

Culturally Responsive Therapy: Establishing a strong therapeutic alliance across cultural lines.

Marginalized Communities deserve equitable access to culturally responsive, identity-affirming therapy.

Lotus Therapy Fund is a program is to make psychotherapy as available, accessible, and approachable as possible to the Asian community.

The American Psychological Association failed in its role leading the discipline of psychology, was complicit in contributing to systemic inequities, and hurt many through racism, racial discrimination, and denigration of people of color, thereby falling short on its mission to benefit society and improve lives. Personalized Medicine.

Therapy is a predominantly white field in the U.S. — 80% of psychologists, 63% of counselors and 59% of social workers are white, according to Data USA, a website that constructs visualizations of public federal data. Many of the founding ideas, techniques and schools of practice of therapy were developed by white scholars or practitioners. As a result, the field has marginalized the experiences of people of color, therapists and patients say. Microaggressions are also pervasive in psychological practice, researchers note, and many immigrants report not attending therapy because of language barriers, a lack of insurance and high costs.

Dosage - Amount - Quantity - Portion Size

Dose is a measured portion or the amount of medicine that is taken at any one time. The quantity of an active substance that is taken in or absorbed by the body at any one time. Dose means quantity in units of energy/mass in the fields of nutrition, medicine, and toxicology. Dosage is the rate of application of a dose, although in common and imprecise usage, the words are sometimes used synonymously. Dose can also mean quantity in units of number/area in the fields of surface science and Ion implantation. Interactions.

Defined Daily Dose is a statistical measure of drug consumption, defined by the World Health Organization (WHO). It is used to standardize the comparison of drug usage between different drugs or between different health care environments. The DDD is not to be confused with the therapeutic dose or with the dose actually prescribed by a physician for an individual patient. The WHO's definition is: "The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults.

Don't Overdo It. Things can add up and build up quickly, or slowly increase over time without being noticed. But how do you know when you have overdone it? How do you know when you are not getting enough? How do you know when things can't be consumed together? How much do I really need to take? How do I stay balanced?

Reference Dose is the maximum acceptable oral dose of a toxic substance. Reference doses are most commonly determined for pesticides.

Therapeutic Index is a comparison of the amount of a therapeutic agent that causes the therapeutic effect to the amount that causes toxicity. The related terms therapeutic window or safety window refer to a range of doses which optimize between efficacy and toxicity, achieving the greatest therapeutic benefit without resulting in unacceptable side-effects or toxicity.

Loading Dose is an initial higher dose of a drug that may be given at the beginning of a course of treatment before dropping down to a lower maintenance dose. Radiation Dose.

Macrodosing is taking a small amount of a drug like psilocybin, just enough to feel it but not get real high and feel colours and smell sounds.

Maintenance Dose is the maintenance rate [mg/h] of drug administration equal to the rate of elimination at steady state. This is not to be confused with dose regimen, which is a type of drug therapy in which the dose [mg] of a drug is given at a regular dosing interval on a repetitive basis. Continuing the maintenance dose for about 4 to 5 half lives (t½) of the drug will approximate the steady state level. One or more doses higher than the maintenance dose can be given together at the beginning of therapy with a loading dose. A loading dose is most useful for drugs that are eliminated from the body relatively slowly. Such drugs need only a low maintenance dose in order to keep the amount of the drug in the body at the appropriate level, but this also means that, without an initial higher dose, it would take a long time for the amount of the drug in the body to reach that level.

Over Eating - Dilution - Soluble - Don't do it Alone - Interventions

Effective Dose in pharmacology is the dose or amount of drug that produces a therapeutic response or desired effect in some fraction of the subjects taking it. It has been stated that any substance can be toxic at a high enough dose. This concept was exemplified in 2007 when a California woman died of water intoxication in a contest sanctioned by a radio station. The line between efficacy and toxicity is dependent upon the particular patient, although the dose administered by a physician should fall into the predetermined therapeutic window of the drug. The importance of determining the therapeutic range of a drug cannot be overstated. This is generally defined by the range between the minimum effective dose (MED) and the maximum tolerated dose (MTD). The MED is defined as the lowest dose level of a pharmaceutical product that provides a clinically significant response in average efficacy, which is also statistically significantly superior to the response provided by the placebo. Similarly, the MTD is the highest possible but still tolerable dose level with respect to a pre-specified clinical limiting toxicity. In general, these limits refer to the average patient population. For instances in which there is a large discrepancy between the MED and MTD, it is stated that the drug has a large therapeutic window. Conversely, if the range is relatively small, or if the MTD is less than the MED, then the pharmaceutical product will have little to no practical value. Personalized Medicine.

Micro-Dose (small amounts) - You must take your Daily Dosage of Information everyday. Learning is the only cure.

Overdose describes the ingestion or application of a drug or other substance in quantities greater than are recommended or generally practiced. An overdose may result in a toxic state or death. Addictions - Intoxication.

Dose-Response Relationship describes the change in effect on an organism caused by differing levels of exposure (or doses) to a stressor (usually a chemical) after a certain exposure time, or to a food. This may apply to individuals (e.g., the dose makes the poison: a small amount has no significant effect, a large amount is fatal), or to populations (e.g.: how many people or organisms are affected at different levels of exposure).

Dosage Form are pharmaceutical drug products in the form in which they are marketed for use, with a specific mixture of active ingredients and inactive components (excipients), in a particular configuration (such as a capsule shell, for example), and apportioned into a particular dose. For example, two products may both be amoxicillin, but one is in 500 mg capsules and another is in 250 mg chewable tablets. The term unit dose can also sometimes encompass non-reusable packaging as well (especially when each drug product is individually packaged), although the FDA distinguishes that by unit-dose "packaging" or "dispensing". Depending on the context, multi(ple) unit dose can refer to distinct drug products packaged together, or to a single drug product containing multiple drugs and/or doses. The term dosage form can also sometimes refer only to the pharmaceutical formulation of a drug product's constituent drug substance(s) and any blends involved, without considering matters beyond that (like how it is ultimately configured as a consumable product such as a capsule, patch, etc.). Because of the somewhat vague boundaries and unclear overlap of these terms and certain variants and qualifiers within the pharmaceutical industry, caution is often advisable when conversing with someone who may be unfamiliar with another person's use of the term.

Renal Threshold is the concentration of a substance dissolved in the blood above which the kidneys begin to remove it into the urine. When the renal threshold of a substance is exceeded, reabsorption of the substance by the proximal convoluted tubule is incomplete; consequently, part of the substance remains in the urine. Renal thresholds vary by substance – the low potency poison urea, for instance, is removed at much lower concentrations than glucose. Indeed, the most common reason for the glucose renal threshold ever being exceeded is diabetes. Renal thresholds vary by species and by physiological condition; thus an animal may have different renal thresholds while hibernating, Renal thresholds can also be altered by many drugs, and may change in characteristic ways during certain illnesses. Taken together, the collection of a kidney's renal thresholds essentially define much of its function in renal physiology. Many tests of kidney function amount to measures of renal thresholds for various substances.

Threshold Model is any model where a threshold value, or set of threshold values, is used to distinguish ranges of values where the behaviour predicted by the model varies in some important way. A particularly important instance arises in toxicology, where the model for the effect of a drug may be that there is zero effect for a dose below a critical or threshold value, while an effect of some significance exists above that value. Certain types of regression model may include threshold effects.

Threshold Limit Value of a chemical substance is believed to be a level to which a worker can be exposed day after day for a working lifetime without adverse effects. Strictly speaking, TLV is a reserved term of the American Conference of Governmental Industrial Hygienists (ACGIH). TLVs issued by the ACGIH are the most widely accepted occupational exposure limits both in the United States and most other countries. However, it is sometimes loosely used to refer to other similar concepts used in occupational health and toxicology, such as acceptable daily intake (ADI) and tolerable daily intake (TDI). Concepts such as TLV, ADI, and TDI can be compared to the no-observed-adverse-effect level (NOAEL) in animal testing, but whereas a NOAEL can be established experimentally during a short period, TLV, ADI, and TDI apply to human beings over a lifetime and thus are harder to test empirically and are usually set at lower levels. TLVs, along with biological exposure indices (BEIs), are published annually by the ACGIH. The TLV is an estimate based on the known toxicity in humans or animals of a given chemical substance, and the reliability and accuracy of the latest sampling and analytical methods. It is not a static definition since new research can often modify the risk assessment of substances and new laboratory or instrumental analysis methods can improve analytical detection limits. The TLV is a recommendation by ACGIH, with only a guideline status. As such, it should not be confused with exposure limits having a regulatory status, like those published and enforced by the Occupational Safety and Health Administration (OSHA). The OSHA regulatory exposure limits permissible exposure limits (PELs) published in 29CFR 1910.1000 Table Z1 are based on recommendations made by the ACGIH in 1968, although other exposure limits were adopted more recently. Many OSHA exposure limits are not considered by the industrial hygiene community to be sufficiently protective levels since the toxicological basis for most limits have not been updated since the 1960s. The National Institute for Occupational Safety and Health (NIOSH) publishes Recommended Exposure Limits (RELs) which OSHA takes into consideration when promulgating new regulatory exposure limits.

Dosage Calculated by Body Weight. Given the weight of a patient and a dosage specified in terms of weight, calculate the necessary dosage. The are problems with a type of pediatric dosage calculations. Most drugs in children are dosed according to body weight (mg/kg) or body surface area (BSA) (mg/m2). Care must be taken to properly convert body weight from pounds to kilograms (1 kg= 2.2 lb) before calculating doses based on body weight. Doses are often expressed as mg/kg/day or mg/kg/dose, therefore orders written "mg/kg/d," which is confusing, require further clarification from the prescriber. Chemotherapeutic drugs are commonly dosed according to body surface area, which requires an extra verification step (BSA calculation) prior to dosing. Medications are available in multiple concentrations, therefore orders written in "mL" rather than "mg" are not acceptable and require further clarification. Dosing also varies by indication, therefore diagnostic information is helpful when calculating doses. The following examples are typically encountered when dosing medication in children.

Dose-Ranging Study is a clinical trial where different doses of an agent (e.g. a drug) are tested against each other to establish which dose works best and/or is least harmful. Dose-ranging is usually a phase I or early phase II clinical trial. Typically a dose ranging study will include a placebo group of subjects, and a few groups that receive different doses of the test drug. For instance, a typical dose-ranging study may include four groups: a placebo group, low-dose group, medium-dose group and a high-dose group. The maximum tolerable dose (MTD) information is necessary to be able to design such groups and therefore dose-ranging studies are usually designed after the availability of MTD information. The main goal of a dose-ranging study is to estimate the response vs. dose given, so as to analyze the efficacy and safety of the drug. Although such a response will nevertheless be available from phase III or phase IV trials, it is important to carry out dose-ranging studies in the earlier phase I or phase II stages. There are some advantages by using healthy volunteers. They are in a steady-state condition showing no different stages of disease and no variation due to disease. In addition, it is easy to recruit and select volunteers among varying age, sex, race etc. under identical conditions in which the test can be repeated. The main reasons for this is to avoid trials in the later phases using doses that are significantly different from those that will subsequently be recommended for clinical use and also to avoid the need for modification of dosing schedules at later stages where a large amount of data has already been accumulated for a different dose range. The duration of action should be determined during dose-ranging study, as it will allow definition of the dosage schedule. Because it is hard to measure reliable pharmacodynamic parameter, it is difficult to determine the duration of action during early clinical trials. Other parameters instead are suggested as a tentative dosage, such as half-lives in plasma and urine in various test species and human, receptor binding in vitro, or pharmacodynamic data in vivo in animals.

Modified-Release Dosage is a mechanism that (in contrast to immediate-release dosage) delivers a drug with a delay after its administration (delayed-release dosage) or for a prolonged period of time (extended-release [ER, XR, XL] dosage) or to a specific target in the body (targeted-release dosage).

Drug Metabolism is the metabolic breakdown of drugs by living organisms.

Pharmacokinetics is a branch of pharmacology dedicated to determining the fate of substances administered to a living organism.

Toxicology is a branch of biology, chemistry, medicine or pharmacology that is concerned with the study of the adverse effects of chemicals on living organisms. Toxins.

Sensitivity and Specificity are statistical measures of the performance of a binary classification test, also known in statistics as a classification function, that are widely used in medicine: Sensitivity (also called the true positive rate, the recall, or probability of detection in some fields) measures the proportion of actual positives that are correctly identified as such (e.g., the percentage of sick people who are correctly identified as having the condition). Specificity (also called the true negative rate) measures the proportion of actual negatives that are correctly identified as such (e.g., the percentage of healthy people who are correctly identified as not having the condition). Note that the terms "positive" and "negative" don't refer to the value of the condition of interest, but to its presence or absence. The condition itself could be a disease, so that "positive" might mean "diseased", while "negative" might mean "healthy".

False Positives and False Negatives is an error in data reporting in which a test result improperly indicates presence of a condition, such as a disease (the result is positive), when in reality it is not present, while a false negative is an error in which a test result improperly indicates no presence of a condition (the result is negative), when in reality it is present.

Deaths from Prescription Drug Over Doses

The CDC said last month that prescription painkillers caused 15,000 U.S. deaths in 2008, more than triple the 4,000 deaths in 1999. Emergency room visits related to Hydrocodone abuse have shot from 19,221 in 2000 to 86,258 in 2009, according to the DEA. In Florida alone, hydrocodone caused 910 deaths and contributed to 1,803 others between 2003 and 2007. The U.S. consumes 99 percent of the world's hydrocodone and 83 percent of its Oxycodone, according to a 2008 study by the International Narcotics Control Board.

The Sackler Family – A Secretive Billion Dollar Opioid Empire (youtube) - False Advertising.

When pharmaceutical prescription dugs become the problem and not the solution, they do more harm then good.

Iatrogenesis is when Doctors prescribe drugs that are an unnecessary treatment just for profit, instead of doing what is right for the patient, causing side effects of possible drug interactions, complications arising from a procedure or treatment, medical error, negligence, unexamined instrument design, anxiety or annoyance in the physician or treatment provider in relation to medical procedures or treatments.

Adverse Event are serious side effects from pharmaceuticals that results in death, illness requiring hospitalization, events deemed life-threatening, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect or medically important condition. Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Drug Overdoses on the Rise - Reducing Addiction Cravings

Drug Overdose describes the ingestion or application of a drug or other substance in quantities greater than are recommended or generally practiced. An overdose may result in a toxic state or death.

Opioid Overdose Help

Naloxone is a medication used to block the effects of opioids, especially in overdose. Naloxone may be combined within the same pill as an opioid to decrease the risk of misuse. When given intravenously, it works within two minutes, and when injected into a muscle, it works within five minutes. The medication may also be used in the nose. The effects of naloxone last about half an hour to an hour. Multiple doses may be required, as the duration of action of most opioids is greater than that of naloxon. Administration to opioid-dependent individuals may cause symptoms of opioid withdrawal, including restlessness, agitation, nausea, vomiting, a fast heart rate, and sweating. To prevent this, small doses every few minutes can be given until the desired effect is reached. In those with previous heart disease or taking medications that negatively affect the heart, further heart problems have occurred. It appears to be safe in pregnancy, after having been given to a limited number of women. Naloxone is a pure opioid antagonist. It works by reversing the depression of the central nervous system and respiratory system caused by opioids. First Aid - 911.

National Center for Biotechnology Information.

About 48,000 women have died from painkiller overdoses between 1999 and 2010, an increase of 400 percent over the period.  In 2010, that amounted to about 18 women every day. For every woman who dies of a prescription painkiller overdose, 30 go to the emergency department for painkiller misuse or abuse. Although men are still more likely to die of prescription painkiller overdoses (more than 10,000 deaths in 2010), the gap between men and women is closing. CDC

Adverse Effects of Medical Treatment resulted in 142,000 deaths in 2013 up from 94,000 deaths in 1990 globally.

Disturbing new research says the number of U.S. babies born with signs of Opiate Drug Withdrawal has tripled in a decade because of a surge in pregnant women's use of legal and illegal narcotics, including Vicodin, OxyContin and Heroin.

The FDA shut down 1,677 illegal Pharmacy Websites in June 2013. - Another Drug War.
So it's OK for legal Pharmacies to Kill?  Maybe Counterfeit Medications are Placebos?
The FBI say's Don't Put Your Health In the Hands of Crooks, but they don't say which crooks?
The National Association of Boards of Pharmacy recently performed an analysis of more than 10,000 websites, and found that 97% did not fully comply with state and federal regulations. - Pharmacy Verification Program.
As of 2006, there were 58,768 Retail Pharmacies throughout the US. and way over 10,000 online pharmacies in the U.S.

Pharming Genetics
Alliance for Human Research Protection
Human Research Protections
Human Research - Human Experimentation
Unethical Human Experimentation in the United States

The time, the people, the resources and the billions of dollars used to make pharmaceutical drugs are just Criminally Negligent and Totally Insane. It just goes to show you how incredibly ignorant people are and how horribly victimized the general public is. People are just Human Guinea Pigs for the greedy. If you were to use that same time, people, resources and money to stop polluting our drinking water and stop poisoning our foods, while at the same time improve education quality and quantity, you would have healthier people and a much healthier planet. Instead you have corrupt and irresponsible corporations making people drug addicts while at the same time polluting the earth, which in turn makes people sicker and even more dependent on drugs. A viscous and ignorant cycle. And these drugs have so many Side Effects that they not only contribute to more Birth Defects, they also create more diseases and more sickness that is actually being alleviated by the drugs themselves. Corporations don’t want to help you, Corporations don’t want to educate you, Corporations don’t even want to protect you, Corporations just want your money no matter whom they kill or whom they injure. Pharmaceutical drugs are an epidemic and a Weapon of Mass Destruction. I’m not saying all drugs are bad, just 90% of them. The most dangerous criminals are not behind bars; they are your Corporate Leaders and the Politicians they own that they Bought with our Money.

Pharmaceutical Drug Errors - Medication Warnings

5 million errors a year tied to wrong medications; some cause injury and death.

Confirm the spelling of the drug because 1,500 drugs have names so similar they’ve been confused with one or more other medications. U.S. outpatient pharmacies filled 3.9 billion 'Legal' prescriptions in 2009. Medical Errors.

Patient Safety Tips - Prescriptions for Profit (deaths and injuries)

A Child Experiences A Medication Error every 8 Minutes. Most of the medication errors involved liquid formulations. Errors were highest among children under the age of 1.

Institute for Safe Medication Practices - Drug Watch

Child-Resistant Packaging is making drug containers hard to open for children to reduce the risk of children ingesting dangerous items. This is often accomplished by the use of a special safety cap and special packaging.

Medical Errors kill around 195,000 Americans each year and costs the health care system as much as $300 billion annually. So please ask about what Safety Guidelines and Procedures that your Hospital and Doctor follows and request a copy of the procedures and guidelines so that you can review them to better understand the decision making and so that you are more aware of your responsibilities and the responsibilities of the Doctor and Hospital. It is extremely important that you know what questions to ask.

Number Needed to Treat (consent)

What really happens when you mix medications? (video and text)

An average of 195,000 people in the USA died due to potentially preventable, in-hospital medical errors in each of the years 2000, 2001 and 2002.

Adverse Events are unintended pharmacologic effects that occur when a medication is administered.

Negligence - Medical Fraud - Consumer Fraud - Marketing Fraud - Food Labels

Adverse Effect is an undesired harmful effect resulting from a medication or other intervention such as surgery.

Side Effect is an effect, whether therapeutic or adverse, that is secondary to the one intended.

Interactions - Overdoses - Too Many Meds - Body Burden - Dosage - Tolerance

Warning Label is a label attached to a product, or contained in a product's instruction manual, warning the user about risks associated with its use, and may include restrictions by the manufacturer or seller on certain uses.

Side Effects from a pharmaceutical drugs and the worst medication side effects of commonly prescribed medications may include: diarrhea, constipation, nausea and vomiting, fever, cancer, life-threatening hospitalizations, death, disability, permanent damage to organs, birth defects, uncontrolled bleeding, decreased appetite, hallucinations or sensing something that is not really present, memory loss, blood clots, stevens-johnson syndrome, low levels of thyroid hormone, severe blisters and peeling skin, blisters around the mouth, red painful palms and feet, pain, pain in muscles, shooting pain, numbness and tingling, loss of smell, cough, shortness of breath, sexual dysfunction, inflammation, a painful permanent erection or priapism, unusual urges for sex and gambling, suicidal thoughts, nightmares, wanting to crawl out of your skin, itching, hives or rashes, compulsive behaviors, nails falling off, dizziness, drowsiness, fatigue or feeling tired, heart issues like palpitations or irregular heartbeats,  heart disease or heart failure.

You should not use a drug that has horrible side effects,
especially if you're a human and have common sense. You should not use a drug if you have other humane treatment options that guarantee healthier outcomes.  

Medical Misdiagnosis - Health Care Statistics - Hospital Connect Search - American Hospital Association - Solicitor Advice

Patient Safety - Health Care Fraud and Abuse

Compliance in medicine describes the degree to which a patient correctly follows medical advice. Most commonly, it refers to medication or drug compliance, but it can also apply to other situations such as medical device use, self care, self-directed exercises, or therapy sessions. Both the patient and the health-care provider affect compliance, and a positive physician-patient relationship is the most important factor in improving compliance, although the high cost of prescription medication also plays a major role.

Consent - Trust - Misinformation Bubble

Can a Doctor prescribe medication without advising the patient first about the medication and how to use it? Do you have the correct prescription for the correct patient? Is the correct dose issued? Are there any changes in doses over time? Did you go through all the steps to ensure safe prescribing. Will there be  appropriate follow-up and monitoring of drug effects and side-effects? Is the patient is being regularly reviewed both in terms of side-effects and with regard to the ongoing need for this medication? Are you satisfied that there is a sufficient evidence base and/or you have experience of using the medicine to demonstrate its safety and efficacy? Did you establish what all the current medical conditions are, current drug history and any over-the-counter drugs? Did you carry out an adequate assessment and identify the likely cause of the condition? Did you ensure that there is enough justification to prescribe and rule out any contra-indications. After a physician decides to treat a patient, the next step is to prescribe a specific medication out of many possible choices. The physicians must determine whether the benefit–harm balance of a medication applies to individual patients, and they often rely on medications they are most familiar with. Safe prescribing issues which need to be considered include: Prescribing within limits of competence. Evidence-based prescribing. Interaction with other drugs. Concordance, tolerability and formulation. Adverse effects. Checking dosages. Using prescribing formularies. Keeping up to date and following clinical guidelines, where available, from the National Institute for Health and Care Excellence (NICE) or Scottish Intercollegiate Guidelines Network (SIGN). Using electronic systems where available that can enhance the safety of prescribing. Responsible delegation of prescribing administration and dispensing.

Thalidomide is a sedative drug discovered at the end of the 50s and available over-the-counter, which caused worldwide deaths and birth defects and caused severe deformities in the children born to mothers who took it. The total number of people affected by use during pregnancy is estimated at 10,000, of which about 40% died around the time of birth.  Those who survived had limb, eye, urinary tract, and heart problems. The drug has been prescribed to many pregnant women in order to relieve pregnancy nausea, which may harm the baby, including resulting in malformation of the limbs. Concerns regarding birth defects were noted in 1961 and the medication was removed from the market in Europe that year. Though the side effects were proven conclusively in 1959 and 1962. But scumbag nazi criminals from Grünenthal continued to sell the drug in other countries and continued marketing the drug as being safe well into the 1970s and '80s, and they never compensated people or paid for the deaths and damages that they caused, even when they made millions of dollars form selling the drug. In males who are taking the medication, condoms are recommended if their partner could become pregnant. Its initial entry into the US market was prevented by Frances Kelsey at the FDA. The birth defects of thalidomide led to the development of greater drug regulation and monitoring in many countries. Kelsey was the second woman to be awarded the President's Award for Distinguished Federal Civilian Service by President John F. Kennedy. The medication is still in use and is used to treat a number of cancers including multiple myeloma, graft-versus-host disease, and a number of skin conditions including complications of leprosy.

Research - Clinical Studies - Random Trials

Evidence-Based Medicine is an approach to medical practice intended to optimize decision-making by emphasizing the use of evidence from well-designed and well-conducted research using quantifiable measurements. Medical Examinations.

Qualitative Research relies on data obtained by the researcher from first-hand observation, interviews, questionnaires on which participants write descriptively, focus groups, participant-observation, recordings made in natural settings, documents, case studies, and artifacts. The data are generally nonnumerical. Qualitative methods include ethnography, grounded theory, discourse analysis, and interpretative phenomenological analysis. Qualitative research methods have been used in sociology, anthropology, political science, psychology, social work, and educational research. Qualitative researchers study individuals' understanding of their social reality.

You should always question research validated programs because people can easily manipulate and misuse data.

Bias in Research - Third Party (unbiased second opining) - DIY Science - Right to Try - Exemptions.

Clinical Research is a branch of healthcare science that determines the safety and effectiveness or efficacy of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment.

Phases of Clinical Research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. For drug development, the clinical phases start with testing for safety in a few human subjects, then expand to many study participants (potentially tens of thousands) to determine if the treatment is effective. Clinical research is conducted on drug candidates, and also on vaccine candidates, new medical devices, and new diagnostic assays.

Clinical Trial are experiments done in clinical research. Statistics.

Clinical Trials Results Database (gov) - Clinical Trials (gov)

Research Gate - Make your Research Visible and Open. - Research Resources.

Pre-Clinical Development is a stage of research that begins before clinical trials or testing in humans can begin, and during which important feasibility, iterative testing and drug safety data are collected and supposed to be shared. The main goals of pre-clinical studies are to determine the safe dose for first-in-man study and assess a product's safety profile. Products may include new medical devices, drugs, gene therapy solutions and diagnostic tools. On average, only one in every 5,000 compounds that enters drug discovery to the stage of preclinical development becomes an approved drug. .

Clinical Study Design is the formulation of trials and experiments, as well as observational studies in medical, clinical and other types of research (e.g., epidemiological) involving human beings. The goal of a clinical study is to assess the safety, efficacy, and / or the mechanism of action of an investigational medicinal product or procedure, or new drug or device that is in development, but potentially not yet approved by a health authority (e.g. Food and Drug Administration). It can also be to investigate a drug, device or procedure that has already been approved but is still in need of further investigation, typically with respect to long-term effects or cost-effectiveness. Some of the considerations here are shared under the more general topic of design of experiments but there can be others, in particular related to patient confidentiality and ethics.

Laboratory Conditions is when the physical environment is specifically controlled or artificially regulated to ensure that conditions remain stable, such as temperature, air quality, humidity and pressure, during an experiment that is conducted, or when a procedure in a laboratory is followed. Controlled Environment or critical environment is an area that must have certain parameters controlled in order to minimize any adverse effects to an experiment that may cause inaccurate readings.

Randomized, Double-Blind, Placebo-Controlled Trial of the efficacy and safety of rilonacept in the treatment of systemic juvenile idiopathic arthritis.

Double-Blind, Randomized, Placebo-Controlled Trial. Objective.

Double-Blind is a test or trial in which any information which may influence the behavior of the tester or the subject is withheld until after the test. If both tester and subject are blinded, the trial is called a double-blind experiment. Life is like a double blind experiment, people don't know what they are giving and people have no idea what they are taking, and no one is telling you the results.

Blind Experiment is an experiment in which information about the test is masked and kept from the participant, to reduce or eliminate bias, until after a trial outcome is known. It is understood that bias may be intentional or unconscious, thus no dishonesty is implied by blinding. Blinded Experiment is when certain information which may influence the participants of the experiment is withheld (masked or blinded) until after the experiment is complete.

Randomized Controlled Trial is a type of scientific or medical experiment which aims to reduce bias when testing a new treatment. The people participating in the trial are randomly allocated to either the group receiving the treatment under investigation or to a group receiving standard treatment or placebo treatment as the control. Randomization minimizes selection bias and the different comparison groups allow the researchers to determine any effects of the treatment when compared with the no treatment (control) group, while other variables are kept constant. The RCT is often considered the gold standard for a clinical trial. RCTs are often used to test the efficacy or effectiveness of various types of medical intervention and may provide information about adverse effects, such as drug reactions. Random assignment of intervention is done after subjects have been assessed for eligibility and recruited, but before the intervention to be studied begins. Cherry Picking People is the same as cheery picking data. Major categories of RCT study designs are: Parallel-group – each participant is randomly assigned to a group, and all the participants in the group receive (or do not receive) an intervention. Crossover – over time, each participant receives (or does not receive) an intervention in a random sequence. Cluster – pre-existing groups of participants (e.g., villages, schools) are randomly selected to receive (or not receive) an intervention. Factorial – each participant is randomly assigned to a group that receives a particular combination of interventions or non-interventions (e.g., group 1 receives vitamin X and vitamin Y, group 2 receives vitamin X and placebo Y, group 3 receives placebo X and vitamin Y, and group 4 receives placebo X and placebo Y). An analysis of the 616 RCTs indexed in PubMed during December 2006 found that 78% were parallel-group trials, 16% were crossover, 2% were split-body, 2% were cluster, and 2% were factorial.

Randomized Experiment are the experiments that allow the greatest reliability and validity of statistical estimates of treatment effects. Randomization-based inference is especially important in experimental design and in survey sampling.

Random Assignment is an experimental technique for assigning human participants or animal subjects to different groups in an experiment (e.g., a treatment group versus a control group) using randomization, such as by a chance procedure (e.g., flipping a coin) or a random number generator. This ensures that each participant or subject has an equal chance of being placed in any group. Random assignment of participants helps to ensure that any differences between and within the groups are not systematic at the outset of the experiment. Thus, any differences between groups recorded at the end of the experiment can be more confidently attributed to the experimental procedures or treatment. Random assignment, blinding, and controlling are key aspects of the design of experiments, because they help ensure that the results are not spurious or deceptive via confounding. This is why randomized controlled trials are vital in clinical research, especially ones that can be double-blinded and placebo-controlled. Mathematically, there are distinctions between randomization, pseudorandomization, and quasirandomization, as well as between random number generators and pseudorandom number generators. How much these differences matter in experiments (such as clinical trials) is a matter of trial design and statistical rigor, which affect evidence grading. Studies done with pseudo- or quasirandomization are usually given nearly the same weight as those with true randomization but are viewed with a bit more caution.

Observational Study draws inferences from a sample to a population where the independent variable is not under the control of the researcher because of ethical concerns or logistical constraints. One common observational study is about the possible effect of a treatment on subjects, where the assignment of subjects into a treated group versus a control group is outside the control of the investigator. This is in contrast with experiments, such as randomized controlled trials, where each subject is randomly assigned to a treated group or a control group. Observations - People Watching.

Cross-Sectional Study involves data collection from a population, or a representative subset, at one specific point in time. Cross-Sectional Study is a type of observational study that analyzes data from a population, or a representative subset, at a specific point in time—that is, cross-sectional data. In medical research, cross-sectional studies differ from case-control studies in that they aim to provide data on the entire population under study, whereas case-control studies typically include only individuals who have developed a specific condition and compare them with a matched sample, often a tiny minority, of the rest of the population. In medical research, social science, and biology, a cross-sectional study is also known as a cross-sectional analysis, transverse study, prevalence study.

Case-Control Study is a type of observational study in which two existing groups differing in outcome are identified and compared on the basis of some supposed causal attribute. Case–control studies are often used to identify factors that may contribute to a medical condition by comparing subjects who have that condition/disease (the "cases") with patients who do not have the condition/disease but are otherwise similar (the "controls"). They require fewer resources but provide less evidence for causal inference than a randomized controlled trial. A case–control study produces only an odds ratio, which is an inferior measure of strength of association compared to relative risk. Case-Control Study was originally developed in epidemiology, in which two existing groups differing in outcome are identified and compared on the basis of some supposed causal attribute.

Crossover Study is a longitudinal study in which subjects receive a sequence of different treatments or exposures. While crossover studies can be observational studies, many important crossover studies are controlled experiments, which are discussed in this article. Crossover designs are common for experiments in many scientific disciplines, for example psychology, pharmaceutical science, and medicine. Randomized, controlled crossover experiments are especially important in health care. In a randomized clinical trial, the subjects are randomly assigned to different arms of the study which receive different treatments. When the trial has a repeated measures design, the same measures are collected multiple times for each subject. A crossover trial has a repeated measures design in which each patient is assigned to a sequence of two or more treatments, of which one may be a standard treatment or a placebo. Nearly all crossover are designed to have "balance", whereby all subjects receive the same number of treatments and participate for the same number of periods. In most crossover trials each subject receives all treatments, in a random order. Statisticians suggest that designs should have four periods, which is more efficient than the two-period design, even if the study must be truncated to three periods. However, the two-period design is often taught in non-statistical textbooks, partly because of its simplicity.

Meta-Analysis is the statistical combination of data from two or more separate studies.

Longitudinal Study is when subjects are followed over time with continuous or repeated monitoring of risk factors or health outcomes, or both. Most longitudinal studies examine associations between exposure to known or suspected causes of disease and subsequent morbidity or mortality. Longitudinal Study is a correlational research study that involves repeated observations of the same variables over long periods of time, often many decades. Longitudinal data, sometimes referred to as panel data, track the same sample at different points in time. The sample can consist of individuals, households, establishments, and so on. In contrast, repeated cross-sectional data, which also provides long-term data, gives the same survey to different samples over time.

Retrospective Cohort Study is a longitudinal cohort study used in medical and psychological research. A cohort of individuals that share a common exposure factor is compared to another group of equivalent individuals not exposed to that factor, to determine the factor's influence on the incidence of a condition such as disease or death. Retrospective cohort studies have existed for approximately as long as prospective cohort studies.

Cohort Study or Panel Study: a particular form of longitudinal study where a group of patients is closely monitored over a span of time.

Ecological Study: an observational study in which at least one variable is measured at the group level.

Case Study is a research method involving an up-close, in-depth, and detailed examination of a subject of study (the case), as well as its related contextual conditions. In public-relations research, three types of case studies are used: Linear, Process-oriented, Grounded. Under the more generalized category of case study exist several subdivisions, each of which is custom selected for use depending upon the goals of the investigator. These types of case study include the following: Illustrative Case Studies. These are primarily descriptive studies. They typically utilize one or two instances of an event to show the existing situation. Illustrative case studies serve primarily to make the unfamiliar familiar and to give readers a common language about the topic in question. Exploratory (or Pilot) Case Studies. These are condensed case studies performed before implementing a large scale investigation. Their basic function is to help identify questions and select types of measurement prior to the main investigation. The primary pitfall of this type of study is that initial findings may seem convincing enough to be released prematurely as conclusions. Cumulative Case Studies. These serve to aggregate information from several sites collected at different times. The idea behind these studies is that the collection of past studies will allow for greater generalization without additional cost or time being expended on new, possibly repetitive studies. Critical Instance Case Studies. These examine one or more sites either for the purpose of examining a situation of unique interest with little to no interest in generalization, or to call into question a highly generalized or universal assertion. This method is useful for answering cause and effect questions.

Artificial Chemist combines AI and Robotics to conduct Autonomous R&D. The Artificial Chemist's brain is an AI program that characterizes the materials being synthesized by the body and uses that data to make autonomous decisions about what the next set of experimental conditions will be. It bases its decisions on what it determines will most efficiently move it toward the best material composition with the desired properties and performance metrics. For example, Artificial Chemist allows "knowledge transfer," meaning that it stores data generated from every request it receives, expediting the process of identifying the next candidate material it is tasked with. In other words, Artificial Chemist gets smarter and faster over time at identifying the right material.

Center for Biotechnology and Interdisciplinary Studies is a research facility at Rensselaer Polytechnic Institute that hopes the new facility will help to encourage collaboration between experts in different fields, allowing them to solve problems that they would be unable to solve alone.

Effectiveness - Risk Benefit Ratio

Drug Efficacy Study Implementation states that all drugs be efficacious as well as safe, was made part of US law. The DESI program was intended to classify all pre-1962 drugs that were already on the market as either effective, ineffective, or needing further study.

Repeatability - Proof of Concept - Drug DevelopmentVaccines - Fast Track

Precautionary Principle is a cautious approach to using new innovations when extensive scientific knowledge on the matter is lacking. It is a broad epistemological, philosophical and legal approach to innovations with potential for causing harm. It emphasizes caution, pausing and review before leaping into new innovations that may prove disastrous. But critics argue that this may be a self-cancelling, unscientific and an obstacle to progress, which is why we need proof, whether the proof is for something or against something, a valid argument must be presented, and not just stated.

Efficacious is something marked by qualities giving the power to produce an intended effect. Producing or capable of producing an intended result or having a striking effect.

Effectiveness is the capability of producing a desired result or the ability to produce desired output. When something is deemed effective, it means it has an intended or expected outcome, or produces a deep, vivid impression.

Comparative Effectiveness Research is the direct comparison of existing health care interventions to determine which work best for which patients and which pose the greatest benefits and harms. The core question of comparative effectiveness research is which treatment works best, for whom, and under what circumstances. Engaging various stakeholders in this process, while difficult, makes research more applicable through providing information that improves patient decision making.

Risk-Benefit Ratio is the ratio of the risk of an action to its potential benefits. Risk–benefit analysis is analysis that seeks to quantify the risk and benefits and hence their ratio. Evaluations of future risk can be: Real future risk, as disclosed by the fully matured future circumstances when they develop. Statistical risk, as determined by currently available data, as measured actuarially for insurance premiums. Projected risk, as analytically based on system models structured from historical studies.
Perceived risk, as intuitively seen by individuals.

Risk Evaluation and Mitigation Strategies is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects. REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. The REMS program was formalized in 2007.

Inverse Benefit Law states that the ratio of benefits to harms among patients taking new drugs tends to vary inversely with how extensively a drug is marketed. A drug effective for a serious disorder is less and less effective as it is promoted for milder cases and for other conditions for which the drug was not approved. Although effectiveness becomes more diluted, the risks of harmful side effects persist, and thus the benefit-harm ratio worsens as a drug is marketed more widely. The inverse benefit law highlights the need for comparative effectiveness research and other reforms to improve evidence-based prescribing.

About 73% of drugs advertised on TV are of ‘low therapeutic value’ — direct-to-consumer advertising is driving demand for expensive treatments, despite the clinical effectiveness of less costly alternatives.

Drug Errors - Interactions - Too Many Drugs

Therapeutic Index or therapeutic ratio is a quantitative measurement of the relative safety of a drug. It is a comparison of the amount of a therapeutic agent that causes the therapeutic effect to the amount that causes toxicity. The related terms therapeutic window or safety window refer to a range of doses optimized between efficacy and toxicity, achieving the greatest therapeutic benefit without resulting in unacceptable side-effects or toxicity.

Federal Food, Drug, and Cosmetic Act is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics.

Emergency Use Authorization is an authority granted to the Food and Drug Administration that authorizes FDA to facilitate availability of an unapproved product, or an unapproved use of an approved product, during a declared state of emergency from one of several agencies or of a "material threat" by the Secretary of Homeland Security.

Biologics License Application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for a license who takes responsibility for compliance with product and establishment standards. Form 356h specifies the requirements for a BLA. This includes: Applicant information, Product/manufacturing information, Pre-clinical studies, Clinical studies and Labeling.

Center for Drug Evaluation and Research is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also legally considered drugs, but they are covered by the Center for Biologics Evaluation and Research. The center reviews applications for brand name, generic, and over the counter pharmaceuticals, manages US current Good Manufacturing Practice (cGMP) regulations for pharmaceutical manufacturing, determines which medications require a medical prescription, monitors advertising of approved medications, and collects and analyzes safety data about pharmaceuticals that are already on the market.

Center for Biologics Evaluation and Research
is responsible for assuring the safety, purity, potency, and effectiveness of biologics and related products (such as vaccines, live biotherapeutics (probiotics), blood products, and cell, tissue, and gene therapies). Not all biologics are regulated by CBER. Monoclonal antibodies and other therapeutic proteins are regulated by the FDA Center for Drug Evaluation and Research (CDER).

Cost-Effectiveness Analysis is a form of economic analysis that compares the relative costs and outcomes or effects of different courses of action. Cost-effectiveness analysis is distinct from cost–benefit analysis, which assigns a monetary value to the measure of effect. Cost-effectiveness analysis is often used in the field of health services, where it may be inappropriate to monetize health effect.

Cost-Benefit Analysis is a systematic approach to estimating the strengths and weaknesses of alternatives used to determine options which provide the best approach to achieving benefits while preserving savings (for example, in transactions, activities, and functional business requirements).

Body Burden - Toxicity

Sensitivity Analysis analysis determines how different values of an independent variable affect a particular dependent variable under a given set of assumptions. In other words, sensitivity analyses study how various sources of uncertainty in a mathematical model contribute to the model's overall uncertainty. Sensitivity analysis is the study of how the uncertainty in the output of a mathematical model or system (numerical or otherwise) can be divided and allocated to different sources of uncertainty in its inputs. A related practice is uncertainty analysis, which has a greater focus on uncertainty quantification and propagation of uncertainty; ideally, uncertainty and sensitivity analysis should be run in tandem. The process of recalculating outcomes under alternative assumptions to determine the impact of a variable under sensitivity analysis can be useful for a range of purposes, including: Testing the robustness of the results of a model or system in the presence of uncertainty. Increased understanding of the relationships between input and output variables in a system or model. Uncertainty reduction, through the identification of model input that cause significant uncertainty in the output and should therefore be the focus of attention in order to increase robustness (perhaps by further research). Searching for errors in the model (by encountering unexpected relationships between inputs and outputs). Model simplification – fixing model input that has no effect on the output, or identifying and removing redundant parts of the model structure. Enhancing communication from modelers to decision makers (e.g. by making recommendations more credible, understandable, compelling or persuasive). Finding regions in the space of input factors for which the model output is either maximum or minimum or meets some optimum criterion (see optimization and Monte Carlo filtering). In case of calibrating models with large number of parameters, a primary sensitivity test can ease the calibration stage by focusing on the sensitive parameters. Not knowing the sensitivity of parameters can result in time being uselessly spent on non-sensitive ones. To seek to identify important connections between observations, model inputs, and predictions or forecasts, leading to the development of better models.

Using machine learning to improve the toxicity assessment of chemicals. Researchers have developed a strategy for assessing the toxicity of chemicals using machine learning. The models developed in this study can lead to substantial improvements when compared to conventional 'in silico' assessments based on Quantitative Structure-Activity Relationship modelling. The importance of the latter is illustrated by the fact that European and US chemical agencies have listed approximately 800,000 chemicals that have been developed over the years but for which there is little to no knowledge about environmental fate or toxicity.

Regression Analysis is a set of statistical processes for estimating the relationships between a dependent variable (often called the 'outcome' or 'response' variable, or a 'label' in machine learning parlance) and one or more independent variables (often called 'predictors', 'covariates', 'explanatory variables' or 'features'). The most common form of regression analysis is linear regression, in which one finds the line (or a more complex linear combination) that most closely fits the data according to a specific mathematical criterion.

Predictive Power is the power of a scientific theory to generate testable predictions, differs from explanatory power and descriptive power (where phenomena that are already known are retrospectively explained or described by a given theory) in that it allows a prospective test of theoretical understanding.

Human Experimentation

Unethical Human Experimentation is human experimentation that violates the principles of medical ethics. Such practices have included denying patients the right to informed consent, using pseudoscientific frameworks such as race science, and torturing people under the guise of research.

Unethical Human Experimentation in the United States describes numerous experiments performed on human test subjects in the United States that have been considered unethical, and were often performed illegally, without the knowledge, consent, or informed consent of the test subjects.

Human Guinea Pigs - Fast Tract - Opioid Deaths

Human experimenting never ends. Experimentation on the bodies and on the minds of vulnerable people are still happening.

Human Subject Research is systematic, scientific investigation that can be either interventional (a "trial") or observational (no "test article") and involves human beings as research subjects. Human subject research can be either medical (clinical) research or non-medical (e.g., social science) research. Systematic investigation incorporates both the collection and analysis of data in order to answer a specific question. Medical human subject research often involves analysis of biological specimens, epidemiological and behavioral studies and medical chart review studies. (A specific, and especially heavily regulated, type of medical human subject research is the "clinical trial", in which drugs, vaccines and medical devices are evaluated.) On the other hand, human subject research in the social sciences often involves surveys which consist of questions to a particular group of people. Survey methodology includes questionnaires, interviews, and focus groups. Human subject research is used in various fields, including research into basic biology, clinical medicine, nursing, psychology, sociology, political science, and anthropology. As research has become formalized, the academic community has developed formal definitions of "human subject research", largely in response to abuses of human subjects. Guinea Pigs.

Research Match search's for healthy research volunteers. Gain of Function Research: Background and Alternatives.

Independent Third Party Testing

Independent Test Organization is an organization, person, or company that tests products, materials, software, etc. according to agreed requirements. The test organization can be affiliated with the government or universities or can be an independent testing laboratory. They are independent because they are not affiliated with the producer nor the user of the item being tested: no commercial bias is present. These "contract testing" facilities are sometimes called "third party" testing or evaluation facilities. Independent testing might have a variety of purposes, such as: Determine if, or verify that, the requirements of a specification, regulation, or contract are met. Decide if a new product development program is on track. Demonstrate proof of concept. Provide standard data for other scientific, engineering, and quality assurance functions. Validate suitability for end-use. Provide a basis for technical communication. Provide a technical means of comparison of several options. Provide evidence in legal proceedings: forensics, product liability, patents, product claims, etc. Help solve problems with current products or services. Help identify potential cost savings in products or services. Corruption - Evidence - Bias.

Third-Party Certification means that an independent organization has reviewed the manufacturing process of a product and has independently determined that the final product complies with specific Standards for Safety, Quality or performance. This review typically includes comprehensive formulation/material reviews, testing and facility inspections. Most certified products bear the certifier’s mark on their packaging to help consumers and other buyers make educated purchasing decisions.

Third-Party Inspection Company must not be involved in any activities other than inspection and testing. Based on this requirement the third party inspection agency must not be involved in design, procurement, fabrication, construction and installation. All companies and parties such as buyers, sellers, engineering companies, plant owners must have access to these agencies and use their services. The confidentiality, independence, impartiality and integrity are important conditions for being a Third Party Inspection Company. Peer Review - Fact Checking - Watchdogs.

Third-Party is someone other than the principals who are involved in a transaction. Intermediary - Impartial (Independent).

U.S. Conformity Assessment System: 3rd Party Conformity Assessment

Replication Study involves repeating a study using the same methods but with different subjects and experimenters.

Replication Crisis refers to a methodological crisis in science in which scientists have found that the results of many scientific experiments are difficult or impossible to replicate on subsequent investigation, either by independent researchers or by the original researchers themselves. While the crisis has long-standing roots, the phrase was coined in the early 2010s as part of a growing awareness of the problem. 70% of them failed to reproduce another scientist's experiments (50% failed to reproduce their own experiment).

Lab Testing (lab tests) - Analytical Chemistry

Scientific Control is an experiment or observation designed to minimize the effects of Variables other than the independent variable. This increases the reliability of the results, often through a comparison between control measurements and the other measurements. Scientific controls are a part of the scientific method.

Treatment and Control Groups. In the design of experiments, treatments are applied to experimental units in the treatment group(s). In comparative experiments, members of the complementary group, the control group, receive either no treatment or a standard treatment. For the conclusions drawn from the results of an experiment to have validity, it is essential that the items or patients assigned to treatment and control groups be representative of the same population. In some experiments, such as many in agriculture or psychology, this can be achieved by randomly assigning items from a common population to one of the treatment and control groups. In studies of twins involving just one treatment group and a control group, it is statistically efficient to do this random assignment separately for each pair of twins, so that one is in the treatment group and one in the control group. In some medical studies, where it may be unethical not to treat patients who present with symptoms, controls may be given a standard treatment, rather than no treatment at all. Another alternative is to select controls from a wider population, provided that this population is well-defined and that those presenting with symptoms at the clinic are representative of those in the wider population.

Data & Safety Monitoring Plans - Guidance for Developing a Data and Safety Monitoring Plan for Clinical Trials Sponsored by NIMH.

European Medicines Agency is an agency of the European Union in charge of the evaluation and supervision of medicinal products and approval vaccine's in the EU.

Propensity Score Matching is a statistical matching technique that attempts to estimate the effect of a treatment, policy, or other intervention by accounting for the covariates that predict receiving the treatment. PSM attempts to reduce the bias due to confounding Variables that could be found in an estimate of the treatment effect obtained from simply comparing outcomes among units that received the treatment versus those that did not.

Number Needed to Treat (vaccines)

Drug Discovery is the process by which new candidate medications are discovered. Modern drug discovery involves the identification of screening hits, medicinal chemistry and optimization of those hits to increase the affinity, selectivity (to reduce the potential of side effects), efficacy/potency, metabolic stability (to increase the half-life), and oral bioavailability. Once a compound that fulfills all of these requirements has been identified, it will begin the process of drug development prior to clinical trials. One or more of these steps may, but not necessarily, involve computer-aided drug design. In the past Drugs were discovered through identifying the active ingredient from traditional remedies or by serendipitous discovery. Later chemical libraries of synthetic small molecules, natural products or extracts were screened in intact cells or whole organisms to identify substances that have a desirable therapeutic effect in a process known as classical pharmacology. Since sequencing of the human genome which allowed rapid cloning and synthesis of large quantities of purified proteins, it has become common practice to use high throughput screening of large compounds libraries against isolated biological targets which are hypothesized to be disease modifying in a process known as reverse pharmacology. Hits from these screens are then tested in cells and then in animals for efficacy.

Busting the billion-dollar myth: how to slash the cost of drug development

Virtual Screening is a computational technique used in drug discovery to search libraries of small molecules in order to identify those structures which are most likely to bind to a drug target, typically a protein receptor or enzyme.

Chemists harness Artificial Intelligence to predict the future of Chemical Reactions. Using machine learning to predict multi-dimensional reaction yields. Chemistry.

Lost to follow-up refers to patients who at one point in time were actively participating in a clinical research trial, but have become lost (either by error in a computer tracking system or by being unreachable) at the point of follow-up in the trial. These patients can become lost for many reasons. Without properly informing the investigator associated with the clinical trial, they may have opted to withdraw from the clinical trial, moved away from the particular study site during the clinical trial, or become ill and unable to communicate or are deceased. (Follow Up Study).

Off-Label Use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs. Off-label use is generally legal unless it violates ethical guidelines or safety regulations. The ability to prescribe drugs for uses beyond the officially approved indications is commonly used to good effect by healthcare providers. For example, methotrexate is commonly used off-label because its immunomodulatory effects relieve various disorders. However, off-label use can entail health risks and differences in legal liability. Marketing of pharmaceuticals for off-label use is usually prohibited.

User-Fee Programs for Prescription Drugs (pdf)

Expanded Access, also known as compassionate use, refers to the use of an investigational new drug (IND) outside of a clinical trial by patients with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress.

Compassionate Use (FDA)

Experts? What is a Professional? What is Competence?

Clinical Research Associate is a health-care professional who performs many activities related to medical research, particularly clinical trials. Clinical research associates work in various settings, such as pharmaceutical companies, medical research institutes and government agencies. Depending on the jurisdiction, different education and certification requirements may be necessary to practice as a clinical research associate. The main tasks of the CRA are defined by good clinical practice guidelines for monitoring clinical trials, such as those elaborated by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

Peer Review - Problem Solving

"Peer reviews are only as good as the peers. Peers have to be intelligent and free from bias in order for the feedback to work and to be accurate and effective." Even Rating Systems can be corrupted.

Systematic Review is a type of literature review that collects and critically analyzes multiple research studies or papers. A review of existing studies is often quicker and cheaper than embarking on a new study. Researchers use methods that are selected before one or more research questions are formulated, and then they aim to find and analyze studies that relate to and answer those questions. Systematic reviews of randomized controlled trials are key in the practice of evidence-based medicine.

Science Collaboration

"It seems that society is a control group for some crazy experiment"

United States Pharmacopeia is a pharmacopeia (compendium of drug information) for the United States published annually by the United States Pharmacopeial Convention (usually also called the USP), a nonprofit organization that owns the trademark and copyright. The USP is published in a combined volume with the National Formulary (a formulary) as the USP-NF. If a drug ingredient or drug product has an applicable USP quality standard (in the form of a USP-NF monograph), it must conform in order to use the designation "USP" or "NF." Drugs subject to USP standards include both human drugs (prescription, over-the-counter, or otherwise), as well as animal drugs. USP-NF standards also have a role in U.S. federal law; a drug or drug ingredient with a name recognized in USP-NF is deemed adulterated if it does not satisfy compendial standards for strength, quality or purity. USP also sets standards for dietary supplements, and food ingredients (as part of the Food Chemicals Codex). USP has no role in enforcing its standards; enforcement is the responsibility of FDA and other government authorities in the U.S. and elsewhere.

Epidemiology - Pathophysiology (diseases)

In-vitro Chip-Based Human Investigational Platform simulates the central nervous system by recording neural activity from multiple brain cell types deposited and grown onto microelectrode arrays. The device could be used to test and predict the effects of biological and chemical agents, disease, or pharmaceutical drugs on the brain over time without the need for human or animal subjects.

When someone says "most people or some people" they are not stating any facts or explaining anything. Everything or everyone could mean 100 percent of a population. But most or some is not a percentage. Many questions must be answered in order to accurately understand how the data was collected and calculated.

Flaws in Research - Bias in Research

Publication Bias is a type of bias occurring in published academic research. It occurs when the outcome of an experiment or research study influences the decision whether to publish or otherwise distribute it. Publication bias is of interest because literature reviews of claims about support for a hypothesis or values for a parameter will themselves be biased if the original literature is contaminated by publication bias, or from the fact that some research is funded or run by the same people who will profit from the so called research.

Fraud - Scam - Manipulation - False Advertising (pseudoscience) - Sensationalizing - Rules of Evidence - Misleading - Risk Underreporting - Odds Not Expressed Accurately - False Pretenses - Precautionary Principle - Negligence.

How Oil and Gas Funding Distorts Energy Research - Favourability towards natural gas relates to funding source of university energy centres.

Plagiarism - Ghost Writing - Correlation Confusion - People are Not Counting the Things That Matter - The End does Not Justify the Means - Waste Law.

Funding Bias refers to the tendency of a scientific study to support the interests of the study's financial sponsor. This phenomenon is recognized sufficiently that researchers undertake studies to examine bias in past published studies. Funding bias has been associated, in particular, with research into chemical toxicity, tobacco, and pharmaceutical drugs. It is an instance of experimenter's bias. Some Private Companies Fund Public-University Research. People Don’t Trust Scientific Research when they know that the same companies who make the product are Involved in the research, like when a soda company sponsors nutrition research, or when an oil conglomerate helps fund climate-related research. Bias in Research Studies.

Manufacturer-Funded Research Compromises Patient Care. Industry sponsorship and research outcome concluded that studies sponsored by a drug or device company lead to “more favorable results and conclusions” about the products studied than independently sponsored ones. Studies authored by groups with conflicts of interest are significantly associated with reporting lower surgical complications and therefore describing positive research findings.

Third Party Research - Reproducibility - Peer Review - Evidence Based Medicine.

Selection Bias is the selection of individuals, groups or data for analysis in such a way that proper randomization is not achieved, thereby ensuring that the sample obtained is not representative of the population intended to be analyzed. It is sometimes referred to as the selection effect. The phrase "selection bias" most often refers to the distortion of a statistical analysis, resulting from the method of collecting samples. If the selection bias is not taken into account, then some conclusions of the study may not be accurate.

Profiling - Survey Errors - Nothing to Hide - Loaded Language

Imputation in statistics is the process of replacing missing data with substituted values.

Misleading Graph or distorted graph is a graph that misrepresents data, constituting a misuse of statistics and with the result that an incorrect conclusion may be derived from it. Graphs may be misleading by being excessively complex or poorly constructed. Even when constructed to display the characteristics of their data accurately, graphs can be subject to different interpretations, or unintended kinds of data can seemingly and ultimately erroneously be derived. Misleading graphs may be created intentionally to hinder the proper interpretation of data or accidentally due to unfamiliarity with graphing software, misinterpretation of data, or because data cannot be accurately conveyed. Misleading graphs are often used in false advertising. One of the first authors to write about misleading graphs was Darrell Huff, publisher of the 1954 book How to Lie with Statistics. The field of data visualization describes ways to present information that avoids creating misleading graphs.

Attrition Bias is a kind of selection bias caused by attrition or loss of participants, discounting trial subjects/tests that did not run to completion. It is closely related to the survivorship bias, where only the subjects that "survived" a process are included in the analysis or the failure bias, where only the subjects that "failed" a process are included. It includes dropout, nonresponse (lower response rate), withdrawal and protocol deviators. It gives biased results where it is unequal in regard to exposure and/or outcome. For example, in a test of a dieting program, the researcher may simply reject everyone who drops out of the trial, but most of those who drop out are those for whom it was not working. Different loss of subjects in intervention and comparison group may change the characteristics of these groups and outcomes irrespective of the studied intervention. Attrition in epidemiology are ratios regarding the loss of participants during an experiment. Attrition rates are values that indicate the participant drop out. Higher attrition rates are found in longitudinal studies.

Cherry Picking is the act of pointing to single individual cases or data that seem to confirm a particular position while ignoring a significant portion of related cases or data that may contradict that position. It is a kind of fallacy of selective attention, the most common example of which is the confirmation bias. Cherry picking may be committed intentionally or unintentionally. Cherry picking is a type of Statistical Hijinks where someone is Dressing up the Facts in order to deceive people or to manipulate people.

Sponsored Content - Invalid Arguments - Information Bubble - Quoting out of Context - Propaganda

Data Dredging is also called data fishing and p-hacking, is the misuse of data analysis to find patterns in data that can be presented as statistically significant when in fact there is no real underlying effect. This is done by performing many statistical tests on the data and only paying attention to those that come back with significant results, instead of stating a single hypothesis about an underlying effect before the analysis and then conducting a single test for it. The process of data dredging involves automatically testing huge numbers of hypotheses about a single data set by exhaustively searching—perhaps for combinations of variables that might show a correlation, and perhaps for groups of cases or observations that show differences in their mean or in their breakdown by some other variable. Conventional tests of statistical significance are based on the probability that a particular result would arise if chance alone were at work, and necessarily accept some risk of mistaken conclusions of a certain type (mistaken rejections of the null hypothesis). This level of risk is called the significance. When large numbers of tests are performed, some produce false results of this type, hence 5% of randomly chosen hypotheses turn out to be significant at the 5% level, 1% turn out to be significant at the 1% significance level, and so on, by chance alone. When enough hypotheses are tested, it is virtually certain that some will be statistically significant but misleading, since almost every data set with any degree of randomness is likely to contain (for example) some spurious correlations. If they are not cautious, researchers using data mining techniques can be easily misled by these results. The multiple comparisons hazard is common in data dredging. Moreover, subgroups are sometimes explored without alerting the reader to the number of questions at issue, which can lead to misinformed conclusions. How were those numbers derived? Gerrymandering.

Fabrication in science is the intentional misrepresentation of research test results by making up data, such as that reported in a journal article. As with other forms of scientific misconduct, it is the intent to deceive that marks fabrication as highly unethical and different from scientists deceiving themselves. In some jurisdictions, fabrication may be illegal. Examples of activities that constitute fabrication include: Outright synthesis of experimental data; reporting experiments that were never conducted. Sometimes referred to as "drylabbing". "Fudging", "massaging", or outright manufacture of experimental data. Some forms of unintentional academic incompetence or malpractice can be difficult to distinguish from intentional fabrication. Examples of this include the failure to account for measurement error, or the failure to adequately control experiments for any parameters being measured. Fabrication can also occur in the context of undergraduate or graduate studies wherein a student fabricates a laboratory or homework assignment. Such cheating, when discovered, is usually handled within the institution, and does not become a scandal within the larger academic community (as cheating by students seldom has any academic significance).

Plagiarism - Standards - Fallacies - Junk Science - How to Fix a Drug Scandal (wiki)

Dry Labbing is a practice whereby research or analysis is claimed to be done, but in reality the conclusions are guessed at or copied from other sources without actually doing any analysis. The act of supplying fictional yet plausible results in lieu of performing an assigned experiment. Dry Lab is a laboratory where the nature of the experiments does not involve significant risk. This is in contrast to a wet lab where it is necessary to handle various types of chemicals and biological hazards. Wet chemistry is also called bench chemistry since many tests are performed at lab benches.

Forensics - Planted Evidence - Drug War

Scientific Misconduct is the violation of the standard codes of scholarly conduct and ethical behavior in the publication of professional scientific research.

False Precision occurs when numerical data are presented in a manner that implies better precision than is justified; (also called overprecision, fake precision, misplaced precision and spurious precision).

Missing Data can occur when no data value is stored for the variable in an observation. Missing data are a common occurrence and can have a significant effect on the conclusions that can be drawn from the data. Missing data can occur because of nonresponse: no information is provided for one or more items or for a whole unit ("subject"). Some items are more likely to generate a nonresponse than others: for example items about private subjects such as income. Attrition is a type of missingness that can occur in longitudinal studies—for instance studying development where a measurement is repeated after a certain period of time. Missingness occurs when participants drop out before the test ends and one or more measurements are missing.

Data Credibility is the extent to which the good faith of a provider of data or source of data can be relied upon to ensure that the data really represents is what the data is supposed to represent, and that there is no intent to misrepresent what the data is supposed to represent.

Outlier in statistics is a data point that differs significantly from other observations. An outlier may be due to variability in the measurement or it may indicate experimental error; the latter are sometimes excluded from the data set. An outlier can cause serious problems in statistical analyses. Outliers can occur by chance in any distribution, but they often indicate either measurement error or that the population has a heavy-tailed distribution. In the former case one wishes to discard them or use statistics that are robust to outliers, while in the latter case they indicate that the distribution has high skewness and that one should be very cautious in using tools or intuitions that assume a normal distribution. A frequent cause of outliers is a mixture of two distributions, which may be two distinct sub-populations, or may indicate 'correct trial' versus 'measurement error'; this is modeled by a mixture model. In most larger samplings of data, some data points will be further away from the sample mean than what is deemed reasonable. This can be due to incidental systematic error or flaws in the theory that generated an assumed family of probability distributions, or it may be that some observations are far from the center of the data. Outlier points can therefore indicate faulty data, erroneous procedures, or areas where a certain theory might not be valid. However, in large samples, a small number of outliers is to be expected (and not due to any anomalous condition). Outliers, being the most extreme observations, may include the sample maximum or sample minimum, or both, depending on whether they are extremely high or low. However, the sample maximum and minimum are not always outliers because they may not be unusually far from other observations. Naive interpretation of statistics derived from data sets that include outliers may be misleading. For example, if one is calculating the average temperature of 10 objects in a room, and nine of them are between 20 and 25 degrees Celsius, but an oven is at 175 °C, the median of the data will be between 20 and 25 °C but the mean temperature will be between 35.5 and 40 °C. In this case, the median better reflects the temperature of a randomly sampled object (but not the temperature in the room) than the mean; naively interpreting the mean as "a typical sample", equivalent to the median, is incorrect. As illustrated in this case, outliers may indicate data points that belong to a different population than the rest of the sample set. Estimators capable of coping with outliers are said to be robust: the median is a robust statistic of central tendency, while the mean is not. However, the mean is generally a more precise estimator.

Precision Bias is a form of cognitive bias in which an evaluator of information commits a logical fallacy as the result of confusing accuracy and precision.

Lead Time Bias is the length of time between the detection of a disease (usually based on new, experimental criteria) and its usual clinical presentation and diagnosis (based on traditional criteria). It is the time between early diagnosis with screening and the time in which diagnosis would have been made without screening. It is an important factor when evaluating the effectiveness of a specific test. 

Length Time Bias is an overestimation of survival duration due to the relative excess of cases detected that are asymptomatically slowly progressing, while fast progressing cases are detected after giving symptoms. It is a form of selection bias, a statistical distortion of results that can lead to incorrect conclusions about factual data. While the raw data of a study may itself be objective and independent, statistical analysis requires parametric inputs of frequency and length of time, which is some arbitrary choice of design originating in the statistician and not the data. If points are chosen randomly in an attempt to prevent observer selection bias, this choice of method itself amounts to a grand bias, because longer or more complex intervals increase possibilities for false detection of significance. Length time bias is often discussed in the context of the benefits of cancer screening, and it can lead to the perception that screening leads to better outcomes when in reality it has no effect. Fast-growing tumors generally have a shorter asymptomatic phase than slower-growing tumors. Thus, there is a shorter period of time during which the cancer is present in the body (and so might be detected by screening) but not yet large enough to cause symptoms, that would cause the patient to seek medical care and be diagnosed without screening. As a result, if the same number of slow-growing and fast-growing tumors appear in a year, the screening test detects more slow-growers than fast-growers. If the slow growing tumors are less likely to be fatal than the fast growers, the people whose cancer is detected by screening do better, on average, than the people whose tumors are detected from symptoms (or at autopsy) even if there is no real benefit to catching the cancer earlier. That can give the impression that detecting cancers by screening causes cancers to be less dangerous even if less dangerous cancers are simply more likely to be detected by screening. Analyze.

Confirmation Bias is the tendency to search for, interpret, favor, and recall information in a way that confirms or supports one's prior beliefs or values. It is an important type of cognitive bias that has a significant effect on the proper functioning of society by distorting evidence-based decision-making. People display this bias when they gather or remember information selectively, or when they interpret it in a biased way. For example, a person may cherry-pick empirical data that supports one's belief, ignoring the remainder of the data that is not supportive. People also tend to interpret ambiguous evidence as supporting their existing position. The effect is strongest for desired outcomes, for emotionally charged issues, and for deeply entrenched beliefs. False Consensus.

Censoring in statistics is a condition in which the value of a measurement or observation is only partially known.

Sampling Bias is a bias in which a sample is collected in such a way that some members of the intended population have a lower or higher sampling probability than others. It results in a biased sample, a non-random sample of a population (or non-human factors) in which all individuals, or instances, were not equally likely to have been selected. If this is not accounted for, results can be erroneously attributed to the phenomenon under study rather than to the method of sampling. Medical sources sometimes refer to sampling bias as ascertainment bias. Ascertainment bias has basically the same definition, but is still sometimes classified as a separate type of bias.

Sampling Error is incurred when the statistical characteristics of a population are estimated from a subset, or sample, of that population. Since the sample does not include all members of the population, statistics of the sample (often known as estimators), such as means and quartiles, generally differ from the statistics of the entire population (known as parameters). The difference between the sample statistic and population parameter is considered the sampling error. For example, if one measures the height of a thousand individuals from a population of one million, the average height of the thousand is typically not the same as the average height of all one million people in the country. Since sampling is almost always done to estimate population parameters that are unknown, by definition exact measurement of the sampling errors will not be possible; however they can often be estimated, either by general methods such as bootstrapping, or by specific methods incorporating some assumptions (or guesses) regarding the true population distribution and parameters thereof.

Reporting Bias is defined as selective revealing or suppression of information by subjects, for example about past medical history, smoking, sexual experiences. In artificial intelligence research, the term reporting bias is used to refer to people's tendency to under-report all the information available. In empirical research, authors may be under-reporting unexpected or undesirable experimental results, attributing the results to sampling or measurement error, while being more trusting of expected or desirable results, though these may be subject to the same sources of error. In this context, reporting bias can eventually lead to a status quo where multiple investigators discover and discard the same results, and later experimenters justify their own reporting bias by observing that previous experimenters reported different results. Thus, each incident of reporting bias can make future incidents more likely.

Recall Bias is a systematic error caused by differences in the accuracy or completeness of the recollections retrieved ("recalled") by study participants regarding events or experiences from the past. Sometimes also referred to as response bias, responder bias or reporting bias, this type of measurement bias can be a methodological issue in research involving interviews or questionnaires, in which case it could lead to misclassification of various types of exposure. Recall bias is of particular concern in retrospective studies that use a case-control design to investigate the etiology of a disease or psychiatric condition. For example, in studies of risk factors for breast cancer, women who have had the disease may search their memories more thoroughly than members of the unaffected control group for possible causes of their cancer. Those in the case group (those with breast cancer) may be able to recall a greater number of potential risk factors they had been exposed to than those in the control group (women unaffected by breast cancer). This can potentially exaggerate the relation between a potential risk factor and the disease. To minimize recall bias, some clinical trials have adopted a "wash out period", i.e., a substantial time period that must elapse between the subject's first observation and their subsequent observation of the same event.

Junk Science is using invalid scientific evidence, research, or analysis that cannot be justified or understood from the standpoint of the current state of credible scientific or medical knowledge. A type of fraud driven by political, ideological, financial, or otherwise unscientific motives. Pseudoscience consists of statements, beliefs, or practices that are claimed to be both scientific and factual, but are incompatible with the scientific method.

Transition Words - Click Bait - Triggers

Pseudoscience describe a claim, belief, or practice presented as scientific, but which does not adhere to the scientific method.

Pseudoscientific - Time Cube

Scientific Misconceptions are commonly held scientific beliefs that have no basis in actual scientific fact. Scientific misconceptions can also refer to preconceived notions based on religious and/or cultural influences. Many scientific misconceptions occur because of faulty teaching styles and the sometimes distancing nature of true scientific texts.

Statistical Significance is when something is very unlikely to have occurred given the null hypothesis, which states that there is no relationship between two measured phenomena, or no association among groups.

Statistics, graphs, percentages and odds can be misrepresented, which can manipulate a persons ability to accurately understand the information. You need to see the actual numbers, and know exactly how those numbers were collected and recorded. And then you have to know how relevant those numbers are when compared to other facts that might be more important. You should never focus on one detail when there are more details to consider. Past Court Rulings. 1 in 100 or 1 in 1,000 does not tell you how many people have been injured or killed by a product. When someone says that something is statistically impossible, that does not mean that something is impossible.

Derived is to obtain something from a specified source. To infer or deduce a conclusion by reasoning.

Retraction is taking back of a previous assertion that was made in error. Retract is to withdraw a statement or accusation because it was untrue or unjustified. To take back what you said and correcting yourself after you realized that you spoke in error.

Retraction Watch is a blog that reports on retractions of scientific papers and on related topics. Retraction Watch.

Retractions in Academic Publishing is writing that is considered invalid as a source of knowledge.

Scientific Studies: Last Week Tonight with John Oliver (HBO, May 8, 2016)

Observation Flaws (people) - Physics

Intention-To-Treat Analysis of the results of an experiment is based on the initial treatment assignment and not on the treatment eventually received. ITT analysis is intended to avoid various misleading artifacts that can arise in intervention research such as non-random attrition of participants from the study or crossover. ITT is also simpler than other forms of study design and analysis, because it does not require observation of compliance status for units assigned to different treatments or incorporation of compliance into the analysis. Although ITT analysis is widely employed in published clinical trials, it can be incorrectly described and there are some issues with its application. Furthermore, there is no consensus on how to carry out an ITT analysis in the presence of missing outcome data.

Correlation does not Imply Causation or Association does not prove causation. Many statistical tests calculate correlations between variables and when two variables are found to be correlated, it is tempting to assume that this shows that one variable causes the other. That "correlation proves causation," is considered a questionable cause logical fallacy when two events occurring together are taken to have established a cause-and-effect relationship. This fallacy is also known as cum hoc ergo propter hoc, Latin for "with this, therefore because of this," and "false cause." A similar fallacy, that an event that followed another was necessarily a consequence of the first event, is the post hoc ergo propter hoc (Latin for "after this, therefore because of this.") fallacy.

Correlation and Dependence is any statistical relationship, whether causal or not, between two random variables or bivariate data. Correlation is any of a broad class of statistical relationships involving dependence, though in common usage it most often refers to how close two variables are to having a linear relationship with each other. Familiar examples of dependent phenomena include the correlation between the physical statures of parents and their offspring, and the correlation between the demand for a limited supply product and its price.

Predatory Open-Access Publishing is an exploitative open-access academic publishing business model that involves charging publication fees to authors without providing the editorial and publishing services associated with legitimate journals (open access or not). The idea that they are "predatory" is based on the view that academics are tricked into publishing with them, though some authors may be aware that the journal is poor quality or even fraudulent. New scholars from developing countries are said to be especially at risk of being misled by predatory practices.

But even with the research, there is still a lot of corruption in the drug industry because of falsified research. More than two-thirds of biomedical papers Retracted over the past four decades were the result of misconduct, not error. More than 67 percent had to be retracted because of fraud, suspected fraud, fudged data, fraudulent studies, lying and duplicate publication or plagiarism.

Scott Hensley - Retraction (editing)

Significant Scientific Agreement? (FDA)

Second Opinion: Laetrile At Sloan-Kettering - by Eric Merola - Watch now free (vimeo) - Second Opinion Film.

Assumptions (jumping to conclusions) - Validity

"It's sad knowing that criminals have manipulated research just for the money, which has caused the premature death of thousands of people, people who can have been saved if they had access to valuable information and knowledge, instead it was covered up and buried."

Patents (copyrights)

No evidence of added benefit for most new drugs entering German healthcare system. International drug development processes and policies are responsible and must be reformed. Between 2011 and 2017, IQWiG assessed 216 drugs entering the German market following regulatory approval, they explain. Almost all of these drugs were approved by the European Medicines Agency for use throughout Europe. Yet only 54 (25%) were judged to have a considerable or major added benefit. In 35 (16%), the added benefit was either minor or could not be quantified. And for 125 drugs (58%), the available evidence did not prove an added benefit over standard care in the approved patient population. The situation is particularly shocking in some specialties, they add. For example, in psychiatry/neurology and diabetes, added benefit was shown in just 6% (1/18) and 17% (4/24) of assessments, respectively.

Quack Watch - Media Literacy - Skepticism (questioning)

The National Council Against Health Fraud

When you hear people saying, "The Evidence Proves", or, "There Is No Evidence", or, "The Research Shows", these people are either lying or they are withholding key information and knowledge that keeps you from fully understanding the problem. So you have to ask, "What Evidence?" Where is this Evidence? What research? Show Me! How was this Research Performed? Who produced the Research? Most research creates more questions then it actually answers, or worse, it doesn't really apply to your particular problem. When you hear someone say "There's No Evidence", what they are actually saying is "I do not have enough information or knowledge to accurately understand this problem". What is the exact question?

Accelerated Approval allows faster approval of drugs for serious conditions that fill an unmet medical need. The faster approval relies on use of surrogate endpoints. Drug approval typically requires clinical trials with endpoints that demonstrate a clinical benefit, such as increased survival for cancer patients. Drugs with accelerated approval can initially be tested in clinical trials that use a surrogate endpoint, or something that is thought to predict clinical benefit. Surrogate endpoints typically require less time, and in the case of a cancer patient, it is much faster to measure a reduction in tumor size, for example, than overall patient survival. Drugs approved under the FDA Accelerated Approval Program still need to be tested in clinical trials using endpoints that demonstrate clinical benefit, and those trials are known as phase 4 confirmatory trials. If the drug later proves unable to demonstrate clinical benefit to patients, the FDA may withdraw approval. The accelerated approval process got its start during the height of the AIDS epidemic.

Human Testing - Guinea Pigs - Errors - Over Doses - Biased Research

Fast Track is a designation by the United States Food and Drug Administration or FDA of an investigational drug for expedited review to facilitate development of drugs that treat a serious or life-threatening condition and fill an unmet medical need. Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and attempt to make a decision within sixty days. A fast track eligible drug must show some advantage over available treatment, such as: Showing superior effectiveness, Avoiding serious side effects of an available treatment, Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome, Decreasing a clinically significant toxicity of an available treatment, Addressing an expected public health need.

Confirmatory Trial is an adequately controlled trial where hypotheses are stated in advance and evaluated according to a protocol. This type of trial may be implemented when it is necessary to provide additional or firm evidence of efficacy or safety. The mechanism of the trial implements a key hypothesis of interest which is rigorously tested at the end of the confirmatory trial and directly follows the predefined primary objective of the trial. Of importance in a confirmatory trial is the process of estimating with due precision potential effects attributable to the treatment, the quantity of effects and relating these effects to their clinical significance. According to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: "Confirmatory Trials are intended to provide firm evidence in support of claims and hence adherence to protocols and standard operating procedures is particularly important; unavoidable changes should be explained and documented, and their effect examined." Basic outline of the process of a confirmatory trial. A design justification and statistical aspects such as the principal features of the planned analysis, is established as part of the initial protocol. The confirmatory trial should be concise in addressing only a specific number of questions. The confirmatory trial should clarify key clinical questions relevant to efficacy and/or safety clearly and definitively. The target patient population segmented for the trial is clearly outlined, understood and defined as this may influence the test sites and scientists (practitioners, specialists, etc.) involved. Orphan Drugs.

Drugmakers are slow to prove medicines that got a fast track to market really work. Faster approval and false hope. When there's an urgent need, the agency can grant what's known as an accelerated approval for a drug, like Clolar, based on preliminary evidence. In the FDA's approval of Clolar, the agency noted there were no gold-standard clinical studies to show whether the drug prolonged patients' lives or improved their health. In exchange for the accelerated approval, the drugmaker, Genzyme, agreed to do definitive follow-up studies to prove that Clolar really worked. But while that work was pending, the company was free to keep selling the drug. But for nearly 18 years on the market, Clolar's most important confirmatory clinical trial remained incomplete. The confirmatory trials FDA requires are meant to show either that the drugs were rightly fast-tracked and should stay on the market or that the original decisions were wrong and the drugs should be withdrawn. But many studies aren't getting done. And in some cases they aren't starting at all. That means many drugs that made it to market with an accelerated approval are being used – sometimes for years – without patients, doctors or regulators knowing if they really work. NPR analyzed 30 years of FDA and National Institutes of Health data and found that 42% of currently outstanding confirmatory studies, or 50 of them, either took more than a year to begin following accelerated approval or hadn't started at all. Nineteen of those required studies still haven't started three years or more after accelerated approval. Four of them haven't started more than ten years later.

Results Of Many Clinical Trials Not Being Reported

Only 13 percent of scientists running clinical trials had reported their results. Not All Trials are Published.

Clinical Trials (wiki) - Clinical Trials (gov) - Regulations (gov) - Under-Reporting

50% of Academic Papers are Never Read - Publication Bias.

Systematic Review are a type of literature review that uses systematic methods to collect secondary data, critically appraise research studies, and synthesize findings qualitatively or quantitatively. Systematic reviews formulate research questions that are broad or narrow in scope, and identify and synthesize studies that directly relate to the systematic review question. They are designed to provide a complete, exhaustive summary of current evidence, published and unpublished, that is "methodical, comprehensive, transparent, and replicable." An understanding of systematic reviews and how to implement them in practice is highly recommended for professionals involved in the delivery of health care, public health, and public policy. Systematic reviews of randomized controlled trials are key to the practice of evidence-based medicine, and a review of existing studies is often quicker and cheaper than embarking on a new study. Contrastingly, systematic reviews of observational studies rank lower in the evidence-based hierarchy. However, another important factor that impacts the quality of the evidence is the accuracy of the methodological design and execution of the systematic review carried out by the authors. While systematic reviews are often applied in the biomedical or healthcare context, they can be used in other areas where an assessment of a precisely defined subject would be helpful. For example, systematic reviews are becoming increasingly common in management, accounting and finance. Systematic reviews may examine clinical tests, public health interventions, environmental interventions, social interventions, adverse effects, and economic evaluations. Intervention reviews assess the benefits and harms of interventions used in healthcare and health policy. Diagnostic test accuracy reviews assess how well a diagnostic test performs in diagnosing and detecting a particular disease. Methodology reviews address issues relevant to how systematic reviews and clinical trials are conducted and reported. Qualitative reviews synthesize qualitative and quantitative evidence to address questions on aspects other than effectiveness. Prognosis reviews address the probable course or future outcome(s) of people with a health problem. Overviews of Systematic Reviews are a new type of study in order to compile multiple evidence from systematic reviews into a single document that is accessible and useful to serve as a friendly front end for the Cochrane Collaboration with regard to healthcare decision-making. Peer Review.

Sharing Clinical Trial Data - Sharing Clinical Trial Data (PDF)

Yale Open Data Access Project - Journal Impact Factors - Wok Info

Databases (information management)

Discontinuation and Nonpublication of Randomized Clinical Trials Conducted in Children.

Open Science

Open Science is the movement to make scientific research, data and dissemination accessible to all levels of an inquiring society, amateur or professional. It encompasses practices such as publishing open research, campaigning for open access, encouraging scientists to practice open notebook science, and generally making it easier to publish and communicate scientific knowledge.

Open Science Data is a type of open data focused on publishing observations and results of scientific activities available for anyone to analyze and reuse. DIY Science.

Center for Open Science increases openness, integrity, and reproducibility of scholarly research.

Science Commons was a Creative Commons project for designing strategies and tools for faster, more efficient web-enabled scientific research. The organization's goals were to identify unnecessary barriers to research, craft policy guidelines and legal agreements to lower those barriers, and develop technology to make research data and materials easier to find and use. Its overarching goal was to speed the translation of data into discovery and thereby the value of research.

Web of Science is an online subscription-based scientific citation indexing service maintained by Thomson Reuters that provides a comprehensive citation search. It gives access to multiple databases that reference cross-disciplinary research, which allows for in-depth exploration of specialized sub-fields within an academic or scientific discipline.

Open Data (sharing data) - Open Source (education) - Internet (connecting minds)

Citizen Science - DIY Chemistry

Citizen Science is scientific research conducted, in whole or in part, by amateur or nonprofessional scientists. Citizen science is sometimes described as "public participation in scientific research", participatory monitoring and participatory action research.

Independent Scientist is a financially independent scientist who pursues scientific study without direct affiliation to a public institution such as a university or government-run research and development body. An independent scientist has the advantage of eliminating a number of inconveniences such as teaching obligations, administrative duties, and writing grant requests to funding bodies. It also permits the scientist to have greater control over research directions, as funding bodies direct grants towards interests that may not coincide with that of the scientist. Furthermore, intellectual property of the inventions belongs to the inventor and not the employer. Modern science requires competence and may require access to scientific equipment. However, independent scientists may have past careers as funded scientists, cooperate with funded colleagues, obtain partial equipment-only grants or choose directions where the most expensive resource required is the researcher's time. If the research succeeds, independent scientists may publish results in the same peer-reviewed journals as funded scientists do. Scientists may choose to work on unusual projects with high risk of failure also when the grant system does not fund them. A scientist could be attributed the status of independent scientist if they work on such projects during a gap between two academic positions, for example.

Independent Scholar is anyone who conducts scholarly research outside universities and traditional academia. Open Science.

Independent Study provides a way for well-motivated students to pursue a topic of interest that does not necessarily fit into a traditional academic curriculum. They are a way for students to learn specialized material or gain research experience. And also provide students opportunities to explore their interests deeper and make important decisions about how and where they will direct their talents in the future. Another way to understand independent study is to understand learning from a distance. Learning from a distance is a theory in which the student is at a physical or a mental distance from his or her teacher. The student and the teacher are connected by something such as a worksheet, an essay, or through a website on the internet.

DIY Science Tools - DIY Biology - Self Directed Learning - DIY Resources

We should be thankful to ordinary people who have educated themselves enough in order to examine the world. Though we can't say that people experimenting on their own is more dangerous then the main stream pharmaceutical industry, but there are still many dangers. When we can all get together and share our notes, and share what we have learned, we won't waste so much time and resources, or kill lots of people unnecessarily. This is another reason why improving education is so important. We have learned a lot, now it's time to put what we have learned into practice. Research Resources.

Hackers on Planet Earth features talks, workshops, demonstrations, tours, and movie screenings.

Four Thieves Vinegar is a volunteer network developing DIY medical technologies and medicines.

Don't take that Pill

Pill Testing is a process used to identify substances contained within a pill, usually illicit substances. With the increased prevalence of drugs being available in their pure forms, the terms "reagent testing" may also be used, with the reagents referred to in context simply as "reagent test kits".

Substance Test Kits - Ez Test Kits

What's In My Baggie? (youtube / 60 mins.)
What's in my baggie website
Britain's Illegal Rave Renaissance: LOCKED OFF (vice) (youtube 37 mins.).

Reagent Testing is used as a simple spot-test to presumptively identify alkaloids as well as other compounds. It is composed of a mixture of formaldehyde and concentrated sulfuric acid, which is dripped onto the substance being tested.

Adulterant is a pejorative term for a substance found within other substances such as food, fuels or chemicals even though it is not allowed for legal or other reasons. Adulterated drugs and devices (21 U.S. Code § 351)

Just because a drug is legal or pure does not mean that it's safe.

Synthetic cannabinoids creates dangers coming from cannabinoid abuse. It's not a soft drug without dangerous health effects if it's abused or over used.

Australian Teens Recreate Key Ingredient in 'Pharma Bro' Drug for Just $20 A group of Australian teenagers have cheaply created the active ingredient in the drug Daraprim, which “Pharma Bro” Martin Shkreli hiked the cost of by 5,500 percent. Sydney Grammar students recreated 3.7 grams of Pyrimethamine, the active ingredient in the drug used to treat parasitic infection in patients with weakened immune systems.

The Deep Web Drug Lab

Designer Drugs is a structural or functional analog of a controlled substance that has been designed to mimic the pharmacological effects of the original drug, while avoiding classification as illegal and/or detection in standard drug tests.

Mephedrone is a synthetic stimulant drug of the amphetamine and cathinone classes. Slang names include drone, M-CAT, White Magic and meow meow. It is chemically similar to the cathinone compounds found in the khat plant of eastern Africa. It comes in the form of tablets or a powder, which users can swallow, snort or inject, producing similar effects to MDMA, amphetamines and cocaine.

Legally High with Doctor Z (video)
Testing Legal Highs could Save Lives

Biopharmaceutical is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, they include vaccines, blood, blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living cells used in cell therapy. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living cells or tissues. They (or their precursors or components) are isolated from living sources—human, animal, plant, fungal, or microbial.

Magic Mushrooms

Designer Drugs gives us more insight on how drugs can be customized towards the individual. But it shouldn't just be about getting high, it should be just enough of the drug to let the brain explore these new chemical compounds and explore the effects on the thinking pathways of the brain. Some drugs might reveal something beneficial, and other times reveal nothing beneficial at all. Drugs should be a temporary adjustment that reveals the persons own natural ability to feel good, and at the same time give the person a short period of time to analyze the world from a different perspective. Showing the person another way of thinking, maybe a more suitable way of processing the information, knowledge and experiences that they have accumulated in life. And once you have learned this, there should be no need for the drug, because now you can repeat the benefits of the drug yourself.  The drug should be just a way of showing you how. But most people can't understand this, another reason why improving education is so important.

"An undisciplined mind, along with the lack of knowledge, always leads to some form of abuse, whether sought or unsought."

"Designer drugs have promise, but we also have all kinds of natural drugs and herbs that we can examine and use."

Science didn't understand my kids' rare disease until I decided to study it: Sharon Terry (video and interactive text). Terry explains how she and her husband became citizen scientists, working midnight shifts at the lab to find the gene behind PXE and establishing mandates that require researchers to share biological samples and work together.

Artificial Leaf as Mini-Factory for Medicine

Genetic Alliance BioTrust holds the space for individuals, families, and communities to participate in translational research. The revolution in health will only happen in a trust environment with people at the heart of it. BioTrust examines and creates policies, and provides novel tools for participants to actively engage in research. The BioTrust Ethics Team, together with the Genetic Alliance Institutional Review Board, provides oversight.

DSM - Diagnostic and Statistical Manual of Mental Disorders

Diagnostic and Statistical Manual of Mental Disorders is a publication by the American Psychiatric Association for the classification of mental disorders using a common language and standard criteria. Disorders Chart (image).

The DSM is like a drug dealer’s training manual. It's not real science or accurate research, it's mostly a drug pushers dream. Everyone has mental disorders if you use all the so called symptoms that psychiatrists and doctors make up. Plus anyone can fake the symptoms, which leads to overprescribing of medications or just plain corrupt behavior. It's a felony to sell or use medications without prescriptions, but somehow Doctors are rarely ever arrested. Only science can fully understand what is happening to the human brain and how the brain is affected by foods, chemicals, environment and poor education. This information needs to be passed on to parents, teachers and the general public. The FDA has failed to protect the general public from bogus pharmaceutical drugs and the claims they make. The FDA is corrupt and part of the drug dealing business. We should reevaluate the responsibilities of FDA and create a more responsible agency that is incorruptible and only serves the publics best interest and not the interests of money and corporations. Parents who believe that their child has ADD or ADHD should seek out child development professionals instead of Doctors. The drugs that treat ADD or ADHD can do more harm than good. This is not to say that all Doctors are ignorant and corrupt, but too many are. This is also not saying that all people who work for the FDA are ignorant and corrupt, because there are some good people who work there.

Over Prescribing Medications - Flawed Assessments - Flawed Observations

Nosology is the branch of medical science that deals with the classification of diseases. Fully classifying a medical condition requires knowing its cause (and that there is only one cause), the effects it has on the body, the symptoms that are produced, and other factors. For example, influenza is classified as an infectious disease because it is caused by a virus, and it is classified as a respiratory infection because the virus infects and damages certain tissues in the respiratory tract. The more that is known about the disease, the more ways the disease can be classified nosologically. Nosography is a description whose primary purpose is enabling a diagnostic label to be put on the situation. As such, a nosographical entity need not have a single cause. For example, inability to speak due to advanced dementia and an inability to speak due to a stroke could be nosologically different but nosographically the same.

Research Domain Criteria aims to be a biologically-valid framework for understanding mental disorders: "RDoC is an attempt to create a new kind of taxonomy for mental disorders by bringing the power of modern research approaches in genetics, neuroscience, and behavioral science to the problem of mental illness. RDoC is in contrast to the Diagnostic and Statistical Manual of Mental Disorders maintained by the American Psychiatric Association.


Smart Drugs

There are many things that we have available that helps improve our Memory, like Exercise, Sleep, meditation, Breathing, Matcha Green Tea, Vitamins, Oils, Supplements, The Human Brain or just a Good Diet to name a few. So there are many alternatives that we have that we can research.

Modafinil is used for treatment of disorders such as narcolepsy, shift work sleep disorder, and excessive daytime sleepiness associated with obstructive sleep apnea. It has also seen widespread off-label use as a purported cognition-enhancing agent.

Neural Oscillation - Synapse

GLYX-13 is an adjunctive therapy (therapy that uses more than one medication or modality for the treatment) of treatment-resistant major depressive disorder, which is a term used in clinical psychiatry to describe cases of major depressive disorder (MDD) that do not respond adequately to appropriate courses of at least two antidepressants.

Etherium Monotomic White Gold (amazon)

Khat is a flowering plant native to the Horn of Africa and the Arabian Peninsula. Among communities from these areas, khat chewing has a history as a social custom dating back thousands of years. Khat contains a monoamine alkaloid called cathinone, an amphetamine-like stimulant, which is said to cause excitement, loss of appetite and euphoria.

Donepezil is a medication used in the palliative treatment of Alzheimer's disease.

Transcranial Random Noise Stimulation (TRNS)

Brain Food - Enhancing Cognition - Brain Maintenance

Intelligence - Study Skills - Learning Methods


The pill only makes you realize the potential that you already have. If you do take a pill, it may do more harm than good. But if you're lucky enough to have a positive experience, then thank your brain for using the chemicals effectively, and thank your brain for helping you to understand the power and potential that you already have inside you. Though it took knowledge and information to make the pill, there is no knowledge inside the pill, because the pill is not teaching you anything, it's only giving you some time to learn, and the pill will not learn for you. So the pill may only make you realize that you have an amazing ability to process knowledge and information, an ability that's inside your brain already. So you don't need more pills, you need more knowledge.

Healthy individuals run the risk of pushing themselves beyond optimal levels into hyperdopaminergic and hypernoradrenergic states, thus vitiating the very behaviors they are striving to improve. The brain doesn’t fully stop developing until age 25 or 30, making cognitive enhancement potentially risky even for users who are well into adulthood.

Adderall Abuse shows you just how incompetent our education system is. Kids who should be educated are not supposed to be ignorant about drugs. When students believe that they're getting an edge using drugs, that means they don't understand learning. And if your using something that will help you pass a test, then you have already failed yourself, what happens after the test? I'm sure you would want to keep your good memory, so what will you be doing in your lifestyle that would help maintain your good memory? And on top of that you have to remember that most testing is flawed, It does not confirm you understand the knowledge, only that you studied enough to pass a particular test. And if the test itself is not even asking the right questions, then your knowledge becomes fragmented, irrelevant and ineffective. I hope you didn't pay for that, if you did, you got ripped off.

Taking Drugs to be Smarter? I thought it was learning that made you smarter?

This reminds me of that movie Limitless where Bradley Cooper in the end of the movie says something like....."If the drug makes you smarter then eventually you should become smart enough not to need the drug at all." That of course implies that the person is learning the right things at the right time, because just having the ability to learn does not guarantee that you will learn the right things at the right time, thus you will still be ignorant. Our Schools are misleading the public, just like our Government is a lot of times.

"If you're not learning how ignorant you are, then you're not learning."

If someone has been taking Adderall for years to help them focus, that means that they have not been focusing on how not to need Adderall, or, focusing on why they would even need Adderall in the first place? Focus on that. What's the point of being interested in things if one of those things isn't you?

Be interested in yourself - Awareness

Don't Confuse Personal Perception for Reality.

Just because something is boring to you, that doesn't mean that it's important or not important. And just because something is interesting to you, that doesn't mean that the thing is important or not important. What is stimulating to one person, may be dull to another. Like adrenaline junkies, fun for some, but not for others. 

Understand the Influences of Hormones.

Dopamine signal is a pleasure signal, it does not measure worth or importance. That is why you have a brain, which is to decide what's important and when it's important. I Like something, but not because dopamine tells me that I like it. Synesthesia. I would not call Dopamine a reward circuit, but more of an enhancing circuit of coincidence. When you have to do something that's important for your health, like eating certain vegetables that you don't like, your brain will not release dopamine, mostly because dopamine is not an indicator of right, wrong, good or bad. I believe that eventually people will learn how to release dopamine only when something they are doing is calculated to be right and good. So the dopamine could help encourage positive behavior and actions. But even then, awareness of our reality must not be compromised or degraded by hormones or by any other things such as chemicals, because we'll become more vulnerable to mistakes. You can't be a slave to feeling good, when feeling good makes you a slave.

Addictions - Plants that Reduce Cravings

Reasoning controls thinking, but reasoning is a skill that requires regular updates and practicing. And reasoning itself must be reasoned with, because if you are not reasoning the things that matter, then being able to reason will not matter.

, feeling bad is not bad, it is a personal feeling and an interpretation of a particular moment, feeling bad is not a measurement of reality. Feeling Sad is OK, Feeling Good is OK, and that time and place in Between is the Balance that we need, feeling aware and connected, and having a purpose, or a goal. Think positive, but not so positive that you positively stop thinking.

Stimulant is an overarching term that covers many drugs including those that increase activity of the central nervous system and the body, drugs that are pleasurable and invigorating, or drugs that have sympathomimetic effects. Coffee.

Performance-Enhancing Substance are substances that are used to improve any form of activity performance in humans. A well-known example involves doping in sport, where banned physical performance–enhancing drugs are used by athletes and bodybuilders. Athletic performance-enhancing substances are sometimes referred to as ergogenic aids. Cognitive performance-enhancing drugs, commonly called nootropics, are sometimes used by students to improve academic performance. Performance-enhancing substances are also used by military personnel to enhance combat performance.

Nootropic are drugs, supplements, and other substances that improve cognitive function, particularly executive functions, memory, creativity, or motivation, in healthy individuals.

Amphetamine is a potent central nervous system (CNS) stimulant exists as two enantiomers: levoamphetamine and dextroamphetamine. Amphetamine properly refers to a specific chemical, the racemic free base.

Methamphetamine is a potent central nervous system (CNS) stimulant. It is rarely prescribed over concerns involving human neurotoxicity and potential for recreational use as an aphrodisiac and euphoriant, among other concerns, as well as the availability of safer substitute drugs with comparable treatment efficacy. Dextromethamphetamine is a much stronger CNS stimulant than levomethamphetamine.

Catecholamine is a monoamine, an organic compound that has a catechol (benzene with two hydroxyl side groups at carbons 1 and 2) and a side-chain amine. Catechol can be either a free molecule or a substituent of a larger molecule, where it represents a 1,2-dihydroxybenzene group. Catecholamines are derived from the amino acid tyrosine, which is derived from dietary sources as well as synthesis from phenylalanine. Catecholamines are water-soluble and are 50%-bound to plasma proteins in circulation. Included among catecholamines are epinephrine (adrenaline), norepinephrine (noradrenaline), and dopamine. Release of the hormones epinephrine and norepinephrine from the adrenal medulla of the adrenal glands is part of the fight-or-flight response. Tyrosine is created from phenylalanine by hydroxylation by the enzyme phenylalanine hydroxylase. Tyrosine is also ingested directly from dietary protein. Catecholamine-secreting cells use several reactions to convert tyrosine serially to L-DOPA and then to dopamine. Depending on the cell type, dopamine may be further converted to norepinephrine or even further converted to epinephrine. Various stimulant drugs (e.g., a number of substituted amphetamines) are catecholamine analogues.

Huperzine A is a naturally occurring sesquiterpene alkaloid compound found in the firmoss Huperzia serrata. Huperzine A has been investigated as a treatment for neurological conditions such as Alzheimer's disease, but a meta-analysis of those studies concluded that they were of poor methodological quality and the findings should be interpreted with caution. Huperzine A inhibits the breakdown of the neurotransmitter acetylcholine by the enzyme acetylcholinesterase. It is commonly available over the counter as a nutrient supplement, and is marketed as a cognitive enhancer for improving memory and concentration.

Acetylcarnitine is an acetylated form of L-carnitine. It is naturally produced by the body, although it is often taken as a dietary supplement. Acetylcarnitine is broken down in the blood by plasma esterases to carnitine which is used by the body to transport fatty acids into the mitochondria for breakdown.

Vitamin E is a group of eight fat soluble compounds that include four tocopherols and four tocotrienols. Vitamin E deficiency, which is rare and usually due to an underlying problem with digesting dietary fat rather than from a diet low in vitamin E, can cause nerve problems. The crucial function played by Vitamin E that makes it a vitamin is poorly understood, but may involve antioxidant functions in cell membranes. Other theories hold that vitamin E – specifically the RRR stereoisomer of alpha-tocopherol – act by controlling gene expression and cell signal transduction. Population studies suggested that people who consumed foods with more vitamin E, or who chose on their own to consume a vitamin E dietary supplement, had lower incidence of cardiovascular diseases, cancer, dementia, and other diseases, but placebo-controlled clinical trials could not always replicate these findings, and there were some indications that vitamin E supplementation actually was associated with a modest increase in all-cause mortality.

Placebos - The Power of the Mind

Placebo is anything of no direct medical benefit which nevertheless makes people feel better. A substance that has no therapeutic effect that is used as a control in testing new drugs. An innocuous or inert medication; given as a pacifier or to the control group in experiments on the efficacy of a drug. A harmless pill, medicine, or procedure prescribed more for the psychological benefit to the patient than for any physiological effect. A measure designed merely to calm or please someone. Placebo is Latin for "I will please".

The placebo is symbolic to the powers of the human mind. So a deep breath can be your placebo or laughing can be a placebo, a way to activate your harmonious state where ever you are, and also, to make yourself more aware of any unharmonious states that you could be experiencing, because the powers of the mind can also work against us. We still have a lot to learn. Besides showing us how ineffective some drugs are, placebos has accidentally helped us to discover some of the powers of the human mind. From research scientists have found that Positivity and Hope is beneficial to the mind and the body because under those conditions the human body releases beneficial signaling molecules that travel all around the body. And depression and stress is not beneficial to the mind and the body because under those conditions the body does not release beneficial molecules. Hypochondriac.

Brain Plasticity - Dopamine - Positive Thinking

Most common shoulder operation is no more beneficial than placebo surgery. Sham surgeries are a kind of extreme placebo, where patients undergo all the rituals and scars of a surgical procedure except for the part meant to help. These patients benefit surprisingly often: In about three-quarters of sham-controlled studies, there's some improvement, according to a 2014 review.

Sham Surgery is a faked surgical intervention that omits the step thought to be therapeutically necessary. In clinical trials of surgical interventions, sham surgery is an important scientific control. This is because it isolates the specific effects of the treatment as opposed to the incidental effects caused by Anesthesia, the incisional trauma, pre- and postoperative care, and the patient's perception of having had a regular operation. Thus sham surgery serves an analogous purpose to placebo drugs, neutralizing biases such as the placebo effect.

Patients who knowingly took placebos reported 30 percent less Pain and 29 percent reduction in disability compared to control group.

Sugar Pills Relieve Pain for Chronic Pain Patients. Placebo benefits can be predicted by brain anatomy and psychological traits. Someday doctors may prescribe sugar pills for certain chronic pain patients based on their brain anatomy and psychology. And the pills will reduce their pain as effectively as any powerful drug on the market, according to new research. Scientists have shown they can reliably predict which chronic pain patients will respond to a sugar placebo pill based on the patients' brain anatomy and psychological characteristics.

Convincing yourself that you slept well tricks your brain into thinking that you did. It's called “Placebo Seep”.

Iceman Wim Hof is able to influence his autonomic nervous system and immune system at will. Focus - Controls.

Don't confuse the placebo effect with having confidence or having willpower.

Can the human brain imitate the effects of a drug just by knowing how and why the drug works?

Smart Drugs (not so smart)

"Anything drugs can do I can do better; I can do anything better than drugs."

Why are placebos sometimes more effective and safer then the actual drug? Is the power of the mind being under estimated and under utilized? Is faith healing just more proof that the power of the mind is real? Is believing in miracles prove that the power of the mind is real? 

How we perceive things can change how we feel about things - Beliefs.

Faith Healing is the ritualistic practice of prayer and gestures (such as laying on of hands) that are claimed to elicit divine intervention in spiritual and physical healing, especially the Christian practice. Believers assert that the healing of disease and disability can be brought about by religious faith through prayer and/or other rituals that, according to adherents, stimulate a divine presence and power. Belief in such divine intervention is derived from religious belief.

Self-Fulfilling Prophecy is the sociopsychological phenomenon of someone "predicting" or expecting something, and this "prediction" or expectation coming true simply because the person believes it will. and the person's resulting behaviors aligning to fulfill the belief. This suggests that people's beliefs influence their actions. The principle behind this phenomenon is that people create consequences regarding people or events, based on previous knowledge of the subject. A self-fulfilling prophecy is applicable to either negative or positive outcomes.

Miracle is an event not explicable by natural or scientific laws. Such an event may be attributed to a supernatural being (a deity), magic, a miracle worker, a saint or a religious leader. Coincidence.

Could certain miracles where people are mysteriously healed just be a placebo effect?

Psychosomatic Medicine is an interdisciplinary medical field exploring the relationships among social, psychological, and behavioral factors on bodily processes and quality of life in humans and animals. Some physical diseases are thought to be particularly prone to be made worse by mental factors such as stress and anxiety.

Hypochondriasis - Paranoid - Ruminate

Spontaneous Remission is an unexpected improvement or cure from a disease that usually progresses. These terms are commonly used for unexpected transient or final improvements in cancer. Spontaneous remissions concern cancers of the haematopoietic system (blood cancer, e.g. leukemia), while spontaneous regressions concern palpable tumors; however, both terms are often used interchangeably.

Functional Symptom in an individual which is very broadly conceived as arising from a problem in nervous system 'functioning' and not due to a structural or pathologically defined disease cause. Functional symptoms are increasingly viewed within a framework in which psychological, physiological and biological factors should be considered to be relevant.

Feeling younger buffers older adults from stress, protects against health decline. People who feel younger have a greater sense of well-being, better cognitive functioning, less inflammation, lower risk of hospitalization and even live longer than their older-feeling peers. A study suggests one potential reason for the link between subjective age and health: Feeling younger could help buffer middle-aged and older adults against the damaging effects of stress.

Biomedicine is a branch of medical science that applies biological and physiological principles to clinical practice. The branch especially applies to biology and physiology. Biomedicine also can relate to many other categories in health and biological related fields. It has been the dominant health system for more than a century.

Medicineless Hospital - Additives - Holistic Medicine

Glucose metabolism responds to perceived sugar intake more than actual sugar intake. Psychological processes may influence biochemical processes, temporarily.

Placebo: Cracking the Code (youtube 12/9/2002) 

Lissa Rankin MD : Is There Scientific Proof We Can Heal Ourselves? at TEDxAmericanRiviera 2012 (video)

Natural Mystery: mind over body 1/3 (video)  investigations into the power of mind over the body. touches on many subjects including self healing (incl. cancer, heavy burns), hypnosis, kung fu, deep free diving, anesthetic free operations, mental exercise.

Placebo Effects of Caffeine on Cycling Performance.

Scientists have identified for the first time the region in the brain responsible for the "placebo effect" in pain relief.

Latrogenesis refers to any effect on a person, resulting from any activity of one or more persons acting as healthcare professionals or promoting products or services as beneficial to health, that does not support a goal of the person affected.

Polywater was a hypothesized polymerized form of water that was the subject of much scientific controversy during the late 1960s. By 1969 the popular press had taken notice and sparked fears of a "polywater gap" in the USA. Water Memory.

Toxoplasmosis is a parasitic disease caused by Toxoplasma gondii. Infections with toxoplasmosis usually cause no symptoms in adult humans. Occasionally there may be a few weeks or months of mild flu-like illness such as muscle aches and tender lymph nodes. In a small number of people, eye problems may develop. In those with a weak immune system, severe symptoms such as seizures and poor coordination may occur. If infected during pregnancy, a condition known as congenital toxoplasmosis may affect the child.

What's in a Placebo? Drug companies manufacture their own placebos and they are not required to list the ingredients. An active placebo is one that is biologically active, rather than inert. Active placebos are designed to mimic the side-effects of drugs under study.

The Human Brain is a Chemical Warehouse, so we don't need more drugs, we need more education and more awareness. Drugs manipulate the auto-pilot or natural functions of the brain, but drugs do not teach us how to manually control our brain, unless the drug was used to direct us towards a particular process, so that we can eventually learn how to control it on our own. 

Endocrine System - Hormones - Emotions

Hypothalamus - Thalamus - Tiny Machines

Peptide are biologically occurring short chains of amino acid monomers linked by peptide (amide) bonds.

Knowledge is a Placebo. When love hurts, a placebo can help. Just believing you’re doing something to help yourself get over your ex can influence brain regions associated with emotional regulation and lessen the perception of pain.

Mind over Body. Our brains are at the top of the body to remind us of mind over matter. The mind must be the hierarchy. The body effects the mind, so the mind must know the difference between what is happening in the body and what is happening in the brain. You don't want the body to control your thinking, but you don't want to ignore the body either. You have to accurately interpret the messages coming from your body, without having the messages effect your thinking ability, because then it will be almost impossible to know what is happening to your body, or to your mind. Our bodies and minds are sensitive because they have to be in order to sense changes that might be a danger to us. But because the mind is sensitive, we have to take extra care not to get confused between what's happening in the body and what's happening in the mind. It's usually the body, but if you don't understand the differences, then you will not be able to accurately analyze the true nature of what is happening in your body, or your mind.

People who have multiple personalities have diseases related to one personality but not the other personality. So one personality is fine, while the other personality suffers from a disease.

Placebo effect can also work against you. When you worry or when you believe that bad things will happen to you, your body will feel this stress in a negative way, and you will not benefit from your thinking.

Nocebo is when a negative expectation of a phenomenon causes it to have a more negative effect than it otherwise would. A nocebo effect causes the perception that the phenomenon will have a negative outcome to actively influence the result. Mental states such as beliefs, expectations and anticipation can strongly influence the outcome of: disease; experience of pain; and even success of surgery. Positive expectations regarding a treatment can result in more positive outcomes and this effect is known as the placebo effect.

Red Pill or Blue Pill? - Pessimism - Worry - Anxiety

Losing Sleep (side effects)

Sudden Unexpected Death Syndrome is sudden unexpected death of adolescents and adults, mainly during sleep. Sudden unexpected death syndrome is rare in most areas around the world.

Pharmaceutical Drugs in Public Drinking Water

A vast array of pharmaceuticals have been found in the Drinking Water supplies of at least 41 million Americans, including antibiotics, Anti-convulsants, Mood Stabilizers and Sex Hormones. (an Associated Press investigation).

Traces of Drugs in Drinking Water - Pharmaceuticals in Drinking Water (PDF)

EPA does not have any guidelines about pharmaceuticals in drinking water.

Damage to the Brain and Body (Body Burden)

Nanomedicine (nano particles)

Pharmaceutical Drug Pollution Concentrates in stream bugs, passes to predators in water and on land. Animals that eat insects in or near streams at risk of being dosed with pharmaceuticals. Sixty-nine pharmaceutical compounds have been detected in stream insects, some at concentrations that may threaten animals that feed on them, such as trout and platypus. When these insects emerge as flying adults, they can pass drugs to spiders, birds, bats, and other streamside foragers.

Pharmaceutical Residues in Fresh Water pose a growing Environmental Risk. Over the past 20 years, concentrations of pharmaceuticals have increased in freshwater sources all over the world, as research by environmental experts has revealed. Levels of the antibiotic ciprofloxacin have reached the point of potentially causing damaging ecological effects.

About 90% of the drug is metabolized. Others aren’t Metabolized as much, and a lot of the parent compound is excreted. The undigested drugs and metabolites, the digested drugs, are either removed from the body as waste or sweat. These are either flushed down toilets are go down the drain in our showers.

Drug Metabolism is the metabolic breakdown of drugs by living organisms, usually through specialized enzymatic systems. More generally, xenobiotic metabolism (from the Greek xenos "stranger" and biotic "related to living beings") is the set of metabolic pathways that modify the chemical structure of xenobiotics, which are compounds foreign to an organism's normal biochemistry, such any drug or poison. These pathways are a form of biotransformation present in all major groups of organisms, and are considered to be of ancient origin. These reactions often act to detoxify poisonous compounds (although in some cases the intermediates in xenobiotic metabolism can themselves cause toxic effects). The study of drug metabolism is called pharmacokinetics. The metabolism of pharmaceutical drugs is an important aspect of pharmacology and medicine. For example, the rate of metabolism determines the duration and intensity of a drug's pharmacologic action. Drug metabolism also affects multidrug resistance in infectious diseases and in chemotherapy for cancer, and the actions of some drugs as substrates or inhibitors of enzymes involved in xenobiotic metabolism are a common reason for hazardous drug interactions. These pathways are also important in environmental science, with the xenobiotic metabolism of microorganisms determining whether a pollutant will be broken down during bioremediation, or persist in the environment. The enzymes of xenobiotic metabolism, particularly the glutathione S-transferases are also important in agriculture, since they may produce resistance to pesticides and herbicides. Drug metabolism is divided into three phases. In phase I, enzymes such as cytochrome P450 oxidases introduce reactive or polar groups into xenobiotics. These modified compounds are then conjugated to polar compounds in phase II reactions. These reactions are catalysed by transferase enzymes such as glutathione S-transferases. Finally, in phase III, the conjugated xenobiotics may be further processed, before being recognised by efflux transporters and pumped out of cells. Drug metabolism often converts lipophilic compounds into hydrophilic products that are more readily excreted.

Scientists Warn that River Systems around the World are Polluted with Pharmaceutical Waste. Analgesics, antibiotics, anti-platelet agents, hormones, psychiatric drugs, and antihistamines. More than 10,000 km of rivers around the world had concentrations of diclofenac that were above the EU "watch list" limit of 100 nanograms per liter. More than 2,400 tonnes of diclofenac is consumed every year, with several hundred tonnes remaining in human waste and only a small fraction of that, around 7 percent, is filtered out by treatment plants. Another 20 percent is absorbed into the ecosystem and the rest of the waste ends up in the oceans. Pharmaceuticals are a special class of micro-pollutants - when present at low concentrations they can be potent pollutants in the environment.

Mapping international drug use through the world's largest wastewater study. A seven-year project monitoring illicit drug use in 37 countries via wastewater samples shows that cocaine use was skyrocketing in Europe in 2017 and Australia had a serious problem with methamphetamine.

Possible Effects of Pharmaceuticals, including Antibiotics, in surface Waters (youtube)

What is vaccine-derived polio? A: Oral polio vaccine (OPV) contains an attenuated (weakened) vaccine-virus, activating an immune response in the body. When a child is immunized with OPV, the weakened vaccine-virus replicates in the intestine for a limited period, thereby developing immunity by building up antibodies. During this time, the vaccine-virus is also excreted. In areas of inadequate sanitation, this excreted vaccine-virus can spread in the immediate community (and this can offer protection to other children through ‘passive’ immunization), before eventually dying out. On rare occasions, if a population is seriously under-immunized, an excreted vaccine-virus can continue to circulate for an extended period of time. The longer it is allowed to survive, the more genetic changes it undergoes. In very rare instances, the vaccine-virus can genetically change into a form that can paralyse – this is what is known as a circulating vaccine-derived poliovirus (cVDPV). It takes a long time for a cVDPV to occur. Generally, the strain will have been allowed to circulate in an un- or under-immunized population for a period of at least 12 months. Circulating VDPVs occur when routine or supplementary immunization activities (SIAs) are poorly conducted and a population is left susceptible to poliovirus, whether from vaccine-derived or wild poliovirus. Hence, the problem is not with the vaccine itself, but low vaccination coverage. If a population is fully immunized, they will be protected against both vaccine-derived and wild polioviruses.

Water Knowledge - Fluoride Dangers.

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